Abstract: The present invention is directed to a pen-type injector equipped with a cartridge holder for a drug delivery device. The cartridge holder has a longitudinal axis and comprises a body for receiving a cartridge, wherein the body comprises at a proximal end engagement means for releasably coupling the cartridge holder to the drug delivery device, a latch member for releasably engaging a cap of the drug delivery device and an alignment element which is visual from the outer side of the body. The alignment element may be an aperture provided in the body and/or a lug which forms the latch member.

Abstract: A housing for a drug delivery device is disclosed having a first housing component adapted to receive a cartridge at least partially filled with a medicament, and a second housing component adapted to receive a drive mechanism to operably engage with the cartridge for dispensing of a dose of the medicament, wherein the first housing component comprises an insert portion to be inserted in an axial direction into a corresponding receptacle of the second housing component, and wherein the insert portion comprises at least one radially outwardly extending first interlock member to positively engage and to rotationally lock with a correspondingly shaped second interlock member of the receptacle of the second housing component.

Abstract: A drug delivery device (100) for administering a low dose of a medicament includes a housing (111) and a drug reservoir (101) disposed in the housing (111). A needle (135) is connected to the drug reservoir (101). A pressure applying member (113) is movably connected to the housing (111) and is movable between first and second positions. The pressure applying member (113) does not apply pressure to the drug reservoir (101) in the first position and applies pressure to the drug reservoir (101) in the second position to dispense medicament stored in the drug reservoir (101). A method of administering a low dose of insulin to simulate a first-phase insulin response of a pancreas is also disclosed.

Abstract: A dispenser assembly is provided that has a rigid plunger with a ring-shaped protrusion. The protrusion contacts the inner wall of a flexible barrel to form a liquid-tight seal. Advantageously, the dispenser assembly does not require additional components, such as o-rings, and can be fabricated by injection molding techniques.

Abstract: A dose setting mechanism for a drug delivery device. The mechanism may comprise a drug delivery device housing. A dose dial component is positioned in the housing and rotatable during dose setting and dose delivery. A split threaded insert is in threaded engagement with the dose dial component. The insert can transform from a first configuration to a second configuration when the dose dial component is rotated. In one dose setting mechanism arrangement, the first configuration may comprise a first open configuration and the second configuration may comprise a second closed configuration.

Abstract: A drive assembly for a drug delivery device comprises a rotation member being configured to be rotated in a first direction during setting of a dose of a drug and to be rotated in a second direction during delivery of the dose, a drive component being configured to follow rotational movement of the rotation member in the second direction during delivery of the dose and a stop member being configured to prevent rotational movement of the drive component in the first direction. The drive component comprises a first drive part and a second drive part, coupled to each other such that relative rotational movement of the first and second drive parts is prevented and relative axial movement is permitted.

Abstract: A retractable needle assembly includes a housing having a sidewall defining a hollow bore, and an elongate plunger, the distal end of the plunger forming a reservoir within the hollow bore for containing a fluid therein. The plunger is adapted for slideable movement within the hollow bore. The assembly includes a hub disposed within the hollow bore and at least partially supporting a cannula therewith, and a needle retraction member engaged with the hub for manually selectable advancement with respect to a portion of the housing. The needle retraction member may be advanced from an initial position in which at least a portion of the needle is disposed outside the housing, to a retracted position in which the needle is fully surrounded by the housing. The elongate plunger may be advanced about the hub for extracting the fluid into the reservoir or expelling the fluid from the reservoir.

Abstract: In an aspect, a medication delivering injector which includes a housing having opposing proximal and distal ends and an accessible internal cavity for inserting and removing a medicament container such as a syringe. The injector is designed to hold and manipulate a medication delivery device such as a large variety of standard and non-standard medical syringes with fixed or attached needles, assembled such that centrally located is a cylinder containing a liquid medicament and attached either permanently or removably to the distal end of the cylinder, is a hypodermic needle or cannula in fluidic communication with the cylinder. The needle can be from one-half inches to one-and-one-half inches in length in the illustrated embodiment and other sizes are possible by changes in scale of the injector. At the proximal end of the cylinder is an opening with an inserted seal or bung with an attached rod thus constituting a plunger.

Abstract: An intracorporeal temperature changing intracorporeal fluid delivery device is described that includes an outer shell forming an internal enclosure comprises at least one heat generation layer and a heater activation system. In one embodiment, the invention is a intracorporeal fluid delivery device, such as an intravenous fluid device. As such it is generally configured for delivery of a heated fluid to a user, and is configured to be worn about an appendage of the user such as an arm, leg, or neck or otherwise operatively connected to a user.

Abstract: The invention relates to a small-volume nebulizer that is pre-filled with at least one unit-dose of medicine and hermetically sealed until use. The nebulizer may be sealed at the top with a removable cap that may be detached at the time of use and replaced with a patient connector. Likewise, the nebulizer may be sealed at the bottom with a bottom cap that is replaced with a gas source at the beginning of a therapeutic aerosol treatment.

Abstract: The present invention relates to an inhalation device used for inhalation of the medicament in dry powder form from capsules.

Abstract: A medicament delivery device (1) comprises an actuation mechanism by successive operation of which a predetermined number of unit doses of medicament can be dispensed. The device includes a locking mechanism for preventing further operation of the actuation mechanism after dispensing of said predetermined number of unit doses. The locking mechanism comprises a resilient member (51), a formation (18) with which the resilient member (51) is engageable to disable operation of the actuation mechanism, and a barrier member (20) that prevents engagement of the resilient member (51) and the formation (18) until said predetermined number of unit doses has been dispensed. The device (1) may be a dry powder inhaler.

Abstract: A respiratory treatment device includes a housing enclosing a chamber, a chamber inlet configured to receive a flow of air into the chamber, a first chamber outlet configured to permit the flow of air to exit the chamber, and a second chamber outlet configured to permit the flow of air to exit the chamber. A vane mounted within the chamber is configured to rotate between a first position where the flow of air is directed to exit the chamber through the first chamber outlet, and a second position where the flow of air is directed to exit the chamber through the second chamber outlet. A blocking member disposed on the vane is moveable relative to the chamber inlet between a closed position where the flow of air through the chamber inlet is restricted, and an open position where the flow of air through the chamber inlet is less restricted.

Abstract: A respiratory apparatus comprising a base and removable chamber, wherein the chamber is configured to hold a supply of water and include a blower arrangement adapted to provide a supply of pressurized air or gas to the supply of water. In certain embodiments the respiratory apparatus includes a split motor, wherein the stationary components are located within a base and the rotating portions are located within a chamber.

Abstract: There is provided herein, a bite block (100) comprising an insertion channel (134) and an airway channel (132) wherein the airway channel is adapted to receive exhaled breath and wherein the first insert channel is adapted to pass a medical instrument. There is provided herein, a bite block comprising an oral insert channel, wherein a portion of said channel opens into a cavity (142) adapted to slidably receive an oral prong (270) the oral insert channel is adapted to receive exhaled breath.

Abstract: Devices and methods are provided for inhibiting mouth breathing and/or improving nasal breathing, e.g., for PAP users or users with other sleeping problems. In an exemplary embodiment, an adhesive device is provided that includes an elongate membrane comprising first and second ends and side edges extending between the first and second ends, a first surface comprising an adhesive layer. The adhesive layer may be a low tack adhesive that is adherent to skin, yet is also easily removable without leaving significant residue. Optionally, the device may include one or more valves to provide one-way flow across the membrane, one or more weakened regions in the membrane, and/or one or more tabs to facilitate removal of the membrane from over a user's mouth.

Abstract: A mask system including a frame module and a cushion module provided to the frame module and adapted to form a seal with the patient's face. The cushion module includes a main body defining a breathing chamber and adapted to interface with the frame module and a cushion adapted to form a seal with the patient's face. The main body and the cushion are comolded with one another.

Abstract: A nasal cannula assembly is disclosed having a face mount part, in use resting against a user's face, which includes at least one nasal prong capable of being fitted into a person's nares. The cannula assembly also includes a manifold part, in fluid communication with the face mount part, having a single horizontal side gases entry. In particular, this cannula assembly is for supplying heated, humidified gases to a patient suffering from COPD. A tie or lanyard is disclosed for use with a breathing assistance apparatus such as a nasal cannula, face or nasal mask or tracheostomy connector. The tie or lanyard transfers the weight of the conduits supplying gases to the breathing assistance apparatus from the breathing assistance apparatus and distributes it onto the neck of the patient.

Abstract: A system for delivering oxygen to a substantially stationary patient without coupling a device to the body of the patient is disclosed. The system includes a source of oxygen coupled to a delivery system wherein the delivery system has a pump configured to pressurize oxygen and an elongate hollow member operatively coupled to the pump. The elongate hollow member has a proximal end and a distal end and is constructed to receive oxygen in its proximal end and deliver oxygen to the patient out the distal end. The length and diameter of the elongate member, the flow of oxygen through the elongate member, and the distance from the distal end of the elongate member to the face of the patient are optimized to collimate a stream of oxygen such that when the stream of oxygen reaches the patients face it envelops the face of the patient.

Abstract: Apparatus and methods are provided for making one or more tubular components of medical catheters or other tubular bodies using a strip of polymer material including a length, a width, and a first surface including a lubricious or other coating or surface modification. The strip is directed adjacent an elongate mandrel, such as beading, such that the length of the strip extends along the mandrel and the coating is disposed towards the mandrel. The strip is rolled at least partially around the mandrel such that the coating or surface modification is disposed inwardly towards the mandrel, and one or more strip-constrainment members are wrapped around the rolled strip. The directing, rolling, and wrapping steps may be substantially continuous to create one or more strip-mandrel-constrainment member subassemblies.

Abstract: A method for visualization and/or administration of medication of and into the sphenopalatine/pterygopalatine recess of a patient is provided. The method includes providing a sphenocath and inserting a guidewire into the nostril of a patient to a target area proximate the sphenopalatine/pterygopalatine recess of the patient. The sphenocath is advanced over the guidewire and a catheter hub of the sphenocath is rotated relative to a sheath hub to conform to an anatomy of the patient's sphenopalatine/pterygopalatine recess, such that the distal end of the catheter tube is proximal to the target area. The sphenocath is then advanced relative to a sheath assembly so that the distal end of a sphenocath catheter tube extends from a sphenocath sheath tube distal end and bends along the guidewire. The guidewire is removed and contrast media, fluids, and/or medication is administered to the patient's sphenopalatine/pterygopalatine ganglion disposed within the sphenopalatine recess of the patient.

Abstract: An agent delivery catheter including a first hollow tube and a second hollow tube that protrudes from a distal opening of the first hollow tube and defines an agent delivery lumen extending along the entire length of the catheter. The distal end of the first tube is coupled to the second tube to form an annular cavity between the first tube and the second tube, the annular cavity provided for accommodating a retractable stylet shaft. An adapting member is disposed on and coupled to a proximal end of a ceramic member and for receiving a distal end of the stylet shaft.

Abstract: A telescopic device is disclosed and includes a first tubular element having an extension member disposed axially within the first tubular element. The device has a first position where a coupling member is located on a conical first section of the extension member closer to a distal end of the extension member and a third axial position wherein the coupling member is affixed within a grooved receiving section of the extension member.

Abstract: A catheter has a metal deflection beam with rectangular cross-section and one or two fiber puller members for predictable on-plane bi-directional deflection. Each fiber puller member is anchored at its distal end to a respective surface of the beam by a metal ferrule that is crimped onto the distal end. The ferrule is shaped to provide a flat outer underside that can lie flat against a beam surface and a thin planar distal section that is welded to the beam. With a distal end of the beam sandwiched between the thin planar distal section of two ferrules, the ferrules and the beam can be welded together by a single laser pulse.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: An adhesive composite dressing useful for applying an active ingredient to a treated skin site, as well as methods of manufacture and use of such dressings. In one embodiment, an adhesive composite dressing comprising an anchor member, a target member, and a folding member, where the anchor member comprises a first skin-contact adhesive, the target member comprises an opening adapted to enable skin treatment, the folding member comprises a drug reservoir, and where the folding member is attached to the anchor portion through a hinge defined by a line of attachment that is not contiguous with an edge of the anchor member.

Abstract: A needle-shaped structure includes a needle-shaped projection and a support substrate supporting the projection wherein the projection contains at least a chitosan and an organic acid, places a low burden on a living body and is able to keep the microscopic form after puncture into the skin.

Abstract: An applicator of one aspect for applying a sheet member to skin includes a body having a bottom surface facing the skin and a first guide configured to guide the sheet member to a space between the skin and the bottom surface, in which the sheet member is applied to the skin after being folded in the space.

Abstract: An ultrasound catheter system and a method for operating an ultrasonic catheter at a treatment site within a patient's vasculature or tissue are disclosed. The ultrasound catheter system comprises a catheter having at least one ultrasonic element and a control system configured to generate power parameters that drive the at least one ultrasonic element to generate ultrasonic energy. The control system is configured to vary at least one of the power parameters and at least one physiological parameter by repeatedly cycling the power parameter and the physiological parameter through two set of values.

Abstract: A medical valve transitions between an open mode that permits fluid flow, and a closed mode that prevents fluid flow. To that end, the medical valve has a housing with an inlet and an outlet, a rigid member movably mounted within the housing, and a resilient member with a sealing portion. The housing also has at least one relief zone that is in fluid communication with the outlet when the valve is in the closed mode. The rigid member may have a proximal end, a distal end, and a flow channel. The relief zone may be radially outward from the sealing portion. The sealing portion may seal the valve and prevent fluid from passing through the valve when in the closed mode.

Abstract: A medical device accessory comprising an interface configured to connect the medical device accessory with a medical device for administration of a medical treatment using the medical device and the medical device accessory, a plurality of electrical contacts proximate the interface, the electrical contacts comprising a lead electrical contact adapted to receive an voltage from a power source associated with the medical device and one or more identifying electrical contacts, and at least one conductor providing an electrical connection between the lead electrical contact and the one or more identifying electrical contacts. An arrangement of the one or more identifying electrical contacts connected to the lead electrical contact identifies a characteristic of the medical device accessory.

Abstract: A system, method, and article for delivering an antimicrobial agent into the lumen of a trans-dermal catheter are disclosed. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter, and the elongate member containing an antimicrobial. In the alternative an antimicrobial agent can be placed on an interior surface of a retaining ring.

Abstract: A valve is provided for controlling flow along a fluid line that includes an outer shell and an inner housing slidably disposed therein that includes connector threads surrounding a boss on one end and a passage through the boss. A backing member is coupled to the outer shell and has a sealing pin extending into the passage. The inner housing is movable helically relative to the outer shell from a closed position wherein a sealing pin engages an outlet opening at the distal end of the boss to seal the opening and an open position in which the inner housing is directed away from the sealing pin to open a fluid path through the valve. A torque limiter mechanism between the outer shell and inner housing resists movement from the valve closed position to the valve open position until a selected torque level is reached.

Abstract: An implantable stimulation lead has electrode contacts that are configured to deliver an electrical stimulation therapy for a patient. A sheath extends along a longitudinal axis. The sheath defines a lumen into which the stimulation lead can be inserted. A distal end of the sheath includes a plurality of base segments that are separated from one another. A plurality of fixation structures are located on the base segments, respectively. In a first configuration, the fixation structures are each disposed proximate to the sheath. In a second configuration, the fixation structures each extend radially outward from the sheath. In a third configuration, the base segments deflect radially inward toward the longitudinal axis.

Abstract: A medical apparatus includes an electrically conductive lead for a medical device, the lead having an internal bore terminating at a distal lead opening, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire for anchoring the guidewire. The fixator is movable between a compact configuration and an expanded configuration. The fixator is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.

Abstract: A system implantable in the coronary venous system, including a pacing lead with an anchoring screw is disclosed. The system includes a stimulation lead (10) for stimulating a left heart cavity of a patient, and a removable catheter (26) for implanting the lead. The lead (10) has at least one stimulation electrode having an anchoring screw (14) that penetrates into the epicardial tissue of the patient. The catheter tube (26) is a pre-shaped tube with two curvatures in the absence of stress. The two curvatures are inscribed in two separate surfaces (38, 40) for self-orientating the distal end of the catheter tube into the target vein and maintaining the axis of the anchoring screw towards the epicardial wall during the screwing of the lead head.

Abstract: Embodiments of the invention provide methods for transdermal delivery of therapeutic agents for treatment of addictive cravings e.g., from nicotine. Embodiment of a method for such delivery comprises positioning at least one electrode assembly in electrical communication with a patient's skin. The assembly includes a solution comprising a therapeutic agent which passively diffuses into skin. A dose of agent is delivered from the assembly into skin during a first period using a first current having a characteristic e.g., polarity and magnitude, to repel agent out of the assembly. During a second period, a second current having a characteristic to attract agent is used to retain agent in the assembly such that delivery of agent into skin is minimized. In particular embodiments, a dose of agent may be delivered on-demand using an input from the patient using an inhalation sensing device which mimics an inhaled form of tobacco.

Abstract: A medical implant system is described for inhibiting infection associated with a joint prosthesis implant. An inventive system includes an implant body made of a biocompatible material which has a metal component disposed on an external surface of the implant body. A current is allowed to flow to the metal component, stimulating release of metal ions toxic to microbes, such as bacteria, protozoa, fungi, and viruses. One detailed system is completely surgically implantable in the patient such that no part of the system is external to the patient while the system is in use. In addition, externally controlled devices are provided which allow for modulation of implanted components.

Abstract: A method and system for creating shear stress and endothelial mechanotransduction through neuromuscular stimulation of the muscle pump. Chronic application a minimum of 30 days triggers the autocrine and paracrine processes which elevates production of vasoactive substances including nitric oxide, prostacyclin, superoxide dismutase, thrombomodulin, glutathion, Krupple-like factor 2 and many others. Chronic application also promotes angiogenesis and development of collateral circulation. This is a cost-effective, non-invasive, drug-free therapy to treat vascular dysfunction and ameliorate or reverse its effects on cardiovascular health.

Abstract: Operational modes or settings of a totally implantable cochlear implant can be adjusted or changed based on movement of an external element. Sensors in the totally implantable cochlear implant detect one of several positions of the external element as that element is moved near the implant. Depending on the position detected, one of a plurality of operational modes or settings can be selected.

Abstract: A method, electrical tissue stimulation system, and programmer for providing therapy to a patient are provided. Electrodes are placed adjacent tissue (e.g., spinal cord tissue) of the patient, electrical stimulation energy is delivered from the electrodes to the tissue in accordance with a defined waveform, and a pulse shape of the defined waveform is modified, thereby changing the characteristics of the electrical stimulation energy delivered from the electrode(s) to the tissue. The pulse shape may be modified by selecting one of a plurality of different pulse shape types or by adjusting a time constant of the pulse shape.

Abstract: Described herein are systems and methods for applying extremely low duty-cycle stimulation sufficient to treat chronic inflammation using feedback to adjust the off times between stimulations. In particular, the feedback include an assessment of the level of inflammation by the patient or the healthcare provider, or by measure the level of an inflammatory analyte or biomarker, or by detecting nerve activity correlated with inflammation.

Abstract: An system may include an electrode arrangement configured for implantation in an epidural space, a neural modulation generator configured to use electrodes in the electrode arrangement to generate modulation fields, at least one storage and a controller operably connected to the neural modulation generator. The storage(s) may be configured to store supra-perception threshold dorsal root modulation field parameter data and therapeutic modulation field parameter data, where the therapeutic modulation field parameter data may be different than the supra-perception threshold dorsal root modulation field parameter data.

Abstract: An implantable neurostimulator system is disclosed, the neurostimulator system comprising a hollow cylindrical electronics enclosure having a top, a bottom, and a side; a coil extending from a first part of the electronics enclosure; and at least one electrode operatively connected to the electronics enclosure.

Abstract: A device for the treatment of snoring is provided. The device may include a flexible substrate configured for removable attachment to a subject's skin, a primary antenna disposed on the flexible substrate, an interface configured to receive a feedback signal that varies based upon a breathing pattern of the subject; and at least one processing device. The processing device may be configured to analyze the feedback signal and determine whether the subject is snoring based on the analysis of the feedback signal, and if snoring is detected, cause a hypoglossal nerve modulation control signal to be applied to the primary antenna in order to wirelessly transmit the hypoglossal nerve modulation control signal to a secondary antenna associated with an implant unit configured for location in a body of the subject.

Abstract: According to various method embodiments, a person is indicated for a therapy to treat a cardiovascular disease, and the therapy is delivered to the person to treat the cardiovascular disease. Delivering the therapy includes delivering a vagal stimulation therapy (VST) to a vagus nerve of the person at a therapeutically-effective intensity for the cardiovascular disease that is below an upper boundary at which upper boundary the VST would lower an intrinsic heart rate during the VST.

Abstract: Devices and methods for single therapy pulse (STP) therapy for tachyarrythmia are disclosed. The STP therapy can be delivered from a far-field position to allow a “global” capture approach to pacing. Due to the global capture in STP, a series of pulses, which is indicative of conventional anti-tachycardia pacing (ATP) delivered by transvenous systems, becomes unnecessary. One to four pulses at most are needed for STP, and after delivery of the one to four pulses, therapy delivery can be interrupted to determine whether the previously delivered therapy has been successful.

Abstract: An implantable medical device configured to be compatible with the environment inside an MRI machine. The implantable medical device includes a housing constructed of an electrically conductive material and pulse generation circuitry within the housing for generating electrical voltage pulses. The implantable medical device further includes a first conductor that is configured to transmit the electrical voltage pulses from the pulse generation circuitry to a patient's cardiac tissue and a second conductor that is configured to provide an electrically conductive path from the patient's cardiac tissue back to the pulse generation circuitry. The implantable medical device further includes a selectively interruptible electrically conductive path connecting the pulse generation circuitry with the housing.

Abstract: A programming system allows a user to program therapy parameter values for therapy delivered by a medical device by specifying a desired therapeutic outcome. In an example, the programming system presents a model of a brain network associated with a patient condition to the user. The model may be a graphical representation of a network of anatomical structures of the brain associated with the patient condition and may indicate the functional relationship between the anatomical structures. Using the model, the user may define a desired therapeutic outcome associated with the condition, and adjust excitatory and/or inhibitory effects of the stimulation on the anatomical structures. The system may determine therapy parameter values for therapy delivered to the patient based on the user input.

Abstract: Embodiments of the invention are related to medical systems and methods that can be used to control features of implanted medical devices, amongst other things. In an embodiment, the invention includes a medical system including an external medical device. The external medical device including a video output and a processor in communication with the video output. The system can be configured to display information through the video output as a graph, the graph comprising data representing pacing rates of an implantable device as a function of activity level over time. The system can further be configured to accept user input through direct manipulation of the graph. Other embodiments are also included herein.