Surgical Stapler Calibration via Motor Current Feedback
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Solution Overview
Problem
Powered surgical stapling devices face challenges in maintaining a uniform tissue gap during procedures, leading to inadequate staple formation and increased risk of contamination due to variations in motor performance, device construction, and mechanical tolerances, which require calibration to achieve optimal tissue compression.
Innovation Solution
A system and method that includes a processor, memory, motor, and sensors in a powered surgical instrument to measure current draw during a nominal thickness firing, adjusting programming code coefficients to ensure precise tissue compression, utilizing a simulation reload with known mechanical parameters for accurate calibration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard variables based on tissue type and device characteristics are used for calibration, then the calibration process can be simplified, but manufacturing variations and mechanical play cause the variables to be ineffective across different devices of the same type
Solution Approach 1:
The system dynamically adjusts motor control parameters (speed, torque, duration) based on real-time feedback from sensors measuring tissue compression forces. This allows the calibration to adapt to specific device variations while maintaining a standardized calibration workflow, resolving the contradiction between simplicity and effectiveness.
Solution Approach 2:
The calibration process incorporates feedback loops where sensors monitor actual tissue compression and staple formation outcomes. This feedback is used to iteratively refine motor parameters for each device, ensuring reliable calibration effectiveness across manufacturing variations without complicating the user workflow.
2Force
If high clamping forces are applied to compress tissue, then adequate tissue compression is achieved, but cantilevered jaws splay outwardly increasing tissue gap
Solution Approach 1:
The system applies counteracting forces through the jaw structure design and motor control to compensate for the splaying tendency under load. By dynamically adjusting motor torque and applying compensating forces, the system maintains jaw alignment and tissue gap uniformity even under high compression forces.
Solution Approach 2:
The jaw system transitions from a static rigid structure to a dynamically controlled system that actively adjusts its stiffness and positioning in response to applied forces. Sensors detect jaw position and tissue resistance, allowing real-time adjustments to maintain compression force while preventing splay-induced gap increases.
3Manufacturing precision
If tissue gap is reduced to achieve effective stapling, then staple formation improves, but device variations make consistent gap control difficult
Solution Approach 1:
Each device performs self-calibration by measuring its own mechanical characteristics during the calibration process. Sensors monitor actual tissue compression and staple formation, allowing the device to automatically adjust its parameters to compensate for manufacturing variations, achieving consistent tissue gap control without requiring complex external calibration equipment.
Solution Approach 2:
The system performs preliminary calibration measurements before actual surgical use, characterizing each device's specific mechanical properties. This preliminary data is stored and used to pre-adjust motor parameters and compression profiles, ensuring consistent tissue gap control from the first surgical procedure without requiring complex real-time adjustments during surgery.
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
The system effectively adjusts tissue compression parameters to maintain a consistent tissue gap, improving staple formation and reducing the risk of contamination by accounting for individual device variations, ensuring optimal tissue compression and staple closure.
Implementation Method 1
A current draw on the motor is measured and the measured current draw is used to determine a mechanical property of the reload
Data Source
AI summary
The present disclosure is directed to a testing systems and methods for testing a powered surgical instrument. The powered surgical instrument includes a processor configured to control operation of the powered surgical instrument, a memory configured to store a tissue compression program, a reload configured to clamp tissue, a motor configured to control the reload to apply a compressive force to the tissue by the reload, and at least one sensor configured to measure a current draw on the motor. The processor executes the simulation program to measure the current draw on the motor through a nominal thickness firing and the measured current draw is used to adjust the tissue compression program.