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: 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 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: 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 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: 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: 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.

Abstract: Methods and devices for the provision of a coating on an implantable medical device. 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 methods and devices provide a coating having improved uniformity and coverage which in turn allow for greater control of the amount and dosage of the coating.

Abstract: A non-polymeric or biological coating applied to a radially expandable interventional medical device in a collapsed, wrapped, or folded configuration. Properties of the coating material applied to the medical device are adjusted or varied to result in a desired combination of coverage of the surface of the medical device, drug loading, and coating thickness. 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.

Abstract: A method of 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 heat in both temperature and duration to achieve a desired amount of cross-linking forming the gel.

Abstract: A method for the provision of a coating on an implantable 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 dissolved 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 dissolved therapeutic agent, to the patient.

Abstract: A method for the provision of a coating on an implantable 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 dissolved 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 dissolved therapeutic agent, to the patient.

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.