Powered Surgical Stapler Stroke Calibration for Precise Tissue Actuation
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Solution Overview
Problem
Existing surgical staplers face challenges in ensuring precise and consistent clamping, cutting, and stapling of tissue during anastomosis procedures, particularly in endoscopic and open surgical procedures, without causing trauma or leakage at the anastomosis site.
Innovation Solution
A motorized circular stapler with a calibrated actuation mechanism, including a rotatable knob for precise tissue gap adjustment, a motor-actuated staple driver and knife, and a user interface for feedback, ensures accurate clamping, cutting, and stapling by aligning staple drivers with forming pockets and providing real-time feedback for proper attachment and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a motorized actuation mechanism is used in a circular stapler, then the productivity and consistency of tissue clamping, cutting, and stapling are improved, but the device complexity increases
Solution Approach 1:
The motor unit is designed to perform multiple functions through a single actuator system. The motor unit can drive the anvil closure stroke, staple driver stroke, and knife stroke sequentially, eliminating the need for separate actuators for each function. This multi-functionality approach maintains high productivity while reducing overall device complexity by consolidating actuation mechanisms.
Solution Approach 2:
The system employs dynamic control of the motor unit to adjust actuation parameters in real-time. The control module modifies motor activation based on detected tissue characteristics, anvil position, and stroke progress. This dynamic adaptation allows the motorized system to maintain consistent performance across varying surgical conditions without requiring overly complex mechanical mechanisms.
2Manufacturing precision
If precise tissue gap adjustment is implemented using a rotatable knob, then the manufacturing precision of the anastomosis is improved, but the ease of operation decreases
Solution Approach 1:
The manual rotatable knob mechanism is replaced with an automated motor-driven adjustment system. The control module electronically controls the motor unit to adjust the tissue gap precision without requiring manual rotation. This substitution maintains high manufacturing precision while significantly improving ease of operation, as the surgeon simply needs to activate the adjustment function rather than manually turn a knob.
Solution Approach 2:
The system incorporates self-adjusting features where the motor unit automatically positions the anvil and adjusts tissue gaps based on pre-programmed parameters and real-time sensor feedback. The calibration module performs automatic calibration routines to ensure precise positioning without requiring manual intervention. This self-service capability maintains manufacturing precision while eliminating complex manual adjustment operations.
3Reliability
If real-time feedback mechanisms are added for alignment monitoring, then the reliability of proper attachment is improved, but the device complexity increases
Solution Approach 1:
The system implements feedback mechanisms through sensors that detect anvil attachment status, tissue clamping force, and staple formation quality. The control module receives this feedback and automatically adjusts motor activation parameters to maintain proper alignment and attachment. This feedback approach improves reliability by providing continuous monitoring while managing complexity through electronic control rather than additional mechanical components.
Solution Approach 2:
The control module serves as an intermediary between the motor unit and the feedback sensors. It processes sensor data, interprets attachment status, and translates this information into appropriate motor control commands. This intermediary function consolidates the complexity into a single control system rather than distributing it across multiple independent monitoring mechanisms, thereby improving reliability while managing overall device complexity.
4Manufacturing precision
If calibration routines are performed before each use, then the manufacturing precision of stapling depth is improved, but the loss of time increases
Solution Approach 1:
The system performs calibration routines in advance, either during device assembly or before the surgical procedure begins. The control module executes calibration sequences that establish baseline parameters for motor activation and anvil positioning. By performing this calibration beforehand, the system ensures precise stapling depth without requiring time-consuming calibration during the actual surgical procedure, thus improving manufacturing precision while minimizing time loss.
Solution Approach 2:
The calibration system operates autonomously without requiring continuous manual intervention. The control module automatically executes calibration routines, adjusts parameters, and stores calibration data for future use. This self-service capability reduces the time investment required for calibration, as the system performs adjustments automatically based on pre-programmed sequences and stored reference data, thereby improving precision while minimizing time loss.
Data Source
AI summary
A method is provided for operating a powered surgical stapler having a motor unit, a controller, and a stapling assembly having a plurality of movable members that are actuatable longitudinally by the motor unit to clamp, staple, and cut tissue. The controller determines that a movable member of the stapling assembly is in a first predetermined position, and then executes an actuation algorithm to activate the motor unit to actuate the movable member longitudinally from the first predetermined position toward a second predetermined position. The controller observes an actual longitudinal displacement of the movable member between the first and second predetermined positions. The controller compares the actual longitudinal displacement to an expected longitudinal displacement and determines that the actual longitudinal displacement differs from the expected longitudinal displacement by a difference value. The controller then adjusts the actuation algorithm based on the difference value.