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: An infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. A motor assembly is configured to act upon the reservoir assembly and dispense at least a portion of the infusible fluid contained within the reservoir assembly. Processing logic is configured to control the motor assembly. The processing logic includes a primary microprocessor configured to execute one or more primary applications written in a first computer language; and a safety microprocessor configured to execute one or more safety applications written in a second computer language.

Abstract: In one embodiment, a method of programming an implantable medical device (IMD) to provide therapeutic operations for a patient, comprises: conducting a first communication session between the IMD with an external programming device when network connectivity for a remote server for medical device management is not available for the external programming device; receiving programming data by the IMD from the external programming device to provide therapeutic operations according to at least one instance of settings data during the first communication session, wherein the at least one instance of settings data is validated by a temporary key; conducting a second communication session between the IMD with an external device when network connectivity to the remote server for medical device management is available for the external device; and replacing validation data signed using the temporary key with the received validation data.

Abstract: The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal dosing of GLP-1 or co-formulation of GLP-1 and insulin. The size and frequency of the basal doses may be controlled by a medication delivery algorithm resident on the wearable drug delivery device based on a basal dosing history and readings from a continuous glucose monitor monitoring the glucose levels of the wearer of the device.

Abstract: The present invention relates to injectors, such as pen-type injectors, that provide for administration of medicinal products from a multidose-cartridge and permit a user to set the delivery dose. The injector may include a housing, a piston rod adapted to operate through the housing, a dose dial sleeve located between the housing and the piston rod, and a drive sleeve located between the dose dial sleeve and the piston rod. The dose dial sleeve may have a helical thread of first lead and the drive sleeve may have a helical groove of second lead. The first lead of the helical thread and the second lead of the helical groove may be the same.

Abstract: Pre-connected analyte sensors are provided. A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured for mechanical coupling of the sensor to testing, calibration, or wearable equipment. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the testing, calibration, or wearable equipment.

Abstract: A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient or user is provided. A soft needle or cannula can be placed in fluid communication with the liquid drug and can be coupled to a needle insertion component that provides access to the patient. A drive system of the drug delivery device can expel the liquid drug from the container to the patient through the soft needle or cannula. The wearable drug delivery device can include components for preventing backflow and eliminating air within the liquid drug. As a result, the comfort of the patient can be enhanced and correct drug dosages can be provided when using the drug delivery device.

Abstract: This invention relates to a feedback predictive controller, systems comprising and methods employing the same. Preferably the feedback predictive controller and/or systems comprising the feedback predictive controller are part of an automatic insulin delivery system. The methods described herein can be used to control blood glucose concentration in a patient with diabetes. Preferably, the insulin delivery system is an artificial pancreas.

Abstract: In one aspect the present disclosure relates to a monitoring device for attachment to an injection device, the monitoring device comprising: a body (51) having an inside surface (52) for engagement with an outside surface (19) of the injection device (1) and having an outside surface (53) opposite to the inside surface (52), an light transmission area (60) extending from the inside surface (52) to the outside surface (53), the light transmission area (60) having an inner end (62) adjacent to the inside surface and having an outer end (63) adjacent to the outside surface (52), wherein the light transmission area (60) provides transmission of light from the inner end (62) to the outer end (63), an image acquisition system (70) arranged inside or on the body (51), and an optical coupling (80) arranged in or extending into the light transmission area (60), wherein the optical coupling (80) is optically coupled to the image acquisition system (70) in a light-transmitting way.

Abstract: A method and device for using insulin sensitivity values to estimate the distribution of future insulin sensitivity values for a given patient based on dimensional relationships between current, prior and delta insulin sensitivity values, and observed future insulin sensitivity values for similar patients or subjects, or based on an individual patient or subject's historical values.

Abstract: An injector for delivering a medicament includes an outer sleeve, an inner sleeve, and a syringe. The inner sleeve is disposed partially within the outer sleeve. A plunger rod of the syringe is engaged with the outer sleeve in a fixed spatial relationship such that the plunger rod and the outer sleeve translate as a unit. The outer sleeve is configured for axial translation relative to the inner sleeve from a first configuration wherein the inner sleeve extends from the outer sleeve a first distance to a second configuration in which the inner sleeve extends from the outer sleeve a second distance that is less than the first distance. Further, in a third configuration the inner sleeve extends from the outer sleeve a third distance that is greater than the second distance and the inner sleeve is restricted from axially translating with respect to the outer sleeve.

Abstract: Loading tools for use with medical devices are disclosed. An example loading tool may be suitable for use with a drug-coated expandable medical device. The loading tool may include a tubular sleeve having a distal end region, a proximal end region, and a lumen extending therethrough. The distal end region may include a reduced distal tip designed to interact with a hemostasis valve having a resilient seal member.

Abstract: An auto-injector device comprising an injector body having a proximal end and a distal end; a syringe received in the injector body; a needle disposed in a first end of the syringe to extend toward an opening in the distal end of the injector body; and a sealing element disposed at the distal end of the injector body for making a seal against a patient's skin. The auto-injector is configured to generate a reduced pressure to draw the auto-injector device against the patient's skin. The auto-injector device comprises a pressure-reducing mechanism configured to generate the reduced pressure within the injector body during an injection process. The pressure reducing mechanism comprises a moveable member configured such that movement of the moveable member from a first position to a second position enlarges a closed volume within the injector body to generate the reduced pressure within the closed volume.

Abstract: A method of manufacturing a needle-equipped outer tube includes a preheating step comprising heating a distal end connecting section to a temperature at or below a softening point of a material forming an outer tube member with a joint member inserted in a distal end connecting section of the outer tube member, and with a needle being inserted or inserted and fixed in the needle insertion hole; and a joint member welding step, performed after the preheating step, comprising thermally welding the joint member to the distal end connecting section of the outer tube member with a distal end portion of the joint member pressed toward the proximal end of the joint member by a pushing member with a pressing force in a range of 4 N to 30 N.

Abstract: Systems and methods are disclosed herein for switching control of an ambulatory medical device from an application executing on the ambulatory medical device to a safe version or a new version of the application without interrupting therapy provided by the ambulatory medical device to a subject. The ambulatory medical device can maintain copies of a safe version and a new version of the application. The disclosed systems and methods can execute the new version, while the prior version of the application continues to execute, determine whether a minimum set of operating conditions are satisfied by the new version, and switch control of the ambulatory medical device from the prior version to the new version. The systems and methods can also automatically revert to the safe version of the application case the current version is malfunctioning without interrupting therapy provided to the subject.

Abstract: An electronic insulin delivery device receives glucose data from a glucose monitor and sets a bolus dose amount. The device may take the form of an insulin pen with automatic priming and accurate dosing provided by a motor in connection with an encoder. The device may communicate with and be controlled by a smart phone device. The smart phone device provides a user interface to receive user data including patient weight, insulin to carbohydrate ratio and exercise factor, and to send instructions to the device, including dose amount. The dose amount is determined taking into account glucose level and trend, and other factors. The delivery device may be in continuous communication with the glucose monitor and smart phone to provide for near real-time adjustments in glucose treatment. Glucose data, insulin injection data, and other relevant data may be stored and accessible to interested parties.

Abstract: Systems, instruments or devices, and methods or procedures are described in which a scalpet array is applied to a target site with the use of a pattern. The scalpet array comprises scalpets positioned on a device. Skin pixels are incised at the target site via application of a load through the scalpet array. A recipient site is prepared by positioning the pattern at the recipient site and applying the scalpet array to generate skin defects. The incised skin pixels are applied at the skin defects of the recipient site.

Abstract: An inspection machine checks and inspects whether an infusion pump is accurately operated and does not require maintenance in a closed system without drainage. This inspection machine includes a syringe and a plunger and moves the plunger backward when an infusion flows into the syringe through a communication hole by the driving of an infusion pump to measure a flow rate by the backward movement amount. An outer peripheral surface of the plunger has an annular recess and a seal ring is fitted thereto. The seal ring is expanded by receiving a liquid pressure of the infusion to be sealed and the plunger is coaxially centered on the syringe. The flow rate of the infusion is accurately reflected to the plunger movement amount. Further, since the infusion is stored in the syringe and does not drip, drainage equipment is not required and an inspection operation can be performed anywhere.

Abstract: Missed meal bolus reminders or alerts require a user to access the user's pump and/or remote control to clear the reminder/alert even when the user skipped a meal such that no meal bolus was needed. CGM data can be leveraged such that the missed meal bolus alert is only triggered when glucose levels rise in response to consuming the meal within the programmed time window. Therefore, the alert is only provided when a meal is actually consumed and no bolus has been delivered. This further allows the user to be alerted sooner, i.e., as soon as glucose levels rise a predetermined amount or passed a predetermined threshold indicating consumption of a meal as opposed to only at the end of the programmed window.

Abstract: A component for an injection device is a combined needle shield and cap component that comprises a unitary compressible body moulded from rubber. The unitary compressible body has formed therein a cavity for shielding a needle, the cavity having an opening at a first end of the component and extending axially within the component. It also has formed thereon a grip arrangement comprising one or more shape features that permit gripping by a user of the component so as to facilitate the application of force by the user along the longitudinal axis of the component. The combined needle shield and cap component has a proximal end configured to be partly insertable into a body of an injection device.