Occlusion Perfusion Catheter: A Universal Next-Generation Drug Delivery Device

Purpose: Advanced Catheter Therapies (ACT) has designed Occlusion Perfusion Catheter (OPC) to function as a universal agent-delivery system that will accommodate any therapeutic agent, including pharmaceuticals, biologics, and live cells.

Materials and Methods: The OPC is a five-lumen catheter designed with proximal and distal occlusion balloons, a center space-occupying balloon, an inflow port, an outflow port, and a guidewire lumen compatible with standard 0.014-inch wire. It is a 5-Fr catheter compatible with a 6-Fr sheath. A fiberoptic pressure sensor is incorporated into the inflow lumen to monitor treatment chamber pressure. Occlusion balloons define the treatment region. Proximal and distal occlusion balloons are inflated simultaneously to control blood flow and create a treatment chamber. They serve to prevent systemic distribution of the agent. Fourth and fifth lumens are for inflow and outflow ports located within the established treatment chamber. Trapped blood is removed from the treatment chamber by flushing with saline. The space-occupying balloon can be inflated to minimize amount of therapeutic agent required when indicated. This balloon never touches the vessel wall. After blood has been evacuated, the therapeutic agent is delivered. A sensor monitor controls and optimizes pressure within the chamber for penetration into the media of the vessel wall, longitudinally and circumferentially.

Results: Preclinical confocal analysis of the vessel wall demonstrated delivery of fluorescent paclitaxel within the media and adventitia, circumferentially and longitudinally. pK analysis demonstrated a straight line of 0.1 mcg/mL for 72 hours. According to Axel et al (Circulation 1997:96:636-645), this is the optimal effective range for treating SMC. Seven-day SEM demonstrated that paclitaxel delayed the healing effect. Twenty-eight-day histology demonstrated normal endothelium. Live cell testing demonstrated delivery of live cells with minimal mechanical damage. Clinical freedom from CD-TLR was 96.4% at 6 months, freedom from CD-TLR was 92% at 12 months, and patency was 89.3% at 6 months.

Conclusions: OPC delivers an agent circumferentially and longitudinally into vessel wall. It delivers an effective range of paclitaxel for 90% to 99% inhibition of the SMC, maintains normal intimal endothelial function in 28 days, delivers multiple agents, supports multiple uses in the same patient with a single device controlled pressure within the chamber, negates requirements for accurate balloon-to-wall measurements, delivers live cells with minimal mechanical damage to cell membranes, minimizes systemic effect via flushing, and decreases cost.