Surgical Stapler Lockout Control for Malformed Staple Detection
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Solution Overview
Problem
Existing surgical stapling instruments lack effective mechanisms for adjusting staple parameters and cutting controls based on real-time sensor feedback, leading to potential malformations and inefficiencies during surgical procedures.
Innovation Solution
Implementing a control circuit in surgical stapling instruments to detect malformed staples, adjust staple parameters, and control cutting member torque based on sensor output signals, along with electronic lockouts to prevent actuation when predetermined conditions are not met.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If surgical stapling instruments use fixed staple parameters and cutting controls, then device complexity is reduced, but manufacturing precision and reliability deteriorate due to potential malformations and inefficiencies
Solution Approach 1:
The control circuit receives sensor output signals that provide real-time feedback on staple formation quality and tissue conditions. Based on this feedback, the system dynamically adjusts staple parameters (such as staple height, spacing, and formation force) and cutting controls to maintain manufacturing precision while preventing malformations
Solution Approach 2:
The system transitions from fixed, static parameters to dynamic, adjustable parameters. The control circuit modifies staple formation parameters and cutting torque in real-time based on sensor feedback, allowing the device to adapt to varying tissue conditions and maintain optimal precision throughout the surgical procedure
2Reliability
If surgical stapling instruments implement real-time sensor feedback and dynamic parameter adjustment, then reliability improves by preventing malformations, but device complexity increases
Solution Approach 1:
Sensor output signals provide continuous monitoring of staple formation processes, allowing the control circuit to detect potential malformations early and adjust parameters proactively. This feedback mechanism enhances reliability by preventing defective staples from being formed while maintaining a manageable control system through automated decision-making algorithms
3Reliability
If electronic lockouts are implemented to prevent actuation under certain conditions, then safety and reliability improve, but ease of operation deteriorates due to additional constraints
Solution Approach 1:
The electronic lockout mechanism preemptively prevents actuation when sensor feedback indicates unfavorable conditions (such as improper tissue clamping or insufficient anvil gap). By blocking potentially harmful actions before they occur, the system enhances surgical procedure reliability while the lockout conditions are designed to be intuitive, minimizing disruption to ease of operation
Data Source
AI summary
A method of adjusting a staple parameter of a surgical stapling instrument is disclosed. The method includes determining, by a control circuit of the surgical stapling instrument, a first stroke length for a first staple driver of the surgical stapling instrument to drive a first row of staples of a circular stapling head assembly of the surgical stapling instrument; detecting, by the control circuit, a malformed staple in the first row of staples; adjusting, by the control circuit, the staple parameter, based on the detection of the malformed staple; and determining, by the control circuit, a second stroke length for a second staple driver of the surgical stapling instrument to drive a second row of staples of the circular stapling head assembly.