Abstract: A biocompatible membrane composite including a cell impermeable layer and a mitigation layer is provided. The cell impermeable layer is impervious to vascular ingrowth and prevents cellular contact from the host. Additionally, the mitigation layer includes solid features. In at least one embodiment, mitigation layer has therein bonded solid features. In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded or otherwise connected to each other to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned external to or within the biocompatible membrane composite to provide support to and prevent distortion. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: A biocompatible membrane composite including a cell impermeable layer and a mitigation layer is provided. The cell impermeable layer is impervious to vascular ingrowth and prevents cellular contact from the host. Additionally, the mitigation layer includes solid features. In at least one embodiment, mitigation layer has therein bonded solid features. In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded or otherwise connected to each other to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned external to or within the biocompatible membrane composite to provide support to and prevent distortion. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: Cell encapsulation devices for biological entities and/or cell populations that contain at least one biocompatible membrane composite are provided. The cell encapsulation devices mitigate or tailor the foreign body response from a host such that sufficient blood vessels are able to form at a cell impermeable surface. Additionally, the encapsulation devices have an oxygen diffusion distance that is sufficient for the survival of the encapsulated cells so that the cells are able to secrete a therapeutically useful substance. The biocompatible membrane composite is formed of a cell impermeable layer and a mitigation layer. The cell encapsulation device maintains an optimal oxygen diffusion distance through the design of the cell encapsulation device or through the use of lumen control mechanisms. Lumen control mechanisms include a reinforcing component that is also a nutrient impermeable layer, internal structural pillars, internal tensioning member(s), and/or an internal cell displacing core.

Abstract: A biocompatible membrane composite that can provide an environment that is able to mitigate or tailor the foreign body response is provided. The membrane composite contains a mitigation layer and a vascularization layer. A reinforcing component may optionally be included to provide support to and prevent distortion of the biocompatible membrane composite in vivo. The mitigation layer may be bonded (e.g., point bonded or welded) or adhered (intimately or discretely) to an implantable device and/or cell system. The biocompatible membrane composite may be used as a surface layer for implantable devices or cell systems that require vascularization for function but need protection from the host's immune response, such as the formation of foreign body giant cells. The biocompatible membrane composite may partially or fully cover the exterior of an implantable device or cell system. The mitigation layer is positioned between the implantable device or bioactive scaffold and the vascularization layer.

Abstract: A biocompatible membrane composite including a first layer (cell impermeable layer), a second layer (a mitigation layer), and a third layer (a vascularization layer) is provided. The mitigation layer may be positioned between the cell impermeable layer and the vascularization layer In some embodiments, the cell impermeable layer and the mitigation layer are intimately bonded to form a composite layer having a tight/open structure. A reinforcing component may optionally be positioned on either side of the biocompatible membrane composite or within the biocompatible membrane composite to provide support to and prevent distortion of the membrane composite. The biocompatible membrane composite may be used in or to form a device for encapsulating biological entities, including, but not limited to, pancreatic lineage type cells such as pancreatic progenitors.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: A microcatheter for delivery of embolic fluids includes an outer member dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen, and an inner member is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen and has a delivery port in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery thereof toward the embolization site.

Abstract: An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.

Abstract: A catheter system is provided. The system includes a catheter having an elongated flexible body and one or more electroactive polymer actuators disposed along the elongated flexible body. The electroactive polymer actuators are adapted to cause a change in configuration of the elongated flexible body. The system also includes a controller adapted to transmit the control signal to the electroactive polymer actuators. The controller includes a memory storing a plurality of control signals corresponding to a plurality of predetermined configurations of the catheter and a user-interface coupled to the memory. The user-interface is configured to select one or more configurations from the plurality of predetermined configurations in response to user input.

Abstract: A method for performing a diagnostic or therapeutic procedure on a partial occlusion within a blood vessel, includes positioning a guide having a sensor configured and adapted to measure at least one of pressure, volume or flow within a blood vessel, advancing the guide through an at least partial occlusion within the blood vessel such that the sensor is downstream of the occlusion, measuring at least one of pressure, volume or flow downstream of the occlusion using the sensor and analyzing data obtained from the sensor to assist in determining the viability of tissue of the blood vessel downstream of the occlusion.

Abstract: A catheter system is provided. The system includes a catheter having an elongated flexible body and one or more electroactive polymer actuators disposed along the elongated flexible body. The electroactive polymer actuators are adapted to cause a change in configuration of the elongated flexible body. The system also includes a controller adapted to transmit the control signal to the electroactive polymer actuators. The controller includes a memory storing a plurality of control signals corresponding to a plurality of predetermined configurations of the catheter and a user-interface coupled to the memory. The user-interface is configured to select one or more configurations from the plurality of predetermined configurations in response to user input.

Abstract: A guidewire for use in a medical procedure includes an elongate guide member dimensioned for insertion within a body vessel of a subject. The guide member includes an elongate body segment and a leading tip segment. The elongate body segment defines a longitudinal opening, and the leading tip segment is adapted and dimensioned to articulate relative to the elongate body segment about a single axis. A control element extends through the longitudinal opening of the elongate body segment and is longitudinally movable through manual manipulation of a clinician to cause corresponding articulating movement of the leading tip segment.

Abstract: A microcatheter for delivery of embolic fluids includes an outer member dimensioned for insertion within a blood vessel adjacent an embolization site. The outer member defines a first longitudinal lumen, and an inner member is selectively positionable within the first longitudinal lumen of the outer member. The inner member defines a second longitudinal lumen and has a delivery port in fluid communication with the second longitudinal lumen for passage and delivery of embolic fluids toward the embolization site. A valve is disposed within the outer member. The valve is dimensioned to establish a substantial seal about the inner member, to minimize entry of the embolic fluids within the first longitudinal lumen of the outer member subsequent to delivery thereof toward the embolization site.

Abstract: A guidewire for use in a medical procedure includes an elongate guide member dimensioned for insertion within a body vessel of a subject. The guide member includes an elongate body segment and a leading tip segment. The elongate body segment defines a longitudinal opening, and the leading tip segment is adapted and dimensioned to articulate relative to the elongate body segment about a single axis. A control element extends through the longitudinal opening of the elongate body segment and is longitudinally movable through manual manipulation of a clinician to cause corresponding articulating movement of the leading tip segment.

Abstract: Embodiments of the invention provide methods for packaging integrated circuits and/or other electronic components with electrochemically fabricated structures which include conductive interconnection elements. In some embodiments the electrochemically produced structures are fabricated on substrates that include conductive vias while in other embodiments, the substrates are solid blocks of conductive material, or conductive material containing passages that allow the flow of fluid to maintain desired thermal properties of the packaged electronic components.