Segmented Left Atrial Appendage Closure Device

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Solution Overview

Problem

Existing left atrial appendage closure devices, such as the Watchman™ device, face challenges in aligning and securing properly due to varying LAA shapes and sizes, leading to potential misfitting and device migration or dislodgement.

Innovation Solution

The development of left atrial appendage closure devices featuring a proximal occluding portion and a distal anchor portion that can be adjusted and anchored within the LAA, utilizing expandable frameworks, shape memory materials, and elastic connections to ensure secure placement and prevent migration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional single-piece pre-shaped devices are used, then the device structure is simple, but the device cannot adapt to varying LAA shapes and sizes leading to misfitting

Engineering Contradiction:
Improveadaptability to varying LAA shapes and sizesVSAvoiddevice structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple segments including a proximal portion, a distal anchor portion, and an intermediate portion with articulation joints. These segments can independently articulate and position themselves to conform to the specific geometry of the LAA, enabling adaptation to varying shapes and sizes while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates dynamic articulation joints that allow the segments to move and adjust their relative positions. This dynamic capability enables the device to adapt to different LAA geometries during deployment, transitioning from a compressed delivery state to an expanded functional state that conforms to the target anatomy.

Inventive Principle:
Principle #15Dynamics

2Reliability

If conventional devices are used, then the device is easy to deploy, but the device is difficult to align and secure properly

Engineering Contradiction:
Improvealignment and securement reliabilityVSAvoidalignment difficulty during placement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device incorporates self-aligning features including a distal anchor portion with articulation capability that can autonomously position itself within the LAA. The intermediate portion with its degrees of freedom allows the device to self-adjust and secure itself without requiring complex manual alignment procedures, improving both reliability and ease of operation.

Inventive Principle:
Principle #25Self-service

3Reliability

If conventional devices are used, then the device can be deployed through a delivery catheter, but the device may migrate or dislodge due to insufficient anchoring

Engineering Contradiction:
Improvedevice security against migration and dislodgementVSAvoidanchoring mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The anchoring function is separated into a distinct distal anchor portion that is structurally different from the proximal occluding portion. This segmented approach allows the anchor to be specifically optimized for securement while keeping the overall device design relatively simple and maintainable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The distal anchor portion incorporates articulation capability that allows it to dynamically adjust its position and orientation to achieve optimal anchoring. This dynamic anchoring mechanism provides enhanced security against migration and dislodgement while maintaining a simple deployable structure through the delivery catheter.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If a single-piece pre-shaped device is used, then the manufacturing process is simple, but the device cannot be adjusted during implantation

Engineering Contradiction:
Improveadjustability during implantationVSAvoidmanufacturing process complexity
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The device is manufactured as multiple separate segments that are assembled together during implantation. Each segment can be independently manufactured using standard processes, and the articulation joints connect them in a relatively simple manner, allowing adjustability during implantation without significantly complicating the overall manufacturing process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates dynamic articulation joints that allow adjustment during implantation. These joints are designed to be simple mechanical connections that provide the necessary degrees of freedom while maintaining ease of assembly and manufacturing.

Inventive Principle:
Principle #15Dynamics

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 solution enables improved alignment and securement of the device within the LAA, reducing the risk of misfitting and migration, thereby enhancing the effectiveness of preventing clot escape and stroke.

Implementation Method 1

The proximal and distal portions can be formed at least in part from shape memory material

Methodology Applied
Scientific EffectShape memory material: Shape Memory Alloy

Implementation Method 2

The mesh body and braided disc can be connected by an elastic member configured to pull the mesh body and braided disc toward each other

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS12016541B2Devices and methods for closing openings in tissue structures
Publication Date: 2024.06.25 TRANSMURAL SYSTEMS LLC
  • US12016541B2 patent drawing
  • US12016541B2 patent drawing
  • US12016541B2 patent drawing

AI summary

In accordance with the disclosure, devices are provided for closing an opening in tissue. The devices include a proximal portion configured and arranged to occlude the tissue opening, and a distal anchor portion configured and arranged to anchor the device in the tissue opening. If desired, the distal anchor portion can be moved proximally or distally with respect to the proximal portion during implantation. The proximal portion can be configured and arranged to fit into a left atrial appendage of a patient, and further wherein the distal anchor portion is configured and arranged to extend into the left atrial appendage.