Dual-agent balloon coating for restenosis and healing
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Solution Overview
Problem
Current treatments for vascular stenoses, such as angioplasty and stenting, face limitations including restenosis and stent thrombosis, where paclitaxel-coated balloons can reduce restenosis but also hinder vascular healing, leading to increased risks of late stent thrombosis and recurrent inflammatory responses.
Innovation Solution
A balloon angioplasty system with a dual therapeutic agent coating, comprising an anti-proliferative or anti-mitotic agent like paclitaxel and a pro-resolving mediator to aid vascular healing, delivered via a drug-coated balloon to inhibit restenosis and promote healing simultaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If paclitaxel-coated balloon is used to reduce restenosis, then restenosis is inhibited, but vascular healing is hindered leading to increased risk of late stent thrombosis
Solution Approach 1:
The patent divides the therapeutic function into two separate agents: paclitaxel for restenosis inhibition and a pro-resolving mediator for vascular healing. This segmentation allows each agent to perform its specific function without the negative side effects of the other, resolving the contradiction between restenosis prevention and healing promotion.
Solution Approach 2:
The patent uses a composite coating containing both paclitaxel and a pro-resolving mediator on the balloon surface. This composite material delivers two therapeutic effects simultaneously, overcoming the limitation of single-agent coatings that either prevent restenosis or promote healing but not both.
2Reliability
If paclitaxel is applied to inhibit smooth muscle cell proliferation, then restenosis is reduced, but inflammatory response is prolonged
Solution Approach 1:
The patent introduces a pro-resolving mediator as an intermediary substance that actively resolves inflammation. This mediator works in conjunction with paclitaxel to not only prevent restenosis but also to accelerate the resolution of inflammatory responses, thereby reducing the duration of inflammation while maintaining restenosis prevention.
3Device complexity
If single-agent coating is used to simplify device complexity, then device manufacturing is easier, but therapeutic effectiveness is limited
Solution Approach 1:
The patent employs a composite coating material that integrates multiple therapeutic agents (paclitaxel and pro-resolving mediator) into a single coating layer. This approach maintains relative device simplicity while achieving enhanced therapeutic effectiveness through the synergistic action of multiple agents.
Solution Approach 2:
The dual-agent coating provides multi-functionality by simultaneously delivering restenosis prevention and inflammation resolution. This universal approach addresses multiple therapeutic needs in a single intervention, improving overall therapeutic outcomes without significantly increasing device complexity.
Data Source
AI summary
A method for treating a target vascular portion of a subject including: providing an angioplasty balloon system including a balloon carrying a first therapeutic agent and a second therapeutic agent on a surface of the balloon, wherein the first therapeutic agent is an anti-proliferative or anti-mitotic agent and the second therapeutic agent is a drug that aids in vascular healing on a surface of the balloon; positioning the balloon proximate the target vascular portion; expanding the balloon to engage the target vascular portion; thereby delivering at least a portion of the active agent to the target vascular portion; and withdrawing the balloon from the subject.