Expandable Stent Drug Loading via Segmented Pores and Shield Gas

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Solution Overview

Problem

Current stent-based drug delivery systems face challenges such as restenosis, sub-optimal release profiles, mechanical trauma, inflammation, and inability to deliver sensitive drugs due to limitations in coating thickness and material compatibility, leading to incomplete healing and potential vascular complications.

Innovation Solution

The method involves loading a beneficial agent into an expandable medical device with a plurality of holes using a dispenser and a shield gas to prevent clogging, allowing for a larger volume of drug delivery and independent release profiles through layered structures, which can include barrier, therapeutic, and cap layers, enhancing drug loading and reducing mechanical stress on the stent.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If surface coating thickness is increased to improve drug release kinetics and control, then drug loading capacity increases, but stent wall thickness increases causing mechanical trauma and reduced flow cross-section

Engineering Contradiction:
Improvedrug loading capacityVSAvoidmechanical trauma to vessel wall
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The invention divides the stent structure into multiple segments by creating holes or pores within the stent wall, allowing drug loading in these cavities rather than requiring thick surface coatings. This segmentation enables drug delivery while preserving the thin-walled structure and avoiding mechanical trauma.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention nests drug-containing layers within holes or pores of the stent structure itself, creating a hierarchical arrangement where the stent wall contains cavities that contain drug layers. This nested configuration allows substantial drug loading capacity while maintaining the overall thin-walled geometry.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Duration of action of moving object

If surface coating thickness is increased to allow increased drug loading, then drug delivery duration increases, but coating vulnerability to mechanical failure increases

Engineering Contradiction:
Improvedrug delivery durationVSAvoidcoating mechanical integrity
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

By segmenting the drug delivery function into discrete holes or pores distributed throughout the stent wall, the invention avoids creating large continuous coating areas that are vulnerable to mechanical failure. Each small drug-containing cavity is mechanically more robust than a large continuous coating.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention applies different structural qualities to different regions of the stent: the bulk stent wall maintains thin-walled geometry for mechanical compliance, while localized holes or pores provide drug loading capacity. This local differentiation allows prolonged drug delivery without compromising overall coating integrity.

Inventive Principle:
Principle #3Local quality

3Quantity of substance

If surface coating is applied to deliver beneficial agents, then drug delivery is achieved, but release kinetics control is limited due to thin coating depth

Engineering Contradiction:
Improvebeneficial agent deliveryVSAvoidrelease kinetics control
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The invention transitions from two-dimensional surface coating to three-dimensional drug loading by creating holes or pores within the stent wall volume. This dimensional change provides additional space for drug layers while enabling better control over release kinetics through manipulation of cavity geometry, volume, and distribution.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 approach enables controlled and prolonged drug release, increased drug capacity, reduced mechanical trauma, and improved safety by allowing for multi-drug combinations and tailored release profiles, while minimizing inflammation and mechanical stress on the vessel wall.

Implementation Method 1

controlling a local environment surrounding a dispensing tip of the dispenser to prevent clogging of the dispenser tip by delivering a shield gas adjacent the tip

Methodology Applied
Scientific EffectGas shielding:

Data Source

PatentUS7785653B2Method and apparatus for loading a beneficial agent into an expandable medical device
Publication Date: 2010.08.31 MICROPORT CARDIOVASCULAR LLC
  • US7785653B2 patent drawing
  • US7785653B2 patent drawing
  • US7785653B2 patent drawing

AI summary

The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a support and dispensing a beneficial agent into a plurality of openings in the medical device with a shield gas for controlling a local environment surrounding the dispenser.