Multi-Lumen Sealant Needle Assembly for Continuous Pleural Sealing
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Solution Overview
Problem
Pneumothorax is a significant complication of lung biopsy procedures, with existing sealant application methods requiring positioning imaging scans that compete with the gelling time of adhesives and often necessitate replacing stylets, prolonging the procedure and increasing the risk of pneumothorax.
Innovation Solution
A sealant injection needle assembly with a multi-stage sealing capability, featuring a cannula and stylet assembly that allows for sequential delivery of multiple sealant components through separate channels, enabling continuous sealing without the need to replace stylets or cannulas during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If positioning imaging scans are performed to apply sealant near pleural layers, then accurate sealant placement is achieved, but procedure time increases and competes with adhesive gelling time
Solution Approach 1:
The needle assembly is pre-configured with multiple sealed lumens and a stylet that can be advanced to different positions to deliver sealant at multiple stages. This preliminary configuration eliminates the need for repeated positioning scans during the procedure, as the system is already prepared to deliver sealant at the precise location and timing needed.
Solution Approach 2:
The multi-lumen needle assembly with movable stylet enables continuous sealant delivery through different lumens at different stages of the procedure. The stylet can be advanced incrementally to expose different lumens, allowing continuous sealing action without interruption or need for stylet replacement, thereby maintaining continuous useful action throughout the procedure.
2Productivity
If stylet is replaced during procedure to continue sealant delivery, then sealant application can proceed, but needle reference moves and adds time to the procedure
Solution Approach 1:
The needle assembly is designed with multiple lumens that can all deliver sealant, making the system multi-functional. Instead of relying on a single stylet that needs replacement, the system can switch between multiple lumens by advancing the stylet to different positions, eliminating the need for stylet replacement while maintaining sealant delivery capability.
Solution Approach 2:
The stylet is designed to be movable along the needle axis, allowing dynamic adjustment of which lumen is active for sealant delivery. This dynamic positioning of the stylet enables the system to adapt and continue sealant delivery through different lumens without replacement, maintaining productivity while avoiding the time loss associated with stylet changes.
3Device complexity
If sealant is delivered through single channel, then delivery is simple, but premature curing occurs and requires stylet replacement
Solution Approach 1:
The delivery system is segmented into multiple lumens within the needle assembly, each capable of delivering sealant. This segmentation allows the sealant delivery function to be distributed across multiple channels, preventing premature curing by providing alternative pathways and eliminating the need for stylet replacement, thereby improving reliability while maintaining reasonable complexity.
Data Source
AI summary
A sealant injection needle assembly includes a cannula assembly and a stylet assembly. The cannula assembly has a cannula hub and a cannula having a first longitudinal sealant passage and a second longitudinal sealant passage. The first longitudinal sealant passage has a first proximal sealant port and a first distal sealant port. The second longitudinal sealant passage has a second proximal sealant port and a second distal sealant port. The stylet assembly has a stylet advance hub and a stylet configured for longitudinal movement in a lumen of the cannula. The stylet has a first stage position and a second stage position. The stylet has a first exterior circumvolving channel longitudinally spaced apart from the second exterior circumvolving channel that are separately selectively and sequentially positionable in fluid communication with both of the first distal sealant port and the second distal sealant port of the cannula.