A microneedle-patterned polymer coating for next-generation drug-coated balloon catheters

Short Description 

 

Next generation drug-coated balloon catheter using a microneedle-patterned polymer coating to penetrate deep into vessel walls and deliver a variety of payloads.

 

Background 

 

Balloon angioplasty remains the standard of care for occlusive cardiovascular diseases, yet its success is often hampered by restenosis and safety concerns. While drug-coated balloons (DCB’s) and other drug-eluting devices aim to address reocclusion, their efficacy is limited, particularly in calcified lesions. The failure to treat deep tissue leads to high re-narrowing rates and often necessitates further interventions. Moreover, DCBs are limited in the types of drugs they can carry and have the potential to wash off their polymer coatings into the bloodstream, causing dangerous emboli. Thus, there is an urgent need for a deep-penetrating, versatile drug delivery system for patients with peripheral artery disease, coronary artery disease, and dialysis access complications.

 

Abstract 

 

This novel drug-coated balloon incorporates microneedle-patterning on the surface to facilitate deep penetration into the vessel walls. Patterning thousands of microneedles on the balloon surface is particularly beneficial to patients with complex calcified lesions, as this breakthrough design enables drug delivery to the lesion epicenter.  Additionally, the microneedle-patterning provides flexibility in treatment options with the ability to deliver all kinds of payloads ((drug, protein, and even DNA/RNA) directly to the disease site.   Following the “nothing-left-behind” principle, this versatile design -- including a bioadhesive layer integrated with a pressure-detachable catheter -- eliminates polymer coating wash-off and leakage into the bloodstream.  By incorporating all these innovative features, this technology improves the effectiveness of the treatment, reduces complications, and offers a safer and more reliable option for patients undergoing critical cardiovascular procedures.