Bioabsorbable Stent with Mixed Material Apices for Vessel Protection

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Solution Overview

Problem

Conventional stents, while effective in the short term, can cause vessel weakening and long-term complications due to prolonged pressure and retention of metal materials, and biodegradable stents often compromise on performance characteristics.

Innovation Solution

A stent design featuring a radially compressible annular ring with apex portions made of spring material and struts partially or fully made of biodegradable material, allowing for controlled degradation and increased flexibility, maintaining performance while reducing long-term pressure and foreign material retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a stent is made from metal or metal alloy to provide significant opening force and reliable performance, then the expansion force and structural strength are improved, but long term pressure against the vessel wall causes vessel stretching, straightening, and weakening

Engineering Contradiction:
Improveexpansion forceVSAvoidvessel weakening
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by transitioning the stent material from non-biodegradable metal to biodegradable materials (such as poly-L-lactide, poly-D-lactide, or their copolymers) that change their mechanical properties over time. The stent maintains sufficient strength during the critical healing period and then gradually degrades, allowing the vessel to return to its natural state without long-term foreign body presence.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements dynamics through the time-dependent degradation behavior of the biodegradable stent. The stent structure evolves from a rigid, high-strength state during deployment and healing to a gradually softening state as the material degrades via hydrolysis and enzymatic breakdown, ultimately becoming fully resorbed by macrophages and osteoclasts.

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If a stent is made from biodegradable material to reduce long term foreign material retention, then vessel weakening is reduced, but the stent does not have the same performance characteristics as metal stents

Engineering Contradiction:
Improveforeign material retentionVSAvoidperformance characteristics
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent employs composite materials by combining biodegradable polymer matrices with reinforcing elements such as metal meshes, ceramic coatings, or natural fiber reinforcements. This composite structure provides the initial mechanical strength and radial support needed for vessel patency while maintaining the biodegradable nature of the stent, allowing gradual degradation without sacrificing critical performance characteristics during the healing period.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent applies local quality by creating stents with non-uniform material distribution, such as varying the crystallinity, molecular weight, or cross-linking density in different regions of the stent. This allows different parts of the stent to degrade at different rates, with the structure maintaining strength where needed while allowing degradation in other areas, thereby optimizing both performance and biodegradability.

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If a stent is designed to be fully biodegradable to eliminate long term pressure effects, then vessel stretching and straightening are prevented, but the stent may lose structural integrity before complete degradation

Engineering Contradiction:
Improvevessel stretchingVSAvoidstructural integrity
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent applies preliminary action through pre-deployment treatments such as balloon expansion, self-expansion mechanisms, or shape memory alloy activation that establish the stent's radial configuration and mechanical strength before degradation begins. The stent is designed to achieve its full structural integrity and provide immediate vessel support upon deployment, with degradation processes initiated only after the vessel has healed and stabilized.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements beforehand cushioning by incorporating degradation delay mechanisms such as protective coatings, cross-linked polymer networks, or crystalline structures that slow down the degradation process. These features act as a cushion, maintaining structural integrity during the critical early healing period and then gradually transitioning to degradation mode once the vessel has sufficiently recovered.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 stent achieves significant expansion force similar to non-biodegradable stents while gradually reducing pressure and foreign material presence, mitigating adverse long-term vessel effects and allowing for natural vessel changes.

Implementation Method 1

the apex portions are made from a first material being a spring material

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

at least one of the struts is formed from or includes a second material being a biodegradable material

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS8888839B2Bioabsorbable stent and implantable medical device
Publication Date: 2014.11.18 COOK MEDICAL TECHNOLOGIES LLC
  • US8888839B2 patent drawing
  • US8888839B2 patent drawing
  • US8888839B2 patent drawing

AI summary

A stent assembly (10) is formed with a plurality of stent rings (12) which have sections (16, 18, 24) which are of a non-biodegradable material and struts and tie bars (20, 14) which are at least partially biodegradable. The stent ring (12) thus partially biodegrades in a patient over time. The structure is such that the apices (16, 18, 24) of the stent ring (12) are of a non-biodegradable material and thus able to behave as a conventional non-biodegradable stent, that is with the same flexibility and expansion force consistent with such stent rings. Parts (34, 44) of the stent ring (12) will degrade in time, thereby reducing the restoring force produced by the stent ring (12) and reducing the amount of foreign material retained within a patient's body. In one embodiment, the stent ring (12) will separate into individual components after a period.