Abstract: A system for heating or cooling a sample is disclosed, which includes an insulated chamber; at least one of a heater or a cooling pad disposed within the chamber; and at least one compliant, fluid filled pillow. The at least one compliant, fluid-filled pillow is disposed in the chamber and adjacent to the at least one thermal device while being heated or cooled to a desired temperature by the heater or the cooling pad, and upon reaching the desired temperature, the at least one compliant, fluid filled pillow substantially conforms to a container containing the sample.

Abstract: A novel class of agents has been identified to serve as cell-guard agents and/or target-specific supplements to increase cell quality and yield, as well as select for target cell populations. Laboratory experiments have demonstrated the use of cell-guard agents and/or target-specific supplements in the bioprocessing of cells as well as in selecting out a desired cell population. Several potential additive agents (both natural and synthetic) have been identified during these studies, including Vitamin D3, NAC, resveratrol, salubrinal, AKT, and tunicamycin (among others) that hold promise for application in cell models. In one embodiment, hypothermic stress regimes are utilized. In another embodiment, normothermic conditions are utilized while other stressors are tested in the processing. The methods of maintaining mass cell cultures and/or selecting out particular cell populations for further research and clinical use represents an important step in therapeutic discovery.

Abstract: A tissue engineered model (TEM) structure, an apparatus and method for making a TEM structure, and methods of using a TEM structure are disclosed. In an embodiment, the TEM structure includes at least one TEM segment. Each TEM segment includes a frame defining a bounded area, the frame having a height, a first edge, and a second edge opposite the first edge, each of the first edge and the second edge defining a perimeter of the bounded area, and the height defining a distance between the first edge and the second edge; a membrane affixed to the first edge about a perimeter of the frame; and a solidified gel and cell matrix disposed within the bounded area within the frame, wherein the solidified gel and cell matrix substantially fills a volume defined by the bounded area and the height of the frame.

Abstract: Cryogenic medical devices and apparatus are disclosed which are capable of generating cryogen to a supercritical state, specifically supercritical nitrogen. The cryogenic medical devices and apparatus disclosed are useful in methods of treating damaged, diseased, cancerous or other unwanted tissues.

Abstract: A tissue engineered model (TEM) structure, an apparatus and method for making a TEM structure, and methods of using a TEM structure are disclosed. In an embodiment, the TEM structure includes at least one TEM segment. Each TEM segment includes a frame defining a bounded area, the frame having a height, a first edge, and a second edge opposite the first edge, each of the first edge and the second edge defining a perimeter of the bounded area, and the height defining a distance between the first edge and the second edge; a membrane affixed to the first edge about a perimeter of the frame; and a solidified gel and cell matrix disposed within the bounded area within the frame, wherein the solidified gel and cell matrix substantially fills a volume defined by the bounded area and the height of the frame.

Abstract: An embodiment of the invention is a cryo-connector, a connector that allows for the delivery and return of a cryogen in an axial configuration. In one embodiment, the connector is a tri-axial configuration allowing for the delivery and return of pressurized cryogen as well as the application of an independent vacuum in the third lumen. Various configurations, however, may accommodate any number of luminary spaces such that cryogen (or other fluids) and/or vacuum spaces may be created in a fashion complementary to the components that the connector will affix to and interconnect with. The connectors can be utilized with any low temperature, cryogenic device and at varying pressures.

Abstract: A cryogenic system as well as a method of generating a pressurized, sub-cooled mixed-phase cryogen and a method of delivering such a cryogen to a cryoprobe are disclosed. In an embodiment, the cryogenic system includes a reservoir containing a liquid cryogen and a sub-cooling coil immersed in the liquid cryogen. The cryogen is supplied to the sub-cooling coil and is cooled under pressure to produce a pressurized mixed phase cryogen within the sub-cooling coil. This pressurized mixed phase cryogen is provided via supply line to a cryo-device for use.

Abstract: A thermal regulation catheter system and method of use are disclosed, for moderating the temperature and other parameters of tissue surrounding a target tissue for an ablation procedure, or for performing a thermal treatment procedure. In an embodiment, the device includes a catheter having a shaft with a fluid supply line and a fluid return line disposed therein, and an inflatable heat exchange vessel at a distal end of the shaft. The fluid supply line supplies fluid to inflate the heat exchange vessel, and the fluid return line conducts fluid away from the heat exchange vessel.

Abstract: One embodiment of the invention is a flexible cryogenic probe tip. The flexible probe tip has a linear freeze zone at a distal end of the probe that allows for its placement and precisely controlled movements. The flexible cryogenic probe tip precisely conforms to the target tissue surface to create a linear lesion. In addition, the probe tip is steerable to facilitate proper placement with minimal access points into a patient's body. Various configurations of the flexible probe tip allow it to conform and ablate tissue of many sizes, shapes, and/or dimensions.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues, particularly as utilized for the ablation of cardiac tissue in the treatment of atrial fibrillation. The device is a closed or semi-closed system in which the liquid cryogen is nitrogen contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state, specifically supercritical nitrogen, and may be utilized in any rapid cooling systems. As designed, the device also integrates endocardial catheters and epicardial probes.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state and may be utilized in any rapid cooling systems. As designed, the device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, baffled linear heat exchanger, multiple pressurization cartridges, a return chamber, and a series of valves to control the flow of the liquid cryogen. The cryogenic medical device promotes the subcooling to any external cryogenic instrument.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state and may be utilized in any rapid cooling systems. As designed, the device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, baffled linear heat exchanger, multiple pressurization cartridges, a return chamber, and a series of valves to control the flow of the liquid cryogen interconnected with cryotreatment devices including cryoprobes and catheters. The cryogenic medical device promotes subcooling to the tips of various external cryogenic instrument configurations.

Abstract: Embodiments of the present invention relate to cryogenic systems and methods useful to cool objects, including living tissue, to freezing or cryogenic temperatures by placing the object in thermal communication with sub-cooled supercritical nitrogen.

Abstract: An endoscopic cryoablation apparatus for the ablation of unwanted tissues is disclosed. A method of utilizing the apparatus for ablating pancreatic cancer, gastrointestinal cancers, or other undesired tissue is also incorporated. The apparatus provides a cryoprobe needle tip covered by an outer sheath at a distal end of a catheter shaft such that the distal end includes a defined ablation zone. As implemented, the cryocatheter can be utilized alone or in combination with and endoscopic ultrasound. A moveable handle attached to the outer sheath is configured such that the handle retracts and protracts the outer sheath to expose and cover, respectively, the cryoprobe needle tip.

Abstract: A tissue engineered model (TEM) structure, an apparatus and method for making a TEM structure, and methods of using a TEM structure are disclosed. In an embodiment, the TEM structure includes at least one TEM segment. Each TEM segment includes a frame defining a bounded area, the frame having a height, a first edge, and a second edge opposite the first edge, each of the first edge and the second edge defining a perimeter of the bounded area, and the height defining a distance between the first edge and the second edge; a membrane affixed to the first edge about a perimeter of the frame; and a solidified gel and cell matrix disposed within the bounded area within the frame, wherein the solidified gel and cell matrix substantially fills a volume defined by the bounded area and the height of the frame.

Abstract: The present disclosure relates to a thermal ablation probe device that integrates deployable sensors with a freezing probe or heating probe for use in ablating tissues. The ablation probe includes a longitudinal body including a thermal ablation energy source which may be, e.g., a cryosource or a heat source. The longitudinal body has a proximal end and a distal end terminating at a probe tip; and at least one deployable assembly disposed within the longitudinal body. The deployable assembly includes a flexible and substantially rigid deployment member, and at least one sensor affixed to a distal end of the deployment member. The ablation probe further includes a control mechanism for controlling deployment and retraction of the deployable assembly.

Abstract: The resorbable cryoprobe device and process is a novel approach for treating localized disease allowing for the precise combined application of freezing temperatures and cytotoxic or cryosensitizing agents within a self-contained matrix/package for optimized tissue destruction. The cryopellet is comprised of a list of components including a source of cryogen to produce the sub-zero temperatures, a porous matrix to contain the cytotoxic agent, cytotoxic agent, and a delivery packet. Data presented herein demonstrates the efficacy of this approach in destroying cancerous tissue. For example, the application of freezing temperatures to ?10° C. results in approximately 15% cell death, while exposure to cytotoxic agents such as TRAIL produces minimal cell death. The utilization of the cryopellet approach results in a synergistic effect yielding complete cell death at the same temperature.

Abstract: The device of the invention takes the form of a catheter/probe and is a closed loop system in which cryogen is delivered along the length of the catheter/probe to the tip where freezing occurs, and then recirculated. The device is a tube within a tube and comprises a number of parts including supply and return (internal) tubes, outer sheath (external tube) seaJed to the inner tubes at one or both ends with a gas filled lumen between the internal and external tubes. The lumen of the external tube is filled with a saturated gas which solidifies upon cooling, thereby creating a vacuum along the catheter length and providing for insulation between the inner and outer tubes, and preventing freezing along the probe shaft length. The outside surface of the internal tubes is modified to potentiate gas nucleation on the outer surfaces of the internal tubes when cooled.

Abstract: The resorbable cryoprobe device and process is a novel approach for treating localized disease allowing for the precise combined application of freezing temperatures and cytotoxic or cryosensitizing agents within a self-contained matrix/package for optimized tissue destruction. The cryopellet is comprised of a list of components including a source of cryogen to produce the sub-zero temperatures, a porous matrix to contain the cytotoxic agent, cytotoxic agent, and a delivery packet. Data presented herein demonstrates the efficacy of this approach in destroying cancerous tissue. For example, the application of freezing temperatures to ?10° C. results in approximately 15% cell death, while exposure to cytotoxic agents such as TRAIL produces minimal cell death. The utilization of the cryopellet approach results in a synergistic effect yielding complete cell death at the same temperature.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues, particularly as utilized for the ablation of cardiac tissue in the treatment of atrial fibrillation. The device is a closed or semi-closed system in which the liquid cryogen is nitrogen contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state, specifically supercritical nitrogen, and may be utilized in any rapid cooling systems. As designed, the device also integrates endocardial catheters and epicardial probes.