Multi-lumen Injection Needle for In Situ Hydrogel Spacer Delivery
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Solution Overview
Problem
Current methods for placing hydrogel spacers between the prostate and rectum during radiation therapy require additional components and procedures for hydro-dissection, leading to increased complications due to additional punctures and insertions.
Innovation Solution
A needle assembly with a hub and an elongate hollow stylet that includes three separate fluid paths, allowing for the delivery of a hydro-dissection solution and precursor materials for a hydrogel spacer through a single injection needle assembly, with a mixing chamber at the distal end for forming the hydrogel in situ.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate components and procedures are used for hydro-dissection and spacer delivery, then the spacer can be placed with proper tissue dissection, but the number of punctures and insertions increases leading to more complications
Solution Approach 1:
The patent combines the hydro-dissection function and spacer delivery function into a single integrated needle assembly. The hub receives both the hydro-dissection solution syringe and the dual-chamber applicator, and the elongate hollow stylet contains multiple lumens that can deliver both the dissection solution and the hydrogel precursor materials through the same insertion site, thereby reducing the number of punctures and procedures while maintaining proper tissue dissection
Solution Approach 2:
The needle assembly is designed as a multi-functional device that can perform multiple functions: delivering hydro-dissection solution through the outer lumen, delivering first and second precursor materials through inner lumens, and providing mixing chambers for in-situ hydrogel formation. This universal device eliminates the need for separate components for each function
2Manufacturing precision
If additional components and procedures are used for hydro-dissection, then proper tissue dissection can be achieved, but the procedure time and complexity increase
Solution Approach 1:
The hub is pre-configured with multiple ports and the elongate hollow stylet is pre-configured with multiple lumens and mixing chambers, allowing all necessary components for both hydro-dissection and spacer delivery to be ready before the procedure begins. This preliminary preparation enables simultaneous or sequential delivery without requiring additional setup time or procedures during the actual treatment
3Adaptability or versatility
If multiple separate insertions are performed for hydro-dissection and spacer delivery, then each function can be optimized, but the risk of complications increases
Solution Approach 1:
By merging the hydro-dissection delivery and spacer delivery into a single needle assembly with multiple lumens, the patent reduces the number of times the needle must penetrate the tissue. The same insertion site is used for delivering the dissection solution and the hydrogel precursors, thereby minimizing tissue trauma and reducing the risk of complications associated with repeated punctures
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
This solution enables the formation of a hydrogel spacer in the intended location with reduced complications by eliminating the need for separate components and procedures, thereby improving the safety and efficiency of the spacer placement process.
Implementation Method 1
a mixing chamber disposed at the distal portion of the elongate hollow stylet... Mixing of the two precursor materials results in a hydrogel being formed in the space
Data Source
AI summary
Delivery devices, as well as systems incorporating the same and methods of using the same are disclosed. A needle assembly includes a hub having first and second input ports and an auxiliary port, and an injection needle assembly. The injection needle assembly includes an elongate hollow stylet extending distally from the hub that includes an outer side wall defining an outer lumen fluidly coupled to the auxiliary port, a first inner side wall defining a middle lumen disposed within the outer lumen that is fluidly coupled to the first input port, a second inner side wall defining an inner lumen disposed within the middle lumen that is fluidly coupled to the second input port, and a mixing chamber fluidly coupled to the outer lumen, the middle lumen, and the inner lumen.