Ramped Biopsy Needle for Eccentric Lesion Sampling
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Solution Overview
Problem
Current biopsy methods for lung peripheries, particularly for eccentric nodules, often result in inadequate tissue yields and require multiple device insertions due to blind procedures, making it difficult to accurately target and sample tissue.
Innovation Solution
A biopsy needle system with a catheter and end cap featuring a ramped lateral opening and visual markers for controlled needle orientation, allowing multiple tissue samples from different angles without repositioning, guided by CT scans or ultrasound.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multiple device insertions are performed to sample tissue from eccentric nodules, then tissue sampling coverage is improved, but procedure complexity and time are increased
Solution Approach 1:
The catheter is segmented into multiple sections with individual control, allowing independent manipulation of each segment to access different tissue locations. The catheter includes a proximal section, intermediate section, and distal section that can be selectively positioned and controlled to sample multiple areas without requiring multiple device insertions.
Solution Approach 2:
The catheter transitions from a linear insertion path to multi-dimensional tissue access by incorporating lateral openings and angled needle paths. The needle can be directed at various angles relative to the catheter axis, enabling sampling of eccentric nodules from multiple directions while maintaining a single insertion point.
2Productivity
If blind biopsy procedures are performed beyond bronchoscope vision, then tissue samples can be obtained, but targeting precision is reduced
Solution Approach 1:
The system incorporates real-time feedback through imaging integration, allowing the operator to visualize the catheter and needle position relative to the target nodule. Imaging guidance provides continuous feedback on needle trajectory and tissue contact, enabling precise targeting even when the needle extends beyond direct visual range of the bronchoscope.
Solution Approach 2:
The system replaces blind mechanical needle insertion with image-guided positioning. Instead of relying solely on tactile feedback and anatomical landmarks, the mechanical insertion process is supplemented or replaced by visual feedback from integrated imaging systems that display needle position and target location.
3Device complexity
If the needle is constrained to a straight path through the catheter, then device simplicity is maintained, but access to eccentric nodules is limited
Solution Approach 1:
The needle path transitions from a fixed straight configuration to a dynamic adjustable path. The needle can be deflected at various angles by manipulating the catheter segments, and the lateral opening allows the needle to exit at angles different from the catheter axis, providing adaptable access to eccentric nodules while maintaining a relatively simple catheter structure.
Solution Approach 2:
The system changes the geometric parameters of needle insertion by incorporating lateral openings positioned at specific angles and locations on the catheter. This allows the needle to be inserted at varied angles and positions relative to the catheter axis, expanding access capability to eccentric nodules without fundamentally redesigning the entire device architecture.
Data Source
AI summary
A biopsy needle system includes a needle extending from a tissue piercing distal end to a proximal end. The needle defines a lumen extending from the distal end at least a portion of a length thereof and houses a target tissue. The system also includes an elongated member defining a channel therethrough open at a proximal end. The channel is sized and shaped to permit passage of the needle therethrough. Further, the system includes an end cap coupled to the distal end of the elongate member. The end cap includes a hole extending through a lateral wall thereof. The hole is sized and shaped to permit passage of the needle therethrough. The end cap further includes a ramp extending from the channel to the hole to guide the needle through the hole. The ramp is angled with respect to a longitudinal axis of the elongated member.