Steerable Bronchial Biopsy Needle for Peripheral Lung Nodules
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Solution Overview
Problem
Existing biopsy methods for peripheral lung nodules face challenges in accessing and sampling due to the difficulty in navigating through small and tortuous bronchial airways, with current needles being inflexible, prone to kinking, and requiring invasive transthoracic approaches, and existing systems struggle to take multiple samples from different regions of a single nodule.
Innovation Solution
A steerable biopsy device with a sheath and integrated needle that can articulate through bronchial airways, allowing navigation to and sampling from peripheral lung nodules, including those in the parenchyma, while maintaining a small profile and enabling multiple sampling sites without increasing bronchoscope size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a straight and relatively inflexible biopsy needle is used in typical transbronchial approaches, then the needle can be guided to the region of interest, but it cannot accurately sample the site of interest if the needle is too stiff to navigate the same path through the tissue
Solution Approach 1:
The biopsy needle is divided into multiple articulated segments that can bend relative to each other, allowing the needle to navigate tortuous paths while maintaining the ability to reach the target site for accurate sampling
Solution Approach 2:
The needle transitions from a static, straight configuration to a dynamic, articulated structure that can adapt its shape to follow the tortuous path of bronchial airways while maintaining sampling capability at the distal end
2Ease of operation
If fine gauge needles are used for fine needle biopsies, then deep tissues can be sampled, but the relatively small quantities of tissue sampled may not be representative of the region of interest
Solution Approach 1:
The needle gauge is changed from fine gauge to a larger bore design, enabling the extraction of greater tissue quantities that are more representative of the region of interest while maintaining the ability to access deep lung nodules through the bronchial airways
3Measurement precision
If open surgical procedures are performed for biopsy, then more tissue can be removed and misdiagnosis is reduced, but the procedures are significantly more expensive, require more time for recuperation, require sutures, can leave a disfiguring scar, require anesthesia, carry a small risk of mortality, and can result in bleeding, infection, and wound healing problems
Solution Approach 1:
The articulated biopsy needle serves as an intermediary tool that bridges the gap between minimally invasive bronchoscopic approaches and open surgical procedures, enabling adequate tissue sampling through the airways without requiring thoracotomy or extensive surgical intervention
4Adaptability or versatility
If transthoracic approach is used to access SPN by puncturing through thoracic cavity, then access to deep peripheral nodules can be achieved, but the approach is more invasive than transbronchial approach and requires more recovery time
Solution Approach 1:
The needle incorporates curved or articulated sections that allow it to follow the natural tortuous path of bronchial airways to reach deep peripheral nodules, eliminating the need for direct transthoracic puncture while maintaining access to the same target sites
Data Source
AI summary
A steerable biopsy device comprises an outer sheath comprising a sheath body having a proximal sheath section and a distal sheath section. The outer sheath further comprises a distal sheath tip and a sheath lumen terminating at a distal port in the distal sheath tip. The biopsy device further comprises a biopsy needle integrated with the sheath body. The biopsy needle is slidably disposed in the sheath lumen. The biopsy needle comprises a needle shaft and a distal needle tip configured for being displaced between a stored position within the sheath lumen and a deployed position outside of the distal port of the distal sheath tip. The biopsy device further comprises an articulation control actuator configured for articulating the distal sheath section, and a needle actuator configured for distally advancing the distal needle tip from the stored position to the deployed position.