The Need: Addressing Vascular Restenosis with Extended Drug Delivery

Vascular restenosis poses a significant medical challenge in the United States, particularly in cases of coronary artery disease treated with bypass grafting. The current methods involve using drug-loaded polymer formulations to deliver compounds locally and inhibit intimal hyperplasia. However, the existing water-based techniques have limited half-lives, leading to restenosis over time, even in transplanted arteries. There is a pressing need for a novel preventive measure to overcome these limitations and provide sustained drug release for extended periods, ultimately reducing restenosis without adverse effects on the treated arteries.

The Technology: Extended Drug Delivery Cuffs

The technology presented involves shaped, hollow polymeric cylinders or cuffs designed to encircle and slowly deliver anti-restenotic drugs, such as rapamycin and paclitaxel, for prolonged periods (months to years). The cuffs are made of biocompatible and biodegradable polymers, particularly Poly(caprolactone) (PCL) and Poly(ethylene glycol) (PEG). These cuffs feature hydrophobic or semi-hydrophobic carriers to maintain the drugs' bioactivity, engineered porosity for controlled drug release, and a relatively high drug volume to sustain optimal drug concentrations over extended durations.

Commercial Applications:

• Drug Delivery for Bypass Grafts: These cuffs can be utilized to deliver anti-restenotic drugs to bypass grafts, ensuring extended drug release to prevent restenosis and maintain graft patency.

• Stent Coatings: The technology can be adapted for use as stent coatings, enabling the controlled release of anti-restenotic compounds and reducing the risk of neointimal hyperplasia.

• Transplanted Artery Treatment: Cuffs can be employed in transplanted artery applications, providing long-term drug delivery to inhibit restenosis and maintain arterial health.

Benefits/Advantages:

• Prolonged Drug Release: The cuffs' design and materials allow for extended drug delivery over months to years, ensuring long-term efficacy in preventing restenosis.

• Controlled and Targeted Delivery: The engineered porosity of the cuffs allows for controlled and sustained release of drugs, directly targeting the treatment site.

• Biocompatibility and Biodegradability: The use of biocompatible and biodegradable polymers, especially PCL and PEG, ensures the safety and compatibility of the technology within the body.

• Minimized Systemic Adverse Effects: By locally delivering drugs to the treatment site, the cuffs significantly reduce systemic adverse effects associated with conventional drug delivery methods.

• Versatile Application: The technology's adaptability makes it suitable for various cardiovascular interventions, including bypass grafts, stents, and transplanted arteries, offering a versatile solution for combating restenosis.

In summary, our extended drug delivery cuffs represent a breakthrough solution to address the pressing issue of vascular restenosis. By providing sustained and targeted drug release over extended periods, this technology has the potential to revolutionize cardiovascular treatments, improving patient outcomes and reducing the burden of restenosis-related healthcare costs.