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.
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 maintain sterility and enable shape sensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If optical connections are established between sterile medical devices and non-sterile capital equipment, then shape sensing capability is enabled, but sterile conditions may be compromised
Solution Approach 1:
The system is divided into sterile and non-sterile segments. The medical device with optical-fiber stylet remains in the sterile field, while the connector module and capital equipment are in the non-sterile field. The surgical drape physically separates these segments, allowing optical signal transmission through the drape without compromising sterility of the medical device.
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 serves as another intermediary, interfacing between the sterile medical device and non-sterile equipment, enabling shape sensing without direct contact between sterile and non-sterile components.
2Object-affected harmful factors
If optical-fiber connector modules are used to maintain sterility, then sterile conditions are preserved, but device complexity increases
Solution Approach 1:
The optical-fiber connector module is designed to perform multiple functions: maintaining sterile barrier, transmitting optical signals for shape sensing, providing mechanical connection, and enabling sensor operation. By integrating these functions into a single module, the overall system complexity is reduced compared to using separate components for each function.
Solution Approach 2:
The connector module combines the sterile barrier function, optical signal transmission path, and electrical connection interfaces into a single integrated component. This merging reduces the number of separate parts and assembly steps, thereby reducing complexity while maintaining sterility.
3Adaptability or versatility
If sensors and power/data wires are integrated into the connector module, then shape sensing functionality is enhanced, but manufacturing complexity increases
Solution Approach 1:
The sensors, power wires, and data wires are pre-integrated into the connector module during manufacturing, before the module is used in the clinical setting. This preliminary integration simplifies the clinical assembly process and ensures proper functionality, though it does increase manufacturing complexity. The module is provided as a pre-assembled unit that requires minimal setup.
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 secure optical connections across sterile and non-sterile fields, allowing for safe and reliable shape sensing of medical devices without compromising sterility.
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
Implementation Method 2
one or more sensors selected from a gyroscope, an accelerometer, and a magnetometer disposed within the housing. The one or more sensors are configured to provide sensor data for determining a reference plane for shape sensing
Implementation Method 3
one or more sensors selected from a gyroscope, an accelerometer, and a magnetometer disposed within the housing
Data Source
AI summary
Optical-fiber connector modules are disclosed. In one example, an optical-fiber connector module can include a receptacle, a cable, 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 can extend 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.


