Balloon Catheter with Elastomeric Sheath for Targeted Drug Delivery
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Solution Overview
Problem
Current balloon catheter devices for delivering therapeutic agents to intravascular sites are limited in their ability to effectively target and distribute therapeutic agents to specific areas within the body, often requiring multiple devices and lengthy coatings processes.
Innovation Solution
A balloon catheter design featuring an inflatable balloon and an elastomeric sheath, both coated with therapeutic agents, which can be configured to move relative to each other along the catheter axis, allowing for targeted delivery of therapeutic agents to specific sites within the body lumen, with the elastomeric sheath expanding to deliver agents to the vessel wall and the balloon delivering agents independently or in conjunction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single balloon catheter with one therapeutic coating is used, then the device simplicity is maintained, but the ability to treat multiple sites or deliver multiple agents is limited
Solution Approach 1:
The catheter device integrates multiple functional components (balloon with therapeutic agent, elastomeric sheath with therapeutic agent, and protective sheath) into a single multi-functional system. The balloon and sheath can be used independently or in combination, allowing the device to treat different lesion types and locations with a single catheter, thereby improving versatility without proportionally increasing complexity
Solution Approach 2:
The catheter is divided into distinct functional segments: the balloon portion with its therapeutic coating, the elastomeric sheath portion with its therapeutic coating, and the protective sheath. Each segment can be independently deployed or activated, allowing selective treatment of different sites while maintaining overall device manageability
2Manufacturing precision
If multiple separate catheters are used to treat different sites, then targeted delivery to specific sites is achieved, but the number of devices and procedures increases
Solution Approach 1:
Multiple therapeutic delivery functions are merged into a single catheter device. The balloon and elastomeric sheath, each capable of independent therapeutic delivery, are combined in one device, allowing treatment of multiple sites or delivery of multiple agents without requiring separate catheters, thereby improving productivity while maintaining targeted delivery capability
3Reliability
If the elastomeric sheath is always expanded, then therapeutic agent delivery to the vessel wall is maximized, but the ability to navigate through the catheter and deploy at the target site is reduced
Solution Approach 1:
The elastomeric sheath transitions from a compressed state during navigation and delivery to an expanded state at the target site for therapeutic agent delivery. This dynamic transformation allows the sheath to be easily deployed through the catheter system while maintaining the capability to expand reliably at the treatment location, balancing delivery efficiency with operational ease
4Adaptability or versatility
If the balloon and sheath cannot move relative to each other, then the device structure is simplified, but the ability to independently deliver therapeutic agents from each component is limited
Solution Approach 1:
The catheter is segmented into movable sections (balloon and elastomeric sheath) that can move independently relative to each other along the longitudinal axis. This segmentation allows each component to be independently positioned and deployed for targeted therapeutic delivery, enhancing versatility while maintaining manageable device complexity through clear functional separation
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
This design enables efficient, targeted delivery of therapeutic agents to multiple sites within the body, potentially reducing the need for multiple devices and simplifying the manufacturing process by allowing a single catheter to treat longer lesions, thus saving time and resources.
Implementation Method 1
an elastomeric sheath including an elastomeric material having a surface with a second therapeutic agent disposed thereon; wherein in a first configuration the inflatable balloon is located within the elastomeric sheath such that expansion of the inflatable balloon to an inflated state expands the elastomeric sheath
Implementation Method 2
positioning a delivery sheath around the balloon, wherein the delivery sheath includes a polymeric material having a therapeutic agent impregnated therein or coated thereon; and applying conditions effective to transfer (e.g., diffuse) the therapeutic agent from the delivery sheath to the surface of the inflatable balloon
Data Source
Figure 1~2
Figure 3A~3C
Figure 4A~4B
AI summary
Balloon catheters that include a balloon and an elastomeric sheath, each having a surface with a therapeutic agent disposed thereon, along with methods of making and methods of using the disclosed balloon catheters.