Vascular Casted Prostheses Using Biodegradable PGS-PCL Composites

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Solution Overview

Problem

Conventional tissue prostheses often cause harsh biological responses, intimal hyperplasia, and mechanical incompatibility, leading to complications such as inflammation, infection, and vessel failure, due to their non-biodegradable nature and inadequate vessel securing mechanisms.

Innovation Solution

Development of bioremodelable vascular casted constructs infused with a biomaterial composition, specifically using sterilized acellular ECM material from mammalian sources and poly(glycerol sebacate) (PGS) with biocompatible poly(ε-caprolactone) (PCL), which includes biologically active agents and pharmacological agents to promote tissue regeneration and modulate healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional non-biodegradable prosthetic materials are used, then mechanical strength and structural stability are maintained, but harsh biological responses, inflammation, and intimal hyperplasia occur

Engineering Contradiction:
Improvestructural stabilityVSAvoidbiological response
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from non-biodegradable to biodegradable, specifically using poly(glycerol sebacate) (PGS) and poly(ε-caprolactone) (PCL) polymers that degrade over time. This parameter change resolves the contradiction by allowing the prosthesis to provide mechanical support when needed and then gradually degrade to eliminate long-term foreign body responses, inflammation, and intimal hyperplasia while maintaining structural stability during the critical healing period

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials combining PGS and PCL polymers in specific ratios to achieve optimal balance between mechanical strength and biodegradability. This composite approach allows tuning of degradation rate and mechanical properties to match tissue healing timelines, providing structural stability initially while progressively reducing biological harm as the composite degrades and is replaced by native tissue

Inventive Principle:
Principle #40Composite materials

2Object-affected harmful factors

If bioabsorbable and biodegradable materials are used, then biological compatibility is improved, but the materials break down at a faster rate than desirable and form large rigid fragments

Engineering Contradiction:
Improvebiological responseVSAvoiddegradation rate
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The patent adjusts the degradation rate parameter by selecting specific polymer compositions (PGS and PCL) and controlling their molecular weight, crystallinity, and crosslinking density. These parameter changes enable the material to degrade at a controlled rate that matches tissue healing, preventing both premature failure and excessive accumulation of degradation fragments

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates local quality variations in the prosthesis structure through controlled porosity and heterogeneous polymer distribution. This allows different regions to degrade at different rates, with the bulk material providing structural support while controlled micro-fracturing and porosity development facilitate gradual degradation without forming large rigid fragments, ensuring safe resorption by macrophages

Inventive Principle:
Principle #3Local quality

3Duration of action of stationary object

If conventional prostheses are designed for extended implantation, then structural support is maintained, but removal requires secondary surgery causing additional trauma and discomfort

Engineering Contradiction:
Improveimplantation durationVSAvoidsurgical trauma
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent fundamentally changes the temporal parameter of the prosthesis from permanent to temporary by using biodegradable polymers with controlled degradation rates. This parameter change allows the prosthesis to provide structural support during the critical early healing period (weeks to months) and then automatically dissolve as native tissue matures, eliminating the need for secondary removal surgery and associated trauma

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies the disposable concept to an implantable prosthesis by designing it as a temporary support structure that fulfills its function and then degrades. The PGS-PCL composite prosthesis acts as a short-living object that provides necessary mechanical support during tissue repair and then safely degrades into small fragments that are cleared by the body's natural processes, avoiding the need for permanent implantation and subsequent removal surgery

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Stability of the object's composition

If mechanical securing means are used to anchor the prosthesis, then positioning stability is improved, but the securing mechanisms have limited success and may cause tissue damage

Engineering Contradiction:
Improvepositioning stabilityVSAvoidtissue damage
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical securing systems (stents, clips, sutures) with a biochemical anchoring mechanism based on the prosthesis material's ability to induce tissue ingrowth and fibrosis. The PGS-PCL composite surface properties and degradation products promote cellular adhesion, proliferation, and matrix deposition, creating a biological bond between the prosthesis and surrounding tissue that is more effective and less damaging than mechanical fixation methods

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3274006B1Vascular casted prostheses and methods of forming same for treating biological tissue
Publication Date: 2020.11.11 CORMATRIX CARDIOVASCULAR INC
  • EP3274006B1 patent drawingFigure 1~2
  • EP3274006B1 patent drawingFigure 3
  • EP3274006B1 patent drawingFigure 4

AI summary

Bioremodelable tissue prostheses having a vasculature that is infused with a biomaterial composition. The present invention is directed to casted constructs for treating, reconstructing or replacing damaged or diseased biological tissue. In a preferred embodiment, the casted constructs comprise an ECM member having a biomaterial composition disposed within the vasculature of the ECM member. In some embodiments of the invention, the casted constructs comprise a seamless ECM material derived from a mammalian tissue source. According to the invention, the seamless ECM material can be derived from various mammalian tissue sources, including, without limitation, small intestine, large intestine and umbilical cord.