3D Compressible Adjunct for Surgical Stapler Sealing
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Solution Overview
Problem
Surgical staplers face challenges in achieving consistent sealing due to varying tissue thickness, leading to potential leakage and tissue tearing, as staples lack the natural flexibility and adaptability to intra-tissue pressures.
Innovation Solution
A three-dimensional compressible adjunct made from a bioabsorbable polymer matrix is integrated with surgical staplers, providing a variable stiffness profile that applies a minimum stress threshold of 29 kPa for at least 3 days, compensating for tissue thickness variations and promoting tissue ingrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If staples are used to close tissue openings, then tissue sealing is achieved, but consistent sealing cannot be achieved when tissue thickness varies
Solution Approach 1:
The adjunct is designed with varying thickness (e.g., thicker in central regions, thinner at edges) to provide different levels of compression and support at different locations within the stapled tissue, ensuring consistent sealing across varying tissue thicknesses
Solution Approach 2:
The compressible adjunct is pre-installed in the stapler cartridge before surgery, positioned to be compressed between the anvil and staple cartridge during firing, thereby pre-preparing the compression force needed to achieve consistent sealing regardless of tissue thickness variations
2Strength
If rigid staples and adjuncts are used to provide structural support, then sealing force is maintained, but tissue flexibility and ability to withstand varying intra-tissue pressures are lost
Solution Approach 1:
The adjunct is constructed from flexible, compressible materials (such as foam or porous polymers) that can deform and adapt to varying intra-tissue pressures while maintaining sealing force, rather than using rigid structures that would resist such pressure variations
Solution Approach 2:
The adjunct material properties are specifically selected to change under compression - becoming denser and more rigid under high pressure to maintain sealing, while remaining compliant and flexible under normal physiological conditions to accommodate tissue movement and pressure variations
3Reliability
If compression force is applied to ensure sealing, then leakage is prevented, but excessive compression can cause tissue tearing
Solution Approach 1:
The compressible adjunct acts as a cushioning element that distributes compression forces evenly across the stapled tissue, preventing localized excessive pressure that could cause tearing while maintaining sufficient overall compression for sealing
Solution Approach 2:
The adjunct utilizes porous or foam materials that can compress gradually and reversibly, allowing controlled deformation under pressure to achieve sealing without transmitting excessive point loads to the tissue that would cause tearing
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 tissue compression and minimizes leakage and tearing by adapting to varying tissue pressures, while promoting healing and reducing the risk of rejection by facilitating tissue integration.
Implementation Method 1
formed from a matrix that includes at least one fused bioabsorbable polymer
Implementation Method 2
facilitating tissue integration
Implementation Method 3
configured to apply a stress at or above a minimum stress threshold to the tissue
Implementation Method 4
formed from a matrix that includes at least one fused bioabsorbable polymer
Data Source
Figure 1
Figure 2~3
Figure 4~5
AI summary
Stapling assemblies for use with a surgical stapler and methods for manufacturing the same are provided. Three dimensional adjuncts for use with a surgical stapling assembly and methods for manufacturing the same are also provided.