Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery
Inventors
Arps, James Howard • Bach, Andrew G.
Assignees
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Publication Number
US-11020513-B2
Publication Date
2021-06-01
Expiration Date
Abstract
The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.
Core Innovation
The invention relates to an insertable medical device for delivering a water-insoluble bioactive agent to an inner lumen of a blood vessel of a subject. The device includes an expandable elastic portion of an angioplasty balloon and a flexible biostable hydrogel matrix layer formed as a coating on an outer surface of the expandable elastic portion, the hydrogel matrix comprising a biodegradable multiblock copolymer and an alkyl methacrylate.
The water-insoluble bioactive agent is provided in neat form and in the form of microparticulates, and is associated with a surface of the flexible biostable hydrogel matrix. Upon expansion of the expandable elastic portion in the blood vessel, the water-insoluble bioactive agent contacts and is released to the inner lumen of the blood vessel, with release characterized by disassociating from the expandable elastic angioplasty balloon portion during expansion.
In a related independent device formulation, the coating comprises the flexible biostable hydrogel matrix on the outer surface of the expandable elastic angioplasty balloon portion, together with a water-insoluble bioactive agent in neat form and in the form of microparticulates. In the method formulation, the water-insoluble antiproliferative agent provides a therapeutic effect to tissue of the subject via disassociation and release into the inner lumen.
Claims Coverage
The partial content includes three independent claims. Across these independent claims, the coverage centers on an expandable elastic angioplasty balloon with a flexible biostable hydrogel matrix coating formed from a biodegradable multiblock copolymer and an alkyl methacrylate, carrying a water-insoluble bioactive agent in neat form and as microparticulates that disassociate during balloon expansion to release into the inner lumen.
Hydrogel-coated expandable elastic angioplasty balloon for lumen delivery
An insertable medical device having an expandable elastic portion of an angioplasty balloon and a flexible biostable hydrogel matrix layer coating an outer surface of the expandable elastic portion, the hydrogel matrix comprising a biodegradable multiblock copolymer and an alkyl methacrylate.
Neat-and-microparticulate water-insoluble bioactive agent associated with hydrogel surface
A water-insoluble bioactive agent that is both in neat form and in the form of microparticulates, associated with a surface of the flexible biostable hydrogel matrix.
Release and disassociation upon balloon expansion into inner lumen
The water-insoluble bioactive agent contacts and is released to the inner lumen upon expansion of the expandable elastic portion, and the microparticulates disassociate from the expandable elastic angioplasty balloon portion during expansion to release the agent.
Method of delivering a water-insoluble antiproliferative agent with therapeutic tissue effect
A method for delivering a water-insoluble antiproliferative agent using an expandable elastic angioplasty balloon with a flexible biostable hydrogel matrix coating and the agent in neat form and as microparticulates associated with the hydrogel surface, so that expansion releases the agent into the inner lumen to provide a therapeutic effect to tissue of the subject.
The independent claims collectively cover a hydrogel-coated expandable elastic angioplasty balloon carrying a water-insoluble bioactive agent in neat and microparticulate form, with release by disassociation during balloon expansion into the inner lumen; the method claim states a therapeutic effect for an antiproliferative agent.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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