Described herein is an intracameral therapeutic agent delivery device in the form of a pen-injector comprising a cartridge container for dispensing multiple doses of a medicament, coupled to an actuation assembly within a housing. A needle assembly is coupled to the distal end of the cartridge container, provided with a removable cap received within the housing will be in optional pre-sterile or no-sterile condition. Use of such device for the prevention or treatment of ocular conditions or diseases is also disclosed.

Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject). In some cases, upon contact of the tissue with the tissue engaging surface of the article, the self-righting article may be configured to release one or more tissue interfacing components. In some cases, the tissue interfacing component is associated with a self-actuating component. For example, the self-righting article may comprise a self-actuating component configured, upon exposure to a fluid, to release the tissue interfacing component from the self-righting article. In some cases, the tissue interfacing component may comprise and/or be associated with the pharmaceutical agent (e.g., for delivery to a location internal to a subject).

A method of controlling flow through a flexible tube includes providing a pinch clamp mechanism including a pinching element and a pinching surface configured to apply a force on the flexible tube when the flexible tube is positioned between the pinching element and the pinching surface. The method also includes displacing the pinching element relative to the pinching surface with a mechanical drive unit and biasing the pinching element toward the pinching surface with a spring.

A pre-filled syringe includes a barrel with a medicament and a stopper within the barrel. The stopper has at least two adjacent sealing rings and a trim ring. The syringe has a head space distance between a distal-most surface of the stopper and the surface of the medicament. The head space (a) provides sufficient space to optimize reconstituting a drug suspension by shaking or agitating the drug suspension, and (b) minimizes frothing and/or clogging of the reconstituted drug suspension in the barrel. Also, a kit includes the syringe, a plunger, a syringe cap, and a needle assembly. Further, a method for stoppering the syringe includes determining the head space distance.

Injector devices and methods for using them to deliver medicament into a patient's body, e.g., sub-retinally within an eye, are provided. The injector includes a cartridge including a piston slidably disposed within an interior for delivering medicament within the interior through an outlet, and a driver including a plunger coupled to the piston, a source of pressurized fluid, and an actuator member for opening a flow path at least partially between the source and the plunger to advance the plunger and piston to deliver medicament from the interior. One or more sensors are operatively coupled to the plunger to measure displacement of the plunger, a processor is coupled to the sensor(s) for analyzing sensor signals to measure volume of medicament delivered from the interior, and an output device, e.g., one or more LEDs or speakers, provide outputs related to the volume of medicament delivered.

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.

Components with relatively high loading of active pharmaceutical ingredients are generally provided. In some embodiments, the component (e.g., a tissue interfacing component) comprises a solid therapeutic agent and a supporting material such that the solid therapeutic agent is present in the component in an amount of greater than or equal to 10 wt % versus the total weight of the tissue interfacing component. Such tissue-interfacing components may be useful for delivery of API doses e.g., to a subject. Advantageously, in some embodiments, the reduction of volume required to deliver the required API dose as compared to a liquid formulation permits the creation of solid needle delivery systems for a wide variety of drugs in a variety of places/tissues (e.g., tongue, GI mucosal tissue, skin) and/or reduces and/or eliminates the application of an external force in order to inject a drug solution through the small opening in the needle. In some cases, a physiologically relevant dose may be present in a single tissue interfacing component.

A masking package (100) for blind testing of materials stored in a syringe, the masking package (100) comprising: an opaque housing (110) defining a syringe chamber (111) adapted to substantially surround a plunger and at least a portion of a barrel of a syringe; and a plunger extender (130) slidably receivable in the syringe chamber (111) and comprising a coupler (132) adapted to couple to the plunger of a syringe received in the syringe chamber (111), wherein movement of the plunger extender (130) relative to the opaque housing (110) moves the plunger of a syringe received in the syringe chamber (111) relative to the barrel of the syringe; and a masking package (200) for blind testing of materials stored in a vial, the masking package (200) comprising an opaque housing (210) defining a chamber (211) for receiving and surrounding a vial, the housing (210) having a length between an upper end and a lower end and comprising a first housing part (212) and a second housing part (214), the first and second housing parts (212, 214) being openable along the length of the housing (210) to define an opening in the chamber (211) that extends the length of the housing (210) for inserting a vial laterally into the chamber (211), wherein the housing is formed with a single piece construction.

Self-actuating articles including, for example, self-actuating needles and/or self-actuating biopsy punches, are generally provided. Advantageously, the self-actuating articles described herein may be useful as a general platform for delivery of a wide variety of pharmaceutical drugs that are typically delivered via injection directly into tissue due to degradation in the GI tract. The self-actuating articles described herein may also be used to deliver sensors and/or take biopsies without the need for an endoscopy. In some embodiments, the article comprises a spring (e.g., a coil spring, a beam, a material having particular mechanical recovery characteristics). Those of ordinary skill in the art would understand that the term spring is not intended to be limited to coil springs, but generally encompass any reversibly compressive material and/or component which, after releasing an applied compressive force on the material/component, the material/component substantially returns to an uncompressed length of the material/component (e.g., the within 95% of the length of the material/component prior to compression).

The present disclosure is directed to a device for screening pre-filled syringes configured to determine whether a stopper position within each syringe falls within an acceptable tolerance prior to final assembly of a syringe into a corresponding autoinjector device, thereby ensuring proper fit of the syringe within the autoinjector device and further ensuring accurate delivery of a desired dose of fluid from the syringe during operation of the autoinjector.