Abstract: Methods and apparatus for estimating flow rate in a blood circulation assist system employing impeller eccentricity. A method includes magnetically rotating an impeller within a blood flow channel of a blood pump. The impeller is levitated within the blood flow channel transverse to the impeller axis of rotation. A rotational speed for the impeller is determined. At least one impeller transverse position parameter is determined. The at least one impeller transverse position parameter is based on at least one of (1) an amount of a bearing current that is used to levitate the impeller transverse to the impeller axis of rotation, and (2) a position of the impeller within the blood flow channel transverse to the impeller axis of rotation. A flow rate of blood pumped by the blood pump is estimated based on the impeller rotational speed and the at least one impeller transverse position parameter.

Abstract: Devices, systems and methods for establishing a blood flow conduit between a chamber in a heart of a patient and a remote location. A blood inflow cannula having an outer surface and proximal and distal end portions. The distal end portion is configured for insertion into the chamber of the heart. First and second anchor elements have respective maximum width dimensions extending outwardly from the outer surface of the cannula. The first anchor element is positioned more distally than the second anchor element defining a tissue receiving space therebetween. The maximum width dimension of the first anchor element may be larger than the maximum width dimension of the second anchor element in use. The first anchor element is configured to be positioned inside the heart chamber and the second anchor element is configured to be positioned outside the heart chamber with heart tissue held in the tissue receiving space therebetween.

Abstract: A medical device includes a mechanism configured to perform a first medical operation, a scanner and a processing circuit. The scanner is configured to scan data displayed on a computer screen by a second medical device separate from the medical device. The processing circuit is configured to receive the scanned data from the scanner. The scanned data comprises an indication that a second medical operation was performed by the second medical device. The processing circuit is configured to proceed with the first medical operation based on the indication that the second medical operation was performed by the second medical device.

Abstract: A method and apparatus for the treatment of blood are disclosed allowing for the determination of an internal convection in a blood purification device e.g. in the form of a dialyzer. The internal convection in the purification device can be determined on the basis of pressure differences in the purification device. The blood purification may be, for instance, a hemodialysis or a hemodiafiltration. Pressure sensors serve for measuring the pressures of the blood at the input and/or output of the purification device as well as optionally for detecting the pressure of a cleaning fluid or dialysis fluid at the input and/or output of the purification device.

Abstract: A device for irrigation and/or insufflation during endoscopic surgery/procedures in a body cavity, comprising a first fluid pump device to deliver fluid to the body cavity, a second fluid pump device to move fluid from the body cavity, a control unit connected to the first and/or second fluid pump device, a blood pressure measuring device, wherein the control unit derives a control signal based on a signal from the blood pressure measuring device, and sends the control signal to the first fluid and/or second fluid pump device, wherein the control signal is derived by processing the signal from the blood pressure measuring device using a correlation factor in the device, dependent on the relationship between a blood pressure measurement signal, and a perfusion pressure of the body cavity, wherein the first and/or second fluid pump device controls the pressure in the body cavity based on the control unit's control signal.

Abstract: A method of preventing extravaation of contrast agent during a computed tomography injection. An automatic injector device facilitates ease of accomplishing the method. The method includes establishing the absence of extravaation using an absorbable injectate, such as saline, prior to injecting the contrast agent. The device includes a computerized injector head capable of switching between two injectates without physical human intervention. The device is controlled by a remote operating panel located in a control room that is protected from X-ray radiation. The device includes various software driven safety features that prevent the occurrence of unsafe conditions.

Abstract: Described herein is a programmable portable infusion device. The infusion device may include electronics such as sensors, and can be programmed to detect parameters related to the proper administration of infusion. If the sensors detect that a parameter is outside of a defined boundary or range, the infusion device may notify a user that it may not be safe to administer infusion and may prevent infusion from occurring.

Abstract: Provided is a cassette unit suitable for use with an auto-injector having an electrically powered drive unit. The cassette unit has a housing defining a cassette unit housing cavity and a needle projection aperture. The housing cavity is arranged for receipt of a syringe suitable for delivery of a drug to a patient. The syringe has a barrel for containing a volume of a liquid drug formulation, the barrel defining a flange at the rear end thereof and a forward shoulder at the forward end thereof. The cassette unit includes one or more shoulder support features for supporting the forward shoulder of the syringe. In use, the one or more shoulder support features act to direct a major part of an applied load path to travel through the shoulder at the forward end of the syringe and lesser load to pass through the flange at the rear end thereof.

Abstract: Provided is a cassette unit suitable for use with an auto-injector having an electrically powered drive unit. The cassette unit has a housing defining a cassette unit housing cavity and a needle projection aperture. The housing cavity is arranged for receipt of a syringe for injected delivery of a drug to a patient. The cassette unit includes a removable cap that in a capping position fits over and thereby acts to close off the needle projection aperture; and connecting to the removable cap, a needle cover defining a needle sheath for sheathing the needle tip of the syringe. The removable cap is provided with one or more first engagement features arranged for selectively engaging one or more second engagement features of the cassette unit housing when the removable cap is in the capping position to thereby restrict/prevent rotation of the removable cap and needle cover relative to the housing.

Abstract: An infusion set insertion device and method of use with an insertion device for an infusion set having an infusion set body including: a barrel defining a pull handle cavity; a pull handle slideably disposed in the pull handle cavity, the pull handle having an outer surface and defining an infusion set cavity and a release button cavity, the pull handle having a cocked position and an advanced position relative to the barrel; a release button slideably disposed in the release button cavity, the release button having a loaded position and a released position relative to the pull handle; and a driver operable to move the pull handle from the cocked position to the advanced position; wherein the release button extends a first axial distance beyond the outer surface when in the loaded position and extends a second axial distance into the infusion set cavity when in the released position.

Abstract: A bidirectional valve for medical use or the like provides different threshold opening pressures in different directions using a valve seat and flapper construction providing improved characterization in operation in contrast to cross-slit valves often used for bidirectional operation. A valve disk supported in a central annular region provides movable portions engaging in valve seats at a peripheral region and a central region.

Abstract: Some embodiments an infusion pump system can be configured to activate an alarm in response to a calculated prediction of the user's future blood glucose levels. Optionally, the predictive calculation of the user's future blood glucose levels can be based at least in part upon a recent blood glucose level, a trend of blood glucose levels over time, and an insulin load of the user.

Abstract: Sensor for dynamically detecting the residual fluid volume Vres of a collapsible reservoir (1,3) characterized by the fact that it is adapted to detect a threshold pressure Pth which corresponds to a phase within said reservoir (1,3) when only said residual fluid volume Vres remains, said residual volume Vres corresponding to a safety volume sufficient to ensure a safety margin to alert the user before the reservoir (1,3) is empty.

Abstract: A programmer device includes an interface that communicates with an implantable fluid delivery device and a user interface that allows a user to troubleshoot a catheter connected to the fluid delivery device by measuring a pressure associated with the catheter. A processor may compare the measured pressure waveform to a previously-acquired waveform or the user interface may display the measured pressure waveform for the user to compare the displayed pressure waveform to a previously-acquired baseline waveform. The comparison between the two waveforms may be based on the pressure decay time. A historical log of measured pressure decays associated with the catheter may be maintained by the programmer device or the implantable fluid delivery device and displayed for the user to determine whether the performance of the catheter is deteriorating.

Abstract: The present invention relates to an injection device for automatic torsion spring driven injection of a liquid drug. The injection device is of the type wherein a telescopically movable needle shield activates the release of the torque of the torsion spring to drive the injection when the needle shield is moved from its extended position to a retracted position. The injection device further has a needle holder carrying the injection needle, which needle holder is axially movable both in relation to the housing and in relation to the needle shield. It is therefore possible to retract the needle shield in relation to the housing and at the same time move the needle holder to its extended position such that the injection needle is presented outside the needle shield thereby providing for easy exchange of the injection needle.

Abstract: In one aspect, a medical injector is provided herein which includes a body; a displaceable plunger disposed in the body; a spring disposed to advance the plunger; a releasable retainer for retaining the plunger in a first state against force of the spring; and, a sleeve disposed on the body, the sleeve being slidable relative to the body. Sliding movement of the sleeve over a predetermined extent relative to the body results in the releasable retainer releasing the plunger thereby allowing the spring to advance the plunger. Advantageously, the subject invention provides a medical injector having an automated plunger drive which is triggered upon sliding movement of the sleeve, thereby minimizing premature or failed activations.

Abstract: A medical syringe apparatus includes a syringe unit, a hypodermic needle attached to the syringe unit and at least one interfacing member for mating a labeled medication container to the syringe unit. A filling needle is attached to the syringe unit for drawing fluid from a container. A movable needle sheath protects the hypodermic needle when not in use and may be moved out of the way when administering an injection. The medication label is visible. The container remains mated to the syringe when the syringe is in use. Risk of mislabeling the syringe may therefore be substantially reduced or eliminated and patient safety may accordingly be improved.

Abstract: The present invention relates to an injection device (1) for setting and injecting set doses from a held drug cartridge (10). The injection device (1) comprises a housing (110, 120, 130, 140), a piston rod (800), a rotatable driver (500, 700) and a dose control member (350). A stored energy source (560) is configured to drive rotation of the driver (500, 700) to cause the piston rod (800) to expel a set dose. The dose control member (350) rotates during dose setting and during dose expelling. A first clutch (C1) is arranged between the dose control member (350) and the driver (500, 700). A second clutch (C2) is arranged between the driver (500, 700) and the housing (110, 120, 130, 140) to control the expelling movement. During dose setting the first clutch (C1) is disengaged and the second clutch (C2) is engaged. During dose expelling the first clutch (C1) is engaged and the second clutch (C2) is disengaged.

Abstract: A drug delivery device is provided for delivering a drug to a target tissue site. The drug delivery device comprises a body comprising a proximal end and a distal end and a chamber disposed therebetween. An upper portion is disposed about the proximal end of the body. A retaining member is disposed within a wall of the body and engageable with the chamber and a plunger is configured for disposal within the upper portion and the chamber. The upper portion is movable about the proximal end of the body to open the chamber such that the plunger is disposed within a passageway defined within the chamber, and movement of the plunger in a distal direction pushes the retaining member such that the drug moves out of the body. Methods are also disclosed.

Abstract: The present invention relates to an injection device for automatic spring driven injection of a liquid drug. The injection device has a dose setting mechanism by which doses of an individual size can be set by a user, and a mechanical dose size display for displaying the size of the set dose. The scale drum (20) is coupled to a rotatable dose dial button (10) which is axially retained in relation to the housing (2) and by which the individual doses can be set.

Abstract: The syringe systems disclosed herein provide in part devices for allowing patients with compromised joint strength to more easily administer medicine. Certain exemplary syringe embodiments include a handle forming a handgrip, a syringe barrel that magnifies the dosage marks located on an inner barrel, and a tip cap slidably engageable with the syringe barrel for shielding a needle.

Abstract: In various embodiments, a needle is employed in refilling drug-delivery devices.

Abstract: An apparatus and method for identifying the flexor retinaculum of the carpal tunnel, injecting an effective amount of an agent into at least a portion of flexor retinaculum or tissue adjacent thereto, wherein the agent is configured to weaken the flexor retinaculum. The system may further include means for increasing the tensile stress in the flexor retinaculum post-injection using hand exercises, thereby weakening its structural integrity and decreasing the pressure within the carpal tunnel that impairs median nerve function.

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: An aerosol delivery system is disclosed that is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize medications for inhalation with a general purpose nebulizer, or for connection with devices usable in endoscopic procedures. The system separates the liquid reservoir from the nebulization process taking place either at the adapter hub, where it fits into an endotracheal tube (ETT), or a gas humidifier, where the aerosol may treat a gas used in an endoscopic procedure, with a multi-lumen tube configured to nebulize liquid and air at its distal end. The refillable liquid reservoir is mounted away from the immediate treatment zone, avoiding orientation issues associated with other types of nebulizers having a self-contained reservoir. The system can produce aerosols having a wide range of droplet sizes, depending upon central lumen diameter, with values of MMAD that range from 4 to 30 ?m.

Abstract: Systems and methods for synchronizing machine-induced expiratory airflow of a subject with user-induced expiratory airflow include an indicator time at which a user should initiate treatment to aid airway clearance of the subject. Such treatment may include compressing the stomach area of the subject. At the indicator time, a user responds to an indication, e.g. an audible sound, by initiating treatment in accordance with a therapeutic regimen.

Abstract: A method of treating lung disease, such as asthma or COPD, is provided that includes determining a parameter indicative of a patient's pulmonary mechanics (such as, without limitation, airway resistance or lung compliance), and delivering positive pressure support to the airway of the patient, wherein the pressure level (which may be constant or variable) of the positive pressure support during at least a portion of the inspiratory phase of the patient is determined based on the determined parameter.

Abstract: The present invention relates to a pressure equalizing device with a pressure equalizing balloon, the volume of which is connected to a further volume, the pressure of which is intended to be kept at as constant a value as possible even in the event of an enforced change in volume.

Abstract: There is provided a neck patch to be adhered on a tracheostoma, which is very light and has a good respiratory activity and an excellent sealing behavior when adhered on top of a tracheostoma in the neck of a patient. The neck patch is made of a thin, planar, flexible foil having a thickness of between 5 and 30 ?m, which is adhesive on its proximal side only and has a centrically arranged hole on its distal side, and around which a hard, round plastic connector disk having a central recess is arranged, the neck patch further comprising a supporting frame that surrounds the outer edge of the film and is approximately five to ten times thicker than the film so that the neck patch can be positioned without being rolled together.

Abstract: A respiratory interface apparatus (6) is provided that includes a patient contacting portion (21) structured to engage a face of the patient, a common chamber (30) fluidly coupled to the patient contacting portion (21), a first control chamber (26), a first flow regulating mechanism (32) provided between the first control chamber (26) and the common chamber (30), a second control chamber (28), and a second flow regulating mechanism (34) provided between the second control chamber (28) and the common chamber (30).

Abstract: A patient interface device (8) includes a cushion assembly (16) including a nasal cushion member (20), and a frame assembly (14) having frame member (48) having a first arm (54A) and a second arm (54B). The cushion assembly is rotatably coupled to the first and second arm such that the cushion assembly rotates with respect to the frame assembly about an axis extending through the first arm and the second arm. In addition, the frame assembly includes a drive mechanism (50) received and held by the frame member, the drive mechanism being operatively coupled to the cushion assembly such that actuation of the drive mechanism changes a tilt angle of the cushion assembly relative to the frame assembly.

Abstract: A respiratory mask includes a frame and an elbow engaged with the frame. The frame has a front surface and a rear surface. The front surface defines a connecting hole. The rear surface defines a receiving chamber. The connecting hole is in communication with the receiving chamber. The connecting hole is in communication with the receiving chamber at the rear surface. The elbow has a first end portion. The first end portion is connected with the connecting hole. The first end portion and the frame cooperatively define at least one air flow path communication air in the receiving chamber with external air.

Abstract: A respiratory mask includes a mask body and an adjusting unit. The mask body has a frame portion, a flexible portion extending from the frame portion, and a forehead pad. The flexible portion has a mask-connecting end that is adjacent to the frame portion, and a pad-connecting end that is distal from the frame portion and connected to the forehead pad. The adjusting unit has a hardness greater than that of the flexible portion, and is removably coupled to the flexible portion for adjusting a curvature of the flexible portion and a distance between the forehead pad and the frame portion.

Abstract: A cushion pad for a mask worn by a patient, comprising a first side to contact skin of the patient, and a second side, opposite the first side, to contact or face the mask. The pad has a main body portion having a central portion shaped to cover a portion of the patient's nose extending from above the nose tip to the nasal bridge region without obstructing the patient's line of sight, and lateral side portions to extend downward and terminate along the sides of the nose or on the patient's cheeks. The main body is made of a breathable material, e.g., foam. The pad may include adhesive and/or an attached portion, e.g., a ring, to couple the pad to the patient and/or portion of the mask.

Abstract: A nasal pillow section for use as part of an apparatus for providing a stream of gases to a user, the pillow section in use located in front of the upper lip and below the nostrils of a user, the pillow section comprising a pillow gasket having a gases aperture which receives a stream of gases in use, and nasal pillows fluidically connected to the pillow gasket which are adapted to substantially seal against the nostrils of a user in use, so that substantially the whole of the stream of gases entering the gasket through the aperture passes into the nasal pillows from the pillow gasket and is delivered to the user, the lower inner surface of the pillow gasket shaped so that in use contact between the upper lip of a user and the pillow gasket is minimised.

Abstract: A connector arrangement joining a respiratory mask and headgear is adapted for single-handed disengagement by the patient. A first, rigid connector part is formed into the rigid mask frame, with a mating second connector attached to a strap of the headgear. The connectors are held away from the patient's face by the connection to the mask frame.

Abstract: A tracheal tube assembly includes a connector body, a cannula extending from the connector body, and an insert that provides rigidity to the connector body and retains the cannula in the connector body. The cannula has an upper end that fits between conforming tapered sections of the connector body inner surface and the insert. The insert may include features to mitigate stress on and around any secondary lumens in the cannula wall. Because the wall is thinner at the site of a secondary lumen, the connector body insert may include a recess into which the cannula wall may expand. The recess may be aligned with the secondary lumen.

Abstract: An air delivery system includes an air flow generator to provide a pressurized flow of air, a patient interface to provide a seal with the patient's face in use, an air delivery conduit to interconnect the air flow generator and the patient interface, and a controllable vent valve to control venting from the patient interface. The vent valve is controlled to maintain a substantially constant air flow in the air delivery conduit and the air flow generator.

Abstract: A multilumen catheter assembly and method of making the catheter assembly is provided that involves providing a plurality of tubes, each tube having a first end, a second end, at least one lumen, and at least one surface, selectively heating at least a portion of the surface of at least a first tube of the plurality of tubes, and contacting the selectively heated portion of the tube with a portion of the surface of a second tube to form a multilumen catheter shaft that is joined together along at least a portion of the length of the catheter shaft.

Abstract: Apparatus, system, and method for creating a curvature on a medical device during a medical procedure, for example, selecting a curvature from a curve database, customizing the curvature for a specific patient anatomy, and applying the curvature to the medical device during the medical procedure.

Abstract: A medical device may include an elongated shaft. The elongated shaft may further include a reinforcement member having a first portion and a second portion. The first portion may include a polymer having a first degree of crystallinity. The second portion may include a second degree of crystallinity different than the polymer of the first portion.

Abstract: A catheter curvature brace, catheter assembly and method for managing fluid in a patient, the brace being attachable to a distal portion of a shaft of a catheter and having an elongated frame with a distal end and a proximal end. The frame is formed with at least one curve in a relaxed curved configuration. At least two coupling elements are connected to the frame, each coupling element configured to engage an outer surface of the catheter. At least the frame is formed of an elastic, biocompatible material capable of being straightened by a force and then returning to the relaxed curved configuration after the force is removed, thereby bending the catheter to substantially conform to the relaxed curved configuration.

Abstract: An introducer sheath is provided with a sheath tube which is formed of a tubular member provided with a hollow portion through which an elongated body is freely inserted and includes a distal portion having a tapering outer diameter and a main body portion having a constant outer diameter. The distal portion of the sheath tube includes a concave portion which is bent radially inward from an end portion, through which an elongated body protrudes, in a concave shape in a cross section parallel to an axial direction, and a convex portion which is contiguous to the concave portion and is bent radially outward in a convex shape in a cross section parallel to the axial direction.

Abstract: A distal tip for use with a medical catheter. The tip includes a member having a wall which defines a lumen therewithin. The wall has a portion at a distal end thereof, the portion curving inwardly toward an axis of the lumen. The lumen is provided with a diameter adaptable to accommodate a device to be recovered therewithin.

Abstract: Steering engagement catheter devices, systems, and methods of using the same for accessing a tissue, including internal and external tissues of a heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the at least one steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

Abstract: Shape-controllable catheters are provided that are versatile in application and that, in human-imaging applications, minimize or reduce patient discomfort. One such catheter is provided with at least one control wire that extends inside the catheter and a control mechanism for tensioning the control wire to produce in the catheter a humped shape or a cantilevered configuration. Hardness of the catheter may be varied along the length thereof to facilitate desired bending. For example, hardness may be reduced in bend areas. Hardness may be maintained or increased in other areas for performance reasons, for example to maintain planarity of an imaging array.

Abstract: A catheter is provided, which includes a tube including a first portion, a second portion connected to the first portion and having a less rigidity than the first portion, and a plurality of holes longitudinally penetrating the first portion and the second portion and being isolated from one another, a wire passing through two of the plurality of holes of the tube, and a cap being engaged with an extrusion portion of the wire extruded from the two holes of the tube in a manner of enclosing the extrusion of the wire, being connected to one end of the tube, and having a greater rigidity than the first portion and the second portion of the tube.

Abstract: This document discusses, among other things, examples of a low profile instrument immobilizer and means for positioning the same. In one example, the low profile instrument immobilizer grasps, secures, and immobilizes an electrode or other instrument that extends through a burr hole in a skull to a target location in a patient's brain.

Abstract: A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient. In one embodiment the stylet is configured for use within a lumen of the catheter and comprises a core wire, an ECG sensor, and a magnetic assembly. The ECG sensor senses an ECG signal of a patient when the stylet is disposed within the lumen of the catheter and the catheter is disposed within the body of the patient. The magnetic assembly includes at least one element capable of producing a magnetic or electromagnetic field for detection by a sensor external to the patient. In another embodiment, the stylet includes a pre-shaped distal segment that is deflected with respect to a more proximal portion of the stylet, which in turn causes a distal segment of the catheter to be deflected when the stylet is received within the lumen.

Abstract: The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only upon necking of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.