Abstract: A Huber safety needle assembly including a body, configured to receive a needle. The body further including an upper portion having a first gripping portion coupled thereto, a lower portion having a second gripping portion coupled to thereto, and a hinge mechanism. The needle having a needle tip configured to be received in the body. The hinge mechanism is configured to operably transition the body between a closed configuration and an open configuration. The closed configuration allowing at least a portion of the needle, including the needle tip, to extend below the bottom surface of the lower portion of the body. The open configuration allowing the needle tip to be securely received within the lower portion such that it does not extend below the bottom surface of the lower portion.

Abstract: A novel nasogastric tube, that when properly inserted within a person, blocks the esophagus of the person to prevent gastric contents from being aspirated. The tube can be left in place during direct langroscopy and the device can include a preferably inflatable balloon for obstructing the person's esophagus. This balloon can be preferably provided on a slidable tube that allows for head movement/flexion without movement of the balloon placement. The tube can be a dual or single lumen device. With a duel lumen device, a first lumen can be connected to a suction tubing to suction gastric contents from the distal end of the tube, while the other lumen can open up above the cuff to allow for easier ventilation with a bag valve mask/BVM.

Abstract: Embodiments relate to systems and methods for catheter manipulation. In particular, systems as described herein can be used to drive a catheter while maintaining control along three degrees of freedom. Systems as described herein can be used in a wide variety of settings, including MRI in which small, non-magnetic robot systems having motors that remain stationary during use are advantageous.

Abstract: The invention relates to a drug delivery device for selecting and dispensing a number of user variable doses of a medicament. The device comprises a dosing element (40, 30), which rotates in a first direction during dose selecting and rotates in a second, opposite direction during dose dispensing, and a display (60) for indicating the selected dose. The display (60) comprises at least one belt (61, 62) having symbols for indicating the selected dose and being coupled to the dosing element (40, 130) such that a rotation of the dosing element (40, 130) spools the belt (61, 62).

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and a monolithic inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The monolithic inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through the balloon to form a tip.

Abstract: Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member.

Abstract: The present invention provides, inter-alia, applicators comprising an array of microneedles for administration of a composition comprising a biocompatible ceramic material effective in augmentation of skin. In particular, the applicators and methods of the present invention are aimed at filling the undesired lines, wrinkles, depressed scars and folds of a subject's skin and restoring youthful fullness to the skin.

Abstract: Method and system for controllably administering and/or withdrawing fluid from a patient. In one embodiment, the system may include a needle assembly, an ultrasound imager, a fluid supply storage unit, a waste storage unit, a fluid pump, and a foot pedal assembly. A syringe may serve as the fluid supply storage unit and the waste storage unit. The pump may include a bi-directional motor and a gear coupled to the motor. The gear may be engageable with a rack on the syringe plunger to drive the plunger either for fluid aspiration or infusion. Depression of one portion of the foot pedal assembly causes the motor to drive the gear in one direction, and depression of another portion of the foot pedal assembly causes the motor to drive the gear the other direction. The system may include a control device to keep pressure in the fluid path from exceeding a limit.

Abstract: A system for delivering fluid to a user transcutaneously includes a subcutaneous infusion cannula base assembly, a cannula inserter assembly and a fluid connection assembly. The subcutaneous infusion cannula base assembly is configured to be located on the user's skin. The cannula inserter assembly is coupled to the cannula base assembly and is configured to drive an infusion cannula through the user's skin in a nominally helical trajectory. The fluid connection assembly is configured to fluidically connect the cannula base assembly to a source of delivery fluid. Cannula and stylet assemblies configured for helical or non-helical insertion are also disclosed.

Abstract: The invention relates to a method of manufacturing of a microneedle array comprising the steps of selecting a soft production mold comprising a set of microscopic incisions defining geometry of the microneedles, said soft production mold being capable of providing the microneedle array integrated into a base plate; using a filler material for abundantly filling the microscopic incisions of the soft production mold thereby producing the microneedle array with pre-defined geometry integrated into the base plate; wherein for the filler material a water or alcohol based ceramic or polymer-ceramic slurry is selected. The invention further relates to a microneedle array 16, a composition comprising a microneedle array, a system for enabling transport of a substance through a barrier and a system for measuring an electric signal using an electrode.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through at least a portion of the balloon.

Abstract: Smart sensors are employed to determine one or more of drug identification, dose, flow rate, concentration, agglomeration, and degradation and/or other characteristics of drug administration that can be detected via sensing technology. A smart sensor(s) can be coupled to or retrofitted onto injection pen injectors and/or drug delivery cartridges and/or infusion sets or cannulae, enabling infusion sets, pen injector systems or drug delivery cartridges to improve tracking of drug self-administration and stop medication errors that occur primarily through self or automated injection (e.g., due to incorrect or incomplete dosing, excessive dose or rate, incorrect drug, or drug degradation).

Abstract: Described is an auto-injector for administering a medicament comprising a case arranged to receive a packaged syringe comprising an injection needle, wherein the case comprises a front case rotatably coupled to a rear case, and a drive spring arranged to advance a plunger relative to the packaged syringe, and a reset mechanism for the drive spring arranged to retract the plunger and compress the drive spring when the front case is rotated relative to the rear case.

Abstract: An article having at least one microneedle (160, 260) is provided. The microneedle includes a base (162), an elongated body (161) having a central axis (130) and a body diameter (168), a tip portion (166), a first channel (170), and a second channel (176). The tip portion includes a tip (164), a beveled surface (140), and a bevel opening (172) in the beveled surface. The first channel extends axially from the bevel opening through at least a portion of the elongated body and has a first wall that is substantially aligned with the central axis. The second channel extends radially from the first channel to the bevel opening and has a second wall that is oriented substantially orthogonal to the central axis. The first channel and second channel merge to form the bevel opening.

Abstract: A compact mechanical pump is provided. The pump is adjustable between a compact form and an expanded form, where the pump can be reduced to a compact form for ease of portability and storage and to the expanded form for use as a pump.

Abstract: This invention relates to a voice therapy and vocal training device which allows performing both exhalation (phonation and breathing) and inhalation (humidifying and breathing) therapies and to humidify and treat vocal folds of a user. The aim of this invention is to provide a voice therapy and vocal training device which aids in carrying out many features together (all-in-one) such as performing voice trainings, humidification of vocal folds, and being used as an inhalation and a spray device. The voice therapy and vocal training device of the invention prevents water from going down the user's throat during inhalation thanks to its special design. Also disclosed is an oral mask which is able to be used with the voice therapy and vocal training device.

Abstract: A positioning device for a medical catheter to be positioned in a bodily orifice or cavity, the device containing an elongated tubular or sleeve-type catheter receiving member, one end of which receives the catheter to be positioned, elongated catheter release member which is held inside or outside the catheter receiving member and which can be displaced in the longitudinal direction of the member and a motion mechanism comprising a motion conversion device, by means of which the catheter receiving member and the catheter release member can be displaced relative to one another in the longitudinal direction of the device, thus releasing the catheter from the catheter receiving member; the motion conversion device has an actuating member, by means of which motion that is carried out transversely to the longitudinal direction of the device or pivoting motion can be converted into longitudinal motion running in the longitudinal direction of the device.

Abstract: A breast pump system having a suction tubing, a milk tubing, a pump, a three way vent valve, a milk bottle, an isolation valve and a breast shield, wherein the first end of the suction tubing and the first end of the milk tubing are fluidly connected to the pump; wherein the second end of the suction tubing and the second end of the milk tubing are fluidly connected to the breast shield; wherein the three way vent valve is fluidly connected between the pump and the breast shield on the suction tubing; wherein the milk bottle is fluidly connected on the milk tubing between the breast shield and the pump; and wherein the isolation valve is connected on the milk tubing between the milk bottle and the pump.

Abstract: The present disclosure relates to a PTA (percutaneous transluminal angioplasty) balloon catheter, preferably high pressure type, optionally introducible as an over the wire catheter. The catheter possess the attribute of injecting fluid to the treated site through a dedicated opening proximal to the balloon member, for introduction of fluids such as contrast enhancing material and/or medication. In some embodiments, a single lumen is used, at least in part, both for fluids transfer and dispersion (“infusion”) as well as for guide wire passage. In some such embodiments, a valve mechanism is used to sustain selective operability of the lumen so that fluids will disperse mostly or solely through the proximal dispersion opening rather than the guide wire distal exit opening.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to methods including selectively neuromodulating afferent or efferent renal nerves. One or more measurable physiological parameters corresponding to systemic sympathetic overactivity or hyperactivity in the patient can thereby be reduced. Selectively neuromodulating afferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a renal pelvis. This can include, for example, neuromodulating via fluid within the renal pelvis. Selectively neuromodulating efferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a portion of a renal artery or a renal branch artery proximate a renal parenchyma. This can include, for example, neuromodulating via a therapeutic element within the portion of the renal artery or the renal branch artery.