Surgical Stapler Electronic Counter and Lockout Mechanism
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Solution Overview
Problem
Surgical staplers used in laparoscopic and endoscopic procedures lack a mechanism to prevent 'empty firing' and provide real-time visual indicators of the number of firings, making it difficult to manage the stapler's usage and data collection for medical facilities and manufacturers.
Innovation Solution
A surgical stapling system with a handle, adapter, and loading unit that includes a controller, motor, force gauge, and identification devices to track and communicate adapter and loading unit data, preventing actuations beyond the predefined limits and displaying visual indicators for the user.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a surgical stapler is designed to be removed and reloaded at the surgical site, then the stapler can perform multiple firings, but it requires removal from the surgical site and increases procedural time
Solution Approach 1:
The stapler is pre-loaded with multiple cartridges (e.g., 3 cartridges with 20 staples each) before entering the surgical site, enabling multiple firings without removal. The system performs preliminary preparation by loading all necessary cartridges into the handle, allowing continuous operation throughout the procedure.
Solution Approach 2:
Multiple cartridges are nested within the handle assembly, with cartridges stored in a magazine or storage compartment that allows sequential access. The loading unit contains a mechanism to hold and transition between multiple cartridges, enabling the stapler to fire multiple times without removal from the surgical site.
2Ease of operation
If no lockout mechanism is provided, then the stapler can be operated freely, but empty firing may occur causing safety issues
Solution Approach 1:
The system includes a microcontroller that continuously monitors the number of firings and the state of cartridges. A visual indicator (LED display) provides real-time feedback to the operator about the number of remaining staples and warns when the stapler is approaching empty firing conditions. The system provides auditory and visual alerts to prevent empty firing.
Solution Approach 2:
The lockout mechanism is designed to prevent empty firing before it occurs. The microcontroller tracks the number of fired staples and activates a lockout mechanism that physically prevents further firing when the cartridge is empty or when a predetermined number of firings has been reached, thereby preventing the harmful effect of empty firing.
3Device complexity
If no visual indicator is provided, then the device is simpler, but the user cannot track the number of firings or remaining staples
Solution Approach 1:
The system uses LED indicators that change color or illumination patterns to communicate the state of the stapler. Different LED colors indicate different conditions: green for sufficient staples remaining, yellow for low staple count, and red for empty or locked-out state. The visual indicator provides clear, intuitive information about the number of remaining firings.
Solution Approach 2:
A microcontroller serves as an intermediary between the mechanical firing mechanism and the visual display system. The microcontroller counts each firing event and translates this information into visual signals through LED indicators, providing the user with information about the number of remaining firings without adding complex mechanical display mechanisms.
4Loss of information
If data collection capability is added, then usage data can be gathered for management and development, but the device complexity increases
Solution Approach 1:
The microcontroller serves multiple functions: it controls the motor-driven firing mechanism, monitors the number of firings, activates the lockout mechanism, drives the visual indicator display, and collects usage data. This multi-functional approach allows data collection without requiring a separate dedicated data acquisition system, thereby minimizing the increase in device complexity.
Solution Approach 2:
The patent replaces mechanical counting mechanisms with an electronic data collection system. Instead of using mechanical counters or physical indicators for tracking firings, the system uses a microcontroller to electronically record and store usage data, which can then be transmitted to external systems for analysis. This substitution reduces mechanical complexity while enabling comprehensive data collection.
Data Source
AI summary
A surgical system includes a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter. The motor is coupled to a drive shaft of the handle. The adapter including an adapter identification device in communication with the controller, configured to store adapter data, and to communicate the adapter data to the controller. The loading unit configured to affect tissue in response to a force transmitted by the adapter from the drive shaft. The loading unit including a loading unit identification device in communication with the controller, configured to store loading unit data, and to communicate the loading unit data to the controller. The controller is configured to adjust output of a motor based on at least one of the adapter data or the loading unit data.