Biodegradable Nanofiber Sleeve for Drug Delivery

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Solution Overview

Problem

Current stent and balloon catheter technologies for treating hollow organs, such as blood vessels, often cause mechanical irritation, clot formation, and restenosis due to material thrombogenicity and mechanical stress, necessitating anticoagulant medication with side effects, and struggle to deliver therapeutic agents effectively for extended periods.

Innovation Solution

A tubular fleece structure made from biodegradable polymer nanofibers is used as an active substance carrier that unfolds within the hollow organ, providing a controlled release of medicinal agents over a predetermined period, reducing mechanical irritation and thrombogenicity while adhering to the organ wall to prevent clot formation and promote healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If conventional stents are used to support hollow organs, then mechanical support is provided, but thrombosis and mechanical irritation occur

Engineering Contradiction:
Improvemechanical supportVSAvoidthrombosis and mechanical irritation
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameters from conventional metals and polymers to biodegradable polymers with controlled degradation rates. The stent material transitions from permanent to temporary support, degrading over periods ranging from weeks to months, thereby reducing long-term thrombogenicity and mechanical irritation while maintaining necessary mechanical support during the critical healing period

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements a discarding principle where the stent is designed to be biodegraded and absorbed by the body after fulfilling its temporary mechanical support function. The biodegradable polymer structure gradually breaks down into biocompatible byproducts that are metabolized and eliminated, eliminating the need for permanent foreign body implantation that causes chronic irritation and thrombosis

Inventive Principle:
Principle #34Discarding and recovering

2Productivity

If balloon catheter inflation is used to dilate constrictions, then vessel opening is achieved, but mechanical injury and restenosis occur

Engineering Contradiction:
Improvevessel dilation effectivenessVSAvoidmechanical injury and restenosis
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by coating the balloon catheter with therapeutic agents before inflation. The coating is pre-applied and designed to be transferred to the vessel wall during the dilation process, providing prophylactic treatment against restenosis before the mechanical injury fully develops and triggers the proliferative response

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces a coating layer as an intermediary substance between the balloon and the vessel wall. This coating acts as a mediator that modifies the interaction during dilation, delivering therapeutic agents that suppress the harmful restenotic response while allowing the necessary mechanical dilation to occur

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If antiproliferative agents are used to prevent restenosis, then vessel wall proliferation is reduced, but stent ingrowth is prevented

Engineering Contradiction:
Improverestenosis preventionVSAvoidstent ingrowth
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies dynamics by using a biodegradable coating that changes its properties over time. The coating provides antiproliferative effects initially to prevent restenosis, then gradually degrades and disappears, allowing natural stent ingrowth and endothelialization to occur in the later stages without permanent inhibition of cellular processes

Inventive Principle:
Principle #15Dynamics

4Quantity of substance

If stents are coated with polymer containing antiproliferative agents, then drug release is achieved, but homogeneous distribution and controlled duration are difficult

Engineering Contradiction:
Improvedrug deliveryVSAvoidhomogeneous distribution and controlled release duration
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent uses composite materials combining biodegradable polymer matrices with embedded therapeutic agents. The composite structure allows controlled degradation of the polymer to release the embedded drugs in a sustained manner, achieving homogeneous distribution through the coating layer and controlling the release duration through polymer selection and formulation

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes physical and chemical parameters of the coating system, including polymer molecular weight, crystallinity, hydrophobicity, and crosslinking density, to control drug release kinetics. These parameter adjustments enable precise tuning of release duration and rate while maintaining homogeneous drug distribution throughout the coating matrix

Inventive Principle:
Principle #35Parameter changes

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 tubular fleece structure effectively delivers therapeutic agents for an extended period, reducing the need for anticoagulant medication, minimizing mechanical irritation, and preventing restenosis by controlled biodegradation, ensuring a consistent drug release and reducing systemic side effects.

Implementation Method 1

the first polymer fibers are designed such that they degrade as slowly biodegradable polymer nanofibers (PL) over an adjustable period of 2 weeks to 3 months

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 2

the drug can be released to a hollow organ wall during this period

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP3922217A1Tubular non-woven structure as an active substance carrier for atraumatic treatment of hollow organs and a method for its production
Publication Date: 2021.12.15 BVS BEST VASCULAR SOLUTIONS GMBH
  • EP3922217A1 patent drawingFigure 1
  • EP3922217A1 patent drawingFigure 2
  • EP3922217A1 patent drawingFigure 3

AI summary

According to the invention, a tubular nonwoven structure serves as a drug carrier for the atraumatic treatment of hollow organs (referred to as "sleeve"), particularly applicable via a balloon catheter, and a method for its production, wherein the sleeve is folded around a longitudinal axis in an initial state and can be unfolded in a final state to conform to the inner wall of a hollow organ, wherein the tubular sleeve is formed from at least first biodegradable polymer nanofibers and the folding of the sleeve is directed as pleating around a longitudinal axis, wherein a medical drug is embedded in the first polymer nanofibers and/or arranged in spaces between the polymer nanofibers, and wherein the first polymer fibers are designed such that the polymer fibers degrade over a period of 2 weeks to 3 months, so that the drug can be released to a hollow organ wall during this period.