Abstract: A blood treatment machine includes a blood pump; an arterial line in fluid communication with the blood pump, the arterial line including an arterial needle; a venous line including a venous needle; and a blood leak detection device including (i) at least one electrical component, (ii) a member configured to secure the at least one electrical component onto a patient's arm adjacent to patient access of at least one of the arterial and venous needles, the at least one electrical component capable of sensing the presence of a blood leak, and (iii) a controller in operable communication with the at least one electrical component, the controller programmed to allow for an amount of expected blood seepage and to cause an alarm if blood greater than the amount of expected blood seepage is sensed by the at least one electrical component.

Abstract: The invention relates to an antimicrobial barrier device and methods of manufacture. The antimicrobial barrier comprises one or more antimicrobial drugs that inhibit biofilm formation and bacterial and/or fungal growth. The antimicrobial barrier is suited for use with insertable devices (e.g., catheters) to reduce the incidence of infection at and around the insertion site.

Abstract: A system and method of managing workflow for a variety of injection procedures preferably includes a display that provides a graphical representation of the steps required to initiate an injection procedure. The system can, for example, set forth a suggested order or sequence for the steps to be completed, and display the suggested sequence of steps graphically. Various steps may optionally require completion of ancillary operations as a requirement for completion of the selected step.

Abstract: Systems and devices for maintaining a consistent input fluid height as fluid is consumed during infusion pump testing including a first hook disposed on an end of a first balancer arm; a second hook disposed on an end of a second balancer arm; and an aperture disposed in a connecting member; where the aperture is configured to be a pivot point for the device; and where the device is rotatable between a deployed position and a stored position.

Abstract: An infusion set has an adhesively secured main hub, and a slidable top cover, needle hub and angled or cantilevered needle that can be used for performing an intradermal needle insertion precisely targeting the upper 3 mm of skin surface, for example, one that substantially duplicates the Mantoux insertion technique, for injecting into the intradermal layers of skin, while maintaining a degree of comfort to the user. By sliding the top cover, the cantilevered needle is loaded and released or the angled needle is slid into an insertion site, while flexible arms and adhesive are used to stretch and/or flatten a skin surface, or otherwise create skin tension, at the insertion site.

Abstract: An optical sensor for a delivery device having a piston that displaces a substance, such as a fluid, from a reservoir. The optical sensor has a light source and a detector array for imaging encoding features disposed along a plunger rod coupled to the piston. By virtue of the pattern of encoding features, an absolute position of the plunger rod relative to a fiducial position may be determined uniquely. Thus, the volume of fluid remaining in the reservoir, the rate of fluid delivery, and proper loading of the reservoir may be accurately ascertained. Additionally, the encoding may serve to uniquely identify a version of the reservoir which may be supplied in various versions corresponding, for example, to differing concentrations of a therapeutic agent to be dispensed.

Abstract: A device for the transcutaneous, in vivo measurement of the concentration of at least one analyte in a living organism includes a catheter which can be introduced into the organism, and a luminescence indicator, which is immobilized on the catheter and which reacts to a change in the concentration of the at least one analyte to be measured with a change in at least one optical property. The luminescence indicator is transcutaneously connected to a source for providing an excitation radiation and a detector for detecting the measuring radiation. The luminescence indicator is immobilized on the outer circumference of the catheter, which is used to dispense a fluid medium, for example a medication, into the organism or to drain a body fluid.

Abstract: A pharmacodynamic (PD), pharmacokinetic (PK), or both and PK guided infusion device, system and method optimizes the safety and efficacy of various forms of treatment or therapy (e.g., drug and/or fluid) in a variety of health-care and other settings.

Abstract: Various embodiments of needle assemblies for use with a drug delivery device to deliver two or more medicaments are provided. Additionally, various embodiments of methods for delivering two or medicaments are provided. In one embodiment, a needle assembly comprises an injection needle, a proximal housing member, a distal housing member, and a medicament transfer element. The proximal housing member contains a first medicament and is configured to attach to a drug delivery device containing a second medicament. The distal housing member is movably engaged with the proximal housing member such that relative axial movement between the proximal and distal housing members causes the first medicament to be delivered. Upon activation of the drug delivery device (e.g.

Abstract: A dual-chamber syringe system is disclosed. Critical system oriented elements are disclosed, including plunger valve designs for accurate measurement and true, non-canting displacement; tamper and inadvertent valve actuation indicators, as well as, valve status indicators; anti-reflux construction; novel indicia patterns for dual-chamber syringe operation; structure and method for quality assurance that no gas can be delivered from a proximal chamber of the dual-chamber syringe and a kit for single step dose transfer. In addition, a tapered fitting valve is disclosed. The tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a tapered fitting. The preferred embodiment of an actuator portion of the valve is elliptical in shape.

Abstract: A portable auto-injector configured to store a dry medication separately from a liquid component, wherein removal of a cap operates a first actuation mechanism which opens a sliding valve and thus allows for the initiation of a mixing step prior to injection. An extendable needle guard is provided over the delivery assembly which prevents premature injection as well as inadvertent sticks or other cross contamination of a needle. The needle guard can also form part of a secondary trigger mechanism which injects the mixed components after the mixing stage is complete.

Abstract: A method and system for providing a drug delivery device. The drug delivery device comprises a dose setting mechanism comprising a spindle and a cartridge holder coupled to the dose setting mechanism. The cartridge holder comprising a cartridge having a movable bung at one end of the cartridge. The cartridge holder must be rotated before a dose may set with the dose setting mechanism.

Abstract: A cartridge engageable with a medical device, the method of making a cartridge comprising an ordered arrangement of N electrical components each with different respective values of an electrical property, and an ordered arrangement of N conductors operably coupled to the ordered arrangement of the N electrical components. A medical device is arranged to receive a cartridge comprises for each of N conductors on the cartridge, at least a first respective contact arranged to electrically couple with the corresponding conductor when the cartridge is engaged with the medical device; the medical device also comprises an evaluation means operable to evaluate the different respective values of an electrical property of N electrical components on the cartridge, wherein the N electrical components form an ordered arrangement which is operably coupled to the N conductors on the cartridge, and a switching arrangement operable to selectively electrically couple a respective pair of contacts to said evaluation means.

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 setting device (400). The dose setting device (400) comprises a predetermined stop to limit the amount of an expelled dose corresponding to the amount of a set dose. A secondary stop limiter includes first (700) and second (270) components and a secondary stop track follower (950) arranged between the first (700) and second (270) components. If the predetermined stop fails to stop the driver (500, 700) at the end of injection, the secondary stop track follower (950) moves towards a safety stop (708) to prevent the driver (500, 700) from rotating further.

Abstract: A system including an adapter (14) for sequential engagement with a cartridge (18) containing a first substance and a vial (16) containing a second substance is disclosed. The adapter is configured to first engage with the vial and subsequently engage with the cartridge such that the cartridge is in fluid communication with the vial via the adapter. The system includes a latch member (150) engageable with a portion of the cartridge. A plunger rod (44) includes a protrusion (50) and is adapted to communicate with the latch member, the plunger rod being transitionable from a disengaged position, in which the protrusion of the plunger rod is disengaged from the latch member and the latch member is locked to the cartridge, to an engaged position, in which the protrusion is engaged with the latch member and the latch member is unlocked from the cartridge and locked to the plunger rod.

Abstract: A display assembly for a drug delivery device (100) is provided. The display assembly comprises a housing (10) having a proximal end (17), a distal end (16) and a longitudinal axis (x). The display assembly further comprises a display member (120) defining a display member window (122), wherein the display member (120) is rotationally locked to but movable with respect to the housing (10) along the longitudinal axis (x). The display assembly further comprises an indication member (60) comprising indicia (66) and a movable member (110) which is rotationally coupled to the indication member (60). The movable member (110) is further coupled to the display member (120) and rotatable with respect to the housing (10). When the movable member (110) is rotated with respect to the housing (10), the rotating movable member (110) moves the display member (120) axially with respect to the housing (10) to display different indicia (66) through the display member window (122).

Abstract: A method of amplifying an injection force of a drug delivery device, comprising the steps of storing energy in an additive force device, connecting the additive force device to the drug delivery device, setting a dose of medicament to be administered, and selectively releasing the stored energy of the additive force device to amplify an injection force of the drug delivery device.

Abstract: A drug delivery device, comprises a housing having a longitudinal axis; an axially moveable component that is moveable along the longitudinal axis between a dose dialing position and a dose delivery position when a user operates the device to deliver a dose of drug; an encoder sleeve; an encoder pattern provided on the encoder sleeve, the encoder pattern comprising relatively conductive portions and relatively non-conductive portions that together comprise coded information; a contact-supporting component; and plural electrical contacts provided on the contact-supporting component. The plural electrical contacts contact the encoder pattern when the dose delivery button is in the dose dialing position and wherein the device is configured to move the contact-supporting component relative to the encoder sleeve as the axially moveable component moves from the dose dialing position to the dose delivery position such as to move the electrical contacts into positions where they do not contact the encoder pattern.

Abstract: A detent mechanism for controlling translation between two components in a longitudinal direction includes a resilient beam on one of the components and a rhomboid ramp member on the other component. The resilient beam is essentially straight when relaxed and has a first beam head and is arranged to interact in a ramped engagement with respectively one of two ramps. Each ramp is on one longitudinal side of the rhomboid ramp member such that application of a translative force between the components in one longitudinal direction with the first beam head engaged to one of the ramps in a first state deflects the resilient beam in one transversal direction and such that application of a translative force between the components in the other longitudinal direction with the first beam head engaged to the other one of the ramps deflects the resilient beam in the other transversal direction.

Abstract: A liquid administration device includes a structure that includes an accommodation body configured to accommodate liquid therein and a needle configured to communicate with an inside of the accommodation body; an operation unit configured to discharge the liquid inside the accommodation body from the needle by moving toward the structure in a distal direction; a cover member that is movable between a protection position at which the needle is covered and an exposure position at which the needle is exposed; a first biasing member that biases the operation unit toward the structure in the distal direction; and a second biasing member that biases the cover member in the distal direction. The operation unit has a first contact portion and the structure has a second contact portion, the contact portions being configured to come into contact with each other when the operation unit moves toward the structure in the distal direction.

Abstract: The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.

Abstract: A medication injector that has an alert indicator that alerts the user when the medication injector is approaching near the end of its medication supply is disclosed. The alert indicator gives the user an opportunity to make preparations to obtain additional medication for the injector if there is an insufficient amount of medication in the injector to enable the user to dispense the required dosage amount with the next injection. Initially, the alert indicator is not visible to the user, but becomes visible to the user when the injector is near empty.

Abstract: A surgical gas delivery system is disclosed that includes a device housing supporting a control unit and a filter interface having a seat for receiving a filter cartridge, the filter cartridge having a filter housing defining an interior reservoir, wherein sensors are coupled to the control unit for sensing a level of liquid within the reservoir of the filter cartridge to prevent contamination of the device, and wherein a set of blocking valves are provided in the device housing for interacting with the filter cartridge when it is received in the filter interface to control flow through suction and pressure lines of the device, and wherein the control unit is adapted to recognize a characteristic of the filter cartridge received in the filter interface.

Abstract: An oscillating positive expiratory pressure device comprising a housing enclosing at least one chamber, a chamber inlet configured to receive exhaled air into the at least one chamber, and a chamber outlet configured to permit exhaled air to exit the at least one chamber. A channel is positioned in an exhalation flow path between the chamber inlet and the chamber outlet, with the channel being moveably connected to a chamber of the at least one chamber. An air flow regulator is moveable with respect to the channel between a first position, where the flow of air through the channel is restricted and a second position, where the flow of air through the channel is less restricted, the air flow regulator being configured to repeatedly move between the first position and the second position in response to a flow of exhaled air.

Abstract: The systems and methods provide for novel a triggering mode that allows the patient to trigger or initiate the delivery of a breath during ventilation on a ventilator. Further, the systems and methods provide for triggering ventilation utilizing a statistical trigger mode. Additionally, the systems and methods provide for analyzing and/or displaying information related to a potential change in a triggering threshold for a currently utilized breath type.

Abstract: An interface for positive pressure therapy includes a mask assembly and a headgear assembly. The mask assembly comprises a mask seal that is adapted to underlie the nose. The mask seal extends up the lateral sides of the nose. The mask seal has a primary seal below the nose and a secondary seal alongside the nose.

Abstract: A shroud (1020) for a mask system includes a retaining portion structured to retain a frame (1040), a pair of upper headgear connectors (1024) each including an elongated arm (1026) and a slot (1027) at the free end of the arm adapted to receive a headgear strap, and a pair of lower headgear connectors (1025) each adapted to attach to a headgear strap. The retaining portion, the upper headgear connectors, and the lower headgear connectors are integrally formed as a one piece structure.

Abstract: Systems and methods to estimate, on a breath-by-breath basis, the fraction of inhaled oxygen during ventilation of a subject. The fraction of inhaled oxygen may be based on exhaled tidal volume, a volume of dead space within the subject interface, leaked exhalation volume, and subsequently inhaled tidal volume and leaked inhalation volume.

Abstract: A heat and moisture exchanger includes: a heat and moisture exchanger material formed by coiling a strip-shaped porous body, the porous body having a plurality of slits formed therein that are arranged along the lengthwise direction, into a spirally-wound shape with the slits facing radially outwardly; and a housing that accommodates the heat and moisture exchanger material. Such a structure for an HME makes it possible to reduce pressure loss and improve moisture retention capabilities by means of a relatively simple structure, thereby allowing the inexpensive provision of an HME that lowers the burden on a patient.

Abstract: An apparatus and method for resuscitating a patient suffering from cardiac arrest or another condition in which normal circulation has been interrupted. A ventilator is used for delivering a gas mixture to the patient. The ventilator is configured to adjust the partial pressure of CO2 to one or more partial pressures high enough to slow expiration of CO2 from the patient's lungs and thereby maintain a reduced pH in the patient's tissues for a period of time following return of spontaneous circulation.

Abstract: The disclosure describes an exhalation valve sensor assembly. The disclosure describes a novel exhalation valve sensor assembly that is configured for refurbishing. Accordingly, the disclosure further describes systems and methods for maintaining an exhalation valve assembly and describes a kit for refurbishing an exhalation valve sensor assembly.

Abstract: A device for the body relaxation and renewal is described. It includes a perpendicular housing, which is a body with two side walls, a rear wall, and a front wall. The walls include vents situated in a lower and an upper part of said walls. A light panel is located inside at least one of said walls with alternately mounted fluorescent lamps and halogen lights. The fluorescent lamps are mounted in three rows of three pieces, in a vertical plane, one above another. The halogen lamps are set in slots mounted to vertical brackets and placed symmetrically in two vertical rows in three sections of two pieces.

Abstract: A guidewire device comprising: a micro-fabricated elongated outer member having an outer surface and an interior surface forming a lumen extending from a proximal end to a distal end, wherein said outer member is formed from two or more stock materials; and an inner member disposed within a portion of said lumen, and embodiments thereof.

Abstract: A urinary catheter generally includes a core lumen, a bladder retention mechanism, and a stent. The core lumen is insertable into a urethra, and defines an inlet end and an outlet end opposite the inlet end. The bladder retention mechanism is coupled to the inlet end of the core lumen for hingedly moving between a release position and a retention position. The stent is coaxially mounted on the core lumen adjacent the bladder retention mechanism, and defines a stent inlet configured to receive a fluid from the bladder, and a stent outlet configured to discharge the fluid around the core lumen and into the urethra.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: A sacrificial catheter assembly and method of use for placing a functional catheter within the body of a patient, such as into the patient's vasculature, is disclosed. In one embodiment, the sacrificial catheter assembly comprises a sacrificial catheter including an elongate body that defines a longitudinally extending lumen. A stylet is removably received within the lumen of the sacrificial catheter such that the catheter and stylet can be advanced together to a target destination within the body of the patient. The sacrificial catheter is configured so as to then be proximally slid over the stylet to remove the sacrificial catheter from the body while the stylet remains in place at the target destination. A functional catheter can then be distally slid over the stylet to place the functional catheter at the target destination. The stylet can then be removed from the body of the patient.

Abstract: A dual braided catheter shaft includes an inner helical braid and outer helical braid than encapsulate an axially extending steering wire there between. In one embodiment, the shaft includes an inner polymer jacket, an inner braid formed on the inner jacket, a steering wire disposed along an outside surface of the inner braid, an outer braid formed over the inner braid and steering wire assembly and an outer jacket formed on the outer braid. The braiding parameters of the inner and outer braids can be varied along the length of the catheter to provide varying mechanical properties.

Abstract: Deflectable apparatus and methods for performing a procedure within a patient's body using such apparatus are provided. Generally, the apparatus includes an elongate tubular member including a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, a deflectable distal portion including first and second lumens spaced apart from one another on generally opposite sides of the longitudinal axis, and a handle coupled to the proximal end of the tubular member. A pull wire includes a loop disposed within the handle and first and second segments extending from the loop and slidably received in the first and second lumens, respectively, and coupled to the distal end. An actuator is provided on the handle for applying tension to either the first or the second segment to cause a distal portion of the tubular member to deflect, e.g., in opposite directions.

Abstract: An intravenous splint cover may include a main body, a pair of opposing securing members, and a splinting member. The main body may be rectangular shaped and have a bottom portion and a top portion. The pair of opposing securing members may be rectangular shaped and be connected to and extend outwardly from the main body and have a bottom portion and a top portion. The splinting member may be rectangular shaped and be carried by the bottom portion of the main body and extend outwardly from the main body to create an elevated portion of the main body. The bottom portions of the pair of opposing securing members may have an adhesive material applied thereto. The bottom portion of the main body that does not carry the splinting member may have an adhesive material applied thereto.

Abstract: An apparatus for delivering devices. The apparatus comprises a catheter with an elongated shaft having a first lumen and a second lumen extending therethrough. The apparatus further comprises a distal section with a lumen in communication with a port in a distal end of the catheter and with the first lumen and the second lumen. The first lumen is configured for a first device and the second lumen is configured for a second device to be disposed therein. The apparatus further comprises a proximal adapter coupled to the elongated shaft with a first port in communication with the first lumen and a second port in communication with the second lumen.

Abstract: The invention relates a safety IV catheter assembly comprising a catheter tube having a distal end and a proximal end; a catheter hub having a distal end and a proximal end; a needle extending through the catheter hub and the catheter tube having opposite proximal and distal ends defining an axial direction A, wherein the proximal end is joined to the needle hub and the distal end forms a needle tip and a change in profile is provided between the proximal and distal ends of the needle; and a tip protector assembly being arranged movably on the needle in-between the catheter hub and needle hub outside the catheter hub in an arrangement engaging with one or more second locking means provided on the catheter hub in its ready position, wherein the first arm is deflected radially outwards by the needle against a restoring force, wherein the tip protector assembly is configured to entrap the needle tip upon withdrawal of the needle from the catheter hub.

Abstract: Various embodiments of the present invention provide a conduit device including an attaching device configured for defining a helical pathway through a tissue wall and complementary ring in cooperation for securing the device within an aperture defined in the tissue wall. Some embodiments of the present invention further provide a system for implanting a conduit device in a tissue wall. More specifically, some embodiments provide a system including a coring device for defining an aperture in a tissue by removing and retaining a tissue core and securely implanting a conduit device therein so as to provide fluid communication between a first and second surface of the tissue wall via the conduit device.

Abstract: The apparatus to administer a skin care composition includes a housing, a suction tip to engage the skin, a control module, a suction pump connected to a motor, a vibrator, and a power supply. The suction tip is placed on the skin with the skin care composition. The suction pump is activated to form an area of negative pressure. The vibrator generates vibrations to the area of negative pressure to further increase absorption of the skin care composition into the skin. The method of administering with the apparatus includes forming the area of negative pressure with the suction tip, and pulsing suction and suction with vibration. The control module regulates suction and vibration to maintain the area of negative pressure through personalized settings of intensity. The vibration is controlled to maintain the seal of the suction tip on the surface of skin.

Abstract: A system for treatment of a wound area of a patient including a first treatment pad comprising a plurality of Light Emitting Diodes (LEDs) for cleaning and exposing a wound area to ultraviolet light, a second treatment pad comprising removal ports for exposing the wound area to a negative pressure, and a control unit interoperably connected to the first and second treatment pads for providing a negative pressure and the ultraviolet light to the wound area.

Abstract: Provided herein is a cell encapsulation device comprising an internal chamber suitable for holding biological agents, wherein the internal chamber is disposed between a first semipermeable layer and a second semi-permeable layer, and the first and second semi-permeable layers are mounted on a supporting frame surrounding a perimeter of the internal chamber; wherein the supporting frame comprises a first frame element and a second frame element, and the first and second frame elements co-operate to position the first and second semipermeable layers at a predetermined separation distance between the layers.

Abstract: An implantable portal includes a septum that has embedded therein an indicia adapted to identify at least one characteristic of the portal. The indicia may be formed as an impression at a base layer of the septum, and is filled with a radiopaque material. The septum base layer is covered by liquid silicone, which bonds with the septum base layer when solidified, so that an integral one-piece septum, with the identifier indicia embedded therein, is effected. The indicia embedded septum is fitted to the reservoir housing of the portal for providing identification information for that portal. The septum embedded indicia is viewable visually and also by x-ray or computer tomography imaging.

Abstract: An implantable medical system that comprises a gas unit for supplying gas that is essentially oxygen and at least one functional cells unit configured to receive oxygen from the gas unit so as to maintain the cells in a viable condition. The cells unit is flexible. Several embodiments are disclosed.

Abstract: A connector for medical lines includes a tubular body having a male luer-lock fitting at one end, intended to be screw-coupled with a complementary female fitting. An outer jacket is coupled in unidirectional rotation with the tubular body in the direction corresponding to the screwing of the male fitting and freely rotatable in the opposite direction. For selectively coupling the outer jacket with the tubular body in the direction corresponding to the unscrewing of the male fitting, at least one side push-button carried by said outer jacket is provided.

Abstract: An apparatus for interfacing between tissues being stimulated is provided. The apparatus includes an electric source capable of generating an applied electric field across a region of tissue and/or a means for altering at least one electromagnetic characteristic of the region of tissue relative to the applied electric field and an interface component, such interface component creating an interface between the region of tissue and the applied electric field or the means for altering at least one electromagnetic characteristic of the region of tissue.

Abstract: A method of forming an implantable electrode array that includes one or more packaged control modules. A control module is packaged by mounting the module to a substrate and forming a containment ring around the module. A conformal coating is disposed over the surface of the module to cover the carrier. Within the containment ring, the conformal coating hardens to form a non-porous shell around the control module. The one or more packaged control modules are placed in a flexible array. Electrodes that are mounted to or embedded in the flexible carrier are connected to the one or more control modules.