Abstract: Systems, instruments, methods, and compositions are described involving removing a portion of the epidermis within a donor site on a subject, and harvesting dermal plugs within the donor site. An injectable filler is formed by mincing the dermal plugs. The injectable filler is configured for injecting into a recipient site on the subject.

Abstract: Some embodiments include burden-free insulin delivery systems and methods. Some embodiments include a method comprising: receiving previous insulin delivery data at a user device from an insulin pump; receiving estimated glucose data at the user device from a continuous glucose monitor; determining that the estimated glucose value is approaching or has passed a threshold; and in response to determining that the estimated glucose value is approaching or has surpassed the threshold, not providing an indication to the user through a user interface that the estimated glucose value is approaching or surpassed the threshold.

Abstract: An insulin infusion device and related operating methods are disclosed. An operating method maintains a configurable, patient-specific, target glucose setpoint for a user of the insulin infusion device, collects historical data associated with operation of the insulin infusion device, and calculates, from the historical data, a target glucose setpoint profile for the user of the insulin infusion device. A current target glucose setpoint value is automatically adjusted over time during a closed-loop operating mode of the insulin infusion device, in accordance with the calculated target glucose setpoint profile. In certain embodiments, the historical data is analyzed to determine a clinically preferred target glucose setpoint value for the user, which is stored for use during the closed-loop operating mode.

Abstract: Systems and methods for automatically delivering medication to a user. An automated drug delivery system may include a sensor and a wearable automated drug delivery device. The wearable automated drug delivery device may be configured to couple to the skin of a user and may include a controller and a pump. The pump may be configured to output the medication. The controller may be within the wearable automated drug delivery device. The sensor may be coupled to the user and may be configured to collect information regarding the user. The controller of the wearable automated drug delivery device may use the collected information to locally determine an amount of medication to be output from the wearable automated drug delivery device and cause delivery of the amount of medication.

Abstract: A medical system includes a probe, an electrooptical measurement unit, a processor and a treatment unit. The probe, which is configured for insertion into a blood vessel of a brain, includes (a) one or more optical fibers configured to guide an optical signal to interact with a brain clot in the blood vessel, and to output the optical signal that interacted with the brain clot, and (b) a channel selected from a group of channels consisting of an irrigation channel and an aspiration channel. The electrooptical measurement unit is configured to collect and measure the outputted optical signal. The processor is configured to identify a composition of the brain clot by analyzing the measured optical signal from the probe. The treatment unit is configured to provide treatment, selected from the group of treatments consisting of dissolving the brain clot by irrigation and aspiring the brain clot through the channel.

Abstract: An insulin device configured to control insulin dispensing based on insulin sensitivity. The insulin device includes a processor configured to receive insulin dosing schedule information, psychological stress level data, and body mass index (BMI) data; a sensor configured to generate a blood glucose level measurement. The sensor is calibrated as a function of the psychological stress level data and the BMI data and the processor is configured to monitor and detect changes of the blood glucose level measurement that are determined to have occurred as a function of changes of the psychological stress level data, and identify a time when the BMI data counteracts a detected change in the blood glucose level measurement. The insulin device also includes an insulin dispensing valve controlled by the processor to change the insulin dosing schedule information in accordance with the counteracting BMI data.

Abstract: Provided are ergoline derivative containing medicaments disposed within a preassembled, prefilled, single-use delivery device, methods for administering a medicament using a preassembled, prefilled, single-use delivery device, and systems or kits that contain one or more preassembled, prefilled, single-use devices and user instructions, such as for treatment of a migraine or other headache.

Abstract: The present disclosure relates to a cap assembly for a medicament delivery device, having a cap containing a tubular body provided with a distal opening, the cap being configured to be mounted to a proximal end of a medicament delivery device, a tubular remover configured to be received in the distal opening of the cap, the remover having flexible radially inwards extending grippers configured to engage with a delivery member shield, and a tubular remover insert configured to be received by the remover and configured to be fixedly attached to the cap to prevent axial displacement of the remover insert relative to the cap, wherein the remover is axially displaceable relative to the cap and relative to the remover insert, from a first position in which the grippers are pressed radially outwards by an outer surface of the remover insert, to a second position located distally relative to the first position, in which second position the grippers are arranged distally beyond the outer surface of the remover insert,

Abstract: Embodiments include a catheter anchoring device for securing a percutaneous medical catheter inserted at a skin puncture site to a skin of a body. The catheter anchoring device may include a catheter capture portion coupled to a skin attachment portion. The catheter capture portion may be configured to engage with a portion of the catheter protruding from the skin when the catheter is subcutaneously placed in a body. The skin attachment portion may be configured to adhesively attach the anchoring device to the skin, wherein the skin attachment portion is primarily attached to the skin overlaying and lateral to the subcutaneously located catheter.

Abstract: An access port for subcutaneous implantation is disclosed. The access port may include a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. The access port may further include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. The subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is included on a molded insert that is sandwiched between base and cap portions of the access port so as to be visible after implantation via x-ray imaging technology.

Abstract: An insulin infusion device and a related operating method are disclosed. The method obtains a blood glucose (BG) measurement of a blood sample from a user, displays the BG measurement on a display element of the infusion device, and receives a confirmation input that indicates user acceptance of the displayed BG measurement. In response to the confirmation input, a glucose sensor calibration routine is automatically initiated, and an insulin bolus calculation is automatically initiated. The calibration routine and the bolus calculation use the confirmed BG measurement. The method continues by controlling delivery of insulin, in accordance with the calculated insulin bolus, from a fluid reservoir of the insulin infusion device. The sensor calibration routine and the insulin bolus calculation are both performed without any additional user involvement or interaction with the user interface other than the user acceptance of the displayed BG measurement.

Abstract: An injection device comprising: a housing arranged to contain a medicament cartridge; a needle holder holding an injection needle; a generally tubular needle sleeve fixed with respect to the needle holder and axially movable with respect to the housing; and a gear assembly comprising a rotary gear fixed to the needle holder, a first gear rack disposed on the needle sleeve and a second gear rack disposed on the housing, wherein the gear assembly is arranged so that movement of the needle sleeve in a proximal axial direction causes movement of the needle holder in the proximal axial direction.

Abstract: An apparatus for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft subcutaneously implanted in a body of a subject. The guiding apparatus comprises an elongated body member comprising a base portion terminating in longitudinal edges, a distance between the longitudinal edges of the base portion being substantially equal to a lateral dimension of the aces graft, and an elongated tubular sleeve defining an pocket having a longitudinal dimension and a lateral dimension configured to receive the body member. The body member is adapted to be received in the pocket of the sleeve for securing adjacent the subcutaneous access graft such that the inner surface of the base portion is aligned with a cannulation point of the graft for guiding location of a needle insertion.

Abstract: An intravenous (IV) set system comprising a primary IV set having a plurality of access points facilitating access to one or more fluid pathways of the primary IV set, and an IV extension set removably coupled to the primary IV set to form an extended primary IV set, the IV extension set comprising an extension flow line defining an extension flow path, and a plurality of access ports on the extension flow line, at least two of the access ports comprising access ports located between first and second ends of the IV extension set. The IV set system further comprises a bypass manifold externally and removably coupled to the extension flow line of the IV extension set via the intermediate access ports on the extension flow line, the bypass manifold comprising a bypass flow line adjacent the extension flow line, and one or more access points that facilitate access to the bypass flow line, wherein the bypass manifold and the bypass flow line are operable to provide a bypass flow path through the IV extension so.

Abstract: A feeding tube assembly and feeding tube tip secure a viewing lens proximal of the distal end of the feeding tube tip. The feeding tube tip can include a plurality of protrusions that extend radially inward to secure the viewing lens. The feeding tube assembly and feeding tube tip can be used to improve image quality by keeping tissue from abutting the viewing lens as the feeding tube tip is inserted into a patient.

Abstract: In some embodiments, an ophthalmic cassette valve may be configured to control flow of an infusion fluid and an ophthalmic substance (e.g., ophthalmic drug, a retina patch material, or an ophthalmic dye) to an infusion cannula. The valve may be configured to provide an alternating or mixed flow of the infusion fluid and the ophthalmic substance to the infusion cannula. In some embodiments, the cassette may include multiple substance chambers with different substances. The cassette may also include a one or more valves to control the flow to the infusion fluid (e.g., on/off for each of the substances and infusion fluid and/or a ratio of the substances and infusion fluid).

Abstract: A tamper evident closure assembly for a fitting including, but not limited to, use in combination with a female fixture or an enteral fixture. A cap is connectable in flow restricting relation to the fitting and includes an indicator member removably connected to an exterior thereof. A housing is dimensioned to removably contain the cap and the connected indicator member. Subsequent to the fixture being connected to the cap, a removal thereof results in the indicator member being detached from the cap and movably disposed in a captured, detached orientation within the housing. Tampering may be evidenced by the indicator member remaining captivated within the housing which may be determined by visual observation or the generation of sound caused resulting from the housing being shaken.

Abstract: A blood glucose control system can generate an indication of total carbohydrate therapy over a period during use by a subject. The system can be connected to a medicament pump configured to deliver insulin therapy, other types of medicament therapy, or a combination of medicament therapies to the subject. The system can determine an amount of a counter-regulatory agent to respond to an impending risk of hypoglycemia or an episode of hypoglycemia and determine a dose of carbohydrate therapy based at least in part on the amount of the counter-regulatory agent. The system can track determined doses of carbohydrate therapy to generate the indication of total carbohydrate therapy over the period.

Abstract: A sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connections may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers.

Abstract: A closure assembly for a medical device such as a syringe comprises a housing having an open end and a hollow interior. A tip cap is removably disposed within the housing and includes a cover connected to the open end by a snap-fit connection. An indicator ring includes an access opening and is removably connected to the cover in interruptive, removable restricting relation to said tip cap. The access opening is dimensioned to facilitate passage of the syringe therethrough into attachment with the tip cap, with the tip cap disposed into disconnecting engagement with said indicator ring concurrent to removal of said tip cap and attached syringe through said open end. Upon removal of the tip cap and attached syringe through the open end of the housing, the indicator ring will be disposed in a surrounding captured disposition on the syringe, thereby providing a clear indication of tampering or use.