Real-Time Biopsy Needle Visualization for Target Tissue Alignment
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Solution Overview
Problem
Conventional radial endobronchial ultrasound (R-EBUS) procedures for tissue biopsy in pulmonary passages lack real-time visualization of the biopsy needle, leading to missed targets, unnecessary trauma, excessive bleeding, and misdiagnosis due to repetitive needle actuations.
Innovation Solution
A tissue sampling system comprising a first component with a tissue sampling element and a second component removably attached to an ultrasound catheter, allowing real-time visualization and precise alignment of the biopsy needle before actuation through a fixed alignment and hyperechoic material marking on the ultrasound image.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional R-EBUS TBNA is used without real-time needle visualization, then the procedure can be performed with simpler equipment, but the biopsy needle frequently misses the target nodule requiring multiple repetitive actuations
Solution Approach 1:
The patent combines the ultrasound imaging system and biopsy needle into a single integrated assembly where the needle is permanently coupled to the ultrasound transducer. This merging allows real-time visualization of the needle tip during advancement, ensuring accurate target acquisition while maintaining procedural efficiency. The integrated design eliminates the need for separate needle advancement and imaging steps.
Solution Approach 2:
The system provides real-time ultrasound feedback during needle advancement, allowing the operator to visualize the needle tip position relative to the target nodule. This continuous feedback enables precise control of needle placement, confirming accurate target acquisition before tissue sampling, and eliminating the need for multiple blind actuation attempts.
2Reliability
If multiple repetitive needle actuations are performed to ensure target biopsy, then the biopsy success rate improves, but unnecessary trauma to healthy tissues and excessive bleeding increase
Solution Approach 1:
The system performs preliminary visualization of the needle tip position and orientation relative to the target nodule before the actual tissue sampling actuation. This preliminary action allows the operator to confirm accurate needle placement in real-time, ensuring that the subsequent biopsy actuation will successfully obtain target tissue while avoiding unnecessary trauma to surrounding healthy structures.
Solution Approach 2:
Real-time ultrasound feedback during needle advancement provides continuous information about needle tip position relative to the target nodule and surrounding structures. This feedback enables the operator to stop advancement at the optimal position, confirm accurate target acquisition, and proceed with biopsy actuation only when properly positioned, thereby avoiding trauma to healthy tissues and reducing excessive bleeding.
3Reliability
If multiple repetitive needle actuations and bronchoscope rotations are performed, then the target nodule is more likely to be successfully biopsied, but procedure duration and cost increase
Solution Approach 1:
By merging the ultrasound imaging and biopsy needle into a single integrated assembly with fixed geometric relationship, the system eliminates the need for repetitive bronchoscope rotations to reposition the needle. The integrated design maintains consistent spatial orientation between the imaging transducer and sampling element, allowing accurate target acquisition through controlled needle advancement alone, thereby reducing procedure time.
Solution Approach 2:
The system performs preliminary real-time visualization of needle position and target alignment before each biopsy actuation. This preliminary assessment confirms accurate target acquisition in advance, allowing the operator to proceed directly to tissue sampling without requiring multiple repetitive actuation attempts, thus reducing overall procedure duration while maintaining high target acquisition success rates.
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 accurate and efficient biopsy by ensuring the needle is aligned with the target tissue in real-time, reducing trauma and misdiagnosis, and minimizing procedure duration and cost.
Implementation Method 1
An ultrasound catheter may extend through the contiguous lumen of the first and second components. The ultrasound catheter may include an ultrasound probe slidably disposed within a sheath
Data Source
AI summary
The present disclosure relates to the field of endoscopy. In particular, the present disclosure relates to systems and methods for real-time visualization of a target tissue, and which allows the location/orientation of the biopsy needle to be determined prior to its first actuation.