Linear Stapler Cartridge Lockout and Spent Indicator
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Solution Overview
Problem
Existing surgical stapling instruments lack a reliable mechanism to prevent inadvertent firing when a spent staple cartridge is not replaced, which can lead to tissue severing without staples, increasing the risk of bleeding and requiring frequent replacement of reusable end effectors.
Innovation Solution
A linear stapler with a cartridge lockout mechanism using deflecting features on the side walls of the cartridge to prevent refiring and a spent cartridge indicator, such as a window or color-coded driver, to visually indicate when the cartridge is empty, ensuring safe operation and reducing component complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a reusable end effector is used for multiple operations, then economic efficiency is improved, but the risk of inadvertent firing with spent cartridges increases
Solution Approach 1:
The cartridge lockout mechanism proactively prevents inadvertent firing by requiring deliberate user action (depressing the lockout button) to disable the lockout feature after cartridge replacement. This preliminary protective measure ensures that even if the cartridge is spent or improperly installed, the instrument cannot fire without intentional deactivation of the safety feature.
Solution Approach 2:
The cartridge lockout button serves as an intermediary control element between the user and the firing mechanism. It mediates the firing capability by interposing a manual deactivation step, ensuring that the reusable end effector maintains safety across multiple operations while allowing legitimate reuse when cartridges are properly replaced.
2Reliability
If a cartridge lockout mechanism is added to prevent inadvertent firing, then safety is improved, but device complexity increases
Solution Approach 1:
The cartridge lockout mechanism is merged with the existing cartridge installation and firing structures. The lockout button integrates with the cartridge lockout feature, and the driver assembly incorporates the spent cartridge indicator. This merging approach improves safety while minimizing the increase in device complexity by utilizing existing structural elements rather than adding completely separate systems.
Solution Approach 2:
The cartridge lockout button serves multiple functions: it disables the lockout feature to enable firing, it indicates proper cartridge installation, and it provides tactile feedback for user confirmation. This multi-functionality reduces the need for additional separate components, thereby improving safety without proportionally increasing device complexity.
3Loss of information
If a spent cartridge indicator is added to visually indicate cartridge status, then operational awareness is improved, but manufacturing complexity increases
Solution Approach 1:
The spent cartridge indicator utilizes color changes or visual differentiation (such as a visible window showing cartridge status or color-coded driver portions) to provide clear operational awareness. This visual indication method is integrated into the existing driver assembly structure, allowing manufacturers to implement the feature through straightforward manufacturing processes such as color coding during molding or simple visual window cutouts, thereby minimizing the increase in manufacturing complexity.
Solution Approach 2:
The spent cartridge indicator is designed to automatically display cartridge status without requiring additional active components or complex mechanisms. The indicator passively reflects the cartridge state through visual means (such as showing whether the cartridge is present, spent, or properly installed), eliminating the need for electronic sensors, power sources, or complex mechanical indicators, thus improving operational awareness while maintaining ease of manufacture.
Data Source
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AI summary
A linear stapler comprises a support base having a proximal end and a distal end; a trigger located at the proximal end of the support base; an end effector located at the distal end of the support base, fired by the trigger and including a cartridge. The cartridge comprises a cartridge body. The cartridge body includes staple slots for accommodating staples; and a cartridge lockout which is forced into an open position to abut against an outer side of a staple driver when the cartridge is not fired and which springs back toward the inside direction of the cartridge body after the staples in the cartridge are fired by the staple driver. Another linear stapler comprises a support base having a proximal end and a distal end; a trigger located at the proximal end of the support base; an end effector located at the distal end of the support base, fired by the trigger and including a cartridge, the cartridge comprising a cartridge body including a spent cartridge indicator.