A pen needle (30) for a delivery device includes a hub (32) supporting a needle (54) and a distal needle shield (70) that can retract to expose the needle during injection and return to the extended position after use and lock in the extended position to cover the needle. A proximal needle shield (0.102) moves from a retracted position to an extended position with respect to the hub to shield or cover a proximal end of the needle when the needle hub is separated from the delivery device. A spring (130) extends between the distal needle shield and the proximal needle shield to bias each needle shield to the respective extended position. The distal needle shield (70) is coupled to the proximal needle shield (102) in an initial position to retain the spring (130) in a compressed state. The distal needle shield (70) is depressed to disengage the distal needle shield from the proximal needle shield (102) so that the spring expands to an extended state and moves the shields to the extended positions. A locking member (142, 156) can be provided to lock the proximal needle shield (70) and distal needle shield (102) in the extended position.

A pen needle (30) for a delivery device includes a hub (32) supporting a needle (54) and a distal needle shield (70) that can retract to expose the needle during injection and return to the extended position after use and lock in the extended position to cover the needle. A proximal needle shield (0.102) moves from a retracted position to an extended position with respect to the hub to shield or cover a proximal end of the needle when the needle hub is separated from the delivery device. A spring (130) extends between the distal needle shield and the proximal needle shield to bias each needle shield to the respective extended position. The distal needle shield (70) is coupled to the proximal needle shield (102) in an initial position to retain the spring (130) in a compressed state. The distal needle shield (70) is depressed to disengage the distal needle shield from the proximal needle shield (102) so that the spring expands to an extended state and moves the shields to the extended positions. A locking member (142, 156) can be provided to lock the proximal needle shield (70) and distal needle shield (102) in the extended position.

In one embodiment, an infusion set and sensor assembly delivered within a subject is disclosed. The assembly includes a cannula that is terminated at a cannula opening. The assembly further includes a sharp that is at least partially within the hollow of the cannula. A sensor having a proximal end and a distal end is also included in the assembly. The proximal end of the sensor is held in a fixed location while the distal end is retained with a portion of the cannula. The sensor further includes sensor slack, wherein transitioning the sharp from a first position to a second position simultaneously inserts the cannula and sensor to a desired insertion depth within a subject via a single point of insertion.

In one embodiment, an infusion set and sensor assembly delivered within a subject is disclosed. The assembly includes a cannula that is terminated at a cannula opening. The assembly further includes a sharp that is at least partially within the hollow of the cannula. A sensor having a proximal end and a distal end is also included in the assembly. The proximal end of the sensor is held in a fixed location while the distal end is retained with a portion of the cannula. The sensor further includes sensor slack, wherein transitioning the sharp from a first position to a second position simultaneously inserts the cannula and sensor to a desired insertion depth within a subject via a single point of insertion.

The present invention provides a method for generating an immune response in a subject, comprising administering to the subject's skin an immunizing composition from a SARS-CoV-2 pathogen, wherein the composition is administered with a microneedle delivery device.

The present invention provides a method for generating an immune response in a subject, comprising administering to the subject's skin an immunizing composition from a SARS-CoV-2 pathogen, wherein the composition is administered with a microneedle delivery device.

Provided is a paracentesis assistance system that identifies the type of biological tissue. The paracentesis assistance system (10) comprises a measurement device that applies high-frequency waves to at least two electrodes (31 and 32) of an electrode needle (3) inserted into a biological tissue (9), and repeatedly measures the electrical impedance of the biological tissue (9) where the electrode (31) is located, the electrodes being arranged at the tip of the electrode needle in a longitudinal direction; and an identification device (2) that identifies the type of biological tissue (9) based on the temporal change in the repeatedly measured electrical impedance.

Drug delivery system, injection device, transfer apparatus, vial holder and method of administering and transferring are disclosed which provide for passive warming of chilled injectable transferred through the transfer apparatus and into the injection device. The injection device may include a skin-facing surface including a skin boundary displacement extension or structure around a needle injection site to create a high pressure zone in the tissue. Radio frequency tracking and monitoring features for tracking patient compliance also may be provided.

An exemplary tissue detection and location identification apparatus can include, for example, a first electrically conductive layer at least partially (e.g., circumferentially) surrounding a lumen, an insulating layer at least partially (e.g., circumferentially) surrounding the first electrically conductive layer, and a second electrically conductive layer circumferentially surrounding the insulating layer, where the insulating layer can electrically isolate the first electrically conductive layer from the second electrically conductive layer. A further insulating layer can be included which can at least partially surrounding the second electrically conductive layer. The first electrically conductive layer, the insulating layer, and the second electrically conductive layer can form a structure which has a first side and a second side disposed opposite to the first side with respect to the lumen, where the first side can be longer than the second side thereby forming a sharp pointed end via the first side at a distal-most portion. The exemplary configuration can be used for (a) determination/detection of a tissue type using impendence of the electrically conductive layers, and/or (ii) determination of a location of at least one portion of the insertion device/apparatus. Another exemplary apparatus can include, for example, a base structure comprising a lumen extending along a length thereof, and at least one optically-transmissive layer circumferentially surrounding the base structure and provided at least at a distal end of the base structure. For example, in operation, the optically-transmissive layer can be configured to transmit a particular optical radiation at the distal end thereof toward a target tissue.

An exemplary tissue detection and location identification apparatus can include, for example, a first electrically conductive layer at least partially (e.g., circumferentially) surrounding a lumen, an insulating layer at least partially (e.g., circumferentially) surrounding the first electrically conductive layer, and a second electrically conductive layer circumferentially surrounding the insulating layer, where the insulating layer can electrically isolate the first electrically conductive layer from the second electrically conductive layer. A further insulating layer can be included which can at least partially surrounding the second electrically conductive layer. The first electrically conductive layer, the insulating layer, and the second electrically conductive layer can form a structure which has a first side and a second side disposed opposite to the first side with respect to the lumen, where the first side can be longer than the second side thereby forming a sharp pointed end via the first side at a distal-most portion. The exemplary configuration can be used for (a) determination/detection of a tissue type using impendence of the electrically conductive layers, and/or (ii) determination of a location of at least one portion of the insertion device/apparatus. Another exemplary apparatus can include, for example, a base structure comprising a lumen extending along a length thereof, and at least one optically-transmissive layer circumferentially surrounding the base structure and provided at least at a distal end of the base structure. For example, in operation, the optically-transmissive layer can be configured to transmit a particular optical radiation at the distal end thereof toward a target tissue.