Bendable Pulmonary Access Device Navigating Tortuous Airways
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for biopsying lung nodules, particularly peripheral ones, face challenges such as difficulty in accessing small and tortuous airways due to stiff biopsy needles, limited flexibility, and inability to take multiple samples from different regions of a solitary pulmonary nodule (SPN) without increasing the size of the bronchoscope, leading to potential kinking and reduced diagnostic yield.
Innovation Solution
A pulmonary access device with a bendable shaft and deflectable tip, integrated with a profiled stylet and pull wire mechanism, allowing for navigation through bronchial airways, puncturing the lung parenchyma, and taking multiple samples from various sites within the SPN without increasing the bronchoscope's working channel 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 incorporates a bendable section with varying stiffness along its length, allowing the needle to dynamically adapt its shape during navigation. The proximal section maintains higher stiffness for stability during sampling, while the distal section becomes more flexible to navigate tortuous airways, resolving the contradiction between sampling accuracy and navigability.
Solution Approach 2:
The needle's lateral stiffness parameter is deliberately varied along its length, with the bendable section having lower stiffness than the proximal section. This parameter change enables the needle to flex in tortuous pathways while maintaining sufficient rigidity at the sampling point for accurate tissue acquisition.
2Adaptability or versatility
If the bronchoscope working channel size is increased to allow multiple biopsy tools, then multiple samples can be taken, but the device becomes more invasive and harder to navigate through airways
Solution Approach 1:
The biopsy needle is designed as a multi-functional device that integrates both navigation and sampling capabilities in a single tool. The needle can navigate tortuous airways using its flexible distal section and then perform multiple sampling actions at the target site by manipulating the bendable section, eliminating the need for multiple separate tools and maintaining compatibility with standard bronchoscope working channels.
3Object-affected harmful factors
If a fine gauge needle is used for fine needle biopsy, then the procedure is less invasive, but the relatively small quantities of tissue sampled may not be representative of the region of interest
Solution Approach 1:
The needle features localized structural variations with a bendable section that has different stiffness properties than the proximal section. This local quality change allows the needle to flex during navigation while maintaining sufficient rigidity at the tip for effective tissue sampling, enabling adequate tissue acquisition through a relatively small gauge needle.
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 and efficient sampling of lung nodules by navigating through tortuous pathways, reducing the risk of needle kinking, and allowing for multiple biopsies from different regions of an SPN, enhancing diagnostic accuracy and safety.
Implementation Method 1
A pull wire mechanism is integrated into the shaft, enabling bending of the shaft section
Data Source
AI summary
A pulmonary access device comprises an elongated shaft having a proximal shaft section, a bendable shaft section, a distal shaft section, and a distal tip. The pulmonary access device further comprises an elongated sheath having a proximal sheath section, a malleable distal sheath section, and working channel. The working channel is configured for slidably receiving the elongated shaft. The pulmonary access device further comprises a handle assembly including a handle body. The handle body is affixed to a proximal end of the elongated shaft. The handle body is removably affixed to a proximal end of the elongated sheath.