RFID Tag Verification for Surgical Stapler Anvil Alignment

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Solution Overview

Problem

Circular staplers face issues with anvil-staple head assembly mismatching and improper orientation, leading to misalignment and potential separation during tissue closure, which can result in improper staple formation and tissue damage.

Innovation Solution

Incorporation of RFID technology to ensure compatibility and proper orientation of the anvil and staple cartridge, using RFID tags and scanners to verify identity and orientation, preventing the stapling process unless proper alignment and compatibility are confirmed.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mechanical lockout is used to prevent multiple fire cycles, then reliability is improved, but device complexity increases

Engineering Contradiction:
Improveprevention of multiple fire cyclesVSAvoidmechanical lockout mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical lockout mechanism with an RFID-based identification and verification system. The RFID tag stores unique identifiers and firing status, while the RFID reader verifies compatibility and prevents subsequent firing through electronic control, eliminating complex mechanical lockout components while maintaining reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The RFID tag acts as an intermediary carrier of identification and status information between the staple cartridge and the surgical instrument. This intermediary enables verification and control functions without requiring direct mechanical interaction or complex lockout mechanisms.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If RFID technology is implemented to verify compatibility, then reliability is improved, but device complexity increases

Engineering Contradiction:
Improvecompatibility verificationVSAvoidRFID system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The RFID tag autonomously stores and provides identification information, compatibility data, and firing status without requiring external verification mechanisms. The system leverages the self-contained nature of RFID technology to simplify integration while maintaining reliable compatibility verification.

Inventive Principle:
Principle #25Self-service

3Manufacturing precision

If anvil and staple cartridge alignment is manually verified, then manufacturing precision is improved, but time consumption increases

Engineering Contradiction:
Improveanvil-staple cartridge alignmentVSAvoidverification time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The RFID tag pre-stores alignment verification data and compatibility information before the surgical procedure. The RFID reader quickly retrieves and verifies this pre-prepared information, eliminating the need for time-consuming manual alignment checks while ensuring precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Manual visual inspection and physical alignment verification are replaced with automated RFID reading and electronic verification. The system uses electromagnetic fields to instantly confirm compatibility and alignment status, dramatically reducing verification time while maintaining precision.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If multiple RFID tags are used for different components, then reliability is improved, but device complexity increases

Engineering Contradiction:
Improvecomponent identification accuracyVSAvoidmultiple RFID tags
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The RFID tag is designed as a universal identification solution that can be applied to multiple components (anvil, staple cartridge, shaft). Each tag follows the same technical standard and communication protocol, enabling simplified integration across different components while maintaining high reliability through consistent identification and verification.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 accurate and secure attachment of the anvil to the stapling head, preventing misalignment and ensuring proper staple formation by verifying compatibility and orientation before initiating the stapling sequence, thereby enhancing surgical precision and safety.

Implementation Method 1

RFID technology can be used to identify the components of a surgical instrument, such as staple cartridges

Methodology Applied
Scientific EffectRadio frequency identification (RFID): Electromagnetic Induction

Data Source

PatentEP3769696B1Surgical systems with multiple RFID tags
Publication Date: 2024.11.13 ETHICON INC
  • EP3769696B1 patent drawingFigure 1
  • EP3769696B1 patent drawingFigure 2
  • EP3769696B1 patent drawingFigure 3~4

AI summary

A surgical instrument is disclosed including a housing assembly, a shaft assembly coupled to the housing assembly, at least one radio-frequency identification scanner configured to receive information from radio-frequency identification tags which correspond to components which are couplable to the surgical instrument, and a control circuit. The control circuit is configured to determine, for each component, authenticity of the component based on the information received from the radio-frequency identification tags.