Guidewire Marker Sensing for Lesion-Only Cutter Activation
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Solution Overview
Problem
Existing medical devices face challenges in preventing the cutting unit from operating in areas other than the intended lesion area during procedures in body cavities, particularly in blood vessels with hardened stenosed sites or bifurcations.
Innovation Solution
A medical device equipped with a rotatable drive shaft, a cutter, a guide wire with markers, and a sensor to detect these markers, along with a controller that switches the cutter's operation state based on marker detection, ensuring it operates only within the lesion area.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the cutting unit is enabled to operate freely in the body cavity, then the productivity of removing stenotic objects is improved, but the reliability of preventing unintended cutting in non-lesion areas deteriorates
Solution Approach 1:
The sensor detects the marker on the guide wire and provides feedback to the controller, which automatically switches the cutter between enabled and disabled states. This closed-loop feedback system ensures the cutter only operates when properly positioned at the lesion site, resolving the contradiction between operational efficiency and safety.
Solution Approach 2:
The guide wire with marker is positioned in advance through the guide tube before the cutter is activated. The marker's position is detected preliminarily to confirm correct placement at the lesion area, enabling safe subsequent cutting operations. This preliminary positioning action prevents unintended cutting while maintaining operational efficiency.
2Reliability
If the cutting unit is protected with position verification mechanisms, then the reliability of preventing unintended cutting is improved, but the device complexity increases
Solution Approach 1:
A simple marker on the guide wire serves as an intermediary element between the positioning system and the cutter control. The sensor detects this simple marker to verify position, providing reliable safety control without requiring complex verification mechanisms. The marker acts as a mediator that simplifies the overall system while ensuring safety.
3Ease of operation
If the cutter operation is automatically controlled by sensor detection, then the ease of operation is improved, but the device complexity increases
Solution Approach 1:
The system performs self-service by automatically switching the cutter's operational state based on sensor detection of the marker, without requiring manual intervention. The controller autonomously determines whether to enable or disable the cutter based on the detected marker position, simplifying the operator's task while implementing automatic control through a straightforward detection mechanism.
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
Prevents the cutting unit from inadvertently starting operations outside the lesion area, ensuring precise and controlled removal of objects like thrombi, plaques, or calcified lesions.
Implementation Method 1
a sensor configured to detect the one or more markers
Data Source
AI summary
A medical device for removing an object in a body cavity, includes a rotatable drive shaft, a cutter attached to a distal end of the drive shaft and by which the object is cut, a guide wire including one or more markers, a guide tube disposed at a distal portion of the drive shaft and including a lumen through which the guide wire can pass and a sensor configured to detect the one or more markers, and a controller configured to control an operation state of the cutter to be an operation disabled state in which the cutter cannot operate and an operation enabled state in which the cutter can operate, and to switch between the operation disabled state and the operation enabled state according to the one or more markers detected by the sensor.