Intraoperative Radiotherapy Applicator Seal Integrity Verification

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Solution Overview

Problem

In intraoperative radiotherapy, existing applicators used in radiation therapy do not guarantee the correct and sterile applicator is used, as they can be mixed up or their sterility status is not reliably verified, potentially leading to incorrect or non-sterile applicators being used during treatment.

Innovation Solution

An applicator with a first machine-readable information memory on a seal that becomes unreadable upon removal or destruction, and a second information memory remote from the seal to ensure continuous identification, along with a radiation therapy device equipped with a reading unit to verify the applicator's sterility and correct identification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If an RFID transponder is attached to an applicator for identification, then the applicator can be identified and selected in software, but it cannot ensure that the identified applicator is actually being used or that sterility is maintained

Engineering Contradiction:
Improveapplicator identification verificationVSAvoidsterility guarantee
Core Design Contradiction:
Loss of informationVSReliability

Solution Approach 1:

The identification system is segmented into two separate information memories: a first machine-readable information memory attached to the seal that becomes unreadable when the seal is removed, and a second information memory remote from the seal that remains readable. This segmentation allows verification of both seal integrity and applicator identity, ensuring that the selected applicator is actually being used while maintaining sterility guarantees.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first information memory is prepared in advance on the seal, containing identification data that will automatically become unreadable when the seal is removed. This preliminary arrangement ensures that any attempt to use an applicator without proper seal verification is prevented before the treatment begins, maintaining both identification accuracy and sterility.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If the first information memory is placed on the seal to verify sterility status, then sterility can be verified, but the information becomes unreadable when the seal is removed

Engineering Contradiction:
Improvesterility verificationVSAvoidapplicator identification continuity
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The information storage is segmented into two locations: the first information memory on the seal for sterility verification, and the second information memory remote from the seal for continuous identification. This segmentation ensures that sterility verification is maintained through the seal's integrity while continuous identification is preserved through the remote memory that remains accessible regardless of seal status.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The second information memory acts as an intermediary that bridges the gap between seal removal and identification needs. It provides continuous applicator identification even when the first information memory on the seal becomes unreadable, ensuring that identification continuity is maintained while sterility verification through the seal remains intact.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If manual selection of applicator in software is used, then applicator can be chosen from menu, but there is no guarantee that the selected applicator is actually used

Engineering Contradiction:
Improveapplicator selectionVSAvoidapplicator usage verification
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The radiation therapy device automatically reads the second information memory on the applicator and verifies that it matches the selected applicator in the software. This feedback mechanism ensures that the applicator actually being used matches the one selected in the software, eliminating the gap between selection and usage while maintaining ease of operation through automatic verification.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The applicator itself provides its identification information through the second information memory, which the radiation therapy device automatically reads and verifies. This self-service approach eliminates the need for manual verification procedures, maintaining ease of operation while ensuring reliability through automatic confirmation that the correct applicator is being used.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3868441B1Radiotherapy device, applicator and method for ensuring the use of a proper applicator in radiotherapy
Publication Date: 2022.12.21 CARL ZEISS MEDITEC AG
  • EP3868441B1 patent drawingFigure 1~3
  • EP3868441B1 patent drawingFigure 4
  • EP3868441B1 patent drawingFigure 5

AI summary

An applicator (1) for intraoperative radiotherapy is provided. The applicator (1) has a receptacle (23) for receiving a radiation probe (11) and an insertion port (21) for inserting the radiation probe (11) into the receptacle (23). The insertion port (21) is closed with a seal (29). Furthermore, a first machine-readable information storage device (25) is provided, which is at least partially attached to the seal (29) in such a way that removing or destroying the seal (29) renders the information storage device (25) unreadable.