Hybrid Stent with Biodegradable Framework and Non-Biodegradable Struts

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Solution Overview

Problem

Existing stents for balloon angioplasty either lack sufficient mechanical strength due to being biodegradable or remain permanently in the vasculature due to being non-biodegradable, leading to re-obstruction and restenosis issues.

Innovation Solution

A hybrid stent system comprising a biodegradable framework with non-biodegradable struts, designed for intraluminal placement, where the framework is operably attached to the struts and expands during deployment, allowing the biodegradable material to degrade while the non-biodegradable struts provide structural support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a biodegradable fabric stent is used, then the stent can degrade in the vasculature, but it lacks sufficient mechanical strength to withstand shear forces

Engineering Contradiction:
Improvestent degradation timeVSAvoidmechanical strength
Core Design Contradiction:
Duration of action of stationary objectVSStrength

Solution Approach 1:

The stent is constructed as a composite structure combining biodegradable fabric material with non-biodegradable metallic struts. The fabric framework provides biodegradability while the metallic struts provide structural strength, creating a hybrid composite stent that simultaneously achieves both degradation capability and mechanical strength requirements.

Inventive Principle:
Principle #40Composite materials

2Strength

If a metallic stent is used, then the stent provides sufficient mechanical strength, but it remains permanently in the vasculature and may require retrieval

Engineering Contradiction:
Improvemechanical strengthVSAvoidstent residence time
Core Design Contradiction:
StrengthVSDuration of action of stationary object

Solution Approach 1:

The stent is segmented into two distinct functional components: a biodegradable fabric framework that will degrade over time, and non-biodegradable metallic struts that provide permanent structural support. This segmentation allows different parts of the stent to have different residence times, with the fabric portion degrading after serving its initial support function.

Inventive Principle:
Principle #1Segmentation

3Reliability

If a stent is placed to prevent re-obstruction, then the artery remains open, but the stent may cause restenosis through cell proliferation and plaque deposition

Engineering Contradiction:
Improveartery patencyVSAvoidrestenosis
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The stent design changes the temporal parameters of arterial support by providing strong mechanical support initially through the metallic struts and fabric framework, then gradually reducing support as the fabric degrades over time. This parameter change in support duration allows the artery to heal and develop its own structural integrity while preventing restenosis during the critical healing period.

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 hybrid stent system effectively reduces re-obstruction and restenosis by providing mechanical strength and eventual biodegradation, minimizing long-term vascular implantation and enhancing therapeutic delivery through coatings.

Implementation Method 1

the framework is allowed to biodegrade within the vessel

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS9056157B2Hybrid biodegradable/non-biodegradable stent, delivery system and method of treating a vascular condition
Publication Date: 2015.06.16 MEDTRONIC VASCULAR INC
  • US9056157B2 patent drawing
  • US9056157B2 patent drawing
  • US9056157B2 patent drawing

AI summary

An intraluminal stent, an intraluminal stent delivery system, and a method of treating a vascular condition. The stent includes a framework composed of a biodegradable material. At least one strut is composed of a non-biodegradable material. The framework is operably attached to the at least one strut. The delivery system includes a catheter and a stent disposed on a portion of the catheter. The stent includes a framework composed of a biodegradable material. The stent further includes at least one strut composed of a non-biodegradable material. The framework is operably attached to the at least one strut. The method includes positioning an intraluminal stent via a catheter within a vessel. The stent includes at least one strut that is composed of a non-biodegradable material and is operably attached to a framework. The framework expands during deployment of the intraluminal stent. The framework is allowed to biodegrade within the vessel.