Abstract: Exemplary embodiments provide a needle shield remover that reliably engages with a distal cap of an automatic injection device and with one or more needle shields coupled to a syringe of the device. When a user removes the distal cap, the needle shield remover reliably removes the needle shields (e.g., a soft needle shield and a rigid needle shield) from the syringe, thereby exposing the injection needle for performing an injection. In an exemplary assembly method, a needle shield remover is engaged to a needle shield coupled to a syringe, prior to insertion of the syringe and needle shield remover assembly into a housing of the device. This exemplary assembly method allows visual inspection, outside the housing of the device, to ensure that the needle shield remover is correctly and reliably engaged to the needle shield before the syringe and needle shield remover assembly is inserted into the housing.

Abstract: A pen needle (101) for use with a drug delivery device (100) includes a hub body (113) having internal threads (216) to receive the drug delivery device (100). A post (121) is connected to the hub body (113). A needle (103) is rigidly fixed to the post (121). The post (121) is separable from the hub body (113) such that the needle (103) is removed with the post (121). The fluid path is not disturbed by such removal because the entire needle (103) is removed with the post (121). Removal of only the post (121) and needle (103) reduces the volume of waste required for disposal, thereby increasing the effective capacity of a sharps container.

Abstract: A safety insulin pen needle, including a needle hub, a needle tube assembly base arranged on the needle hub, a needle tube, a trigger protector arranged outside the needle hub and a spring arranged between the trigger protector and the needle hub. A guide groove with a special structure is arranged on the side wall of the trigger protector, and a clamping column corresponding to the guide groove is arranged on the outer edge of the side wall of the needle hub, so that the trigger protector is in a to-be-triggered state before use, and is triggered only when in use. Thus, an injection needle can be protected from being exposed to the outside after use, and cross-infection caused by mistakenly touching or reusing is avoided.

Abstract: A hypodermic injection device configured to be attached to a portable electronic device is disclosed herein. The hypodermic injection device can be an auto-injector for delivering a dose of an injectable medicament. The injection device can include a durable barrier providing a sheath over an injectable cannula to maintain sterility of an injectable cannula that delivers the medicament. The injection device can also include tamper proof features such as by requiring that deployment of the device only be possible after completing two mechanical manipulations so as to prevent accidental discharge of the injection device. By incorporating the injection device within a case for a portable electronic device, the injection device is readily available to those that rely on auto-injectors to provide emergency therapeutic treatment, and is much less likely to be forgotten or left behind by a user than a typical auto-injector.

Abstract: A fluid warming device may include a housing comprising a main body, a heat exchange body receiving compartment, and a cover movably coupled to the main body between an open position and a closed position; a heater assembly disposed within the main body and having a heat conducting surface disposed proximate the heat exchange body receiving compartment; and a heat exchange body removably disposable in the heat exchange body receiving compartment of the main body and having an input port and an output port to couple the heat exchange body to tubing to flow a fluid to be warmed through the heat exchange body. In another aspect, a fluid warming system increases or decreases power to a heater assembly to adjust the fluid temperature to ensure that the fluid is at an appropriate temperature when it reaches the patient.

Abstract: A method for filling a plurality of microdepressions in a major surface of a web with finely divided powder in which the web is fed continuously to and through a powder filling stage including a driven roller. A method of manufacturing an elongate carrier with microdepressions containing finely divided powder comprising steps filling a plurality of microdepressions in a major surface of a web as described, removing from upper surface of the web excess powder not filled within the microdepressions and remaining on areas of the surface between the depressions, and optionally slitting and/or cutting the web in width and/or length.

Abstract: A dose counter for an inhaler, the dose counter having a display tape arranged to be incrementally driven from a tape stock bobbin onto an incremental tape take-up drive shaft, the bobbin having an internal bore supported by and for rotation about a support shaft, at least one of the bore and support shaft having a protrusion which is resiliently biased into frictional engagement with the other of the bore and support shaft with longitudinally extending mutual frictional interaction.

Abstract: A tape system for a dose counter for an inhaler, the tape system having a main elongate tape structure, dosing indicia located on the main elongate tape structure, tape positioning indicia located on the main elongate tape structure, a tape size marker located on the main elongate tape structure indicating a number of dosing indicia on the tape, and priming indicia located on the main elongate tape structure, the priming indicia being located between the dosing indicia and one end of the tape.

Abstract: A device for treating nasal congestion and/or relieving sinusitis symptoms in a patient comprises: a vibration generator, a fastener configured to attach the vibrator to a location adjacent to the patient's nasal cavity, nasal passageway or sinuses and a generator of a fluid stream which delivers the fluid stream to the respiratory tract of the patient. The vibration includes a motor, an eccentric member rotatable by the motor and an impact member mechanically linked to the eccentric member such that the impact member is vibratable by the eccentric member.

Abstract: Example embodiments presented herein are directed towards a system, and corresponding method, for providing ventilation synchronization between breathing gas supplied by a mechanical ventilator and the breathing needs of a patient. In providing the ventilation synchronization, a total amount of energy required during an inspiratory phase of breathing is calculated. Based on the calculated energy, a decay factor is determined. The decay factor is supplied to an inspiratory triggering system in order to provide the ventilation synchronization.

Abstract: A resuscitator has a patient airway interface device, a bag, a flow passage coupled between the bag and patient airway interface device, and a sensor assembly. The patient airway interface device may be a mask or an endotracheal tube. The sensor assembly has a display, at least one sensor coupled to the flow passage and configured to provide a measurement of at least one parameter, and a processor coupled to the display and the at least one sensor. The processor is configured to receive the measurement from the sensor and provide information on the display based on the received measurement. The information may include a current breath rate, a pressure-vs-time curve, and guidance to the user to assist in achieving a target breath rate.

Abstract: A collapsible joint for use with a nebulizer includes a housing connected to the source of carrier gas flow, an extensible and flexible airway and an extension connected to a patient applicator. A swivel joint for use with a nebulizer includes a swivel housing, a rotating airway pivoted in the swivel housing about a first axis of rotation; and an airway base coupling coupled to the swivel housing rotatable with respect to the swivel housing about a second axis of rotation. The first and second axes of rotation are mutually orthogonal at least in part to each other.

Abstract: Exhalation valve including a diaphragm for opening and closing an outlet of an exhalation flow path for guiding exhaled air to the outside air, a back chamber provided opposite the exhalation flow path in the diaphragm and forming a space together with the diaphragm, and a pump unit fixed to the circumference of the back chamber for adjusting the air pressure inside the back chamber by feeding and discharging of air to and from the back chamber. The diaphragm closes the outlet of the exhalation flow path when the air pressure inside the exhalation flow path is lower than the air pressure inside the back chamber, and opens the outlet of the exhalation flow path when the air pressure inside the exhalation flow path is higher than the air pressure inside the back chamber.

Abstract: A method is provided for treating a neuromuscular defect in a subject. One step of the method includes locating a target nerve. After locating the target nerve, a treatment probe is provided. The treatment probe includes an elongated body member having a proximal end portion and a distal end portion. The distal end portion includes an energy delivery mechanism for stimulating or ablating the target nerve, a monitoring mechanism, and a fluid aspiration/delivery mechanism. Next, the target nerve is verified as an appropriate target for ablation by stimulating and then monitoring the target nerve via the energy delivery mechanism and the monitoring mechanism, respectively. After verifying the target nerve, a tumescent fluid is injected into the tissue surrounding the target nerve. An electric current is then delivered to the energy delivery mechanism to substantially ablate the target nerve.

Abstract: A chip may be programmed to emit and/or augment energy tuned to interact with bodily functions through transdermal contact. The chip may be programmed by using a pair of Tesla pancake coils, each coupled to a spherical electrode and driven to create an energetic field between the electrodes. Embodiments may include systems that include the programmed chip in a fabric body. The systems may be wearable so that the effects of the programmed chip may be applied to selected areas of the human body. Some embodiments may be useful for augmenting healing of ailments.

Abstract: A medical tube includes a first portion, a second portion, a third portion, and a fourth portion in this order from a proximal side to a distal side thereof. The first portion has a tubular resin layer, the second portion has a tubular inner layer and outer layer, the third portion as an inner layer and outer layer, and the fourth portion has a tubular resin layer. When flexural rigidity of the first portion, the second portion, the third portion, and the fourth portion is G1, G2, G3, and G4, respectively, the flexural rigidity of each portion being configured to have a relationship with each other portion based upon the following expression (1): G1>G2>G3>G4??(1).

Abstract: An injection catheter system that includes (a) an actuator; (b) an outer needle comprising a sharp tip and a tubular body defining a lumen, and extending distally from the actuator; and (c) an inner needle at least partially disposed within the lumen and extending distally from the actuator, the inner needle having a distal tip configured such that at least a portion of the distal tip has a surface contour with an interstitial cavity adapted to receive a therapeutic gel. The system is configured such that (a) in a first position, the distal tip is fully disposed within the lumen to temporarily retain the therapeutic gel in the interstitial cavity and (b) in a second position, the outer needle is retracted proximally, exposing the interstitial cavity to deliver the therapeutic gel to a target area in a body.

Abstract: A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: The present invention is an electrophysiology, RF ablation, or similar catheter (i.e., catheter or sheath) that includes an actuator that significantly increases the length of travel (i.e., steering travel) of the actuation wires, as compared to the length of travel provided by prior art actuators. The catheter includes a hollow flexible tubular body, a pair of actuation wires disposed in a side-by-side relationship in the body, a handle attached to a proximal end of the body, an actuator pivotally mounted to the handle, an arcuate internal gear rack disposed on the actuator, one or more pulleys pivotally mounted on the handle and coaxially coupled to a pinion gear engaged with the gear rack, and a guide block mounted within the handle. The one or more pulleys include a first channel in which the first actuation wire resides and a second channel in which the second actuation wire resides. The actuation wires pass through holes in the guide block, which aligns the wires into their respective channels.

Abstract: A balloon catheter includes an inner shaft with a distal variant portion and a proximal variant portion. A bulged portion is provided at the distal end of a reinforcement member, and the bulged portion is configured to move in an axial direction between the distal variant portion and the proximal variant portion. Thus, the balloon catheter may smoothly pass through a curved blood vessel with improved kink resistance of the reinforcement member.

Abstract: A balloon coating method for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter includes: inserting a core member into a guide wire lumen penetrating the balloon, disposing a proximal portion of the core member on a proximal side of a region of inflation of the balloon, with a distal portion of the core member protruded distally beyond a distal opening portion of the guide wire lumen, and fixing by clamping together with the core member a part of the balloon catheter that is on a distal side of the region of inflation; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in an axial direction of the balloon, while rotating the balloon about an axis of the balloon, thereby to apply the coating liquid to the outer surface of the balloon.

Abstract: A device for positioning a catheter at an ostium. The device includes an attachment mechanism for direct attachment to the catheter at a location proximal to a treatment device positioned on the catheter, the attachment mechanism having a proximal end, a distal end, and a longitudinal axis extending from the proximal end to the distal end. The device also including a stopper element extending from the distal end of the attachment mechanism and projecting away from the longitudinal axis, the stopper element being bendable in a direction toward the proximal end of the attachment mechanism.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: The present disclosure provides improved devices and methods to treat periprosthetic breast implant infections.

Abstract: The invention relates to an immersion device comprising a nitrogen monoxide generating unit and a volume unit provided for immersing objects. The invention also relates to the use of said device for treating diseases, in particular chronic wounds and diabetes, and also to blood flow impairments associated with blood vessel disorders.

Abstract: A self expanding cannula with improved drainage properties based upon its greater length is provided, along with methods of using the cannula in cardiopulmonary bypass.

Abstract: Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems.

Abstract: Embodiments of the invention are directed to flush syringe assemblies comprising an integrated contamination-prevention device integrated with device connector flushing positioned so that the practitioner cannot forget to apply disinfectant. The flush syringe assemblies comprise a barrel with an elongate plunger rod disposed therein and a cap comprising a passageway. The plunger rod includes a stopper of which at least a portion can be embedded in the passageway of the cap to form a plug in the cap.

Abstract: A luer lock adaptor including a housing defining an axis, an internal luer lock element having a threading, the internal luer lock element being located internally of the housing and being rotatably mounted thereto for rotation about the axis relative to the housing, in a manner which permits rotation of the luer lock element relative to the housing in a first rotation direction about the axis and limits rotation of the luer lock element relative to the housing in a second rotation direction about the axis, opposite to the first rotation direction, whereby the location of the internal luer lock element internally of the housing prevents manual access to the internal luer lock element for limiting rotation thereof in the first rotation direction.

Abstract: Some fluid coupling devices described herein are configured for use in fluid systems for purposes of providing a single-use, aseptic disconnection functionality that substantially prevents fluid spillage when being disconnected.

Abstract: The present invention relates to a reinforcement means (400) for a lead (300), especially a lead (300) for neural applications, preferably a lead (300) for a neurostimulation and/or neurorecording system, wherein the reinforcements means (400) has at least predetermined and/or customizable bending motion capabilities and/or is configured such that the minimum bending radius of the lead (300) is at least partially limited. Furthermore, the present invention relates to a lead, a neurostimulation and/or neurorecording system and an interlocking annular element for a reinforcement means.

Abstract: An insertion system for inserting an implantable electrode carrier includes an insertion instrument having a housing with a proximal end and a distal end, and a vibration generator coupled adjacent to the housing. The proximal end is configured to hold the implantable electrode carrier. The vibration generator is configured to generate vibrations in at least a portion of the electrode carrier.

Abstract: An apparatus and method for implanting and securing an implanted medical device in a recipient. The implantable medical device of the generally includes an electrode assembly that comprises an elongate carrier member having at least one stimulating electrode positioned thereon. The carrier member further has a fixation structure positioned thereon configured to interact with a portion of the rigid structure to longitudinally secure the carrier member in the recipient.

Abstract: One aspect relates to a method of producing an electrode structure, including producing a longitudinal body having a core and at least one layer made of an electrode material surrounding the core. A part of the layer made of electrode material is removed while forming a plurality of electrodes that are arranged such as to be distributed in the longitudinal direction and which are separated from each other, and contact paths that extend in the longitudinal direction and adjoin the electrodes, each, as the same part. A layer made of a polymeric material is applied while embedding, at least in part, the electrodes and/or contact paths.

Abstract: The invention relates to an implantable nerve electrode (1) that comprises an electrically insulating substrate (2) with conductor traces (3) running therein, electrode contacts (4) and connection contacts (5), wherein the conductor traces (3) connect the electrode contacts (4) to the connection contacts (5), and wherein the electrode contacts (4) can be connected to the nerves of a nervous system, each of the conductor traces (3) having an at least partial sheathing (13) made of a polymer that is mechanically strong and a good insulator. The invention further relates to a method for producing an implantable nerve electrode (1).

Abstract: Some embodiments of pacing systems employ wireless electrode assemblies to provide pacing therapy. The wireless electrode assemblies may wirelessly receive energy via an inductive coupling so as to provide electrical stimulation to the surrounding heart tissue. In certain embodiments, the wireless electrode assembly may include one or more biased tines that shift from a first position to a second position to secure the wireless electrode assembly into the inner wall of the heart chamber.

Abstract: A cardiac pacing system that includes an implantable pulse generator and electrical leads that include a lead body portion having a distal end and a proximal end, a connector configured to electrically connect the proximal end of the lead body to the pulse generator, and at least one electrode disposed at the distal end of the lead body for delivering electrical stimulation to a patient's heart, wherein the distal end of the lead body is configured to terminate within the mediastinum of the thoracic cavity of the patient, proximate to the heart.

Abstract: A method for determining whether the relative position of electrodes used by a neurostimulation system has changed within a patient comprises determining the amplitude of a field potential at each of at least one of the electrodes, determining if a change in each of the determined electric field amplitudes has occurred, and analyzing the change in each of the determined electric field amplitudes to determine whether a change in the relative position of the electrodes has occurred. Another method comprises measuring a first monopolar impedance between a first electrode and a reference electrode, measuring a second monopolar impedance between second electrode and the reference electrode, measuring a bipolar impedance between the first and second electrodes, and estimating an amplitude of a field potential at the second electrode based on the first and second monopolar impedances and the bipolar impedance.

Abstract: A non-user controllable electro-therapy device has a housing for a microprocessor, power source, status indicator, activation switch, and one or more channels for electrode contact. Only the activation switch is user-accessible. The microprocessor generates a non-user controllable frequency dependent mixed electrical signal through the electrodes, wherein the mixed electrical signal is a combination of at least two different frequencies, a first frequency having a first minimum and maximum microamp range and a second frequency having a different second minimum and maximum microamp range. The higher of the two frequencies is superimposed on the lower frequency, creating a current intensity window as an envelope along a profile of the lower frequency. The mixed electrical signal is automatically applied for a pre-determined period of time, and amplitude and/or duration and/or frequencies is varied according to a pre-set schedule programmed into a controller coupled to the one or more electrodes.

Abstract: In one aspect, the disclosure features systems for providing auditory signals to a subject. The systems include a sensor front-end circuit configured to be connected to an acoustic sensor and to convert analog signals received from the acoustic sensor to digital electric signals. The systems further include a sound processor circuit configured to be connected to the sensor front-end circuit and receive the electric signals provided by the sensor front end circuit. The sound processor includes multiple filters that spectrally decompose the received electrical signals into multiple spectral channels during operation of the system. The multiple spectral channels include at least a low frequency channel and a high frequency channel and the sound processor circuit is configured to operate the low frequency channel at a sample rate lower than a sample rate of the high frequency channel.

Abstract: The present invention provides methods for stimulating cells using quantum dots. In addition, the present invention provides methods for treating a variety of clinical conditions using stimulation of quantum dots to induce cell stimulation and/or function.

Abstract: This disclosure concerns a method for enhancing vision for a vision impaired user comprises. A processor, such as a controller of a retinal prosthesis, determines based on input image data a shape associated with an object represented by the input image data. The processor then determines for each of multiple areas of the input image data a coverage value that indicates to what extent the shape covers that area of the input image. Each of the multiple areas is associated with one of multiple imaging elements of the retinal prosthesis. The processor then determines an output value for each of the multiple imaging elements of the retinal prosthesis, such that when the output values are applied to the imaging elements to create a visual stimulus, a contrast is perceivable between a first element and a second element based on their respective coverage values.

Abstract: The present invention relates to a movement recovery system, and a method of improving the functional motor recovery of a subject with a movement disorder. The present invention provides for a system and method, which in some embodiments can accurately quantify therapy parameters including compliance, task time spent, muscle coordination and functional improvement by utilizing kinetic, gyroscopic or other movement related information, and/or electromyography (EMG) data. In other embodiments, the system and method provide for functional electrical stimulation (FES) to help control the exercise therapy. The present invention further includes the methods of controlling or utilizing the movement related information, EMG and/or FES to detect, monitor, and control the exercise therapy.

Abstract: Electrode structures for transvascular nerve stimulation combine electrodes with an electrically-insulating backing layer. The backing layer increases the electrical impedance of electrical paths through blood in a lumen of a blood vessel and consequently increases the flow of electrical current through surrounding tissues. The electrode structures may be applied to stimulate nerves such as the phrenic, vagus, trigeminal, obturator or other nerves.

Abstract: The disclosure relates to a device including a plurality of electrodes for stimulation of both ventricles with application of an atrioventricular delay and of an interventricular delay, a processor configured to multidimensionally measure an interventricular conduction delay, and monitor the evolution of a patient's condition. For the multidimensional measurement of the interventricular conduction delay, the device produces stimulation of one of the ventricles and collects, in the other ventricle, two endocardial electrogram signals on separate respective channels, giving two respective temporal components. Both temporal components are combined in one single parametric 2D characteristic representative of the cardiac cycle, and a comparison is made with reference descriptors for deriving an index representative of the evolution of the patient's condition.

Abstract: Electrical stimulation may be delivered to a patient's heart using a plurality of cardiac electrodes. Each electrode combination may be evaluated based on one or more first parameters and one or more second parameters. In many cases, the one or more first parameters are supportive of cardiac function consistent with a prescribed therapy and the one or more second parameters are not supportive of cardiac function consistent with the prescribed therapy. The electrode combination selected to deliver a cardiac pacing therapy may be more associated with the one or more first parameters supportive of cardiac function consistent with the prescribed therapy and less associated with the one or more second parameters inconsistent with cardiac function.

Abstract: A system for transferring power to, and communicating with, at least one body-implantable active device includes an external power transfer system associated with an external device disposed outside of a body, operable to transfer power through a dermis layer to each body-implantable active device, and communicate data to and from each body-implantable active device, and also includes a power receiving system associated with each body-implantable active device, operable to receive power transferred from the external power transfer system, and communicate data to and from the external power transfer system. The body-implantable active device may include an implantable neurostimulation system.

Abstract: A method of performing transthoracic defibrillation is described. The method includes generating at least two different defibrillation waveforms using at least two different defibrillation circuits contained in separate housings, delivering each of the at least two different defibrillation waveforms across a respective electrical path of a plurality of electrical paths established across the thoracic cavity and through the heart of a patient by at least three electrodes attached to the thorax of the patient, and synchronizing delivery of the at least two different defibrillation waveforms with communications between the separate housings.

Abstract: A wearable defibrillator system includes a support structure with one or more electrodes in an unbiased state. A monitoring device monitors, for the long term, a parameter of the person that is not the person's ECG; rather, the monitored parameter can be the person's motion, a physiological parameter, or both. When a value of the monitored parameter reaches a threshold, such as when the person is having an actionable episode, the electrode becomes mechanically biased against the person's body, for making good electrical contact. Then, if necessary, the person can be given electrical therapy, such as defibrillation. As such, the electrodes of the wearable defibrillator system can be worn loosely for the long term, without making good electrical contact. This can reduce the person's aversion to wearing the defibrillation system.

Abstract: Configurations are described for utilizing light-activated proteins within cell membranes and subcellular regions to assist with medical treatment paradigms, such as hypertension treatment via anatomically specific and temporally precise modulation of renal plexus activity. The invention provides for proteins, nucleic acids, vectors and methods for genetically targeted expression of light-sensitive proteins to specific cells or defined cell populations. In particular the invention provides systems, devices, and methods for millisecond-timescale temporal control of certain cell activities using moderate light intensities, such as the generation or inhibition of electrical spikes in nerve cells and other excitable cells.