Thermally Stable Electrospun Barrier for Hernia Repair

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Solution Overview

Problem

Current synthetic surgical meshes for hernia repair and other tissue replacement applications face issues with high recurrence rates, chronic pain, and long-term complications due to instability and rapid degradation of electrospun materials, which affect patient quality of life and tissue regeneration.

Innovation Solution

Development of thermally stable electrospun barrier materials comprising multiple fiber populations with a major absorbable and a minor non-absorbable component, co-mingled and distributed throughout, to provide modularity in strength, modulus, and porosity, maintaining structural integrity and stability under biological and thermal conditions without additional processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If electrospun materials are used for surgical meshes, then the materials can provide a barrier with topography similar to native extracellular matrix, but the materials undergo uncontrolled crystallization and shrinkage at body temperature due to glass transition

Engineering Contradiction:
ImprovetopographyVSAvoiddimensional stability
Core Design Contradiction:
ShapeVSStability of the object's composition

Solution Approach 1:

The patent modifies the glass transition temperature of the polymer material through compositional changes (copolymer selection, additives, or blending) to ensure Tg remains below physiological temperature ranges. This parameter adjustment prevents unintended phase transitions and crystallization at body temperature, thereby maintaining dimensional stability while preserving the beneficial nanofibrous topography for tissue integration.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If completely absorbable meshes are used, then the meshes do not need removal and do not disrupt collagen formation, but the replacement collagen layer is not strong enough to prevent hernia recurrence

Engineering Contradiction:
Improveno removal neededVSAvoidmechanical strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent employs polymers with controllable degradation kinetics that dynamically adjust their mechanical properties over time. The material maintains high strength during the critical early healing phase when mechanical support is most needed, then progressively degrades as host tissue regenerates. This temporal dynamic allows the mesh to provide temporary structural support without requiring surgical removal, resolving the contradiction between ease of operation and mechanical strength.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent utilizes polymer composition parameters (molecular weight, crystallinity, crosslinking density) to precisely control the degradation rate and mechanical strength profile. By adjusting these parameters, the mesh can be engineered to maintain sufficient strength for hernia repair while ensuring complete absorption after tissue regeneration, eliminating the need for removal surgery.

Inventive Principle:
Principle #35Parameter changes

3Strength

If non-absorbable synthetic meshes are used, then the meshes provide long-term structural support, but they cause chronic pain, fibrosis, and mesh contraction complications

Engineering Contradiction:
Improvestructural supportVSAvoidchronic complications
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies the concept of temporary structural support using biodegradable materials that fulfill their mechanical support function during the healing period and then naturally dissolve. This eliminates the long-term presence of foreign material that causes chronic pain and fibrosis, while still providing adequate structural support when needed. The 'disposable' nature of the absorbable mesh resolves the contradiction between providing structural support and avoiding long-term complications.

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

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 solution achieves dimensional and thermal stability, reducing shrinkage and maintaining mechanical properties, enhancing tissue ingrowth and regeneration while minimizing complications such as hernia recurrence and chronic pain, by providing a stable scaffold that mimics native tissue properties.

Implementation Method 1

By applying a critical voltage to overcome the surface tension of the polymer solution, along with sufficient molecular chain entanglement in solution, fiber formation can occur. Application of a critical voltage induces a high charge density forming a Taylor cone

Methodology Applied
Scientific EffectElectrostatic force: Electrostatics

Implementation Method 2

By applying a critical voltage to overcome the surface tension of the polymer solution

Methodology Applied
Scientific EffectSurface tension: Surface Tension

Implementation Method 3

fiber formation occurs on the order of milliseconds due to the rapid evaporation of the solvent (i.e., solution electrospinning), inhibiting polymer crystallization

Methodology Applied
Scientific EffectEvaporation: Evaporation

Implementation Method 4

Exposing temperature sensitive materials to temperatures near or at their Tg ultimately yields crystallization events which have both micro and macroscopic effects on electrospun fabrics

Methodology Applied
Scientific EffectCrystallization: Crystallisation

Implementation Method 5

these materials can undergo both morphological and mechanical property changes when exposed to heat due to cold crystallization as well as stress relief via application of heat

Methodology Applied
Scientific EffectStress relief: Stress Relaxation

Data Source

PatentUS20240018707A1Time-dependent synthetic biological barrier material
Publication Date: 2024.01.18 POLY MED INC
  • US20240018707A1 patent drawing
  • US20240018707A1 patent drawing
  • US20240018707A1 patent drawing

AI summary

Thermally stable absorbable fiber populations, i.e. fiber populations that do not undergo thermally induced crystallization, can be intermixed to yield a stabilizing effect without altering morphological properties of a first fiber system. By addition of a stabilizing fiber population one may minimize thermally induced shrinkage and maintain physical properties of electrospun materials in the as-formed state. In one particular abstract, medical barrier materials may be formed from the electrospun materials to provide improved medical barriers for treatments.