Cardiovascular disease is the leading cause of death across the globe. Atherosclerosis, or the deposition of plaques on the arterial walls, contributes to this statistic by leading to the blockage of blood flow to the heart, periphery, and other vital organs. Percutaneous intervention, often involving balloon angioplasty, is the preferred choice to mitigate these impositions on blood flow and reduce morbidity. However, despite improving patency, the adoption of drug-coated balloons remains limited by cost and procedural demands.

Accordingly, researchers have developed a novel method and system for applying therapeutic drug coatings to uncoated balloon catheters to aid in the maintenance of patency in occluded intrabody regions. This technology involves a tube assembly in which the inner surface is coated with at least one therapeutic agent and is configured to contact the outer surface of an expandable balloon when the balloon is in its expanded state, allowing the balloon to acquire a drug-coated surface.

Notably, this technology is advantageous as this approach allows custom onsite coating, recoating, and reuse of a single balloon catheter during medical procedures such as balloon angioplasty. This system enables the delivery of anti-proliferative or other therapeutic drugs, including paclitaxel, sirolimus, and excipients, effectively to targeted intrabody sites. This system can be provided as a component of a medical kit which may feature multiple tubes with various drugs for serial drug delivery at multiple lesion sites, enhancing treatment flexibility while reducing costs compared to commercially available pre-coated drug-coated balloons.

The inventors are seeking licensing partners and research sponsors to support continued development of the technology; interested organizations are encouraged to contact the university's technology transfer office to discuss licensing opportunities, collaborative research, and funding partnerships.

Technology Overview

Current Challenges

While drug coated balloons have shown superiority to uncoated balloon angioplasty in maintaining patency of occluded arteries and veins, their prohibitive cost, enhanced technical demand, and increase to procedure time has impeded their adoption into clinical practice. Moreover, due to the diffuse nature of these blockages, multiple drug-coated balloons would be necessary in most cases.

Our Innovation

Researchers have developed a novel methodology and system to apply a therapeutic drug coating to uncoated angioplasty balloons onsite in the surgical room. Importantly, this strategy allows for reuse and re-coating of a single angioplasty balloon during the procedure, helping to mitigate the cost and technical demands associated with commercially available drug-coated balloons.

Benefits of this Technology

  • Enables coating of uncoated balloons onsite in the surgical room, reducing costs associated with commercially available pre-drug coated balloons.
  • Allows for multiple drug coatings and re-coatings on the same balloon, enabling the treatment of multiple lesions with the same balloon during a single procedure.
  • Utilizes tubing that mimics the properties of an artery, helping to prevent balloon damage while maximizing drug transfer.
  • Minimizes training requirements as the coating process mimics standard balloon deployment techniques, and the tubing is compatible with the balloon catheter of the clinician’s choice.
  • Controlled inflation times enable the achievement of transfer of clinically relevant doses of the therapeutic drug to the target tissue.

Stage of Development

This technology is currently at the preclinical development stage, with the invention defined through a detailed system and method for intraoperative coating of standard angioplasty balloons using a drug-lined tube assembly. The invention includes a drug-lined tube assembly, methods for transferring anti-restenotic agents such as paclitaxel or sirolimus onto balloon surfaces, and provisions for sterile packaging and clinical deployment. The technology has established design feasibility and a defined clinical workflow, with future development expected to focus on optimization of drug transfer efficiency, validation of coating performance, and preclinical and clinical evaluation of safety and efficacy.