Surgical Stapler Safety Algorithms for Blade Obstacle Detection
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Solution Overview
Problem
Existing surgical stapler devices face challenges in distinguishing between tissue resistance and lockout obstacles during the stapling process, which can lead to damage to the device or inadvertent tissue damage, and in detecting the end-of-stroke obstacle to prevent further advancement of the blade assembly.
Innovation Solution
Implementing safety control algorithms that adjust motor power and speed dynamically, using encoders and current level monitoring to detect lockout and end-of-stroke obstacles, and notify the user of potential failures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the surgical stapler uses an electric motor to provide power for clamping tissue and delivering staples, then the productivity and efficiency of the surgical procedure is improved, but the risk of distinguishing between tissue resistance and lockout obstacles increases, which can lead to device damage or inadvertent tissue damage
Solution Approach 1:
The system performs preliminary detection of obstacles before they cause damage. The safety control algorithm continuously monitors motor current and position encoder data during the stapling process to identify lockout obstacles or end-of-stroke conditions before they result in device damage or tissue injury. This proactive detection allows the system to take preventive action.
Solution Approach 2:
The system implements a feedback mechanism where the microcontroller receives real-time data from the position encoder and current monitor, processes this information through safety control algorithms, and adjusts motor operation accordingly. When an obstacle is detected, the system provides feedback to the user through visual or audible alerts, and automatically adjusts motor power to prevent damage.
2Reliability
If the surgical stapler continuously monitors motor current and position to detect obstacles, then the reliability and safety of the device is improved, but the device complexity increases due to additional sensors and control algorithms
Solution Approach 1:
The microcontroller serves multiple functions: it controls motor operation, processes encoder position data, monitors current levels, implements safety control algorithms, and provides user feedback. By consolidating these functions into a single control unit, the system achieves reliable obstacle detection without proportionally increasing overall device complexity.
Solution Approach 2:
The safety monitoring system uses the existing motor current and position encoder data that are already being collected for normal operation. The safety control algorithm processes this existing information to detect obstacles, meaning the system essentially monitors itself using data it already generates during normal stapling operations, avoiding the need for separate dedicated sensing systems.
3Reliability
If the surgical stapler uses a lockout assembly to prevent further advancement of the blade assembly, then the safety and protection of the device is improved, but the difficulty of detecting and measuring the lockout obstacle increases
Solution Approach 1:
The system replaces mechanical obstacle detection methods with electronic sensing. Instead of relying on mechanical switches or physical contacts to detect the lockout obstacle, the system uses a position encoder to monitor blade assembly position and a current monitor to detect abnormal current draw when the obstacle is encountered. This electronic approach makes obstacle detection more reliable and less complex than mechanical methods.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Prevents damage to the reloadable cartridge assembly and inadvertent tissue damage by accurately detecting and responding to lockout and end-of-stroke obstacles, ensuring safe and controlled stapling operations.
Implementation Method 1
using encoders and current level monitoring to detect lockout and end-of-stroke obstacles
Implementation Method 2
Implementing safety control algorithms that adjust motor power and speed dynamically, using encoders and current level monitoring
Data Source
AI summary
Safety control algorithms for surgical devices, including safety control algorithms for surgical stapler devices, and associated systems, devices, and methods. In one embodiment, a method of operating a surgical stapler comprises tracking a position of a distal end of a blade assembly of a reloadable cartridge assembly of the surgical stapler as the distal end of the blade assembly is moved, via actuation of a motor and a corresponding drivetrain, along a stroke of the blade assembly. The method can further comprise adjusting a current limit for current levels in the drivetrain based on the position of the distal end of the blade assembly along the stroke.