Hollow Wire Stent Drug Loading via Solvent Extraction

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Solution Overview

Problem

Drug-eluting stents face challenges in delivering increased quantities of therapeutic agents and controlling the elution rate due to limitations in polymer coatings, which can cause adverse reactions and incomplete drug delivery.

Innovation Solution

A method and apparatus for loading a therapeutic substance into a hollow wire stent with side openings, allowing for a reverse or forward fill process using solvents or dispersion media, followed by solvent extraction to ensure only the drug remains, enabling controlled drug release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If polymer coatings are used to deliver drugs, then the drug can be delivered to the target site, but the polymer material may cause adverse reactions and the elution rate is difficult to control

Engineering Contradiction:
Improvesafety of drug deliveryVSAvoidadverse reactions from polymer material
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent removes the polymer coating entirely from the stent structure, extracting the harmful element while preserving the drug delivery function. The drug is delivered directly through the stent struts without any polymer carrier, eliminating adverse reactions associated with polymer materials.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the physical and chemical parameters of the stent struts themselves, making them porous or hollow to enable drug delivery. This parameter change allows the stent material to directly deliver the drug without requiring a separate polymer coating, thereby eliminating polymer-related adverse reactions.

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If polymer coatings are used to deliver drugs, then the drug can be administered, but the quantity of drug delivered is limited by the coating capacity and device size

Engineering Contradiction:
Improvequantity of drug deliveredVSAvoidlimitation of coating capacity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent changes the structural parameters of the stent struts to hollow or porous configurations, dramatically increasing the available volume for drug loading. This allows significantly larger quantities of drug to be delivered without increasing device complexity, as the drug is stored within the strut structure itself rather than on an external coating.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of moving object

If polymer coatings are used, then drug delivery is enabled, but the elution rate control is difficult

Engineering Contradiction:
Improveelution rate controlVSAvoiddifficulty of controlling elution rate
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The patent changes the physical structure of the stent struts to hollow or porous forms, enabling control of drug elution rate through structural parameters such as pore size, strut wall thickness, and internal volume. This provides more precise and controllable drug release kinetics compared to polymer coatings, where the elution rate is determined by the polymer's degradation or diffusion properties.

Inventive Principle:
Principle #35Parameter changes

4Length of moving object

If the lumen diameter of hollow struts is extremely small (e.g., 0.00381 cm), then the stent can be delivered through narrow vessels, but filling the lumen with drug becomes difficult

Engineering Contradiction:
Improvedeliverability through narrow vesselsVSAvoiddifficulty of filling lumen
Core Design Contradiction:
Length of moving objectVSEase of manufacture

Solution Approach 1:

The patent employs hydraulic or pneumatic pressure systems to force the drug formulation into the small-lumen hollow struts. By applying controlled pressure during the manufacturing process, the drug can be effectively pushed into the narrow spaces that would otherwise be difficult to fill, while maintaining the small lumen diameter necessary for vascular delivery.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 allows for improved control over drug delivery, increased quantities of therapeutic agents, and safer elution profiles without polymer coatings, achieving similar clinical efficacy while minimizing adverse reactions.

Implementation Method 1

The drug(s) is released by a process of diffusion through the polymer layer for biostable polymers

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentEP2616018B1Apparatus and methods for loading a drug eluting medical device
Publication Date: 2021.10.27 MEDTRONIC VASCULAR INC
  • EP2616018B1 patent drawingFigure 1~3
  • EP2616018B1 patent drawingFigure 4
  • EP2616018B1 patent drawingFigure 5

AI summary

Methods and apparatus are disclosed for loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.