Surgical Robot Service Mode Lockout for Safe Clinical Transition
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Solution Overview
Problem
The risk of unintentionally using a surgical robotic system in a service mode for performing surgery due to engineers forgetting to transition it to the clinical mode, which can compromise patient safety and regulatory compliance.
Innovation Solution
A control system with a safety mechanism that prevents the surgical robot from transitioning to the clinical mode unless it is calibrated and determined to be in a safe configuration, including power cycling and disabling input devices if in service mode.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the service mode mirrors the clinical mode with full functionality, then testing and diagnostics can be performed unimpeded, but the risk of unintentional surgery in service mode increases
Solution Approach 1:
The patent extracts the safety verification step from the mode transition process. Before allowing transition from service mode to clinical mode, the system separately checks whether safety features are enabled, isolating this critical safety check from the normal transition flow to ensure it cannot be bypassed.
Solution Approach 2:
The patent applies preliminary anti-action by proactively verifying safety feature status before mode transition is permitted. The system preemptively checks whether safety features are enabled and blocks the transition if they are not, preventing the harmful state of performing surgery with disabled safety features.
2Adaptability or versatility
If safety features are disabled in service mode to enable testing, then development testing can occur, but regulatory compliance for surgery is violated
Solution Approach 1:
The patent makes the safety feature status dynamic rather than fixed. The system automatically adjusts the enabled/disabled state of safety features based on the current operating mode (service vs. clinical), allowing flexibility for testing while ensuring compliance when surgery is performed.
Solution Approach 2:
The patent implements feedback by continuously monitoring the operational mode and automatically adjusting safety feature status accordingly. The system receives feedback about which mode is active and responds by enabling or disabling safety features to match the appropriate operational requirements.
3Ease of operation
If the control system allows mode transition without verification, then operational flexibility is maintained, but unintended surgery with disabled safety features becomes possible
Solution Approach 1:
The patent performs the safety verification action before the mode transition is completed. By checking safety feature status in advance and requiring explicit confirmation, the system ensures that safety considerations are addressed before the transition takes effect, preventing unintended surgery.
Solution Approach 2:
The patent introduces an intermediary verification step between service mode and clinical mode. This intermediate safety check acts as a mediator that must be satisfied before the transition can occur, ensuring that safety features are properly configured regardless of the ease of transition.
Data Source
AI summary
A control system for implementing a safety mechanism for a surgical robot, the surgical robot operable in a clinical mode in which the surgical robot can perform surgery in response to inputs received at a surgeon input device of a remote surgeon console, the clinical mode comprising safety features, and the surgical robot operable in a service mode in which tests and diagnostics can be run on the surgical robot in response to inputs received from a service interface, the service mode mirroring the clinical mode except in that several of the safety features of the clinical mode are disabled, the control system configured to, in the safety mechanism: receive a transition command to transition the surgical robot to a surgical clinical mode or a calibration clinical mode in which the surgical robot is calibrated for surgery; in response to receiving the transition command, determine if the surgical robot is operating in the service mode; and if the surgical robot is determined to be operating in the service mode, prevent the surgical robot from being transitioned to the surgical clinical mode or the calibration clinical mode.