Balloon-Expanded Infusion Scaffold for Uniform Vessel-Wall Delivery
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Solution Overview
Problem
Current infusion catheter systems for treating peripheral artery disease (PAD) face limitations such as single infusion channels, fixed needle lengths, and user-dependent delivery, leading to inconsistent coverage of therapeutic agents circumferentially and longitudinally along vessel lesions, particularly in below-the-knee interventions.
Innovation Solution
An intravascular apparatus with an inflatable balloon and expandable infusion scaffold featuring axially-extending spines and needles that are movable relative to a rail, allowing for uniform delivery of therapeutic agents to the vessel wall by expanding circumferentially and longitudinally, with multiple needles spaced to ensure comprehensive coverage without requiring device repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single infusion channel and fixed needle approach is used, then the device structure is simple, but the coverage of therapeutic agents along the vessel lesion is inconsistent and incomplete
Solution Approach 1:
The single infusion channel is divided into multiple infusion channels arranged circumferentially around the balloon. Each channel has its own needle assembly that can be independently deployed. This segmentation allows therapeutic agents to be delivered to multiple locations along the vessel lesion simultaneously, ensuring consistent and complete coverage without requiring complex repositioning operations.
Solution Approach 2:
The needle assemblies are made movable relative to the infusion channels through a rail system. The needles can be axially moved along the rail tracks to different positions, allowing dynamic adjustment of the delivery locations. This dynamic capability enables the system to adapt to varying lesion characteristics and achieve consistent coverage while maintaining a relatively simple overall structure.
2Manufacturing precision
If a fixed length single needle approach is used, then the device is easy to manufacture, but it cannot provide uniform delivery along different lesion lengths
Solution Approach 1:
The needle assemblies incorporate movable components that allow axial movement along rail tracks. This dynamic design enables the needles to be positioned at different lengths along the balloon circumference, providing uniform delivery coverage for lesions of varying lengths. The standardized rail system and modular needle assemblies maintain ease of manufacture while achieving precise delivery uniformity.
Solution Approach 2:
The system allows changing the effective needle length and position parameters through axial movement along the rails. By adjusting these parameters, the delivery can be customized to match different lesion lengths and geometries. This parameter flexibility achieves manufacturing precision for uniform delivery without requiring complex custom-manufactured components for each lesion type.
3Productivity
If user-dependent delivery methods are used, then the device operation is flexible, but the treatment time increases and coverage becomes inconsistent
Solution Approach 1:
The rail systems and needle assemblies are designed to self-align and self-position through the inflation and expansion process. As the balloon inflates, the needles automatically move to their deployed positions along the rails without requiring complex user manipulation. This self-service mechanism dramatically improves treatment efficiency and consistency while keeping the operation relatively simple for the user.
Solution Approach 2:
The needle assemblies are designed to deploy and begin delivering therapeutic agents continuously as the balloon expands, rather than requiring discrete user actions for each needle deployment. This continuous useful action eliminates gaps in coverage and reduces treatment time, while the automated deployment process maintains ease of operation.
4Reliability
If multiple axially-spaced needles are deployed from each infusion spine, then comprehensive circumferential and longitudinal coverage is achieved, but the device complexity increases
Solution Approach 1:
The delivery system is segmented into modular components: multiple infusion spines circumferentially spaced around the balloon, with each spine containing multiple axially-spaced needles. This modular segmentation allows comprehensive coverage through simple repetition of identical units rather than complex integration. Each module can be manufactured and assembled independently, reducing overall device complexity while achieving complete coverage.
Solution Approach 2:
The rail systems and needle assemblies are designed as universal components that can be reused across multiple spines and at multiple axial positions. The same rail design and needle assembly structure are deployed at each location, providing comprehensive coverage through replication rather than customization. This universality simplifies manufacturing and assembly while achieving complete circumferential and longitudinal coverage.
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 apparatus enables efficient and reliable delivery of therapeutic agents to the adventitial tissue, improving patency rates and reducing treatment time by ensuring uniform coverage along the lesion length, overcoming limitations of existing systems.
Implementation Method 1
The apparatus includes an inflatable member and an expandable infusion scaffold. The scaffold may include at least first and second axially-extending infusion spines circumferentially spaced about an outer surface of the inflatable balloon... the expandable infusion scaffold may be coupled to the outer surface of the inflatable balloon such that a circumferential distance between the at least first and second axially-extending infusion spines increases as an inflation pressure within the inflatable balloon is increased and as the inflatable balloon is expanded.
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 include expanding an expandable member such as an inflatable member to expand an expandable scaffold outward toward a lumen wall.