Abstract: One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.

Abstract: An implantable medical device performs a method that includes detecting a cardiac event interval that is greater than a P-wave oversensing threshold interval. In response to detecting the cardiac event interval greater than the P-wave oversensing threshold interval, the device determines the amplitude of the sensed cardiac signal and withholds restarting a pacing interval in response to the amplitude satisfying P-wave oversensing criteria. A pacing pulse may be generated in response to the pacing interval expiring without sensing an intrinsic cardiac electrical event that is not detected as a P-wave oversensing event.

Abstract: An implantable medical device performs a method that includes detecting a cardiac event interval that is greater than a P-wave oversensing threshold interval. In response to detecting the cardiac event interval greater than the P-wave oversensing threshold interval, the device determines the amplitude of the sensed cardiac signal and withholds restarting a pacing interval in response to the amplitude satisfying P-wave oversensing criteria. A pacing pulse may be generated in response to the pacing interval expiring without sensing an intrinsic cardiac electrical event that is not detected as a P-wave oversensing event.

Abstract: A motor driven system for raising and lowering a window covering executes motor ramp trajectory speed control. The motor ramp trajectory limits acceleration of an external motor from the idle (stationary) state to full operating speed, and limits deceleration of the motor from full operating speed back to the idle state. This function reduces stresses on a continuous cord loop drive mechanism. A control system manages solar heating effects in response to sunlight entrance conditions such as system sensor outputs, external weather forecasts, and other data sources. The system automatically opens or close the window covering to increase or decrease admitted sunlight under appropriate conditions. The input interface of the control system includes a visual display and input axis, which are aligned vertically if the window covering mechanism raises and lowers the window covering, and are aligned horizontally if the window covering mechanism laterally opens and closes the window covering.

Abstract: An implantable medical device performs a method that includes detecting a cardiac event interval that is greater than a P-wave oversensing threshold interval. In response to detecting the cardiac event interval greater than the P-wave oversensing threshold interval, the device determines the amplitude of the sensed cardiac signal and withholds restarting a pacing interval in response to the amplitude satisfying P-wave oversensing criteria. A pacing pulse may be generated in response to the pacing interval expiring without sensing an intrinsic cardiac electrical event that is not detected as a P-wave oversensing event.

Abstract: One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.

Abstract: A transseptal access stability system (TASS) and method of use thereof is disclosed. The TASS includes a venous sheath for reducing the likelihood of complications that may arise when performing transseptal punctures. The TASS uses either suction force or cryo-based energy for securing the fossa ovale against the rim of the orifice of the venous sheath. A method of performing a transseptal puncture using the presently disclosed TASS also is disclosed.

Abstract: An embodiment in accordance with the present invention provides an automatic external defibrillator including an anterior pad designed such that it can be used during an endoscopic or surgical procedure that may generate electromagnetic interference. The anterior pad has a first arm adhered longitudinally along and substantially parallel to a left side of a sternum of the subject and a second arm adhered along a 5th intercostal space of the subject. The device also includes a posterior pad. Both the anterior and posterior pads include electrodes for delivering a shock to the subject. The device can also include a wearable component containing sensing electrodes for measuring heart rhythms and a transmitting them to a monitor. The monitor monitors these heart rhythms and alerts the subject or medical care providers to irregularities in the rhythms.

Abstract: A system and method for solvent recovery in a batch fluidized bed process is provided. The disclosed embodiment of the fluidized bed system includes a fluidized bed vessel adapted to contain a batch of solvent-containing product; an influent or intake circuit adapted to supply an inert fluidizing gas to the fluidized bed vessel; an effluent circuit adapted to remove the solvent containing inert fluidizing gas from the fluidized bed vessel; a first recycle circuit coupling the effluent circuit to a solvent recovery means; a second recycle circuit directly coupling the effluent circuit to the intake circuit and a flow control valve operatively disposed to divide the effluent between the first recycle circuit and the second recycle circuit based on the operating regime of the fluidized bed process.

Abstract: A cryogenic refrigeration system for lyophilization is disclosed. The cryogenic refrigeration system includes a cryogenic heat exchanger system adapted for vaporizing a liquid cryogen and using the gaseous cryogen to cool heat transfer fluid and a heat transfer cooling circuit that cools the lyophilization chamber as well as the condenser. The disclosed heat transfer cooling circuit includes a primary recirculation loop adapted for cooling the lyophilization chamber with the heat transfer fluid, a secondary recirculation loop adapted for cooling a condenser with the heat transfer fluid, and one or more valves operatively coupling the cryogenic heat exchanger system, the primary recirculation loop, and the secondary recirculation loop.

Abstract: A method and system for controlled rate freezing of biological materials is provided. The presently disclosed system and method provides the ability to rapidly cool the biological materials contained in vials or other containers within a cooling unit via forced convective cooling using a laminar and uniform flow of cryogen in proximity to the plurality of vials disposed within the cooling unit. The rapid cooling of the biological materials is achieved by precisely controlling and adjusting the temperature of the cryogen being introduced to the system as a function of time.

Abstract: An embodiment in accordance with the present invention provides an automatic external defibrillator including an anterior pad designed such that it can be used during an endoscopic or surgical procedure that may generate electromagnetic interference. The anterior pad has a first arm adhered longitudinally along and substantially parallel to a left side of a sternum of the subject and a second arm adhered along a 5th intercostal space of the subject. The device also includes a posterior pad. Both the anterior and posterior pads include electrodes for delivering a shock to the subject. The device can also include a wearable component containing sensing electrodes for measuring heart rhythms and a transmitting them to a monitor. The monitor monitors these heart rhythms and alerts the subject or medical care providers to irregularities in the rhythms.

Abstract: A system and method for bulk freezing is provided. In one embodiment, the system and method for bulk freezing includes a bulk freezing container adapted to hold at least one and preferably a plurality of bags holding a biopharmaceutical liquid. The bulk freezing container includes at least a first and second shelf having corrugations wherein the second shelf is vertically arranged above the first shelf with the bags disposed between the shelves. The bags and the corrugations of the first and second shelves define a plurality of substantially parallel flow channels through which a cryogenic cold fluid or a warming fluid is passed to freeze and/or thaw the biopharmaceutical fluid. In another embodiment, the bulk freezing system and method includes a bulk freezing container with a plurality of adjacent elongated chambers adapted for holding the biopharmaceutical fluid.

Abstract: A system and method for solvent recovery in a batch fluidized bed process is provided. The disclosed embodiment of the fluidized bed system includes a fluidized bed vessel adapted to contain a batch of solvent-containing product; an influent or intake circuit adapted to supply an inert fluidizing gas to the fluidized bed vessel; an effluent circuit adapted to remove the solvent containing inert fluidizing gas from the fluidized bed vessel; a first recycle circuit coupling the effluent circuit to a solvent recovery means; a second recycle circuit directly coupling the effluent circuit to the intake circuit and a flow control valve operatively disposed to divide the effluent between the first recycle circuit and the second recycle circuit based on the operating regime of the fluidized bed process.

Abstract: A cryogenic refrigeration system for lyophilization is disclosed. The cryogenic refrigeration system includes a cryogenic heat exchanger system adapted for vaporizing a liquid cryogen and using the gaseous cryogen to cool heat transfer fluid and a heat transfer cooling circuit that cools the lyophilization chamber as well as the condenser. The disclosed heat transfer cooling circuit includes a primary recirculation loop adapted for cooling the lyophilization chamber with the heat transfer fluid, a secondary recirculation loop adapted for cooling a condenser with the heat transfer fluid, and one or more valves operatively coupling the cryogenic heat exchanger system, the primary recirculation loop, and the secondary recirculation loop.

Abstract: A cryogenic refrigeration system includes a cryogenic heat exchanger system adapted for vaporizing a liquid cryogen and using the gaseous cryogen to cool heat transfer fluid and a heat transfer cooling circuit that cools the lyophilization chamber as well as the condenser. The disclosed heat transfer cooling circuit includes a primary recirculation loop adapted for cooling the lyophilization chamber with the heat transfer fluid, a secondary recirculation loop adapted for cooling a condenser with the heat transfer fluid, and one or more valves operatively coupling the cryogenic heat exchanger system, the primary recirculation loop, and the secondary recirculation loop.

Abstract: A method and system for controlled rate freezing of biological materials is provided. The presently disclosed system and method provides the ability to rapidly cool the biological materials contained in vials or other containers within a cooling unit via forced convective cooling using a laminar and uniform flow of cryogen in proximity to the plurality of vials disposed within the cooling unit. The rapid cooling of the biological materials is achieved by precisely controlling and adjusting the temperature of the cryogen being introduced to the system as a function of time.

Abstract: The invention relates to an inhaler comprising a compressed gas, such as Heliox gas in a first chamber which is in communication with an equalization chamber having pressure lower than the pressure of the gas in the first compressed chamber and having a drug storage chamber which is detachably coupled to the equalization chamber operable such that a portion of the compressed gas from the equalization chamber fluidizes and aerosolizes the drug to produce a drug cloud and which can then be injected into a spacer where it can be inhaled by a user.

Abstract: An inhaler comprising a compressed gas, such as Heliox gas is provided. The disclosed inhaler includes a first chamber containing a compressed gas which is in communication with an equalization chamber having pressure lower than the pressure of the gas in the first chamber. The inhaler also includes a drug storage chamber which is detachably coupled to the equalization chamber and operable such that a portion of the compressed gas from the equalization chamber fluidizes and aerosolizes the drug to produce a drug cloud. The drug cloud is directed into a spacer where it can be inhaled by a user.

Abstract: A cryogenic refrigeration system for lyophilization is disclosed. The cryogenic refrigeration system includes a cryogenic heat exchanger system adapted for vaporizing a liquid cryogen and using the gaseous cryogen to cool heat transfer fluid and a heat transfer cooling circuit that cools the lyophilization chamber as well as the condenser. The disclosed heat transfer cooling circuit includes a primary recirculation loop adapted for cooling the lyophilization chamber with the heat transfer fluid, a secondary recirculation loop adapted for cooling a condenser with the heat transfer fluid, and one or more valves operatively coupling the cryogenic heat exchanger system, the primary recirculation loop, and the secondary recirculation loop.