Calendered P4HB Surgical Meshes for Smooth Surface and Burst Strength

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Solution Overview

Problem

Existing surgical meshes for tissue reinforcement, such as those used in pelvic organ prolapse treatment, often have rough surfaces and thick profiles, which can cause friction and are not ideally suited for applications requiring smoother, thinner options with high burst strengths.

Innovation Solution

Development of calendered surgical meshes made from poly-4-hydroxybutyrate (P4HB) polymers or copolymers, which are smoother, thinner, and retain high burst strengths, allowing for tissue ingrowth and resorbability, particularly suitable for pelvic organ prolapse treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If surgical meshes are made from non-resorbable fibers (polypropylene, polyester), then high burst strength and durability are achieved, but surface roughness and thick profile cause friction and are not suitable for tissue reinforcement applications

Engineering Contradiction:
Improveburst strengthVSAvoidsurface roughness and friction
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies calendering processing to change the physical parameters of the mesh surface, transforming it from rough to smooth while maintaining the underlying structural integrity and burst strength through controlled application of pressure and heat

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses poly-4-hydroxybutyrate (P4HB) as a composite material that combines resorbability, adequate burst strength, and the ability to achieve smooth surfaces through calendering, resolving the contradiction between strength and surface quality

Inventive Principle:
Principle #40Composite materials

2Strength

If surgical meshes are made from non-resorbable fibers, then high burst strength is maintained long-term, but they cannot provide scaffold for tissue in-growth and must be removed or cause complications

Engineering Contradiction:
Improveburst strengthVSAvoidtissue integration and resorbability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent employs a resorbable material (P4HB) that is designed to be temporarily present to provide structural support and scaffold for tissue in-growth, then naturally degrades and is absorbed by the body, eliminating the need for removal surgery and reducing long-term complications

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

Solution Approach 2:

The patent controls the degradation parameters of P4HB through molecular weight selection and calendering processing, ensuring the mesh maintains adequate strength during the healing period and then degrades at an appropriate rate to allow complete tissue integration

Inventive Principle:
Principle #35Parameter changes

3Reliability

If surgical meshes are made from P4HB resorbable fibers, then tissue integration and resorbability are achieved, but surface roughness and thick profile make them unsuitable for applications requiring smooth, thin meshes

Engineering Contradiction:
Improvetissue integrationVSAvoidsurface smoothness and profile thickness
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The patent uses calendering to change the surface morphology and thickness parameters of the P4HB mesh, achieving smooth surfaces and thin profiles while preserving the resorbable nature and tissue integration capabilities of the P4HB material

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent performs calendering processing before implantation to pre-smooth the surface and reduce thickness, ensuring the mesh is ready for immediate use in applications requiring smooth, thin profiles without compromising the underlying P4HB properties

Inventive Principle:
Principle #10Preliminary action

4Shape

If meshes are calendered to reduce thickness and smooth surface, then profile and surface quality improve, but burst strength may be compromised

Engineering Contradiction:
Improveprofile thickness and surface smoothnessVSAvoidburst strength
Core Design Contradiction:
ShapeVSStrength

Solution Approach 1:

The patent optimizes calendering parameters (pressure, temperature, duration) to achieve the desired surface smoothness and thickness reduction while minimizing damage to the P4HB fibers and maintaining adequate burst strength through controlled processing

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent leverages the inherent properties of P4HB material, which allows it to be calendered effectively while maintaining strength, creating a composite solution that achieves both surface quality improvement and strength preservation

Inventive Principle:
Principle #40Composite materials

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 calendered meshes provide a smoother surface with high burst strength, reduced friction, and adequate pore sizes for tissue ingrowth, making them suitable for tissue reinforcement applications like pelvic organ prolapse without significant loss of burst strength or fiber orientation.

Implementation Method 1

The mesh is calendered to provide a smooth surface, reduce the thickness of the mesh, and maintain the burst strength and pore size of the mesh

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentEP3678715B1Calendered surgical meshes comprising polyhydroxyalkanoates
Publication Date: 2024.10.30 TEPHA INC
  • EP3678715B1 patent drawingFigure 1

AI summary

Calendered surgical meshes comprising polyhydroxyalkanoate polymers have been developed. These meshes, preferably made from poly-4-hydroxybutyrate or copolymer thereof, have a thickness that is between 50 to 99% of the thickness of the mesh prior to calendering, and a burst strength that is not less than 20% of the burst strength of the mesh prior to calendering. The thinner calendered meshes are particularly suitable for surgical applications where a thinner profile mesh with high burst strength is required, and where it is advantageous to have a mesh with a smooth surface. The meshes may be partially or fully resorbable, and are particularly suitable for use in the treatment of pelvic organ prolapse.