Multi-lumen Biologic-Injecting Needle for Tissue Perfusion
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Solution Overview
Problem
Current methods for delivering bioactive agents and biologic materials, such as stem cells, to treat critical limb ischemia require numerous injections due to limited perfusion, necessitating a need for improved needle arrangements that can effectively distribute these agents across an extended volume of tissue.
Innovation Solution
A biologic-material-delivering needle with a dual lumen system, featuring a first lumen with side ports and a second lumen with a distal opening, allows for simultaneous and controlled delivery of bioactive agents and biologic materials into tissue, enhancing perfusion and distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate injections are used to deliver bioactive agents, then the bioactive agent can be delivered to treat CLI, but the number of injections required increases due to limited perfusion
Solution Approach 1:
The needle is divided into multiple lumens (first lumen with side ports, second lumen with distal opening) that can deliver bioactive agents through different pathways simultaneously. This segmentation allows distributed delivery into extended tissue volume, improving perfusion coverage without requiring multiple separate injection procedures.
Solution Approach 2:
The invention transitions from single-point injection to multi-dimensional delivery by incorporating side ports along the needle shaft and a distal opening, enabling bioactive agents to be distributed radially and longitudinally into three-dimensional tissue volume. This dimensional expansion significantly increases the treated volume per injection.
2Device complexity
If a single lumen needle is used, then the device structure is simple, but the distribution of bioactive agent into tissue is limited
Solution Approach 1:
The needle is divided into multiple lumens (first lumen with side ports, second lumen with distal opening) that can deliver bioactive agents through different pathways simultaneously. This segmentation allows distributed delivery into extended tissue volume, improving perfusion coverage without requiring multiple separate injection procedures.
Solution Approach 2:
The second lumen is positioned within the first lumen, creating a nested configuration where multiple delivery pathways are integrated within a single needle structure. This nesting approach enables complex multi-directional delivery while maintaining a compact, manageable device form factor.
Data Source
AI summary
Arrangements and methods for delivering bioactive agents and/or cells into an extended volume of tissue are disclosed. In one embodiment, a cell-delivering needle arrangement has a tube positioned within a tube and fixedly attached to a wall thereof. In one exemplary method, a cell-delivering needle is advanced into tissue, a suspension of cells is passed through a first lumen and out of side ports, and a suspension of cells is passed through a second lumen and out of a distal opening. Other embodiments are disclosed.