Degradable Scaffold for Electrospun Medical Device Coatings

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Solution Overview

Problem

Challenges in coating medical devices with electrospun materials include uneven coatings, damage to devices during the electrospinning process, and the inability of coatings to stretch, due to the use of materials and chemicals in the electrospinning process.

Innovation Solution

A method involving the formation of a degradable scaffold on the medical device's exterior surface, followed by electrospinning a polymer coating onto the scaffold, and then removing the scaffold while maintaining the coating, using degradable materials like PEG, PLGA, and ice structures to support and guide the coating application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a sacrificial scaffold is used to support the electrospun coating during application, then the coating uniformity and device protection are improved, but the process complexity and material selection constraints increase

Engineering Contradiction:
Improvecoating uniformityVSAvoidprocess complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

A sacrificial scaffold is introduced as an intermediary structure that temporarily supports the electrospun coating during the electrospinning process. The scaffold serves as a mediator between the coating material and the medical device, enabling uniform coating application while protecting the device from direct exposure to harsh chemicals. After coating completion, the scaffold is removed through dissolution or degradation, leaving the desired porous coating on the device.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The scaffold is applied to the medical device surface before the electrospinning process begins. This preliminary action prepares the surface with a temporary support structure that guides the electrospun material deposition, ensuring uniform coating formation and preventing device damage during the subsequent electrospinning operation.

Inventive Principle:
Principle #10Preliminary action

2Ease of manufacture

If degradable materials are used for the scaffold, then the scaffold removal is simplified and coating integrity is maintained, but the material selection range is limited

Engineering Contradiction:
Improvescaffold removal easeVSAvoidmaterial selection range
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The scaffold is constructed from degradable materials whose physical or chemical parameters change over time or under specific conditions. These materials can undergo dissolution, hydrolysis, or enzymatic degradation, transforming from a stable structural support into removable byproducts. This parameter change enables simplified scaffold removal while maintaining coating integrity, as the degrading scaffold material can be eliminated without disrupting the completed electrospun coating.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If traditional electrospinning is applied directly to the medical device, then the process is simple, but the device may be damaged by chemicals and the coating will be uneven

Engineering Contradiction:
Improveprocess simplicityVSAvoiddevice integrity
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The sacrificial scaffold acts as a protective intermediary between the medical device and the electrospinning chemicals. By placing the scaffold on the device surface before electrospinning, the harsh solvents and polymers are prevented from directly contacting and potentially damaging the device. The scaffold absorbs the chemical exposure while providing a template for uniform coating deposition.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

Applying the sacrificial scaffold before electrospinning is a preliminary protective measure that prevents device damage. This pre-treatment step prepares the device surface with a protective layer that will be removed after coating, ensuring both device integrity and coating uniformity without requiring complex modifications to the electrospinning process itself.

Inventive Principle:
Principle #10Preliminary 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

This method allows for uniform, gapless, and stretchable porous coatings on medical devices, protecting the devices from damage and enabling the application of desired shapes and sizes, while ensuring the scaffold's removal does not disrupt the electrospun coating.

Implementation Method 1

electrospinning a polymer to apply the porous coating on the scaffold

Methodology Applied
Scientific EffectElectrostatic deposition: Electrostatic Deposition

Implementation Method 2

removing the scaffold from the medical device while maintaining the porous coating on the medical device. Forming the scaffold comprises applying a degradable material along the exterior surface of the medical device

Methodology Applied
Scientific EffectSolvation: Solvation

Data Source

PatentEP3562524B1Degradable scaffolding for electrospinning on a medical device
Publication Date: 2021.04.07 BOSTON SCIENTIFIC SCIMED INC
  • EP3562524B1 patent drawingFigure 1
  • EP3562524B1 patent drawingFigure 2
  • EP3562524B1 patent drawingFigure 3

AI summary

Various aspects of the present disclosure are directed toward apparatuses, systems and methods that include a porous coating on a medical device. The porous coating may be formed by forming a scaffold along an exterior surface of the medical device to support the porous coating during application thereof and electrospinning a polymer to apply the porous coating on the scaffold.