Optical-Fiber Connector Module for Sterile Shape-Sensing Access

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Solution Overview

Problem

There is a need for an optical-fiber connector module that allows single-use medical devices like PICCs and CVCs to be optically connected to non-sterile capital equipment without compromising sterile conditions, as existing methods expose patients to ionizing radiation.

Innovation Solution

An optical-fiber connector module with a housing, receptacle, cable, and optical fiber, configured to establish optical connections between medical devices and interrogators, while incorporating sensors and power/data wires to facilitate shape sensing and secure attachment to patients, enabling connections through surgical drapes without compromising sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If optical connections are established between sterile medical devices and non-sterile capital equipment, then real-time shape sensing capability is improved, but sterile conditions are compromised

Engineering Contradiction:
Improveshape sensing capabilityVSAvoidsterile conditions
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The system divides the optical connection path into two separate segments: a sterile segment (optical fiber stylet integrated with the medical device) and a non-sterile segment (capital equipment). These segments communicate through optical signals that can pass through the surgical drape barrier, allowing shape sensing without compromising sterility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The surgical drape acts as an intermediary medium that allows optical signals to pass through while maintaining the sterile barrier. The optical fiber connector module is positioned on the non-sterile side of the drape, receiving optical signals from the sterile side without breaching the sterile field.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If X-rays are used to check for catheter displacement, then displacement detection is achieved, but patients are exposed to ionizing radiation

Engineering Contradiction:
Improvedisplacement detectionVSAvoidionizing radiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical/radiological detection system (X-rays) with an optical sensing system. Optical fibers embedded in the catheter transmit shape and position information electronically, eliminating the need for ionizing radiation while providing continuous real-time monitoring of catheter displacement.

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

3Measurement precision

If optical fiber stylets are integrated into medical devices, then shape sensing is enabled, but connection to non-sterile equipment compromises sterile field

Engineering Contradiction:
Improveshape sensingVSAvoidconnection procedure
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The surgical drape serves as an intermediary that facilitates the connection procedure. Optical signals can pass through the drape material, allowing the optical fiber stylet in the sterile field to communicate with the connector module on the non-sterile side without requiring physical penetration of the sterile barrier.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system creates an optical copy or representation of the catheter's shape and position data through the optical fiber signals. This optical information can be processed and displayed without requiring physical access to the sterile field, simplifying the connection and monitoring procedures.

Inventive Principle:
Principle #26Copying

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

Enables safe and sterile optical connections between medical devices and non-sterile equipment, allowing for real-time shape sensing and reducing radiation exposure.

Implementation Method 1

The optical fiber is configured to convey input optical signals from the optical interrogator to the optical-fiber stylet and reflected optical signals from the optical-fiber stylet to the optical interrogator

Methodology Applied
Scientific EffectOptical fiber transmission: Optical Fibre

Data Source

PatentEP4007932B1Optical-fiber connector modules including shape-sensing systems and methods thereof
Publication Date: 2025.12.31 BARD ACCESS SYSTEMS INC
  • EP4007932B1 patent drawingFigure 1~2
  • EP4007932B1 patent drawingFigure 3
  • EP4007932B1 patent drawingFigure 4~5

AI summary

Optical-fiber connector modules are disclosed. In one example, an optical -fiber connector module can include a receptacle disposed in a housing, a cable extending from the housing, and an optical fiber within at least the cable. The receptacle can be configured to accept insertion of a first plug for establishing a first optical connection between the optical-fiber connector module and an optical-fiber stylet of a medical device. The cable can include a second plug for establishing a second optical connection between the optical-fiber connector module and an optical interrogator. The optical fiber extends from the receptacle through the cable to the second plug. The optical fiber can be configured to convey input optical signals from the optical interrogator to the optical-fiber stylet and reflected optical signals from the optical-fiber stylet to the optical interrogator. Shape-sensing systems including the optical-fiber connector modules and methods of the foregoing are also disclosed.