Surgical Stapler End Effector With Adjustable Gap for Tissue Thickness
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Solution Overview
Problem
Current surgical staplers used in vertical sleeve gastrectomy lack consistency and quality in creating staple lines due to tissue thickness variations and deflection issues, leading to complications such as leaks and suboptimal anatomy, which are not adequately addressed by existing calibration tubes and surgeon estimation.
Innovation Solution
An end effector with an anvil and cartridge that can adjust gaps and staple leg lengths to accommodate varying tissue thickness, featuring adjustable alignment mechanisms and interchangeable magazines to ensure precise staple placement, supported by a flexible member and tensioning device for secure clamping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If standard surgical staplers with fixed gap design are used, then device simplicity is maintained, but staple line quality deteriorates due to tissue thickness variations
Solution Approach 1:
The anvil is designed with movable adjustment mechanisms that allow the gap between the anvil face and cartridge face to be dynamically changed during the surgical procedure. This enables the surgeon to adapt the staple formation gap to match varying tissue thicknesses, thereby maintaining high staple line quality without requiring a completely complex device architecture.
Solution Approach 2:
The patent implements adjustable gap parameters between the anvil and cartridge by providing multiple anvil positions or interchangeable anvils with different gap configurations. This parameter adjustment allows the stapler to accommodate different tissue thicknesses, improving staple line quality while keeping the overall device structure relatively simple through modular design.
2Measurement precision
If fixed anvil-cartridge gap is used, then device simplicity is maintained, but anatomical precision deteriorates due to inability to accommodate tissue thickness variations
Solution Approach 1:
The alignment mechanism incorporates dynamic adjustment capabilities that allow the anvil to be positioned at multiple angles or distances relative to the cartridge. This enables precise anatomical alignment tailored to the specific tissue thickness and surgical site requirements, while the adjustment mechanism itself is designed to be intuitive and relatively simple for surgical use.
3Reliability
If uniform staple leg length is used, then manufacturing simplicity is maintained, but reliability deteriorates due to tissue thickness variations causing leaks
Solution Approach 1:
The cartridge is designed with zones of staples having different leg lengths, where each zone is optimized for the local tissue thickness in that region. This local differentiation of staple properties ensures reliable staple formation and prevents leaks in areas with varying tissue thickness, while the overall cartridge structure remains a single integrated component rather than multiple interchangeable parts.
4Measurement precision
If surgeon estimation and calibration tubes are used, then device simplicity is maintained, but measurement precision deteriorates leading to suboptimal anatomy
Solution Approach 1:
The end effector incorporates self-aligning features such as guide rails, alignment pins, or geometric constraints that automatically position the anvil and cartridge relative to each other and to the tissue. This eliminates the need for separate calibration tubes or complex manual alignment procedures by the surgeon, achieving high measurement precision through the device's own structural features.
Data Source
AI summary
An end effector for stapling and cutting an anatomical structure includes an anvil, a cartridge, and a blade. The anvil has an anvil face and a plurality of staple pockets positioned on the anvil face. The cartridge has a cartridge face defining a cartridge blade channel, the cartridge being configured to retain a plurality of staples. Each of the plurality of staples comprises a first staple leg, a second staple leg, and a crown connecting the first and second staple legs and having a midpoint. Each of the plurality of staples comprises an open staple configuration and a closed staple configuration where a first portion of the first staple leg and a second portion of the second staple leg are bent relative to the crown such that the first portion of the first staple leg and the second portion of the second staple leg cross the midpoint of the crown.