Echogenic Orientation Pins for Radial EBUS Needle Alignment
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Solution Overview
Problem
Current radial endobronchial ultrasound (EBUS) technology is limited in its ability to determine the direction of peripheral lung tumors due to the radial ultrasound probe's 360° image not showing the orientation of the needle relative to the lesion, leading to lower diagnostic yield for tumors off-axis from airways.
Innovation Solution
Incorporation of echogenic orientation pins visible on the ultrasound image, which provide real-time feedback on the rotational orientation of the distal end of the access device and needle relative to the target, ensuring accurate alignment with the lesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a radial EBUS miniprobe is used to visualize peripheral lung tumors, then the lesion can be seen in the 360° ultrasound image, but the orientation of the needle relative to the lesion cannot be determined
Solution Approach 1:
The patent introduces orientation pins as intermediary objects that are visible on the ultrasound image. These pins serve as mediators between the needle and the lesion, providing visual reference points that allow the operator to determine needle orientation relative to the lesion without directly visualizing the needle itself. The pins are positioned at known angles on the catheter and appear as distinct structures in the 360° ultrasound image, enabling spatial relationship assessment.
Solution Approach 2:
The orientation pins are designed to be echogenic (highly reflective to ultrasound waves), making them appear as bright, distinct structures in the ultrasound image. This echogenicity creates a visual contrast that allows the pins to be easily identified and used as reference points, similar to how color changes provide visual information in other imaging modalities.
2Ease of operation
If the guide sheath is extended beyond the reach of the bronchoscope for peripheral sampling, then access to peripheral tumors is achieved, but the distal end of the guide sheath becomes invisible
Solution Approach 1:
The orientation pins serve as intermediary visual markers that allow the operator to see the distal end of the catheter system indirectly. Since the pins are attached to or near the distal end and are echogenic, they provide visual information about the position and orientation of the otherwise invisible distal structures in the 360° ultrasound image.
3Adaptability or versatility
If a sampling needle extends off-axis from the catheter to reach peripheral tumors, then sampling capability is improved, but rotational orientation control becomes difficult
Solution Approach 1:
The orientation pins provide real-time visual feedback on the rotational orientation of the catheter and needle assembly. By observing the position and orientation of the echogenic pins in the 360° ultrasound image, the operator can determine the rotational angle of the needle and adjust it accordingly to achieve the desired sampling orientation toward the lesion.
Solution Approach 2:
The echogenic orientation pins create high-contrast visual signals in the ultrasound image, making it easy for the operator to detect and interpret the rotational orientation of the needle assembly. The bright appearance of the pins against the darker background of surrounding tissue provides clear visual feedback for orientation control.
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
Enhances diagnostic accuracy by allowing precise alignment of the sampling needle with the tumor, improving the diagnostic yield for peripheral lung tumors located off-axis from airways.
Implementation Method 1
a radial endobronchial ultrasound (EBUS) miniprobe is then threaded through the guide sheath and used to determine the approximate location of the tumor
Implementation Method 2
Incorporation of echogenic orientation pins visible on the ultrasound image, which provide real-time feedback on the rotational orientation
Data Source
AI summary
A system for determining orientation of a distal end of a catheter. The system includes a radial ultrasound system configured to generate images based on data received from a radial ultrasound probe. The system also includes a display device to present the generated images, a medical device, and a catheter system. The catheter system includes a flexible shaft having a first lumen configured to receive the radial ultrasound probe and a second lumen configured to receive the medical device, a cap portion having a longitudinal axis, and at least one orientation pin. The cap portion includes a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the fourth lumen and the exit port.