Drug-Eluting LAA Closure Device with Rivaroxaban Coating

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Solution Overview

Problem

Current medical devices for occluding the left atrial appendage are inadequate in preventing thrombi formation and subsequent stroke risk, as they lack effective anti-thrombogenic coatings and controlled drug release profiles.

Innovation Solution

An occlusive medical device with an expandable frame and a drug eluting coating containing rivaroxaban dispersed in a polyvinylidene fluoride copolymer, which provides a controlled release rate to prevent thrombi formation while promoting endothelialization, thereby reducing the risk of stroke.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current medical devices for occluding the left atrial appendage are used, then the device structure is simple and easy to manufacture, but the device is inadequate in preventing thrombi formation and subsequent stroke risk

Engineering Contradiction:

Improvethrombi prevention effectivenessVSAvoiddevice structure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device employs a composite coating system comprising a drug-eluting layer with rivaroxaban dispersed in a polyvinylidene fluoride copolymer matrix, overlaid with a protective top coat. This multi-layer composite structure enhances thrombi prevention effectiveness while maintaining manufacturing feasibility through sequential coating processes.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The invention utilizes controlled drug release kinetics by adjusting the polymer matrix composition and coating thickness parameters. The rivaroxaban release rate is controlled to maintain therapeutic levels at the device surface, transforming the static device into a dynamically active system that adapts to the biological environment.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If a drug eluting coating with controlled release rate is applied, then thrombi formation is prevented and tissue healing is promoted, but the manufacturing process becomes more complex

Engineering Contradiction:

Improvethrombi prevention effectivenessVSAvoidcoating application complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The drug-eluting coating is applied to the device surface before implantation, pre-loading the rivaroxaban into the polymer matrix. This preliminary action ensures immediate therapeutic effect upon deployment, eliminating the need for post-implantation drug administration and simplifying the overall treatment protocol.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The polyvinylidene fluoride copolymer acts as an intermediary carrier that binds rivaroxaban and controls its release kinetics. This mediator enables sustained drug delivery without requiring complex pump or reservoir systems, maintaining ease of manufacture while achieving controlled release functionality.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If a higher concentration of pharmaceutically active component is used, then the drug release rate increases to better prevent thrombi, but the risk of excessive drug release and tissue damage increases

Engineering Contradiction:

Improvethrombi prevention effectivenessVSAvoidexcessive drug release risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention optimizes the concentration of rivaroxaban within the polymer matrix to achieve a controlled release rate that maintains therapeutic effectiveness while preventing toxic accumulation. The polymer matrix composition and coating thickness are adjusted as parameters to fine-tune the release kinetics.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The sustained release mechanism ensures continuous delivery of rivaroxaban at therapeutic levels over an extended period, maintaining constant protection against thrombi formation. This continuous action prevents both sub-therapeutic gaps and supratherapeutic peaks that could lead to treatment failure or toxicity.

Inventive Principle:

Principle #20Continuity of useful action

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 effectively inhibits thrombi formation and supports tissue healing by maintaining a controlled drug release rate, ensuring minimal tissue coverage and preventing thrombi from entering the bloodstream, thus reducing the risk of stroke.

Implementation Method 1

a drug eluting coating containing rivaroxaban dispersed in a polyvinylidene fluoride copolymer, which provides a controlled release rate

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS20250090174A1Left atrial appendage closure device with drug-eluting composition

Publication Date: 2025.03.20 BOSTON SCIENTIFIC SCIMED INC

AI summary

Medical devices as wells as methods for making and using medical devices are disclosed. An example medical device may include a left atrial appendage device. The occlusive medical device includes an expandable frame configured to shift between a first configuration and an expanded configuration and a fabric disposed along at least a portion of the expandable frame. A drug eluting coating is disposed on the fabric, the drug eluting coating including a pharmaceutically active component dispersed within a polymeric carrier.