Abstract: A cryo-fixation lead extraction device includes a lead extraction catheter having longitudinally spaced proximal and distal catheter ends and an elongate catheter lumen. A liner has longitudinally spaced proximal and distal liner ends and an elongate liner lumen. The liner lumen is configured to selectively accept at least part of a lead being extracted longitudinally therethrough. At least a portion of the liner is located circumferentially within and/or circumferentially surrounding the catheter lumen. At least one cryogen supply line extends longitudinally through at least a portion of the liner lumen. The cryogen supply line is configured to place a cryogen fluid source into fluid communication with the distal liner end. The cryogen supply line is configured to selectively generate a patient tissue cooled zone adjacent the distal catheter end. A method of cryo-fixation lead extraction is also provided.

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: 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: 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: 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: A cryoablation device is provided herein which, in an embodiment, includes a catheter shaft; a cryogen return line disposed within the catheter shaft; and a cryogen supply line disposed within the cryogen return line, such that the cryogen supply line, the cryogen return line, and the catheter shaft are all substantially coaxial. A needle tip probe is disposed at a distal end of the cryogen return line. The cryogen supply line extends in a distal direction beyond a distal end of the cryogen return line and into the needle tip probe, and the catheter shaft is axially movable relative to the needle tip probe and the cryogen return line, and the catheter shaft is configured such that the catheter shaft is distally extended over the needle tip probe in an extended position.

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. Several additive agents (both natural and synthetic) have been identified, 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 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 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: 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: 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 invention is a multi-functional ablation device that encompasses the use of both heat energy and cryogenic energy as integrated into one medical device. In one embodiment, the medical device integrates a heat source such as RF or HIFU in combination with a source of cryogenic energy such that the multi-functional ablation device is a dual thermal ablation device capable of utilizing either energy source alone or in combination.

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 invention is a multi-functional ablation device that encompasses the use of both heat energy and cryogenic energy as integrated into one medical device. In one embodiment, the medical device integrates a heat source such as RF or HIFU in combination with a source of cryogenic energy such that the multi-functional ablation device is a dual thermal ablation device capable of utilizing either energy source alone or in combination.

Abstract: The invention is a multi-functional ablation device that encompasses the use of both heat energy and cryogenic energy as integrated into one medical device. In one embodiment, the medical device integrates a heat source such as RF or HIFU in combination with a source of cryogenic energy such that the multi-functional ablation device is a dual thermal ablation device capable of utilizing either energy source alone or in combination.

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: 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.