Compressible Bioabsorbable Adjunct for Surgical Stapling
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Solution Overview
Problem
Surgical staplers face challenges in achieving consistent sealing and tissue compatibility due to varying tissue thickness and lack of natural flexibility, leading to undesirable leakage and tissue tearing.
Innovation Solution
A compressible, bioabsorbable non-fibrous adjunct is integrated with surgical stapling assemblies, formed from a matrix of fused bioabsorbable polymers, which can be 3D printed and configured to deform and compensate for tissue thickness variations, promoting tissue ingrowth and maintaining compression under intra-tissue pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If staples of uniform height are used, then manufacturing simplicity is improved, but the ability to accommodate varying tissue thickness deteriorates
Solution Approach 1:
A compressible adjunct is introduced as an intermediary component between the staples and the tissue. This adjunct compensates for tissue thickness variations by compressing to different degrees based on the local tissue thickness, allowing uniform staples to effectively accommodate varying tissue depths without requiring complex variable-height staple designs.
Solution Approach 2:
The adjunct's compressibility parameter is utilized to adapt to different tissue thickness conditions. By changing the compression state of the adjunct based on tissue depth, the system maintains effective sealing and tissue engagement across varying thicknesses while using identical staple components throughout.
2Reliability
If staples are used to close tissue openings, then sealing function is improved, but tissue flexibility and pressure resistance deteriorate
Solution Approach 1:
The adjunct is constructed from a porous compressible material that provides both structural support and flexibility. The porous structure allows the material to conform to tissue movements and withstand intra-tissue pressures while maintaining the sealing function created by the staples, thereby improving both reliability and strength characteristics.
Solution Approach 2:
The adjunct combines compressible material properties with the stapling mechanism to create a composite system. This composite structure integrates the rigid sealing function of staples with the flexible, pressure-resistant characteristics of the compressible adjunct material, achieving both sealing reliability and tissue mechanical strength.
3Adaptability or versatility
If compressible adjunct material is added, then tissue thickness compensation is improved, but device complexity increases
Solution Approach 1:
The stapling assembly is segmented into distinct functional components: the staple cartridge providing the sealing function, and the compressible adjunct providing the thickness compensation function. This segmentation allows each component to be optimized independently and simplifies the overall design by assigning specific responsibilities to separate elements rather than requiring a single complex integrated structure.
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 allows for consistent tissue compression and ingrowth, minimizing leakage and tissue tearing, while accommodating varying tissue thicknesses with staples of uniform height, enhancing surgical outcomes.
Implementation Method 1
the adjunct is configured to compress to a compressed height when the adjunct is stapled to tissue
Implementation Method 2
the adjunct allows for consistent tissue compression and ingrowth, minimizing leakage and tissue tearing, while accommodating varying tissue thicknesses
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.