Multi-lumen Infusion Catheter Tip for Biologics
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Solution Overview
Problem
Existing infusion systems face challenges in preventing particle flocculation during intravascular delivery, ensuring controlled and effective delivery of therapeutic agents like stem cells, and managing blood flow to prevent complications such as heart attacks and suboptimal retention rates.
Innovation Solution
An infusion system featuring a multi-lumen catheter with a separator to prevent flocculation, a configurable balloon valve to control blood flow, and a recollection chamber to manage fluid velocity, ensuring that particles are delivered as individual cells or small groups, and the balloon valve coordinates blood flow with infusion rates to minimize pressure on the vessel wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the passageway diameter is increased to accommodate small groups of particles, then the particles can be delivered as small groups, but the rate at which particles can be carried through the passageway is reduced
Solution Approach 1:
The catheter is divided into multiple separate lumens (e.g., first lumen, second lumen, third lumen) instead of a single passageway. Each lumen has a diameter sized to accommodate individual particles or small groups of particles. This segmentation allows the system to deliver controlled small groups of particles through each lumen while maintaining an overall high delivery rate through the combined capacity of all lumens.
2Stability of the object's composition
If the passageway diameter is decreased to prevent particle flocculation, then particles remain separated, but the ability to deliver small groups of particles is compromised
Solution Approach 1:
Multiple lumens provide separate pathways that prevent particles from interacting and flocculating within a single large passageway. Each lumen's diameter is controlled to allow individual particles or small groups to pass through separately, maintaining particle separation while still enabling the delivery of small groups through the segmented structure.
Solution Approach 2:
The separator positioned within the catheter acts as an intermediary structure that further prevents particle flocculation. It creates additional flow paths and separation zones within the lumens, ensuring particles remain separated as they travel through the catheter system.
3Productivity
If the fluid flow rate is increased to maintain high delivery rate, then productivity is improved, but the impact on the vessel wall when fluid exits the catheter is increased
Solution Approach 1:
The total fluid flow is divided into multiple smaller streams through the multiple lumens. Each lumen exits with a lower individual flow rate, which reduces the impact force on the vessel wall when the fluid exits. The combined delivery rate across all lumens maintains high productivity while each individual stream has reduced harmful impact.
4Stability of the object's composition
If a separator is added to prevent particle flocculation, then particle separation is improved, but the device complexity increases
Solution Approach 1:
The separator is designed as a segmented structure with multiple openings or channels that correspond to the lumens. This segmentation allows the separator to be integrated into the existing multi-lumen structure without requiring a completely separate complex mechanism. The separator's segmented design simplifies manufacturing and integration while effectively preventing particle flocculation.
Data Source
AI summary
A system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal separator. The separator is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter. Importantly, the diameter of each lumen is dimensioned to sequentially receive particles therethrough, to prevent the particles from flocculating before they enter the stream of the second fluid. A recollection chamber in fluid communication with the separator allows for reconsolidation of the fluid after leaving the separator and for minimizing the damage caused to the vessel when the fluid exits the catheter. An inflatable balloon, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid and increase retention of particles in targeted tissue.