Surgical Stapler Anvil State Indicator for Gap Control
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Solution Overview
Problem
Current surgical stapling instruments face challenges in ensuring a secure and leak-proof end-to-end anastomosis between anatomical lumens, particularly in maintaining an appropriate gap distance between the anvil and stapling head to prevent leakage or tissue damage during the anastomosis process.
Innovation Solution
The development of a circular stapling instrument with a mechanism that includes a rotatable knob and actuation system to precisely adjust the gap distance between the anvil and stapling head, featuring a trocar actuation rod with different threading sections for controlled movement and a trigger lockout assembly to prevent actuation unless the gap is within a clinically acceptable range, ensuring proper tissue compression and stapling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the gap distance between anvil and stapling head is not precisely controlled, then the device is easier to operate, but the reliability of anastomosis decreases due to potential leakage or tissue damage
Solution Approach 1:
The anvil state indicator provides visual feedback to the operator about the gap distance between the anvil and stapling head. The indicator includes a first position indicating proper gap distance and a second position indicating improper gap distance, allowing the operator to adjust the anvil position until the indicator shows the correct state, thereby ensuring reliable anastomosis without requiring complex measurement tools
Solution Approach 2:
The patent replaces complex mechanical measurement and adjustment mechanisms with a simpler indicator-based system. Instead of requiring precise mechanical control systems to maintain exact gap distances, the invention uses a visual indicator that simplifies the adjustment process while maintaining anastomosis reliability
2Manufacturing precision
If the anvil position is not properly adjusted, then the operation is faster, but the tissue compression and stapling quality deteriorates
Solution Approach 1:
The anvil state indicator enables the adjustment mechanism to essentially self-regulate. The indicator automatically reflects the current gap distance state, and the operator simply needs to observe the indicator position and make minor adjustments until the indicator shows the proper state, eliminating the need for complex measurement procedures or multiple adjustment steps
Solution Approach 2:
The indicator may utilize visual distinctions (such as different positions, colors, or states) to clearly indicate whether the gap distance is proper or improper, allowing for rapid visual assessment and immediate correction without requiring time-consuming measurements or interpretations
3Measurement precision
If a simple anvil adjustment mechanism is used, then the device is easier to manufacture, but the measurement precision of gap distance decreases
Solution Approach 1:
The indicator provides immediate visual feedback about the gap distance state without requiring complex sensors, actuators, or electronic measurement systems. The mechanical or visual indicator can be manufactured using standard surgical device manufacturing techniques, achieving precise gap distance indication through simple, reliable mechanical linkages or positional indicators
Solution Approach 2:
The indicator mechanism uses simple, easily manufactured components that can be produced cost-effectively. The indicator may be a simple mechanical linkage, a visual flag, or a positional marker that requires minimal manufacturing complexity while providing accurate gap distance information
Data Source
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AI summary
A surgical instrument includes a stapling head assembly, an anvil, an anvil adjustment assembly, and an indicator assembly. The anvil is configured to couple with the stapling head assembly. The anvil adjustment assembly includes a translating member, which is operable to translate relative to the body to thereby adjust a gap distance between the anvil and a distal surface of the stapling head assembly. The indicator assembly includes a first member and a second member. The first member is configured to translate in response to translation of the translating member relative to the body. The second member is configured to remain stationary relative to the body. The indicator assembly is configured to provide feedback indicating whether the gap distance is sized to release tissue from between the anvil and the distal surface based on positioning of the first member in relation to the second member.