Multi-Lumen CED Catheter With Sealed Stylet Lumen to Limit Reflux
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Solution Overview
Problem
Conventional CED catheters face limitations such as limited distribution of therapeutic agents, difficulty in achieving uniform distribution in larger tumors or complex anatomical regions, air bubbles disrupting flow, reflux issues, and the need for general anesthesia during infusion procedures.
Innovation Solution
A multi-lumen catheter design with a sealed stylet lumen and capillary tube, featuring a retractable stylet for rigidity during insertion and flexibility post-insertion, incorporates a reinforcement sleeve and a step design for minimizing reflux, and incorporates sensors for detecting infusion parameters, which includes a capillary tube and a step design for minimizing reflux, and a step design for minimizing reflux.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-port catheter is used for CED therapy, then the catheter structure is simple, but the distribution of therapeutic agent is limited and uniform distribution in larger tumors is difficult to achieve
Solution Approach 1:
The catheter is divided into multiple lumens (first lumen for stylet, second lumen for capillary tube, third lumen for sensors) to enable simultaneous stylet insertion, therapeutic agent delivery, and real-time monitoring, resolving the contradiction between simple structure and effective drug distribution
2Ease of operation
If the catheter lumen is open at the distal end to allow stylet insertion, then the stylet can be inserted, but air bubbles can enter and disrupt therapeutic agent flow
Solution Approach 1:
The catheter is divided into multiple lumens with the first lumen sealed at the distal end to prevent air bubble entry while allowing stylet insertion through the sealed membrane, maintaining both ease of operation and flow reliability
Solution Approach 2:
A sealed distal end with a membrane structure acts as an intermediary that allows the stylet to pass through during insertion while preventing air bubbles from entering the therapeutic agent delivery pathway, thus maintaining reliable flow
3Ease of manufacture
If a simple catheter design is used, then the catheter is easy to manufacture, but reflux occurs when therapeutic agent flows out and backs up along the external surface
Solution Approach 1:
The catheter incorporates a sealed distal end structure that segments the internal lumens from the external environment, preventing therapeutic agent from leaking along the external surface and causing reflux, while maintaining ease of manufacture through a straightforward sealing design
4Strength
If the catheter is rigid to provide structural support, then the catheter maintains its shape, but the patient requires general anesthesia during infusion due to discomfort
Solution Approach 1:
The catheter employs a dynamic design where the stylet provides rigidity during insertion and the sealed distal end maintains structural integrity during infusion, allowing the catheter to adapt to different operational phases without requiring general anesthesia, thus improving patient comfort while maintaining structural support
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
The efficacy of the multi-lumen catheter design enhances targeted drug delivery, reduces reflux, and allows for conscious sedation during procedures, improving patient comfort and accessibility.
Implementation Method 1
Convection-enhanced delivery (CED) is a promising technique for delivering therapeutic agents directly to brain tissue. It bypasses the blood-brain barrier, a delicate defense system that restricts the passage of large molecules from the bloodstream into the brain.
Implementation Method 2
A pressure gradient is then established, driving the therapeutic agent through the interstitial fluid, bathing a larger volume of tissue compared to traditional diffusion-based methods, with significantly higher concentration of drug.
Implementation Method 3
The first lumen being sealed at the distal end forms a hermetic barrier that vents only proximally through a hub of the catheter and limits entrainable gas volume to microliter order under high pressure
Implementation Method 4
The catheter further includes a retractable (removable) stylet carried in the first lumen of the multi-lumen tube. The stylet is adapted to stiffen the multi-lumen tube during a placement process
Implementation Method 5
CED works by infusing drugs through a catheter placed within the brain parenchyma. A pressure gradient is then established, driving the therapeutic agent through the interstitial fluid
Data Source
AI summary
A medical catheter includes a multi-lumen tube comprising a proximal end, a distal end, a first lumen, and a second lumen, the first lumen being sealed at the distal end. A retractable stylet of the catheter is carried in the first lumen of the multi-lumen tube. The stylet is adapted to stiffen the multi-lumen tube during a placement process and is movable relative to the multi-lumen tube. The first lumen being sealed at the distal end prevents the retractable stylet from protruding from the distal end of the multi-lumen tube. A capillary tube of the catheter is associated with the second lumen of the multi-lumen tube. The capillary tube has a distal tip for releasing an agent at the distal tip to a biological tissue. The distal tip of the capillary tube is an exposed portion of the capillary tube that protrudes beyond the distal end of the multi-lumen tube.