Abstract: A bodily lumen, such as a blood vessel, can be treated by forming a structural support in situ within the bodily lumen. This can be done by ejecting a formulation that includes a polymer that solidifies over a period of time, such as due to DMSO exchange or photocrosslinking. This can also be done by cooling a formulation until it freezes in situ. The structural support can also be made from a plaque which is already present in the bodily lumen. The plaque can be compressed by a balloon catheter and cooled so that it hardens and thereby forms the structural support. The bodily lumen can also be treated using a preformed structural support made of ice, for example frozen isotonic saline, or a fast degrading polymer, such as PEG. The preformed support is created outside of the bodily lumen, and then transported on a catheter to the treatment zone.

Abstract: A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon while retaining, at least partially, the original balloon folds as the balloon is pressurized and de-pressurized within a crimper head. By at least partially retaining the original balloon folds, a uniformity of scaffold expansion by the balloon is improved.

Abstract: Medical devices and methods for forming an arteriovenous (AV) fistula include a stent having an arterial tubular portion and vein supporting tongue connected by a pre-shaped connector and a venous frustoconical stent having a distal end for maintaining a take-off angle for the venous portion of the AV fistula. Also disclosed is an angled balloon for assisting with the formation of the AV fistula. The medical devices disclosed herein support an AV fistula formation having a desired take off angle of about 30 degrees, or between about 15 and 45 degrees.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, wherein the cytostatic therapeutic agent and the at least one excipient have a weight ratio of about 20:1 to about 1:20, and further wherein the coating provides increased efficiency of therapeutic transfer to a body lumen.

Abstract: The present invention relates to implantable medical devices coated with polymer having tunable hydrophobicity and their use in the treatment of vascular diseases.

Abstract: A system and method for coating an expandable member of a medical device comprising a support structure to support the expandable member and a dispenser positioned with at least one outlet proximate a surface of an expandable member. A drive assembly establishes relative movement between the at least one outlet and the surface of the expandable member to apply fluid on the surface of the expandable member along a coating path. A guide maintains a substantially fixed distance between the at least one outlet and the surface of the expandable member during relative movement therebetween by displacing the expandable member relative to the at least one outlet.

Abstract: The present invention relates to implantable medical devices coated with polymer having tunable hydrophobicity and their use in the treatment of vascular diseases.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Abstract: A system and method for coating an expandable member of a medical device comprising a support structure to support the expandable member and a dispenser positioned with at least one outlet proximate a surface of an expandable member. A drive assembly establishes relative movement between the at least one outlet and the surface of the expandable member to apply fluid on the surface of the expandable member along a coating path. A guide maintains a substantially fixed distance between the at least one outlet and the surface of the expandable member during relative movement therebetween by displacing the expandable member relative to the at least one outlet.

Abstract: Methods, devices, kits and compositions to treat a myocardial infarction. In one embodiment, the method includes the prevention of remodeling of the infarct zone of the ventricle. In other embodiments, the method includes the introduction of structural reinforcing agents such as those agents containing aloe-derived pectin. In other embodiments, the structural reinforcing agent may be accompanied by other therapeutic agents. These agents may include, but are not, limited to pro-fibroblastic and angiogenic agents.

Abstract: Medical devices, such as stents, including a fibrous layer including particles are disclosed. Methods of forming such medical devices using electrospinning are disclosed.

Abstract: A catheter apparatus for treatment of a human patient is described, the catheter apparatus having a central axis and comprising a shaping structure moveable between a delivery state having a first helical shape, and a deployed state having a second helical shape. The shaping structure is configured to have a reverse taper with a structural diameter that varies over the length of the shaping structure such that the structural diameter of the shaping structure at the proximal end is smaller than the structural diameter of the shaping structure at the distal end.

Abstract: The present invention relates to systems for and corresponding methods of delivering a therapeutic agent to a vessel wall of a body lumen by providing a compound capable of being crosslinked after intraluminal release onto a vessel wall so that the therapeutic agent is temporarily retained at the site of delivery by the crosslinked compound.

Abstract: Balloon catheter configured to deliver a therapeutic agent upon provision of electric potential to the balloon, the catheter comprising an electrode disposed proximate the outer surface of the expandable member, a coating disposed on at least a portion of the outer surface, the coating including a therapeutic agent; and a power source in electrical communication with the electrode is described.

Abstract: Compositions for forming a self-reinforcing composite biomatrix, methods of manufacture and use therefore are herein disclosed. Kits including delivery devices suitable for delivering the compositions are also disclosed. In some embodiments, the composition can include at least three components. In one embodiment, a first component can include a first functionalized polymer, a second component can include a second functionalized polymer and a third component can include silk protein or constituents thereof. In some embodiments, the composition can include at least one cell type and/or at least one growth factor. In some embodiments, the composition can include a biologic encapsulated, suspended, disposed within or loaded into a biodegradable carrier. In some embodiments, the composition(s) of the present invention can be delivered by a dual lumen injection device to a treatment area in situ, in vivo, as well as ex vivo applications.

Abstract: It is provided herein methods, devices, and compositions for trans-arterial local delivery of therapeutic agent for the treatment of liver cancers.

Abstract: This invention relates to the targeted delivery of hydrophobic drugs or combinations of hydrophobic drugs with photodynamic therapy agents to vascular lesions by complexation of the drugs to blood serum lipoproteins, which have an affinity for and accumulate in such vascular lesions.

Abstract: A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon while retaining, at least partially, the original balloon folds as the balloon is pressurized and de-pressurized within a crimper head. By at least partially retaining the original balloon folds, a uniformity of scaffold expansion by the balloon is improved.

Abstract: Formulations and methods are disclosed which provide controlled, sustained release of a biologic therapeutic to a space within the body. More specifically, formulations comprising a plurality of hydrophilic polymer strands, and methods of forming and administering such formulations, are disclosed. In some embodiments, the formulations exhibit a burst release, an initial release, a triphasic release, and release over thirty to ninety days of the biologic therapeutic. In some embodiments, the formulations exhibit reversible precipitation of the biologic therapeutic into precipitates having a diameter of about 50 nm to about 10 ?m.