Real-Time Sampling Sheath for Off-Axis Tumor Guidance
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Solution Overview
Problem
Current ultrasound visualization and sampling tools for peripheral lung tumors are limited in their range of motion and diagnostic capabilities, particularly for tumors off-axis from airways, as they fail to provide orientation guidance for the sampling needle relative to the lesion.
Innovation Solution
A device with a multi-lumen sheath and handle system that integrates a radial ultrasound probe and a medical tool, allowing real-time orientation and alignment of the needle relative to the tumor through ultrasound artifacts, and includes anti-buckling mechanisms to prevent tool buckling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a radial EBUS miniprobe is used to locate the tumor, then the approximate location can be determined, but the orientation and direction of the tumor relative to the probe cannot be discerned
Solution Approach 1:
The patent introduces an intermediary mechanism (the guide sheath with visual markers and the relationship between the probe and sheath orientation) that mediates between the ultrasound probe and the operator. The visual markers on the guide sheath act as an intermediary to convey orientation information that the radial probe alone cannot provide, allowing the operator to infer needle-to-lesion orientation through the combined visual and ultrasound information.
2Length of moving object
If the guide sheath is extended beyond the reach of the bronchoscope, then access to peripheral tumors is achieved, but the distal end of the guide sheath becomes invisible
Solution Approach 1:
The patent applies visual markers (color changes or visual indicators) on the guide sheath that are visible through the bronchoscope. These markers allow the operator to see the position and orientation of the guide sheath distal end even when extended beyond the bronchoscope reach, resolving the visibility issue while maintaining the extended length needed for peripheral access.
3Adaptability or versatility
If a sampling needle extends off-axis from the catheter, then access to off-axis tumors is enabled, but rotational orientation knowledge is required which is not provided by radial ultrasound
Solution Approach 1:
The patent implements a feedback mechanism where the operator can see the orientation of the guide sheath and needle relative to anatomical landmarks through visual markers in the bronchoscope view. This visual feedback allows the operator to adjust the rotational orientation of the needle without needing to mentally calculate or infer the orientation from the radial ultrasound alone, making off-axis sampling easier to control.
4Measurement precision
If real-time viewing beyond endoscope range is enabled, then tissue sampling accuracy is improved, but device complexity increases
Solution Approach 1:
The patent makes the guide sheath and handle system multi-functional by integrating both visual marker display and tool guidance capabilities into a single device structure. The same guide sheath that provides mechanical guidance also carries the visual markers for orientation, and the handle system manages both bronchoscope connection and needle actuation. This universality reduces the need for separate devices and minimizes overall system complexity while achieving real-time viewing capability.
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, real-time tissue sampling or drug delivery beyond the endoscope's viewing range by providing visual orientation of the needle relative to the tumor and preventing tool buckling, enhancing diagnostic yield for off-axis tumors.
Implementation Method 1
A radial endobronchial ultrasound (EBUS) miniprobe is first passed through the guide sheath and used to determine the approximate location of the tumor
Implementation Method 2
The shaft portion includes an anti-buckling device that limits buckling of at least one of the sheath or the medical tool within the shaft portion and the manifold includes an anti-buckling device that limits buckling of the medical tool within the manifold
Data Source
AI summary
A device and system for allowing real-time viewing of a procedure beyond a distal end of an endoscope. An exemplary device includes a sheath that has at least two lumens and a handle. The handle includes a connector that connects to a proximal end of an endoscope, a shaft portion that rotatably connects to a proximal end of the connector and a manifold that is slidably received by the shaft portion. The manifold connects to the sheath and allows for insertion of a radial ultrasound probe and a medical tool into the sheath. A stopping device in the manifold avoids accidental needle deployment.