Surgical Stapler Lockout Detection and Motor Force Control

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Solution Overview

Problem

Endoscopic surgical instruments, such as surgical staplers, often fail due to unknown causes, requiring extensive analysis to determine the failure mode, which is costly and challenging, and lacks user feedback for the cutting/stapling operation, leading to acceptance issues among physicians.

Innovation Solution

A surgical instrument with sensors and a memory device that records the conditions of the end effector and trigger, allowing for monitoring and recording of instrument states, including a sensing system to detect lockout conditions and control the electric motor-driven element to adjust force transmission, providing user feedback on deployment and loading force.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If surgical instruments are used without recording capabilities, then the device complexity is low, but the analysis of instrument failures becomes costly and time-consuming

Engineering Contradiction:
Improveanalysis timeVSAvoidinstrument complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by recording operational data before failures occur. Sensors continuously monitor and store operational parameters (temperature, pressure, usage patterns) in memory during normal instrument operation, so that when a failure happens, the pre-recorded data is already available for immediate analysis, eliminating the need for time-consuming retrospective investigations

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses sensors and memory devices as intermediaries between the instrument's operation and the failure analysis process. These components mediate by capturing and preserving operational information, allowing analysts to objectively reconstruct event sequences without needing to physically examine or experimentally recreate the failure conditions

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If surgical instruments lack user feedback mechanisms, then the device complexity is low, but physician acceptance and control are reduced

Engineering Contradiction:
Improvephysician controlVSAvoidinstrument complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent implements feedback by providing users with real-time information about instrument operation through displays that show operational parameters, recorded data summaries, and system status. This allows physicians to monitor instrument performance, verify proper operation, and make informed decisions during procedures, significantly improving ease of operation and physician acceptance

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The instrument applies self-service by automatically recording operational data and generating status information without requiring manual intervention from the physician. The system autonomously monitors parameters, stores data in memory, and presents relevant information through displays, reducing the cognitive burden on users while enhancing their control and awareness

Inventive Principle:
Principle #25Self-service

3Reliability

If extensive analysis is performed to determine failure modes, then the reliability of future operations improves, but the loss of time and resources increases

Engineering Contradiction:
Improveoperation reliabilityVSAvoidanalysis time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

By pre-recording detailed operational data during normal use, the system eliminates the need for extensive post-failure investigations. The stored sensor data provides direct evidence of what occurred leading up to and during the failure event, allowing rapid determination of failure modes and immediate implementation of corrective actions, thereby maintaining high reliability while minimizing analysis time

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11000275B2Surgical instrument
Publication Date: 2021.05.11 CILAG GMBH INTERNATIONAL
  • US11000275B2 patent drawing
  • US11000275B2 patent drawing
  • US11000275B2 patent drawing

AI summary

A surgical stapler comprising an end effector, a sensing system, a housing, and a control system is disclosed. The end effector comprises a firing member configured to move at least partially through the end effector and a stop configured to create a lockout condition by impeding the advancement of the firing member through the end effector. The sensing system is configured to detect the lockout condition. The housing comprises an electric motor-driven element configured to transmit a force to the firing member. The control system is configured to control the electric motor-driven element. The sensing system is in communication with the control system. The control system controls the electric motor-driven element to adjust the force transmitted to the firing member when the lockout condition is communicated to the control system.