Surgical Stapler Electronic Counter and Lockout Mechanism
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Solution Overview
Problem
Surgical stapling systems lack a mechanism to prevent 'empty firing' during laparoscopic and endoscopic procedures, and there is a need for a visual indicator to show the number of firings and remaining firings, as well as data collection for medical facilities and manufacturers.
Innovation Solution
A surgical stapling system with a handle, adapter, and loading unit, featuring a controller, motor, and identification devices that communicate data on adapter and loading unit conditions, including force measurements, to prevent excessive firing and display firing status, with a method for updating data and recommending replacement cartridges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a surgical stapler is designed to provide multiple firings without removal from the surgical site, then productivity is improved, but the risk of empty firing increases
Solution Approach 1:
The patent implements a feedback mechanism through an electronic counter that tracks the number of firings and provides real-time visual indication via LEDs. The system monitors cartridge status and provides feedback to the operator, preventing empty firing by indicating when the cartridge is depleted or when a lockout condition occurs after partial firing.
Solution Approach 2:
The patent introduces an intermediary lockout mechanism that acts as a mediator between the firing mechanism and the cartridge. This lockout prevents the firing mechanism from operating when the cartridge is empty or when a partial firing has occurred, thereby preventing harmful empty firing while maintaining multiple firing capability.
2Reliability
If a lockout mechanism is implemented to prevent empty firing, then reliability is improved, but device complexity increases
Solution Approach 1:
The lockout mechanism is integrated with an electronic counter and visual indicator system that provides feedback on cartridge status. This feedback approach allows the lockout function to be implemented through software/control logic rather than complex mechanical interlocks, reducing overall device complexity while maintaining reliability.
Solution Approach 2:
The patent replaces traditional mechanical lockout mechanisms with an electronic control system that uses a motor, controller, and electronic counter. This substitution reduces mechanical complexity while achieving the same safety function of preventing empty firing through electronic monitoring and control.
3Ease of operation
If visual indicators are added to show firing status, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The patent uses color-changing LEDs as visual indicators to show firing status. Different colors indicate different states (e.g., green for available firings, red for depleted cartridge). This simple optical approach provides clear visual feedback without adding significant complexity, improving ease of operation.
Solution Approach 2:
The visual indicator system is integrated into the existing device structure and automatically provides status information without requiring additional user action. The system self-monitors cartridge status and displays information, reducing the need for separate indication mechanisms and minimizing added complexity.
4Loss of information
If data collection capability is implemented, then loss of information is reduced, but device complexity increases
Solution Approach 1:
The data collection system is integrated with the existing electronic counter and control system, using the same feedback infrastructure to monitor and record firing data. This approach allows data collection without adding separate measurement systems, minimizing the increase in device complexity while reducing information loss.
Data Source
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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.