Surgical Instrument Sterile Barrier Interface

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Solution Overview

Problem

Current surgical instruments face challenges in maintaining a sterile environment while transmitting data and power across a sterile barrier, and in ensuring proper connection and authentication of modular components, which affects the reliability and safety of surgical procedures.

Innovation Solution

A surgical instrument system with a disposable outer housing that creates a sterile barrier, an electrical interface assembly for wireless and wired transmission of data and power, and a control circuit for detecting compatible connections and adjusting signal parameters to improve throughput, along with mechanisms for authenticating modular components and preventing unauthorized use beyond the lifecycle.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sterile barrier is introduced to maintain sterility, then reliability is improved, but device complexity increases due to the need for separate interface portions on both sides of the barrier

Engineering Contradiction:

Improvesterility maintenanceVSAvoidinterface assembly structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The electrical interface assembly is divided into a first interface portion positioned on one side of the sterile barrier and a second interface portion positioned on the other side. This segmentation allows each portion to be optimized for its specific environment while maintaining electrical connectivity through the barrier via induction coupling, thereby resolving the contradiction between maintaining sterility and managing interface complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sterile barrier itself acts as an intermediary element that enables electrical coupling between the first and second interface portions through induction. This mediator approach allows power and data transmission without direct physical contact across the barrier, maintaining sterility while enabling communication.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If wireless transmission is used to communicate through the sterile barrier, then ease of operation is improved, but reliability may be affected by signal transmission challenges

Engineering Contradiction:

Improveconnection simplicityVSAvoidsignal transmission

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system replaces traditional mechanical wired connections with wireless induction coupling across the sterile barrier. This substitution eliminates the need for physical penetration of the barrier, simplifying operation while maintaining reliable power and data transmission through electromagnetic field coupling between the two interface portions.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If modular components are introduced for flexibility, then adaptability is improved, but difficulty of detecting and measuring connection compatibility increases

Engineering Contradiction:

Improvemodular component compatibilityVSAvoidconnection authentication

Core Design Contradiction:

Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

The system incorporates authentication mechanisms that provide feedback to verify compatible connections between modular components. The control circuit receives and processes authentication data from the second interface portion, enabling the system to detect and confirm compatible connections, thereby resolving the difficulty of detecting connection compatibility while maintaining modular adaptability.

Inventive Principle:

Principle #23Feedback

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 reliable and safe transmission of data and power across the sterile barrier, authenticates modular components, and prevents unsafe use, enhancing the reliability and safety of surgical procedures.

Implementation Method 1

The first interface portion is configured to form a wireless electrical interface with the second interface portion to facilitate a wireless transmission of the at least one of data signal and power between the control inner core and second interface portion

Methodology Applied

Scientific EffectElectromagnetic induction: Electromagnetic Induction

Data Source

PatentUS12016559B2Powered surgical instruments with communication interfaces through sterile barrier

Publication Date: 2024.06.25 CILAG GMBH INTERNATIONAL

AI summary

A modular surgical instrument system that comprises modular components and a control circuit electrically couplable to the modular components. The modular components comprise a shaft and a handle assembly. The handle assembly comprises a disposable outer housing. The disposable outer housing is movable between an open configuration and a closed configuration. The handle assembly further comprises a control inner core receivable inside the disposable outer housing in the open configuration. The disposable outer housing is configured to isolate the control inner core in the closed configuration. The modular components further comprise a loading unit releasably couplable to the shaft and a staple cartridge releasably couplable to an end effector. The loading unit comprises the end effector. The control circuit is configured to generate an interrogation signal, detect a response signal, determine a modular configuration of the modular surgical instrument system, and assess authenticity of the modular configuration.