Articulating Biopsy Needle for Flexible Endoscope Navigation
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Solution Overview
Problem
Existing biopsy devices with rigid puncturing stylets are limited by small working channels in flexible endoscopes, restricting the size and quality of biopsy specimens and limiting access to diverse body lumens.
Innovation Solution
A medical device with a needle comprising a plurality of links and a distal tip, movable between a flexible and rigid configuration, allowing fluid flow through a conduit, and transitioning between configurations via a handle-actuated mechanism, enabling navigation through tortuous anatomy and specimen collection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid puncturing stylet-needle is used for biopsy, then the needle can maintain structural integrity and puncture force, but it cannot be positioned in flexible small diameter endoscopes
Solution Approach 1:
The needle is designed with articulating segments that allow it to dynamically change its configuration. When flexing force is applied, the segments articulate relative to each other, allowing the needle to bend and follow the curvature of the flexible endoscope. When support is provided (e.g., by the endoscope wall or during puncture), the needle maintains its rigid configuration for effective tissue penetration.
Solution Approach 2:
The needle is divided into multiple articulated segments or links that can move relative to each other. This segmentation allows the needle to flex when needed while maintaining overall structural integrity. Each segment can articulate independently, enabling the needle to navigate tortuous paths within the flexible endoscope while still providing sufficient rigidity for biopsy functions.
2Adaptability or versatility
If a flexible needle is used to navigate through endoscope, then the needle can access diverse body lumens, but it cannot provide sufficient rigidity for effective puncture and specimen collection
Solution Approach 1:
The needle transitions from a flexible state during navigation to a rigid state during puncture and specimen collection. The articulating segments are designed to maintain relative articulation during flexion for navigation, but can be stabilized to provide rigidity when force is applied to the distal tip for tissue penetration and sample acquisition.
Solution Approach 2:
The mechanical properties of the needle, specifically its rigidity, are changed based on the operational phase. During navigation, the needle exhibits flexible behavior with segments articulating to follow curved paths. During puncture and specimen collection, the needle maintains or transitions to a rigid configuration to provide the necessary structural support and force transmission for effective tissue sampling.
3Object-affected harmful factors
If smaller diameter endoscopes are used to reduce trauma and access diverse lumens, then patient trauma is reduced and access is improved, but the working channel size is reduced limiting biopsy specimen quality
Solution Approach 1:
The articulated needle design allows it to be introduced through small working channels in flexible endoscopes while maintaining the capability to collect adequate biopsy specimens. The segmented structure enables the needle to flex during insertion through the narrow channel, then maintain rigidity for effective tissue sampling, thus preserving specimen quality despite the small access route.
Solution Approach 2:
The needle dynamically adapts its configuration to match the operational requirements. During insertion through the small-diameter endoscope, the needle flexes to navigate the narrow channel. Once positioned, the needle maintains rigidity for puncture and specimen collection, ensuring that the small access route does not compromise the quality of the biopsy sample obtained.
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 efficient navigation through flexible endoscopes and rigid specimen collection, optimizing device configuration for both flexibility and rigidity to enhance biopsy specimen quality and access to diverse body lumens.
Implementation Method 1
The medical device may include a spring configured to bias the needle into the first configuration
Data Source
AI summary
A medical device may include a needle, including a plurality of links and a distal tip, reciprocally movable between a first configuration and a second configuration, and a conduit including a lumen extending through the needle, the conduit being coupled to the distal tip, wherein longitudinal movement of the conduit is configured to transition the needle between the first configuration and the second configuration.