Abstract: A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented. In the de-coupled state, axial movement of the drive sleeve transfers force in a longitudinal direction for actuation of a drug delivery device.

Abstract: The present invention relates to an automatic torsion spring based injection device having a dial-up/dial-down mechanism by which a dose can be set by rotating a dose setting member in a first direction and which dose size can be reduced by rotating the same dose setting member in a second and opposite direction. The dial-up/dial-down mechanism operates a torsion spring which is strained when setting a dose and unstained when rotating the dose setting element in the second direction.

Abstract: A drive member for driving a piston rod in a drug delivery device is provided. The drive member is configured to be driven in a rotational movement by an actuating member. The drive member comprises a track for transmitting a driving load from the actuating member to the drive member. The track comprises both sections running in a distal and sections running in a proximal direction of the drive member. Moreover, a drug delivery device comprising such a drive member is provided.

Abstract: Medical needle shield apparatus for covering a needle after use. The medical needle shield apparatus includes a first member, such as, for example, a syringe barrel having a needle mounted therewith. A second member, such as, for example, a shield is mounted with the first member. The shield is movable between a first position whereby the needle is exposed and a second position whereby the needle is covered. A lock is mounted with the barrel such that the shield is slidably movable along an outer surface of the lock. The lock includes a tang that is movable radially outward to fix the shield in the second position.

Abstract: A bubble entrapment device includes at least one entrapment chamber between an inlet and an outlet. The chamber outlet port is approximately in the center, and so bubbles will rise in the chamber into a space above the chamber outlet port.

Abstract: A medical gas condition system for supplying a liquid hydration fluid to a hydrator before or during an ongoing medical procedure by coupling the flow of liquid hydration fluid into the hydrator to either the absence of flow of medical insufflation gas into the hydrator or to a condition where the liquid hydration fluid can be absorbed by a hydrator without being forced through the hydrator in liquid form.

Abstract: A method of assembling an inhaler for inhaling medicament, the inhaler having a body for retaining a medicament store and a dose counter having a moveable actuator and a chassis mounted on the body, the method including heat staking the chassis of the dose counter onto the body.

Abstract: An active inhaler for delivery of an inhalation formulation has an overall flow resistance of at least 60,000 Pa1/2 s/m3 for ambient air drawn into a mouthpiece of the inhaler. This flow resistance when air and the aerosol are sucked via the mouthpiece is produced by the sizing of at least on air supply opening and/or an insert within the mouthpiece.

Abstract: There is provided herein a system for weaning a patient from mechanical ventilation (MV), the system comprising a ventilation device and a controller comprising an interface module configured to receive two or more measured patient parameters, wherein at least one measured patient parameters parameter comprise a CO2 related parameter, wherein said controller is further configured to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more weaning related parameters in said ventilation device.

Abstract: The present invention relates to an integrated sleep diagnosis and treatment device, and more particularly to an integrated apnea diagnosis and treatment device. The present invention additionally relates to methods of sleep diagnosis and treatment. The sleep disorder treatment system of the present invention can use a diagnosis device to perform various forms of analysis to determine or diagnose a subject's sleeping disorder or symptoms of a subject's sleep disorder, and using this analysis or diagnosis can with or in some embodiments without human intervention treat the subject either physically or chemically to improve the sleeping disorder or the symptoms of the sleeping disorder. The diagnostic part of the system can use many different types of sensors and methods for diagnosing the severity of the symptoms of or the sleep disorder itself. The treatment part of the system can use a device to physically or chemically treat the subject's symptoms or sleep disorder itself.

Abstract: Described is a system including a sensor and a processing arrangement. The sensor measures data corresponding to a patient's breathing patterns. The processing arrangement analyzes the breathing patterns to determine whether the breathing patterns are indicative of a REM sleep state. In another embodiment, the processing arrangement analyzes the breathing patterns to determine whether the breathing patterns are indicative of one of the following states: (i) a wake state and (ii) a sleep state. In another embodiment, a neural network analyzes the data to determine whether the breathing patterns are indicative of one of the following states: (i) a REM sleep state, (ii) a wake state and (iii) a sleep state. In another embodiment, the processing arrangement analyzes the data to determine whether the breathing pattern is indicative of an arousal.

Abstract: The volume of a hyperinflated lung compartment is reduced by sealing a distal end of the catheter in an airway feeding the lung compartment. Air passes out of the lung compartment through a passage in the catheter while the patient exhales. A one-way flow element associated with the catheter prevents air from re-entering the lung compartment as the patient inhales. Over time, the pressure of regions surrounding the lung compartment cause it to collapse as the volume of air diminishes. Residual volume reduction effectively results in functional lung volume expansion. Optionally, the lung compartment may be sealed in order to permanently prevent air from re-entering the lung compartment.

Abstract: A limb for a breathing circuit manufactured from very thin walled polymer materials has an elongate axial reinforcing spine lying freely inside the conduit and fixed to each end connector. The spine is laterally compliant but axially stiff. The spine provides resistance to tensile and compressive loads on the conduit, including that induced by prevailing internal pressures.

Abstract: In various arrangements, a nebulizer element of a nebulizer may be energized with a drive signal. A phase offset of the drive signal may be measured. A phase delta may be determined. The phase delta may indicate a difference between a target phase offset and the measured phase offset. The target phase offset may indicate a non-zero target phase difference between the voltage of the drive signal and the current of the drive signal. A frequency of the drive signal may be changed to decrease the phase delta.

Abstract: A catheter includes a handle, a catheter sheath having at least one conductor within a lumen of the catheter sheath, and a stylet received within the catheter sheath. The catheter sheath is fabricated by providing a tubular member, forming an aperture in a wall of the tubular member at a distal part of the tubular member and inserting a conductor into the lumen of the tubular member. An exposed distal end of the conductor is attached to an electrode, which is then mounted onto an external surface of the tubular member to cover the aperture. The tubular member is then treated by heat to seal the electrode.

Abstract: A transseptal needle assembly comprised of a cannula, a handle assembly and a stylet is described. The cannula of the needle assembly is of a uniform body construction such that the cannula main portion and needle portion are fluidly connected in one-piece. The handle assembly comprises a handle housing, a handle sleeve and a handle slug. The handle slug provides ballast which improves tactile feel of the needle assembly. In addition, the stylet comprises a stylet housing having a hinged designed that allows for easier control of the stylet.

Abstract: Various embodiments provide systems and methods for controlling a catheter with a catheter positioning device by using a remote controller and a guidewire control mechanism that may be used to draw a guidewire through a catheter coupled with the catheter positioning system. As the catheter is advanced over the guidewire by the catheter positioning device, the guidewire control mechanism may draw the guidewire away, such as collecting any slack on the guidewire. In further embodiments, the guidewire control mechanism may match the speed at which the guidewire is drawn to the speed at which the catheter advances and thereby maintain the position of the guidewire relative to the patient.

Abstract: Drive systems and methods of use are disclosed herein for performing medical procedures on a patient. The drive systems include various handle types and triggers for controlling catheters and end effectors. The various handle types include a flexible handle and ambidextrous handles that can alter the handedness of the handle for particularized use. The handles drive articulation sections of the catheter and end effectors with various degrees of freedom, and include locks for holding the catheter and/or end effector in place. The catheter systems include structures for allowing degrees of freedom, such as notches, mechanical interlocks, and articulation joints. In addition, the catheters articulate via cables or fluids.

Abstract: An elongated optical guidewire assembly, such as for optically imaging a patient from within another catheter, can have a lead portion and a probe portion. A connector between the lead and probe portions can include a bore including first and second bore ends. The first bore end can include a substantially circular cross-sectional profile. The second bore end can include a substantially non-circular cross-sectional profile. The bore can be configured to receive the optical guidewire assembly at the first bore end and configured to deform the optical guidewire assembly at the second bore end such that probe and lead ends of the optical guidewire assembly are deformed into a substantially non-circular profile and located between the first and second bore ends.

Abstract: A catheter configured for performing reperfusion by alternatively occluding a vessel so as to prevent fluid flow and removing that occlusion to allow fluid flow is described. A first catheter includes an outer member and a retractable valve to allow and prevent fluid flow in the vessel. A second catheter includes a sheathed expansion member that can be deployed and recaptured to prevent and allow, respectively, fluid flow. A third catheter includes an angioplasty balloon to open a vessel occlusion, in which an occlusion balloon is used to allow and disallow fluid flow. A fourth catheter includes an expandable member for providing mechanical plunging action to urge thrombotic material to a more distal location. A fifth catheter includes an accessory catheter that can be used to perform reperfusion with another catheter. A sixth catheter includes an inner balloon within an outer balloon configured to perform reperfusion.

Abstract: A method of manufacturing a balloon catheter in which an extruded tubular balloon parison is attached to a component of a catheter shaft prior to blow molding a balloon from the extruded tubular balloon parison. A distal end region of the tubular balloon parison is attached to the outer surface of the elongate catheter shaft component to form a distal bond region between the tubular balloon parison and the catheter shaft component, and then the assembly is positioned in a balloon mold. An annular space between an inner surface of the tubular balloon parison and the outer surface of the elongate tubular member is pressurized to expand the tubular balloon parison in the cavity of the balloon mold to form an inflatable balloon.

Abstract: Disclosed is an apparatus for reinforcing medical balloons. The apparatus may be used for reinforcing any medical balloon by using a hollow tubular reinforcement sleeve. The sleeve may be in the form of a tubular braid, a tubular warp knitted fabric, a tubular weft knitted fabric or a tubular woven fabric. The apparatus may also be used for wrapping reinforcement yarns around the balloon.

Abstract: A method that includes introducing a catheter assembly to an obstructed region of a blood vessel lumen and recanalizing the obstructed region with the catheter assembly is disclosed. Prior to or during recanalization, a treatment agent may be delivered through the catheter assembly to a vessel region downstream to the obstructed region. The treatment agent may have a property that will inhibit reperfusion injury. Alternatively, a medical device may be introduced to an obstructed region of a blood vessel lumen and the obstructed region recanalized with the medical device. The treatment agent may be delivered to a vessel region downstream to the obstructed region. The treatment agent may include at least one of an immunosuppresant and an antioxidant.

Abstract: Devices and methods for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having chronic obstructive pulmonary disease. The methods and devices create channels in lung tissue and maintain the patency of these surgically created channels in tissue. Maintaining the patency of the channels allows air to pass directly out of the lung tissue which facilitates the exchange of oxygen ultimately into the blood and/or decompresses hyper-inflated lungs.

Abstract: An enema includes a liquid in a dispenser having a bottle, a nozzle attached to the bottle, and a valve. The valve may be a membrane having a slit and a thickness of at most 0.90 mm. The valve may be attached to the bottle or it may be attached to the nozzle. The enema can be administered more easily, with a lower amount of force. A method of bowel cleansing includes inserting the enema into a rectum and applying a compression force to the enema bottle.

Abstract: A syringe includes a sleeve and a pressure vessel with high pressure fluid therein. The sleeve further comprises a sleeve piston. As the high pressure vessel contacts the sleeve piston, and a bump on the sleeve piston destroys the airtight status of the high pressure vessel. While the seal of the high pressure vessel is removed, the compressed fluid flows into the sleeve through the opening of the high pressure vessel and the hole of the sleeve piston. When the closed end of the sleeve moves closer to the closed end of the sleeve piston, the fluid in the sleeve is pressed and flows out of the sleeve through the sleeve hole of the sleeve.

Abstract: According to one embodiment, a method for manufacturing a hollow needlelike object including a hollow part inside includes: a step of preparing a first needlelike-object base having a face comprising a groove forming at least a part of the hollow part; and a step of covering the face of the needlelike-object base with a covering member.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Abstract: A venous access port assembly having a base, a peripheral surface, and a septum. The base defines an interior reservoir. The peripheral surface includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the peripheral surface from a top surface to a bottom surface thereof. According to one aspect, the peripheral surface may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material, or they may be formed by voids in the X-ray discernable material. According to another aspect, the peripheral surface may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the peripheral surface applied with the radiopaque agent.

Abstract: Silicone tube structures are formed having a particular dimensional accuracy. In one embodiment, a silicone tube structure can include an extruded hollow body having an inner bore. The extruded hollow body can have an inner diameter, an outer diameter, and a length of at least approximately 20 m. The extruded hollow body can also have a dimensional accuracy that is measured by the standard deviation of the inner diameter being no greater than approximately 0.8% of an average inner diameter of the extruded hollow body over the length. In an embodiment, the silicone tube structure can be cut to form a number of silicone tubes.

Abstract: System, apparatus and method for opening a heat-bonded connection formed between two hollow, flexible thermoplastic conduits. A pressure difference is created between the inside of at least one of the conduits and the ambient atmosphere sufficient to cause expansion of a wall of the tubing conduit in the vicinity of a frangible portion at least partially blocking the connection to disrupt the frangible portion and reduce the blocking.

Abstract: The present application provides a device and methods of making and using these devices. The devices comprise porous caps and porous vents made from sintered porous polymeric media comprising plastic particles, elastomeric particles or a combination thereof. These devices are used with medical devices or components thereof to provide ease of use, resistance to infection, sterilization and venting.

Abstract: A medical connector for use with one or more medical implements. In some embodiments, the connector minimizes or eliminates the retrograde flow of fluid into the connector from one end or port upon the disconnection of a medical implement from the other end or port. In some embodiments, the connector generates a positive flow of fluid out of the connector from one end or port when a medical implement is disconnected from the other end or port.

Abstract: Provided is a method of transfecting cells of the cochlea with an agent by electroporation, and in certain embodiments using a cochlear implant to provide at least one electroporation electrode.

Abstract: A peelable lid system includes a peelable lid, a seal configured to seal the peelable lid to a container, a handle coupled to the peelable lid, and a lifting mechanism coupled to handle. The lifting mechanism can be coupled to the peelable lid at a plurality of attachment points, including at least one attachment point coupled to the peelable lid away from the handle. The lifting mechanism can be configured to lift at least one portion of the peelable lid near each of the plurality of attachment points.

Abstract: A medical microelectrode includes an elongate electrode body including a tip section, a main body section and, optionally, a coupling section. The tip section, the main body section and, optionally, the coupling section are embedded in a first electrode matrix element, which is substantially rigid, biocompatible and soluble or biodegradable in a body fluid. Additionally the microelectrode includes a dissolution retarding layer on the first electrode matrix element and/or a second electrode matrix element disposed between the first electrode matrix element and the electrode. Upon dissolution or biodegradation of the first electrode matrix element a drug comprised by the first electrode matrix element or the second electrode matrix element is released into the tissue. Also disclosed are bundles and arrays of the electrodes and their use.

Abstract: An electrical stimulation lead includes at least one lead body and at least one thin, elongate anchoring element. The lead body defines at least one anchoring lumen extending longitudinally along at least a portion of the lead body and at least one open slot in the lead body where each anchoring lumen is open at one of the at least one open slot. For each anchoring element, the first end of the anchoring element is disposed in one of the at least one anchoring lumen and the second end of the anchoring element is configured and arranged preferentially to extend out of the open slot associated with the anchoring lumen and away from the lead body in a deployed configuration unless the second end is constrained in a constrained configuration adjacent or within the lead body.

Abstract: An embodiment of a system includes a power source and at least two electrode assembles. The power source that an output current that alternates between a maximum current value and a minimum current value; a pair of electrode assemblies. Each electrode assembly is configured to be held in contact with a skin layer of a user. Additionally, each electrode assembly includes an electrode that is coupled to the power source to receive the output current from the power source. At least one of the electrode assemblies in the pair includes a medium that carries an active agent having a charge, the medium being provided on the at least one electrode assembly to enable the output current to repel the active agent into the skin layer for a duration in which the output current has a polarity that is the same as a polarity of the active agent.

Abstract: A sound sensor implantable in a recipient of a hearing device. The sound sensor comprises a biocompatible housing comprising a cavity having an opening at a first end of the housing, and a membrane attached to the housing so as to hermetically seal the opening. The membrane vibrates in response to vibration of at least on a structure of the recipient's ear and fluid within one of the recipient's body cavities. The sound sensor also comprises a vibrational sensor disposed in the housing configured to detect vibrations of the membrane, and configured to generate signals representative of the detected vibrations; and a transmitter configured to provide the generated signals to one or more other components implanted in the recipient.

Abstract: Arrangements are described for fitting a cochlear implant system to an implanted patient. A test stimulation sequence is delivered to the implanted patient which is based on a concatenated sequence of time shifted envelopes of sinusoidal amplitude modulated (SAM) signals that have a carrier frequency fc modulated by a jittered modulation frequency fm+?, where ? is a frequency jitter component selected from a jitter range of [??1,+?1]. Patient responses to the test stimulation sequence are simultaneously measured including an auditory steady-state response (ASSR) measurement signal and a psychophysical pitch discrimination response. The time shifted envelopes are adapted to avoid measurement artifacts in the ASSR measurement signal around the modulation frequency fm.

Abstract: An exemplary system includes a processing facility configured to process an audio signal presented to a cochlear implant patient and a control facility configured to direct a cochlear implant to apply electrical stimulation representative of the audio signal to the cochlear implant patient by 1) directing the cochlear implant to concurrently apply a first biphasic stimulation pulse by way of a first electrode and a second biphasic stimulation pulse by way of a second electrode during a first time slot, and 2) directing the cochlear implant to concurrently apply a third biphasic stimulation pulse by way of the second electrode and a fourth biphasic stimulation pulse by way of a third electrode during a second time slot that immediately follows the first time slot. The third and fourth biphasic stimulation pulses are flipped in phase compared to the first and second biphasic stimulation pulses.

Abstract: An exemplary system includes an electro-acoustic stimulation (“EAS”) device, a cochlear implant, an electrode lead comprising a plurality of basal electrodes configured to be disposed within a basal region of a cochlea of a patient and a plurality of apical electrodes configured to be disposed within an apical region of the cochlea; and a loudspeaker communicatively coupled to the EAS device. The EAS device is configured to operate in an EAS mode by 1) disabling the apical electrodes for standard electrical stimulation, 2) detecting, while the apical electrodes are disabled for standard electrical stimulation, audio content presented to the patient and included in an acoustic stimulation frequency range, 3) directing the loudspeaker to apply acoustic stimulation representative of the audio content included in the acoustic stimulation frequency range to the patient, and 4) periodically directing the cochlear implant to apply conditioning stimulation by way of the disabled apical electrodes.

Abstract: A method comprising detecting an epileptic event in a patient; applying an electrical therapy to a first target area in at least one of a brain region or a cranial nerve of said patient in response to said detecting; receiving a body signal responsive to the electrical therapy, wherein said body signal is selected from an autonomic signal, a neurologic signal, a metabolic signal, an endocrine signal, or a tissue stress marker signal; determining whether said body signal indicates that said electrical therapy has an efficacious effect; and terminating the application of said electrical therapy if the response indicates that the electrical therapy has an efficacious effect. An apparatus capable of performing the method. A non-transitive, computer-readable storage device for storing data that when executed by a processor, perform the method.

Abstract: A neurostimulation system comprising stimulation output circuitry configured for delivering stimulation pulses to target tissue in accordance with a set of stimulation parameters.

Abstract: A control system for use with a neurostimulator comprises a user interface for receiving an input from a user and a controller. The user interface has a first control and a second control. The controller is configured for, in response to actuating the first control, operating the neurostimulation control system in a PNFS programming mode, and for, in response to actuating the second control, operating the neurostimulation control system in a PNS programming mode. A method of providing therapy to a patient comprises initially conveying pulsed electrical current at a pulse width into a peripheral tissue region of the patient to create a side effect via stimulation of one of a nerve ending and neural axon, and subsequently conveying pulsed electrical current at an adjusted pulse width into the peripheral tissue region to create a therapeutic effect via stimulation of the other one of the nerve ending and neural axon.

Abstract: Methods for bridging brain sites between which there is substantially no effective communication, and associated neural prosthetic devices, are provided. A neural spike in a first neural site in a subject is detected, and a stimulus to a second neural site in the subject is delivered within a defined period of time after the detection of the neural spike, wherein there is substantially no effective communication between the first and second neural sites. The method forms an artificial bridge between the two neural sites, and establishes lasting communication between the two sites. The present disclosure provides, among other things, a neural prosthetic device comprising an integrated circuit that comprises a recording front-end comprising a plurality of recording channels; a processor unit; and a stimulus delivering back-end comprising a plurality of stimulation channels.

Abstract: Disclosed herein are methods, systems, and apparatus for treating a medical condition in a patient using an implantable medical device by applying an electrical signal characterized by having a number of pulses per microburst, an interpulse interval, a microburst duration, and an interburst period to a portion of a cranial nerve of said patient, wherein at least one of the number of pulses per microburst, the interpulse interval, the microburst duration, or the interburst period is selected to enhance cranial nerve evoked potentials.

Abstract: A method of treating motor deficits in a stroke patient, comprising assessing a patient's motor deficits, determining therapeutic goals for the patient, based on the patient's motor deficits, selecting therapeutic tasks based on the therapeutic goals, performing each of the selected therapeutic tasks repetitively, observing the performance of the therapeutic tasks, initiating the stimulation of the vagus nerve manually at approximately a predetermined moment during the performance of the therapeutic tasks, stimulating the vagus nerve of the patient during the performance of the selected therapeutic tasks, and improving the patient's motor deficits.

Abstract: Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A titration process is used to gradually increase the stimulation intensity to a desired therapeutic level. This titration process can minimize the amount of time required to complete titration so as to begin delivery of the stimulation at therapeutically desirable levels.

Abstract: A system and method for programming a neurostimulation device coupled to a plurality of electrodes implanted adjacent tissue of a patient are provided. A first electrode configuration corresponding to a first mode of programming the neurostimulation device is defined. A second programming mode of programming the neurostimulation device different from the first programming mode is selected. A second electrode configuration is defined based on the first electrode configuration in response to the selection of the second programming mode. The neurostimulation device is programmed using the second programming mode.