Abstract: Pump cassettes, infusion systems, and methods are described. An example pump cassette may include a rigid body including two opposing edge sections, an inlet port, an outlet port, and a controllable fluid pathway extending from the inlet port to the outlet port. The pump may include a slider coupled to the two opposing edge sections and articulable with respect to the rigid body; and a flow stop valve operably coupled to the controllable fluid pathway.

Abstract: Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.

Abstract: An insertion device for an infusion set includes an advancement unit or a sliding element for moving the infusion set along a central axis from a proximal position into a distal position, a retaining element for retaining the infusion set that includes a guide element, a base part for accommodating the retaining element that includes a mating guide element and a contact surface for placing the insertion device on an application point of a patient's body, and a head part arranged rotatably about a central axis in relation to the base part. Upon relative rotation between the head part and the base part in one direction, the guide element of the retaining element can be guided with the mating guide element provided on the base part such that the retaining element is movable along the central axis relative to the base part from the distal position into the proximal position.

Abstract: A fluid delivery Y-site is described that is configured to receive and control delivery of two or more fluid flows. Fluid flow is controlled within a chamber by a valve and float. Flow of a primary fluid into the chamber is reduced or halted by the movement of a valve. The valve may occlude a first flow port into the chamber in response fluid flowing from a second flow port into the chamber. A float is moveably disposed within the chamber and configured to engage the valve in response a fluid flow into the chamber from the second flow port. As fluid flow from the second flow port into the chamber is reduced or ceases, the valve and float allow the flow from the primary flow port to once again enter the chamber and exit from an outlet port.

Abstract: A drug delivery apparatus provides autonomous variable rate delivery of a substance. In some embodiments, the delivery apparatus may be programmable. In some embodiments, the delivery apparatus may be disposable. Optionally the rate of delivery may be dependent on a temperature of a component of the apparatus. Optionally, there may be a time delay between activation of the apparatus and delivery power of the substance.

Abstract: An apparatus for optimizing a patient's insulin dosage regimen over time, comprising: at least a first computer-readable memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen and the patient's blood-glucose-level measurements determined at a plurality of times; a processor operatively connected to the at least first computer-readable memory, the processor programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen in order to maintain the patient's future blood-glucose-level measurements within a predefined range; and a display operative to display information corresponding to at least the patient's present insulin dosage regimen.

Abstract: The present disclosure is directed to a method and apparatus to autonomously stimulate a plurality of nerve fiber groups. The method and apparatus predicts stimulus parameters that can activate 0-100% of the nerve fiber groups selectively according to a patient's characteristics and proportional to therapeutic outcomes, such as determined by experimental data. The method and apparatus may further be configured to input experimental third-party data to obtain a high efficacy from a patient without invasive neurosurgery.

Abstract: A syringe assembly includes a barrel fitted internally with a head of a plunger, an inner plug, an outer plug each slidably engaged to the barrel, and a collapsible framework. A first chamber for containing a solvent is between the head and the inner plug, a second chamber for containing a solute is between the inner plug and the outer plug, and a third chamber containing the collapsible framework is between the outer plug and a discharge end of the barrel. The head, the inner plug, and the outer plug move sequentially through the first, second, and third chambers, respectively, collapsing the framework between the outer plug and the discharge end for sequentially initially mixing the solvent with the solute in the second chamber, turbulent mixing the solvent and the solute in the third chamber, and injecting the solution through the discharge end from the third chamber.

Abstract: A method includes moving an actuation lock of a medical injector from a first position to a second position. The actuation lock has an extended portion disposed between a shoulder of a housing and the base when the actuation lock is in the first position. The extended portion is spaced apart from the base when the actuation lock is in the second position. A distal end portion of a base, which is movably coupled to an end portion of the housing, is placed into contact with a body. The base is actuated after the placing to release an energy from an energy storage member within the housing to produce a force to move a needle from a first needle position to a second needle position. At least a portion of the needle extends through the base when the needle is in the second needle position.

Abstract: A pharmaceutical injection device includes a main body case, a cartridge holder, a latching receiver, a driver, and a manipulation component. The cartridge holder has a holding space and a holder latching component. The holding space is capable of holding a pharmaceutical cartridge. The latching receiver is configured to latch or release the holder latching component according to whether the cartridge holder is closed or open. The driver is configured to automatically release a latching of the latching receiver and the holder latching component. The manipulation component is configured to manually release the latching of the latching receiver and the holder latching component by moving the latching receiver upon being subjected to external pressure. The driver or the manipulation component is configured to release the latching between the latching receiver and the holder latching component.

Abstract: A needle assembly includes: a retaining portion; and an elastic member that includes a close contact portion that closely contacts and retains the needle tube such that the needle tube protrudes toward a fitting opening, and a deformation portion that extends from the close contact portion toward the fitting opening and is configured to deform when the drug ejection portion comes into contact with the elastic member, and which is provided in a fitting portion. Further, the length of the deformation portion is in a range of 35% or more and 50% or less with respect to the length of the elastic member, and the length of a portion of the needle tube which protrudes from the close contact portion toward the fitting portion is in a range of 45% or more and 245% or less with respect to the deformation portion.

Abstract: The invention relates to a piercing means protective device for a syringe having a syringe body and a piercing means arranged at the distal end of the syringe body, comprising a dimensionally stable sleeve element, which extends along an axial direction and at least partially encloses an inner element extending along an axial direction, wherein the inner element consists of a resilient material and at least partially encloses the piercing means. The piercing means protective device is characterized in that a connection element connected to the sleeve element has at least one projection extending in an axial direction, which projection is received at least in portions in a recess of the inner element, so that a connection with a force fit and/or an interlocking fit exists between the sleeve element and the inner element.

Abstract: This disclosure relates to a cap assembly for a medicament delivery device that has a cap body arranged to be connected to a medicament delivery device for protecting and for removing a medicament delivery member shield. The cap body has an inner cap structure defining a channel extending along the central axis of the cap body, and a gripping member configured to be received in the channel with a friction fit and to receive a medicament delivery member shield. The gripping member has a first leg, a second leg, and a transverse portion extending between the first leg and the second leg, which transverse portion defines the leading edge of the gripping member when received by the channel.

Abstract: A single-use cover assembly that obscures a substantial majority or an entirety of an injection needle from view before, during, and after an injection procedure. The cover assembly includes a housing and a needle sleeve that retracts and extends by sliding axially within the housing. The needle sleeve carries a locking collar that moves from a first position to a second position once the needle sleeve is fully retracted. In the first position the locking collar allows retraction of the needle sleeve from a fully extended position. In the second position, a portion of the locking collar covers a tip of the needle, thereby preventing retraction of the needle sleeve from the fully extended position.

Abstract: A pneumatic retractable syringe has a plunger having an interior retraction lumen. The plunger and syringe barrel have cooperating locking elements so that the plunger is locked after use within the syringe barrel. After injection of medicament is completed, the needle is retracted into the lumen by compressed gas that is released from a gas cell within the syringe when the gas cell is ruptured just before the plunger reaches the end of its downstream path of travel.

Abstract: Apparatus and methods for delivering medicament. The apparatus may include a fitting for a fluid dispenser. The fitting may include a detent that is configured to limit insertion of the dispenser into the fitting by contacting a terminal surface of the dispenser; and a seal for sealing against the surface. The apparatus may include an insert for the fitting. The insert may include a gasket to seal against the terminal surface of the dispenser; a proximal rim to engage a lateral wall of the dispenser; and a connector fixed to the gasket and the rim. The apparatus may include a coupler to engage a pre-filled dispenser; and a body defining a passageway that is configured to be placed in fluid communication with the dispenser. The apparatus may include a dispenser that includes a detent and a seal. The detent may limit insertion of the dispenser into a fitting.

Abstract: A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Abstract: Embodiments disclosed herein are directed to methods, compositions and apparatus for administering active agents to the lungs of a subject.

Abstract: A device for delivering medication is presented. The device has a conduit with an upstream end and a downstream end. The downstream end of the conduit delivers the medication. The device has a housing with an open end and an end forming a flat substrate. The housing receives a syringe containing medication and having a plunger. The device also has mechanism for releasing the medication from the syringe and a mechanism for pressurizing the medication. The device has a connector from providing a connection between the syringe and the upstream end of the conduit.

Abstract: A dry-powder inhaler comprising a housing comprising at least one air inlet to a first air passage and a second air passage extending from the first air passage and terminating in a mouthpiece; the housing thereby providing a continuous air passage through the at least one air inlet, the first and second air passages, and the mouth piece; a rigid, fixed, powdered-medicament reservoir comprising a base, the reservoir being associated with the first air passage, and together with the first air passage forming a powder chamber; wherein air passing through the powder chamber travels substantially parallel to an upper surface of the reservoir and powdered-medicament positioned on the base in the reservoir, the upper surface of the reservoir having a surface area, and the reservoir having a volume.

Abstract: A valve (1, 11, 19) for an inhalation device comprising an interior volume that is delimited at least partially by a valve wall (4, 17, 21), a permanent opening (29) as well as a valve functional area (6), whereby the valve functional area (6) is configured to be at least almost closed below an opening pressure difference and to be open above an opening pressure difference such that above the opening pressure difference, a fluid can flow through the permanent opening (29) into the interior volume and out of the valve functional area (6), the valve comprising an inversion protector that is configured to impede or prevent inversion of the valve wall (4, 17, 21).

Abstract: A pressurized metered dose dispenser (100) for dispensing an aerosol formulation comprising particles of a medicament suspended in liquefied propellant, optionally in combination with one or more excipients, the dispenser comprising an aerosol container (1) equipped with a metered dose valve (10), where a formulation chamber is defined in part by the internal walls of the container, and wherein the dispenser further comprises a porous, fluid permeable, particulate semi-permeable body (40) located within the formulation chamber adjacent to the metered dose valve.

Abstract: An actuator for an inhaler, in particular a nasal actuator, is disclosed, the actuator comprising a body, a stem post and fixing means for fixing the stem post in the body. The body comprises a delivery passage for delivery of a medicament and a canister opening for insertion of a canister having a metering valve with a valve stem. The stem post comprises a stem socket for receiving the valve stem of a canister and comprises an orifice for discharging a medicament to the delivery passage. The stem post and body are adapted so they cooperate to define a transition chamber when the stem post is fixed in the body. Also disclosed is a method of forming an component for an actuator for an inhaler, and a method of assembling an actuator for an inhaler by inserting the stem post through the canister opening and into the body thereby.

Abstract: A system and method to in-exsufflate a subject is described. The system provides an effective non-invasive alternative to invasive treatments such as a tracheostomy for ALS patients. The system detects airway collapse during exsufflation and adjusts in-exsufflation therapy settings to minimize airway collapse, thus maximizing the efficacy of the in-exsufflation therapy. In some embodiments, tidal volume, tidal flow rate, and/or other parameters are monitored during in-exsufflation. Exsufflation pressure is adjusted based on the monitored parameters to maintain an open airway during exhalation of the subject. Exsufflation pressure is adjusted based on a comparison of an actual exhalation tidal volume to a target exhalation tidal volume, an actual exhalation flow rate to a target exhalation flow rate, an actual inhalation tidal volume to a target inhalation volume, and/or other comparisons.

Abstract: An airflow perturbation device for measuring respiratory resistance of a patient breathing with the use of a ventilator comprises a sealed housing having a first port and a second port each configured to couple to a ventilator hose, a perturbation mechanism to periodically alter air flow resistance between the first port and the second port, a pneumotachometer comprising a flow sensor to measure airflow between the first port and the second port, a pressure sensor to measure a difference in air pressure between the first port and the second port, and a computing system comprising at least one processor configured to receive data from the flow sensor and pressure sensor. The computing system determines an airflow resistance based on the received data. Embodiments of the present invention further include a method and computer program product for measuring respiratory resistance of a ventilated patient in substantially the same manners described above.

Abstract: Systems and methods for providing ventilation assistance or control are disclosed. Systems and methods for providing randomized ventilation are disclosed. Methods for operating a ventilation system while preventing or reducing the occurrence of ventilator associated lung injury are disclosed. Devices, systems, and methods for providing passive ventilation are disclosed.

Abstract: The present invention provides a system and method for delivery of nitric oxide to the upper respiratory tract without resulting in nitric oxide delivery to the lungs. In certain embodiments, the invention comprises the use of a flow sensor to sense the exhalation of the subject, and delivering a nitric oxide containing gas upon sensed exhalation.

Abstract: A neck strap for a headgear includes a one-piece main body adapted to engage a patient's neck, first and second lower connection portions adapted to connect to respective first and second lower mask connection straps, and first and second upper connection portions adapted to connect to respective first and second lateral crown straps.

Abstract: An oxygen face mask and component system is provided, the mask is designed to cover a user's nose and at least partially cover a user's mouth, the mask having lateral ports. Systems and assemblies including such a face mask and additional components are further provided, including a colorimetric CO2 detector, a sealing cap with or without a resilient sealing flap, a capnography gas analysis unit, a non-rebreather valve, a pulmonary function module, nebulizer, a gas scavenging system, a gas reservoir system, a gas filter, sample lines that are either straight or at an angle, and an aerosol mask platform; and methods of making and using such a face mask are also provided.

Abstract: Disclosed is a method of providing oxygen rich gas. Oxygen is separated from ambient air with an oxygen separator in discrete pulses, one pulse at a time. The start of the pulse is synchronized with the beginning of an inhalation of a person. The oxygen rich gas in each pulse is separated from the ambient air in real time during a nitrogen adsorption step concurrent with each inhalation.

Abstract: A breathable gas inlet control device permits flow regulation at the inlet of a flow generator for a respiratory treatment apparatus such as a ventilator or continuous positive airway pressure device. The device may implement a variable inlet aperture size based on flow conditions. In one embodiment, an inlet flow seal opens or closes the inlet to a blower in accordance with changes in pressure within a seal activation chamber near the seal. The seal may be formed by a flexible membrane. A controller selectively changes the pressure of the seal activation chamber by controlling a set of one or more flow control valves to selectively stop forward flow, prevent back flow or lock open the seal to permit either back flow or forward flow. The controller may set the flow control valves as a function of detected respiratory conditions based on data from pressure and/or flow sensors.

Abstract: A system includes a head-mounted device to be worn by a person; a content generator driving the head-mounted device to engage the person to keep the person still in a predetermined position with sexually explicit visualization for the patient and sensors to detect a body position of the person and if the person have moved the body position, the sensors notify the content generator to encourage the person to move back into the predetermined position.

Abstract: Medical devices useful in the delivery of chemotherapeutic agents, kits and methods are described. An example catheter comprises an elongate member having an elongate member proximal end, an elongate member distal end, and an elongate member main body extending between the elongate member proximal end and the elongate member distal end. The elongate member main body defines an elongate member circumferential wall, first, second, and third openings on the elongate member proximal end, a first heating lumen extending from the first opening toward the elongate member distal end, a second heating lumen extending from the second opening toward the elongate member distal end, and a treatment lumen extending from the third opening toward the elongate member distal end. The treatment lumen comprises a blind passage. The elongate member circumferential wall defines a plurality of passageways providing fluid communication between the treatment lumen and an environment external to the catheter.

Abstract: A catheter system including an accelerometer-based sensing assembly is provided. In particular the present teachings relate to an accelerometer based assembly used to determine contact between a catheter and surrounding proximate tissue, such as cardiac tissue. An embodiment of such a system may, for example, be used for visualization, mapping, ablation, or other methods of diagnosis and treatment of tissue and/or surrounding areas.

Abstract: A medical elongated body is disclosed, which can improve the operability by suppressing anisotropy of torque transmission performance in accordance with the rotational direction while maintaining flexibility. The medical elongated body has a proximal shaft, which extends in an axial center direction and includes at least a part of which a spiral slit is formed. The proximal shaft includes a site in which the spiral inclination angles, which are angles in an extending direction of a spiral of the slit with respect to a cross-section orthogonal to the axial center direction, are different from each other, and a stepped portion in which the angle of the slit changes locally with respect to the spiral inclination angle is formed on one opposed surface constituting the slit, and an abutting portion on which the stepped portion abuts when the proximal shaft is twisted.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a medical instrument (such as a catheter or the like) and secures the instrument in place relative to a skin penetration point. In some circumstances, the anchor device may allow the anchor device to be used after medical instrument is already in place without the need for a second penetration point for the anchor device.

Abstract: The present invention relates to a catheter apparatus with an anchoring device to stabilize the catheter tip when in use, such as when infusing, injecting, or delivering substances, devices or other catheters into a patient. The apparatus according to various embodiments deploys an anchoring device that stabilizes the catheter tip and enables adjustment of the blood flow during use.

Abstract: A catheter assembly includes a hollow catheter; a catheter hub to which the catheter is fixed; an inner needle including a needle tip, the inner needle being detachably disposed inside of the catheter; a needle hub to which the inner needle is fixed; a catheter operation member configured to move the catheter relative to the inner needle; and a support member disposed at the needle hub. The support member includes a support main body portion that is movable between (i) a first position located on a side of the catheter opposite the catheter operation member, at which the catheter is interposed between the support member and the catheter operation member, and the support main body portion contacts and supports the catheter, and (ii) a second position that is a different position from the first position, at which the support main body portion does not contact the catheter.

Abstract: An intravenous catheter apparatus (10) comprising: a catheter tube (14); a catheter hub (12) having a distal end (22) and a proximal end (24), wherein the distal end (24) is joined to the catheter tube (14) and the proximal end (24) defines a housing (48); a needle (20) extending through the catheter hub (12) and the catheter tube (14) and defining an axial direction (A), wherein the needle (20) has opposite proximal and distal ends, the distal end forming a needle tip; a needle hub (16) attached to the proximal end of the needle (20); a needle guard (26) slidably arranged on the needle (20), wherein the needle guard (26) is movably retained in the housing (48) of the catheter hub (12), when the needle (20) extends through the catheter hub (12) and the catheter tube (14), wherein the needle guard (26) is removable from the catheter hub (12) once the needle tip is received in the needle guard (26) upon withdrawal of the needle (20) from the catheter tube (14), and wherein the housing (48) defines a chamber (54

Abstract: A method of making a core metal element for a medical guidewire including providing a wire of nickel titanium alloy having a length that includes a proximal portion having a first diameter and a distal portion having a second diameter. The method further includes applying cold work to the distal portion and not applying cold work to the proximal portion, thereby imparting to the distal portion a third diameter that is smaller than the second diameter; and then applying a reducing process to the wire whereby the proximal portion is reduced to have a fourth diameter that is less than the first diameter.

Abstract: A balloon for a balloon catheter includes a body section and cone sections. At least one of the cone sections defines a plurality of grooves spaced around the circumference of the cone section.

Abstract: The present invention is an improved applicator comprising an applicator body having a top portion, a bottom portion and a central portion, a bladder positioned between the bottom portion and the central portion of the applicator body and designed for holding alcohol solution, a hinge lever extending from an inner side of the central portion and extending outwards from the top portion of the applicator body and a hinge door positioned on the central portion of the applicator body. The cartridge of swabs can be easily loaded by opening the hinge door and rests between the bottom portion and the central portion of the applicator body. The used swabs can be easily discarded by clicking the hinge lever. The improved applicator allows easy application of alcohol solution to the patient's skin in a simple and safe manner and provides a safe and convenient hand-held method for safe preparation of skin.

Abstract: In an embodiment, a connector or connector assembly for attaching a nasal cannula with a gas delivery hose includes a sensor port for a sensor probe positioned near an end of a nasal cannula, which can allow the sensor probe to be placed closer to the patient's nostrils than previous connector parts allowed. The connector can be configured to advantageously allow the nasal cannula to rotate relative to the gas delivery hose, thereby allowing a patient or healthcare provider to untangle or otherwise straighten the hose or the cannula. The connector assembly can be configured to automatically align locking protrusions on a first component with locking recesses on a second component, where insertion of the second component within the first component causes the second component to rotate relative to the first component, thereby aligning the locking protrusions with associated locking recesses.

Abstract: Cap and cleaning devices antiseptically maintain patient fluid line access valves to minimize the risk of infection via catheters. The devices have a cap that may contain a dry pad impregnated with an antimicrobial agent. The cap covers the access portion of the access valve when not in use. The devices have a hood that contains a wet pad impregnated with a cleaning solution and, optionally, an antimicrobial agent. The wet pad cleans the access portion of the access valve prior to and optionally, after the access valve is utilized to access the patient fluid line.

Abstract: Cap and cleaning devices antiseptically maintain patient fluid line access valves to minimize the risk of infection via catheters. The devices have a cap that may contain a dry pad impregnated with an antimicrobial agent. The cap covers the access portion of the access valve when not in use. The devices have a hood that contains a wet pad impregnated with a cleaning solution and, optionally, an antimicrobial agent. The wet pad cleans the access portion of the access valve prior to and optionally, after the access valve is utilized to access the patient fluid line.

Abstract: A flow control clamp having a first member and a second member movable from a first open position to a second irreversibly closed position wherein flow through a tube associated with the clamp is irreversibly prevented and cannot be restored. Systems and methods using such clamps are also disclosed.

Abstract: The present invention relates to a wearable band for low frequency therapy and, more specifically, to a wearable band for low frequency therapy, the wearable band enabling a wearer to connect to a low frequency therapy device while wearing, on a body part, a cylindrical wearable band in which knitted pile yarn is formed from conductive fiber, thereby providing low-frequency stimulation to the part of the wearer's body such that the wearer can receive physical therapy.

Abstract: The disclosure is directed to programming implantable stimulators to deliver stimulation energy via one or more implantable leads having complex electrode array geometries. The disclosure also contemplates guided programming to select electrode combinations and parameter values to support efficacy. The techniques may be applied to a programming interface associated with a clinician programmer, a patient programmer, or both. A user interface permits a user to view electrodes from different perspectives relative to the lead. For example, the user interface provides a side view of a lead and a cross-sectional view of the lead. The user interface may include an axial control medium to select and/or view electrodes at different axial positions along the length of a lead, and a rotational control medium to select and/or view electrodes at different angular positions around a circumference of the lead.

Abstract: The present invention relates to a method for positioning a tip of a pacemaker lead that has passed through coronary sinus into an interventricular septum. More particularly, it relates to a method for positioning a tip of a pacemaker lead that has passed through a coronary sinus into an interventricular septum in order to more effectively transmit an electrical stimulus in a treatment using a pacemaker for patients with arrhythmia. A method of positioning a tip of a pacemaker lead, which has passed through a coronary sinus, into an interventricular septum, in order to effectively transmit electrical stimulus, includes: inserting into an intervention wire through a superior vena cava and a coronary sinus to pass through the interventricular septum and then guiding the intervention wire to an inferior vena cava; and positioning the tip of the lead into the interventricular septum by inserting the pacemaker lead along the intervention wire.

Abstract: A lead for an implanted medical device is disclosed in which the lead is adapted for electrical communication with an electrical signal source and has a distal tip with an electrode. The lead comprises a wire adapted to be placed in electrical communication with electrode. The wire includes: (i) a core comprising a polymeric material, and (ii) a metallic layer surrounding an outer surface of the core. The metallic layer includes a first section having a first thickness and a second section having a second thickness, wherein the first thickness is greater than the second thickness. The lead is substantially transparent to radio frequency waves in clinically-applicable magnetic resonance environments to reduce radio frequency absorption and avoid substantial heating effects.