Variable Construction Surgical Mesh for Tissue Integration
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Solution Overview
Problem
Existing surgical meshes have deficiencies in mechanical properties, tissue response, and durability, leading to issues such as tissue erosion, adhesions, and shrinkage, which affect the long-term efficacy of treatments for urinary incontinence and pelvic floor disorders.
Innovation Solution
A substantially two-dimensional surgical mesh with varying areas of different materials, such as biocompatible polymeric fibers, that promote tissue response, bioinert properties, or block tissue ingrowth, reducing adhesions and erosion, and enhancing bonding to target tissue, while allowing for biodegradability and color differentiation for placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a uniform surgical mesh is used throughout the implantation area, then the mesh structure is simple and easy to manufacture, but it causes tissue erosion, adhesions, and shrinkage due to inadequate differentiation of mechanical properties and tissue response characteristics
Solution Approach 1:
The surgical mesh is divided into multiple zones with different constructions: a first zone with a first construction (e.g., higher density, smaller pores) and a second zone with a second construction (e.g., lower density, larger pores). Each zone is optimized for its specific function - the first zone may provide stronger support and resistance to tissue erosion, while the second zone may promote tissue ingrowth or reduce adhesions. This local differentiation resolves the contradiction by improving reliability through targeted functionality while maintaining reasonable overall complexity.
Solution Approach 2:
The mesh combines different materials or material configurations in different zones. For example, one zone may use a biocompatible polymeric fiber mesh with specific pore sizes, while another zone uses a different material composition or weave pattern. This composite approach allows each material to contribute its strengths - improving durability where needed while reducing harmful effects like erosion and adhesions in other areas, thereby resolving the reliability-complexity contradiction.
2Reliability
If the mesh uses a single material composition, then manufacturing is simplified, but tissue response issues arise including excessive adhesions, erosion, or insufficient integration
Solution Approach 1:
Different zones of the mesh use different material compositions or treatments. For instance, one zone may use a material that promotes tissue ingrowth (larger pores, more porous structure), while another zone uses a material that resists adhesions (smoother surface, different polymer composition). This local material differentiation improves tissue response quality without requiring completely separate manufacturing processes, as the variations can be achieved through controlled fabrication parameters within a single manufacturing run.
Solution Approach 2:
The mesh varies material parameters such as pore size, fiber diameter, density, or cross-linking degree across different zones. These parameter changes allow optimization of tissue response - for example, larger pores in one area promote cell infiltration and integration, while smaller pores in another area reduce fluid permeability and prevent adhesions. Such parameter variations can be implemented through controlled manufacturing processes, balancing improved tissue response with manufacturing feasibility.
3Duration of action of stationary object
If the mesh has uniform mechanical properties throughout, then structural consistency is maintained, but it leads to shrinkage and loss of support effectiveness over time
Solution Approach 1:
The mesh employs zones with different mechanical properties - for example, a central zone with higher tensile strength and stiffness for primary support, and peripheral zones with lower stiffness or different elasticity for flexibility and tissue integration. This local mechanical differentiation prevents uniform shrinkage by allowing different parts of the mesh to respond differently to tissue forces, thereby maintaining support effectiveness over time while accepting controlled structural variation.
Solution Approach 2:
The mesh combines materials or structures with different mechanical characteristics in different regions. One zone may use a more rigid, stable material composition to maintain structural integrity and prevent shrinkage, while another zone uses a more flexible or compliant material to adapt to tissue movement and reduce stress concentration. This composite structural approach enhances long-term durability by distributing mechanical stresses appropriately across different zones.
Data Source
AI summary
According to one aspect, the present invention provides a substantially two-dimensional surgical mesh comprising a base material, a first area having a first characteristic and a second area having a second characteristic that differs from the first characteristic. The surgical mesh may further comprise a third area having a third characteristic that may be the same as or different from the first and second characteristics, and so on.