Abstract: Transdermal insertion of a transcutaneous filling apparatus, for the purpose of filling a fill chamber of an implanted therapy delivery device, is monitored by measuring each impedance between pairs of electrodes of a needle of the apparatus, and comparing each to a threshold impedance; the electrodes, preferably at least three in number, are isolated and spaced apart from one another along a length of the needle. A confirmation signal is generated when at least one of the measured impedances is greater than the threshold impedance, and another is less than the threshold, the condition indicating that one of the electrodes is located within a non-conductive septum, through which the apparatus must pass to access the fill chamber. A detection circuit, which may be located in a housing of the apparatus that is attached to a proximal end of the needle, measures and compares the impedances.

Abstract: An injection device, which can be, e.g., an insulin pen, can capture and transmit injection and/or medicament information to another device, such as, e.g., a blood glucose meter. The injection and medicament information can include, e.g., time and date of injection, type of medicament injected, and dosage amount. The injection device can include a dial cap that can be rotated to select a dosage amount to be injected. In some embodiments, the dial cap can include a microcontroller with transmitter, a Hall effect sensor, and a ring magnet. In some embodiments, the injection device can include a medicament cartridge with a 1-wire EEPROM, which can have medicament information stored therein. Methods of operating an injection device are also provided, as are other aspects.

Abstract: According to an aspect of the present disclosure, a pump system for individualized healthcare use includes an infusion pump, a display, an input interface, and a pump controller. The pump controller is associated with a memory in which a closed set of predefined infusion therapies and a personalized identifier associated with an individual patient are stored. The pump controller is programmed to display the personalized identifier; to operate according to a first operational state, wherein the pump controller receives an input via the input interface, selects a predefined infusion therapy according to the input received, and controls the infusion pump to provide the selected predefined infusion therapy; to operate according to a second operational state; and to receive an operational state code via the input interface, and to change from the first to the second operational state only when the operational state code is received.

Abstract: Systems, devices, and methods are described for using an autoinjector device. In one aspect, an autoinjector device comprises a housing and a plunger slidably mounted to the housing, the plunger including a tapered region. An actuator urges the plunger with respect to the housing from a storage position to a launch position, and a friction element about a portion of the tapered region resists a movement of the plunger from the storage position to the launch position.

Abstract: A system and method for delivery of a biological material using a gas-assisted delivery, including a gas entry port at the proximal end of the delivery system, particularly useful for the delivery of a two-part biological component.

Abstract: An infusion set adapted to be secured to a skin surface includes a fixed base member connectable to the skin surface and a movable member. A needle or cannula is connected to the movable member and movable relative to the fixed base member. The movable member is movable from a first position in which the needle or cannula is not exposed externally of the fixed base member to a second position in which the needle or cannula is exposed externally of the fixed base member. A release member retains the movable member in the first position. Removal of the release member allows movement of the movable slide member to the second position.

Abstract: A catheter device is useful in a procedure in which an injectable material or device is injected into a tissue of a patent. In one implementation, for example, the catheter device is useful in injecting a compound into a tissue of the heart, such as the myocardium. The distal tip portion of the catheter may include an extensible and retractable needle in combination with a camera, a balloon, a vacuum port, or any combination thereof.

Abstract: A patient care system is configured for infusing fluid to a patient. The system includes a plurality of fluid infusion pumps, each of which is connected to a respective fluid supply for pumping the contents of a fluid supply to a patient via fluid supply lines. The system includes a pressure sensor downstream of the fluid infusion pumps for determining if a particular fluid is connected to a designated infusion pump.

Abstract: Applicators for a microprojection array and methods of using the applicators are described.

Abstract: An apparatus for creating an accessory maxillary ostium for purposes of ventilation, irrigation, or procedural work within the maxillary antrum. An introducer having a ventilation tube and grommet is provided to create and then provide access through the accessory maxillary ostium. An irrigation catheter may be advanced through the ventilation tube in order to irrigate or express the contents of the sinus cavities. A secondary irrigation catheter or a balloon catheter may be advanced through an outer irrigation catheter, deeply into the sinus cavity, in order to irrigate or express the contents of the sinus cavities. Moreover, the balloon catheter may alternatively or additionally be employed to for dilation of the natural ostium. Still further, a device for delivering drugs, fluids or the like, may be coupled to the ventilation tube for delivery of same.

Abstract: The embodiments disclosed herein relate to lockable syringe assemblies and related devices and methods. The syringe assembly may include a barrel, a plunger, and a locking mechanism. In some arrangements, the locking mechanism is an elastomeric locking ring or a rigid partial ring. The plunger may include a plurality of ribs and is longitudinally moveable within the barrel. Once the plunger is disposed at a desired longitudinal location, the plunger can be axially rotated and locked in such a way that further longitudinal movement is restricted.

Abstract: An injection device (1) for delivering a predetermined fixed dose of liquid drug, the device (1) comprising a base member, preferably a housing (2), a first tubular member (7) and a second tubular member (10). The first tubular member (7) and the base member are engaged via a first track (8) and a first protruding part (9), and the first tubular member (7) and the second tubular member (10) are engaged via a second track (11) and a second protruding part (12). The first track (8) comprises a first portion (8a) which the first protruding part (9) travels during setting of the predetermined fixed dose, and the second track (11) comprises a first portion (11a) which the second protruding part (12) travels during setting of the predetermined fixed dose.

Abstract: A device including a first member extending along an axis. The first member includes an inner surface defining a cavity extending through a first surface and an opposite second surface and a side surface extending between the first and second surfaces. The inner surface defines an opening extending that is in communication with the cavity. A pivoting member is disposed in the cavity and includes an inner surface defining a passageway having a second member disposed therein. An engaging member is disposed in the opening. The pivoting member is movable between a first orientation such that the engaging member is spaced apart from the pivoting member and the pivoting member is rotatable to a selected trajectory relative to the longitudinal axis and a second orientation such that the engaging member engages the pivoting member and the second member is fixed in the selected trajectory. Methods of use are disclosed.

Abstract: Embodiments of the invention provide infusion systems for the intravenous or other delivery of drugs and other therapeutic agents to a patient including a human or mammal. The therapeutic agents may be dissolved in solution or comprise the solution itself. Embodiments of the systems can utilize a chemical reaction to predictably drive a flow of drug(s) through a catheter or other flow path and into the patient. More specifically, the reaction may include an acid-base reaction or any other reaction that produces a gaseous substance. The gas is produced and contained in an expandable drive balloon when the acid-base reactants are combined with a liquid. As the gas is produced, the drive balloon expands to exert pressure on a separately-contained drug reservoir which, in turn, pushes drug(s) from the reservoir into the flow path where the drug is ultimately delivered to the patient in a controlled and predetermined manner.

Abstract: An injection device for injecting a material into tissue may include a sheath having a distal end. The injection device may also include an injector having an outlet tube. The outlet tube may be received in the sheath, and may include a distal portion with a penetrating tip for penetrating the tissue. The sheath and the outlet tube may be slidable relative to each other, to extend a length of the distal portion from the distal end. The injection device may also include an adjuster operatively coupled to at least one of the sheath and the outlet tube. The adjuster may be configured to control relative movement between the sheath and the outlet tube for selectively adjusting the extended length.

Abstract: A method of infusing liquid medicaments including insulin via an insulin pump, includes identifying an insulin delivery protocol associated with ingestion of carbohydrates wherein the insulin delivery protocol is likely to lead to a postprandial drop in blood glucose to a level below a basal level, then proposing at least one alternative insulin delivery protocol to inhibit the postprandial drop in blood glucose by delivering a metered amount of insulin that is appropriate to facilitate the metabolism of the carbohydrates without the postprandial blood glucose level drop. The invention further includes querying the patient as to whether to apply the alternative insulin delivery protocol, receiving instructions from the patient in response to the query, and applying the alternative insulin delivery protocol following receiving instructions from the patient to apply the alternative insulin delivery protocol.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

Abstract: This disclosure covers various concepts to use for obtaining measurement of tension in catheter pullwires to improve controllability of a robotic surgical system.

Abstract: Methods and apparatus are provided for treating tissue with apparatus that includes an priming portion for initiating a healing response in the tissue to be treated, and which delivers a bioactive agent during or after preparing tissue adjacent the apparatus, as by generating or aiding a healing, regeneration or repair response in the tissue. The priming portion may comprise an abrasive surface, fluid ejection ports, and/or stimulation by electrical, thermal, or light energy.

Abstract: A controller in an ambulatory drug delivery device automatically creates gradual transitions between basal rates entered by a user. The user may enter at least two target basal rates and two corresponding durations for delivering a medication at each rate. Systems and methods for such drug delivery are described.

Abstract: The subject matter described herein relates to controlling and automating a delivery of one or boluses of a fluid medication to a patient. A user interface can display lists of parameters, such as a list of types of fluid in the fluid medication, a list of modes for delivery of the one or more boluses, a list of flow rates of each bolus delivery, a list of durations corresponding to each bolus, a list of initiation times of each bolus, and a list of initiation events for each bolus. In response, a clinician can select and/or specify parameters for the one or more boluses. Subsequently, the infusion device can deliver the one or more boluses based on the selected or specified parameters. Related apparatus, systems, techniques and articles are also described.

Abstract: A guide catheter assembly includes an outer sheath and an inner catheter disposed, at least partially, within the outer sheath. A tether tethers the inner catheter to the outer sheath. The guide catheter assembly has a first configuration where the tether is untensioned and distal ends of the outer sheath and inner catheter are pointing in a first direction. In a second configuration of the guide catheter assembly, the tether is tensioned, the distal end of the outer sheath is pointing in the first direction, the distal end of the inner catheter is pointing in a second direction that is different from the first direction, and the tether is oriented at an angle different from both the first direction and the second direction.

Abstract: Adjustable balloon catheter including an inner tubular member that has an inflation lumen. An expandable member is coupled to the distal end portion of the inner tubular member and has an inner chamber in fluid communication with the inflation lumen. The expandable member is transitionable between a deflated and an inflated configuration. The expandable member defines has a non-cylindrical shape including a first section having a first diameter in the inflated configuration and a second section having a second diameter when in the inflated configuration. The first diameter is different than the second diameter. An outer tubular member is movable relative to the inner tubular member. The outer tubular member is moveable between an extended position disposed over the expandable member and a fully retracted position proximal to the extended position. The outer tubular member is selectively positioned between the extended position and the fully retracted position.

Abstract: An assembly includes a dispensing syringe device configured to receive an amount of biomaterial and to dispense the biomaterial. The dispensing syringe device includes a syringe barrel for receiving the biomaterial, a discharge outlet for dispensing the biomaterial from the syringe barrel, and a plunger received in the syringe barrel. The plunger has a plunger body and a plunger passageway extending therethrough configured to receive a stylet. The assembly further includes a cannulus device configured to be coupled with the dispensing syringe device, to receive biomaterial from the dispensing syringe device, and to dispense the biomaterial. The cannulus device includes a cannulus passageway configured to receive the biomaterial and a dispensing opening configured for dispensing the biomaterial.

Abstract: According to an aspect of the disclosure, a treatment method may include treating a wall of a portion of a gastrointestinal tract of a patient. Treating the wall may include positioning one or more injection units adjacent to the wall. Treating the wall may also include affecting at least one of movement of gastrointestinal tract contents through the gastrointestinal tract and absorption of gastrointestinal tract contents by the gastrointestinal tract, by injecting material into the wall using the one or more injection units. Injecting the material may include injecting the material between layers forming at least a portion of the wall.

Abstract: Medical device designs for enteral nutrition that inhibit the relative motion of one device member to another device member are herein disclosed. The gastric and/or intestinal feeding tube shaft is disposed of teeth, furrows, ridges, indentions, tabs, or corrugations that operate with an external retaining member. Alternative embodiments utilize an external retaining member with a collet fitting that applies pressure against the gastric and/or intestinal feeding tube shaft. The assemblies prevent the relative motion of the internal retention member relative to the external retaining member and assist in maintaining the internal retention member against the gastric wall.

Abstract: A set of instruments configured to deliver a therapy to a bone can include a cannulated syringe. The cannulated syringe can extend along a longitudinal axis between a proximal and a distal end. The cannulated syringe can have an inner tube and an outer tube that are interconnected at the distal end as a single fixed unit. A first cannulation can be formed along the longitudinal axis of the cannulated syringe within the inner tube and a second cannulation can be formed within an annular space between the inner and outer tubes. The outer tube can define an opening through a sidewall thereof. The cannulated syringe can be closed from fluid communication between the inner and outer tubes.

Abstract: Portable or ambulatory infusion devices and systems capable of remotely updating an ambulatory fluid delivery device include safety protocols that verify the status of the ambulatory fluid delivery device before and after a field update of software. Methods of accomplishing the same field update of software are also described.

Abstract: An infusion management platform specifies, for each of a plurality of containers, an identification for one of a plurality of patients, an identification for an infusion module, and attributes characterizing fluid within the container for infusion into the corresponding patient. Thereafter, the infusion management platform receives data from a plurality of infusion modules characterizing administration of fluid to each of a plurality of patients. It can then be determined by the infusion management platform for each container using a rule set, an amount of the fluid infused to the corresponding patient and an amount of fluid remaining in the container. Data can then be provided that characterizes the determined amount of infused fluid and the determined amount of remaining fluid for each container. Related apparatus, systems, techniques and articles are also described.

Abstract: Infusion devices, systems, and methods can detect a presence or absence of an infusion cartridge in an infusion pump. Embodiments may include a loading sequence, recording loading pulse width modulation (PWM) commands applied to an infusion pump motor during the loading sequence, setting a value of threshold PWM commands based on the commands applied during the loading sequence and comparing values of operational PWM commands applied during pumping operations to the value of the threshold PWM commands. If the value of the operational PWM commands drops below the threshold by a predetermined amount, a missing infusion cartridge warning may be generated.

Abstract: Medical guide devices, systems and methods are provided, comprising a base member and a rotatable medical guide component seated on the base member. The guide component defines a path extending through the guide component. The guide component includes a first radio-opaque marker located at a first end of the guide component corresponding with an entry point of the path and a second radio-opaque marker located at a second end of the guide component corresponding with an exit point of the path, and the second end is opposite the first end.

Abstract: A substance delivery device includes an elongated tubular body having opposing proximal and distal ends, and a diaphragm that is in slideable sealing engagement with an inside wall of the tubular body. The diaphragm is movable in opposite first and second directions within the tubular body. A substance is contained within the tubular body between the diaphragm and the tubular body distal end, and a slave fluid is contained within the tubular body between the diaphragm and the tubular body proximal end. When pressure is exerted on the slave fluid, the slave fluid causes the diaphragm to move and eject the substance through the tubular body distal end.

Abstract: A fluid delivery catheter that uses micro-needles for fluid delivery though a vessel wall. The catheter may provide fluid delivery therapy for various procedures, such as, for example, delivery of tumescent fluid or renal denervation. The catheter includes an elongate member with deployable and retractable needles disposed about a distal end of the elongate member. The needles may be disposed radially about the distal end and/or along a length of the distal end.

Abstract: An infusion set adapted to be secured to a skin surface includes a fixed base member and a movable slide member. The fixed base member is connectable to the skin surface. The movable slide member has a needle or cannula connected thereto and is movable relative to the fixed base member. The movable slide member is movable from a first position in which the needle or cannula is not exposed externally of the fixed base member to a second position in which the needle or cannula is exposed externally of the fixed base member. A hub is fixedly connected to the movable member and has a slot extending rearwardly in a lower surface from a first end thereof. The needle or cannula is received in the slot. The movable slide member is locked to the fixed base member in the second position.

Abstract: A steerable surgical needle (10) includes an elongated needle shaft (12), a beveled tip portion (14), and a flexural element (16) that connects the needle shaft (12) with the tip portion (14) and permits the tip portion to deflect relative to the needle shaft. A method for steering the surgical needle (10) through tissue includes the steps of advancing the needle in the body tissue to induce tip flexure which causes the needle to follow a curved trajectory, and rotating the needle about its longitudinal axis in place, without advancement, to remove the tip flexure.

Abstract: A system for tracing tubing which forms a conduit from a source of infusion liquid to a patient by way of an infusion pump has a vibration generator manually operable by a user to generate vibrations at an origin location along the tubing, wherein the vibrations are propagated by the tubing and have a vibration signature. A vibration sensor arranged at a destination location along the tubing receives the vibrations and generates a digital vibration signal. Signal processing circuitry connected to the vibration sensor processes and evaluates the digital vibration signal to determine a trace status of the tubing between the vibration generator and the vibration sensor. An indicator connected to the signal processing circuitry provides an indication of the determined trace status. Trace status possibilities include clear, cross-over, and null. A likely number of cross-overs may also be indicated.

Abstract: A regeneration device and method for sealing annular tears between the nucleus pulposus and the annulus fibrosus of an intervertebral disc. The regeneration device includes a trocar having a sharp tip at a distal end, an inner cavity, and a handle portion attached to a proximal end of the trocar. The device further includes a plunger coupled to a catheter that extends through the inner cavity. The regeneration method includes inserting the trocar into an intervertebral disc via Kambin's triangle, and once the trocar reaches the nucleus pulposus, the catheter is extended alongside the annulus fibrosus wall to surround the nucleus pulposus. A syringe is mounted to the plunger and injects a biochemical, biological and/or synthetic material through multiple ports in the catheter to form a collagen barrier that prevents the nucleus pulposus from protruding through the annulus fibrosus.

Abstract: Microstructure arrays and methods for using and manufacturing the arrays are described.

Abstract: The current subject matter describes generation and use of infusion channel identifiers that identify infusion channels transporting medication from an infusion pump to a patient. The infusion pump includes a user interface device, a controller, and at least one infusion device. At a first user interface of the user interface device, data associated with an infusion channel is received. Based on the data, the controller generates an infusion channel identifier identifying the infusion channel. On the first user interface, the infusion channel identifier is displayed. At a second user interface of the user interface device, the infusion channel identifier, a beginning time of a desired provision of the medication to the patient, and a time duration of the desired provision is received. The controller actuates the infusion device and the infusion channel at the beginning time for the time duration. The infusion device delivers, via the infusion channel, the medication to the patient.

Abstract: A medical probe, including a flexible insertion tube having a distal end for insertion into a body cavity, and a channel contained within the insertion tube and configured to convey a fluid to the distal end. A terminal member is fixed to the distal end of the insertion tube and includes a distal tip configured to be brought into contact with tissue in the body cavity, the distal tip having a first diameter, and a protruding shoulder surrounding the distal tip and having a second diameter, which is greater than the first diameter. The distal tip has one or more spray ports passing through the shoulder which are coupled to the channel so as to direct the fluid from the shoulder toward the tissue so as to irrigate the tissue.

Abstract: Embodiments disclosed herein are directed to devices, methods, and systems for the treatment of tissue using energy delivery. Specifically, certain embodiments may utilize a thermochemical reaction between at least two reagents where a first reagent has been preloaded into a catheter while a limiting reagent is circulated through the catheter to react with the first reagent. The resulting chemical reaction may be exothermic or endothermic, and a heat transfer fluid may be used to exchange energy between the chemical reaction and surrounding tissue.

Abstract: A transdermal drug delivery patch and a method of controlling the drug release of the transdermal drug delivery patch by near-IR are disclosed. The transdermal drug delivery patch comprises a substrate, carriers and drugs. The drugs are encapsulated in the carriers, and the carriers having the drugs are disposed on a surface of the substrate. The carriers are formed of biodegradable polymers, and nano-particles with a photothermal conversion effect are loaded in the carrier. When the carriers are punctured into the skin and the nano-particles in the carrier absorb the near-IR, the near-IR is converted into heat by the nano-particles to melt the carrier and thus releasing the drugs encapsulated in the carrier into the skin. Accordingly, the speed of releasing the drugs encapsulated in the carrier can be controlled accurately by the near-IR.

Abstract: A method for puncturing a pericardial membrane of a human patient, the method comprising inserting a needle into the chest of the human patient, detecting a phase of a mechanical activity of the heart of the human patient, advancing the needle toward the heart of the human patient in synchronization with the detected phase of the mechanical activity of the heart of the human patient, and repeating the detecting and advancing steps until the pericardial membrane of the human patient is punctured.

Abstract: A method of delivering a therapeutic fluid to the tissue of a mammal using pulsatile flux to prevent fluid backflow.

Abstract: Articulable introducer sheaths and related methods and systems for accessing various surgical sites are disclosed. An introducer sheath comprises a tubular body and a filament. The tubular body has a proximal portion, a distal portion, and a central lumen. The filament is constrained on or within at least a portion of the proximal portion and unconstrained over at least a portion of the distal portion. The distal end of the filament is held or attached near a distal end of the tubular body so that advancement of the filament relative to the tubular body causes the unconstrained portion to bow out or extend radially outward, such as to engage a body tissue so as to steer the tubular body when the tubular body has been introduced into a surgical site, such as an epidural space. A surgical tool or medical implant can then be advanced through the sheath.

Abstract: A method of treating a fracture includes creating an access path to a fracture site in a bone and inserting a guidewire through the access path into the fracture site is provided. The method includes the steps of positioning a cannulated drill bit having a distal end including helical flutes configured for drilling through bone over the guidewire into the fracture site, and advancing the drill bit to create a passageway in the bone configured to receive a screw. Positioning a cannulated inflatable bone tamp over the guidewire and inflating the inflatable bone tamp to compress at least a portion of the bone in or near the fracture site so as to create a void. Delivering a bone void filler into the void through the access path to fill the void. Systems and kits are disclosed.

Abstract: Various handheld medical dispensing configurations and methods including the following: Handheld medical dispensing system comprises a syringe, which has a plunger, releasably mounted to syringe actuation apparatus, the apparatus having an actuator configured such that it can move the plunger more than once to dispense a plurality of amounts of substance from the syringe. A method of dispensing fluid from a syringe comprises holding a medical substance delivery system including a syringe, which has a needle, and which is secured to syringe actuation apparatus configured to dispense predetermined amounts of the substance from the syringe, penetrating the needle at one patient site and using the apparatus to deliver a predetermined amount of the substance, and penetrating the needle at another patient site and using the apparatus to deliver a predetermined amount of the substance.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. The distal end may be provided with a cavity creation element, such as an inflatable balloon. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Abstract: A fluid injection system for controlling at least one fluid delivery system is provided. The fluid injection system includes at least one computing device in communication with the at least one fluid delivery system. The at least one computing device is configured to: display, on or with at least one display device, at least one graphical user interface configured to facilitate a user selection of at least one injection protocol of a plurality of injection protocols; receive, from at least one user, at least one selected injection protocol from the plurality of injection protocols; retrieve, from at least one remote server computer, the at least one selected injection protocol; and control the at least one fluid delivery system based at least partially on the at least one selected injection protocol.

Abstract: A device for delivery of a radiopharmaceutical and, in some embodiments, delivery of a pharmaceutical agent are provided herein.