Abstract: An integrated injection device with pre-packaged medication is disclosed. The integrated injection device includes an ampule that is filled with a fluid medication and a collar with hypodermic needle. The collar includes an axial valve that is positioned between a first end of the collar a second end that includes an exit aperture that is connected to the hypodermic needle. The valve is movable from a first position where the valve blocks fluid communication between the first end and the second end and a second position where valve provides fluid communication between the first end and the exit aperture in the second end. The valve cooperates with a frangible webbing that extends over the second end of the collar and causes the valve to move to the second position when twisted to separate the frangible webbing from the injection device to expose the hypodermic needle.

Abstract: An infusion set preferably for use with an inserter is disclosed. The infusion set includes a septum cap that encapsulates an upper resilient septum and a lower resilient septum of a base, and includes at least one radial port to receive insertion of a blunt cannula when an extension set hub is engaged with the infusion set in a direction substantially parallel to the skin surface. The extension set hub is configured to provide a snap-fit engagement with the septum cap, wherein the blunt cannula of the extension set hub is guided through the radial port of the septum cap and penetrates the interface between the upper septum and the lower septum. The extension set hub and the septum cap can be rotated in a 360 degree manner about the base of the infusion set.

Abstract: A medical blood access system used for hemodialysis treatment to enable blood withdrawal for processing of blood by an external apparatus and return the same blood to a patient, comprising an interfacial fluid conduit between the machine and patient's blood supply which is repeatedly connectable along a guided pathway passing through epidermis and subcutaneous tissue via a naturally formed tissue tract to enter blood space, providing improved patient safely, convenience, effective prophylaxis, without bleeding or tissue trauma or pain, and is executable by the patient to precisely connect and disconnect with minimal disfigurement or life restrictions, and is useable on virtually all patients soon after placement and is robust and safe to high blood flow.

Abstract: A dispense interface for use with a drug delivery device. The dispense interface comprises a main outer body and an inner body. The inner body may be configured for connection to a drug delivery device and defines a first reservoir and a second reservoir. A first piercing needle is in fluid communication with the first reservoir and positioned for piercing a first cartridge of a drug delivery device. A second piercing needle is provided and in fluid communication with the second reservoir and positioned for piercing a second cartridge contained with a drug delivery device. A manifold is positioned adjacent the inner body and comprises a fluid groove arrangement. A valve arrangement is positioned between the inner body and the manifold and controls fluid communication of a first fluid contained in the first cartridge and a second fluid contained in the second cartridge by way of the fluid groove arrangement to a holding chamber.

Abstract: A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site is provided. The system includes a manifold delivery tube and a balloon having an inner space. The balloon is capable of assuming collapsed and expanded positions. The system further includes a manifold having a plurality of flow channels. The manifold is disposed within the inner space of the balloon. A sharp tip is configured to be delivered within the manifold delivery tube to puncture the balloon.

Abstract: Devices for delivery of medical compositions in either liquid or powder form include a piercing device for piercing a flexible sheet material in which when contained in a flexible blister dosage form, the piercing device serves as a delivery channel for compositions contained in the blister. The device is configured to reduce or inhibit puncture flap interference with the delivered spray or mist by forming a substantial non-contact drape in the material prior to puncture.

Abstract: A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit “flashback” of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.

Abstract: This disclosure relates to drug delivery devices and related systems and methods. In some aspects, a drug delivery device includes a drug vial holder and a mechanism configured to compress a drug vial between upper and lower members of the drug vial holder.

Abstract: An access port, wherein the access port may include a body having an exterior surface and a chamber defined therein, a bore defined in the body providing fluid communication between the chamber and the exterior surface, a needle in fluid communication with the chamber, a passage defined in the body providing communication between the chamber and the exterior surface, a seal secured within the passage, and an actuator in communication with the needle, configured to move the needle relative to the passage or move the passage relative to the needle.

Abstract: Some embodiments disclosed herein relate to a medical connector having a backflow resistance module configured to prevent fluid from being drawn into the connector when a backflow inducing event occurs. In some embodiments, the backflow resistance module can include a variable-volume chamber configured to change in volume in response to a backflow-inducing event and a check valve configured to resist backflow. In some embodiments, the medical connector can include a fluid diverter configured to direct fluid flowing through the medical connector into the variable volume chamber to prevent fluid stagnation therein. In some embodiments, the medical connector includes a body member, a base member, a seal member, a support member, and a valve member.

Abstract: Disclosed herein is a novel pharmaceutical delivery device that provides controlled, sustained local delivery of a therapeutic agent of interest to a target tissue of interest, for example, the vitreous tissue of the eye, over an extended period of time.

Abstract: Multi-lumen catheter devices having at least one split-tipped end are disclosed, together with methods of forming such split tip catheters. In one aspect of the invention, the manufacturing methods can include the steps of: providing a catheter body having at least a first and a second internal lumen extending longitudinally through the catheter body; removing a distal portion of the catheter body to form a first distal tip segment such that the first lumen extends longitudinally within this tip segment beyond the second lumen; and joining a second lumen tip segment to the catheter body in communication with the second lumen. The second tip segment can be joined to the catheter body such that it is at least partially separated from the first tip segment and, in some embodiments, preferably diverges at an angle relative to the first tip segment.

Abstract: An infusion set component of a fluid infusion device and/or a fluid infusion port component for delivery of fluid to a patient is compatible with a cooperating fluid channel module. The fluid channel module includes a body section having coupling features to mate with a base of the component. The fluid channel module also includes an interior fluid flow channel formed within the body section to receive fluid from the fluid infusion device and/or from a syringe or pen delivery device. The fluid channel module also includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: Described here are unit dose containers, methods, and kits for treating asthma and other pulmonary conditions by nebulization. The unit doses of active agents are provided in a low volume formulation, which results in faster nebulization of the unit doses. The containers are also formed to minimize internal surface area so that effective re-dispersion of the active agents can be achieved while reducing adsorption to the walls of the containers.

Abstract: The present disclosure provides a cannula useful for introducing a thermally responsive polymer in situ. In embodiments, the cannula possesses more than one cannula, with the thermally responsive polymer introduced in one cannula, and a material such as a coolant in a second cannula which prevents premature gelling of the thermally responsive polymer.

Abstract: A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit “flashback” of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.

Abstract: A device for inserting a cannula into tissue, including a cannula, a protective element which can accommodate said cannula, an operating element for moving the cannula out of the protective element, and a holder fixedly connected to the cannula. The invention encompasses a system for connecting a liquid supply to the cannula.

Abstract: A medical device has an interior for containment of fluids; an opening into the interior, an elastomeric wall comprising a fixedly placed, flexible barrier across the opening; and a retention wall positioned adjacent to a peripheral portion of the elastomeric wall. The retention wall defines a central opening and has a generally rigid retention zone surrounding the central opening, to engage and retain a connector tube which is advanced into the central opening to open a flow aperture through the elastomeric wall, for flow through the wall and connector tube. One of the retention zone and connector tube may be made of a material of sufficient hardness that material of the other engaging member is deformed by engagement therewith, which increases the strength of retention between the retention wall and the connector tube.

Abstract: A device for priming and venting a hazardous drug within an intravenous administration set. The device includes various access ports and fluid channels to permit direct injection of a hazardous drug into the fluid reservoir, while eliminating the possibility of undesirable exposure to the hazardous drug. The device further includes priming and flushing ports to enable flushing of a hazardous drug from the system following an infusion procedure.

Abstract: A cannula connector adapted for a resealable septum component and assemblies comprising a combination of connectors are provided. The connectors are reversibly engageable and lockable to provide a fluid path between the components. Assemblies comprising the connector and various septum components are provided.

Abstract: A catheter for delivering a medical implant in a patient's vasculature includes an elongate catheter having a distensible and frangible cap mounted across the open distal end thereof. The cap is distendable by pressure within the catheter to provide a bumper tip for guiding the catheter through a patient's vasculature. At the desired site for deploying the medical implant, the cap is ruptured to permit the implant to be advanced through the distal opening. Methods of using the catheter are also disclosed.

Abstract: A user-initiated fluid pathway connection includes: a connection hub, a piercing member, a sterile sleeve, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the piercing member is initially retained within the sterile sleeve between the connection hub and the pierceable seal of the drug container. The connection hub may include an internal aperture within the connection hub which functions as a flow restrictor and wherein a piercing member is connected to one end of the internal aperture and a fluid conduit is connected to another end of the internal aperture. A drug delivery pump with integrated sterility maintenance features includes a housing, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection as described above, a power and control system, and a drive mechanism connected to a drug container are mounted. Methods of assembly and operation are also provided.

Abstract: A vascular access port having a novel septum design that while allowing for larger septum access area and larger degree of access allows for an overall small profile. The present invention further provides for a novel septum and reservoir design that eliminates angular junctions.

Abstract: A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit “flashback” of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.

Abstract: A sealing assembly is utilized for a fluid infusion device that cooperates with a fluid reservoir having a reservoir port and a hollow fluid reservoir needle at least partially located within the reservoir port. The sealing assembly has a reservoir port receptacle with a proximal end, a distal end extending from the proximal end, and a needle opening formed in the distal end to receive the hollow fluid reservoir needle. The sealing assembly also has a fluid chamber located at least partially in the reservoir port receptacle, and a needle sealing element having a self-sealing needle opening formed therein. The needle sealing element is located within the reservoir port receptacle between the distal end and the fluid chamber. The the self-sealing needle opening accommodates the hollow fluid reservoir needle when the reservoir port engages the reservoir port receptacle.

Abstract: A drug solution filling plastic ampoule having gas, steam and light ray barrier properties, a drug permeation preventing capability and an absorption/adsorption preventing capability, and a production method for the plastic ampoule. The drug solution filling plastic ampoule includes a container body, a fusion-bonded portion which seals a mouth of the container body, and a wrench-off holder tab connected to the fusion-bonded portion. The ampoule is formed from a parison including two or more layers, at least one of which is a functional layer having at least one characteristic property selected from the group consisting of a gas permeation preventing capability, a steam permeation preventing capability, a light ray permeation preventing capability, a drug permeation preventing capability and a drug absorption/adsorption preventing capability.

Abstract: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: The present invention relates generally to a vascular access device having a septum positioned within a lumen of the device, the device further having a pusher for providing a fluid pathway through the septum. In particular, the present invention relates to systems and methods for improving flow of a fluid through the access device, while minimizing stagnation of fluids within the device. These systems and methods include various modified fluid pathways and interactions between the vascular access device body, the septum and the pusher.

Abstract: Fluid delivery devices, systems and methods. The fluid delivery devices may be used to delivery fluid (e.g., insulin) to a user. The devices may have one or more inlets, and may be configured for use with an injection device, such as a syringe, and/or with a pump.

Abstract: Fluid delivery device includes a body, a cannula adapted to extend into subcutaneous tissue, and a septum member adapted to allow a needle to puncture the septum member and to reseal the puncture once the needle is withdrawn from the puncture. The septum member is at least one of; a cap-shaped member, a member having at least two non-parallel walls that can each be punctured by a needle, and a member having a generally planar wall and a generally cylindrical wall which can each be punctured by a needle.

Abstract: A drug delivery system has a fluid store that has a first tubing having an outlet fitted with a connector of a given configuration that prevents the connector from being coupled to a conventional counterpart connector. The system further has a tube retaining device that has a catheter extending out of one of its ends and an inlet connector at its other end that has a configuration complementary to the configuration of the outlet connector of the first tubing, so that the first tubing may be matingly connected to the tube retaining device to establish a through fluid path from the first tubing to the catheter. A one-way valve may be provided to the tubing to prevent fluid from flowing backwards into the tubing. The tubing can be selectively occluded and opened to regulate the flow of fluid from the tubing to the catheter.

Abstract: A convenience kit, use of which transforms a conventional IV container spiking and dispensing system to a safety system for handling hazardous drugs. The kit provides a spike receiving subsystem which is interposed between a spike of an IV set and a needle-less syringe connector affixed to a hazardous drug containing IV container to provide a closed pathway for delivering hazardous drugs and a means for detaching a spent container without exposing hazardous drug to a surrounding environment.

Abstract: Disclosed is a portable fluid dispensing device for infusing a fluid into the body of a user and/or for sensing an analyte within the body. The device includes at least one housing to retain a source of energy to energize the device, the source of energy comprising at least one electrochemical cell to produce electrical energy upon exposure of the cell to air, and a seal to prevent exposure of the at least one cell to air when the source of energy is not in use and to enable exposure of the at least one cell to air prior to energizing the device with the source of energy. The at least one housing includes an opening to provide access to the seal to enable actuation of the seal to control exposure of the at least one cell to air.

Abstract: Devices for delivery of medical compositions in either liquid or powder form include a piercing device for piercing a flexible sheet material in which when contained in a flexible blister dosage form, the piercing device serves as a delivery channel for compositions contained in the blister. The device is configured to reduce or inhibit puncture flap interference with the delivered spray or mist by forming a substantial non-contact drape in the material prior to puncture.

Abstract: The present invention discloses an attachment (1) for a device for enteral feeding, which comprises at least two connecting pieces (2, 5), wherein the first connecting piece (2) can be connected to the connection nozzle (3) of a feeding container (4), and the second connecting piece (5) can be connected to a transfer unit (6) so that a food flow from the feeding container through the connection nozzle and the attachment into transfer unit is made possible. Furthermore, the attachment comprises a means for opening (7) of the feeding container. Furthermore, a device for enteral feeding comprising the attachment according to the invention is disclosed.

Abstract: The present invention relates to an insert for the infusion of drugs. The insert is suitable for connection to a vial and preferably to a circuit or an infusion line. Moreover the insert comprises a main body, a resilient element and a piercing spike. The piercing spike has an axis X and defines a first channel and a second channel and is movable relative to the main body along the axis X between a first closed position A and a second open position B. Moreover the resilient element presses against the piercing spike so as to keep it in the first closed position A when no external forces are applied.

Abstract: The application relates to a device for an intermittent or continuous administration of a therapeutical substance, such as insulin, including a base part to which an injection part and a delivery part are fastened. The delivery part includes a reservoir and a pump, and the injection part includes base plate, a cannula part with a body with a through-going opening, and at least one cannula having a proximal end protruding from the lower side of the body and an adhesive portion for fastening the base plate to the skin of the user. The delivery part and the injection part are assembled through a connector having a fluid path leading fluid from the reservoir to the through-going opening in the cannula part.

Abstract: The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: An infusion device for subcutaneously administering a medication or a therapeutic fluid to a patient includes a base element which has fluid receiving means for receiving the fluid and fluid communication means for transferring the fluid into a cannula. The base element has at least one recess accommodating a septum that is pierceable by a needle. The septum is secured to the base element by a septum housing in such a way that a fluid transfer volume is formed in the recess between an internal surface of the septum and an inner section of the recess. The fluid transfer volume is in communication with the fluid communication means, and the septum housing accommodates a premounted septum. The septum housing is fixed and fluid sealed to the base element in the inner section of the recess.

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Abstract: A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Abstract: The present invention relates to a barrier membrane arrangement for a medical device for providing a substantially liquid tight seal between a piercing member and a barrier member and a method for manufacturing such a barrier member arrangement. The present invention also relates to a method for connecting a first and a second medical device at the barrier member arrangement. The barrier member arrangement comprises a first member, a second member and a barrier member. The second member can be interlocked to the first member by means of a connection arrangement at an optional stage by a user. After interlocking the second member to the first member, the barrier member has been compressed to provide for an increased leakage security. The barrier member arrangement also provides for a prolonged working life of the barrier member and any medical device which comprises such a barrier member arrangement.

Abstract: A pen needle assembly is provided herein for use with a medical injector containing an injector body and a reservoir sealed by a septum encased in the injector body. The pen needle assembly includes a hub and a needle fixed to the hub. The hub is formed to be telescopingly mounted onto a distal end of the injector body using a track that accommodates a guide key. When mounting the hub of the pen needle assembly onto the injector body, a first portion of the track is configured to receive the guide key and to guide the guide key in a straight line across sufficient distance to permit a proximal end of the needle to fully pierce through the septum, without rotation of the needle. A second portion of the track is configured to permit the pen needle assembly to be turned with the proximal end of the needle being located proximally of the septum.

Abstract: The present invention refers to a tubing set (126) suitable for use in co-operation with a machine (100) for carrying out a hemodialysis treatment of a patient's blood. The tubing set comprises: a blood out-tube (102) for supplying the blood from the patient to a filter (106) of said machine; a blood in-tube (114) for supplying the blood from the filter back to the patient; and a substitution tube (116) connected to one of said blood in-tube or blood out-tube suitable for providing a substitution fluid in the patient's blood. According to the invention, the substitution tube comprises an insert (30) for the infusion of drugs. The invention further refers to the insert and to a vial (34) suitable to co-operate with the insert. The invention finally refers to a method for delivering drugs.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: The disclosures made herein relate to an infusion device specifically adapted for syringe injections. In one embodiment of the disclosures made herein, an infusion device comprises a body including an accessible surface having a single inlet port therein, an engagement surface having a single outlet port therein, a medication delivery channel extending between the single inlet port and the single outlet port, and an identification feature on the accessible surface of the body adjacent to the single inlet port. The single inlet port of the medication delivery channel is tapered thereby forming a funnel-shaped entry into the medication delivery channel. A cannula is coupled to the body at the single outlet port and is adapted for receiving medication from the single outlet port and transmitting the medication therethrough.

Abstract: A plurality of dosage-control members are detachably connected to the plunger rod of a multi-dose syringe along two opposing sides of the rod. Each dosage-control member has a cut in which the external diameter of the top rim of the syringe fits to prevent forward and reverse movement of the rod. Removal of one dosage-control member from one of the two opposing sides of the rod permits forward movement of the rod and plunger until the top rim snaps into the cut of another dosage-control member. Flexible salient arms extend obliquely from the rod in one-to-one correspondence with the dosage-control members to prevent reverse movement of the rod.

Abstract: Fill stations and base stations are provided for personal pump systems. The fill stations may be opened and closed to accept a reservoir and to allow fluid to be introduced into the reservoir for use with personal pump systems. The fill stations may hold the reservoir at a tilt relative to an underlying surface and may discourage overfilling of the reservoir. The filling stations may also include viewing windows having fluid lines marked thereon for indicating volume of fluid within the reservoir.