Abstract: Sterile injectable formulations, which comprise the following: (a) a ablation agent in an amount effective to cause necrosis of tissue, and (b) a biodisintegrable viscosity adjusting agent in an amount effective to render the formulation highly viscous, (c) an optional imaging contrast agent, (d) an optional therapeutic agent, and (e) an optional liquid selected from water and an organic solvent. Also described are novel prostatic ablation formulations, which comprise a prostatic ablation agent selected from free-radical generating ablation agents, oxidizing ablation agents and tissue fixing ablation agents. Further aspects of the invention relate to methods of treating a variety of diseases and conditions, including benign prostatic hypertrophy, in which above injectable formulations are injected into the tissue of a subject, optionally with the assistance of a non-invasive imaging technique.

Abstract: The present invention generally relates to a medical device for delivering a therapeutic agent to an internal portion of a patient's body. The medical device includes a shaft and a self-expanding delivery member in operative communication with the shaft. The delivery member is shaped from a porous material that is capable of releasing a therapeutic agent to an internal portion of a patient's body. The medical device further includes a therapeutic agent delivery lumen in fluid communication with the delivery member to fluidly connect the delivery member with a therapeutic agent source. A retention member may also be provided to selectively collapse the delivery member.

Abstract: A device, system, and method for direct delivery of a therapeutic to a target site that utilizes the non-Newtonian characteristics of shear thinning and shear thickening to allow easy passage of a therapeutic through a delivery lumen yet facilitate retention of the therapeutic in the target site. The device, system, and method includes increasing the shear rate or shear stress of a non-Newtonian fluid having therapeutic properties thereby increasing or decreasing the viscosity of the non-Newtonian fluid.

Abstract: The medical device of the invention comprises a surface comprising at least one outermost portion and a plurality of depressions. The depressions occupy at least about 80% of the surface area of the surface. The depressions contain a coating material that preferably comprises a biologically active material and/or polymer, and the outermost portion is substantially free of any coating material. The invention is also directed to a method for manufacturing a medical device. The method comprises applying a coating material to the surface of the medical device by using at least one roller.

Abstract: The present invention relates generally to decellularized extracellular matrix of conditioned body tissues. The decellularized extracellular matrix contains a biological material, preferably vascular endothelial growth factor (VEGF), produced by the conditioned body tissue that is in an amount different than the amount of the biological material that the body tissue would produce absent the conditioning. The invention also relates to methods of making and methods of using said decellularized extracellular matrix. Specifically, the invention relates to treating defective, diseased, damaged or ischemic cells, tissues or organs in a subject by administering, injecting or implanting the decellularized extracellular matrix of the invention into a subject in need thereof. The invention is further directed to a tissue regeneration scaffold for implantation into a subject inflicted with a disease or condition that requires tissue or organ repair, regeneration and/or strengthening.

Abstract: Novel nitric-oxide releasing lipid molecules are provided which comprise a lipid molecule selected from (a) phosphoglycerides, (b) lipids having a sphingosine base as a backbone, (c) monoacylglyerols, (d) diacylglycerols, (e) glycosylacylglycerols, and (f) sterol compounds of the formula: 1

Abstract: The present invention provides an apparatus and method that uses positive displacement of coating material using a computer controlled, motorized dispensing device. The flow rate of the dispensing device is controlled, and the positive displacement apparatus and method result in a precise amount of coating that is dispensed. The positive displacement coating apparatus and method allow for much more accurate and consistent coating from part to part. Because the positive displacement coating apparatus precisely controls the flow rate of the coating, differences in viscosity of the coating do not adversely affect the amount of the coating that is dispensed. In addition, the fluid flow path or pressure differential do not adversely affect the amount of the coating that is dispensed.

Abstract: The present invention provides a catheter and catheter assembly for delivering micronized therapeutic agents to a target site in the body and, in particular, to a target site in the heart. The micronized therapeutic agents are delivered in aerosol form or dry powder form. The present invention also provides a method of delivering micronized therapeutic agents to a target site in the body by placing the therapeutic agents in a catheter, positioning the catheter in the target site, and exposing the therapeutic agents to an energizing mechanism sufficient to create supersonic flow to carry the therapeutic agents from a stationary state in the catheter to a mobile state towards the target site.

Abstract: A method for furnishing a therapeutic-agent-containing medical device is provided. The method comprises: (a) providing a reactive layer comprising a cross-linking agent on a medical device surface; and (b) subsequently applying a polymer-containing layer, which comprises a polymer and a therapeutic agent, over the reactive layer. The cross-linking agent interacts with the polymer to form a cross-linked polymeric region that comprises the therapeutic agent. Examples of medical devices include implantable or insertable medical devices, for example, catheters, balloon, cerebral aneurysm filler coils, arterio-venous shunts and stents.

Abstract: A medical device, such as a stent, for delivering a therapeutic agent to body tissue of a patient and a method of making such a medical device are disclosed. The medical device comprises a surface, a first coating layer comprising a biological activator such as a transfection agent adhering to at least a portion of the surface, and a second coating layer comprising a therapeutic agent disposed over at least a portion of the first coating layer. The transfection agent enhances the delivery of the therapeutic agent to the targeted body tissue, and reduces the surface tension of the surface of the medical device. The transfection agent may be a poloxamer and the therapeutic agent may be a genetic material. The disclosed method allows for greater efficiency in applying the therapeutic agent onto the medical device surface and enhances delivery of the therapeutic agent to the targeted body tissue.

Abstract: Many conventional pharmaceutical articles contain seemingly inert components that come into contact with a pharmaceutically active material during use, which contact substantially reduces the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to these incompatible components, which are effective to diminish the reduction in pharmaceutical effectiveness.

Abstract: Novel nitric-oxide releasing lipid molecules are provided which comprise a lipid molecule selected from (a) phosphoglycerides, (b) lipids having a sphingosine base as a backbone, (c) monoacylglyerols, (d) diacylglycerols, (e) glycosylacylglycerols, wherein the lipid molecole is provided with a nitric-oxide contianing group which comprises a (a) a —S—N═O moiety, (b) a —O—N═O moiety, or (c) a moiety. Also provided are methods of forming such nitric oxide releasing lipid molecules. Various pharmaceutical compositions, topical liquids and drug delivery systems comprising the ntric-oxide releasing lipid molecules are also described. Further provided are methods for therapeutically administering nitric oxide to patients, methods for treating or preventing various conditions, methods for promoting wound healing and methods for reducing the cells present in an atherosclerotic lesion which methods utilize the nitric-oxide releasing lipid molecules.

Abstract: The present invention is generally directed to medical devices, and more specifically to medical devices that are at least partially insertable or implantable into the body of a patient. The medical devices generally comprise (a) a therapeutic agent, more typically, a high-molecular-weight therapeutic agent, and (b) at least one polymeric layer, which typically acts to control the release of the therapeutic agent from the medical device. Also disclosed herein are methods of making such medical devices.

Abstract: There is provided a minimally-invasive smart device which can detect enviornmental conditions in the vicinity of a target site within a patient's body and autonomously determine whether the medical device on the distal end of the instrument should be activated to perform, or inhibited from performing, a desired minimally-invasive medical procedure. The smart device includes a medical device affixed to the distal end of a lumen, at least one environmental condition sensor adapted to detect an environmental condition adjacent to the medical device, and at least one medical device actuator which responds to signals from an environmental condition sensor to either cause the medical device to perform the desired medical procedure or to inhibit operation of the medical device actuator.

Abstract: An apparatus for delivery of biologically active materials comprises a catheter and balloon having micro-needles or pores. In the apparatus, the balloon can have a polymer coating containing the biologically active material, and the apparatus can include a sheath surrounding the balloon. In one embodiment the biologically active material is delivered through lumens in the micro-needles. Another embodiment of the invention is an apparatus for delivery of biologically active materials comprising a catheter with a balloon disposed thereon and a shockwave generator for producing a shockwave for delivering the biologically active material to a body lumen. Methods for delivery of biologically active materials are also disclosed.

Abstract: The present invention relates to microarray polymeric barriers designed to control the release rate of therapeutic agents. By varying the thickness of the coating or affecting, physically and/or chemically, the constituents of the barrier composition, the release profile of the underlying therapeutic agent can be modified and controlled.

Abstract: Injection devices are provided, which reduce potential outflow of therapeutic agents from an injection site. Devices are provided having at least a first lumen containing one or more therapeutic agents and a second lumen containing a second material for injection into tissue. Other devices are provided having an inner lumen with an injection needle to inject a therapeutic agent and an outer lumen that provides a vacuum seal between the injection needle and the needle track. Further provided are methods of delivering a therapeutic agent to tissue.

Abstract: A medical device and system capable of providing on-demand delivery of biologically active material to a body lumen patient, and a method of making such medical device. A first coating layer comprising a biologically active material and optionally a polymeric material is disposed on the surface of the medical device. A second coating layer comprising magnetic particles and a polymeric material is disposed on the first coating layer. The second coating layer, which is substantially free of a biologically active material, protects the biologically active material prior to delivery. The system includes the medical device and a source of energy, such as an electromagnetic or mechanical vibrational energy. When the patient is exposed to the energy source, the magnetic particles move out of the second coating layer and create channels therein through which the biologically active material can be released.

Abstract: Devices and methods of delivering therapeutic agents to tissue are provided, which provide reduced outflow of therapeutic agents from an injection site. The methods include delivering one or more clot-promoting substances, such as platelets, fibrin and/or thrombin, to the injection site to entrap the therapeutic agent in the injection site. Devices include devices that are suitable for use in the provided methods.

Abstract: The present invention relates to medical devices that are to be implanted or inserted into the body of a patient for the purpose of removing undesired body tissues. In one embodiment of the invention the medical device comprises a body tissue removal agent for removing undesired body tissue simultaneously with or prior to treatment of body tissue that is in proximity to the undesired body tissue with a biologically active material. Such biologically active material may facilitate regeneration of the body tissue that was removed or may prevent the recurrence of the undesired body tissue.