Compressible Tissue Cushion Adjunct for Staple Pull-Through Prevention
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Solution Overview
Problem
Existing surgical staplers lack effective means to reinforce the mechanical fastening of tissue and prevent staples from pulling through or tearing, particularly in varying tissue thicknesses, and do not provide optimal compression and support during stapling.
Innovation Solution
The introduction of a tissue thickness compensator or buttress assembly, comprising a flexible material with adhesive layers and hemostatic agents, which is securely attached to the surgical stapler's end effector to reinforce staple lines and provide structural support, while also incorporating compressible nodules or protrusions that enhance tissue engagement and compression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical staplers are used without tissue reinforcement, then the device complexity is reduced, but the reliability of tissue fastening deteriorates due to staple pull-through and tearing
Solution Approach 1:
A tissue thickness compensator is introduced as an intermediary component between the stapler and tissue. This compensator includes a compressible body with hemostatic material that reinforces the tissue-staple interface, preventing staple pull-through and tissue tearing while maintaining system reliability without requiring complex modifications to the stapler mechanism itself
Solution Approach 2:
The tissue thickness compensator utilizes composite material construction, combining compressible material with hemostatic material in a single integrated component. This composite structure provides both mechanical reinforcement to prevent staple pull-through and hemostatic functionality to control bleeding, thereby improving tissue fastening reliability without increasing device complexity
2Adaptability or versatility
If the stapler is designed for varying tissue thicknesses, then the adaptability is improved, but the manufacturing precision of staple depth control deteriorates
Solution Approach 1:
The tissue thickness compensator changes its physical parameters (compression depth, density) in response to varying tissue thicknesses. The compressible body compresses to different extents depending on tissue thickness, automatically adjusting the effective stapling depth without requiring precise pre-programming or complex control mechanisms, thus maintaining manufacturing precision while achieving adaptability
Solution Approach 2:
The compensator introduces dynamic adjustment capability through its compressible structure. As the stapler applies force, the compensator dynamically compresses to accommodate different tissue thicknesses, allowing the system to adapt to varying conditions while maintaining consistent staple penetration depth through the compressible medium, thereby preserving manufacturing precision across different tissue thicknesses
3Strength
If no tissue compression is provided during stapling, then the ease of operation is improved, but the strength of tissue sealing deteriorates
Solution Approach 1:
The tissue thickness compensator provides beforehand cushioning by being pre-loaded with compressible material that automatically compresses during the stapling process. This pre-positioned compressible element ensures consistent tissue compression and contact pressure at the stapling interface, improving tissue sealing strength without requiring the operator to apply additional manual compression force, thereby maintaining ease of operation
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 solution ensures secure staple fixation, reduces the risk of staple pull-through and tissue tearing, and provides consistent compression across varying tissue thicknesses, enhancing the sealing and fastening process.
Implementation Method 1
The tissue thickness compensator may include an adhesive layer and/or a hemostatic agent
Implementation Method 2
incorporating compressible nodules or protrusions that enhance tissue engagement and compression
Implementation Method 3
The tissue thickness compensator may include an adhesive layer and/or a hemostatic agent
Data Source
AI summary
An adjunct configured for use with an end effector of a surgical stapler includes a plurality of resiliently compressible elements interconnected with each other. The adjunct also includes a tissue-engaging face configured to contact tissue clamped by the end effector during closure thereof, and a stapler-engaging face configured to be releasably secured to a stapling surface of the end effector. Each resiliently compressible element of the plurality of resiliently compressible elements includes a hollow interior and an open end at one of the tissue-engaging or stapler-engaging faces. The hollow interior expands outwardly toward the open end. Each resiliently compressible element of the plurality of resiliently compressible elements is configured to be captured and compressed by a corresponding staple ejected from the end effector into the clamped tissue and thereby reinforce the engagement between the ejected staples and the clamped tissue.