Abstract: An implantable medical device includes a polymer substrate and at least one nanofiber. The polymer substrate includes a surface portion extending into the polymer substrate from a surface of the substrate. The at least one nanofiber includes a first portion and a second portion. The first portion is interpenetrated with the surface portion of the substrate, and mechanically fixed to the substrate. The second portion projects from the surface of the substrate.

Abstract: Fatty acid-derived biomaterials, methods of making the biomaterials, and methods of using them as drug delivery carriers are described. The fatty acid-derived biomaterials can be utilized alone or in combination with a medical device for the release and local delivery of one or more therapeutic agents. Methods of forming and tailoring the properties of said biomaterials and methods of using said biomaterials for treating injury in a mammal are also provided.

Abstract: Provided herein are methods comprising the use of a macroinitiator and application protocols to apply a hydrophilic coating to latex, or natural rubber, and compositions resulting from such methods. This coating results in e.g., an increased sense of lubrication when in contact with water or an aqueous solution.

Abstract: Methods of making medical devices are described. A method of making a medical device for delivering a bioactive includes preparing a suitable solution comprising the bioactive; placing a vessel containing the solution over a substrate comprising a biocompatible foam and defining open cells; initiating flow of the solution from the vessel and toward the substrate such that the solution exits the vessel and contacts the substrate; and maintaining flow of the solution for an amount of time sufficient to achieve a desired volume of the solution within the substrate. Medical devices made by the methods are also described.

Abstract: A surgical collection assembly for filtering material from liquid obtained during surgery. A jar having an inlet and an outlet each adapted for connection to a suction line. A set of orientation features to position an upper portion of a collection basket within the jar such that an upper portion of the collection basket does not impede a flow of material entering the jar through the inlet. A bottom surface with a pattern of recessed paths in the bottom surface, the pattern of recessed paths connected to the outlet. A plunger assembly that may be reversibly attached to the jar so that a distal end of a plunger may be used to compress collected material within the collection basket to help remove fluid from the collected material. For certain uses, the surgical collection assembly may have a simple jar lid without an integrated plunger.

Abstract: A system and method for a modular external interface for a skin penetrating appliance is provided. The modular device prevents internalization of bacteria, other infectious agents, or other unwanted materials from entering the access point for a catheter, Steinman pin, Kirschner wires, or other percutaneous instruments. The modular external interface provides for the hermaticity in the vicinity of the skin-appliance interface with fluid exudate or transudate egressing from the vicinity of the skin-appliance interface. The modular external interface forms a hermetic seal with the external neck of an implanted appliance with a locking feature that joins the main body of the modular external interface together around the neck of the appliance. The modular external interface provides mechanical stability to an implanted appliance so as to speed healing around a semi-permanent implanted appliance, as well as connection points for vacuum lines and drive lines for the insertion of medical devices.

Abstract: A breast milk collection system includes a storage bag and at least one coupling member formed separately from the storage bag and defining a first side and a second side. The storage bag includes a storage chamber, a closure strip for selectively closing the storage chamber, two bag flaps each extending away from the closure strip, and two coupling components each coupled to a different one of the two bag flaps. Each of the two coupling components includes a plurality of flap protuberances. The first side of the at least one coupling member includes a plurality protuberances extending therefrom, and the second side of the at least one coupling member is at least partially covered with adhesive for selective application of the at least one coupling member to a breastpump apparatus. At least one of the two coupling components selectively couples with the at least one coupling member.

Abstract: This document discusses, among other things, systems and methods to reduce ischemic or metabolic injury to a patient's heart. A system to reduce ischemic or metabolic injury to a patient's heart may include a pulse generator for generating electrical pulses or shock, a pacing lead with at least one pacing electrode configured to deliver electrical pulses received from the pulse generator to the patient's heart, a controller configured to control timing of electrical pulses to reduce wall stress of the heart, and a reservoir, fluidically coupled to a lumen and a pump, wherein the pump is configured, under control of the controller, to move contents from the reservoir through the lumen to an area of the heart with the reduced wall stress, wherein the contents include autologous respiration-competent mitochondria or other respiratory-promoting agents.

Abstract: This disclosure relates to a method for determining a fluid balance between a first volume flow in a first section of a fluid circuit and a second volume flow of a second section of the fluid circuit. The method may also include adjusting, assuming or detecting a first temperature in the first section of the fluid circuit and a second temperature in the second section of the fluid circuit, or detecting a temperature difference between the first and the second sections. The method may also include detecting a second volume flow in a second section of the fluid circuit and forming a balance from at least the first volume flow and a corrected value of the second volume flow. The corrected value is determined from the detected second volume flow and the second temperature and/or the temperature difference.

Abstract: A peristaltic pump for an apparatus for extracorporeal blood treatment, especially for a dialysis machine, for delivering fluid in the apparatus is disclosed. The peristaltic pump includes a rotor driven to rotate about a rotor axis and a pump casing surrounding the rotor at least in part and including a supporting surface being configured to be curved around the rotor axis, wherein an elastically deformable fluid line is adapted to be positioned between the rotor and the supporting surface and is deformed between the rotor and the supporting surface while forming a cross-sectional constriction for fluid delivery by rotation of the rotor, the pump casing having a modular design and including a supporting surface module forming the supporting surface and a casing module adapted to be coupled to the former and surrounding the rotor at least in part.

Abstract: A peristaltic pump for an apparatus for extracorporeal blood treatment, especially for a dialysis machine, for conveying fluid in the apparatus is disclosed. The peristaltic pump includes a rotor driven by a drive shaft, the rotor interacting with an elastically deformable fluid line so as to form a cross-sectional constriction which is displaced along the fluid line for conveying fluid by rotation of the rotor, wherein the rotor is coupled to the drive shaft by a coupling structure so as to transmit a torque, wherein the coupling structure couples the rotor and the drive shaft with a play in the direction of rotation relative to each other.

Abstract: The invention relates to systems and methods for sensing fluid characteristics of peritoneal dialysate infused into and removed from a patient during treatment. The systems and methods include sensors, processors, and flow paths for determining patient health based on the fluid characteristics of the peritoneal dialysate. The system can be a peritoneal dialysis cycler which can include an infusion line; an effluent line; at least one pump positioned in the infusion and/or effluent line; and at least one sensor fluidly connected to the effluent line. The sensor can be at least one of a flow sensor, an ion selective electrode, a pH sensor, a pressure sensor, a refractive index sensor, and a temperature sensor. The method can include infusing peritoneal dialysate through an infusion line; removing peritoneal dialysate through an effluent line; and determining at least one fluid characteristic of the peritoneal dialysate in the effluent line.

Abstract: The invention relates to systems and methods for optimizing a peritoneal dialysate therapy session based on one or more patient or system parameters obtained from a previous peritoneal dialysis therapy session. The systems and methods include various sensors, flow paths, and processors to adjust a peritoneal dialysis prescription for a subsequent therapy session based on data received during or after one or more previous therapy session. For example, a first peritoneal dialysis therapy session can provide data on patient or system parameters that can adjust the dialysis parameters used to deliver a subsequent peritoneal dialysis therapy session. The method can be computer implemented. The system can also include a peritoneal dialysate generation flow path.

Abstract: The invention relates to systems and methods for optimizing a peritoneal dialysate prescription based on one or more fluid characteristics sensed from a filtrate removed from a patient. The systems and methods include sensors, flow paths, and processors to adjust a peritoneal dialysate prescription and deliver peritoneal dialysis therapy to a patient based on the adjusted prescription. The method can include the steps of removing fluid from a peritoneal cavity of a patient; sampling one or more characteristics of the removed fluid; and adjusting a peritoneal dialysate prescription based on the one or more characteristics of the removed fluid. The system can include a peritoneal dialysate effluent line; at least one concentrate source fluidly connectable to the peritoneal dialysate flow path; and at least one sensor positioned in the peritoneal dialysate effluent line.

Abstract: The invention relates to systems and methods for adjusting one or more dialysis parameters for delivering a peritoneal dialysis cycle to a patient based on patient or system parameters. The systems and methods include various sensors, flow paths, and processors to adjust the dialysis parameters used to deliver peritoneal dialysis therapy, for a specific peritoneal dialysis cycle. For example, a first peritoneal dialysis cycle can provide data on patient or system parameters that can be used to adjust the dialysis parameters used to deliver a subsequent peritoneal dialysis cycle. One or more peritoneal dialysis cycles are contained in a particular peritoneal dialysis therapy session. Patient parameters can include patient blood pressure; volume of fluid removed; patient goal; blood solute level; effluent solute level; effluent temperature; effluent color or clarity; patient posture; tidal volume remaining in patient; and intraperitoneal pressure.

Abstract: The invention relates to systems and methods for making intracycle adjustments to an osmotic agent concentration of peritoneal dialysate inside the peritoneal cavity of a patient. The systems and methods include osmotic agent sources, flow paths, and processors to adjust the osmotic agent concentration of dialysate in the peritoneal cavity of the patient. The method can include infusing peritoneal dialysate containing an osmotic agent into the peritoneal cavity of a patient; monitoring one or more patient parameters; and adjusting the osmotic agent concentration of the peritoneal dialysate in the peritoneal cavity of the patient by infusing a concentrated osmotic agent solution or by infusing sterile fluid into the peritoneal cavity of the patient using an on-line peritoneal dialysis machine. The system can include a peritoneal dialysis cycler.

Abstract: The invention relates to systems and methods for monitoring the long term health of the peritoneum and catheter in a patient undergoing peritoneal dialysis (PD) treatment. The systems and methods include processors and sensors for determining changes in the peritoneum health or catheter of a PD patient to support analysis, replacement, and possible medical intervention. The method can include receiving a prior history of a patient; storing the prior history in a machine-readable storage medium, which when executed performs the steps of trending the one or more fluid parameters from the prior history; and determining a change in peritoneum health or catheter patency from the trended prior history. The system can include a peritoneal dialysis cycler having an infusion line and an effluent line; at least one sensor positioned in the infusion line, the effluent line, or combinations thereof; and a processor in communication with the sensor.

Abstract: The invention relates to devices, systems, and methods for generating a peritoneal dialysate having purity and sterility characteristics suitable for Peritoneal Dialysis (PD). The peritoneal dialysate can be generated from water of variable quality using a purity control system having one or more ultrafilters for sterilization of the peritoneal dialysate Peritoneal dialysate generation system and related methods are described that can generate sterilized peritoneal dialysate and deliver peritoneal dialysis therapy to a patient.

Abstract: The present invention relates to an apparatus for carrying out an apheresis treatment, wherein the apparatus has an extracorporeal circuit in which a regenerable single adsorber is located for separating substances from blood or for separating substances from plasma acquired by means of a plasma separator, wherein a line is provided for conducting the blood or the plasma which extends to the adsorber and via which blood or plasma is applied to the adsorber, wherein a reservoir is provided for receiving blood or plasma and is arranged upstream of the adsorber in the line or is in communication with the line upstream of the adsorber; and in that a controller or switching means is provided which is configured such that the reservoir is filled with blood or plasma and the application of blood or plasma to the adsorber is suppressed when the regeneration of the adsorber is carried out.

Abstract: In vivo and ex vivo positionable magnetic filtration devices are provided that magnetically filter one or more therapeutic agents conjugated to a magnetic particle in blood flowing in a blood vessel.

Abstract: Filtering systems, methods, and devices, particularly adapted for apheresis of cellular bodies and more specifically for apheresis of circulating tumor cell bodies (CTCs) employs a cross-flow channel. Systems and methods as well as devices for such a system are described. Embodiments include a cylindrical filter that employs a thin micro-machined porous filter membrane with a regular array of pores and reliably pass blood while trapping CTCs.

Abstract: The present invention relates to a cannula for femoral arterial bidirectional (a heart direction and a distal lower extremity direction) perfusion. The cannula, which has a cannula tube to be inserted into a blood vessel of the femoral artery, includes a perfusion guide channel formed as a concave part from a predetermined portion of an inner circumferential surface at an end of the cannula tube to the opposite end thereof in a length direction and further includes a through-hole provided at a boundary portion between the perfusion guide channel and the cannula tube in an end direction of the cannula tube, or includes a through-hole provided in a predetermined portion of to an inner circumferential surface of an end of the cannula tube and a guide cover provided at an upper portion of the through-hole to cover the upper portion of the through-hole and guide perfusion.

Abstract: A portable trans anal irrigation device has a hand-held water management unit removably connectable to an irrigation arm. The water management unit includes a water cartridge and a controller. The irrigation arm has a cone head for interfacing with the user's body.

Abstract: A trans anal irrigation device that can be used on a bed. The device includes a rectal catheter connected to an irrigation fluid supply. A waste collection bag is also connected to the catheter. The catheter may be insertable in a seat attached to a fluid supply line. A valve in one of the catheter or seat selectably allows or prevents fluid communication between the catheter and a waste collection bag. The catheter may include an inflationless cuff made of a flexible material that permits it to be inserted in the rectum to prevent leakage around the exterior of the catheter.

Abstract: A compact medical infusion pump includes a base unit and a compact pump mechanism coupled to the base unit. The compact pump mechanism also includes a carriage member shaped to support a medical syringe, is movable in a first linear direction relative to the base unit, and is fixed to a first guide rod arm. The mechanism further includes a plunger driver shaped to selectively engage a plunger portion of the medical syringe, is moveable in a second linear direction opposite the first linear direction, and is fixed to a second guide rod arm. The mechanism also includes a rotatable drive member that is centrally located with respect to the base unit and is driven by a drive train assembly. The rotatable drive member engages both the first guide rod arm and the second guide rod arm to translate the carriage member and the plunger driver in opposite directions.

Abstract: Variable fill drug delivery devices for delivering a therapeutic agent to a patient are provided. A variable fill drug delivery device includes a drug container to store a variable amount (or user-selectable amount) of a therapeutic agent. A plunger of the variable fill drug delivery device is positioned in the drug container. An infusion engine of the variable fill device is coupled to the plunger. The infusion engine retains the plunger prior to activation of the variable fill drug delivery device and releases the plunger after activation of the variable fill drug delivery device. After activation, the infusion engine drives the plunger from a first position within the drug container to a second position within the drug container to expel the variable amount of the therapeutic agent from the drug container for delivery to a patient.

Abstract: A fluid delivery device comprises a fluid reservoir for containing medicament. The fluid reservoir is sealed proximate one end with a sliding seal piston. A delivery path is configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device. A basal engine mechanism is configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate. A bolus mechanism configured to move the basal engine relative to the fluid reservoir and directly or indirectly move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time.

Abstract: A drive mechanism includes a housing, a piston adapted to impart movement to a plunger seal within a drug container, a plurality of biasing members disposed in parallel, and a retainer. The biasing members are disposed to release energy to cause movement of the piston from a retracted first position to the extended second position, the piston bearing against the plunger seal to dispense medicine. The retainer is disposed to maintain the biasing members in the energized position and to release the biasing members to permit the piston to dispense the medicine. The drive mechanism may also include an end-of-dose indicator to identify at least one of when the sleeve assembly is disposed subjacent a window in the housing, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

Abstract: A securement device, comprising a first tape having a first top surface and a first bottom surface, a second tape having a second top surface and a second bottom surface, the second bottom surface at least partially connected to the first bottom surface, a first adhesive pad secured to the first top surface at a first location, and a second adhesive pad at least partially secured to the first top surface at a second location.

Abstract: In an indwelling needle assembly, a safety mechanism part is provided with an outer-needle-hub engaging part to be engaged with an outer needle hub, and an engaging-part opposing wall. Relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall is restricted, and at least one of the outer-needle-hub engaging part and the engaging-part opposing wall displaces integrally with urging parts. When an inner needle is pulled out of the outer needle hub, a block part engaged with the inner needle through an inner-needle engaging part is moved relative to the urging parts and forced to a non-contact state, and the urging parts displace in a direction approaching the inner needle, thereby preventing a needle tip of the inner needle from protruding from the safety mechanism part and releasing engagement of the outer needle hub with the safety mechanism part.

Abstract: A system and method for monitoring and delivering medication to a patient. The system includes a controller that has a control algorithm and a closed loop control that monitors the control algorithm. A sensor is in communication with the controller and monitors a medical condition. A rule based application in the controller receives data from the sensor and the closed loop control and compares the data to predetermined medical information to determine the risk of automation of therapy to the patient. A system monitor is also in communication with the controller to monitor system, remote system, and network activity and conditions. The controller then provides a predetermined risk threshold where below the predetermined risk threshold automated closed loop medication therapy is provided. If the predetermined risk threshold is met or exceeded, automated therapy adjustments may not occur and user/clinician intervention is requested.

Abstract: Methods and systems for controlling an insulin pump in response to glucose measurements are responsive to a base insulin delivery profile and a temporary insulin delivery profile. These can be used, e.g., to control blood glucose level of a subject using a continuous glucose monitor and an insulin infusion pump. During a selected time range, an insulin amount for the pump to supply is determined using the temporary insulin delivery profile. Outside that time range, the insulin amount is determined using the base insulin delivery profile. The temporary insulin delivery profile can specify an exact amount to be supplied (a “hard” profile), a nominal amount to be supplied if doing so does not drive glucose out of a desired zone (“soft”), or a soft profile with a minimum amount of insulin to be delivered (“semi-soft”).

Abstract: Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Abstract: Provided is a drive unit for an auto-injector having a drive unit housing arranged for docking receipt of a syringe or of a cassette unit comprising a syringe movable from a rest position, in which a needle tip of the syringe is within the drive unit housing to a use position, in which the needle tip protrudes from a needle delivery aperture; and a drive arrangement including one or more electrically powered sources of axial drive; a first drive transfer element for advancing the syringe to said use position; and a second drive transfer element for moving a plunger into the barrel of the syringe to eject liquid contents thereof. The drive unit housing is provided with a skin sensor arrangement having an array of plural skin sensor electrodes located about the needle delivery aperture.

Abstract: A medical device assembly is disclosed. The medical device assembly includes a therapeusis delivery portion and an algometer portion. The therapeusis delivery portion includes a body having a proximal end and a distal end. The algometer portion includes a body having a proximal end and a distal end. The body of the therapeusis delivery portion defines a therapeusis-delivering passage and an algometer-receiving passage. The algometer-receiving passage may be sized to receive a portion of the algometer portion for connecting the algometer portion to the therapeusis delivery portion. A portion of medical device assembly is also disclosed. A method is also disclosed.

Abstract: Provided is a barrel with needle including: a barrel body; and an injection needle, wherein the barrel body has a cylindrical body wall, and an end wall through which the injection needle is inserted, and the inner wall surface of the end wall expands in a direction intersecting the axial direction of the body wall and inclined toward the other opening side of the body wall, with a specific position between an outer circumferential edge and an inner circumferential edge on a proximal end surface of the injection needle serving as a starting point.

Abstract: The invention provides a syringe assembly comprising a syringe barrel having an inside surface defining a chamber, an open proximal end, and a distal end having an opening therethrough. An elongated plunger rod extends between a first end and a second end, with a cap or guard disposed on the first end of the plunger rod. A plunger head extends within the chamber of the syringe barrel, and is adapted for slidable movement within the syringe barrel between the proximal end and the distal end, with the second end of the plunger rod connected with the plunger head through a pivotable connection. The plunger rod is adapted to pivot with respect to the plunger head between a first position in which the guard is adjacent the distal end of the syringe barrel and a second position in which the plunger rod is in general axial alignment with the syringe barrel, and is further adapted for axial movement so as to cause sliding movement of the plunger head through the syringe barrel to expel contents thereof.

Abstract: Plunger sub-assemblies for automatic injectors include a plunger outer having one or more engagement prongs, a plunger inner having one or more engagement slots which correspond with the engagement prongs of the plunger outer, and a retraction biasing member. The retraction biasing member is retained in a first energized state between the plunger outer and plunger inner when the engagement prongs of the plunger outer are releasably engaged with the engagement slots of the plunger inner. The one or more engagement prongs are capable of flexing substantially radially to release from engagement with the engagement slots of the plunger inner to permit the retraction biasing member to expand from the first energized state to a second expanded state. An automatic injector having a plunger sub-assembly includes a housing, an activation mechanism, and a plunger sub-assembly at least partially mounted within a syringe cartridge having a needle assembly.

Abstract: A multi-piece plunger configured to be slideably advanced through a syringe barrel to expel fluid therefrom is provided. The plunger includes a head portion having a proximal end, a distal end, and an annular sidewall extending therebetween. The sidewall can define at least two annular grooves. The plunger also includes annular seals disposed within each of the at least two annular grooves, such that at least a portion of each of the annular seals protrudes radially beyond an outer surface of the sidewall to form a slideable seal with an inner sidewall of the syringe barrel. The head portion can be formed from a first material, such as a rigid plastic material, and the annular seals can be formed from a second material, such as a thermoset rubber or a thermoplastic elastomer. A prefilled syringe including the multi-piece plunger is also provided herein.

Abstract: The present invention relates to a rectal delivery device in the form of a syringe with improved locking mechanism for the delivery of an appropriate dosage of a medicament, thereby minimizing errors. More particularly, the present invention provides syringes with improved lock control units for delivering diazepam formulations for the treatment of patients experiencing epileptic seizures.

Abstract: The disclosure relates to a sensor arrangement for an injection device to determine an axial position of at least one device component of the injection device inside a housing of the injection device. The sensor arrangement includes an elongated member located inside the housing, extending in an axial direction and having at least a first section and a second section of different magnetization. The first and second sections are separated in an axial direction. The sensor arrangement also includes at least one magnetic sensor element attached to the housing to detect the axial position of at least one of the first and second sections.

Abstract: Systems and methods for monitoring an operational state and/or a fill status of a drug container of a drug delivery device are provided. The drug container can hold a liquid drug. A plunger can be positioned within the drug container. A drive system can advance the plunger to expel the liquid drug from the container. A monitoring system can detect a movement and/or a position of the plunger and/or any component coupled to the plunger. The detection can enable determination of an amount of liquid drug that has been expelled and/or an amount of liquid drug remaining in the drug container. Dosing rates, flow rates, and dosage completion can also be determined.

Abstract: Plunger systems for expelling a liquid drug from a drug container within a wearable drug delivery device are provided. A rotation system coupled to a plunger rotates the plunger about a central axis of the plunger to overcome a static friction between the plunger and the drug container. After rotating the plunger, a drive system moves the plunger forward into the drug container to expel the liquid drug for delivery to the patient. A collapsible plunger includes a cavity. A radial torsion spring positioned in the cavity can provide an outward radial force on the collapsible plunger. The cavity enables the collapsible plunger to compress radially when entering and passing through a region of a drug container having a relatively narrower width. The radial torsion spring can radially expand the collapsible plunger when entering and passing through a region of the drug container having a relatively wider width.

Abstract: A fluid injection needle has a relatively precision fluid flow path. The needle comprises a needle shaft and a sizing shaft axially extending within the needle shaft lumen a selected distance distal of a fluid entry port into the lumen. The sizing shaft has a cross-sectional size smaller than the lumen to define a fluid flow path between the sizing shaft and the needle shaft. An injection device employing such an injection needle and a method of making such a needle are also disclosed.

Abstract: An auto-injector automatically dispenses a predetermined dose of medicament upon activation. The auto-injector includes a needle cover operative to engage an injection site and activate the injector. The needle cover is configured to move from a locked retracted position prior to a medicament dispensing operation to a locked extended position after the medicament dispensing operation. The non-removable needle cover prevents contact with the needle both before and after the medicament dispensing operation.

Abstract: A method of using a medicine injection device including a syringe filled with a medicine; a needle tube having a needle tip for puncturing the skin; a flange-like skin contact portion that is disposed in a manner so as to cover an area surrounding the needle tube and makes contact with and/or faces the skin when the living body is punctured with the needle tube; and an absorption part that is disposed in the skin contact portion of the needle hub. The method includes removing air from the medicine injection device prior to injection of the medicine, whereby medicine spilled from the needle tip is caught in the skin contact portion; the absorption part absorbing the spilled medicine staying in the skin contact portion; positioning the skin contact portion adjacent the skin; puncturing the skin with the needle tip; and injecting medicine from the needle tip into the skin.

Abstract: A syringe plunger for insertion within a barrel of a syringe for expelling the contents of the barrel from an open end thereof and a pressure indicator for fitting to a syringe plunger. The syringe plunger and pressure indicator comprising: a first portion; a second portion moveable with respect to the first portion if a relative force between the first portion and the second portion exceeds a threshold; and an indicator, wherein translation of movement of the first portion relative to the second portion causes mechanical movement of the indicator.

Abstract: A dry powder inhalation device is disclosed. In one optional aspect, the device includes a housing, a base plate, a receptacle for a medicament and a mouthpiece. The base plate is engageable with the housing to form a main space with a main air inlet. The mouthpiece includes an inner conduit connected to its outlet and is engageable with the base plate to fluidly connect the inner conduit to the receptacle. The receptacle is fluidly connected to the main space, so that upon inhalation by a user, air can be drawn through the main air inlet into the main space and onward through the receptacle into the inner conduit. The mouthpiece and the base plate form an auxiliary space with an auxiliary air inlet, wherein the auxiliary space is fluidly connected to the main space.

Abstract: A method of delivering a substance in aerosol or powder form to the upper respiratory tract is provided. The substance is orally administered into the larynx, through the pharynx, and out from the nose while minimizing inhalation into the lungs, whereby deposition of particles in the upper respiratory tract is achieved with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for oral inhalation of a flow of a substance into the upper respiratory tract and a flow restrictor for enabling arrestment of the flow minimizing inhalation into the trachea, lower airways and lungs, which provides for a deposition of particles in the upper respiratory tract with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for admission of a flow of a substance into the upper respiratory tract and a flow generator for pressuring the substance into travel through the upper respiratory tract.

Abstract: An aerosol-generating system is provided, including an aerosol-generating device including a heater element, and an aerosol-generating article configured to engage with the aerosol-generating device. The aerosol-generating article includes a medicament source, a volatile delivery enhancing compound source, and at least one frangible barrier sealing the medicament source and the volatile delivery enhancing compound source. The aerosol-generating system also includes at least one piercing element disposed on one of the aerosol-generating device and the aerosol-generating article, the at least one piercing element being configured to pierce the at least one frangible barrier when activated by a user.