Endoluminal Drug Delivery Catheter with Shape-Memory Needle
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Solution Overview
Problem
Current methods for delivering numbing medication to treat varicose veins require multiple painful injections through the skin, which are inefficient and cause discomfort for patients.
Innovation Solution
An endoluminal drug delivery device with a flexible catheter and a needle made of shape-memory material that can be advanced through a single puncture to deliver medication to the surrounding tissue, allowing multiple injections without moving the guidewire, using a system with multiple exit ports and a handpiece assembly for precise control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple injections are delivered through the skin to treat varicose veins, then the medication can be delivered to the treatment area, but the patient experiences pain and the procedure becomes inefficient
Solution Approach 1:
The catheter is segmented into multiple sections with multiple exit ports along its length, allowing the needle to access different treatment areas through a single puncture site. This segmentation enables multiple injections to be delivered through one entry point, reducing the number of skin punctures required and improving procedure efficiency while minimizing patient pain.
Solution Approach 2:
The catheter acts as an intermediary device that bridges the single puncture site and the multiple treatment areas along the vein. By advancing the catheter over the guidewire and extending the needle through different exit ports, the system delivers medication to multiple locations without requiring multiple separate skin punctures, thereby reducing patient discomfort while maintaining treatment effectiveness.
2Object-affected harmful factors
If a single puncture is used to deliver multiple injections, then patient discomfort is reduced, but the device complexity increases
Solution Approach 1:
The device employs a nested structure where the needle is housed within the catheter, which itself is advanced over the guidewire. The needle can be extended through exit ports in the catheter wall, creating a nested configuration that allows multiple injection functions from a single puncture site. This nesting approach consolidates multiple functions into one integrated device, reducing patient discomfort while managing complexity through hierarchical organization.
Solution Approach 2:
The catheter-needle-g guidewire assembly serves multiple functions: the guidewire provides access and support, the catheter provides a pathway with multiple exit ports for different injection sites, and the needle delivers medication. This multi-functional design allows a single device to perform what would otherwise require multiple separate instruments, reducing patient pain while the modular nature of the components helps manage overall device complexity.
3Ease of operation
If the needle is made of shape-memory material, then the needle can automatically assume its curved shape when advanced, but the manufacturing precision requirements increase
Solution Approach 1:
The needle is manufactured from shape-memory material with specific physical parameters (such as transformation temperature and curvature radius) that enable it to automatically assume its intended curved configuration when advanced through the catheter. By carefully selecting and controlling the material parameters during manufacturing, the system achieves automatic needle deployment and positioning, simplifying the operation while the precision requirements are managed through material science approaches rather than mechanical adjustment.
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
Enables efficient and minimally invasive delivery of medication to the target area, reducing patient discomfort and procedural inefficiencies by allowing multiple injections through a single skin puncture, improving the treatment process for varicose veins.
Implementation Method 1
The needle includes a needle lumen configured to be in fluid communication with a drug delivery system. The needle is configured to bias out of the exit port and away from the second lumen when the needle is longitudinally distally advanced. The needle includes a shape-memory material, such as nitinol, that is shape-set to have a curved distal portion.
Data Source
AI summary
A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.