Rapamycin Coated Expandable Balloon for Restenosis Prevention
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Solution Overview
Problem
Current treatments for vascular diseases, such as restenosis and atherosclerosis, face challenges with restenosis recurrence and vascular remodeling after procedures like percutaneous transluminal coronary angioplasty, where existing stents may not be suitable or desirable for long-term implantation in larger vessels or specific anatomical locations.
Innovation Solution
A medical device featuring an expandable member coated with a liquid formulation of rapamycin, specifically sirolimus and BHT in a solvent system, is used for local and regional delivery of therapeutic agents directly to the vascular tissue, preventing thrombosis and promoting healing without the need for long-term implantation devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If stents are implanted for long-term support in larger vessels or specific anatomical locations, then vascular structural support is improved, but device complexity and long-term implantation risks increase
Solution Approach 1:
The patent extracts the essential function of vascular support from permanent stents and separates it from the drug delivery function. The expandable balloon device provides temporary mechanical support during angioplasty while delivering rapamycin, then is removed. This eliminates the need for long-term stent implantation in larger vessels or specific anatomical locations where stents are not suitable.
Solution Approach 2:
The patent applies preliminary action by coating the expandable balloon with rapamycin before the angioplasty procedure. The drug is delivered to the vascular tissue during the brief inflation period (seconds to minutes), preventing restenosis without requiring long-term device presence. This preliminary drug delivery eliminates the need for subsequent long-term stent implantation.
2Quantity of substance
If therapeutic agents are delivered systemically, then broad coverage is improved, but local concentration and reduced systemic toxicity worsen
Solution Approach 1:
The patent applies local quality by coating the expandable balloon surface with rapamycin, creating a localized drug reservoir at the treatment site. When the balloon is inflated during angioplasty, the drug is delivered directly to the vascular tissue in high concentration at the lesion site, achieving local therapeutic effect with minimal systemic exposure and reduced toxicity.
3Reliability
If restenosis prevention is achieved through multiple procedures, then treatment effectiveness is improved, but treatment time and patient compliance worsen
Solution Approach 1:
The patent merges two separate treatments into one procedure: mechanical angioplasty (balloon expansion) and pharmacological restenosis prevention (rapamycin delivery). The rapamycin-coated balloon delivers the therapeutic agent during the same procedure as vessel opening, eliminating the need for multiple separate interventions and reducing overall treatment time while improving patient compliance.
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 rapamycin formulation effectively inhibits smooth muscle cell proliferation, reduces neointimal hyperplasia, and prevents vascular remodeling, offering a sustained reduction in restenosis and inflammation, even in areas where stent placement is not feasible, with minimal systemic toxicity and improved patient compliance.
Implementation Method 1
A medical device featuring an expandable member coated with a liquid formulation of rapamycin, specifically sirolimus and BHT in a solvent system, is used for local and regional delivery of therapeutic agents directly to the vascular tissue
Implementation Method 2
an expandable member coated with a liquid formulation of rapamycin
Data Source
AI summary
Medical devices may be utilized for local and regional therapeutic agent delivery. These therapeutic agents or compounds may reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including restenosis, vulnerable plaque, and atherosclerosis in type 2 diabetic patients.