Compressible Adjunct for Surgical Stapler Tissue Reinforcement
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Solution Overview
Problem
Current surgical staplers lack effective mechanisms for reinforcing tissue fastening and preventing staple pull-through, leading to potential tissue tearing and bleeding at the surgical site.
Innovation Solution
The surgical stapler incorporates a buttress assembly with a strong, flexible material, such as polyglactin 910, and a hemostatic agent like fibrin, which is securely attached to the staple cartridge and anvil using adhesive layers to provide structural support and reduce bleeding, and a compressible adjunct with resilient nodules that apply a spring force to ensure secure stapling and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If surgical staplers use traditional stapling mechanism without reinforcement, then the device complexity is low, but the tissue fastening strength is insufficient leading to staple pull-through and tissue tearing
Solution Approach 1:
The patent applies composite materials by integrating a buttress assembly comprising multiple layers including a first buttress layer, a second buttress layer, and an adhesive layer bonding them together. This multi-layer composite structure provides enhanced mechanical strength and tissue reinforcement while preventing staple pull-through, directly resolving the contradiction between fastening strength and device complexity.
Solution Approach 2:
The buttress assembly is segmented into distinct functional layers: a first buttress layer for primary reinforcement, a second buttress layer for additional support, and an adhesive layer for secure attachment to tissue. This segmentation allows each layer to perform its specific function optimally, achieving superior tissue fastening strength while maintaining manageable device complexity through modular design.
2Object-affected harmful factors
If surgical staplers use traditional stapling mechanism without hemostatic agents, then the procedure is simpler, but bleeding occurs at the surgical site
Solution Approach 1:
The patent merges multiple functions into a single integrated buttress assembly: mechanical reinforcement from the buttress layers, hemostasis from incorporated hemostatic agents, and tissue adhesion from the adhesive layer. This combination addresses bleeding control while managing device complexity by consolidating multiple therapeutic functions into one component rather than requiring separate devices.
3Reliability
If surgical staplers use non-compressible adjuncts, then the device complexity is low, but the stapling and sealing effectiveness is reduced due to variable tissue thickness
Solution Approach 1:
The patent applies dynamics by incorporating a compressible adjunct with compressible material that can dynamically adapt to variable tissue thickness. The compressible nature allows the adjunct to be compressed during stapling, ensuring consistent contact and effective sealing regardless of initial tissue thickness variations, thereby improving reliability while the controlled compressibility keeps device complexity manageable.
4Reliability
If surgical staplers reinforce tissue with multiple layers and hemostatic agents, then tissue fastening and bleeding control improve, but the manufacturing process becomes more complex
Solution Approach 1:
The patent applies preliminary action by pre-assembling the multi-layer buttress assembly with hemostatic agents and adhesive layers before surgical use. The layers are pre-bonded and pre-positioned, allowing the entire reinforced structure to be applied as a single unit during surgery. This pre-manufacturing of the complex multi-component structure improves reliability of tissue fastening and bleeding control while simplifying the surgical application process.
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 enhances the mechanical fastening of staples, reduces the risk of tissue tearing, and minimizes bleeding by providing structural reinforcement and hemostasis, ensuring a secure and effective seal of the stapled tissue.
Implementation Method 1
each resiliently compressible member is configured to resiliently compress when the end effector is closed on tissue
Implementation Method 2
securely attached to the staple cartridge and anvil using adhesive layers
Implementation Method 3
a hemostatic agent like fibrin, which is securely attached to the staple cartridge and anvil
Data Source
AI summary
An adjunct configured for use with a surgical stapler end effector includes an adjunct body configured to overlie and directly contact a stapling surface of a surgical stapler end effector, and a plurality of resiliently compressible members coupled with the adjunct body. Each resiliently compressible member extends away from the adjunct body in a first plane that intersects the adjunct body and along which the resiliently compressible member is configured to receive a respective staple of the surgical stapler end effector. In response to closure of the surgical stapler end effector, each resiliently compressible member is configured to resiliently compress within the first plane without deforming in a second plane that perpendicularly intersects the first plane.