Surgical Instrument Security Escalation for Wireless Hub Pairing

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Solution Overview

Problem

Medical facilities face challenges in adopting new technologies due to patient safety concerns and a preference for traditional practices, leading to slow implementation of improved systems and inadequate communication between facilities, which hampers the sharing of knowledge and best practices.

Innovation Solution

A computer-implemented interactive surgical system that includes a surgical hub connected to a cloud-based system, enabling communication and data sharing between surgical instruments, robotic systems, and visualization systems, facilitating the integration of advanced technologies while maintaining sterility and efficiency in surgical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If surgical facilities implement new technologies and interconnect systems, then communication and knowledge sharing between facilities improve, but patient safety risks and system complexity increase

Engineering Contradiction:
Improveknowledge sharingVSAvoidpatient safety
Core Design Contradiction:
Loss of informationVSReliability

Solution Approach 1:

The surgical hub acts as an intermediary device that mediates communication between surgical instruments and cloud-based systems. It processes and validates data locally before transmitting to the cloud, ensuring patient safety while enabling knowledge sharing. The hub serves as a trusted intermediary that filters information flow between the surgical environment and external networks.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system is segmented into distinct functional components: surgical instruments, surgical hub, and cloud-based system. This segmentation allows each component to operate independently with defined interfaces, reducing overall system complexity while enabling interconnected functionality. The hub segment handles local processing and safety-critical functions, while the cloud segment handles data storage and analytics.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If surgical instruments are connected to cloud-based systems, then real-time data analysis and situational awareness improve, but device complexity and management overhead increase

Engineering Contradiction:
Improvedata analysisVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Complex cloud-based processing and data analysis functions are extracted from the surgical instruments themselves and relocated to the surgical hub and cloud system. The instruments focus on generating data, while the hub and cloud handle complex analysis, reducing instrument complexity while maintaining advanced analytical capabilities.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The surgical hub serves multiple functions: it acts as a communication gateway, data processor, security validator, and coordination center for multiple instruments. This multi-functionality consolidates complexity into a single universal device rather than distributing it across multiple specialized components.

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

3Reliability

If traditional practices are maintained without interconnection, then patient safety and system reliability are preserved, but communication and shared knowledge between facilities remain inadequate

Engineering Contradiction:
Improvepatient safetyVSAvoidcommunication
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The system implements feedback loops where surgical data is collected, analyzed, and used to generate insights that feed back into surgical practice. Cloud-based analytics process aggregated data from multiple facilities and return actionable insights, creating a continuous improvement cycle that maintains safety while enhancing communication and knowledge sharing.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3506290B1Detection and escalation of security responses of surgical instruments to increasing severity threats
Publication Date: 2024.06.26 ETHICON INC
  • EP3506290B1 patent drawingFigure 1
  • EP3506290B1 patent drawingFigure 2
  • EP3506290B1 patent drawingFigure 3

AI summary

A surgical instrument for use with a surgical hub in a surgical procedure is disclosed. The surgical instrument includes a surgical end effector, a communication module configured to wirelessly pair the surgical instrument to the surgical hub, and a control circuit. The control circuit is configured to detect a first security violation, cause the surgical instrument to generate a first response to the first security violation, store a record of the first security violation, detect a second security violation, and cause the surgical instrument to generate a second response to the second security violation, wherein the second response is escalated from the first response.