Abstract: The present invention relates to a shield (10) for the distal extremity of an administration device (3) comprising a hub (2) on which said shield (10) is to be removably engaged, said shield (10) having a wall (13) the internal face (14) of which defining an interior cavity (15) for receiving the extremity of the administration device (3), at least a portion (14a) of said internal face (14) being intended to be in contact with said hub (2) when said shield (10) is engaged on the extremity of said administration device (3), whereby said portion (14a) has, distributed over a major portion of said portion (14a), a surface feature (16, 17) that defines the amount of contact between said portion (14a) and said hub (2).

Abstract: Disclosed is a Huber needle assembly that may include an upper body connected to a lower body, the assembly being structured to retain a needle for insertion/extraction of the needle into/from an insertion site. The upper body can statically retain the needle while the lower body may slidably receive the needle. The lower body can further include a catch that engages a tip of the needle and/or misaligns the tip of the needle with a needle aperture of the lower body to place the assembly in a safety-lock position, preventing rebound, needle-stick injury, and/or any type of exposure of the needle tip to an environment outside of the lower body. The assembly can further bias the needle in a direction so as to prevent re-emergence of the needle tip after being withdrawn into the lower body.

Abstract: The invention refers to a needle safety device (1) comprising a needle cap (5) arranged to cover and protect a needle (4), a needle shield (6) relatively movable with respect to a drug delivery device (2) to cover and protect the needle (4) and a needle cap remover (7). The needle cap remover (7) has an outer part (8) adapted to be arranged to the needle shield (6) and an inner part (9) adapted to carry the needle cap (5), wherein the outer part (8) comprises a front end (10) having an opening (11) which at its edge exhibits a projection (12) directed inwards adapted to catch a front projection (13) of the inner part (9) and the inner part (9) comprises a back end (14) having a grip member (15) adapted to grip a back end (16) of the needle cap (5).

Abstract: An injection device for administering a liquid medicament includes a generally elongate housing, a syringe holder in which a syringe can be placed, said syringe containing a medication, a stop and a needle on the distal area thereof, a needle protection housing which is arranged so it can be moved axially on the housing and which protrudes at a certain distance from the distal end of the housing.

Abstract: In one aspect, a pen needle assembly is provided herein which includes a hub, and a needle fixed to the hub, the needle having proximal and distal ends with a lumen extending therebetween. The needle extends distally from the hub to define an exposed length between the distal end of the needle and the hub in the range of about 5.0 to 9.0 mm. The hub defines a post formed about the needle, the post having a distally-facing first skin engaging surface. The exposed length of the needle extends distally from the first skin engaging surface. The hub also defines a distally-facing second skin engaging surface which at least partially circumscribes the first skin engaging surface. The second skin engaging surface being located proximally of the first skin engaging surface. Advantageously, a pen needle assembly is provided having two skin engaging surfaces which provide stability in achieving subcutaneous injections.

Abstract: A pharmaceutical injection device may comprise a main body case having a cartridge holder, a piston that pushes out the pharmaceutical of a pharmaceutical cartridge held in the cartridge holder, a light emitting component, a light receiving component, and a controller. The light emitting component may shine light of different colors on the pharmaceutical cartridge disposed in the cartridge holder. The light receiving component receives light that has been shined from the light emitting component onto the pharmaceutical cartridge and reflected by the pharmaceutical cartridge. The controller may shine from the light emitting component and identify the type of pharmaceutical cartridge.

Abstract: The present invention provides an end fitting (1) for a spacer assembly and a spacer assembly having such an end fitting for fitting to a drug delivery inhaler device (21). The spacer assembly has a spacer body (17) with opposing first and second axial ends. The end fitting comprises an end panel having an upper end face (2) and a lower end face (3). A lower annular recess (4) is provided on the lower end face for receiving the first axial end (18) of the spacer body in a first configuration. An upper annular recess (12) is provided on the upper end face for receiving the second axial end (20) of the spacer body in a second configuration. The end fitting further comprises an open-ended tubular projection (16) extending from the upper end face and an aperture extending through the end panel from the lower end face to the tubular projection.

Abstract: A dry powder inhaler may include a powder storage, an inlet channel, a dispersion chamber, and an outlet channel. A geometry of the inhaler may be such that a flow profile is generated within the dispersion chamber that causes an actuator to oscillate, enabling the actuator when oscillating to deaggregate powdered medicament within the dispersion chamber to be aerosolized and entrained by the air and delivered to a patient through the outlet channel.

Abstract: An inhaler comprising a source of inhalable composition. An outlet flow path is provided for the composition from the source to a composition outlet at an outlet end of the inhaler. Means are provided to generate a flow of composition from the source along the outlet flow path and out of the composition outlet when suction is applied to the outlet end. A pair of air outlets at the outlet end are arranged on opposite sides of the composition outlet through which air is drawn in respective air jets when suction is applied to the outlet end. The composition and air outlets are arranged such that, in use, the pair of air jets impinge on the composition plume.

Abstract: The present disclosure describes systems and apparatuses related to a bronchial blocking tube and/or a laryngeal mask or similar device, and methods for using the same. In an exemplary airway device, the device may comprise a mask portion being defined at a distal end of the airway device, and may be configured and dimensioned to be positioned in a hypopharyngeal area of a patient to cover and seal around a glottis of the patient; and a channel portion extending from a proximal end of the airway device to the mask portion. The channel portion may include first and second channels, wherein the second channel may obliquely merge with the first channel proximate to an opening of the first channel. In an exemplary embodiment, a third channel may form a combined pharyngeal-gastric access channel.

Abstract: A respiratory mask can have a frame supporting a sealing arrangement. Various features of the frame and sealing arrangement can improve comfort and reduce the occurrence of pressure sores. The frame can include cheek supports that have a large surface area configured to spread loads over a greater area of the patient's face and therefore reduce the forces applied to the face and the occurrence of point loads. The seal can have a main body that includes a spring with a silicone skin, wherein the spring applies a substantially constant force to the face and/or nares of the patient.

Abstract: A nasal interface device configured to be positioned about a user's nose includes an air supply interface body including an air supply opening, at least one nasal opening, and first and second side slots and first and second elastic members extending through the first and second side slots, respectively, on the air supply interface body. Each of the first and second elastic members includes first and second adhesive means on an outer end thereof distal from the air supply interface body. The nasal interface device includes a bendable metallic member including a bridge portion between first and second ends, wherein the first and second elastic members attach to the first and second ends of the bendable metallic member, respectively.

Abstract: A mask system for delivery of respiratory therapy to a patient includes a nares portion and a mouth portion and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas. The mask system is adapted to selectively utilize the nares portion and/or the mouth portion in a first mode utilizing both the nares portion and the mouth portion, and in a second mode utilizing the nares portion and not utilizing the mouth portion.

Abstract: A medical delivery device is disclosed having separate adaptors that are removably secured to the inlets of a manifold member through the use of mating locking mechanisms. The locking mechanisms allow the adaptors to be unsecured and switched, or other adaptors secured, which allows the same y-shaped member to increase its functional use to various different applications. Preferably, the delivery device comprises three separate pieces comprising a Y-shaped member having two inlets and an outlet, a first valve adaptor removably secured to one of the inlets and an angled shaped adaptor removably secured to the other inlet. As the two adaptors are removably secured to the Y-shaped member they can be unsecured and their resecurement switched. The mating locking mechanisms also aid in making sure that the adaptors are properly aligned with the inlets when secured thereto.

Abstract: A humidification breathing apparatus for generating and delivering humidified air to a patient at a desired humidity proximate the patient, the apparatus comprising an air flow path and a controller for controlling operation of the humidification breathing apparatus, wherein the controller is configured to operate the humidification breathing apparatus to control humidity at a point in the flow path to achieve the desired delivered humidity proximate the patient based on the patient exhaled humidity and flow.

Abstract: A method to improve digestion for an individual, especially the digestion issue caused by the individual's mental issues, may include steps of choosing one or more individuals having digestive discomfort caused by mental issues that may happen periodically; generating a sound file of digestion sounds for a predetermined length of time; administrating the sound file to the individual for a predetermined period of time; and determining if the individual's digestion is improved. In one embodiment, the step of generating a sound file of digestion sounds may include steps of recording the digestion sounds from a person during good digestion and editing the digestion sounds. In another embodiment, the predetermined length of time can be ten minutes.

Abstract: A light emission control device includes a light emission controller which controls a light emitter and performs normal control and wake-up control, the normal control being control for causing the light emitter to emit light having a color temperature and luminance according to an instruction of a user, the wake-up control being control for causing the light emitter to emit light at increasing luminance over time to wake up the user who is sleeping. The maximum luminance of light emitted by the light emitter in the wake-up control is greater than the maximum luminance of light emitted by the light emitter in the normal control.

Abstract: An infant garment is disclosed that can provide certain vibrations, in an evenly distributed manner, that can mimic patting and massaging of the infant, thereby providing a calming effect to the infant and promote relaxation and sleep and further prevent irritability, fussing, crying, and screaming, among other advantages. In particular, the infant garment can include a first compartment disposed in a middle region of the garment, wherein the compartment can also include a first flap and a second flap, and wherein the first flap at least partially overlaps the second flap. In addition, the infant garment may also include a second compartment disposed within the first compartment, wherein the second compartment is elastic. Further, the infant garment may also include a vibrating electronic device disposed within the elastic second compartment and secured therein.

Abstract: This invention relates to systems for delivering medical devices, as well as related systems and methods. The invention also relates to methods of prevention and treatment of biofilm related contamination of systems or devices for medication delivery and methods of treating medical devices, such as catheters, to prevent infection from said device.

Abstract: A neurovascular catheter is provided, such as for distal neurovascular access or aspiration. The catheter includes an elongate flexible tubular body, having a proximal end, a distal end and a side wall defining a central lumen. A distal zone of the tubular body includes a tubular inner liner, a tie layer separated from the lumen by the inner liner, a helical coil surrounding the tie layer, an outer jacket surrounding the helical coil, and an opening at the distal end. Adjacent windings of the helical coil are spaced progressively further apart in the distal direction. The opening at the distal end of the tubular body is enlargeable from a first inside diameter for transluminal navigation to a second, larger inside diameter to facilitate aspiration of thrombus into the lumen.

Abstract: A device, a method of making a device and a method of inserting a device into a tubular path. The device includes a tubular sheath with one or more helical slots formed therein and a control element that fits within the sheath. In one form, the device is an endoluminal device that simultaneously improves flexibility and structural rigidity though variations in one or both of slot width along the length of the slot and slot pitch along the length of the tubular sheath. When the operator pulls at the proximal end of the control element while holding the outer sheath in place, the slots will tend to close in a preferential manner such that more precise control of device length and bending is enabled, while simultaneously providing improvements in structural rigidity during device insertion and navigation through a body lumen or related tubular member where tortuous paths may be encountered along the member path.

Abstract: Methods and kits for delivering pharmaceutical agents to an adventitia and other regions outside an external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of a pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent. In one example, catheters are used to deliver dexamethasone and other anti-inflammatory agents to a peripheral vasculature and other vasculature to treat peripheral vascular disease and other conditions.

Abstract: The teachings herein relate to devices for insertion into a cavity, opening or other passageway that requires the bending of the device to conform to a curved or even tortuous shape of the path. The devices include axial support components for translating forces for moving the device forward in the path. The axial support components preferably include adjacent components capable of rocking for tilting the device in one or more directions. The device preferably includes one or more lateral support components for limiting any lateral motion of an axial support component relative to an adjacent axial support component.

Abstract: A securement device for securing a medical article is disclosed. The securement device comprises a base and a first securing portion comprising a strap that is movable between an open position and a closed position and a connector disposed on the base. The strap cooperates with the connector in the closed position to form an enclosure. The strap further comprises a curvilinear segment that projects inwardly into the enclosure in a convex orientation when the strap is in the closed position. Securement systems for securing medical articles and methods of securing at least a portion of a medical article to a patient are also provided.

Abstract: The dressing has a first section that includes a bubble for covering over a housing of a Huber needle embedded in a patient and a second section that folds over the first section to encase a tubing of the Huber needle between the two sections. A slit is formed in the first section to allow passage of the tubing. In one embodiment, an insert of foam material is provided in the bubble to rigidify the bubble.

Abstract: Provided is a catheter fixing band for fixing a tube bent and connected to a catheter to the catheter fixing band. According to the present disclosure, a catheter fixing band includes: a body detachably fixed to a human body and having a catheter hole open to expose a portion of the human body; and a cover unit detachably attached to the body to open or close the catheter hole, in which the cover unit includes a fixing member fixing the catheter to a predetermined position of the cover unit, and has a shape forming integral concept in relation to flow of fluid in the catheter when the cover unit covers the catheter hole and the catheter is fixed to the fixing member.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Abstract: Intravascular devices, systems, and methods are disclosed. In some instances, the intravascular device is a guide wire having a core wire formed of multiple materials. For example, a sensing guide wire is provided that includes a core member having an inner section and an outer section surrounding the inner section, wherein the inner section is formed of a first material and the outer section is formed of a second material that is different than the first material; and a sensing element coupled to a distal portion of the core member. Methods of making, manufacturing, and/or assembling such intravascular devices and associated systems are also provided.

Abstract: Systems for providing access across a site of obstruction and methods for manufacturing and using such systems. Such systems may include a sleeve having an inflation lumen; a bushing disposed in a distal section of the sleeve; and an everting member coupled to the sleeve with the bushing, the everting member being movable from an inverted position inside the sleeve to an everted position outside the sleeve in response to an increase in pressure in the inflation lumen.

Abstract: A deep vein intravenous introducer has a wheel located toward the front end of the device that can be rotated by the index finger of the user. After placement of the needle in the lumen of the vessel, the user rotates the wheel, which turns a drive wheel. The drive wheel has an outer surface that advances the guide wire through the center of the needle and into the patient. Once the guide wire is advanced into the vessel lumen the catheter can be advanced over the guide wire with a hub or finger tab on the catheter close to the index finger. The operation can be performed by one hand without moving the hand from its initial position.

Abstract: Described here are devices, systems, and methods for treating conditions or diseases of the nose, ear, or throat with an expandable device having a drug coating. The expandable devices may be delivered to a body cavity in a low-profile configuration and expanded to contact surrounding tissue. The expandable devices may deliver or release the drug coating to the tissue. Multiple expansions of a single device may be employed during treatment. Various coating excipients and manufacturing parameters for the expandable devices may also be adjusted to enhance or slow transfer of the drug coating and/or release of the drug to the target tissue site. The drug transferred to the tissue may act as an in situ depot that enables maintenance of a therapeutic level of locally delivered drug for a desired time period after removal of the expandable devices.

Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: A method for use with a balloon catheter device that includes a selectively bendable portion with a balloon disposed thereon, a control device for controlling bending of the selectively bendable portion, and a camera located at an end of a distal portion, includes inserting the distal portion into the nostril while the distal portion is straight; viewing an image provided by the camera; stopping insertion of the distal portion after the ethmoidal bulla is viewed in the image; articulating the distal portion in an upward direction to view the opening to the frontal sinus ostium or a downward direction to view the opening to the maxillary sinus ostium using the control device; inserting the distal portion into the frontal sinus ostium or the maxillary sinus ostium while the distal portion remains in the bent position; and inflating the balloon in the frontal sinus ostium or the maxillary sinus ostium.

Abstract: The presently disclosed delivery systems utilize microtools, also referred to as theragrippers, to deliver a drug or other therapeutic agent to targeted tissue. More particularly, the drug delivery system and methods provide a delivery system that is capable of anchoring to a tissue site and then delivering a drug or therapeutic agent to the tissue directly to or in the vicinity of the site over an extended period of time. Any number of theragrippers may be deployed as desired to deliver different doses of a desired drug or therapeutic agent. The theragrippers also can be biodegradable such that they remain in place for an extended period of time and then degrade without adversely affecting the surrounding tissue.

Abstract: Implementations of a delivery device and method are disclosed. One implementation is a delivery device comprising a flow chamber with an inlet port for receiving a fluid flow in the flow chamber, and an outlet port for exiting a material from the flow chamber. The flow chamber may include a formation portion in which a suspension of the material is formed, and a collection portion that directs the suspension toward and/or into the outlet port. An amount of the material may collect in the collection portion adjacent the outlet port. The device may further comprise an insertion port for permitting insertion of the material in the flow chamber, and/or a pusher operable to move the amount of material through the outlet port. Related devices and methods also are disclosed.

Abstract: This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices.

Abstract: A soft tip applicator with flexible tendrils attaches to a syringe for spreading expressed liquid from the syringe onto a surface, such as skin. A detachable connector engages a cannula hub allowing liquid to be drawn into the syringe for later expulsion onto the surface.

Abstract: The applicator includes a housing and a motor contained therewithin which includes an output member, such as a shaft, which in operation moves in a reciprocating manner. A contact member is mounted for operation and moves in response to the action of the output shaft, such that the contact element in operation repeatedly contacts a selected skin area, moving toward and away from the skin area, substantially perpendicularly thereto. The contact member moves at a frequency within the range of 50 Hz to 200 Hz and with an amplitude of 0.010 to 0.075 inches. The repeated tapping action of the contact member against the skin increases the absorption of a skin formulation into the skin area being contacted.

Abstract: Containment devices and methods of manufacture and assembly are provided. In an embodiment, the device includes at least one microchip element, which includes a containment reservoir that can be electrically activated to open, and a first electronic printed circuit board (PCB) which comprises a biocompatible substrate. The first PCB may have a first side on which one or more electronic components are fixed and an opposed second side on which the microchip element is fixed in electrical connection to the one or more electronic components. The device may further include a second PCB and a housing ring securing the first PCB together with the second PCB. The microchip element may include a plurality of containment reservoirs, which may be microreservoirs, and/or which may contain a drug formulation or a sensor element.

Abstract: An in vivo sensing device and system may contain or be used in conjunction with an image sensor and a body lumen clearing element or agent. A method may enable clearing a body lumen for in vivo sensing while using the device of the invention.

Abstract: The invention relates to a jig for microneedle array placement that is provided with a main jig body with through holes through which the microneedles of the microneedle array will pass and a guiding part that guides the microneedle array to be incorporated into the main jig body and leads the microneedles into the through holes, and a microneedle array device using the jig for microneedle array placement. The invention prevents the deformation of the skin surface during puncture and allows penetration of the microneedles to the prescribed depth under the skin.

Abstract: Microneedle arrays and methods of forming the same can include one or more bioactive components bonded to a biocompatible material such that the one or more bioactive components are cleavable in vivo to release the bioactive component from the biocompatible material.

Abstract: In some embodiments, the present disclosure pertains to a method of delivery of an active agent to a target tissue, in a subject in need thereof comprising positioning a high intensity focused ultrasound transducer to enable delivery of ultrasound energy to the target tissue. Such a method comprises energizing the high intensity focused ultrasound transducer; imaging at least a portion of the target tissue; and discontinuing delivery of ultrasound energy. Further, such a method may comprise administering the active agent to the subject under the conditions of thermal stimulation. In another embodiment, the present disclosure relates to a method of treating a tumor in a subject in need thereof comprising administering a therapeutic agent to the subject and providing thermal stimulation to the tumor. In some embodiments, there is provided a method for increasing the efficacy of a therapeutic agent in a target tissue.

Abstract: Systems and methods for delivering a drug or other therapy over an extended period of time (e.g., several hours, days, weeks, months, years, and so forth) are disclosed herein, as are systems and methods for monitoring various parameters associated with the treatment of a patient. Systems and methods are also disclosed herein that generally involve CED devices with various features for reducing or preventing backflow.

Abstract: Hemostasis valves and hemostasis valve assemblies can be coupled to a proximal end of an introducer sheath to prevent blood loss through the proximal end of the introducer sheath. Some hemostasis valve assemblies may include an elastomeric member with a variable-width channel that is designed to form a liquid-tight seal over elongate members of different diameter or a single elongate member of variable diameter.

Abstract: The present invention relates generally to medical equipment, more particularly, the use of fluid hoses coupling tanks to cannulas, as part of medical gas therapy, such as oxygen therapy. The invention describes a collection system for managing excess flexible hose that a patient might need to wear for medical reasons such as home oxygen medical therapy. It comprises a collection container, a non-spooling roller system for collecting excess hose into the collection container and extraction from the collection container, and power system to power and control the roller system.

Abstract: A ported catheter adapter and septum actuator having various features to prevent displacement and dislodging of the septum actuator when accessing the patient's vasculature via the inserted infusion device. In particular, the systems and methods of the present invention provide an intravenous infusion device incorporating a septum actuator with a retention tab that interacts with a retention ring that is incorporated into the valve of a side port. This interaction retains the septum actuator within the lumen of the catheter adapter, thereby allowing for subsequent access to the patient's vasculature.

Abstract: Adaptors, cannulas, caps, tube couplers, and systems thereof provide endovascular access through an established ECLS system. Adaptors having curved or angled shafts navigate right angle side ports of standard bypass cannulas and permit hemostatic introduction and direction of an intervention device to the axial flow path of the cannula lumen and bypass system. A modified cannula having an angled side port is also provided for use as an arterial cannula. A cap having an occluding surface may be inserted into the angled side port to prevent blood from stagnating in the angled side port. A tube coupler is also provided having an access port, such as an angled access port, and may be spliced into an established bypass system for vascular access point. Multiple couplers can be used to provide multiple access points. The adaptors and occlusive cap are interchangeable with each other and with secondary circuits.

Abstract: A bolus control device for use with an injection device includes a valve body having a proximal end opposite a distal end. The valve body defines a fluid channel therethrough to allow a passage of medical fluid from the proximal end to the distal end. A connector at the proximal end and is configured for connecting to a fluid inlet line. A connector subassembly at the distal end and is configured for connecting to a fluid outlet line. A compressible check valve is disposed within the fluid channel, such that the compressible check valve is adjustable to control a cracking pressure at which the compressible check valve closes.