Abstract: A drug delivery system is disclosed that includes a drug delivery device having a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, and one or more controllable elements. The drug delivery system may further include one or more sensors coupled to the drug delivery device, and a controller coupled to the one or more sensors and the one or more controllable elements. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device. Furthermore, the controller may be configured to control the controllable element based on the condition or the operational state of the drug delivery device and/or identity information stored in a memory onboard the device. A method for use with a drug delivery device is also disclosed.

Abstract: An autoinjector comprises a housing, a product container, a displaceable needle protection sleeve, a plunger rod displaceable by a preloaded discharge spring, a dose setting element with at least two different rotational positions relative to the housing, and a dosing sleeve. The dosing sleeve or the plunger rod has a dose selection stop, and the other has at least one dosing stop. By rotating the dose setting element, the dosing sleeve or the plunger rod is rotated relative to the other. Upon displacement of the needle protection sleeve, the spring displaces the plunger rod, whereby, if the dose setting element is in the first rotational position, the dose selection stop and the first dosing stop strikes against each other, and, if the dose setting element is in the second rotational position, one of the dose selection stop and the first dosing stop is or can be moved past the other.

Abstract: The present disclosure relates to a safety mechanism for a medicament delivery device for mechanical shock absorption, which safety mechanism has a medicament delivery member sleeve, a housing having a proximal opening arranged to receive the medicament delivery member sleeve, wherein the medicament delivery member sleeve is axially displaceable inside the housing, between an extended position in which a proximal end portion of the medicament delivery member sleeve extends proximally from the housing and a retracted position in which the proximal end portion is received by the housing, wherein the proximal end portion has a resilient structure, enabling compression of the proximal end portion in the distal direction upon impact of an axial force greater than a threshold value.

Abstract: The present invention is directed to a device and method for monitoring and assessment of movement disorder symptoms. The device and method disclosed herein are particularly amenable to remote monitoring of a subject's movement disorder symptoms. Briefly stated, in certain preferred embodiments of the present invention the movement disorder monitoring device accompanies a subject to a remote location where the device is used to record data relating to the severity of a subject's movement disorder symptoms over a period of time. This data is then subsequently used by physicians or other clinicians in optimizing and assessing treatment options directed at alleviating a subject's movement disorder symptoms. The method and device of the present invention can be used to monitor symptoms of a number of movement disorders including but not limited to dystonia, essential tremor, Huntington's disease, various ataxias, multiple sclerosis, psychogenic tremor, and Parkinson's disease.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. The insertion device may include a body having a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion is designed to guide a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: Described herein are devices, methods and kits for assessing and/or enhancing the accessibility of a subvalvular space of a heart, accessing the subvalvular space of the heart (e.g., to provide access for one or more other devices), and/or positioning one or more devices in the subvalvular space of the heart. The devices described herein may, for example, comprise catheters that may be used to manipulate one or more chordae tendineae, diagnostic catheters having different sizes and/or shapes (e.g., different curvatures), guide catheters having different sizes and/or shapes (e.g., different curvatures), and visualization catheters. In some variations, the devices, methods, and/or kits may be used to visualize a target site, such as a subannular groove of a heart valve. In certain variations, the devices, methods, and/or kits may be used to manipulate chordae tendineae to provide additional space in a ventricle of a heart (e.g., enhancing the accessibility of the ventricle).

Abstract: An injection device and method are shown. Devices and methods include a forceps and a needle advancement mechanism to clamp a portion of tissue and control a depth of penetration of the needle between gripping ends of the forceps. An injection device and method are shown where selected components of the injection device such as a syringe and forceps are disposable, while the remaining portions of the injection device are reusable. Devices and methods are shown that utilize micro-needles to control a depth of penetration.

Abstract: A device which regulates the flow of a medical liquid includes a first and a second body, the first body featuring a first passage fluidly connected to a regulation channel, the second body featuring a second passage which may be positioned at a desired point of the regulation channel and set, during use, in fluid passage communication with the first passage by means of the regulation channel. The device includes a limiter which, once engaged, can no longer be disengaged during normal use of the regulation device, the first body or the second body featuring at least a first stop, and the limiter, when engaged, encountering the first stop in order to prevent the second passage being positioned in a predetermined portion of the regulation channel and/or at the first passage.

Abstract: A deflectable catheter shaft with compression resistance coils configured to create different curve shapes when the catheter is steered or deflected in different directions. One or more compression resistance coils may include an elongated-pitch section. The compression resistance coils may be pull wire compression coils or body compression coils.

Abstract: A syringe stabilizing apparatus has a base and a syringe support. The syringe support is vertically disposed above the base, elevating a fluid-filled portion of an infusion set vertically above the base and orienting a delivery end of the fluid-filled portion upwardly relative to a horizontal plane to take advantage of a gravitational effect on a fluid during delivery of the fluid from the fluid-filled portion to a patient. The syringe support comprises a first retainer and a selectively actuated tube clamp. The first retainer has an opening in which a rigid portion of the infusion set is received and retained therein without further user intervention. The selectively actuated tube clamp is operatively aligned with the first retainer. A flexible tube extending from the rigid portion of the infusion set extends through the selectively actuated tube clamp.

Abstract: MVO is treated by introducing injectate into blood vessels affected by MVO at precise flow rates, while blocking retrograde flow, such that the natural pumping of the heart aids in forcing the injectate into the affected microvessels. Monitoring pressure distal of an occlusion balloon is used to determine treatment effectiveness and heart health.

Abstract: One or more embodiments of the disclosure relate, generally, to a system to assist with manual dosing of insulin. Such a system may include a glucose sensor system, a reusable insulin dosing detector, and a recommendation system. The reusable insulin dosing detector may be configured to be reversibly connectable to a disposable component that may form part of an insulin manual delivery assembly. The reusable insulin dosing detector may be configured to detect insulin delivery associated with the insulin manual delivery assembly. The recommendation system may be configured to analyze blood glucose data and determine adjustments to insulin therapy settings.

Abstract: A blinding cap for covering a needle shield that is covering a needle of a syringe includes an elongated body extending between a proximal end and an opposing distal end, the body at least partially bounding a chamber. An annular sleeve projects from the proximal end of the body and at least partially bounds a channel. A first flange radially inwardly projects from the body into the chamber, the first flange at least partially bounding an opening that provides communication between the chamber and the channel.

Abstract: Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.

Abstract: An apparatus (1) for CRRT is provided comprising a blood circuit (10, 20, 30, 60) with a blood removal line (20), a treatment unit (10), and a blood return line (30). A replacement fluid container (78) is configured for containing a medical fluid, a pre-infusion line (70) has a first end (70-1) connected to the replacement fluid container (78) and a second end (70-2) connected to the blood removal line (20) and a blood pump (22) is active on the blood circuit. A replacement fluid pump (72) is active on the pre-infusion line (70), a dialysate circuit (40, 50, 70) comprises an effluent line (50) configured for discharging fluid from the second chamber, and a control unit (80) is connected to the replacement fluid pump (72) and to the blood pump (22) and is configured for performing a rinse-back procedure for restituting blood to a patient.

Abstract: A method of performing a rhizotomy includes directing an electrocautery probe through an incision in the body of a patient, navigating a distal tip of the probe to a location adjacent a target nerve, energizing the probe to deliver energy to the target nerve, and moving the distal tip of the probe in a plurality of directions to direct the energy at the target nerve.

Abstract: A laparoscopic suction/irrigation device of the disclosed invention encases a rigid inner cannula with a flexible outer cannula, the outer cannula functioning to insulate the inner cannula from unwanted electrical discharges. Upon translating the distal end of the outer cannula beyond the distal end of the inner cannula, the outer cannula returns to a preexisting curvilinear shape. This curved extension can thereafter be positioned via a proximal handle to concavities within the surgical site for precise and effective fluid retraction.

Abstract: The present invention provides an implantable microneedle and a manufacturing method therefor. An implantable microneedle according to the present invention comprises a coating layer for covering at least one part of the surface of a tip part of the microneedle. When exposed to moisture, the coating layer can be separated from the tip part of the microneedle and thus be implanted.

Abstract: Methods for treating fluid overload in a subject comprise shifting fluids directly and non-invasively from an interstitial compartment of the subject to skin of the subject through controlled local sweating. Methods of the invention allow for removal of excess fluid from the interstitial compartment of the subject and treat fluid overload in the subject. Sweat stimulation systems comprise a chamber and first and second relative humidity sensors. The chamber is sized to fit around a body part of a subject, comprises an inlet and an outlet, and is configured such that air flows through the chamber from the inlet to the outlet. The first relative humidity sensor is operably located inside the inlet, and the second relative humidity sensor is operably located proximate the outlet.

Abstract: One or more embodiments of the disclosure relate, generally, to a diabetes management system. The diabetes management system may include a computing device that is configured to receive data relating to prior insulin use of a user and calculate a sliding scale glucose correction based, at least in part, on the data relating to prior insulin use.