Stent With ECM Coating and Microporous Voids

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Solution Overview

Problem

Current medical stents face challenges in maintaining luminal patency while minimizing migration and allowing for removability, as they either experience tissue ingrowth leading to re-occlusion or migration issues due to coating and design limitations.

Innovation Solution

A stent design featuring a micropatterned surface with protrusions and voids coated with an extracellular matrix material, which acts as a mucosal adhesive to secure the stent initially and promote tissue ingrowth for long-term anchorage, while being bioabsorbable to facilitate removal without trauma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stent is coated with adhesive material to prevent migration, then migration is reduced, but tissue ingrowth may lead to re-occlusion

Engineering Contradiction:
Improvestent anchorageVSAvoidtissue ingrowth causing re-occlusion
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The stent surface is segmented into multiple functional layers: a microporous polymer coating layer and an outer extracellular matrix layer. This segmentation allows the inner layer to provide adhesive anchorage while the outer layer controls tissue interaction, preventing harmful tissue ingrowth that causes re-occlusion while maintaining reliable stent positioning.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stent coating applies local quality by providing different properties at different depths: the microporous polymer layer provides adhesive properties for initial anchorage, while the outer extracellular matrix layer provides a controlled interface for tissue interaction. This localized differentiation allows simultaneous achievement of secure anchorage and prevention of harmful tissue ingrowth.

Inventive Principle:
Principle #3Local quality

2Reliability

If a stent uses a coating to maintain luminal patency, then patency is improved, but the stent becomes difficult to remove without trauma

Engineering Contradiction:
Improveluminal patencyVSAvoidstent removability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The coating materials are selected to be bioabsorbable, meaning their physical and chemical properties change over time through controlled degradation. The extracellular matrix layer and microporous polymer layer gradually break down into biocompatible products, allowing the stent to be removed without trauma while maintaining luminal patency during the absorption period.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The bioabsorbable coating acts as a temporary, disposable protective layer that fulfills its function of maintaining luminal patency and providing anchorage, then degrades completely. This allows the underlying stent to be removed without trauma, as the coating no longer provides adhesive resistance after degradation.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Ease of manufacture

If a stent uses traditional coating methods, then manufacturing is simple, but the stent cannot simultaneously achieve migration prevention and removability

Engineering Contradiction:
Improvecoating applicationVSAvoiddual function of anchorage and removability
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The stent employs a composite coating structure consisting of a microporous polymer coating layer and an outer extracellular matrix layer. This composite structure can be applied using conventional dip-coating or spray-coating methods, maintaining manufacturing simplicity while providing the dual functionality of initial adhesive anchorage and subsequent bioabsorbable degradation for trauma-free removal.

Inventive Principle:
Principle #40Composite 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 stent effectively reduces migration and allows for tissue ingrowth to maintain patency, while being removable without causing trauma, addressing the limitations of existing stent designs.

Implementation Method 1

an extracellular matrix material coating disposed over the polymeric covering and within the plurality of voids

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

applying a liquid extracellular matrix hydrogel over the polymeric covering and drying the extracellular matrix hydrogel to form an extracellular matrix material

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentUS20230248551A1Coated stent
Publication Date: 2023.08.10 BOSTON SCIENTIFIC SCIMED INC
  • US20230248551A1 patent drawing
  • US20230248551A1 patent drawing
  • US20230248551A1 patent drawing

AI summary

An implantable medical device may comprise an elongated tubular body having a scaffolding forming a plurality of cells. A polymeric covering may be disposed over at least a portion of the stent. The covering may include a plurality of voids formed in an outer surface thereof. An extracellular matrix material coating may be disposed over the polymeric covering and within the plurality of voids.