Abstract: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: Fatty acid-based, pre-cure-derived biomaterials, methods of making the biomaterials, and methods of using them as drug delivery carriers are described. The fatty acid-derived biomaterials can be utilized alone or in combination with a medical device for the release and local delivery of one or more therapeutic agents. Methods of forming and tailoring the properties of said biomaterials and methods of using said biomaterials for treating injury in a mammal are also provided.

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: Fatty acid-derived biomaterials, methods of making the biomaterials, and methods of using them as drug delivery carriers are described. The fatty acid-derived biomaterials can be utilized alone or in combination with a medical device for the release and local delivery of one or more therapeutic agents. Methods of forming and tailoring the properties of said biomaterials and methods of using said biomaterials for treating injury in a mammal are also provided.

Abstract: A method, a kit, and an apparatus provide a coating on an implantable medical device. The apparatus includes housing, a sealed reservoir chamber disposed in the housing, a reducing template, and a reservoir access port. The sealed reservoir contains the coating material. The reducing template is sized to receive a medical device therethrough for application of the coating material. A seal breaching mechanism can be provided and adapted to breach the sealed reservoir upon activation of the apparatus. The reservoir access port, which is disposed in the housing, is adapted to fluidly couple the reducing template with the reservoir chamber upon activation of the apparatus for coating the medical device.

Abstract: An apparatus and a method for applying a coating to a medical device such as a stent, balloon, or catheter, shortly before insertion or implantation are described. The apparatus and method produce uniform consistent coverage of the medical device in a predictable, repeatable and controllable manner and reduce the need for preservative components in the coating or for excessive curing or hardening of the coating.

Abstract: A barrier device is formed of a barrier component that can exhibit anti-inflammatory properties, non-inflammatory properties, and/or adhesion-limiting properties, as well as generate a modulated healing effect on injured tissue. The barrier component can be a non-polymeric cross-linked gel derived at least in part from a fatty acid compound, and may include a therapeutic agent. The barrier device can have anchoring locations to provide an area on the barrier device to interface with an anchoring mechanism. The anchoring locations can include openings and/or anchor elements. The barrier device can also include truss structures that provide additional strength to the barrier component. The barrier device is implantable in a patient for short term or long term applications, and can include controlled release of the therapeutic agent.

Abstract: Exemplary embodiments of the invention provide a dispersing liquid for coating internal body tissues with a bio-absorbable oil, a method of making the dispersing liquid, methods of using the dispersing liquid and a kit for coating internal body tissues using the dispersing liquid. The dispersing liquid includes a suspension of a bio-absorbable oil suspended in a liquid carrier. The invention results in a uniform thin coating of bio-absorbable oil on internal body tissues.

Abstract: A surgical mesh is formed of a biocompatible mesh structure with a coating that provides anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a implantation in a patient. The coating is generally formed of a fish oil, can include vitamin E, and may be at least partially cured. In addition, the coating can include a therapeutic agent component, such as a drug or other therapeutic agent.

Abstract: A barrier layer device is formed of an underlying biocompatible structure having a barrier layer coating that can exhibit anti-inflammatory properties, non-inflammatory properties, and/or adhesion-limiting properties, as well as generate a modulated healing effect on injured tissue. As implemented herein, the barrier layer is a non-polymeric cross-linked gel derived at least in part from a fatty acid compound, and may include a therapeutic agent. The underlying structure can be in the form of a surgical mesh. The barrier device is further provided with anchoring reinforcements to aid with the fastening of the barrier device for implantation purposes and reinforcing truss sections or portions that prohibit or substantially reduce the occurrence of excessive stretching and tearing. The barrier device is implantable in a patient for short term or long term applications, and can include controlled release of the therapeutic agent.

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: 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: 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 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.

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: 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.