Balloon Infusion Scaffold With Multi-Depth Needle Drug Delivery
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Solution Overview
Problem
Current infusion catheter systems for treating peripheral artery disease (PAD) are limited by single infusion channels, fixed needle lengths, and user dependency, leading to inconsistent drug delivery and prolonged treatment times, especially in below-the-knee interventions, where intimal and medial calcification creates barriers to effective drug penetration.
Innovation Solution
An intravascular apparatus with an inflatable balloon and expandable infusion scaffold featuring primary and secondary spines, equipped with deployable needles and openings, allows for simultaneous delivery of therapeutic agents to different depths within the vessel wall, including the intima and adventitia, ensuring uniform circumferential and longitudinal coverage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single infusion channel and fixed needle approach are used, then the device complexity is reduced, but the delivery consistency and coverage uniformity deteriorate
Solution Approach 1:
The single infusion channel is divided into multiple independent infusion channels (first and second infusion channels) with separate needles. Each channel can be independently positioned and controlled, allowing simultaneous delivery to different depths of the vessel wall (intima and adventitia), thereby improving delivery consistency without requiring a completely complex multi-component system
Solution Approach 2:
The system transitions from a single-point delivery approach to a multi-dimensional delivery approach by positioning needles at different radial depths within the vessel wall. The first needle extends to the intimal layer while the second needle extends to the adventitial layer, creating delivery coverage across multiple spatial dimensions (radial depth, circumferential distribution, longitudinal coverage)
2Device complexity
If a fixed length single needle approach is used, then the device structure is simplified, but the adaptability to different lesion lengths and locations deteriorates
Solution Approach 1:
The needle lengths are made variable rather than fixed. The first needle has a first length optimized for reaching the intimal layer, while the second needle has a second length optimized for reaching the adventitial layer. This dynamic length configuration allows the device to adapt to different lesion characteristics, vessel sizes, and treatment requirements without complicating the overall device structure
Solution Approach 2:
Different portions of the vessel wall are targeted with different needle lengths according to their specific requirements. The intimal layer receives delivery from the first needle with appropriate length, while the adventitial layer receives delivery from the second needle with appropriate length. This local quality approach ensures optimal delivery to each target region while maintaining overall device simplicity
3Ease of operation
If user-dependent delivery methods are used, then the device operation is more flexible, but the treatment time and efficiency deteriorate
Solution Approach 1:
The device is pre-configured with multiple infusion channels and needles positioned at specific orientations and depths before delivery to the lesion site. The first and second needles are pre-positioned to target different vessel wall layers, eliminating the need for time-consuming user-dependent positioning adjustments during the procedure while maintaining operational flexibility through controlled deployment
4Device complexity
If drug delivery is limited to the vessel lumen surface, then the delivery system is simpler, but the treatment effectiveness for deep vessel wall lesions deteriorates
Solution Approach 1:
The delivery system extends from the two-dimensional vessel lumen surface into the three-dimensional vessel wall structure. The first needle delivers to the intimal layer while the second needle delivers to the adventitial layer, creating multi-depth delivery coverage. This dimensional extension enables effective treatment of deep vessel wall lesions while maintaining relative simplicity through a straightforward multi-needle architecture
Data Source
AI summary
Medical devices and methods for delivering fluid. The medical devices include one or more needles for delivering fluid. The methods may optionally include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall. The methods may include delivering a first fluid out of one or more needles, and delivering a secondary fluid (which may be the same type of fluid as the first fluid, or a different type of fluid) from the device without delivering the secondary fluid through a needle.