Improved systems and methods for medicine delivery, and in particular, improved insulin pen needles and related devices are provided. Smart injection devices record and transfer data including medicine level, delivered dose, dose confirmation, and dose time and date. Additional data captured may include glucose concentration, insulin level, carbohydrates ingested, stress level, exercise, blood pressure, and glucose high and low excursion events. Various means of data collection and analysis are provided and systems can identify and flag patients who require intervention. Smart sleeves and add sensing capability to standard insulin pens. Pen needles are provided with sensing capability to confirm and measure doses delivered by insulin pen. A two-part pen cap include a primary sleeve that connects to the insulin pen and an end cap that provides for capturing the time of dose delivery, and monitoring the hold time for a dose delivery after plunger movement.

Medical devices such as medical containers can be formed of glass and annealed which produces a clean device having a low bio-burden, or formed by plastic molding which produces a clean device. The clean devices are immediately transferred to a controlled environment such as a clean room or localized area to avoid the need to maintain cleanliness levels in an entire room. Syringe tip closures can be introduced into the housing assembly, where syringe barrels and tip closures are cleaned with filtered ionized air and the tip closures are coupled to the barrels. The syringe barrels can be filled with a substance and a closure member attached. While still in the housing assembly the syringe barrels can be formed into an array and placed in a clean outer container, which is then closed and sealed.

The present invention relates to an assembly (101) comprising: an injection device (1) comprising a container (2) for a product, said container comprising a distal tip (3), an adaptor (5) comprising a ring (6) mounted onto said distal tip (3), characterized in that said assembly (101) further comprises a heat-shrinkable film (9) covering part (2a) of said container (2) and part (5a) of said adaptor (5), said film (9) maintaining said adaptor (5) blocked in rotation and in translation with respect to said container (2) when said film (9) is in its heat-shrunk condition. The invention further relates to a method for manufacturing such an assembly.

Provided is a needle removal operation cover with which a user can safely perform an injection needle removal operation even when a needle tip is directly inserted into the needle removal operation cover, and with which the user can remove the injection needle without requiring a wrist twisting motion. In a needle removal operation cover which is configured such that an injection needle which is detachably and threadedly mounted on a distal end of an injection cylinder is threadedly removed by rotating the injection needle, the needle removal operation cover is formed in a cylindrical shape such that a needle tube of the injection needle including a needle tip is accommodated in the needle removal operation cover and integral mounting of a needle hub in the needle removal operation cover is allowed, a flange body for a rotating operation is formed on a cylindrical outer peripheral surface in a projecting manner, an outer periphery of the flange body is formed of a plurality of continuous mountain-like ridge portions, and among the mountain-like ridge portions, the mountain-like ridge portions which correspond to a rotational direction along which the injection needle is released from the injection cylinder are formed into a shape which allows easy engagement of a finger for an operation with the ridge portions.

A needle hub assembly for a pen needle includes a needle hub, a cannula or needle coupled to the needle hub, a retractable and compressible sleeve covering at least one end of the cannula, and an outer cover. The outer cover encloses the needle hub and the retractable sleeve. The retractable sleeve is coupled to the hub to cover the end of the cannula where the sleeve can pass through or can be pierced by the cannula and the sleeve retracts axially on the cannula. The sleeve is resilient and returns to an original configuration when an insertion force is released. The needle hub can have a first sleeve to cover a patient end of the cannula, and second sleeve to cover a non-patient end of the cannula where the sleeves retract onto the cannula or hub and expand to the original configuration to cover the ends of the cannula.

The invention is related to an apparatus comprising a dispense interface comprising a lockout element for use with a drug delivery device, the lockout element comprising at least one spring component removeably maintained in a respective first position such that when the dispense interface is first attached and then removed from said drug delivery device, each spring component moves into a respective second position, which respective second position is configured to prevent said dispense interface from being reattached to a drug delivery device.

A pen needle, comprising a reusable adapter configured for attachment to a distal end of a medication pen, the adapter having a proximal needle for accessing the interior of the pen injector and a fitting on the distal side for mating with a patient end needle assembly, and a disposable patient-end needle assembly having a base configured for mating with the fitting on the distal side of the adapter and a patient-end needle extending from a distal end of the base.

A needle attachment and detachment assist device includes a frame body, a syringe guide jig, and a needle guide jig. A guide hole is formed in the syringe guide jig. In the needle guide jig, a needle insertion hole is formed on a central axis of the guide hole. The needle insertion hole includes a center hole portion and a rib guide groove. When a syringe is inserted into the guide hole, and a needle member is further inserted into the needle insertion hole, rotation prevention of the needle member is achieved. In this state, when the syringe is rotated in a first direction, the needle member can be clamped to a thread portion of the syringe. When the syringe is rotated in a second direction, the needle member can be loosened.

A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes providing, on the injector, a plurality of indicia only at prescribed doses of 50 μg, 100 μg, 150 μg and 200 μg settable via the dose setter without indicia between said prescribed doses; and permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter, wherein the injector is configured to provide at least one audible feedback during the rotation.

A medication injection pen is provided comprising a housing (218), for housing a dose set knob (220), a leadscrew (226), a driver (224), a setback member (222), and a dose stop member (228). The dose set knob (220) is rotatable with respect to said housing (218) to set a desired injection dose, and comprises at least one internal thread (291). The leadscrew (226) includes a thread element by which it is advanceable in a first direction via a corresponding thread engagement, said first direction being that which expels medication from a cartridge (36). The driver (224) is rotationally fixed to said leadscrew (226) for preventing relative rotation therebetween, said driver (224) being rotatable in a first direction to rotate and advance said leadscrew (226) in said first direction. The setback member (222) is rotationally fixed to said driver (224) for preventing relative rotation therebetween.