Abstract: A coated medical balloon that includes a polymeric material having a surface with a therapeutic agent-containing mixture coated thereon, wherein the mixture includes a therapeutic agent, an unsaturated carboxylic acid, and a salt of the unsaturated carboxylic acid.

Abstract: A vascular access product is provided having a component with a plurality of external surfaces. At least one of the surfaces is coated with an antimicrobial treatment, wherein the antimicrobial material comprises a silane quaternary ammonium salt. The silane quaternary ammonium salt may comprise 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride. The vascular access product may be IV administration tubing, a catheter and the associated caps, luers, Y sites, connectors, drip chambers, PICC lines, stopcocks and similar IV components such as needleless IV connectors having valve mechanisms.

Abstract: The invention relates to compounds, compositions and methods for biofilm disruption and prevention. In particular, the invention relates to pharmaceutical compositions for the disruption of biofilm and prevention of biofilm in patients. The invention also relates to anti-biofouling compositions for the disruption of biofilm and prevention of biofilm on surfaces. The invention also relates to the removal of biological material from surfaces. The compositions of the invention include microbial deoxyribonucleases.

Abstract: A method of providing an antioxidant to a medical device and a kit are described.

Abstract: A catheter pump includes an impeller and a drive shaft coupled with the impeller. The catheter pump includes a motor assembly coupled with the drive shaft. The motor assembly includes a motor housing having an opening through a wall of the motor housing and a flexible member disposed about the opening, the flexible member configured to engage a connection portion of a platform.

Abstract: A catheter pump is disclosed. The catheter pump can include an impeller and a catheter body having a lumen therethrough. The catheter pump can also include a drive shaft disposed inside the catheter body. A motor assembly can include a chamber. The motor assembly can include a rotor disposed in the at least a portion of the chamber, the rotor mechanically coupled with a proximal portion of the drive shaft such that rotation of the rotor causes the drive shaft to rotate. The motor assembly can also comprise a stator assembly disposed about the rotor. The motor assembly can also include a heat exchanger disposed about the stator assembly, the heat exchanger may be configured to direct heat radially outward away from the stator assembly, the rotor, and the chamber.

Abstract: An impeller for a pump is disclosed herein. The impeller can include a hub having a fixed end and a free end. The impeller can also have a plurality of blades supported by the hub. Each blade can have a fixed end coupled to the hub and a free end. The impeller can have a stored configuration and a deployed configuration, the blades in the deployed configuration extending away from the hub, and the blades in the stored configuration being compressed against the hub.

Abstract: A method for assisting blood circulation in a patient includes drawing a flow of blood from a patient's heart into a blood flow channel formed by a housing. The flow of blood is passed through a motor stator to a rotor disposed within the blood flow channel. The motor stator is arranged circumferentially around the blood flow channel. The rotor has permanent magnetic poles for magnetic levitation and rotation of the rotor. The motor stator is controlled to act as a radial bearing for magnetic levitation of the rotor and to rotate the rotor within the blood flow channel. The rotor is levitated within the blood flow channel in the direction of the rotor axis of rotation via passive magnetic interaction between the rotor and the motor stator. The flow of blood is output from the blood flow channel to the patient.

Abstract: A flow rate of blood through an implantable blood pump is determined based on a parameter related to the flow, such as a parameter related to thrust on the rotor of the pump. An amount of current supplied to the pump is used to determine each of a first flow rate value and second flow rate values. Each of the first and second flow rate values, in combination with the parameter related to thrust on the rotor of the pump, are used to calculate a flow rate of blood through the pump.

Abstract: This disclosure relates to making medical solutions. In certain aspects, a method is performed by a data processing apparatus. The method includes introducing liquid into a container that contains a dissolvable solid concentrate in a manner so that a layer of solution above the solid concentrate is maintained at a depth that allows the liquid introduced into the container to agitate the solution adjacent to the solid concentrate to cause mixing of the solid concentrate with the solution.

Abstract: A method of operating a disposable pumping unit includes enabling the disposable pumping unit to be loaded into a peritoneal dialysis hardware unit between a door and a housing of the hardware unit; structuring the disposable pumping unit to have a fluid pump receptacle, the fluid pump receptacle constructed and arranged to extend from both surfaces of the unit so as to fit within a first opening provided in the door and a second opening provided in the housing of the hardware unit; and enabling the disposable pumping unit to be guided into the hardware unit such that the fluid pump receptacle becomes aligned with the opposing first and second openings when the door is closed against the housing.

Abstract: A dialysis system includes a dialysis machine configured to control fluid loss or ultrafiltration (“UF”) volume over a treatment; a graphical user interface (“GUI”) that allows selection of a prescription entry for the treatment; and a processor operating with the GUI, the processor programmed to (i) receive a plurality of prescription entries via a local or wide area mode of data communication, each prescription entry including at least one prescribed parameter for operating the dialysis machine to control the fluid loss or UF volume, and (ii) enable an operator to choose between the prescription entries provided at the GUI, and select one of the prescription entries for the treatment.

Abstract: Extracorporeal blood treatment is performed daily on a large number of patients by use of for example a dialysis filter, plasma filter or a centrifuge. The purpose of the treatment is to separate minor components and molecules in a liquid or in the blood from larger ones, for example in connection with different disease conditions or with a view to extracting blood plasma, target substances such as blood components or molecules from for example blood donors. According to the present invention two separation steps are used together with a solution or a suspension containing at least one component, which specifically may bind to the component or the blood component to be specifically reduced, or to be refined/extracted during the treatment or during the blood treatment.

Abstract: A method of causing an object to act as a cavitation nucleus comprising the steps of providing a sound energy source capable of generating a sound energy over a plurality of frequency ranges, providing a target object contained in a liquid, coupling the sound energy source to the liquid, determining a specific frequency range, within the frequency ranges, that resonates the target object, and exposing the target object to sound energy at the specific frequency range to cause the target object to act as a cavitation nucleus.

Abstract: A method and a kit for the prevention of venous stenosis associated with the use of hemodialysis AV shunts. The kit may use a bifurcated needle for providing access to the shunt or blood vessel. One of the arms is used for returning the blood to the subject after dialysis treatment, while the other arm is used for inserting a device for cleaning the vein, the device being either an autonomous crawling device, or a passive tethered device moved down the vein by the blood flow. The autonomous crawling device may be a series of sequentially inflatable chambers, the stenosis being cleared by pressure from the outer walls of the chambers when inflated and moved. The passive device may be an element having a flexible disc-like structure, whose flexible peripheral edge slides along the inner walls of the blood vessel, compressing or clearing the material attached thereto.

Abstract: A medical fluid injector device injecting a patient with a mixed medical fluid and capable of simply setting injection conditions for the mixed medical fluid. A medical fluid injector includes an injector head injecting a diluted contrast medium into a patient and a controller unit. The controller unit receives an input relating to an injection rate of the diluted medical fluid receives an input relating to a mixture ratio by an operator, calculates an injection rate of a contrast medium based on the mixture ratio, and calculates an injection rate of physiological saline based on the mixture ratio. The injector head injects the contrast medium and the physiological saline at the calculated injection rate of the contrast medium and the calculated injection rate of the physiological saline, respectively.

Abstract: A method and device for adjusting the unstored length of tubing directed to improving the use of infusion sets that deliver fluids to a user. The device includes a storage module and other features for adjusting, storing and securing the length of the tubing. The method of adjusting the length of the tubing to a desired length typically comprises removably attaching the tubing to the adjuster, adjusting the tubing by wrapping the tubing around a hub or post of the adjuster, and fixing the length of the unstored tubing by attaching the tubing to a securing device such as a friction structure or fastener.

Abstract: A reservoir and straight-line, push-on connector assembly is provided for connecting the reservoir and one of a standard Luer line set and a custom Luer line set to any number of infusion pump configurations using a simple straight-line, push-on motion, wherein the push-on connector assembly is provided and configured to secure the line set and reservoir with the infusion pump. One simple straight-line, push-on motion, preferably performed by gripping an expander sleeve, places and secures the reservoir (i.e., locates the reservoir on the x, y, and z axes) in the pump reservoir cavity, and one simple straight-line, pull-off motion releases and removes the reservoir from the pump reservoir cavity. Rotational orientation is not required for connection, pump engagement, or pump function, and any pulling of the tube set will not release the reservoir as the expansion sleeve through which the tube set is routed is not moved from the securing position by tension on the tube set or Luer fitting.

Abstract: A drug delivery device, including a body (104, 116) having a reservoir (160) disposed therein for containing a medicament and an injection needle (152) for penetrating the skin of a patient, the needle (152) providing a path for the medicament between the reservoir (160) and the patient. The device also includes a rotor (580) rotatably disposed in the body (104, 116) for activating the device upon rotation of the rotor (580), a needle cover (112) for covering the injection needle, and a needle cover clip (560) disposed on the needle cover (112) to rotate from a first position preventing rotor rotation to a second position permitting rotor rotation.

Abstract: A system for safe delivery of drug to a patient employs a programmable memory card for transferring drug delivery instructions and patient information between a server in a pharmacy and a drug delivery apparatus in a patient room. The server in the pharmacy checks the prescription for safety and the drug delivery apparatus checks for the drug delivery instructions and also the patient identity. The drug delivery apparatus records the information about the drug delivered to the patient onto the programmable memory card at the end of the drug delivery.

Abstract: An autoinjector includes a main body having a container, the container having a drug therein, a hollow needle coupled to the container through which the drug can be delivered. The autoinjector also has a power source having a liquefied gas therein as a driver, a flow regulator, and at least one outlet through which some of the driver can exit the power pack in a gaseous state. The power source and container are coupled together for operation such that, when an injection is initiated, the flow regulator will control an exit rate of the driver such that the liquefied gas in the power source is maintained at substantially its vapor pressure and the power source will adjustably apply a force to deliver the drug via the hollow needle at a delivery rate that is a constant delivery rate.

Abstract: A syringe filter for containing a filter membrane is disclosed and includes first and second fluid distribution surfaces configured to be positioned on opposing sides of a membrane. An inlet port is in fluid communication with the first fluid distribution surface and a first plurality of distribution pathways formed on the first fluid distribution surface. An outlet port is in fluid communication with the second fluid distribution surface and a second plurality of distribution pathways formed on the second fluid distribution surface. The first plurality of distribution pathways is configured to distribute fluid flow from the inlet port to one side of the membrane while the second plurality of distribution pathways is configured to direct fluid flow from another side of the membrane to the outlet port.

Abstract: A pump for pumping fluid includes a tube platen, a plunger, a bias member, inlet and outlet valves, an actuator mechanism, a position sensor, and a processor. The plunger is configured for actuation toward and away from the infusion-tube when the tube platen is disposed opposite to the plunger. The tube platen can hold an intravenous infusion tube. The bias member is configured to urge the plunger toward the tube platen.

Abstract: An injection device (210) is described. A housing (212) receives a syringe and includes a return spring (226) for biasing the syringe from an extended position in which its needle (218) extends from the housing (212) to a retracted position in which the it does not. A drive spring (230) acts on a first drive element (232) and a second drive element (234) acts upon the syringe to advance it from its retracted position to its extended position and discharge its contents through the needle. The first drive element (232) is capable of movement relative to the second (234) once a nominal decoupling position has been reached. A release mechanism is activated when the first drive element (234) is further advanced to a nominal release position, to release the syringe (214) from the action of the drive spring (230), whereupon the return spring (226) restores the syringe (214) to its retracted position.

Abstract: The present invention concerns an injection device with a housing adapted to receive a syringe having a discharge nozzle, the housing having an indicator opening. There is a trigger and a forward drive arranged to act upon the syringe on actuation of the trigger to advance the syringe from a retracted position to an extended position thereby discharging the contents of the syringe through the discharge nozzle. A support member is in contacting juxtaposition with the housing and a return drive is supported by the support member and arranged to act upon the syringe after the contents of the syringe has been discharged so that the syringe can be withdrawn from the extended position to the retracted position. Advantageously, the support member is arranged in the housing so that the second drive does not obscure an inspection of the contents of the syringe through the indicator opening. Hence, it can be clearly determined whether the contents of the syringe have been expelled from the syringe.

Abstract: A needleless fluid injection device including a flexible shaft with a proximal end, a distal end, an injection lumen extending from the proximal end to the distal end of the shaft, and at least one injection orifice extending through a wall of the injection lumen at the distal end of the shaft. The injection lumen can include a depth-limiting system (462) at its distal end for controlling the depth of insertion of the injection lumen relative to a target tissue of a patient. The injection lumen can alternatively or additionally include at least one guidance feature. The injection lumen can alternatively or additionally include at least one flow-modifying protrusion extending from the inner tubular wall of the injection lumen and toward a longitudinal axis of the injection lumen.

Abstract: The drive mechanism for a drug delivery device comprises a piston rod, which is displaced in a distal direction for a delivery of a dose and in a proximal direction for a reset, and a rotatable drive member, which is threadedly engaged with the piston rod and rotates during the delivery of the dose. A biasing member is provided, which is loaded by the rotation of the drive member during the delivery of the dose and tends to rotate the piston rod with respect to the drive member in such a way that the piston rod is screwed into the drive member and is thereby advanced in the proximal direction. The drug delivery device is provided with such a drive mechanism.

Abstract: A drug delivery system (1) comprising first (35) and second reservoir units (30) with first and second identifiers (32), and a main unit (10) adapted to receive either of the first (35) and second reservoir units (30) in a mounted position. The main unit (10) comprises drug expelling means having dose setting means (11, 1, 14, 15, 19) comprising a rotational dose setting member allowing a user to set a desired dose size for the given drug, the dose size being set in fixed increments for a given state. The drug expelling means has a first state in which an increment corresponds to a first volume of drug, and a second state in which an increment corresponds to a second volume of drug, wherein the drug expelling means is set in the first state by means of the first identifier when a first reservoir unit is mounted, and the drug expelling means is set in the second state by means of the second identifier when a second reservoir unit is mounted.

Abstract: A self-injection device (100, 200), including a pen body (108, 208) connectable to a pen needle (10), and a cap (104, 204) selectively connectable to the pen body (108, 208) in a first orientation with respect to the pen body (108, 208) to minimize the length or volume of the self injection device (100, 200), and in a second orientation to provide sufficient length or volume in an interior of the cap (104, 204) to house a pen needle (10) connected to the pen body (108, 208).

Abstract: The injection assembly (2) includes a prefilled injection device (3), such as a syringe, provided with a coupling tip (16), for example of the Luer-Lock type, and a protection device (4) comprising a protective portion (23) removably mounted on the coupling tip (16), a supporting portion (30) connected to the protective portion (23), and an injecting element (34) removably mounted on the supporting portion (30) in a storage position. The injecting element (34) comprising an injection needle (35) and a connecting tip (36) fluidly connected to the injection needle (35), the connecting tip (36) being adapted to be mounted on the coupling tip (16) of the injection device (3) in a position of use of the injecting element (34). The injecting element (34) and the supporting portion (30) are arranged in such a way that, in the position of storage of the injecting element (34), the connecting tip (36) is accessible to cooperate with the coupling tip (16).

Abstract: A piston for use in an injector comprising a cylinder having a longitudinal axis and an inner wall, which piston has a deformable sealing element with a convex surface, which deformable sealing element when the piston is inserted in the cylinder abuts the inner wall of the cylinder at an abutting interface and seals an annular gap between the piston and the inner wall of the cylinder. The abutting interface and the deformable sealing element have axial dimensions parallel with the longitudinal axis. The ratio between the axial dimension of the abutting interface and the axial dimension of the deformable sealing element is in the range between 0.01 and 0.2. In another aspect, an injector includes the piston and is used in a disposable syringe of the piston. The piston can prevent refilling of a syringe.

Abstract: The syringe comprises a body containing the liquid and having fitted thereto an endpiece for fastening a needle carrier. The safety device comprises a protective sheath and a syringe support that is received inside the sheath. The sheath and the support are axially movable relative to each other between two positions, namely an uncovered position of the needle, and a retracted position of said needle. The support includes anti-rotation means for constraining it in rotation about its axis and comprising at least one pawl urged resiliently into a position in which the pawl is designed to co-operate with complementary anti-rotation means of the fastener endpiece. The sheath and the support include complementary anti-rotation means for constraining them in rotation relative to each other about their axes and activated at least when the sheath and the support are in their uncovered position of the needle.

Abstract: An instrument, article and method are provided for minimizing pain during administration by injection of a liquid, such as, an anesthetic. The instrument has a forward end. A rod or lightpipe mounted freely for vibration projects out of the forward end. The article, a single use tip, is composed of a tip sleeve removably mounted on the forward end of the instrument and a tip member removably mounted on the projecting rod or lightpipe to vibrate a preselected injection site on a human or animal. The tip sleeve and tip member are covered by an elastic overmold that enables the tip member to vibrate freely with respect to the tip sleeve and light from the lightpipe to illuminate the injection site. The overmold of the single use tip is torn during removal of the single use tip from the instrument.

Abstract: An aerosol transfer device for medical aerosol generators includes a body, fluidically coupled to a nebulizer and to a patient interface. An ambient air intake is formed into a lower body. The body is shaped and configured to optimize mixing of ambient air from the ambient air intake and the aerosol generated by the nebulizer, resulting in the formation of an aerosol plume having optimum characteristics for delivery of the aerosol to the patient's pulmonary system, such as the central or deep lung regions. The shape and dimensions of the body are further designed to minimize aerosol deposition, thus improving delivery efficiency.

Abstract: An automated drug delivery and monitoring system for use on mechanically ventilated patients in the intensive care unit is presented. Medication in the form of respirable particles is transported through ventilator circuitry by a delivery unit. Multiple medications may be delivered into the gas flow of the ventilator, with each medication delivered in a defined dose for a frequency and interval as specified by an operator. The particles mixed into the gas flow of the ventilator are inhaled and ingested by the patent's lungs.

Abstract: A method for regulating gas flows into and out of a patient includes repetitively forcing respiratory gases out of the lungs. Respiratory gases are prevented from entering back into the lungs during a time between when respiratory gases are forced out of the lungs. Periodically, an oxygen-containing gas is supplied to the lungs.

Abstract: The systems and methods include providing, displaying, and/or utilizing leak estimation during ventilation of a patient with a ventilator. The systems and methods include providing, displaying, and/or utilizing internal leak estimation, total leak estimation, and/or external leak estimation during ventilation of a patient with a ventilator.

Abstract: An artificial airway device to facilitate lung ventilation of a patient, having an airway tube, a gastric drain tube and a mask at one end of the airway tube, the mask including a backplate and having a peripheral formation capable of forming a seal around the circumference of the laryngeal inlet, the peripheral formation surrounding a hollow interior space or lumen of the mask and the airway tube opening into the lumen of the mask, wherein the mask includes an atrium for passage to the gastric drain tube of gastric matter leaving the esophagus is disclosed.

Abstract: There is provided an airway tube for breath sampling, comprising a breath sampling port comprising two or more inlets adapted to sample breath from the airway tube. The inlets are connected to each other through a junction located outside of the air passageway of the airway tube.

Abstract: A non-invasive ventilation system may include an interface. The interface may include at least one gas delivery jet nozzle adapted to be positioned in free space and aligned to directly deliver ventilation gas into an entrance of a nose. The at least one gas delivery jet nozzle may be connected to a pressurized gas supply. The ventilation gas may entrain ambient air to elevate lung pressure, elevate lung volume, decrease the work of breathing or increase airway pressure, and wherein the ventilation gas is delivered in synchrony with phases of breathing. A support for the at least one gas delivery jet nozzle may be provided. A breath sensor may be in close proximity to the entrance of the nose. A patient may spontaneous breathe ambient air through the nose without being impeded by the interface.

Abstract: A filtration module for comprises a filter housing defining two or more filter compartments. The housing has an input side with a gas inlet in fluid communication with each of the filter compartments and a gas outlet in fluid communication with each of the filter compartments. A filter element resides in each of the compartments intermediate the gas inlet to the compartment and the gas outlet from the compartment. One application for the filtration module is a respiratory therapy device.

Abstract: A system for providing multi-sensory therapy including a computer having an audio output and a screen, wherein the computer is configured to provide audio stimulus and visual stimulus, a motion chair, and an actuator coupled to the motion chair, wherein the actuator is configured to cause movement of the motion chair, wherein the motion of the motion chair is configured to provide tactile stimulus, vestibular stimulus and proprioceptive stimulus to a patient seated in the motion chair, wherein the stimuli provided by the computer is provided concurrently with the stimuli provided by the motion chair.

Abstract: An apparatus and method for use in treating tinnitus, employs a sound processing unit, a tactile unit, and an interface therebetween. The tactile unit comprises an array of stimulators each of which can be independently actuated to apply a tactile stimulus to a subject, and an input for receiving a plurality of actuation signals from the interface and directing individual actuation signals to individual stimulators. The sound processing unit receives an audio signal at an input, analyses the signal with a digital signal processor to generate the actuation signals which are representative of the audio signal, and provides the plurality of actuation signals to the interface. In a preferred embodiment the digital signal processor divides the audio signal into a series of frames in the time domain, performs a transform on each frame to generate a set of coefficients representing said frame, and maps the set of coefficients to a set of actuation signals to be applied to the array.

Abstract: A wire organizer includes a basin having an inner surface that defines a reservoir. The reservoir has a liquid therein. A hub is positioned within the reservoir. A plurality of spools are positioned on the hub such that the spools are spaced apart from the inner surface and are rotatable relative to the basin. The spools each have a wire wrapped around each of the spools. At least a portion of each of the wires extends through the liquid. Systems and methods are disclosed.

Abstract: A hemodialysis wand holder includes a container having a plurality of side walls configured to form an open top end and a cavity extending downwardly from the open top end. A lid is removably coupled to the open top end wherein the lid has at least one aperture formed therein. At least one hemodialysis wand is removably inserted through the at least one aperture such that the at least one hemodialysis wand is suspended above a bottom one of the side walls. A collection tray is adjustably situated along the bottom side wall. Such a collection tray is removably reciprocated along a linear travel path registered transverse to a front one of the side walls. A fluid-absorbent liner is removably positioned within the collection tray for receiving fluids dripping down from the at least one hemodialysis wand suspended partially within the cavity.

Abstract: A catheter system having an intussuscepting balloon and a handle for a catheter system. The handle includes a fluidic system for preventing overpressure conditions during balloon intussuscepting and includes a locking mechanism disposed outside of the fluidic system for preventing unintended or accidental movements of a plunger assembly included in the fluidic system. The system includes standard sized components and non-standard sized components. During handle assembly, specific sizes of non-standard sized components are selected to match the length and/or the diameter of a specific selected balloon and are assembled with the standard sized components to form the catheter system.

Abstract: Embodiments of the present invention provide a continuum manipulator that can be used, for example, as a steerable catheter tip. The manipulator of the embodiments comprises a plurality of segments arranged in a stack, which is then able to bend in a range of directions away from the long axis of the stack. In one embodiment the segments include a helical portion which winds in the direction of the long axis of the stack, and can thus bend away from the long axis in any direction. In some embodiments a carbon fiber rod is included as a backbone for the stack, to minimize hysteresis and improve repeatability of bending. In addition, in embodiments of the invention tendon control channels are provided formed within the segments, through which tendon control wires extend to apply compression and/or bending forces to the stack.

Abstract: A catheter has an elongate tubular component that defines a pull wire lumen, which extends along at least a portion of a length thereof. A pull wire extends within the pull wire lumen with a distal end of the pull wire being secured near a distal end of the catheter. The catheter includes a pull wire actuation mechanism slidably disposed thereon that is operably coupled to a proximal end of the pull wire. The pull wire actuation mechanism includes a first or upper housing portion that is longitudinally translatable in a first direction relative to the guide catheter and a second or lower housing portion that is longitudinally translatable in an opposite, second direction relative to the catheter to actuate the pull wire and selectively operate the distal end thereof.

Abstract: A fixation device including a base structure such as a faceplate having an inferior surface capable of contacting a surface of a skull of a patient, having a superior surface, and defining at least two securement features. Each securement feature can be engaged by a cranial fastener to attach the faceplate to the skull. The device further includes a fixation structure such as an alignment plate or a flexible fixation member carried by the base structure and positionable at least one of (i) over an opening in the skull and (ii) within an opening in the skull. At least one surface of the fixation structure defines at least one channel in which an intracranial device is capable of being placed, and further defines at least one fixation feature to enable the intracranial device to be secured to the fixation device.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.