Abstract: A barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.

Abstract: A stand-alone film is derived at least in part from fatty acids. The stand-alone film can have anti-adhesive, anti-inflammatory, non-inflammatory, and wound healing properties, and can additionally include one or more therapeutic agents incorporated therein. Corresponding methods of making the stand-alone film include molding, casting, or otherwise applying a liquid or gel to a substrate, and curing or otherwise treating to form the stand-alone film. The resulting stand-alone film is bioabsorbable.

Abstract: A method and apparatus for the provision of a coating for application to a medical device results in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a therapeutic agent component and solvent can also be provided. The solvent is removed from the coating before the coating is applied to the medical device. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the therapeutic agent, to the patient.

Abstract: A coated medical device an a method of providing a coating on an implantable medical device result in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a therapeutic agent component can also be provided. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the therapeutic agent, to the patient.

Abstract: A method of UV curing and corresponding resulting non-polymeric cross-linked gel are provided. The cross-linked gel can be combined with a medical device structure. The cross-linked gel can provide anti-adhesion characteristics, in addition to improved healing and anti-inflammatory response. The cross-linked gel is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel derived from at least one fatty acid compound. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent. The curing method can vary the application of UV light in both intensity and duration to achieve a desired amount of cross-linking forming the gel.

Abstract: A barrier layer and corresponding method of making provide anti-inflammatory and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel derived from at least one fatty acid compound. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.

Abstract: A therapeutic agent-eluting stylet treats a catheter by at least temporarily locating the stylet in a lumen of an indwelling catheter placed into a patient. The therapeutic agent-carrying stylet provides a localized therapeutic effect to the catheter and patient by eluting one or more therapeutic agents directly into the lumen of the catheter, into the fluid within the catheter, into the fluid and tissue in contact with the catheter, and onto the surface of the catheter. By removal and replacement of the temporary stylet from the catheter, renewable therapeutic agent doses can be provided to a component, such as the lumen, of the catheter while the catheter remains within in a patient. One or more therapeutically effective doses of medicated agents can be tailored along the length of the stylet and controlled by the length of time by which the stylet remains installed in the catheter.

Abstract: An apparatus for establishing a re-usable, recurring, mechanical connection to an organ within a patient is provided. A body fluid cartridge exchange platform device includes a hollow cartridge platform housing with a first end having an opening. The platform housing can additionally have a second end with a second opening. The first opening and the second opening facilitate insertion of an exchange cartridge insert that sealably engages the housing. The first opening and the second opening additionally facilitate removal of the exchange cartridge insert. The exchange cartridge insert can facilitate a flow path between a first leg and a second leg of the platform housing, and can facilitate a flow path between the platform housing and an external location for medical procedure or drug delivery purposes.

Abstract: A radially expandable fluid delivery device for delivering a fluid to a treatment site within the body is disclosed. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device. The fluid delivery device includes a tubular member defined by a wall having a thickness transverse to the longitudinal axis of the tubular member and extending between an inner and an outer surface. The wall is characterized by a microstructure of nodes interconnected by fibrils. The tubular member is deployable from a first, reduced diameter configuration to a second, increased diameter configuration upon the introduction of a pressurized fluid to the lumen.

Abstract: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The wettable liquid can be formed of a drug and/or an agent, such that the resulting polymer contains and emits the drug upon positioning at a target location of a patient body. The expandable polymer can also have the drug or agent added to its structure at a polymer resin preparation stage, through use of an aqueous solution mixed with one or more fluoropolymers, or in a mixing stage. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material.

Abstract: A method of making a radially expandable fluid delivery device includes providing a tube of biocompatible fluoropolymer material with a predetermined porosity based on an extrusion and expansion forming process, applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension, and removing the radial expansion force. The tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device.

Abstract: A non-polymeric or biological coating applied to porous radially expandable interventional medical devices provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device. Thus, atraumatic local tissue transference delivery is achieved for uniform therapeutic agent distribution and controlled bio-absorption into the tissue after placement within a patient's body with a non-inflammatory coating.

Abstract: A non-polymeric or biological coating applied to radially expandable interventional medical devices provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device. Thus, atraumatic local tissue transference delivery is achieved for uniform therapeutic agent distribution and controlled bio-absorption into the tissue after placement within a patient's body with a non-inflammatory coating.

Abstract: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The wettable liquid can be formed of a drug and/or an agent, such that the resulting polymer contains and emits the drug upon positioning at a target location of a patient body. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material.

Abstract: Disclosed are vascular grafts including an expanded copolymer of tetrafluoroethylene (TFE) and perfluoropropylene vinyl ether (PPVE). In certain embodiments, the copolymer includes between about 0.01% and about 1.5% PPVE. Vascular grafts exhibit superior performance properties, e.g., radial strength, and suture strength, and manufacturing properties, e.g., sinter time. Methods of forming vascular grafts from the copolymer also are described.

Abstract: A medical ink is loaded with a number of therapeutic agents. The ink is then applied directly to the tissue of a patient, either internally or externally, resulting in a therapeutic ink marking. The therapeutic ink marking can include surface activation of an immobilizing medication, controlled medication release, and/or the ability to use dyes or pigments to delineate different active ingredients by location and dosage. The active medicinal compounds can be placed on selective areas of the tissue as applied in the marking. The marking can provide a detectable and dosemetric controllable delivery to a specific targeted and localized location to provide the maximum therapeutic benefit. The medicated ink may be applied to a number of different methods. Dimensions of the markings can further serve to control and identify to the user the dosage amount of the medical agent applied to the tissue. Multiple types of medical agents with multiple application methods can be used.

Abstract: A medical device is loaded with a number of therapeutic agents using a corresponding method to apply a medicated ink mark. The resulting medical device can include surface activation of an immobilizing medication, controlled medication release, and the ability to use dyes or pigments to delineate different active ingredients by location and dosage. The active medicinal compounds can be placed on selective areas of the medical device. The medical device having the medicated ink mark can provide a detectable and dosemetric controllable delivery to a specific targeted and localized location to provide the maximum therapeutic benefit. The medicated ink may be applied to the medical device by a number of different methods, by a manufacturer or by the user at the time of medical device use. Dimensions of the markings printed onto the medical device can further serve to control and identify to the user the dosage amount of the medical agent available on the marked medical device.

Abstract: A method of delivering a therapeutic agent to a targeted location within a patient efficiently delivers the agent with a reduced systemic effect. The method includes providing a non-perforated delivery device having at least one wall through which a fluid at first fluid pressure can pass through. The non-perforated delivery device is positioned to provide a radial fluid force against the targeted location. The fluid, including at least one therapeutic agent, is supplied to the therapeutic agent delivery device at the first fluid pressure. The fluid passes through the at least one wall of the delivery device to create a semi-confined space external to the delivery device at a second fluid pressure. The delivery device applies the radial fluid force against the semi-confined space and the fluid disposed therein while simultaneously facilitating the fluid passing through the delivery device to maintain the second fluid pressure in the semi-confined space at the targeted location.

Abstract: A therapeutic agent delivery system includes an irrigating shaped form, such as a non-perforated irrigating shaped form, fluidly coupled with a container storing a first agent. The irrigating shaped form is sized and dimensioned for positioning within a patient's body. A second agent is disposed at the irrigating shaped form. The second agent can either be supplied separately to the irrigating shaped form, pre-exist within the irrigating shaped form, exist as a coating or other residual element on the irrigating shaped form, or the like. The irrigating shaped form is expanded to maximum predetermined diameter and pressed against a targeted location within a patient's body. In a corresponding method, upon delivery of a first agent from the first agent container through the irrigating shaped form, the first agent reacts with the second agent forming a therapeutic agent, which can be pressurized. The therapeutic agent emits from a portion of the irrigating shaped form at the targeted location.

Abstract: A therapeutic delivery device includes a non-perforated insufflating shaped form, such as a catheter irrigating shaped form, coupled to a first gas source. The insufflating shaped form is sized and dimensioned for positioning within a patient body. A second gas is stored within the insufflating shaped form. The second gas can be stored within an inner chamber of the insufflating shaped form, within the walls of the insufflating shaped form, or the like. In a corresponding method, a first gas reacts with the second gas upon delivery of the first gas from the first gas source through the insufflating shaped form. The reaction forms a gas mixture, which emits from the insufflating shaped form to a targeted location within the patient body. The insufflating shaped form serves to maintain a predetermined concentration of the gas mixture at the targeted location for a desired dwell time.