The present disclosure relates generally to coating medical devices. In particular, the present disclosure provides materials and methods for coating a portion of a balloon catheter with a pharmaceutical agent using electrodeposition techniques. Although angioplasty and stenting can be effective methods for treating vascular occlusions, restenosis remains a pervasiveness problem. Therefore, coating portions of a balloon catheter with a pharmaceutical agent that inhibits restenosis can reduce the likelihood of restenosis.

Methods for treating or preventing neointima stenosis are disclosed. The methods generally involve the use of a TGFβ inhibitor, a SMAD2 inhibitor, an FGF Receptor agonist, a Let-7 agonist, or a combination thereof, to inhibit endothelial-to-mesenchymal transition (Endo-MT) of vascular endothelial cells into smooth muscle cells (SMC) at sites of endothelial damage. The disclosed methods can therefore be used to prevent or inhibit neointimal stenosis or restenosis, e.g., after angioplasty, vascular graft, or stent. Also disclosed are methods for increasing the patency of biodegradable, synthetic vascular grafts using a composition that inhibits Endo-MT. A cell-free tissue engineered vascular graft (TEVG) produced by this method is also disclosed.

The invention features the use of a matrix consisting of low molecular weight components for use as a self-eliminating coating for implantable medical devices. The matrix coatings can be used to enhance biocompatibility and to control the local delivery of biologically active agents.

The present disclosure is directed toward composite materials comprising high aspect ratio habits of drug crystals which can be partially or fully extending into a substrate, and additionally, can be projecting from a substrate at an angle of about 20° to about 90°. The present disclosure is directed toward medical devices, such as medical balloons, comprising said composite and methods of using and making the same. The described composite can be used for the local treatment of vascular disease. The present disclosure is also directed toward paclitaxel crystals with a hollow acicular habit.

A balloon catheter includes an inflatable balloon defining an inner and an outer surface. A first biocompatible layer that includes hyaluronic acid is releasably disposed on the outer surface of the balloon. A second drug containing layer is disposed on the first biocompatible layer. The second drug containing layer includes paclitaxel and urea.

Embodiments herein include delivery systems for active agent coated balloons and related methods. In an embodiment, a delivery system can include a tunneling sheath and a balloon catheter. The tunneling sheath can include a tubular shaft having an outer diameter and defining a lumen. The tunneling sheath can include a proximal collar defining a lumen. The balloon catheter can include a balloon catheter shaft disposed within the tubular shaft. The balloon catheter shaft can include a lumen for the passage of a fluid therein. The balloon catheter can include an expandable balloon disposed on the balloon catheter shaft. The balloon catheter shaft can include an active agent layer disposed on the expandable balloon. The position of the expandable balloon can be configured to be stationary relative to the tubular shaft as the delivery system is passed through a blood vessel of a patient. Other embodiments are also included herein.

Embodiments herein include catheters and methods for the localized treatment of tissues through transcatheter delivery of active agents. In an embodiment, a method herein can include inserting a catheter into the lumen of a blood vessel. The catheter can include an inflatable balloon, a first lumen within the shaft for delivering a fluid to inflate the balloon, an active agent delivery port, and a second lumen disposed within the shaft for delivering the active agent composition through the shaft to the active agent delivery port. The method can include inflating the balloon to at least partially occlude the flow of blood through the blood vessel. The method can include ejecting the active agent composition from the active agent delivery port into the blood vessel. In an embodiment, a catheter for treating a localized region of the body with an active agent composition is included. Other embodiments are also included herein.

Provided herein is a drug delivery system comprising: a. substrate; b. a plurality of components combined with the substrate to form the drug delivery system; wherein at least one components comprises a bioabsorbable polymer and at least one other component comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

The invention is an improved biocompatible surface for a variety of medical purposes. The biocompatible surface employs a unique tight microstructure that demonstrates enhanced cellular response in the body, particularly when placed in contact with blood. As a blood contact surface, the present invention can be beneficially employed in a wide variety of implantable devices and in many other devices and equipment that come in contact with blood.

The invention relates to medical devices and, more in particular, to medical devices suitable for use as stents that contain an antimicrobial coating and, optionally, a drug customized to patients requirements. The invention also relates to methods for obtaining devices having the above features.