Surgical Stapler Lockout for Missing or Spent Cartridges

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Solution Overview

Problem

Existing surgical stapling and cutting instruments lack effective mechanisms to prevent unintended firing or cutting when the staple cartridge is not properly seated or has already been partially fired, posing risks during surgical procedures.

Innovation Solution

A surgical stapling system with a staple firing lockout mechanism that prevents the firing member from advancing distally when the staple cartridge is not properly seated or has already been partially fired, utilizing a coupling element with a proximally-extending tail to engage a lockout mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If no lockout mechanism is provided, then the device complexity is reduced, but the reliability deteriorates due to risk of unintended firing

Engineering Contradiction:
Improveprevention of unintended firingVSAvoidstructure of lockout mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The lockout mechanism proactively prevents firing before it can occur unintentionally. The coupling element with tail is positioned in advance to engage the lockout structure, blocking the firing member's path before unintended firing can happen. This preliminary prevention ensures reliability without requiring complex real-time detection systems.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The coupling element acts as an intermediary between the staple cartridge and the firing mechanism. Its tail portion mediates the interaction by engaging the lockout structure, ensuring that the firing member can only advance when the cartridge is properly seated. This intermediary component provides a simple yet effective solution to the reliability-complexity contradiction.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a lockout mechanism is implemented, then the reliability improves by preventing unintended firing, but the ease of operation deteriorates due to additional steps required

Engineering Contradiction:
Improveprevention of unintended firingVSAvoidoperation of firing mechanism
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The lockout mechanism is self-activating based on the physical state of cartridge installation. When the staple cartridge is properly seated, the coupling element automatically engages with the lockout structure, enabling firing without requiring the user to manually activate or deactivate any switches. This self-service approach maintains ease of operation while ensuring reliability.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The proper installation of the staple cartridge itself performs the preliminary action of engaging the lockout mechanism. By designing the coupling element to automatically interact with the lockout structure during cartridge insertion, the system eliminates the need for separate user actions to enable or disable the lockout, thereby maintaining operational simplicity.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If the firing member can advance freely, then the productivity is improved by allowing rapid firing, but the safety deteriorates due to risk of firing without proper cartridge seating

Engineering Contradiction:
Improvespeed of stapling operationVSAvoidsafety risk of unintended firing
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The lockout mechanism applies preliminary anti-action by blocking the firing member's distal advancement before unintended firing can occur. The coupling element's tail engages the lockout structure to create a mechanical barrier, preventing the firing member from moving unless the cartridge is properly seated. This preliminary blocking eliminates safety risks without impeding productivity when the cartridge is correctly installed.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The coupling element serves as an intermediary that mediates between the firing member and the lockout structure. It allows rapid firing (maintaining productivity) when the cartridge is properly seated by enabling the firing member to advance, while simultaneously preventing unsafe firing by blocking advancement when the cartridge is improperly installed.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Ensures safe and controlled stapling and cutting operations by preventing unintended firing or cutting, enhancing surgical precision and reducing the risk of complications.

Implementation Method 1

a lockout spring configured to apply a force to the tail

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP4164515B1Stapling instrument comprising a firing lockout
Publication Date: 2025.10.15 CILAG GMBH INTERNATIONAL
  • EP4164515B1 patent drawingFigure 1
  • EP4164515B1 patent drawingFigure 1B
  • EP4164515B1 patent drawingFigure 1C

AI summary

A surgical stapling instrument comprising a tissue cutting knife movable through a staple cartridge to perform a staple firing stroke is disclosed. The stapling instrument further comprises a lockout system configured to prevent the tissue cutting knife from being moved through the staple firing stroke if the staple cartridge is missing from the stapling instrument and/or if the staple cartridge has been previously fired. The lockout system comprises a flexible spring that acts on the bottom of the tissue cutting knife at the initiation of the staple firing stroke to push the tissue cutting knife into a lockout recess if the staple cartridge is missing or has been previously fired.