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 • Sojitra, Prakash • ABIZAID, ALEXANDRE
Assignees
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Publication Number
US-9259518-B2
Publication Date
2016-02-16
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 of a blood vessel having a plurality of layers. The device includes an outer surface coated with a plurality of nano-carriers having average diameters in the range of 10 nm to 300 nm, suitable for penetrating an adventitia layer through inter-tissue pores present in an intima layer and associated with vasa vasorum in a media layer and in an adventitia layer.
Each nano-carrier includes a sirolimus drug surrounded by an encapsulating medium. The encapsulating medium comprises at least one of a biological agent, a blood excipient, and a phospholipid, and a surface of each nano-carrier is devoid of the sirolimus drug. Nano-carriers penetrating into the adventitia layer 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 in-tissue diffusion for a prolonged time to supply a maximum portion of a lesion with the sirolimus drug. The document describes size-dependent penetration and drug release behavior in which drug release occurs after encapsulating-medium dissolution, with an adventitia-penetrating population acting as an in-tissue diffusion reservoir to reduce restenosis and delayed healing and to address improper healing and healing delay associated with lesions.
Claims Coverage
The document includes one independent claim. It recites a drug-delivering insertable medical device with nano-carrier size-based penetration to the adventitia, prolonged residence and reservoir behavior, and prolonged diffusion across adventitia, media, and intima for lesion drug supply, with a defined sirolimus nano-carrier architecture and a prolonged time of 65 days.
Nano-carriers with size range for adventitia penetration via inter-tissue pores and vasa vasorum
An outer surface coated with a plurality of nano-carriers having average diameters ranging from 10 nm to 300 nm suitable for penetrating an adventitia layer of the blood vessel through the inter-tissue pores present in an intima layer of the blood vessel and associated with vasa vasorum in a media layer and in an adventitia layer.
Sirolimus nano-carriers with encapsulating medium and drug-free carrier surface
Each nano-carrier comprises a sirolimus drug surrounded by an encapsulating medium, the encapsulating medium comprising at least one of a biological agent, a blood excipient, and a phospholipid, and a surface of each nano-carrier being devoid of the sirolimus drug.
Adventitia residence as a reservoir for slow prolonged release
The nano-carriers penetrating into the adventitia layer 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.
Prolonged in-tissue diffusion across adventitia, media, and intima to supply a maximum portion of a lesion
The sirolimus drug diffuses across the adventitia layer, the media layer, and the intima layer during the prolonged time to provide in-tissue diffusion for the prolonged time to supply a maximum portion of a lesion with the sirolimus drug, wherein the prolonged time comprises 65 days.
Overall claim coverage focuses on a sirolimus nano-carrier coating configured for size-dependent penetration to the adventitia, prolonged adventitia residence serving as a drug reservoir for slow release, and prolonged diffusion across adventitia, media, and intima to supply a maximum portion of a lesion, with the prolonged time specified as 65 days.
Stated Advantages
Reduces restenosis.
Reduces delayed healing by supporting in-tissue diffusion for prolonged drug delivery to lesion tissue.
Addresses improper healing and healing delay associated with lesions.
Documented Applications
Treating a medical condition associated with a blood-vessel body lumen having a plurality of layers, including lesions where delivery aims to supply a maximum portion of the lesion with sirolimus.
Drug-delivering insertable vascular medical device use for restenosis reduction and delayed healing reduction in the context of vessel lesions.
Use with device forms including a stent, a balloon, a stent mounted on a balloon, and a balloon catheter.
Evaluation of sirolimus-loaded nano-carriers and stent systems with measured in-vitro release and in-vivo follow-up, including reported efficacy/safety metrics and healing observations.
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