Abstract: A method for collecting plasma includes determining the weight and hematocrit of a donor, and inserting a venous-access device into the donor. The method then withdraws blood from the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate (1) a percentage of anticoagulant in the collected plasma component, and (2) a volume of pure plasma collected within the plasma collection container. The volume of pure plasma may be based, at least in part, on the calculated percentage of anticoagulant. The method may continue until a target volume of pure plasma is collected within the plasma collection container.

Abstract: In a blood transfusion system (a blood transfusion kit, a blood transfusion kit for emergency blood transfusion, or a method of using a blood transfusion kit), a flow path through which blood flows is formed using a tube having a channel therein. The flow path includes: a first path that connects an upstream path and a downstream path and has a leukocyte removal filter removing leukocytes at an intermediate position of the channel; and a second path that connects the upstream path and the downstream path and bypasses the leukocyte removal filter.

Abstract: A container for collecting, storing and dispensing fluid, as in enteral feeding and/or medication deliver to neonatal infants. The container includes a hollow tube with a body, a first end, a second end, and an outer diameter. The hollow tube is configured to receive a movable plunger that advances and retracts therein to define a variable contained volume. The container also includes a sealing head assembly removably mounted at an end of the hollow tube. The sealing head assembly has a diameter or outside dimension that is substantially similar or identical to a corresponding outside diameter or dimension of the hollow tube, so that the container lies flat within the receiver of an enteral feeding pump.

Abstract: An intravascular blood pump having a drive section (11), a catheter (14) fastened to the drive section proximally and a pump section (12) fastened to the drive section distally possesses an electric motor (21) whose motor shaft (25) is mounted in the drive section (11) with two radial sliding bearings (27, 31) and an axial sliding bearing (40). During operation, purge fluid is conveyed through the bearing gap of the axial sliding bearing (40) and further through the radial sliding bearing (31) at the distal end of the drive section (11). The purge fluid is highly viscous, for example 20% glucose solution.

Abstract: A blood pump can include a pump housing, an impeller, and a hub. The pump housing can be configured to move blood from an inlet to an outlet thereof. The impeller can be housed in the pump housing, have a plurality of blades joined by a central ring, and be radially supported at the central ring by a bearing. The hub can transmit torque to the impeller using a radial magnetic coupling.

Abstract: Systems, devices, and methods are provided for removing carbon dioxide from a target fluid, such as, for example, blood, to treat hypercarbic respiratory failure or another condition. A device is provided including first and second membrane components for removing dissolved gaseous carbon dioxide and bicarbonate from the fluid, which can be done simultaneously. The device can be in the form of a cartridge configured for use in a dialysis system. A method of treatment is also provided, involving drawing blood from a patient and bringing the patient's blood in contact with a first membrane component having a sweep gas passing therethrough, and a second membrane component having a dialysate passing therethrough. The dialysate's composition can be selected such that charge neutrality is maintained.

Abstract: The present disclosure relates to a system for extracorporeal blood circulation, including an oxygenator which includes a heat exchanger configured for warming or cooling blood in extracorporeal blood circulation of a patient, and a heater/cooler configured for exchanging a quantity of heat with the heat exchanger, wherein the heater/cooler includes a thermoelectric heater/cooler and wherein the heater/cooler (14) is connected to the heat exchanger (11) by a thermal connecting element (15).

Abstract: A medical treatment system, such as peritoneal dialysis system, may include control and other features to enhance patient comfort and ease of use. For example, a peritoneal dialysis system may include patient line state detector for detecting whether a patient line is primed before it is to be connected to the patient. The patient line state detector can also the ability to detect whether a patient line has been properly mounted for priming. Both patient line presence/absence and fill state can be determined using an optical system, e.g., one that employs a single optical sensor.

Abstract: An automated peritoneal dialysis (APD) system using gravity to deliver fluid from one or more source dialysate bags to the patient as the destination, and using gravity to deliver fluid from the source patient to the destination drain container or drain receptacle, and heats at least one dialysate bag placed onto a heated plate, and using a disposable tubing set is used for dialysate delivery to and from the patient, and using one or more solenoid-operated, normally closed, electronically-controlled pinch valves which pinch or release the disposable tubing set's tubing to stop or start fluid flow, respectively.

Abstract: The invention provides apheresis devices and their use for removal of substantially all types of cell free DNA (cfDNA) in patients' blood, including nucleosome-bound cfDNA, exosome-bound cfDNA and unbound cfDNA (including double stranded DNA (dsDNA), single stranded DNA (ssDNA) and oligonucleotides), to limit the negative effects of the circulating cfDNA and to treat various diseases.

Abstract: Method for treating an arteriovenous fistula dilated venous segment in a hemodialysis patient whose arteriovenous fistula exhibits abnormally high venous blood flow or/and pressure. Includes: surgically reconstructing the AVF dilated venous segment, to form an AVF reconstructed venous segment, followed by covering and supporting the AVF reconstructed venous segment with implantable blood vessel external support, such that the arteriovenous fistula will exhibit normal venous blood flow and pressure. Also disclosed is a method for pre-determining an arteriovenous fistula reconstructed venous segment lumen diameter, as guidance for treating AVF dilated venous segments in hemodialysis patients. Also disclosed is use of an implantable blood vessel external support for treating a hemodialysis AVF dilated venous segment.

Abstract: A medical device is provided for irrigation of a patient wound site. The device contains a tube having a proximal portion adapted to receive an irrigation solution, a distal portion having a nozzle and an intermediate portion for transporting the solution. The tube has a barrel portion that may be manipulated by a user to position the device relative to the wound site. A distinctive nozzle has a body formed with a distally leading channel presenting a semispherical first spatial conformation and a proximally leading opening formed in the body presenting a second spatial conformation intersecting the semispherical terminus. This geometry, derived from principles of flow mechanics discussed herein, defines what will be described as an “effective diameter” of the nozzle. An assembly and system utilizing the device are also disclosed. The invention utilizes a fluid-isolating durable peristaltic pump for a continuous flow of irrigation solution, along with a single use tube set that embodies the device.

Abstract: Apparatus and a method are presented, including disinfecting a disinfection chamber that is defined between (i) a prefilled therapeutic substance reservoir and (ii) a sterile fluid path disposed within a therapeutic substance delivery device. The sterile fluid path includes a needle at an upstream end of the sterile fluid path and an injection assembly at a downstream end of the sterile fluid path. The disinfection occurs subsequently to the prefilled therapeutic substance reservoir being engaged with the therapeutic substance delivery device. Subsequently to disinfecting the disinfection chamber, the disinfection chamber and then the reservoir are penetrated with the needle. Other applications are also described.

Abstract: Various novel arrangements for facilitating adherence of an on-body injector onto a patient's skin and subsequently removing the injector after drug delivery has occurred. Such arrangements can include adhesive configurations that conform to body contours, adhesive configurations that include pull rings or chords, tabs, or perforated seams to facilitate one-step or two-step removal, and/or injector bodies with gripping features to facilitate manual grasping.

Abstract: Embodiments of the present disclosure enable a user-wearable infusion pump that may have a limited user interface including no display to be paired with a remote control device that can include a remote consumer electronic device such as a smartphone and/or a dedicated remote controller.

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: Provided is a precision variable flow rate infusion system and method for delivering a liquid from a reservoir having an initial potential outflow rate to a patient. The system includes at least a first flexible flow rate tubing having a pre-defined flow rate selected at a maximum dosage flow rate for the liquid from the reservoir, the pre-defined flow rate being less than the initial potential outflow rate of the reservoir. Also provided is an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

Abstract: The present disclosure relates to systems and methods for controlling an MRI safe patient care/monitoring system. The system may include a an MRI safe infusion pump that contains a co-processor which acts as a central brain for all other patient care/monitoring devices in the MRI room. The co-processor is separated from the primary processor by a buffer in the infusion pump's memory, so that no actions by the co-processor can affect the primary processor. The co-processor controls the display software, alert software and alerts database. All other patient care/monitoring devices are connected to the MRI safe infusion pump in a daisy chain, so that they can share a single connection to outside the MRI room. Outside the MRI room the co-processor has access to the remote control & display, which contains the remote control GUI, and to the interne, through which it will access an external medical network, which contains an algorithm database.

Abstract: A drug delivery device is provided that includes an on-board controller to determine when proper placement on the patient's body has occurred as well as an amount of drug delivered to the patient. The controller can also be used to determine if and when the proper placement has been disturbed during drug delivery and/or if less than a full dose of the drug has been dispensed.

Abstract: Disclosed herein are apparatuses and methods for improved use of infusion sites for infusion pumps. Apparatuses and methods for delivery of medicaments such as insulin disclosed herein can increase the effectiveness of therapy by more accurately determining when an infusion site is no longer absorbing insulin at an acceptable rate as well as determining the effectiveness of different infusion sites on the body with respect to each other and over time.

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: A protection device for a syringe having a syringe body extending along a longitudinal axis comprising, at a first end an end tip including an orifice for the passage of liquid and, at a second end, an opening for the passage of a piston provided with a maneuver head; wherein the device is adapted to at least partially cover said syringe body and is made at least in part of a radioprotective material providing protection against ionizing radiation, and wherein the device is in the form of a clamp comprising two half-jaws joined together by a hinge, which clamp includes operating means configured so that said half-jaws are moveable between: a closed operative position, in which said half-jaws are assembled to form a cylinder to at least partially cover said syringe body, and an open inactive position, adapted for the introduction and extraction of said syringe body into said half-jaws.

Abstract: An auto-injector (100) for use with a primed safety syringe (200). The auto-injector comprises: a first detector (312) configured, after activation of the auto-injector, to detect movement of a plunger (206, 222) of the safety syringe to a point on a delivery stroke thereof that is indicative of full dose delivery of a substance from the safety syringe.

Abstract: The invention proposes a method and a device for needleless injection of liquid into a substrate, in particular of a liquid pharmaceutical or cosmetic preparation into a biological tissue, which allows a particularly fine liquid jet to be reliably injected completely into the substrate in a particularly advantageous manner. According to the invention, this is achieved by setting the ejected liquid jet in rotation about its jet axis before its impingement on the substrate, so that the jet receives a rotational movement and thus practically drills into the substrate without splashing away laterally.

Abstract: A medical monitoring system increases patient safety and confidence. The system has a disposable injection device with a container holder for holding a container such as a cartridge or a syringe with a liquid drug for subcutaneous injection. The system includes a passive machine-readable tag mounted to a device housing of the injection device and coding or storing drug information about the drug in the container. The system also includes an electronic module or supplemental device releasably attachable to the injection device. The electronic module comprises injection status sensing means for monitoring a status of an injection or for tracking progress of a medication event, as well as a tag reader different from the sensing means for reading drug information from the machine-readable tag. The system includes a drug status signaling or interfacing unit for signaling to a user a drug status based on, or derived from, the drug information.

Abstract: A system and method for generating a dosing aid label for a syringe are described. In a method, patient information and medicament information are received. The medicament information includes one or more of a description of the medicament, a recommended dosage of the medicament and concentration information relating to the medicament. A dosing aid associated with the patient information and medicament information is generated. The dosing aid includes dosing information which is usable in guiding administration of a dose of the medicament. A print instruction message is transmitted to a printing device. The instruction message is configured to instruct the printing device to print a dosing aid label including the dosing aid on the syringe or a sheet of material configured to be affixed to a syringe. The dosing aid label is usable in guiding administration of the dose of the medicament to the patient.

Abstract: An injection device includes an elongated housing extending along a longitudinal axis, a piston rod to operably engage with a piston of a cartridge filled with the medicament, a dose tracker selectively operably engageable with the piston rod, wherein the dose tracker is longitudinally displaceable relative to the housing from an initial position in a proximal direction towards at least a first activation position for setting of the dose and wherein the dose tracker is longitudinally displaceable relative to the housing in a distal direction from the at least first activation position towards the initial position for dispensing of the dose, a spring to urge the dose tracker in the proximal direction relative to the housing, an interlock to lock the dose tracker in the initial position relative to the housing, and a release member to release the interlock.

Abstract: A drug delivery device includes a housing defining a shell comprising a front portion and a rear portion slidably coupled to the front portion, a drug delivery assembly at least partially disposed within the housing, at least one electronic component, a power source which powers the electronic component, and a switch assembly. The switch assembly is adapted to selectively cause the power source to provide power to the at least one electronic component.

Abstract: An injector includes a needle movable from a retracted position to an injection position. A rotary biasing assembly is stabilized in a stored energy state and releasable into an energy releasing state and includes a cam. A cam follower couples the rotary biasing assembly with the needle and is configured to transform rotation of the rotary biasing assembly in the energy releasing state thereof into translation of the needle from the retracted position to the injection position. An activation switch is rotatable from an unactivated position, stabilizing the rotary biasing assembly in the stored energy state thereof, to an activated position, releasing the rotary biasing assembly into the energy releasing state thereof. An activation button is movably mounted to the injector housing and is translatable from an unactuated position to an actuated position, whereby the translation rotates the activation switch from the unactivated position to the activated position thereof.

Abstract: The present invention relates to a syringe and medical kit, which allow for doses of epinephrine of 0.15 mg or 0.15 mL, 0.3 mg or 0.3 mL, and 0.5 mg or 0.5 mL, the most commonly prescribed doses which are utilized today in treating anaphylaxis or other allergic reactions. Currently, existing syringes may include many markings of ten or more dosages. Although these prior art syringes are useful, it is difficult to use them for a patient who must quickly identify a correct dose level among many other marks. The above problem can be addressed by a syringe design which has only a few dosage markings, which correspond to commonly used standard dosages for children and adults. When used with a standard concentration of 1:1000 epinephrine solution, such a device can rapidly provide a known quantity of medicine to a patient who is in urgent need of it.

Abstract: A dual chambered syringe includes: an inner barrel defining a first inner chamber, the inner barrel having an apertured stopper at its distal end, the inner barrel being open at its proximal end; a shaft adapted to fit within the inner barrel, the shaft having a distal end which is engageable with the aperture of the stopper; a device for controlling engaging and disengaging of the distal end of the shaft with the aperture of the stopper; an outer barrel concentric with the inner barrel defining a second inner chamber, the outer barrel having a distal end for receiving and dispensing fluids and a proximal end into which the distal end of the inner barrel is insertable into the second inner chamber; the apertured stopper engages the second inner chamber of the outer barrel and selectively prevents or permits the passage of fluids between the outer barrel second chamber and the inner barrel first chamber; the inner barrel having an engageable surface on its outside surface; and, the outer barrel having operativ

Abstract: Described is an autoinjector comprising a case, a chassis slidably arranged in the case, a syringe carrier operably coupled to the chassis, an outer plunger selectively engaged to the chassis, an inner plunger selectively engaged to the outer plunger, and a drive spring applying a biasing force to the outer plunger. The biasing force is applied to the inner plunger when the inner plunger is engaged to the outer plunger. Rotation of the chassis causes the inner plunger to rotate relative to the outer plunger and disengage the outer plunger to remove the biasing force from the drive spring on the inner plunger. When the inner plunger disengages the outer plunger, the biasing force of the drive spring pushes the chassis to retract the syringe carrier relative to the case.

Abstract: An embodiment in accordance with the present invention is directed to a device for fixation, stabilization, and securement of an intravascular cannula to tissue. The fixation device affixes relative to the cannula and cannulated tissue, allowing the needle to be inserted to a shallow depth and then rapidly secured with one motion, using just one hand. The device works to secure cannulae not only in small vessels but also in situations non-permissive to current state-of-the-art cannulas—such as on wet, adhesive-incompatible surfaces, in intra-operative applications, or when hands-free securement is required. The device can also be utilized to access the umbilical arteries and vein for purposes of placental perfusion for cord blood collection or to facilitate and extend the duration of conventional cord blood collection.

Abstract: A two-stage temper evident injector lock with a security indicator on the two-stage temper evident injector lock and a method of locking the two-stage temper evident injector lock, which has been developed for guaranteeing a security for that a dosage of a fluid contained in the medical injectors (syringes) that are filled with the medications prepared at medication preparation areas, and mostly with specific fluids is not altered before being applied to a subject.

Abstract: A magazine (18) that stores a plurality of needles (56) configured to engage a medication pen (2) for medication delivery, the magazine (18) comprising a magazine housing (20) enclosing a removable array (26) having a plurality of hub chambers (22) each enclosing one of a plurality of needle hubs (50), a connector (28) in each of the plurality of huh chambers (22), each connector (28) engages one of the plurality of needle hubs (50), a plurality of peel tabs (30) each sealing one of the plurality of hub chambers (22), and an electronic indicator (62) to identify a status of the plurality of needle hubs (50), wherein the electronic indicator (62) identifies how many of the plurality of needle hubs (50) are unused.

Abstract: A method of delivering a medication or a pharmaceutical product to a patient includes operations of activating an active mesh of an active mesh nebulizer, the active mesh being in contact with a liquid formulation of the medication, and configured to generate a plume of particles having a particle diameter between 1 and 6 micrometers, directing the plume of particles to a mouth of a patient during an inhalation by a patient; and stopping the plume of particles during the inhalation by the patient such that a substantial majority, or nearly all, of the plume of particles is inhaled by the patient.

Abstract: A nebulizer for nebulizing a fluid and a reservoir with a fluid are proposed. The reservoir includes a collapsible bag with the fluid, where the bag extends in a circumferential direction within the housing part and wherein the reservoir is manually rotated for tensioning the nebulizer.

Abstract: The invention related to dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients.

Abstract: An actuator housing (100) for use with a metered dose inhaler (MDI) device which comprises a housing portion (115) having a nozzle block (130) in which an actuator seat (135) and an actuator nozzle (145) are formed. The housing portion has an axis (120) which is angled with respect to a vertical plane which is perpendicular to a base portion or thumb grip (150) formed at a closed end thereof. A mouthpiece portion (125) is joined to the housing portion which has a roof section (180) and a floor section (125b). The roof section is angled upwards with respect to the floor portion, and provides a cross-piece (185) with which teeth of a patient can engage. Such an actuator housing addresses problems associated with buccal and tongue deposition of medicaments, as a spray of medicament from the actuator nozzle is directed over the tongue and into the airway.

Abstract: An accessory device for delivering medications from attached press-and-breathe metered-dose inhalers (MDIs), including those medications containing hydrofluoroalkane propellants. The device includes a collapsible flexible bag to which is attached a bidirectional mouthpiece and an adaptor that receives the MDI. The mouthpiece contains a reed that functions as an audible signal. The adaptor positions the MDI at an angle to direct the aerosol spray toward the center of the bag. When triggered, the MDI discharges the aerosolized medication into the center of the bag, which medication may then be inhaled by the user through the mouthpiece. The user's inhalation causes the bag to collapse. The reed emits an audible sound if the user inhales above a pre-determined flow rate. A cap seals a gap between the adaptor and an attached canister, making the device in combination with the MDI into a closed-bag system.

Abstract: A nasal pod is described for dispensing a compound such as asthma medication to air inhaled through the nose.

Abstract: A respiratory therapy system configured to deliver gases to a patient can have a non-sealed gas flow generating arrangement configured to deliver a high flow of positive gas to an airway of a patient and a negative flow of gas away from an airway of the patient. The positive and negative flows of gas can be generated simultaneously. The flow of positive and negative gases reduces exhaled gases in anatomical dead spaces of the patient.

Abstract: The present invention is a mechanical ventilation device which delivers intermittent positive pressure ventilation by compressing AMBU. As the device uses existing AMBU for the ventilation, it is intended to automate the process of hand ventilation and will hence keep the costs and skill requirement low. Due to usage of the AMBU and simple mechanics, it is easy to manufacture and maintain the device.

Abstract: Methods and apparatus provide communications among respiratory therapy device (“TD”), server and intermediary (e.g., a control device (“CTLD”) for the therapy device) to improve security. More secure communication channel(s) may be established using shared secrets derived with different channels. The communications may include transmitting therapy data from TD to server for authentication. The CTLD may receive the data and a nonce from a server. The CTLD receives from the TD a signing key dependent on the nonce and a secret shared by TD and server. The CTLD generates an authorisation code with received therapy data and the key for authentication of the data by the server upon its receipt of the code and data. The server computes (1) a key from the nonce and the secret known to TD, and (2) another authorisation code from received therapy data and the key. Data authentication may involve comparing received and computed codes.

Abstract: The present disclosure describes a system that automatically detects patient-ventilator asynchrony and trends in patient-ventilator asynchrony. The present disclosure describes a framework that uses pressure, flow, and volume waveforms to detect patient-ventilator asynchrony and the presence of secretions in the ventilator circuit.

Abstract: Algorithms for detecting endotracheal intubation and/or misplacement of endotracheal tubes in child patients during anesthesia for use with anesthesia machines, mechanical ventilators, and/or respiratory function monitors. An algorithm uses end-tidal carbon dioxide (EtCO2), and tidal volume (TV) or peak inspiratory pressure (PIP) to detect exact intubation time. Another algorithm uses respiratory parameters to identify and/or confirm the type of airway device used during mechanical ventilation, and to detect if and when an issue has arisen with use of a specific airway device to provide real-time decision support to attending medical care professionals.

Abstract: Airway devices, systems, and methods are disclosed that can achieve ventilation of lungs through a mask that seals around the glottis and connects to a flexible airway channel, while also providing evacuation of gastric and/or pharyngeal body fluid and/or blood during upper airway surgeries or procedures.

Abstract: A double-lumen oropharyngeal cannula of the type used for pervious maintenance of the upper airway of a patient under anesthetic sedation, the cannula including a single piece formed by a biting block from whose frontal portion a frame is projected that composes a base for laying in the patient's mouth, while on the opposite side a channel is projected, destined for inserting a bronchofibroscope with or without orotracheal tube; the biting block has a reduced-width oblong shape where openings are provided, one opening being circular peripheral shape and having extended diameter and another parallel opening of oblong shape, both, separated by an orthogonal wall in order to compose the double lumen to enable the entry and exit of gas during inspiration and expiration or insertion of an orotracheal rescue tube and to allow insertion of a medical instrument such as an endoscopic or echoesophageal probe and/or a bronchofibroscope.

Abstract: The present disclosure relates to an oxygen mask comprising: a mask body defining a cavity configured to be positioned over the mouth and nose of a patient, an oxygen port formed on the upper half of the mask body, an annular aperture formed on the mask body, and at least one vent port formed on the mask body, wherein each vent port is formed on the bottom half of the mask body in a manner that patient's exhaled gases are directed towards the vent port.

Abstract: A respirator fixing module applied to a breathing tube includes a cap, a nasal mask structure, a first strap, a second strap, and a third strap. The cap has a first joint; the nasal mask structure has a nasal mask, two first assembling members and a second assembling member extending from the left, the right, and the top sides of the nasal mask respectively, and a communicating pipe and a breathing tube connected to each other; the first strap is installed between the two first assembling members and encircled into a headband; the second strap is connected to the cap, and the second strap has an end surrounding the breathing tube and a second joint adjustably combined with the first joint; and the third strap has an end fixed to the second assembling member and the other end having a third joint adjustably combined with the first joint.