Abstract: Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

Abstract: The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to a user provided insulin delivery amount, including a user provided insulin delivery amount that varies from a recommended insulin delivery amount.

Abstract: A system and method enabling the receipt of image data of a patient, identification of one or more locations within the image data depicting symptoms of lung disease, analyzing airways and vasculature proximate the identified locations, planning a pathway to the one or more locations, navigating an extended working channel to one of the locations, identifying the direction of blood flow within vasculature serving the location, positioning a catheter proximate the location, and temporarily isolating a portion of the identified vasculature serving the location depicting symptoms of lung disease.

Abstract: A medical valve assembly includes a tube extending between a first and second tube end along an axis, and a plunger plate extends radially from the second tube end. A valve housing surrounds the tube and includes a radially inwardly extending flange. A compression member is biased against the plunger plate and compresses an elastomeric seal from a non-compressed condition to a compressed condition to establish a sealed condition of the medical valve assembly. An inner surface of the elastomeric seal in the non-compressed condition has a plurality of planar portions and a plurality of radiused portions, with adjacent planar portions interconnected with one of the radiused portions to improve a closure of the elastomeric seal during compression. The inner surface preferably includes three planar portions and three radiused portions to define a generally triangular-shaped inner surface as viewed in cross section in the non-compressed condition.

Abstract: The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include adjusting user specific dosage parameters in response to a user provided insulin delivery amount, including a user provided insulin delivery amount that varies from a recommended insulin delivery amount. Methods and systems may include locking out automated modification of a baseline basal rate of insulin for the user for the time period after a user provides an insulin delivery amount.

Abstract: A reservoir for liquid medicament includes a first boundary portion and a second boundary portion forming at least one cavity to receive the medicament. The first boundary portion is flexible, while the second boundary portion is rigid. At least one of the first and second boundary portions is a transparent boundary portion covered by an opaque cover which is at least partially detachable from the transparent boundary portion.

Abstract: A drug administration controller has a sensor that generates a sensor signal to a physiological measurement device, which measures a physiological parameter in response. A control output responsive to the physiological parameter or a metric derived from the physiological parameter causes a drug administration device to affect a treatment of a person, such as by initiating, pausing, halting or adjusting a dosage of drugs administered to the person.

Abstract: A closed loop catheter useable for heat exchange is manufactured by forming a plurality of generally transverse bore holes though a flexible, multilumen catheter body, lacing a tube trough the bore holes so that loops of the tube protrude from the catheter body, connecting one end of the tube to an inflow lumen of the catheter and connecting the other end of the tube to an outflow lumen of the catheter. A heated or cooled heat exchange medium may then be circulated through the tube while the catheter is inserted in the vasculature of a subject, thereby resulting in heat exchange between the subject's flowing blood and the heat exchange medium being circulated through the tube.

Abstract: A splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves obtaining, by a control system associated with the infusion device, measurement values indicative of a condition of the patient provided by a sensing device, identifying an event pattern based at least in part on the measurement values for the condition and historical data associated with the patient, generating a notification indicative of the event pattern in response to identifying the event pattern, and adjusting operation of the infusion device to deliver the fluid to the patient in a manner that is influenced by the event pattern in response to receiving user input confirming the event pattern.

Abstract: A power-injectable access port and methods of making are described. One method of making includes forming a power-injectable access port housing, creating a screen including one or more apertures through the screen in the shape of one or more alphanumeric characters, suspending a radiopaque material in a silicone material to form a radiopaque suspension, and depositing the radiopaque suspension onto a surface of the power-injectable access port housing through the one or more apertures of the screen to create at least one radiopaque identification feature. The at least one radiopaque identification feature may have a thickness protruding from an outer surface of the port base such that it is perceivable by sight and touch prior to implantation of the power injectable access port, and is observable via imaging technology subsequent to subcutaneous implantation of the power-injectable access port.

Abstract: A method of maintaining an overall flow rate during a sequential delivery of at least two fluids to a patient's blood vessel includes delivering at least a first fluid into the patient's blood vessel at a first flow rate, delivering at least a second fluid into the patient's blood vessel at a second flow rate, and adjusting at least one of a first flow profile of the first flow rate and a second flow profile of the second flow rate to dampen a transient increase in the overall flow rate during a transition between delivering one of the first fluid and the second fluid to delivering the other of the first fluid and the second fluid.

Abstract: A syringe including a barrel, a plunger moveably arranged within said barrel and a plunger rod for driving said plunger is provided. The syringe includes a first engagement member arranged at the plunger rod such that a longitudinal movement of the plunger rod yields a rotational movement of said first engagement member, said first engagement member including a grooved surface, and a second engagement member arranged at the barrel to engage with said grooved surface of the first engagement member such that feedback is given to a user as the plunger rod is moved relative to the barrel for driving said plunger. Wherein, for a given distance D travelled by the plunger rod relative to the barrel, a point of the grooved surface of the first engagement member moves a distance d, wherein d?D.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves obtaining, by a control system associated with the infusion device, an input meal indication, obtaining historical data for the patient associated with the input meal indication, determining an estimated carbohydrate amount corresponding to the input meal indication based at least in part on the historical data, determining a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount, and operating an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.

Abstract: Disclosed are methods and medical device systems for automated delivery of therapies for pain and determination of need for and safety of treatment. In one embodiment, such a medical device system may comprise a sensor configured to sense at least one body signal from a patient; and a medical device configured to receive a first sensed body signal from the sensor; determine a patient pain index based at least in part on said first sensed body signal; determine whether said patient pain index is above at least a first pain index threshold; determine a safety index based at least in part on a second sensed body signal; select a pain treatment regimen based on at least one of said safety index and or a determination that said pain index is above said first pain index threshold; and deliver said pain treatment regimen.

Abstract: Methods for mass production of new microfluidic devices are described. The microfluidic devices may include an array of micro-needles with open channels in fluid communication with multiple reservoirs located within a substrate that supports the micro-needles. The micro-needles are configured so as to sufficiently penetrate the skin in order to collect or sample bodily fluids and transfer the fluids to the reservoirs. The micro-needles may also deliver medicaments into or below the skin.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves obtaining, by a control system associated with the infusion device, user input indicating an activity by the patient, obtaining historical data for the patient corresponding to the activity, determining a probable patient response corresponding to the activity based at least in part on the historical data for the patient, determining an adjustment for delivering the fluid by the infusion device based at least in part on the probable patient response, and operating the infusion device to deliver the fluid to the patient in accordance with the adjustment.

Abstract: A fluid injection system that includes an injector head having a syringe for delivering a fluid to a patient; a mounting structure pivotally connected to the injector head and configured to support the injector head above a surface; and a control system operationally coupled to the injector head for controlling an injection procedure is disclosed. The fluid injection system is provided with various sensors to control various aspects of the fluid injection system, such as the establishment of a reference plane, the determination of a tilt angle of the injector head, and the determination of a temperature of an actuation system of the injector head.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a patient involves predicting, by a control system associated with the infusion device, a future occurrence of an event based at least in part on historical data associated with the patient, and prior to the future occurrence of the event, automatically adjusting a control parameter for operating the infusion device based at least in part on the event and automatically operating an actuation arrangement of the infusion device to deliver the fluid to the patient based at least in part on a current measurement of the physiological condition and the adjusted control parameter.

Abstract: A drug delivery device is provided having a housing, a lead screw that is rotatably fixed with respect to the housing during dose setting and during dose delivery and that is axially moveable in a delivery direction relative to the housing for dose delivery, a number sleeve threadedly engaged with the housing to be screwable relative to the housing, and a dial link which is axially moveable and rotatable with respect to the housing for dose setting and which is prevented from rotation with respect to the housing for dose delivery. The dial link is rotatably fixed with the number sleeve when the dial link and the number sleeve are in a first arrangement, and the number sleeve and the dial link are rotatable with respect to one another when the dial link and the number sleeve are in a second arrangement.