Abstract: Core annular flow is used to enable the subcutaneous delivery of a viscous fluid such as a protein therapeutic formulation. The high-viscosity fluid is surrounded by a low-viscosity fluid, and the low-viscosity fluid lubricates the passage of the high-viscosity fluid. This allows the use of protein formulations that have a higher concentration and a higher viscosity at comparatively reduced injection forces and reduced injection times. Several different embodiments of injection devices that provide core annular flow are described herein.

Abstract: A method and apparatus for treatment of cardiac and renal diseases associated with the elevated sympathetic renal nerve activity by implanting a device to block the renal nerve signals to and from the kidney. The device can be a drug pump or a drug eluding implant for targeted delivery of a nerve-blocking agent to the periarterial space of the renal artery.

Abstract: Accordingly, it is an aspect of the present invention to provide a medicament delivery system with a delay mechanism to ensure dose completion prior to activation of at least one subsystem or operation. The foregoing and/or other aspects of the present invention are achieved by providing a medicament delivery system, including a medicament container and a delay mechanism that is activated prior to completion of medicament delivery from the medicament container. The delay mechanism automatically activates a subsystem or initiates an operation subsequent to completion of medicament delivery. The foregoing and/or other aspects of the present invention are also achieved by providing a method of delivering a medicament, the method including receiving an activation command, and in response to receiving the activation command, releasing an ejection mechanism to eject medicament from a container.

Abstract: A system for optimizing a patient's insulin treatment, comprising a drug delivery device (320) with an identifier representing information for a specific drug contained in a reservoir. An accessory device (310) comprises a blood glucose meter (BGM) and a processor programmed to determine for at least two pre-defined specific drugs a recommendation for an amount of the given drug based on a blood glucose value. The recommendation for a given pre-defined drug can be calculated when the corresponding identifier has been captured with the accessory device in a current mounted state, the recommended dose being calculated based on one or more blood glucose values, one or more patient specific parameters as well as parameters for the identified specific type of drug.

Abstract: An infusion set has a retraction dial that can be removably assembled with the infusion set and access a threaded needle hub contained therein such that the dial can be used to advance or retract a needle hub and an inserted needle to a more precisely controlled insertion depth to deliver insulin or other medicament intradermally (i.e. to the upper 3 mm of skin surface). Position of the inserted needle can be maintained by providing a separated and isolated needle hub, main base and main hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver content to the upper 3 mm of skin surface during normal use.

Abstract: An infusion data communication system provides a communication link among a fluid container, an infusion pump, and a patient through which identification data may be communicated. Data devices are located at the fluid container and the patient and conduct low frequency RF energy at a low power level containing the data into the medical fluid. The data-laden RF energy propagates through the medication fluid to data readers at the infusion pump which receives the RF energy and reads the data. A comparison is made to verify that the right medication is mounted to the infusion pump for administration to the right patient. RFID devices may be used for the data devices and readers. Pump programming data may also be propagated to the infusion pump from the container RFID tag. The RFID device at the patient may be writable and may be used to store a patient MAR.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature, and the infusion device includes a sensing arrangement proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In other embodiments, the control module identifies an anomalous condition based at least in part on the sensed position of the detectable feature.

Abstract: A needle system for penetrating to or passing thought an object or an organ comprising a semiconductor die, one or more needles, wherein the needles slide over the plane of the die, one or more actuators that move the needles relative to the die plane, and one or more actuator drivers controlled by a controller wherein the controller instruct the needle to penetrate into or to pass through and/or retract from the object or organ. The needle system is used for drug delivery or blood extraction or blood analysis or glucose measurements or blood measurements or nerve system stimulus treatment or hair removal or skin lesions removal.

Abstract: An injection system including a wearable component (e.g., a patch) adapted to be worn by a user, and a medication delivery component (e.g., injection device) configured to cooperate with the wearable component to deliver medication to the user. The wearable component can provide a target area to the user for targeting the medication delivery component during use, and further serve to prepare the injection site to minimize the potential for injection site reactions. Both the wearable component and the medication delivery component can include electronics and/or other devices for detecting and/or communication information regarding usage of the injection system including dose amount, frequency, time, etc. The system can be configured to communicate such information to a third party, such as a health care professional.

Abstract: A plunger-type control handle for controlling the deflection of a distal tip of a catheter. The control handle includes a spool driven by a gear, the spool being connected to the proximal end of at least one pull wire. For bi-directional deflection, a second proximal end of a pull wire is connected to the spool such that when one of the proximal ends is collected by the spool, the other of the proximal ends is released in an equal amount. The gear is operatively coupled to the plunger and engages a gear rack disposed on the control handle housing, such that when there is relative movement between the housing and the plunger, the gear and spool are rotated. In one embodiment, a switching mechanism is provided that reverses the rotation direction of the gear and spool, thereby providing full stroke resolution of the plunger in each of the bi-directional directions.

Abstract: Devices and methods for delivering substances to lung tissue through an extra-anatomic passage created in an airway.

Abstract: An administration device for the administration of a liquid drug in adjustable doses may comprise an injection unit and an electronic indication unit. The injection unit may comprise a dosing mechanism and a manually operated dose setting component. The manually operated dose setting component may adjust the dosing mechanism to administer an administration dose amount of the liquid drug. The electronic indication unit may indicate a relationship between the administration dose amount and a target dose amount. A method for setting a dose of a liquid drug for administration may comprise providing an administration device, operating a manually operated dose setting component of the administration device, and continuing to operate the dose setting component until an electronic indication unit indicates that the administration dose amount is equal to the target dose amount.

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: The invention relates to an assembly that includes an infusion set and a patch intended for receiving a pump for the transcutaneous administration of a product, said patch including an adhesive portion and a non-adhesive portion, the assembly being characterised in that said set includes patch-guiding elements and sliding elements intended for sliding along the guiding elements.

Abstract: Materials and methods for reducing or preventing bleeding and associated side effects during and after percutaneous medical procedures.

Abstract: The invention generally relates to a continuous anesthesia nerve conduction apparatus and method thereof, and more particularly to a method and system for use in administering a continuous flow or intermittent bolus of anesthetic agent to facilitate a continuous or prolonged nerve block. In one embodiment, the apparatus includes a sheath having a proximal end, a distal end and at least one lumen extending from the proximal end to the distal end. The sheath also includes an embedded conductive element for transmitting an electrical signal from a proximal portion of the sheath to a distal portion of the sheath. A cannula is arranged in the at least one lumen of the sheath and has a distal end protruding from a distal portion of the sheath. The cannula is electrically coupled to at least a portion of the embedded conductive element and is configured to provide nerve stimulation.

Abstract: A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented. In the de-coupled state, axial movement of the drive sleeve transfers force in a longitudinal direction for actuation of a drug delivery device.

Abstract: A method for providing a substantially painless injection of medication into a patient, including inserting an injection needle having an outside diameter greater than 0.20 mm and less than about 0.38 mm, and injecting a medicament through the needle and into the patient at a substantially constant volumetric flow rate of about 0.05 ?L/s to about 50 ?L/s that provides a painless injection. The method does not require the use of an anesthetic or that the medical personnel to spend a substantial amount of time performing the injection procedure, is relatively simple and inexpensive to perform and operate, and provides a relatively high degree of safety for both the medical personnel and for the patient.

Abstract: An infusion set has a partially integrated ballistic inserter that can insert a needle at a controlled rate of speed to a depth to deliver content to the upper 3 mm of skin surface, and a skin-securing adhesive layer to secure the skin surface at the insertion site such that the inserter that can insert a needle with a reduced risk of tenting of the skin surface. A removable turnkey or pushable handle can be provided to release a driving spring of the ballistic inserter to insert a needle at a controlled rate of speed, of 3.3 ft/sec. (1.0 m/sec.) up to and including those greater than 10 ft/sec. (3.0 m/sec.), then release from the set for disposal. The infusion set can further include an extendable interface ring that retracts when the inserter is removed from the infusion set.

Abstract: A device for topical cooling of the nervous system via cooling of cerebrospinal fluid, or CSF, using a solid thermally conductive material. The solid thermally conductive material is coupled to a heat exchange apparatus. The thermally conductive material may be coupled to any catheter that is used in existing clinical standard of care for acute neuronal injuries, such as catheters used to monitor and relieve intracranial pressure. The thermally conductive material is a biocompatible and solid material, for instance, metals such as steel, tungsten and titanium, and non-metallic materials such as thermal diamond paste.

Abstract: A needle assembly includes a needle and a needle shield device. The needle shield device includes an inner shield connectable to at least one a base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

Abstract: A patient's pharyngeal wall is treated by inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the pharyngeal wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the treatment includes stabilization of at least a portion of the pharyngeal wall after compression of portions of the wall.

Abstract: A medical device includes a substrate having at least a portion thereof functionalized with at least one reactive member and a chemotactic agent functionalized with at least one complementary reactive member. The at least one reactive member and the at least one complementary reactive member are covalently bonded, adhering the chemotactic agent to the substrate.

Abstract: Various embodiments of bulking or cushioning agents or material and related medical devices and methods are disclosed. For example, a method of performing a medical procedure in a tract of a body may include injecting a material in a liquid phase proximate a target site between a first tissue layer and a second tissue layer, allowing the material to transition from the liquid phase to the gel phase in response to a raise in temperature of the material to approximately at or above the predetermined temperature, and performing a surgical procedure on the target site. The material may have the liquid phase at temperatures below a predetermined temperature and a gel phase at temperatures approximately at or above the predetermined temperature.

Abstract: A needle assembly comprises a body configured for attachment to a drug delivery device. The body defines a cavity. A septum is positioned within the cavity and a stopper positioned within the cavity such that the cavity, septum, and stopper define a reservoir. A double ended needle is positioned in the stopper and septum, the needle comprising a proximal end and a distal end. A release mechanism is positioned near a distal end of the body. A biasing element is positioned to drive the stopper. During a dose dispensing step, the release mechanism drives the proximal end of the needle out of the septum so that the proximal end resides in said reservoir. The biasing element may also drive the stopper proximally.

Abstract: Methods and devices for placement of a medical device using illumination are disclosed.

Abstract: A mechanical leech system may include a fluid exchange assembly. The fluid exchange assembly may be attached to a patient's target tissue area via suturing or the like, and may be activated to perform blood removal and treatment agent infusion. The fluid exchange assembly may include an inflow pathway for infusion of treatment agents into the tissue area, and an outflow pathway for removal of blood. The outflow pathway may be sized and/or shaped to promote laminar fluid flow and avoid coagulation. The assembly may include a channel housing, gasket, and base. Needles seated in the assembly may receive blood from a patient and infuse a treatment agent into the patient. The assembly may be connectable to a pump to urge the blood and the treatment agent through the inflow and outflow pathways. A cradle optionally provides protection and storage for the assembly.

Abstract: An apparatus includes a simulated medicament delivery device and an electronic circuit system. The simulated medicament delivery device includes a housing, and is devoid of a medicament delivery mechanism that causes a medicament to be delivered. The electronic circuit system is coupled to the housing and includes an audible output device and a cover. The housing of the medicament delivery device and the cover of the electronic circuit system collectively define an acoustic enclosure. The audible output device is configured to be disposed within the acoustic enclosure.

Abstract: In accordance with another embodiment, a controller in a fluid delivery system initiates drawing fluid into a chamber of a diaphragm pump. During a delivery phase of pumping the fluid in the chamber to a target recipient, the controller applies pressure to the chamber. At multiple different times during the delivery phase, the controller temporarily discontinues application of the pressure to the chamber to calculate how much of the fluid in the chamber has been pumped to the target recipient.

Abstract: The present disclosure relates to a safety needle assembly that includes a syringe and a safety mechanism. The safety mechanism includes a housing defining an internal cavity, a shield member at least partially disposed within the internal cavity, and first and second locking members that are configured to selectively engage and maintain the shield member in one or more predetermined positions. The locking members are movable between a locked position, in which the locking members are in engagement with the shield member to substantially prevent axial movement thereof, and a release position, in which the locking members are disengaged from the shield member to permit axial movement thereof. The first and second locking members each include biasing members. The biasing member of the each locking member is positioned to cooperate with the other locking member to normally bias the locking members towards the locked position.

Abstract: The current invention relates to a method for detecting a limit of use of a medical device comprising the steps of starting a timer of a medical device when said medical device is used for the first time, detecting the limit of use of the medical device and indicating the limit of use of the medical device. The technical problem of providing a method and a medical device, the safety of which is further increased and at the same time the limit of use is not prematurely induced is solved by a generic method wherein the limit of use is reached when at least one of a first criterion and a second criterion is met, wherein the first criterion is that the timer reaches or exceeds a time limit and wherein the second criterion is that at least one operation of a drive train of said medical device reaches or exceeds a limit. The technical problem is further solved by a medical device for performing a method according to the invention.

Abstract: An adhesive composite dressing useful for applying an active ingredient to a treated skin site, as well as methods of manufacture and use of such dressings. In one embodiment, an adhesive composite dressing comprising an anchor member, a target member, and a folding member, where the anchor member comprises a first skin-contact adhesive, the target member comprises an opening adapted to enable skin treatment, the folding member comprises a drug reservoir, and where the folding member is attached to the anchor portion through a hinge defined by a line of attachment that is not contiguous with an edge of the anchor member.

Abstract: Surgery is performed on a patient with a novel device by: excising tissue from tissue mass within a patient to create a cavity within the tissue mass; inserting a novel device of this invention into the cavity; shaping a flexible expandable component of the device to adjust dimensions on the flexible expandable component; providing a liquid into the component through the liquid input port; and controlling pressure or flow rate of the liquid in the component to move the liquid through the multiple openings and into the cavity. The device has a liquid inlet port, an exterior surface having length, width and depth, and multiple openings in the surface distributed throughout the length, width and depth to act as liquid delivery ports; the exterior surface of the liquid delivery device being shapeable by internal pneumatic pressure or hydraulic pressure to better fit inside dimensions of a surgical cavity; the multiple openings deliver the liquid through the multiple openings.

Abstract: Systems and methods are provided for performing a medical procedure within a patient's body that involves a thoracic duct including an ostium communicating with the patient's venous system. A distal end of a catheter is introduced through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct. An expandable member on the distal end of the tubular member may be expanded adjacent the ostium, e.g., within the body lumen or the thoracic duct itself, and used to isolate the thoracic duct from the body lumen, whereupon a medical procedure may be performed via the thoracic duct. For example, lymphatic fluid may be removed from the thoracic duct through a lumen of the tubular member and/or one or more agents may be introduced into the thoracic duct through the tubular member.

Abstract: A method for controlling a device using a shape-memory alloy wire is disclosed. The method includes determining an ontime for the shape-memory alloy wire based on a target volume to be pumped by a pump plunger, determining the temperature of the shape-memory alloy wire and adjusting the ontime based on the temperature of the shape-memory alloy wire.

Abstract: Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Abstract: A safety syringe system including a safety syringe and an injection site preparation patch adapted for use with the safety syringe. The safety syringe includes a syringe body and a safety shield slidably disposed about the syringe body. The injection site preparation patch has a tissue-facing side and a syringe-facing side, and may include a substrate, a syringe adhesive layer adapted to adhere to a distal flange of the safety shield, a hydrogel layer adapted to adhere to tissue, and removable release liners disposed on either side. The patch may include a medicament, anesthetic, or a thermal compound. Adhesion between the patch and the flange is less than adhesion between the patch and tissue, so that the patch adheres to the shield with sufficient strength to enable the shield to slide over the needle upon withdrawal, but with insufficient strength to cause the patch to pull away from a patient's skin.

Abstract: A fluid medicament delivery device includes a patient attachment unit and a separate indicator unit. The patient attachment unit includes a housing and a fluid channel located therein, wherein at least a portion of the fluid channel includes a flexible member substantially coterminous with the housing. The separate indicator unit is adapted to be detachably coupled to the housing of the patient attachment unit and includes a first sensing element for contacting the flexible member when the indicator unit is coupled to the housing to sense a flexure of the flexible member.

Abstract: A medicament delivery device includes a housing, a medicament container disposed within the housing, an activation mechanism, a cover and an electronic circuit system. The activation mechanism includes an energy storage member configured to produce a force to deliver the dose of a medicament and/or vaccine. The cover is configured to receive at least a portion of the housing. The electronic circuit system is coupled to the housing such that a protrusion of the cover electrically isolates a battery from a portion of the electronic circuit system when the portion of the housing is received by the cover. The electronic circuit system is configured to be electrically coupled to the battery and to produce a recorded speech output when the portion of the housing is at least partially removed from the cover. The electronic circuit system configured to produce a signal when the activation mechanism is actuated.

Abstract: Stylet assemblies include one or more securing members extending from a base portion of the stylet assembly and configured to removably attach to a portion of an associated structure. Catheter kits and catheter assemblies may include such stylet assemblies. Methods of using a catheter assembly may include inserting at least a portion of a stylet coupled to a stylet cap in a catheter associated with a catheter connection and securing a portion of the stylet cap to only a portion of the catheter connection hub.

Abstract: The invention relates to a device for inserting needles, including a body defined by a proximal end and a distal end, a mounting movably mounted inside the body, at least one needle secured to the mounting, a drive means suitable for driving the mounting towards said distal end, said mounting comprising a distal surface onto which the needle projects, said distal end comprising a contact area intended for contacting the tissue, the mounting being configured so as to reach a position, after activating the driving means, in which the distal surface thereof, relative to said proximal end, is more distant than said contact area, wherein the device is further configured so as to enable a gradual passive return movement of the mounting once said position has been reached.

Abstract: A system and method for resetting a locking mechanism of a medicament delivery or training device is provided herein. The system and method include a central shaft comprising a slotted ring, a pronged ring, a spring, a spring clamp, an actuator button, and a lock ring. Following the firing of the medicament device, wherein the actuation member has been activated and the lock ring in the unlocked position, the system and method can be initiated to reset the locking mechanism such that the components of the system and the lock ring are reset to the locked position before the actuation member can be actuated for a subsequent injection or training.

Abstract: Methods and systems are disclosed for creating an aqueous flow pathway in the trabecular meshwork, juxtacanalicular trabecular meshwork and Schlemm's canal of an eye for reducing elevated intraocular pressure. Some embodiments described apparatus and methods useful in photoablation of tissues. In some embodiments, a photoablation apparatus is used to perforate a tissue, forming an aperture into a space behind the tissue. Gases formed during a photoablation process can be used to pressurize the space behind the tissue to enhance patency of the space. In some embodiments the tissue is the trabecular meshwork of the eye and a wall of Schlemm's canal, and the space behind the tissue is a portion of the lumen of Schlemm's canal. In some embodiments, the method is useful in the treatment of glaucoma by improving outflow from the anterior chamber of the eye into Schlemm's canal, reducing intraocular pressure.

Abstract: Various methods and devices are described for affecting nerve function in the carotid body, renal nerves, and other nerves. Syringes, endovascular catheters, drug-eluting balloons, drug-eluting stents, and agent delivery patches are used to deliver a neuromodulatory agent to one or more nerves in order to treat a disease state.

Abstract: A needle assembly that has a flexible shield movable between (i) a first position, where the flexible shield is uncompressed, and (ii) a second position, where the flexible shield is compressed and an administering member located within the flexible shield, where at least one of the administering member and the flexible shield is axially movable with respect to the other of the administering member and the flexible shield in an unlocked position prior to and during usage of the needle assembly, and the at least one of the administering member and the flexible shield is no longer axially movable with respect to the other of the administering member and the flexible shield in a locked position. Prior, during and after use of the needle assembly, the needle is never exposed. After a single usage of the needle assembly, the needle is locked within the flexible shield and cannot be reused.

Abstract: One embodiment is directed to a method of conducting an injection, comprising: providing an assembly of a syringe plunger movably coupled to a syringe body which may contain fluid for infusion, the syringe body having a distal end that is removably coupled to a Luer adaptor, the Luer adaptor defining a needle lumen through which a needle may be coupled, the Luer adaptor comprising a distal surface configured to be removably coupled to a Luer fitting of another device; deciding upon infusion via needle injection or Luer coupling; and selectably configuring the assembly for needle injection or Luer coupling by removing the Luer adaptor to further expose the needle for needle injection, or by leaving the Luer adaptor in place and coupling it to the Luer fitting of the other device.

Abstract: Medical devices, systems and methods for modifying a left atrial appendage (“LAA”). In one embodiment, a medical device system includes a jailing member or structure positioned over the ostium of an LAA and at least one tissue growth member positioned within the LAA and retained within the LAA by the jailing member. In another embodiment, a medical device includes an atrial stent coupled with a patch that is configured to cover the ostium of an LAA. The patch may have a tissue growth member associated therewith. In another embodiment, the patch may include an open-cell frame which may be used as a jailing member or structure.

Abstract: A dilating cannula includes a radially expandable flange and an expandable shaft. The radially expandable flange is disposed at a proximal end portion of the dilating cannula and includes two or more sectors that are each independently movable. The expandable shaft extends from the proximal end portion to a distal end portion of the dilating cannula and defines an inner passageway of the dilating cannula and includes two or more arms. A first branch of the two or more arms extends from one end of the base section and a second branch of the two or more arms extends from another end of the base section. The first branch is connected to a first sector of the two or more sectors of the radially expandable flange and the second branch is connected to a second, different sector of the two or more sectors of the radially expandable flange.

Abstract: A medical device is disclosed. The medical device may include an elongate member having a proximal end and a distal end an expandable end effector assembly extending distally from the distal end of the elongate member. The end effector assembly may include a plurality of end effector units each having an injector for simultaneously delivering material into tissue.

Abstract: A medical balloon device includes an outer member extending along an axis. An inflatable member has a proximal end extending from a first end of the outer member and a distal end. An inner member is positioned within the outer member and the inflatable member such that a first end of the inner member is coupled to the distal end of the inflatable member. A support member is movably disposed within the inner member and includes a first end configured to removably engage the first end of the inner member. Translation of the support member along the axis causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second reduced length and a second reduced profile. Methods of use are disclosed.