Compliant E-Beam Stapling Assembly for Variable Tissue Thickness
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Solution Overview
Problem
Existing surgical stapling and severing instruments face challenges in accommodating varying tissue thicknesses, leading to issues such as loose staples in thin tissues and excessive compressive force in thick tissues, which can result in necrosis, bleeding, or poor staple formation.
Innovation Solution
The development of a surgical stapling and severing instrument featuring a compliant E-beam firing bar with flexible components, such as horizontal slits, relieved areas, and resilient materials, that adjusts the spacing between the anvil and staple cartridge to accommodate different tissue thicknesses, ensuring proper staple formation and retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a rigid stapling instrument is used, then staple formation is consistent for standard tissue thickness, but it causes excessive compressive force and tissue damage for thick tissues
Solution Approach 1:
The firing bar is designed with flexible components including horizontal slits and relieved areas that allow it to bend and adjust its position dynamically. This enables the firing bar to accommodate varying tissue thicknesses by flexing to different degrees, maintaining consistent staple formation while reducing excessive compressive force on thick tissues.
Solution Approach 2:
The instrument changes the physical state of the firing bar from rigid to flexible by incorporating horizontal slits and relieved areas. This parameter change allows the firing bar to adapt its stiffness and position based on tissue thickness, resolving the contradiction between consistent staple formation and tissue damage prevention.
2Device complexity
If a rigid stapling instrument is used, then structural simplicity is maintained, but it cannot accommodate varying tissue thicknesses
Solution Approach 1:
The firing bar is segmented into multiple sections separated by horizontal slits and relieved areas. This segmentation allows each section to move independently, enabling the firing bar to flex and adapt to different tissue thicknesses while maintaining a relatively simple overall structure without requiring multiple separate components.
3Device complexity
If the spacing between anvil and staple cartridge is fixed, then device complexity is reduced, but loose staples occur in thin tissues
Solution Approach 1:
The firing bar's flexible design with horizontal slits and relieved areas enables dynamic adjustment of the spacing between the anvil and staple cartridge. As the firing bar flexes to accommodate different tissue thicknesses, it automatically adjusts the spacing to maintain optimal contact, preventing loose staples in thin tissues while avoiding excessive compression in thick tissues.
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 instrument effectively adjusts to varying tissue thicknesses, preventing loose or overly compressed staples, thereby improving staple line consistency and reducing the risk of tissue damage during surgical procedures.
Implementation Method 1
a compliant E-beam firing bar with flexible components, such as horizontal slits, relieved areas, and resilient materials, that adjusts the spacing between the anvil and staple cartridge
Data Source
AI summary
A method for deforming a staple comprising a base, a first staple leg, and a second staple leg, wherein the base, the first staple leg, and the second staple leg are positioned within a common plane prior to being deformed, the method comprising positioning the first staple leg within a first cup of a staple pocket, the first cup comprising a first inner surface, applying a first compressive force to the first staple leg to bend the first staple leg toward the base and the second staple leg, contacting the first inner surface with the end of the first staple leg to bend the end of the first staple leg toward a first side of the base, and deforming the first staple leg such that the end of the first staple leg crosses a mid-line of the staple defined between the first staple leg and the second staple leg.