Abstract: The present inventions provide various embodiments of methods for one or more of treating vascular injury, neointima proliferation and/or local inflammation in a mammal by locally administering therapeutic compound comprising a mTOR targeting compound and a calcineurin inhibitor. In various aspects, the therapeutic compound comprises a bio-absorbable carrier component carrier component at least partially formed of a cellular uptake inhibitor and a cellular uptake enhancer, a mTOR targeting compound and a calcineurin inhibitor. In various aspects, the present invention provides for controlled delivery, which is at least partially characterized by total and relative amounts of a cellular uptake inhibitor and cellular uptake enhancer in a bio-absorbable carrier component.

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: A tunneling device is provided for implanting a natural tissue vascular graft in a body. The tunneling device may include a flexible sheath to assist in locating the vascular graft in the body. According to one example, a connector having a longitudinal coupler, such as a surgical tie, may be used to locate the natural tissue graft within the sheath. The natural tissue graft can be secured to the surgical tie when the sheath is retracted. Before tunneling, the sheath can be extended to cover the natural tissue graft to protect the natural tissue graft from damage and aid in locating the natural tissue graft in the body. When the natural tissue graft is positioned as desired in the body, the sheath is removed.

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 reinforced sections or portions to aid with the fastening of the barrier device for implantation purposes and prohibits or substantially reduces 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: 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: A radially deployable covered stent that predictably and dependably expands to an increased diameter state at relatively low deployment pressures while concomitantly minimizing the risk of tearing of the stent covering during expansion. The stent covering includes an inner cover and an outer cover that are bonded together through and around the stent structure to cover the stent. The stent cover is constructed from expanded polytetrafluoroethylene (ePTFE) having a structure of nodes interconnected by fibrils. The stent covering has a radial thickness of at least about 0.008? and an average internodal distance (IND) of at least about 100 microns when the stent is in the reduced diameter, unexpanded state. The covered stent deploys at an average deployment pressure of less than or equal to about 10 atm.

Abstract: A non-polymeric or biological coating applied to radially expandable medical delivery device provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The delivery device is expanded using the pressure of an inflation fluid. After expanding the delivery device to a pre-determined size and shape, the inflation fluid weeps through the porous surface of the delivery device. The coating releases the delivery device and floats on the inflation fluid until bonding to the tissue due to its affinity for the tissue. Once the coating bonds or affixes to the tissue, through an absorption mechanism by the tissue cells of the coating material, the coating and any therapeutics contained therein are delivered to the tissue. The fluid can contain a therapeutic agent, or can be otherwise biocompatible and/or inert.

Abstract: Coatings for medical devices, methods of making the coatings, and methods of using them are described.

Abstract: An apparatus for hanging a medical device is provided. The apparatus includes a shaft, a mounting portion coupled to an end portion of the shaft and configured for mounting the apparatus for movement with respect to the medical device, and a hook portion positioned at an opposite end portion of the shaft and configured for hanging the apparatus from a support. The shaft is configured to permit rotation of the hook portion with respect to the mounting portion, thereby facilitating orientation of the hook portion with respect to the support.

Abstract: A method for the sterilization and packaging of a chemically sensitive medical device is provided. The chemically sensitive medical device has a coating derived from fish oil, a vitamin E compound or a combination thereof. The packaging pouch for the chemically sensitive medical device comprises a non-permeable chamber and a gas-permeable header. The sterilizing agent is administered to the packaged chemically sensitive medical device at a temperature of between about 20° C. and 40° C.

Abstract: An apparatus for establishing a re-usable, recurring, mechanical connection to an organ within a patient is provided. A subcutaneous needle connection system for providing bidirectional, straight and turbulent-free fluid flow access to a vascular system of a patient includes a housing defining a needle access opening for receiving a needle, a cannula opening in communication with the vascular system and a passageway connecting the needle access opening to the cannula opening. The housing can additionally have a second needle access opening connected to a second cannula opening via a second passageway. The subcutaneous needle connection system allows for blood to be removed from the vascular system via one cannula opening, passed to a hemodialysis system via a needle inserted in an associated needle access opening, treated using the hemodialysis system, and returned to the vascular system via the other needle access opening and associated cannula opening.

Abstract: A bio-absorbable stand-alone film is derived at least in part from fatty acids. The bio-absorbable 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. The stand-alone film has one or more perforations or depressions formed therein. Corresponding methods of making the bio-absorbable stand-alone film with one or more perforations or depressions include molding, cutting, carving, puncturing or otherwise suitable methods to create the perforations or depressions in the bio-absorbable stand-alone film. The resulting stand-alone film is bioabsorbable.