Shock Deferral Unit Authentication

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Solution Overview

Problem

Inappropriate shock therapy delivery by implantable and wearable defibrillators poses risks to patients, as both inappropriate shocks and failure to deliver shocks can be hazardous, and existing systems lack effective mechanisms to safely defer shocks without human error.

Innovation Solution

A portable shock deferral system that includes a bi-directional communication device, user interface, and authentication interface, allowing patients or caregivers to receive notifications of impending shocks and authenticate to defer therapy, thereby reducing the risk of inappropriate shock delivery through a user-friendly and secure process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If patients and caregivers are allowed to defer impending shock treatment, then inappropriate shocks can be avoided, but the risk of human error or inadvertent interaction resulting in inappropriate shock deferral increases

Engineering Contradiction:
Improveinappropriate shock deliveryVSAvoidrisk of inappropriate shock deferral
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

An external defibrillator controller is introduced as an intermediary device between the patient and the implantable defibrillator. This controller receives deferral inputs from patients or caregivers and transmits authenticated deferral commands to the defibrillator, thereby enabling safe shock deferral while minimizing the risk of human error through controlled access and authentication mechanisms

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system changes the parameter of user access control by implementing authentication requirements (such as passwords or biometric verification) before allowing shock deferral. This parameter change ensures that only authorized individuals can defer shocks, reducing the risk of inappropriate deferral while maintaining the ability to prevent inappropriate shock delivery

Inventive Principle:
Principle #35Parameter changes

2Reliability

If authentication mechanisms are implemented to prevent human error, then the risk of inappropriate shock deferral is reduced, but the complexity of the system increases

Engineering Contradiction:
Improveauthentication of user intentVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The external defibrillator controller serves as an intermediary that handles authentication and command transmission functions. By placing authentication mechanisms in this external device rather than integrating them directly into the implantable defibrillator, the system achieves reliable user verification while minimizing the complexity of the implanted device

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system is segmented into two distinct components: an external defibrillator controller that handles authentication and user interaction, and an implantable defibrillator that executes shock delivery. This segmentation allows authentication complexity to be isolated in the external device, reducing the complexity burden on the implantable device

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3452167B1Authentication of shock therapy deferral
Publication Date: 2021.02.24 CARDIAC PACEMAKERS INC
  • EP3452167B1 patent drawingFigure 1
  • EP3452167B1 patent drawingFigure 2
  • EP3452167B1 patent drawingFigure 3

AI summary

The current technology relates to a shock deferral unit that is portable by an ambulatory patient. The shock deferral unit has a bi-directional communication device configured to receive a notification of an impending shock from a defibrillator and configured to send an instruction to defer the impending shock to the defibrillator. An authentication interface is configured to receive authentication data from a user. A user instruction interface is configured to receive the instruction to defer the impending shock from the user. An authentication device is configured to authenticate the user based on the authentication data and instruct the bi-directional communication device to send the instruction to defer a shock upon authentication and receipt of the instruction to defer the shock.