A drive mechanism suitable for use in drug delivery devices is disclosed. The drive mechanism may be used with injector-type drug delivery devices, such as those permitting a user to set the delivery dose. The drive mechanism may include a housing, a dose dial sleeve, and a drive sleeve. A clutch is configured to permit rotation of the drive sleeve and the dose dial sleeve with respect to the housing when the dose dial sleeve and drive sleeve are coupled through the clutch. Conversely, when the dose dial sleeve and drive sleeve are in a de-coupled state, rotation of the dose dial sleeve with respect to the housing is permitted and rotation of the drive sleeve with respect to the housing is prevented. In the de-coupled state, axial movement of the drive sleeve transfers force in a longitudinal direction for actuation of a drug delivery device.

The present invention provides a drug injection device (100) comprising a first element (140) and a second element (103) configured to undergo unidirectional movement relative to each other corresponding to an action performed on or by the drug injection device (100), wherein the first element (140) comprises a plurality of serially disposed protrusions (143), wherein the second element (103) comprises first and second deflectable transducers (103a/153a, 103b/153b) configured for sequentially cooperating with the plurality of protrusions (143), and wherein a processor (151) is electrically connected with the first and second deflectable transducers (103a/153a, 103b/153b) to register activation signals, wherein the protrusion configuration is so disposed on the first element (140) and the first and second deflectable transducers (103a/153a, 103b/153b) are so disposed on the second element (103) that a second activation signal generated by the second deflectable transducer (103b/153b) is delayed relative to a first activation signal generated by the first deflectable transducer (103a/153a) as the first element (140) and the second element (103) move relative to each other, and wherein the processor (151) is configured to provide a) a first control action if a time delay between the first and second activation signals is above or equal to a pre-defined value, and b) a second control action if said time delay is below said pre-defined value.

An actuation mechanism is presented for a medicament delivery device having a plunger rod arranged to act on a stopper of a medicament container, an actuator arranged slidable and connected to the plunger rod for acting on the stopper when said actuator is operated by displacing it in a longitudinal direction of the actuation mechanism, and an activator for activating the actuation mechanism and for setting a dose. The activator having a generally tubular activator sleeve provided with a spirally extending groove on an outer surface, the groove arranged with a length corresponding to the total amount of medicament to be delivered in a number of doses contained in said medicament container, where the groove is provided with an end wall, a stop ring arranged coaxial with said activator sleeve. The activator sleeve arranged with a follower positioned in the groove and the follower arranged to abut the end wall when the total amount has been delivered.

An injection device is provided, comprising a cartridge configured to hold a volume of fluid, the cartridge having a proximal end and a distal end through which the fluid is dispensed; a first stopper disposed in the cartridge and configured to move from the proximal end toward the distal end to cause the fluid to be dispensed through the distal end of the cartridge; a second stopper disposed at the distal end of the cartridge, the second stopper including an aperture through which the fluid is dispensed; a reflector disposed at the distal end of the cartridge; and a transmitter and a receiver disposed in the first stopper, the transmitter configured to transmit one or more waves toward the reflector and the receiver configured to receive reflections of the one or more waves from at least the reflector.

Disclosed in some forms is a process of limiting the impact of surgery on a nerve, the process comprising applying a therapeutic substance to the nerve during surgery. In some aspects, disclosed is a formulation for reducing nerve trauma comprising an active pharmacological ingredient adapted to intervene in the activation of pathways of cellular degradation within the nerve and a carrier adapted to reduce dissemination of the active pharmacological ingredient beyond the site at which its effect is intended.

A delivery system for delivering a drug depot to a site within a patient, the system comprising: a cannula; a delivery stylet configured and dimensioned to be receivable by and slidable forwardly and backwardly within the cannula including to a position wherein a distal portion of the stylet protrudes beyond the distal end of the cannula; a drug depot retainable by the stylet at the distal end of the stylet, the drug depot being visualizable by a diagnostic imaging beam or modality; and an actuator for ejecting the drug depot from the stylet to a site within the body using fluid pressure. Also disclosed are methods using, and uses of, the delivery system, including for treating scoliosis.

Medicinal fluid delivery devices and methods for advancing and retracting needles are disclosed. According to an aspect, a medicinal fluid delivery device includes a tube that defines an interior space that extends between a first and second openings. The device includes a needle including a proximal end and a distal end that substantially align in a first direction. A portion of the distal end is biased to extend in a second direction different than the first direction. A mechanism is attached to the proximal end and configured to position the distal end between a first position and a second position. In the first position, the portion of the distal end is constrained by the interior wall such that is does not extend in the second direction. In the second position, the distal end is not constrained by the interior wall such that it extends in the second direction.

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs), e.g., Factor VIII (FVIII) including PEGylated and other forms of stabilized FVIII, within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

In general, systems and methods for patient monitoring using drug administration devices are provided.

A wearable drug delivery device that can deliver a liquid drug stored in a container to a patient is provided. The container can be a prefilled cartridge that can be loaded into the drug delivery device by the patient or that can be preloaded within the drug delivery device when provided to the patient. A sealed end of the container is pierced to couple the stored liquid drug to a needle conduit that is 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 cartridge to the patient through the needle conduit. The drive system can include a spring coupled to a plurality of force transfer elements. The force transfer elements can have a variety of shapes and configurations.