Abstract: Apparatus, systems and methods related to monitoring intravenous fluids during administration to a subject are disclosed. These apparatus, systems and methods provide near real-time monitoring of the identity of one or more components of an intravenous fluid.

Abstract: A medical device includes a body and a cannula extending from the body, for insertion into a patient's skin. The medical device also includes a guard covering the cannula, an adhesive for securing the medical device to the patient's skin, and an adhesive liner covering the adhesive. The guard is connected to the adhesive liner to enable conjoint and at least partial removal of the guard and the adhesive liner.

Abstract: Some embodiments of an infusion pump system can be configured to provide improved safety monitoring features so that a user receives proper dosage amounts.

Abstract: A pharmaceutical injection device comprises a main body case (2); a pharmaceutical syringe mounting component (3) that is provided inside the main body case (2) and onto which a pharmaceutical syringe (4) is mounted; a piston (5) provided movably with respect to the pharmaceutical syringe (4) mounted onto the pharmaceutical syringe mounting component (3); a drive mechanism (6) for driving the piston (5); a memory (46) that stores a preset pharmaceutical injection schedule; and a controller (7) that resets a current pharmaceutical dose by comparing a planned cumulative pharmaceutical dose, which is a planned cumulative amount of pharmaceutical injected up to the last time on the basis of the pharmaceutical injection schedule stored in the memory, and an actual cumulative pharmaceutical dose, which is a cumulative amount of pharmaceutical actually injected up to the last time.

Abstract: The present invention relates to a medication delivery device, to dosing mechanisms suitable for use in such medication delivery device, in particular in pen-type injectors, preferably having a dose setting member and a drive device enabling the dose setting and the administration of a medicinal product from a multi-dose medication cartridge, to methods using such device, and to methods of manufacturing and assembly of such device.

Abstract: A transdermal adhesive patch assembly and method of using same. The assembly can include a backing, and an adhesive and a matrix coupled to the backing. The matrix can include an active ingredient. The assembly can further include a microneedle array in at least partially overlapping relationship with the matrix; and a carrier that couples the microneedle array to the matrix opposite the backing, wherein the carrier and the microneedle array form a skin treatment assembly that, along with the matrix, can be located on a flap. The method can include adhering at least a portion of the adhesive to skin to form an anchor; applying pressure adjacent the microneedle array to treat an area of the skin; moving the flap away from the skin; removing the skin treatment assembly to expose the matrix; and replacing the flap to position the matrix over the treated area of the skin.

Abstract: An internal bolster for use securing a medical device, such as a feeding tube, within a body of a patient is disclosed. In one embodiment, a feeding tube includes an internal bolster, comprising one or more bolster arms that each include a first end hingedly connected to a distal end of the medical device and a free second end. The bolster arms are selectively deployable between a first position wherein the bolster arms are substantially in-line with an axis of feeding tube, and a second position wherein the bolster arms are substantially deflected from the axis of the feeding tube to enable securement of the feeding tube within a stoma or other opening defined in the body. Various means for selectively moving the bolster arms between the first and second positions are disclosed. Related methods of use are also disclosed.

Abstract: The present disclosure relates to systems and methods for delivering microneedles to a patient's skin. In one aspect, the present disclosure provides a system for delivering a microneedle array to a patient's skin surface, the system comprising: a delivery apparatus including a housing; and an infusion device detachably received in the housing.

Abstract: Interstitial tissue structure is treated with a flowable liquid agent by: providing a delivery cannula having a proximal end and a distal end and an external surface with at least one expandable member located on the external surface of at least one catheter or needle. The delivery cannula is inserted into live tissue, creating a hole in the tissue surrounding the delivery cannula. Contact is made against an inner surface of the hole with contact pressure from the at least one expandable member, said contact pressure establishing a first level of stress in tissue surrounding the hole in the tissue. The expandable member is expanded to increase the contact pressure and provide a second level of stress in the tissue surrounding the hole in the tissue to a second level of stress that is greater than the first level of stress.

Abstract: The delivery of biological compounds to ischemic and/or infarcted tissue are described herein where such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Additionally, any number of therapeutic tools can also be passed through the deployment catheter and into the imaging hood for performing any number of procedures on the tissue for identifying, locating, and/or accessing ischemic and/or infarcted tissue.

Abstract: A distributed infusion pump system is provided with long-term recording of the type of medication, nutrition or hydration, pump output pressure, corresponding infusion flow, infusion flow resistance, and an automatic or manual alarm in the event that thresholds applied to these parameters or their derivatives are exceeded.

Abstract: The present invention relates to a catheter that has adjustable stiffness that enables a user to select the stiffness of at least one region of the catheter during insertion and navigation through a body lumen. A preferred embodiment of the invention works in combination with a guidewire to enable placement of the catheter at a position within the vascular system, for example, to enable treatment of a variety of medical conditions. The catheter can include segments that undergo relative movement in response to actuation by the user to adjust the flexibility of the at least one region, preferably located at or near the distal end of the catheter.

Abstract: Systems, methods, and devices can detect a dangerous or adverse condition or anticipated condition that indicates an undesirable amount of electric current in a patient-connected tube providing fluid to a patient. The fluid flow to the patient is stopped responsive to the detection. Stoppage of fluid flow to the patient can reduce or prevent electric current in the fluid from reaching a patient, flowing through the patient to ground, and/or continuing to flow through the patient.

Abstract: A syringe for retracting and storing of the needles for transferring the fluids is provided. The syringe includes a hollow rotatable and retractable syringe plunger body, a hollow syringe barrel slidably disposed inside the hollow rotatable and retractable syringe plunger body a plunger slidably disposed in the hollow syringe barrel, a syringe adapter attached to the front end of the hollow syringe barrel, a syringe plunger adapter attached to the syringe adapter, a hollow retractable barrel body attached to the hollow rotatable and retractable syringe plunger body. The syringe further includes plurality of springs, a first needle and a second needle for injecting and ejecting fluid, on using the first needle, the first needle is retracted and then the second needle stored in the syringe barrel is pushed out the hollow retractable barrel.

Abstract: A syringe includes a barrel, a plunger, and a sealing member creating a seal between the plunger and the barrel. The barrel includes a first portion with a first inner diameter and a second portion with a second inner diameter that is larger than the first inner diameter. The sealing member engages the first portion of the barrel to give rise to a first contact pressure when the barrel is filled with product. The first contact pressure is sufficient to maintain a gas-tight seal over the expected temperature ranges ?25° C. to 40° C. A first force is applied to the plunger to overcome the first contact pressure and move the plunger out of the first portion and into the second portion to dispense product. The sealing member engages the second portion of the barrel to give rise to a second contact pressure that is lower than the first contact pressure.

Abstract: A modular injection system enables a user to control the dilution ratio of mixed injectable fluid. In one embodiment, modular injection system includes a handheld injection device operatively connected to a separate control device. In one embodiment, the control device includes a drive unit configured to apply extrusion forces to fluids. In another embodiment, the handheld injection device includes the drive unit. In one embodiment, the modular injection system produces the mixed injectable fluid based on a selected dilution ratio. In one embodiment, the modular injection system produces the mixed injectable fluid based on selected injection rates.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: An apparatus for delivery of fluids to a patient includes an inlet tube and an outlet tube connected to each other at an angular joint. A rotary valve and a piston are fitted to the angular joint forming a chamber. The rotary valve is provided with a priming channel notch and a pumping notch. For priming operation with the fluid delivery apparatus, a user sets the rotary valve to a priming position. During pumping operation, the rotary valve rotates in coordination with the piston to transfer a quantum of fluid from the inlet tube to the outlet tube via the chamber. A second piston is optionally provided on the outlet tube for smoothing out flow rate pulsations.

Abstract: An endoscopic injection needle device includes a flexible elongate sheath attached to a handle. Disposed within the sheath is drive shaft having a lumen within and a needle at its distal end. The drive shaft is movable longitudinally within the sheath and is attached at its proximal end within the handle to an actuator. Advancing the actuator extends the needle from the distal end of the device. The actuator includes a locking mechanism that locks it in place with the handle when advanced a certain distance. The locking mechanism includes multiple locking positions wherein the exposed length of the needle corresponds to the distance advanced by the actuator at each locking position. Also included in the distal end of the sheath are a spring coil and a collar. The collar is positioned distal to the spring coil and includes a dome shaped distal end that extends beyond the distal end of the sheath. The drive shaft extends through the spring coil and, when retracted, the needle is housed within the collar.

Abstract: A reloadable auto injector wherein a syringe assembly is movably positioned between a first position in which the needle is accommodated inside a housing and a second position in which the needle protrudes outside the housing. The assembly comprises a syringe, a plunger rod and a plunger rod driver configured to apply a force to the plunger rod to advance the plunger rod in the syringe for delivering at least one dose of medicament. A syringe driver is configured to apply a force to the assembly thereby moving the assembly from the first position to the second position. A reload handle may be connected to the assembly so that user operation of the reload handle retracts the assembly to the first position and simultaneously reload the syringe driver to thereby ready the auto injector for delivering a further dose of medicament. The plunger rod driver is not re-activated.

Abstract: Disclosed herein are devices for minimally invasive vertebral augmentation and restoration of spinal lordosis using a steerable cannula assembly. When deployed, the articulating cannula, including an outer cannula and an inner cannula extending into a central lumen of the outer cannula and coupled to each other at their distal ends, can be manipulated to curve/bend the body of the articulating cannula. This manipulation is used to create a void within the interior body and may also be used to control delivery of a treatment element to the interior body.

Abstract: Devices, systems, and methods for performing injections with lowered likelihood of infection include needles and other injection means with protective sleeves or sheaths. The protective sleeve can protect the needle before, during, or before and during an injection. The force needed to administer an injection or penetrate an insertion site using an injection device or system with a protective sleeve can be about the same to up to 50% more than the force needed for a system or device without a protective sleeve. The force needed to collapse the protective sleeve can be less than 100 gram-force. The material, the thickness, or both the material and the thickness of the protective sleeve may differ when comparing the portion of the sleeve near the needle tip and the portion near the base of the needle.

Abstract: A method of treating glaucoma or other eye disease in a patient is provided. The method includes injecting an eye of the patient with a cohesive monophasic gel containing cross-linked hyaluronic acid or its salt. The injection can be under the scleral flap and/or conjunctiva of the eye, thereby creating and maintaining a conjunctival bleb, and/or the injection can be in the supra-scleral and/or supra-choroidal (sub-scleral) space of the eye thereby reducing the intraocular pressure.

Abstract: A key-shaped portable injector for delivering a dose of medication, the injector preferably including a cap, a body having an internal cavity, a syringe or cartridge with an attached needle within the internal cavity, a protective sleeve, an activation mechanism and a safety mechanism wherein the injector is reconfigurable from a first, non-deployed configuration where the activation mechanism, syringe or cartridge and a safety mechanism are all in a first position with respect to the body to a second, deployed configuration where the safety mechanism, activation mechanism, and syringe or cartridge are all in a second position with respect to the body and to a third, depleted configuration where the activation mechanism is back to its first position and a protective sleeve is in its second position.

Abstract: Disclosed are an ultrasound apparatus and a control method thereof, in which the thickness of subcutaneous tissue is measured using an ultrasound probe or vital data regarding a subject is acquired to select an appropriate injection needle and determine suitability of injection to a corresponding body region, which ensures safe and effective drug administration. In the ultrasound apparatus and the control method thereof, a map containing results of selection of an appropriate injection needle and determination of injection suitability is generated and provided to a patient, which ensures safe self-administration by the patient without a hospital visit. The ultrasound apparatus includes a data acquirer to acquire ultrasound data regarding a subject, a thickness calculator to calculate the thickness of subcutaneous tissue inside the subject based on the ultrasound data, and a needle selector to select a needle corresponding to the calculated thickness of subcutaneous tissue.

Abstract: Devices and methods of use for obtaining and maintaining vascular access for the insertion of diagnostic or therapeutic drugs or devices into a patient. A device may include a first conduit extending along a longitudinal axis between a first end and a second end, the first end configured for coupling to a needle and the second end configured for coupling to a syringe. The device also includes a second conduit oblique to the first conduit and in communication with the first conduit. And the device includes a valve in communication with the second conduit, the valve being operatable between a closed position and an open position, wherein the open position is configured to provide access to the second conduit, such that an object may be introduced through the valve and second conduit into the first conduit and out the needle.

Abstract: Thermochemical ablation techniques may provide ablation of bodily tissue using chemical reaction energy.

Abstract: Embodiments of the current invention provide minimally invasive methods for interbody fusion. In one aspect, the invention relates to a method of treating a patient that includes the steps of introducing a channel-forming instrument into a first vertebra, forming a channel through an endplate of the first vertebra and into a nucleus of an adjacent intervertebral disc without penetrating an annulus of the disc, and supplying a therapeutic agent to the nucleus of the disc via the channel.

Abstract: A device for moving a piston inside a cartridge having a cartridge body and the piston displaceable along a longitudinal axis of the cartridge body is presented. The device comprises a first portion having first coupler for coupling the cartridge body to the first portion such that in both directions of the longitudinal axis, a connection exists between the cartridge body and the first portion; and a second portion having second coupler for coupling the piston to the second portion such that in both directions of the longitudinal axis, a connection exists between the piston and the second portion. The first and second portions move relative to each other to effect at least a forward displacement of the piston coupled to the second portion inside the cartridge body coupled to the first portion along the longitudinal axis. The second coupler establishes and releases the connection with the piston.

Abstract: A system and method for introducing one or more stimulating drugs and/or applying electrical stimulation to the brain to treat mood and/or anxiety disorders uses an implantable system control unit (SCU), specifically an implantable signal/pulse generator (IPG) or microstimulator with one or more electrodes in the case of electrical stimulation, and an implantable pump with one or more catheters in the case of drug infusion. In cases requiring both electrical and drug stimulation, one or more SCUs are used. Alternatively and preferably, when needed, an SCU provides both electrical stimulation and one or more stimulating drugs. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one SCU includes a sensor, and the sensed condition is used to adjust stimulation parameters.

Abstract: A device for delivering fluid, comprising an elongated outer casing (10) provided with a substantially cylindrical inner chamber (11); a plunger (21) movable axially along a longitudinal axis A-A of an inner reservoir (22) towards an outlet (28); an actuator comprising a multi-stage lead-screw with a plurality of coaxial, screwably-interconnected bushings and an output spindle or an output bushing linked to the movable plunger (21), whereby a rotation of the rotating element causes a translation of the bushings relative to each other in telescopic fashion, and a translation of the movable plunger in the cartridge.

Abstract: Disclosed herein is an injector device for delivering an implant, the device including a retracting element, a cannula needle, and a plunger. The device may comprise an latch that, when actuated by a user, causes the retracting element to move the cannula needle away from the delivery site, allowing the plunger to eject the implant into the site. The device may be configured for intraocular drug delivery.

Abstract: A device and method for creating microchannels in the stratum corneum. The device includes a handle and a substrate detachably attached to the handle by a coupler. The substrate has a plurality of microstructures for creating microchannels in the stratum corneum. The substrate is detachable from the handle for disposal.

Abstract: An auto injector having sequential control of needle insertion and dose injection is disclosed. A syringe with a needle is movably positioned in a housing between a first position in which the needle is accommodated inside the housing and a second position in which the needle protrudes outside the housing. A plunger rod tube has at least one locking member configured to normally lock a plunger rod to the plunger rod tube. A syringe driver applies a force to the syringe to move the syringe together with plunger rod tube, plunger rod and plunger rod driver from the first position to the second position. In the second position, the locking member is unlocked and releases the plunger rod to thereby activate the plunger rod driver to advance the plunger rod in the syringe for delivering of at least one dose of medicament.

Abstract: Devices and methods are provided for processing adipose tissue with a hand-held device. This device may include a processing chamber, a cannula, a vacuum source, a digestion area, and a product cell concentration chamber.

Abstract: A bioactive agent delivery device having a plurality of reservoirs wherein each reservoir houses a solvent provides a means for separable and segregated delivery of bioactive agent(s) to a patient. The device can include a plurality of absorbent materials wherein each absorbent material is pretreated with a bioactive agent and a delivery mechanism operable to deliver to any of the plurality of absorbent materials a controlled portion of solvent from any of a plurality of reservoirs. A diffusion layer interposed between the absorbent materials and an epidermis transfers the bioactive agent from the absorbent materials to the epidermis for delivery of the bioactive agent.

Abstract: Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or microparticles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.

Abstract: A hybrid cannula may comprise a first portion formed from a first material, a second portion formed from a second material overmolded to the first portion, a third portion formed from a third material and a fourth portion formed from a fourth material overmolded to the third material. The third portion is coupled to the first portion. The first portion may prevent the proximal end of the hybrid cannula from being pushed through a portal. The second portion may include a membrane and the fourth portion may include a dam, the dam defining interior spaces thereof between the proximal and distal ends of the hybrid cannula. The membrane and/or dam may prevent liquid from projecting during insertion or removal of instruments. The distal end of the hybrid cannula may comprise a variety of features.

Abstract: A portable medicament dispensing device having a mechanism which is not susceptible in jamming for dispensing the medication to a user. The device employs employs a coupling for coupling the relative motion between reciprocating body members housing the ancillary components and a barrel plunger associated with the syringe. One embodiment provides a pivoting coupling whereas an alternate uses a rack and pinion system. The advantage of simplifying such mechanisms results in a structure which has smooth unemcumbered motion with fewer parts to avoid mechanical jamming during use.

Abstract: A fluid dispensing device is provided for dispensing a measured amount of fluid into a living organism. The device has a needle having a first end and a second end. The needle is adapted for interfacing, on the first end, with a septum of a flexible hollow membrane, and at a second end thereof, for subcutaneously inserting into a living organism. The needle is guided by a guide to permit an injection into the living organism at a substantially non-orthogonal angle with respect to a surface of the living organism. The first and second ends of the needle pierce their respective piercing surface while translating together in a common direction. In other embodiments, the dispensing device includes a main housing, a flexible fluid reservoir, an injection assembly and a trigger mechanism. The main housing houses the operative components of the device.

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

Abstract: A fluid delivery device is provided for delivering fluid to a target site such as an intervertebral disc during discography. The fluid delivery device includes pressure and volume sensors to determine the pressure and the volume of the fluid delivered to the intervertebral disc. The fluid delivery device is hand-held during use and includes a syringe assembly having a plunger with threads that enables controlled discharge of the fluid from the fluid delivery device by rotating the plunger in a housing of the fluid delivery device. The fluid delivery device includes a communication module to wirelessly transfer data to an external device outside of a sterile field, while the fluid delivery device is in the sterile field. The fluid delivery device may also include a physiological sensor to monitor involuntary pain responses based on changing physiological parameters such as increases in body temperature or blood pressure.

Abstract: A system for optimizing a patient's basal insulin dosage regimen over time, adapted to determine from blood glucose values whether and by how much to vary a patient's present recommended amount of the insulin-containing drug in order to maintain the patient's future blood glucose level measurements within a predefined range, and wherein a given blood glucose value is disregarded if no patient-actuated operation being indicative of the administration of a dose of an insulin containing drug has been detected in a pre-defined amount of time prior to the determination of the given blood glucose value.

Abstract: A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.

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: In accordance with aspects of the present invention, an applicator assembly suitable for application of a catheter patch about an insertion site of a percutaneous device includes a body having a distal end, a proximal end, and laterally extending right and left side gripping members, a pull tab member attached toward the proximal end of the body, and a release tab connected to the pull tab member, wherein the release tab is positioned toward the distal end of the body so that a lower surface of the release tab abuts an upper surface of the body. The release tab may have a securing mechanism for securing a catheter patch to a lower surface of the body toward the distal end of the body. A method of applying a catheter patch about an insertion site of a percutaneous device using an applicator assembly is provided.

Abstract: An accessory for a syringe is disclosed, including a body with a proximal end having at least one zone for application of an injection force in order to apply a force for discharging a product from the syringe, and a distal end having a bearing element for bearing against a needle mounted on the mouth of the syringe with a force that includes a radial component perpendicular to the longitudinal axis of the syringe and directed towards the centre of the syringe. An assembly including such an accessory and a syringe is also disclosed.

Abstract: Sterile micron-sized gold particles contained in capped vials, a kit of part including the vial and a liquid capable of suspending the particles, as well as their preparation, medical devices or medicaments prepared by their preparation as well as uses thereof in treating inflammation. Also, gold coated implants preferably for use in combination with the medical devices.

Abstract: Described here are devices and methods for the delivery of molecules, including biologically active molecules, into tissues. The devices and methods are generally particle based, and devised to deploy the molecules into a target tissue in a controlled manner to minimize tissue damage. The devices and methods may further be devised to tailor molecule delivery parameters to a variety of tissue types. Kits including various device components are also described.

Abstract: A removable clip for connection with a catheter for a remote surgical procedure is provided. The clip includes a body and an arcuate concave surface configured to rest upon a central portion of the body and opposed first and second legs that each extend therefrom. A ramp surface extends from the body portion, the ramp surface with a portion that extends at an acute angle with respect to a longitudinal axis through the concave surface. A portion of the ramp surface is configured to extend within an aperture within a side wall of a catheter when the clip is fixed to the side wall of the catheter.