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: A catheter device includes an elongate tubular housing, a cannula, and a flexible proboscis. The cannula defines a cannula lumen which is in fluid communication with a cannula exit port located adjacent the distal end of the elongate housing. The distal tip of the cannula is disposed within the cannula lumen. The cannula defines a proboscis lumen and the cannula has a proboscis exit port in fluid communication with the proboscis lumen. The proboscis exit port is located at the distal tip of the cannula. The flexible proboscis has a distal tip and is disposed within the proboscis lumen.

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 invention provides devices that can be used to deliver a therapeutic agent to a treatment site within the vessel of a patient at increased pressure, while limiting the contact with and pressure placed on the vessel walls. Devices according to the invention include an expandable structure arranged around and on a tube having a lumen. The expandable structure may include a sealing ring that makes contact with the interior surface of a vessel to prevent or decrease fluid flow during delivery of a therapeutic agent. This allows delivery of a therapeutic agent with decreased risk of injury to the treatment site. The invention also provides for large lumen diameters, preventing shearing stress on therapeutic agents such as cell slurries.

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: A catheter device comprising a proboscis shaft and a proboscis disposed within the proboscis shaft. In certain embodiments, the catheter device further comprises an elongate tubular member, wherein the proboscis shaft is disposed within the elongate tubular member. In certain embodiments, the catheter device comprises a tissue surface engagement structure, which has a first configuration and a second configuration. In the second configuration, the tissue surface engagement structure presents a larger transverse profile in comparison to the first configuration. The tissue surface engagement structure may have any of various designs, including an expandable assembly and a hinged assembly. In certain embodiments, a deformable cushion is positioned at the distal end of the proboscis shaft. The deformable cushion comprises a pocket that is filled with a reshapeable material. In certain embodiments, the proboscis shaft comprises a longitudinally compressible portion.

Abstract: The present invention relates to the direct delivery of therapeutic to a target tissue. In one embodiment a method for direct injection of plug forming material into a body tissue is provided. The method may comprise providing a catheter including an injection tube having a first channel, a second channel and a piercing tip. The first and second channels can be in fluid communication with a pressure source and a plug forming material. The injection tube may be slidably positioned in a pressure apron and moved from a first position to a second position so that the piercing tip extends beyond the tissue-mating surface in the second position to deliver the plug forming material.

Abstract: A catheter device includes an elongate tubular housing, a cannula, and a flexible proboscis. The cannula defines a cannula lumen which is in fluid communication with a cannula exit port located adjacent the distal end of the elongate housing. The distal tip of the cannula is disposed within the cannula lumen. The cannula defines a proboscis lumen and the cannula has a proboscis exit port in fluid communication with the proboscis lumen. The proboscis exit port is located at the distal tip of the cannula. The flexible proboscis has a distal tip and is disposed within the proboscis lumen.

Abstract: The present invention regards the delivery of therapeutic at a target site. Systems that employ the present invention may employ a medical device sized to be inserted into a target site, a driving layer covering at least a portion of an accessible surface of the medical device, and a therapeutic interfaced with at least a portion of the driving layer. In this system, the driving layer may have a material characteristic that serves to release the therapeutic from the medical device when the medical device is at the target site. Other systems that employ the invention may also have properties that include having a driving layer with a higher solubility than the therapeutic at the target site, a medical device that is hydrophobic while the therapeutic is hydrophilic, and a coating covering at least a portion of the therapeutic.

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. Moreover, in certain embodiments, the polymer-containing layer does not comprise the cross-linking agent at the time the polymer-containing layer is applied over the reactive layer. Examples of medical devices include implantable or insertable medical devices, for example, catheters, balloon, cerebral aneurysm filler coils, arterio-venous shunts and stents.

Abstract: The invention provides devices that can be used to deliver a therapeutic agent to a treatment site within the vessel of a patient at increased pressure, while limiting the contact with and pressure placed on the vessel walls. Devices according to the invention include an expandable structure arranged around and on a tube having a lumen. The expandable structure may include a sealing ring that makes contact with the interior surface of a vessel to prevent or decrease fluid flow during delivery of a therapeutic agent. This allows delivery of a therapeutic agent with decreased risk of injury to the treatment site. The invention also provides for large lumen diameters, preventing shearing stress on therapeutic agents such as cell slurries.

Abstract: A pressure apron for insitu plug formation is provided. In one embodiment an injection tube having a first channel and a piercing tip is provided, the first channel in fluid communication with a pressure source. In this embodiment, the injection catheter may also include a pressure apron with a tissue-mating surface. In another embodiment a medical kit for delivering a therapeutic is provided. This medical kit may include a catheter having a channel and a piercing tip, the piercing tip in fluid communication with a pressure source and slidably placed in the channel. The catheter in this embodiment may include a pressure apron with a tissue-mating source while a therapeutic may be included with the kit.

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 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: 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: 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: 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 pressure apron for insitu plug formation is provided. In one embodiment an injection tube having a first channel and a piercing tip is provided, the first channel in fluid communication with a pressure source. In this embodiment, the injection catheter may also include a pressure apron with a tissue-mating surface. In another embodiment a medical kit for delivering a therapeutic is provided. This medical kit may include a catheter having a channel and a piercing tip, the piercing tip in fluid communication with a pressure source and slidably placed in the channel. The catheter in this embodiment may include a pressure apron with a tissue-mating source while a therapeutic may be included with the kit.