Ultrasound Sampling Access Device With Needle Orientation Feedback
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Solution Overview
Problem
Current medical devices for ultrasound visualization and sampling of peripheral lung tumors are limited in their range of motion and diagnostic capabilities, particularly when tumors are located off-axis, as they lack the ability to determine the orientation of the sampling needle relative to the lesion.
Innovation Solution
An elongated access device with a sheath and intraluminal tip featuring ramp and nose donuts, orientation pins, and a flexible ultrasound probe, allowing for real-time orientation of the medical tool towards the target by reflecting ultrasound signals and providing a 360° image with pin feedback for precise needle placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If a radial EBUS miniprobe is used to visualize peripheral tumors, then the operator can see the tumor location, but cannot determine the orientation of the sampling needle relative to the lesion
Solution Approach 1:
The patent incorporates orientation pins that are visible on the ultrasound image, providing real-time feedback about the needle's rotational orientation relative to the tumor. This allows the operator to adjust the needle angle to ensure accurate targeting of off-axis lesions that are visible on the 360° ultrasound image.
Solution Approach 2:
The patent introduces an intermediary visual reference system using orientation pins that mediate between the ultrasound image and the needle orientation. These pins serve as a visual bridge, allowing the operator to correlate the needle's physical orientation with its position relative to the tumor on the ultrasound display.
2Length of moving object
If the guide sheath is extended beyond the bronchoscope reach, then the sampling needle can reach peripheral tumors, but the distal end of the guide sheath becomes invisible
Solution Approach 1:
The orientation pins provide continuous visual feedback along the extended guide sheath, allowing the operator to monitor the needle's position and orientation in real-time even when the distal end of the guide sheath is beyond the visible range of the bronchoscope.
Solution Approach 2:
The patent adds a rotational orientation dimension to the existing longitudinal visualization. By incorporating angular orientation information through the orientation pins visible on the ultrasound image, the system provides complete spatial awareness (both radial and angular dimensions) of the needle's position relative to the tumor.
3Adaptability or versatility
If the sampling needle extends off-axis from the sheath, then the needle can target off-axis tumors, but requires knowledge of rotational orientation which is not provided by radial ultrasound
Solution Approach 1:
The orientation pins provide real-time rotational orientation feedback that is directly visible on the ultrasound image. This eliminates the need for the operator to mentally calculate needle orientation angles and provides intuitive visual guidance for accurately targeting off-axis tumors.
Solution Approach 2:
The orientation pins appear as distinct visual markers (analogous to color changes) on the ultrasound image that indicate the rotational orientation of the needle. These visual markers provide immediate feedback about the needle's angular position relative to the tumor, making it easy to adjust the needle orientation for optimal targeting.
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 orientation and sampling of off-axis tumors by ensuring the medical tool is directed towards the target, enhancing diagnostic yield and accuracy in peripheral lung tumor procedures.
Implementation Method 1
an intraluminal tip featuring ramp and nose donuts, orientation pins, and a flexible ultrasound probe
Implementation Method 2
A ramp device is received within the hub. The medical tool is configured to deflect off-axis when engaged with the ramp device
Data Source
AI summary
An elongated access device used in a medical system. The elongated access device slidably received a medical tool and an ultrasound probe. The elongated access device includes a sheath and an intraluminal tip attached to the distal end of the sheath. The intraluminal tip includes ramp and nose donuts being spaced apart from one another and configured to be attached to one or more elongated sleeves. One or more orientation pins are engaged with the respective ramp and nose donuts and may be anchored within the sheath. The medical tool is engaged with a ramp formed in the ramp donut or a remp received within the ramp donut. The ultrasound probe is configured to engage with the intraluminal tip so as to ensure that the medical tool directionality is oriented toward a target during a procedure.