Compressible Bioabsorbable Stapler Adjunct for Tissue Sealing
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Solution Overview
Problem
Surgical staplers face challenges in achieving consistent staple configurations due to varying tissue thickness, leading to unsealed sites and potential leakage, and staples lack tissue flexibility, resulting in undesirable tearing and leakage.
Innovation Solution
A non-fibrous adjunct is developed with a plurality of interconnected unit cells, formed from bioabsorbable polymers, that can withstand stress ranges of 30 kPa to 90 kPa with strains of 0.1 to 0.7, providing stress plateaus and varying compression zones to match tissue flexibility and maintain seal integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional staples are used to close tissue openings, then the stapling procedure can be performed, but the staples cannot adapt to varying tissue thickness, resulting in unsealed sites and potential leakage
Solution Approach 1:
The adjunct is designed with a compressible lattice structure that dynamically adapts to varying tissue thicknesses. The unit cells compress under tissue pressure, allowing the adjunct to conform to different tissue depths and maintain consistent staple deployment across the entire tissue surface, thereby ensuring reliable seal integrity regardless of tissue thickness variations
Solution Approach 2:
The adjunct utilizes controlled parameter changes in its mechanical properties through the lattice structure design. By adjusting the unit cell geometry and material composition, the adjunct achieves optimal compressibility and resilience parameters that enable it to adapt to different tissue thicknesses while maintaining sufficient structural support for reliable sealing
2Ease of operation
If rigid staples and materials are used for stapling, then the stapling function can be achieved, but the materials lack tissue flexibility, resulting in tissue tearing and leakage
Solution Approach 1:
The adjunct employs a flexible lattice structure composed of thin-walled unit cells that can bend and deform with tissue movement. This flexible architecture allows the adjunct to move harmoniously with the surrounding tissue, eliminating stress concentration points that would otherwise cause tissue tearing while maintaining the necessary mechanical function for sealing
Solution Approach 2:
The adjunct is constructed from composite materials that combine the strength needed for structural integrity with the flexibility required for tissue compatibility. The lattice structure uses materials with optimized mechanical properties that mimic natural tissue behavior, providing both support and flexibility to prevent tissue damage during and after stapling
3Stability of the object's composition
If non-compressible materials are used for stapling adjuncts, then the structure maintains its shape, but it cannot withstand varying intra-tissue pressures, leading to seal failure
Solution Approach 1:
The lattice structure provides dynamic pressure resistance through its compressible unit cells. When intra-tissue pressure increases, the unit cells compress to absorb the pressure variation while maintaining overall structural stability. This dynamic response allows the adjunct to withstand varying pressures without compromising seal integrity or structural collapse
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 adjunct ensures consistent staple deployment across varying tissue thickness, enhances tissue integration, and reduces tearing and leakage by mimicking tissue flexibility and maintaining seal integrity.
Implementation Method 1
The adjunct has a plurality of repeating unit cells that are interconnected such that the adjunct, while under an applied stress in a range of 30 kPa to 90 kPa, undergoes a strain in a range of 0.1 to 0.7
Data Source
Figure 1
Figure 2A~2B
Figure 2C
AI summary
Stapling assemblies for use with a surgical stapler are provided. In one exemplary embodiment, the stapling assembly includes a cartridge having a plurality of staples disposed therein and a non-fibrous adjunct formed of at least one fused bioabsorbable polymer and configured to be releasably retained on the cartridge. Adjunct systems for use with a surgical stapler are also provided. Surgical end effectors using the stapling assemblies are also provided. Methods for manufacturing stapling assemblies and using the same are also provided.