Surgical Stapler Tissue Cushion with Staple Leg Constraints
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Solution Overview
Problem
Current surgical staplers lack effective mechanisms for securely fastening and reinforcing tissue, leading to potential complications such as staple pull-through and tissue tearing, especially in varying tissue thicknesses and during multiple firing strokes.
Innovation Solution
The surgical stapler incorporates a buttress assembly with a compressible adjunct and staple leg constraints, including pocket extending members, suture strands, and bores, to guide and secure staple legs, ensuring proper alignment and engagement with staple forming pockets, and a wedge sled with a fin member for optimal tissue cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical staplers are used without additional reinforcement mechanisms, then the device complexity is low, but the reliability of tissue fastening is insufficient leading to staple pull-through and tissue tearing
Solution Approach 1:
A tissue reinforcement member (buttress) is introduced as an intermediary element between the tissue and staples. This buttress member provides additional support and distribution of forces, preventing staple pull-through and tissue tearing while maintaining a relatively simple stapler design.
Solution Approach 2:
The tissue reinforcement member is constructed from composite materials including a porous expandable core and an adhesive layer. This composite structure provides both mechanical support and secure attachment to tissue, enhancing fastening reliability without requiring complex device mechanisms.
2Manufacturing precision
If the surgical stapler uses a simple staple driving mechanism, then the device complexity is low, but the manufacturing precision of staple formation deteriorates especially in varying tissue thicknesses
Solution Approach 1:
The anvil surface is designed with variable geometry including crowned portions and recesses that adapt to different tissue thicknesses. This allows the staple formation process to maintain precision across varying tissue conditions without requiring complex adjustment mechanisms.
Solution Approach 2:
The anvil features localized structural variations such as crowned portions at specific locations and recesses at other locations. These local quality changes provide precise staple formation control in different areas of the tissue without requiring the entire device to be complex.
3Duration of action of moving object
If the surgical stapler is designed for single firing stroke operation, then the device complexity is low, but the duration of action is insufficient for multiple firing strokes on varying tissue thicknesses
Solution Approach 1:
The anvil is designed with dynamic geometric features including crowned portions and recesses that adapt during multiple firing strokes. This allows the device to maintain effective tissue sealing and staple formation across varying tissue thicknesses through multiple operations without requiring complex adjustment mechanisms.
Solution Approach 2:
The tissue reinforcement member with its porous expandable core and adhesive layer provides multiple functions: initial tissue support, staple formation assistance, and continued sealing support during multiple firing strokes. This multi-functionality extends operational duration without proportionally increasing device complexity.
4Strength
If no tissue reinforcement is provided, then the device complexity is low, but the strength of tissue sealing is insufficient leading to potential complications
Solution Approach 1:
The tissue reinforcement member acts as an intermediary between the staples and tissue, distributing forces and preventing staple pull-through. This intermediary structure significantly enhances tissue sealing strength while adding minimal complexity to the overall device.
Solution Approach 2:
The reinforcement member uses composite materials with a porous expandable core providing mechanical strength and an adhesive layer providing secure attachment. This composite construction achieves high tissue sealing strength without requiring complex device mechanisms.
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 tissue reinforcement, reduces the risk of staple pull-through, and maintains secure staple formation across varying tissue thicknesses, ensuring effective sealing and minimizing complications during multiple firing strokes.
Implementation Method 1
a compressible adjunct and staple leg constraints, including pocket extending members
Implementation Method 2
an adhesive layer, the tissue reinforcement member may comprise a porous, expandable core
Data Source
AI summary
A surgical instrument includes an end effector including a first jaw having a plurality of pockets and a second jaw. The first and second jaws are operable to clamp tissue therebetween. The surgical instrument also includes a stapling assembly supported by the second jaw of the end effector. The stapling assembly includes a deck, a plurality of staple openings extending through the deck, and a plurality of staples slidably housed within corresponding staple openings. Each staple has a respective pair of legs configured to be driven into contact with a corresponding pocket. The surgical instrument further includes a plurality of staple leg constraints. Each staple leg constraint is aligned with and extends at least partially across a corresponding staple opening for guiding a respective leg of the corresponding staple toward the corresponding pocket.