Abstract: Embodiments of the current disclosure are directed toward systems, devices and methods for diabetes management. In particular, the present disclosure relates to systems, devices and methods for dispensing insulin to a patient using a miniaturized and portable patch pump.

Abstract: Embodiments of the present disclosure, inter alia, are directed to a one piece continuous glucose monitoring (CGM) device (device or sensor) and a fully disposable, one piece, mounting unit for mounting the CGM device, is provided. The device and the mounting unit, in some embodiments, are pre-assembled in the factory to a one piece, disposable, mounting assembly. The mounting assembly, can be comprised of sealed compartment that includes a portion of the sensor and a non-sealed compartment that includes another portion of the sensor. The mounting assembly can be fully automatic, at a button press the sensor is adhered to the skin, and the sensor probe is inserted into the subcutaneous tissue.

Abstract: Embodiments of the present disclosure relate to systems, devices and methods for continuous glucose monitoring. In some embodiments, a continuous glucose monitoring (CGM) device is provided that includes a subcutaneous implantable electrochemical sensing probe (sensor). The sensor is planar and comprises counter and working electrodes that are deposited at both sides of the sensing probe. A biocompatible layer deposited at the entire sensor circumference minimizes inflammatory reaction. A reel to reel production process provides “per sensor” layers' deposition at predefined spots on a base sheet during displacement between production stations. Production processes are conducted initially at one side of the base sheet followed by production processes on the opposite side.

Abstract: Embodiments of the current disclosure are directed toward systems, devices and methods for diabetes management. In particular, the present disclosure relates to devices and methods for dispensing insulin to a patient. A portable fluid infusion device, comprising a disposable part (DP) and a reusable part (RP) is disclosed. The DP comprises a first reservoir and a second reservoir, the second reservoir less than or equal to the first reservoir in length, while the RP comprises a first compartment configured to receive the first reservoir, a second compartment configured to receive the second reservoir and a gasket for sealing a junction between the second reservoir and the second compartment upon connection of the RP and the DP.

Abstract: Embodiments of the present disclosure are directed to systems, methods and devices for providing, in some embodiments, embolic protection in a patient. For example, a medical device and implantation method for implanting a medical device within a blood vessel of a subject are provided and comprise, for example, providing a medical device configured for arrangement within a blood vessel, where the device comprises a filament configured to include a first device end (posterior) and a second device end (anterior), an un-deployed state including at least a portion configured to fit within a lumen of a needle, and a deployed state wherein the filament automatically forms a helix wound in a first direction as viewed from the first device end to the second device end, the helix optionally including at least one of a support portion and a filter portion.

Abstract: Embodiments of the current disclosure are directed toward systems, devices and methods for diabetes management. In particular, the present disclosure relates to systems, devices and methods for dispensing insulin to a patient using a miniaturized and portable patch pump.

Abstract: Embodiments of the current disclosure are directed toward systems, devices and methods for diabetes management. In particular, the present disclosure relates to devices and methods for dispensing insulin to a patient. A portable fluid infusion device, comprising a disposable part (DP) and a reusable part (RP) is disclosed. The DP comprises a first reservoir and a second reservoir, the second reservoir less than or equal to the first reservoir in length, while the RP comprises a first compartment configured to receive the first reservoir, a second compartment configured to receive the second reservoir and a gasket for sealing a junction between the second reservoir and the second compartment upon connection of the RP and the DP.

Abstract: Some embodiments of the present disclosure are directed generally to systems and methods for delivering an implant to a body vessel of a patient. Such disclosed implants may be a monofilament implant, and disclosed systems for implanting the implant may be automatic. Some embodiments may enable retraction of said implant back into the delivery system following partial exteriorization of the implant from the delivery system. Some embodiments may be configured for retraction of said implant from the patient's body following complete exteriorization of the implant from the delivery system. Some of the embodiments are directed at delivering a monofilament implant for preventing embolic stroke. Other embodiments are directed at preventing pulmonary embolism, occluding a body vessel such as the left atrial appendage, occluding a body passageway such as a patent foramen ovalae, stenting a body vessel, or releasing a local therapeutic agent such as a drug or ionizing radiation.

Abstract: A transfer station for transferring a medical fluid between at least one supply container and at least one administration container of an infusion device is described. In an embodiment, the transfer station comprises at least one supply port configured for fluidic connection of the at least one supply container to the transfer station, and at least one exit port configured for fluidic connection of the at least one administration container to the transfer station. A transfer mechanism for automatically transferring a predetermined amount of medical fluid from the at least one supply container to the at least one administration container, and an electronic processing unit connected to an actuation means are provided with the transfer station. A processing unit controls the transfer mechanism and fluid transfer conditions according to a predetermined transfer demand entered by the actuation means.

Abstract: Embodiments of the present disclosure are directed to systems, methods and device for providing embolic protection in a patient, and implantation of devices (and systems thereof) for enabling such functionality. In some embodiments, a device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an un-deployed state and a deployed state. In the un-deployed state, the device or a portion thereof is configured to reside in the lumen of a thin needle or cannula having a diameter of less than about 0.5 mm (for example). The needle may include a curved portion, fix the deployed state, the device has an axis which, when implanted, is positioned approximately parallel to the fluid flow of the vessel. In some embodiments, the device comprises a thin filament body whereby in a deployed state, at least a portion of the filament takes on a helical shape. In some embodiments, at least one helix coil has height or pitch greater than the coil diameter.

Abstract: Embodiments of the present invention are directed to devices, systems and methods for delivering therapeutic fluid (e.g., insulin) into the body, including a skin adherable cradle, for retaining a therapeutic fluid dispenser for delivering a therapeutic fluid to a user.

Abstract: Embodiments of the present disclosure are directed to systems, methods and devices for providing embolic protection in a patient. In some embodiments, the device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an undeployed state and a deployed state. In the undeployed state, the device or a portion thereof has a substantially linear shape configured to reside in the lumen of a thin needle having a diameter of less than about 0.5 mm (for example), in the deployed state, the device has a primary axis. When the device is implanted the primary axis is approximately perpendicular to the fluid flow. In some embodiments, the device comprises a thin filament body. In the deployed state the filament takes a helical shape. Emboli that are larger than the distance between consecutive turns or windings of the helix are thus filtered by the device and are prevented from causing deleterious conditions such as stroke or pulmonary embolism.

Abstract: Embodiments of the present disclosure are directed to systems, methods and devices for providing embolic protection in a patient. In some embodiments, the device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an undeployed state and a deployed state. In the undeployed state, the device or a portion thereof has a substantially linear shape configured to reside in the lumen of a thin needle having a diameter of less than about 0.5 mm (for example), in the deployed state, the device has a primary axis. When the device is implanted the primary axis is approximately perpendicular to the fluid flow. In some embodiments, the device comprises a thin filament body. In the deployed state the filament takes a helical shape. Emboli that are larger than the distance between consecutive turns or windings of the helix are thus filtered by the device and are prevented from causing deleterious conditions such as stroke or pulmonary embolism.

Abstract: Embodiments of the present disclosure are directed to systems, methods and devices for providing embolic protection in a patient, and implantation of devices (and systems thereof) for enabling such functionality. In some embodiments, a device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an un-deployed state and a deployed state. In the un-deployed state, the device or a portion thereof is configured to reside in the lumen of a thin needle or cannula having a diameter of less than about 0.5 mm (for example). The needle may include a curved portion. In the deployed state, the device has an axis which, when implanted, is positioned approximately parallel to the fluid flow of the vessel. In some embodiments, the device comprises a thin filament body whereby in a deployed state, at least a portion of the filament takes on a helical shape. In some embodiments, at least one helix coil has height or pitch greater than the coil diameter.

Abstract: Embodiments of the present invention are directed to devices, systems and methods for delivering therapeutic fluid (e.g., insulin) into the body, including a skin adherable cradle, for retaining a therapeutic fluid dispenser for delivering a therapeutic fluid to a user.

Abstract: Disclosed is a fluid dispensing device that includes at least one reservoir to hold the therapeutic fluid, at least one other unit requiring communication with ambient air, at least partly, to operate, and at least one housing defining an interior to retain the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent port is adapted to direct or communicate air to maintain pressure equilibrium between the air pressure in the interior of the at least one housing and the ambient air pressure outside the at least one housing, and provide communication with the ambient air to the at least one other unit requiring air to enable operation of the at least one other unit.

Abstract: Disclosed is an ambulatory therapeutic fluid delivery device. The device includes at least one housing connectable to a cannula, the at least one housing retaining a reservoir to hold the therapeutic fluid. The device also includes a mechanically powered pumping mechanism to cause delivery of at least some of the fluid from the reservoir, and a power-transfer mechanism to transfer manually-delivered power provided by a user to mechanically actuate the pumping mechanism.

Abstract: A portable therapeutic fluid delivery device with a flow detector comprising a heating element and two temperature sensors is presented. Upon activation of the heating element, a flow condition of the fluid inside the delivery tube is determined based on a signal provided by the temperature sensors. A temperature gradient within the therapeutic fluid is detected. The determined flow condition can be one of: air bubbles within the delivery tube, occlusion within the delivery tube, or leakage within the delivery tube. The device can have two parts, for example, a reusable part and a disposable part. Upon pairing of these parts, the heating element and the temperature sensors touch the delivery tube.

Abstract: Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient's vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.

Abstract: Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient's vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.