Abstract: A medication injection pen comprises a dose set knob rotatable with respect to a housing to set a desired injection dose. The dose set knob comprises at least one internal thread. A leadscrew includes a thread element for advancing in a first direction via a corresponding thread engagement. A driver is rotationally fixed to the leadscrew and is rotatable in a first direction to rotate and advance the leadscrew in the first direction. The setback member is rotationally fixed to the driver. The dose stop member is rotationally coupled to the setback member and is axially movable relative to the dose set knob when the dose set knob is rotated relative to the setback member. Axial movement of the dose stop member limits the user from setting a dose that is greater than an injectable volume of medication remaining in a cartridge.

Abstract: The disclosure relates to a drug delivery device comprising: a case adapted to hold a medicament container, a plunger disposed within the case and slidable from a proximal position into a distal position for delivering a medicament from the medicament container, at least one feedback mechanism that is in operative connection with the plunger, the feedback mechanism comprising a collar, a control spring biasing the collar in a distal direction, a needle shroud, operatively axially abutting the collar in a first coupled state and prevented from axially decoupling the collar by the plunger in its proximal position, wherein the plunger, when approaching the distal position during movement from the proximal position towards the distal position, is adapted to allow axial decoupling of the needle shroud from the collar, thus allowing for a limited axial movement of the collar relative to the needle shroud until the collar axially abuts the needle shroud in a second coupled state.

Abstract: The present specification relates to a syringe comprising a barrel, a plunger moveably arranged within the barrel and a plunger rod for driving the plunger, and a mechanism for providing feedback to a user as the plunger rod is moved relative to the barrel for driving said plunger such that feedback is given to a user as the plunger rod is moved relative to the barrel for driving the plunger. The plunger rod is arranged to drive the plunger such that a predetermined relative movement between at least a portion of the plunger rod and the plunger is allowed. The present specification further relates to a plunger assembly wherein a predetermined relative movement between at least a portion of the plunger rod and the plunger is allowed.

Abstract: The present disclosure relates to a feedback mechanism for a drug delivery device, the feedback mechanism comprising a bushing, the bushing comprising a central aperture adapted to accommodate a piston rod, wherein one or more resilient flaps are provided on the bushing, the flaps extending into the central aperture to allow them to engage one or more transversal ribs on the piston rod.

Abstract: The present disclosure provides devices for implanting tissue or other substances within the body. The devices can include a feedback mechanism, which can assist a surgeon in implanting the tissue or other substances by preventing excess shear force or pressure on the tissue or substance to be implanted.

Abstract: A nasal spray assembly for administering a medicament to the nose of a user includes a nasal device and a container that has a reservoir containing the medicament. The reservoir is sealed by a movable piston. The nasal device includes a body, a cap that defines a socket into which the body can be inserted, an outlet, and a piercing element. The piercing element includes a piercer inlet and extends into the socket from a piercer stop within the socket. The nasal spray assembly is arranged such that, as the body is moved into the socket along a first axis, the piercing element pierces and passes through the piston such that the piercer inlet lies within the reservoir, contact between the piercer stop and piston forces the piston into the container, reducing the reservoir volume and forcing medicament from the reservoir through the conduit and out of the outlet.

Abstract: It is an objective of the present invention to reduce the disadvantages in currently available Vaporizers by providing a method and system of controlling the output voltage of the Battery such that the electrical current within and the temperature of the heating element and Extract are controllable. The present invention discloses the Battery that operates by supplying voltage that varies with time and provides various automatically or manually selectable voltage-time profiles. The voltage is controlled by an integrated controller that is able to vary the battery output voltage via voltage modulation and is able to continuously vary the output voltage. The voltage is modulated using pulse width modulation. The integrated controller is capable of storing and executing an embedded program for voltage modulation.

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 nosepiece for delivering substance to a nasal cavity of a subject, the nosepiece comprising a body part which comprises a base portion which defines a flow passage therethrough, and a projection at a distal end of the base portion which at least in part provides a tip of the nosepiece and confers a rigidity in the sagittal direction, which enables the tip to open fleshy tissue at an upper region of the nasal valve and thereby expand an open area of the nasal valve, and a flexibility in a lateral direction, orthogonal to the sagittal plane, which facilitates insertion of the tip into the nasal valve.

Abstract: A nozzle for use in delivering a mixture of aerosol propellant and drug formulation. The nozzle includes a drug product inlet configured to receive a mixture of aerosolized propellant and an intranasal dosage form. The inlet is disposed at the proximal end. A nozzle body is secured to the drug product inlet. Two or more channels are disposed within the body. Two or more orifice apertures are disposed at the distal end of the nozzle.

Abstract: An aromatherapy device may define a plurality of wells arranged in an array to be filled with fluid as scented pairs such that two adjacent wells may be positioned beneath nostrils of a user while resting a portion of the device against the upper lip. The wells may be formed in respective cylinders positioned between the portion of the device that is designed to rest against the lip. There may be a plurality of wells that face a first direction and that face an opposite second direction. The wells may be similar shaped and sized so as to receive similarly viscous fluids therein having different scents associate therewith. The viscosity of the fluids should be high enough to resist the pull of gravity and preclude the fluid from flowing out of the well when the device is positioned upside down and some of the wells are, at least temporarily, downwardly facing.

Abstract: A blower includes a housing including an inlet and an outlet, a stationary component provided to the housing, an impeller positioned between the inlet of the housing and the stationary component, a shield portion including an outer edge substantially aligning with or extending beyond an outer edge of the impeller, and a motor adapted to drive the impeller. The housing and the stationary component cooperate to define a volute that directs air towards the outlet, and the housing includes a separating wall constructed and arranged to divide the volute into a high speed airpath region and a low speed airpath region. The outer edge of the shield portion and the separating wall define a gap between the high speed airpath region and the low speed airpath region.

Abstract: The systems and methods provide for novel a triggering mode that allows the patient to trigger or initiate the delivery of a breath during ventilation on a ventilator. Further, the systems and methods provide for triggering ventilation utilizing a statistical trigger mode. Additionally, the systems and methods provide for analyzing and/or displaying information related to a potential change in a triggering threshold for a currently utilized breath type.

Abstract: A pulmonary secretion clearing airway structure and related airway management system is disclosed that has a double lumen portion which each lumen of the double lumen portion operably secured to an airway management system so that inspiratory fluid (air/oxygen mixtures, with or without added water vapor) is delivered to the distal end of the ventilation catheter through one of the two lumens and expired inspiratory fluid, pulmonary secretions, and pulmonary fluids are removed from the patient through the other lumen. The expiratory fluid pathway preferably includes a secretion collection system for removing the pulmonary secretions and the like from the pathway, thereby improving operation and safety of the system. The airway structure can be a ventilation catheter or a supraglottic airway system such as laryngeal mask and the like.

Abstract: A comfortable low-leak mask assembly for use with Non-Invasive Positive Pressure Ventilation (NIPPV) is provided to improve patient compliance and/or treatment. The mask system may include headgear having straps that are substantially inextensible and/or micro-adjustable; and/or a mask and/or cushion that includes various structures to allow enhanced/tailored sealing and/or fit at selected locations on the patient's face.

Abstract: A breathing tube for a patient ventilator system providing humidified breathable gas is provided, the tube including inhalation and exhalation pathways formed in part by inhalation and exhalation tubes. A coupler member is attached at one end to the exhalation tube and forms part of the exhalation pathway, the coupler member has an integrated coupler-member electrical heating device electrically connected to the tube-portion electrical heating device. A connecting piece is detachably attachable to the other end of the coupler member and forms a part of the exhalation pathway, the connecting piece and coupler member together forming a hollow space therewithin extending from within the connecting piece to within the coupler member. A filter element is within the hollow space and extends from within the connecting piece into the coupler member, the coupler-member heating device is along the hollow space, surrounding the filter element, and adapted to heat the filter element.

Abstract: A heating apparatus includes a heating element which converts electrical power to heat energy, a heatable element having a first surface and a second surface, and a dielectric laminate layer between the heating element and the first surface of the heatable element, wherein the dielectric laminate layer is thermally conductive to transfer heat energy from the heating element to the heatable element, and wherein the second surface of the heatable element is configured heat a liquid in a container.

Abstract: A method for promoting continuous sleep of a subject by eliminating and/or preventing sleep associations includes: (a) providing an apparatus including at least one sensor and at least one output device; (b) monitoring a state of the subject using the apparatus; (c) determining the subject is in an awake state using the at least one sensor; (d) in response to determining the subject is in the awake state, initiating and maintaining an output using the at least one output device; (e) determining the subject is in a sleep state using the at least one sensor; (f) halting the output in response to determining that the subject is in the sleep state such that the apparatus does not produce any output; (g) repeating at least step (b) during a sleep session. The method further includes modifying an intensity of the output over time until the intensity reaches zero.

Abstract: An exemplary catheter can be provided which can include, for example, a first inflation arrangement configured, in operation, to substantially seal and/or anchor the catheter inside the bladder when inflated, a second inflation arrangement configured, in operation, to substantially float in urine when inflated, wherein the second arrangement can be located at a predetermined distance from the first inflation arrangement, and an aperture provided between the first inflation arrangement and the second inflation arrangement, where the first and second arrangements can cause the aperture to be (i) open when the second inflation arrangement can be located at a first position relative to the first inflation arrangement, and (ii) closed when the second inflation arrangement can be located at a second position relative to the first inflation arrangement, and where the second position can be different than the first position.

Abstract: An inner catheter is disclosed, which includes an elongated inner shaft to be inserted into a blood vessel; and a hub connected to a proximal end of the inner shaft. The inner shaft forms a first shape at least a part of which is wound in a state where the inner shaft is suspended in a gravity direction, and forms a second shape at least a part of which is wound and in which a length of the inner shaft along the gravity direction is shorter than a length of the inner shaft along the gravity direction in the first shape in a state where the inner shaft is placed on a flat reference plane perpendicular to the gravity direction.

Abstract: Fluid delivery systems and methods of delivering an agent and treating a disorder are disclosed that include a subcutaneously implantable port having a body defining a chamber with an open top and a delivery opening and a septum coupled to the body to extend over the open top of the chamber. The systems and methods can further include an intrathecal catheter having an proximal end configured to be coupled to the port and fluidly coupled to the delivery opening of the chamber and a plug having a body with a passage to receive the intrathecal catheter therethrough. The plug can be configured to be inserted into the fascia to protect against leakage of cerebrospinal fluid.

Abstract: A catheter for use in a patient's heart, especially for mapping a tubular region of the heart, has a catheter body, a deflectable intermediate section and a distal a mapping assembly that has a generally circular portion adapted to sit on or in a tubular region of the heart. A control handle of the catheter allows for single-handed manipulation of various control mechanisms that can deflect the intermediate section and contract the mapping assembly by means of a deflection control assembly and a linear control assembly. The deflection control assembly has a deflection arm and a rocker member. The linear control assembly has a linear control member, an inner rotational member and a cam. A pair of puller members are responsive to the deflection control assembly to bi-directionally deflect the intermediate section. A third puller member is responsive to the linear control assembly to contract the generally circular portion of the mapping assembly.

Abstract: A device for penetrating tissue with reduced force and placing a guidewire is provided. The device includes a driving actuator generating reciprocating motion at less than 20 kHz. A penetrating member having a lumen dimensioned to accommodate a guidewire is provided, and may be coaxial or axially offset from the driving actuator. A coupler mechanically connects the driving actuator and the penetrating member, transferring the reciprocating motion to the penetrating member. At least one frictional member facilitates the movement of the guidewire through the lumen for placement at the target tissue. The frictional member(s) may be operated manually or by a guidewire actuator. A housing including a channel also dimensioned to accommodate the guidewire may also be provided, and may further include the frictional member(s) for facilitating movement of the guidewire. A side port may also be included at the penetrating member or coupler for introduction of the guidewire.

Abstract: A catheter that includes a reinforcing body including a wire wound or woven so that a gap is provided between each winding or weave of the wire; an inner layer, the reinforcing body being embedded in at least a part of the inner layer; and an outer layer that covers an outer periphery of the inner layer in a circumferential direction, and the reinforcing body is formed integrally including a first diameter portion with a first outer diameter, a second diameter portion with a second outer diameter larger than the first outer diameter, and a tapered portion increasing in diameter toward a distal end side or a proximal end side between the first diameter portion and the second diameter portion, and at least the second diameter portion of the reinforcing body is embedded in the outer layer.

Abstract: A balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Abstract: A dual guidewire lumen catheter includes a first elongated member and a second elongated member. The first elongated member includes a first integral portion, a first free portion, and a first lumen extending there through. The first lumen is configured to receive a first guidewire. The first free portion has a first distal end and a first aperture configured to receive the first guidewire. The second elongated member includes a second distal end and a second lumen there through. The second lumen is configured to receive a second guidewire and the second distal end has a second aperture configured to receive the second guidewire. The second elongated member is integral with the first integral portion of the first elongated member and the first free portion is moveable with respect to a central axis of the catheter.

Abstract: Described embodiments include apparatus (28) that includes a shunt (26). The shunt includes a flared distal portion (40), a flared proximal portion (44), and an intermediate portion (42), disposed between the distal portion and the proximal portion. The apparatus further includes a constricting flexible longitudinal element (38) passing circumferentially along the intermediate portion of the shunt, configured to constrict the intermediate portion of the shunt, and one or more proximal-portion-collapsing flexible longitudinal elements (36) configured to collapse the proximal portion of the shunt. Other embodiments are also described.

Abstract: Access to a paranasal sinus is provided through implantation of an implant device with a conduit of the implant device disposed through a fistula surgically-formed between a location in the lacrimal apparatus and a paranasal sinus. As implanted, the implant device has a proximal end disposed in the lacrimal apparatus in the orbit, a distal end disposed in the paranasal sinus and an internal passage that provides fluid communication between the lacrimal apparatus in the orbit and the paranasal sinus.

Abstract: A self cleaning inlet head for use on a shunt. The head has a tube with openings disposed in predetermined positions in its wall, and a cleaning element installed inside the tube. The cleaning element may comprise a central shaft with a number of bristles protruding therefrom, preferably in locations substantially identical to the positions of the openings in the wall of the tube. Mutual vibratory motion between the cleaning element and the tube causes at least some of the bristles to enter the openings, thereby keeping them clear, and preventing tissue growth into them. The vibratory motion may be generated by the action of an external field on a responsive part of the cleaning element, such as an external magnetic field operating on a magnetic or magnetized part of the cleaning element or the bristles. Alternatively, the external field may be an ultrasound field operating on the bristles.

Abstract: The present invention is premised upon an improved balloon dilator, more particularly to an improved balloon dilator comprising an expandable balloon, a core wire which extends through the expandable balloon, and a single visual marker band positioned at a geometric center within the balloon dilator which may selectively reflect certain wavelengths of light.

Abstract: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

Abstract: The devices 400, 500 include microneedles 450, 550 that may be separable from the drug delivery devices, control drug release rate and/or direction, or a combination thereof. When the microneedles are separable, a force applied to the drug delivery devices may be effective to penetrate a biological tissue with the microneedles and then to separate the microneedles from the drug delivery devices. The drug delivery devices may be capable of achieving discrete periods of drug release.

Abstract: The invention relates to an implantable access device for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port, comprising: at least one inlet opening, at least one outlet opening and at least one passageway between the at least one inlet opening and the at least one outlet opening, further comprising at least one valve assembly in the at least one passageway, which in a first, unactuated operating condition prevents a fluid flow through the at least one passageway and in a second, actuated operating condition permits a fluid flow through the at least one passageway, which is characterized in that the at least one valve assembly in the first, unactuated operating condition is longitudinally elongated and radially compressed in such a way to prevent a fluid flow through the at least one passageway and that the at least one valve assembly in the second, actuated operating condition is longitudinally compressed and radially elongated in such a way to permit

Abstract: The various implementations described herein include a percutaneous port for promoting tissue in-growth around the percutaneous port. In one aspect, the percutaneous port includes a tubular structure having an outer surface, and a coil having an outer surface and comprised of a plurality of loops. Furthermore, at least a portion of the outer surface of the coil is joined to the outer surface of the tubular structure.

Abstract: Mixing systems and methods include a mixing device comprising a primary tube having a proximal end, a distal end, an outer surface and an inner lumen and at least one secondary tube having a proximal end, a distal end, an outer surface and an inner lumen. The at least one secondary tube is substantially parallel to the primary tube. The distal end of the at least one secondary tube is fluidly connected to the primary tube at a junction located on the primary tube close to the distal end of the primary tube.

Abstract: A connector device includes a connector. An electrical lead wire is positioned in the connector. The electrical lead wire is configured to provide communication between the connector device and an external device. In certain embodiments, the electrical lead wire includes a contact point on a surface of the connector for electrically coupling the connector device to the external device. In addition to or as an alternative to the electrical lead wire, the connector device may include an optical coupling or channel in the connector configured for optical light transmission between the connector device and the external device.

Abstract: A connector for transferring fluid and method therefor. The connector may have a first port and a second port which may be coupled together at a main channel with a valve element therein controlling fluid flow through the first port. The first port joins the main channel to provide a fluid path around the valve element and through the second port.

Abstract: Fluid transfer device and method that allows for sterile wet connections, allows the connection to be reversed, and allows the connection to be reconnected, while leaving the connectors sterile and reusable under pressure. In certain embodiments, the device includes a first member and a second member, the latter adapted to receive the former in locking engagement upon actuation of the device to create fluid communication between the two in a sterile manner. Each of the members include a door that when opened, allows the first member to be linearly displaced into the second member to allow fluid to be transferred. When fluid transfer is complete, the first member can be retracted from the second member, and the doors closed.

Abstract: A method may include positioning a catheter, including at least one electrode, within an esophagus such that the electrode is proximate to at least one sympathetic ganglion. The methods may further include recruiting the sympathetic ganglion via an electrical signal, monitoring the recruitment of the sympathetic ganglion, and, based on the monitoring the recruitment of the sympathetic ganglion, adjusting the electrical signal from the at least one electrode.

Abstract: Systems, devices, and techniques are disclosed for forming an elongate lead body module of a modular lead. The method may comprise rotating a mandrel, wherein the mandrel extends through a through-hole of a conductor hub, wherein each conductor of a plurality of conductors extend through a respective channel of a plurality of channels of the conductor hub, wherein each conductor of the plurality of conductors extends from a respective bobbin of plurality of bobbins to the channels, wherein the plurality of bobbins are coupled to a carriage, the carriage defining a central opening through which the mandrel passes. The method may comprise moving the carriage away from the conductor hub along a length of the mandrel while the mandrel rotates causing the conductors to coil around the mandrel.

Abstract: Described here are devices, systems, and methods for treating one or more conditions, such as allergic rhinitis, non-allergic rhinitis, nasal congestion, ocular allergy, and/or symptoms associated with these conditions, by providing stimulation to nasal or sinus tissue. In some variations, the handheld devices may have a stimulator body and a stimulator probe having one or more nasal insertion prongs, and the nasal insertion prongs may be configured to deliver an electrical stimulus to the tissue.

Abstract: Apparatus for transcutaneous electrical nerve stimulation in a user, the apparatus comprising: a stimulator for electrically stimulating at least one nerve; a stimulator housing; a monitor for monitoring transient motion of the stimulator housing; an analyzer for analyzing transient motion monitored by the monitor for determining whether transient motion of the stimulator housing has occurred; and a controller for automatically transitioning at least one of the stimulator, the monitor, and the analyzer between a standby mode and a power save mode; wherein the power save mode supports a subset of the functionality of the stimulator and the monitor which is available in the standby mode so as to conserve battery power in the power save mode.

Abstract: The exemplified systems and methods facilitate a nerve conduction block at a target nerve using electrical stimulation applied from one or more electrodes located on a percutaneous lead that are placed in parallel, or substantially in parallel, and without direct contact, to a long axis of the peripheral nerve over an overlapping nerve region of greater than about 3 millimeters. The exemplified system and method can be further configured to block nerve condition without eliciting onset activity and co-excitation of non-targeted structures. The exemplified method and system can be performed using conventional percutaneous leads, though an improved percutaneous lead design is disclosed herein. In an aspect, an introducer is disclosed that facilitates accurate and consistent insertion of the percutaneous lead to the specified or intended position relative to the target nerve. In another aspect, a treatment kit comprising the various system components to treat pain is disclosed.

Abstract: An exemplary method treating a chronic low back pain condition in a patient includes 1) generating, by an electroacupuncture device implanted beneath a skin surface of the patient, stimulation sessions at a duty cycle that is less than 0.05, and 2) applying, by the electroacupuncture device in accordance with the duty cycle, the stimulation sessions to a target tissue location within the patient by way of an electrode array located within the patient at an acupoint corresponding to the target tissue location.

Abstract: An example of a system may include an electrode arrangement and a neuromodulation device configured to use electrodes in the electrode arrangement to generate a neuromodulation field. The neuromodulation device may include a neuromodulation generator, a neuromodulation control circuit and a storage. The storage may include a stochastically-modulated neuromodulation parameter set and the stochastically-modulated neuromodulation parameter set may include at least one stochastically-modulated parameter. The controller may be configured to control the neuromodulation generator using the stochastically-modulation parameter set to generate the neuromodulation field.

Abstract: The invention provides methods for treating a neurological disorder or deficit, such as tinnitus and phantom limb pain.

Abstract: A neurostimulation system provides for capture verification and stimulation intensity adjustment to ensure effectiveness of vagus nerve stimulation in modulating one or more target functions in a patient. In various embodiments, stimulation is applied to the vagus nerve, and evoked responses are detected to verify that the stimulation captures the vagus nerve and to adjust one or more stimulation parameters that control the stimulation intensity.

Abstract: A therapeutic neuromodulation system configured for providing therapy to a patient. The therapeutic neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes implanted within tissue, analog output circuitry configured for delivering therapeutic electrical energy between the plurality of electrical terminals in accordance with a set of modulation parameters that includes a defined current value, a voltage regulator configured for supplying an adjustable compliance voltage to the analog output circuitry, and control/processing circuitry configured for automatically performing a compliance voltage calibration process at a compliance voltage adjustment interval by periodically computing an adjusted compliance voltage value as a function of a compliance voltage margin.

Abstract: A method and device for performing electrical current therapy on biological tissue. The device can operate continuously as a bio-energetic thermostat to continuously provide electrical current therapy, or based on sensing parameters and providing electrical current therapy only when the parameters indicate that the electrical current therapy is to be applied.

Abstract: Methods and systems are described for managing synchronous conducted communication for an implantable medical device (IMD). The IMD further comprises electrodes and sensing circuitry. The sensing circuitry is configured to detect physiologic events. A receiver amplifier is coupled to the electrodes. The receiver amplifier is configured to receive conducted communications signals via the electrodes. A controller is configured to establish synchronous conducted communication with a transmit device. The controller includes a receive window timing (RWT) module configured to manage an on-off cycle of the receiver amplifier based on first and second receive window timing schemes. The RWT module switches between the first and second receive window timing schemes based on a condition of the synchronous conducted communication.