Abstract: The present disclosure relates to a medicament delivery device. The medicament delivery device comprises a housing, a needle and a reservoir. The needle is configured to project from a distal end of the housing. The reservoir is disposed in the housing and has a flexible wall. The medicament delivery device further comprises a dispensing member and a biasing member. The dispensing member is disposed in the housing and the biasing member is configured to bias the dispensing member to move in an arcuate path relative to the housing such that the dispensing member moves across the flexible wall of the reservoir to dispense medicament from the reservoir when the reservoir contains medicament.

Abstract: Ambulatory medicament devices that provide therapy to a subject, such as blood glucose control, are disclosed. Disclosed systems and methods can implement one or more features that improve the user experience, by modifying delivery of therapy to a subject after determining that a possible occlusion exists in a medicament delivery system, monitoring the status of an ambulatory medical device and the health condition of a subject that receives therapy from the ambulatory medical device and annunciating alarm condition when necessary, selectively muting alarm annunciations while a Do Not Disturb mode is activated, implementing various power saving modes to save power, controlling operation of the device and medicament delivery based on the user gesture controls, and controlling medicament delivery based on a condition of the ambulatory medicament device.

Abstract: A system and method for patient-adaptive hemodynamic management is described. One embodiment includes a system for hemodynamic management including transfusion, volume resuscitation with intravenous fluids, and medications, utilizing monitored hemodynamic parameters including the described dynamic predictors of fluid responsiveness, and including an intelligent algorithm capable of adaptation of the function of the device to specific patients.

Abstract: A gas elimination apparatus and a method for use in an intravenous delivery system are provided. The apparatus includes in a fluid inlet coupling a fluid flow into a liquid chamber, a fluid outlet protruding into the liquid chamber, and a flow diversion member proximal to the fluid outlet. The flow diversion member configured to block a direct flow between the fluid inlet and the fluid outlet. The apparatus includes a membrane separating a portion of the liquid chamber from an outer chamber and a gas venting valve fluidically coupling the outer chamber with the atmosphere. The flow diversion member may be mechanically supported by at least one strut or elongate member extending along a flow direction into the liquid chamber.

Abstract: A fluid control device includes an interface to a remote fluid monitoring sensor that detects fluid flow in a patient. In some embodiments, a processor within the fluid delivery device is programmed to adjust the delivery or withdrawal of fluids based on the fluid flow signals provided by the sensor. In some embodiments, the fluid control device can display and/or record fluid flow signals thereby acting as a hemodynamic monitor.

Abstract: A mixing and/or reconstitution system reduces the possibility of user error and provides a well mixed and/or reconstituted drug in a short time. The system comprises a device containing a first material within a first chamber, a housing, and a plunger, the plunger comprising a second chamber containing a second material, wherein one of the first and the second material is a fluid, and a movable element with an electric, magnetic, or paramagnetic characteristic, wherein the second chamber is initially closed; and a base unit comprising a recess for accommodation of the device, a control unit, and an electromagnetic unit which is adapted to produce an electromagnetic field penetrating the recess, wherein the control unit can electrically operate the electromagnetic unit such that the element contained in the second chamber moves in a direction of the device determined by the electromagnetic field and fluidly communicates the first and second chambers.

Abstract: A drug delivery device has a housing with an adhesive pad associated with the lower surface of the housing and configured to removably attach to a human body surface. A deformable drug reservoir is positioned within the housing and includes an outlet, with a needle fluidically connected to the drug reservoir and configured to define at least a portion of a fluid flow path between the drug reservoir and said human body surface. A delivery assembly is associated with the drug reservoir and includes a roller and a drive assembly, with the drive assembly being controlled by the controller during a drug delivery routine to move the roller from a first position to a second position so as to cause the roller to contact and deform the reservoir, thereby conveying a drug from the reservoir via the outlet.

Abstract: An auto-injector includes a chassis and a carrier subassembly. The carrier subassembly includes a carrier arranged inside a case, a drive spring, a plunger comprising a ramp member, the plunger configured to be pushed in a proximal direction by the drive spring, and a ramp attached to the carrier, wherein the ramp member on the plunger in an initial state is locked to the ramp on the carrier to form a ramped engagement to the carrier, the plunger prevented from rotating out of the ramped engagement depending on a relative longitudinal position of the carrier relative to the chassis, wherein the plunger is arranged to be released and to rotate out of the ramped engagement upon the carrier translating a pre-defined distance in a proximal direction relative to the chassis.

Abstract: Catheter tubing comprises: an elongate body comprising a base thermoplastic polyurethane; and a compounded thermoplastic polyurethane co-extruded with the base thermoplastic polyurethane to provide a section of catheter tubing discrete from the elongate body, the compounded thermoplastic polyurethane comprising a thermoplastic polyurethane and a radiopaque material, wherein the catheter tubing comprises a first elastic modulus under first conditions prior to entry into a patient; and wherein when exposed to second conditions comprising two or more in vivo stimuli for a duration of time the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus.

Abstract: Apparatuses, systems and methods for the wireless communication of medical devices in a subcutaneous fluid delivery system are disclosed. A system for subcutaneous fluid delivery includes a primary patch pump adapted to attach a first infusion cannula to a user and to perform a plurality of primary patch pump functions, and a secondary patch pump adapted to attach a second infusion cannula to a user. The secondary patch pump is further adapted to perform a plurality of secondary patch pump functions substantially similar to the plurality of primary patch pump functions if an error condition associated with the primary patch pump is determined.

Abstract: A medical device system. The system includes a first medical device, a first remote interface, and a second remote interface in communication with the first remote interface and the first medical device, wherein the first medical device sends a command to the first medical device through the second remote interface, and wherein when the second remote interface receives the command, the command must be confirmed by the second remote interface before the command is send by the second remote interface to the first medical device.

Abstract: An injection apparatus for sequentially injecting a patient with at least two medicaments may include a hand-held unit comprising a grip for being held by an operator, a single needle, a base unit coupled to the hand-held unit via at least one connecting tube, at least two containers for holding medicaments removably coupled to the base unit, and at least one pump. The at least one connecting tube can be flexible enough to enable easy maneuvering of the hand-held unit and rigid enough to prevent widening of the tube due to inner pressure when medicaments pass from the containers to the hand-held unit. The injection apparatus can be used to administer the at least two medicaments sequentially at different injection points.

Abstract: Embodiments disclosed herein are directed to a securement device including a retainer defining a channel and at least one mounting wing extending therefrom. The mounting wing extends distally of an insertion site a skin surface adjacent to the insertion site to prevent “rocking” or “pistoning.” The mounting wing further includes channels of reduced thickness configured to impart malleable properties on the mounting wing. This can allow the mounting wing to be shaped to fit different portions of the patient. The retainer further includes various locking and anti-rotational features to guide the catheter into position within the retainer and further prevent “rocking” or “pistoning.” The securement device also includes a protective pad to inhibit abrasions from a medical line, spin nuts, and the like, and includes a clasping feature to retain a portion of the release liner to prevent obstructing ingress/egress of the catheter.

Abstract: The disclosure is directed to a pressure sensor of an implantable medical device. The pressure sensor may utilize detect fluid pressure based on a changing capacitance between two capacitive elements. The pressure sensor may define at least a portion of a fluid enclosure of the IMD. In one example, the pressure sensor has a self-aligning housing shape that occludes an opening in the pump bulkhead of the IMD. An operative surface of the pressure and the portion of the fluid enclosure may be formed of a corrosion resistant and/or biocompatible material. A first capacitive element of the pressure sensor may be a metal alloy diaphragm that deflects in response to external fluid pressure. A second capacitive element of the pressure sensor may be a metal coating on a rigid insulator sealed from the fluid by the diaphragm and a housing of the sensor.

Abstract: Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods are provided. In one embodiment, a method of dispensing a substance to an intended user is provided. The method comprises receiving an input from a biometric sensor; determining, based on the received input, whether an intended user's unique biometric attribute is detected by the biometric sensor; receiving an input from an environmental sensor; determining, based on the received input, whether a mouthpiece is positioned within a user's mouth; receiving an input from a capacitive sensor array of the mouthpiece; determining, based on the received input, whether an intended user's unique dentition is positioned within a recess of the mouthpiece; and dispensing a substance from a reservoir to a mouth of the intended user in response to determining that the intended user's unique biometric attribute is detected by the biometric sensor.

Abstract: An insertion apparatus for inserting an object into a body comprising a housing, a piercing structure with a lumen, wherein the piercing structure extends distally from the housing, a vacuum chamber that communicates with the lumen of the piercing structure, a plunger configured to fit within the vacuum chamber, a guidewire, and a pressure monitoring channel communicating with the lumen, wherein the insertion apparatus is configured to be operated with a single hand.

Abstract: A drug delivery device has a housing including upper and lower surfaces, with an adhesive pad associated with the lower surface of the housing and configured to removably attach to a human body surface. A drug reservoir is positioned within the housing, with a needle fluidically connected to the drug reservoir and configured to define at least a portion of a fluid flow path between the drug reservoir and said human body surface. A controller is configured to control the components of the drug delivery device to execute a drug delivery routine, with a display coupled to the controller and configured to receive signals from the controller so as to provide an indicium visible through the upper surface of the housing. The display may be electrical or mechanical in nature.

Abstract: An extension member is has a body with a proximal end and an opposing distal end. It includes a hollow lumen extending therethrough from the proximal end to the distal end. It has a female luer lock connector proximate its proximal end and a male luer lock connector proximate its distal end. Its body has an outer surface with a driven member.

Abstract: An on-body injector includes a drug reservoir with an associated temperature sensor. A piston having an associated force sensor is driven to convey a drug out of the drug reservoir during a drug delivery routine. The temperature and force sensors are electrically coupled to a controller that controls the components of the on-body injector to execute a drug delivery routine. The controller receives signals from the temperature sensor indicative of a temperature of the drug within the reservoir and from the force sensor indicative of a force experienced by the piston during the drug delivery routine. The controller analyzes the signals to determine whether the measured force is different from an expected force at the measured temperature. The controller generates an error signal when the measured force is different from the expected force at the measured temperature.

Abstract: A wearable injector for automated delivery of biologic drugs that solves the problem of high volume and high viscosity drug administration by providing a device that can be worn by the patient through use of an adhesive patch to deliver the medication slowly over extended periods of time.