Re-establishment of blood flow in blocked human arteries by transferring nano-encapsulated drug through medical devices, designed for the same and releasing the nano-encapsulated drug in human artery with body ph
Inventors
Doshi, Manish • Sherdiwala, Divyesh • Sojitra, Prakash • Vyas, Ashwin • Gandhi, Pankaj • Murthy, Zagabathuni Venkata Panchakshari
Assignees
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Publication Number
US-8778013-B2
Publication Date
2014-07-15
Expiration Date
Abstract
A drug-delivering insertable medical device for treating a medical condition associated with a body lumen is disclosed. The drug-delivering insertable medical device includes an outer surface coated with two or more nano-carriers having two or more average diameters. A nano-carrier of the two or more nano-carriers has an average diameter suitable for penetrating one or more layers of two or more layers of the body lumen. The nano-carrier includes a drug surrounded by an encapsulating medium. The encapsulating medium includes one or more of a biological agent, a blood excipient, and a phospholipid.
Core Innovation
The invention relates to a drug-delivering insertable medical device for treating a medical condition associated with a body lumen comprising an artery having a plurality of layers. The device includes a stent with an outer surface coated with a plurality of nano-carriers having a first average diameter, a second average diameter, and a third average diameter. A nano-carrier comprises a sirolimus drug surrounded by an encapsulating medium comprising at least one of a biological agent, a blood excipient, and a phospholipid, and the nano-carrier surface is devoid of the drug.
The nano-carriers are configured for size-dependent penetration through the artery layers via inter-tissue pores and vasa vasorum associated with different layers. A first set of nano-carriers having a first average diameter ranging from 800 nm to 1500 nm penetrates an intima layer through inter-tissue pores present in the intima layer. A second set having a second average diameter ranging from 300 nm to 800 nm penetrates a media layer through a vasa vasorum associated with the media layer and the inter-tissue pores present in the intima layer.
A third set having a third diameter ranging from 10 nm to 300 nm penetrates an adventitia layer through 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. The nano-carriers of the third set remain in the adventitia layer for a prolonged time and act as a reservoir of the sirolimus drug to slowly release the sirolimus drug over a prolonged time.
During the prolonged time, the sirolimus drug diffuses across the adventitia layer, the media layer, and the intima layer to provide an in-tissue diffusion of the drug for the prolonged time to supply a maximum portion of a lesion of the artery with the sirolimus drug, wherein the prolonged time comprises 39 days.
Claims Coverage
The independent claim defines 5 inventive features centered on a coated stent device using three size sets of sirolimus-loaded nano-carriers for layer-specific penetration and reservoir-based prolonged diffusion, with a prolonged time of 39 days.
Three-size nano-carrier coating for multi-layer penetration
An outer surface coated with a plurality of nano-carriers having a first average diameter, a second average diameter, and a third average diameter.
Sirolimus-loaded nano-carrier with drug-devoid surface and encapsulating medium
A nano-carrier comprising a sirolimus drug surrounded by an encapsulating medium comprising at least one of a biological agent, a blood excipient, and a phospholipid, wherein the surface of the nano-carrier is devoid of the drug.
Intima penetrating nano-carriers via inter-tissue pores
A first set of nano-carriers having a first average diameter ranging from 800 nm to 1500 nm suitable for penetrating an intima layer of the artery through inter-tissue pores present in the intima layer.
Media penetrating nano-carriers via vasa vasorum and intima pores
A 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 artery through a vasa vasorum associated with the media layer and the inter-tissue pores present in the intima layer.
Adventitia penetrating nano-carriers remain as reservoir for prolonged release
A third set of nano-carriers having a third diameter ranging from 10 nm to 300 nm suitable for penetrating an adventitia layer of the artery 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 the third set remains in the adventitia layer for a prolonged time and acts as a reservoir of the sirolimus drug to slowly release the sirolimus drug over a prolonged time.
Prolonged time in-tissue diffusion across artery layers
The sirolimus drug diffuses across the adventitia layer, the media layer, and the intima layer during the prolonged time to provide an in-tissue diffusion of the drug for the prolonged time to supply a maximum portion of a lesion of the artery with the sirolimus drug, wherein the prolonged time comprises 39 days.
The claim coverage centers on three nano-carrier size sets on a stent outer surface, loaded with sirolimus in an encapsulating medium and with a drug-devoid carrier surface, to drive size-dependent penetration through intima, media, and adventitia, while adventitia-remaining carriers act as a reservoir to slowly release and diffuse sirolimus for a prolonged time of 39 days.
Stated Advantages
Reduce restenosis and thrombus formation.
Minimize delayed/improper healing and long-term anti-platelet therapy.
Provide in-tissue diffusion of the drug for a prolonged time to supply a maximum portion of a lesion of the artery with the sirolimus drug.
Documented Applications
Treating a medical condition associated with a body lumen comprising an artery by implanting an insertable drug-delivering stent device coated with nano-carriers for sirolimus diffusion across artery layers.
Delivering sirolimus by nano-carriers sized to penetrate intima, media, and adventitia, with adventitia carriers acting as a reservoir to slowly release and diffuse the drug over a prolonged time comprising 39 days.
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