Abstract: The present invention is directed toward fatty acid-based particles, and methods of making such particles. The particles can be associated with an additional, therapeutic agent. Also provided herein is a method of forming fatty acid particles, comprising associating a cross-linked, fatty acid-derived biomaterial with a cryogenic liquid; and fragmenting the bio material/cryogenic liquid composition, such that fatty acid particles are formed. The particles can be used for a variety of therapeutic applications.

Abstract: A non-setting agent for positioning a surgical mesh prosthesis against a tissue defect during surgical hernia repair enables a surgeon to position the surgical mesh prosthesis at an optimal location against the tissue defect without pre-measuring suture location and pre-suturing. The surgical mesh prosthesis can be repositioned by removing and replacing, or by sliding, the mesh along the tissue defect without traumatizing the tissue. The positioning agent is provided with adhesion and lubricity characteristics providing an adhesion strength required to temporarily maintain the surgical mesh in place, otherwise unsupported, against tissue of a targeted tissue location, and providing a viscosity that permits removal and replacement, or slidable movement, of the surgical mesh along the tissue upon receipt of a non-gravitational external force applied to the surgical mesh so movement of the surgical mesh that is atraumatic to the tissue.

Abstract: The present invention is directed toward fatty acid-based particles, and methods of making such particles. The particles can be associated with an additional, therapeutic agent. Also provided herein is a method of forming fatty acid particles, comprising associating a cross-linked, fatty acid-derived biomaterial with a cryogenic liquid; and fragmenting the bio material/cryogenic liquid composition, such that fatty acid particles are formed. The particles can be used for a variety of therapeutic applications.

Abstract: Exemplary embodiments of the present invention provide adhesion barriers having anti-adhesion and tissue fixating properties. The adhesion barriers are formed of fatty acid based films. The fatty acid-based films may be formed from fatty acid-derived biomaterials. The films may be coated with, or may include, tissue fixating materials to create the adhesion barrier. The adhesion barriers are well tolerated by the body, have anti-inflammation properties, fixate, well to tissue, and have a residence time sufficient to prevent post-surgical adhesions.

Abstract: A chest drainage system includes a collection device and a fluid pathway configured to extend from the collection device to a patient. A pressure source is configured to selectively provide sub-atmospheric pressure to the fluid pathway. The system is configured to introduce sub-atmospheric pressure from the pressure source at a substantially constant target pressure and at a dynamic pressure that varies from the target pressure. A method is also disclosed for draining a pleural cavity of a patient. The method involves applying dynamic pressure to the pleural cavity of a patient by changing sub-atmospheric pressure applied to the patient such that the patient's pleura moves without any or limited patient activity, thus facilitating removal of loculated fluid from the pleural cavity. The method may involve the use of the chest drain system.

Abstract: A vascular graft suitable for implantation, and more particular to a vascular graft having an expandable outflow region for restoring patency of the graft after implantation into a body lumen.

Abstract: A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.

Abstract: A pleural drainage system having an inflatable membrane and a method of using the system are disclosed. The pleural drainage system includes a pleural drainage catheter system. The pleural drainage catheter system includes an inflatable membrane and a drainage catheter integrally coupled to the inflation membrane, the drainage catheter defining a drainage lumen through which fluid is drawn from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane. The pleural drainage system further includes a suction system coupled to the drainage catheter and a fluid collector coupled to receive fluid from the drainage catheter. The pleural drainage system further includes an inflation system connected to deliver inflation fluid to the interior of the inflatable membrane. The pleural drainage system may be used to monitor an associated airleak in the pleural cavity of a patient.

Abstract: A hernia patch supporting tissue in-growth conforms to a tissue wall upon surgical installation and fixation within a patient. The hernia patch can include a base and positioning straps. The base is formed of two layers that are affixed to each other around the perimeter of the patch, for example by stitching. A stabilizing washer is provided between the two layers, and the stitch is provided peripherally around the stabilizing washer, keeping the washer free-floating between the layers. The base, positioning straps, and stabilizing washer are formed of a structure that does not separate the layers of the implant or form a space in the form of a pocket, and promotes more uniform and confluent tissue incorporation or in-growth after implantation. The hernia patch may further include a hydrolysable bioabsorbable cross-linked coating of a fatty acid based material, such as an omega-3 fatty acid based material.

Abstract: Exemplary embodiments of the present invention provide adhesion barriers having anti-adhesion and tissue fixating properties. The adhesion barriers are formed of fatty acid based films. The fatty acid-based films may be formed from fatty acid-derived biomaterials. The films may be coated with, or may include, tissue fixating materials to create the adhesion barrier. The adhesion barriers are well tolerated by the body, have anti-inflammation properties, fixate, well to tissue, and have a residence time sufficient to prevent post-surgical adhesions.

Abstract: A chest drainage system including a collection device configured to receive fluid from the pleural cavity of a patient. A sensor is included to detect a pressure differential in the fluid. A display is configured to display a trend in occurrences of changes in pressure of the fluid over time in predetermined time increments based on a number of detections of pressure differentials that exceed a predetermined pressure differential during each of the predetermined time increments. The trend is correlative to the percentage of time that the patient is deemed to have an air leak in the pleural cavity in the predetermined time increments. The trend is derived from a ratio of the quantity of respiratory cycles of the patient for which the predetermined pressure differential is detected (QRCleak) in the predetermined time increments to the total quantity of respiratory cycles of the patient in respective predetermined time increments (QRCtotal).

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 medical device including a mesh prosthesis having a first mesh layer affixed to a second mesh layer along a perimeter area. An enclosure is defined between the first and second layers and extends inwardly from the perimeter area. An opening in the first layer passes through the first layer to the enclosure. A fixation guide template defines a guide pocket within the enclosure. A resilient deployment structure is removably disposed within the enclosure and extending toward the perimeter area. The resilient deployment structure has an elasticity that generates a resilient deployment force for urging the mesh prosthesis to a deployed configuration from a non-deployed configuration. A shield projection extends outwardly from a perimeter of the resilient deployment structure and is engaged within the guide pocket to prevent relative rotational movement between the resilient deployment structure and the mesh prosthesis. A method of using a medical device is also included.

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: 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 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 medical device including a mesh prosthesis having a first layer having an opening a second layer secured to the first layer and forming a pocket therebetween. A deployment device is positioned in the pocket and arranged to resiliently exert a deployment force on the mesh prosthesis to urge the mesh prosthesis into a deployment shape. The deployment device has a first shape when deployed that has at least one dimension larger than that of the opening to frustrate removal of the deployment device therethrough. Upon application of a suitable pulling force the deployment device is reconfigurable into a second shape that permits the deployment device to be removed from the pocket through the opening upon application of the suitable pulling force. A method of using a medical device is also included.

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: 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 chest drainage system includes a collection device and a fluid pathway configured to extend from the collection device to a patient. The fluid pathway has a proximal portion configured to extend proximally toward the patient and a distal portion configured to extend distally from the patient. The chest drainage system also includes a pressure source including an accumulator configured to selectively provide sub-atmospheric pressure to the distal portion of the fluid pathway and a valve configured to selectively relieve pressure in the proximal portion of the fluid pathway. The system is configured to open the valve and to introduce the sub-atmospheric pressure from the accumulator of the pressure source when a predetermined pressure differential is detected between the proximal and distal portions of the fluid pathway.