Non-Sensing Interventional Device Length Tracking via Shape-Sensed Guidewire
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Solution Overview
Problem
Existing medical devices without shape sensing fibers require accurate length and angle measurements to be registered with shape-sensed guidewires for precise visualization, but manufacturing variances lead to inaccurate length measurements, and the interaction between shape-sensed and non-shape-sensed devices is critical for certain applications.
Innovation Solution
A system that determines the length of a non-shape-sensed interventional device by securing it to a FORS guidewire via a hub, using a registration module to align the distal tips, and a determination module to calculate the device's length based on known positions, along with a detection module to monitor the guidewire's state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a non-shape-sensed device is used, then the device complexity is reduced, but the measurement precision of the device position and length is degraded
Solution Approach 1:
A hub is introduced as an intermediary component that couples the non-shape-sensed device to the shape-sensed guidewire. The hub provides a known reference point and mechanical coupling, allowing the shape sensing system to indirectly track the position and orientation of the non-shape-sensed device through the guidewire's shape data, thus maintaining measurement precision while using simpler devices
Solution Approach 2:
The patent replaces direct mechanical shape sensing in the non-shape-sensed device with an optical shape sensing system embedded in the guidewire. The optical fiber-based shape sensing measures the guidewire's curvature and position, which is then used to calculate the position of the non-shape-sensed device relative to the hub, substituting complex mechanical sensors with lighter optical sensing
2Ease of manufacture
If manufacturing variances are present, then the ease of manufacture is improved, but the measurement precision of device length is degraded
Solution Approach 1:
The system uses real-time shape sensing feedback from the guidewire to dynamically calculate and adjust the position of the non-shape-sensed device. By continuously monitoring the guidewire's shape and using the known hub position as a reference, the system compensates for manufacturing variances in device length, allowing standard manufacturing tolerances while maintaining precise position tracking
Solution Approach 2:
The patent changes the approach from relying on fixed manufacturing parameters to using dynamic shape parameters measured during use. Instead of depending on precisely manufactured length markings that are sensitive to manufacturing variances, the system measures the actual shape and position of the guidewire in real-time, transforming static manufacturing parameters into dynamic measurement parameters that adapt to actual conditions
3Measurement precision
If the interaction between guidewire and interventional device is monitored, then the measurement precision of device state is improved, but the device complexity is increased
Solution Approach 1:
The shape-sensed guidewire serves multiple functions: it provides mechanical support for delivering the interventional device, acts as a shape sensing probe to track device position, and enables detection of device-g guidewire interactions. This multi-functionality allows the system to monitor device state without adding separate sensing systems to the interventional device itself, thus improving measurement precision while minimizing the increase in device complexity
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 precise visualization of non-shape-sensed devices during procedures by generating a virtual representation, allowing accurate tracking and visualization without requiring shape sensing systems in the device, and providing feedback on the guidewire's state for proper device performance.
Implementation Method 1
A medical device may be enabled with shape sensing by embedding an optical fiber(s) within the device. Optical shape sensing (OSS) or Fiber-Optical RealShape
Data Source
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AI summary
A system and method for determining the length of a non-shape-sensed interventional device (102) which includes a shape-sensed guidewire (106) that is received in the lumen (103) of the device. A hub (107) is configured to secure a position of the shape-sensed guidewire and interventional device. A registration module (124) is configured to register a position of the distal tip (117) of the non-shape-sensed interventional device to a position of the shape-sensed guidewire. A determination module (126) determines the length of the non-shape-sensed interventional device using a known position of the device in the hub and the position of the distal tip of the device. The system includes a detection module (146) that receives curvature data from the shape-sensed guidewire and is configured to determine the state of the shape-sensed guidewire with respect to an interventional device.