Compliant Surgical Staples 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. Additionally, current instruments lack mechanisms to adjust staple height and clamping forces based on tissue thickness, potentially damaging thinner tissues.
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, and a closure system that limits clamping forces based on tissue thickness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a rigid stapling instrument with fixed spacing between anvil and staple cartridge is used, then staple formation is consistent for standard tissue thickness, but it causes excessive compressive force on thick tissues leading to necrosis and bleeding
Solution Approach 1:
The firing bar is designed with flexible components including horizontal slits, relieved areas, and resilient materials that allow dynamic adjustment of spacing between the anvil and staple cartridge. This enables the instrument to adapt to varying tissue thicknesses by flexing the firing bar, thereby maintaining appropriate clamping force and preventing excessive compression on thick tissues while ensuring proper staple formation.
Solution Approach 2:
The patent modifies physical parameters of the firing bar by incorporating horizontal slits, relieved areas, and resilient materials. These changes allow the firing bar to change its spacing parameter dynamically in response to tissue thickness variations, transforming a fixed-parameter system into a variable-parameter system that can accommodate different tissue conditions.
2Device complexity
If a rigid stapling instrument with fixed spacing is used, then structural simplicity is maintained, but it results in loose staples in thin tissues due to inability to adjust for varying tissue thicknesses
Solution Approach 1:
The firing bar incorporates flexible components that provide dynamic adjustment capability without requiring complex mechanical systems. The horizontal slits, relieved areas, and resilient materials enable the structure to flex and adapt to thin tissues, ensuring proper staple formation and retention while maintaining relative structural simplicity.
Solution Approach 2:
The patent uses flexible elements within the firing bar structure, including resilient materials and relieved areas that create a flexible, adaptable component. This flexible design allows the instrument to conform to varying tissue thicknesses, ensuring reliable staple formation in thin tissues without requiring complex adjustment mechanisms.
3Ease of operation
If uniform clamping force is applied to all tissues, then operational simplicity is maintained, but it causes damage to thinner tissues due to lack of adjustment capability
Solution Approach 1:
The firing bar is designed to automatically adjust its spacing and thereby its clamping force based on the tissue thickness it encounters. The flexible components and relieved areas enable the instrument to self-regulate the applied force, eliminating the need for manual adjustment while preventing damage to thin tissues.
Solution Approach 2:
The patent enables the clamping force parameter to change automatically in response to tissue thickness variations. The resilient materials and structural features of the firing bar allow it to modify its mechanical properties and applied force dynamically, providing tissue-appropriate clamping without requiring complex control systems.
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 staple formation to match tissue thickness, preventing damage and ensuring proper staple retention, while maintaining consistent staple quality across varying tissue thicknesses, thereby reducing the risk of bleeding and necrosis.
Implementation Method 1
compliant E-beam firing bar with flexible components, such as horizontal slits, relieved areas, and resilient materials
Data Source
AI summary
A staple having a crown, a deformable leg extending from the crown, and a spring extending from the crown configured to compress tissue between the spring and the deformable member. Owing to the flexibility of the spring, the staple can accommodate a wide range of tissue thicknesses while still compressing the tissue captured therein. As a result, a single staple design can be used in a wide variety of surgical procedures thereby reducing the amount of staple designs that must be provided to the surgeon. In at least one embodiment, the staple includes a crushable member. This crushable member can include a plastically deformable first portion and an elastically deformable second portion. The present invention can also include, in various embodiments, a crown, a first deformable member extending from the crown, and means for compressing the tissue against the first deformable member.