Balloon catheter providing decreased irritation and improved drug release and drug penetration

摘要

A drug-delivering medical device for delivering a drug to a target site in a body lumen is disclosed. The drug-delivering medical device includes a balloon catheter and an inflatable balloon positioned on the balloon catheter. The inflatable balloon has a hydrophilic surface. One or more portions of the hydrophilic surface are coated with two or more nano-carriers. A nano-carrier of the two or more nano-carriers includes a drug surrounded by an encapsulating medium. As the drug is surrounded by the encapsulating medium, the surface of the nano-carrier is devoid of the drug. When the inflatable balloon is inflated upon coming in proximity to a target site in the body lumen, about 30% to 80% of the two or more nano-carriers are released from the hydrophilic surface within 15-90 seconds.

主权项

1. A drug-delivering medical device for delivering agents to treat a target site via a blood vessel, comprising:
a balloon catheter; and
an inflatable balloon positioned on the balloon catheter,the inflatable balloon having a hydrophilic surface,at least one portion of the hydrophilic surface being coated with a plurality of nano-carriers, including: a first set of nano-carriers comprising a pro-healing agent, a second set of nano-carriers comprising an anti-proliferative agent, and a third set of nano-carriers comprising one or both of an anti-inflammatory agent and an anti-thrombogenic agent, the first set of nano-carriers having a first average diameter ranging from 800 nm to 1500 nm suitable for penetrating an intima layer of a blood vessel through inter-tissue pores present in the intima layer, the second set of nano-carriers having a second average diameter ranging from 300 nm to 800 nm suitable for penetrating a media layer of the blood vessel through a vasa vasorum associated with the media layer and the inter-tissue pores present in the intima layer, and the third set of nano-carriers having a third diameter ranging from 10 nm to 300 nm suitable for penetrating an adventitia layer of the blood vessel through the inter-tissue pores present in the intima layer, the vasa vasorum associated with the media layer and a vasa vasorum associated with the adventitia layer; wherein a first time required for the third set of nano-carriers to release from the hydrophilic surface upon coming in proximity of the target site is less than a second time required for the second set of nano-carriers and the first set of nano-carriers to release from the hydrophilic surface; wherein the third set of nano-carriers exhibit a rapid rate of release from the hydrophilic surface and wherein the second set of nano-carriers and the first set of nano-carriers exhibit slower rates of release from the hydrophilic surface as compared with the rate of release of the third set of nano-carriers; at least one adjacent portion of the hydrophilic surface being uncoated and exposable to a blood or a tissue environment for rapid dissolution from the inflatable balloon and for rapid dissolution from underneath the nano-carriers of an adjacent coated portion of the hydrophilic surface, the rapid dissolution from underneath providing an increase in the rapidity of release of the nano-carriers of the adjacent coated portion; each nano-carrier of the plurality of nano-carriers comprising a respective agent surrounded by an encapsulating medium, wherein a surface of each nano-carrier is devoid of the respective agent and 30% to 80% of the plurality of the nano-carriers are released from the hydrophilic surface within 15-90 seconds when the inflatable balloon is inflated upon coming in proximity to the target site in the blood vessel; and wherein the third set of nano-carriers penetrating into the adventitia layer remain in the adventitia layer for a prolonged time and act as a reservoir of the one or both of the anti-inflammatory agent and the anti-thrombogenic agent to slowly release the one or both of the anti-inflammatory agent and the anti-thrombogenic over the prolonged time.