Protecting a needle point

A drug delivery device may include sterile needle covered by removable a sterility preserving protector. The device optionally includes skin contact surface and a needle protector for preventing a stick hazard upon removal of the skin contact surface from an injection site or angle without Removing completely. Optionally, the needle protector may include a shield that interferes with replacement of the needle protector. In some embodiments, the needle cover may interfere with deployment of the needle protector.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to a protecting a needle point and, more particularly, but not exclusively, to a shield or sensor for needle protection upon removal of a pharmaceutical delivery device from an injection site.

U.S. Pat. No. 6,500,150 discloses, “A drug delivery device having a base member defining a skin-contacting surface, a syringe serving as a reservoir for the drug, and means for expelling drug from the syringe. The syringe is connected to the base member such that the longitudinal axis of the syringe is substantially parallel to the skin surface. A delivery needle is in communication with the syringe. The needle has an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface. In use, the tip of the needle is adapted to penetrate the skin of the subject.”

U.S. Pat. No. 6,824,529 discloses “a drug delivery device having a base member defining a skin-contacting surface, a syringe serving as a reservoir for the drug, and means for expelling drug from the syringe. The syringe is connected to the base member such that the longitudinal axis of the syringe is substantially parallel to the skin surface. A delivery needle is in communication with the syringe. The needle has an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface. In use, the tip of the needle is adapted to penetrate the skin of the subject.”

U.S. Pat. No. 6,843,782 discloses, “A drug delivery device having a base member defining a skin-contacting surface, a syringe serving as a reservoir for the drug, and means for expelling drug from the syringe. The syringe is connected to the base member such that the longitudinal axis of the syringe is substantially parallel to the skin surface. A delivery needle is in communication with the syringe. The needle has an angled bend which directs the tip of the needle substantially perpendicular to the skin-contacting surface. In use, the tip of the needle is adapted to penetrate the skin of the subject.”

U.S. Patent Publication No. 20140163526 discloses that, “an automated injection device may be loaded with a standard type syringe and/or hypodermic needle. Optionally the syringe may be supplied loaded with medicine and/or covered with a sterile needle cover. The syringe may be loaded into the injector with in a sterile state with needle cover in place. Injector may include for example a fastener (for example an adhesive base). In some embodiments, the fastener may assist a user to hold injector steady on the skin of a patient for an extended period. For example, injector may be used to give injections of volume ranging between 0.5 and 3.0 ml over a time period ranging between 30 sec to 180 sec.”

U.S. Patent Publication No. 20150088071 discloses, “ . . . an activation mechanism (20) and a safety latch (122). The activation mechanism is operative to deploy a needle (116) to protrude out of a housing (112), the needle (116) having a longitudinal axis. The safety latch (122) is movably mounted on the housing (112) and formed with a needle opening (129) to allow the needle (116) to pass therethrough. The safety latch (122) has a first position wherein the needle (116) is aligned to pass through the needle opening (129) and a second position wherein the safety latch (122) is moved with respect to the housing (112) such that the needle (116) is blocked from movement in a direction parallel to the longitudinal axis thereof by a portion of the safety latch (122) distanced from the needle opening (129).”

International Published Patent Application 2015048791 discloses, “ . . . a method of preparing a compound device (500) for use. The device may include a sealed component (560) and an active outer surface (579). The outer surface may be protected by a surface cover (589). Preparing the device may include activating the active outer surface by removing the surface cover and exposing an internal portion of the sealed component to the exterior of the device by unsealing the sealed component and synchronizing the activating and said unsealing using a coupler (592) attached to the surface cover and the sealed component.”

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the invention, there is provided an injector with a needle stick protector comprising: a frame having a skin contact surface and defining an aperture in the skin contact surface; a needle having a sharp point configured to advance through the aperture; a needle protector removable mounted over the needle; a stick protector movably attached to the frame and biased against the needle protector.

According to some embodiments of the invention, the injector further includes a handle for pulling the needle protector away from the needle thereby freeing the stick protector to moving to a shielding position shielding the sharp point.

According to some embodiments of the invention, the needle protector protrudes through the aperture.

According to some embodiments of the invention, the biasing causes the stick protector to overhang the aperture.

According to some embodiments of the invention, the injector further comprises: a pharmaceutical reservoir in fluid communication with the needle and having a long axis parallel to the skin contact surface.

According to some embodiments of the invention, the needle is rigidly attached to the pharmaceutical reservoir.

According to some embodiments of the invention, a longitudinal axis of the needle at a sharp tip thereof is oriented at an angle of between 30 to 150 degrees with respect to a long axis of the pharmaceutical reservoir.

According to some embodiments of the invention, the pharmaceutical reservoir includes a cylindrical bore and the long axis is the longitudinal axis of the bore.

According to some embodiments of the invention, the needle is sterile and the needle protector protects a sterility of the needle.

According to some embodiments of the invention, the skin contact surface includes an adhesive.

According to an aspect of some embodiments of the invention, there is provided a needle protection system for an autoinjector comprising: a frame including a skin contact surface having an aperture; a sterile needle including a sharp tip on a distal portion thereof, a connection between the needle movably and the frame defining a pathway of movement for advancing the tip through the aperture; a needle protector removably attached to the needle the needle protector removable from the needle along a trajectory defined by sliding of the needle cap along a axis of the distal portion of the needle; a shield connected to the frame for movement between a deployed position blocking the pathway and the trajectory, an open position clearing the pathway and the trajectory and a primed position blocking the trajectory and clearing the pathway.

According to some embodiments of the invention, the needle protector inhibits contamination of the sharp tip.

According to some embodiments of the invention, the needle shield is coupled to the needle protector such that removing the needle protector causes the shield to move from the open position to the shielding position.

According to some embodiments of the invention, the shield blocks replacement of the protector when the shield is in the shielding position.

According to some embodiments of the invention, the system further comprises: a needle driver configured to control the advancing of the needle tip and wherein the shield is interconnected to the needle driver to prevent the advancing when the shield is in the shielding position.

According to some embodiments of the invention, the shield includes a latch that pivotally mounted to the frame.

According to some embodiments of the invention, the shield includes a needle opening large enough to allow the needle tip to pass therethrough but smaller than the aperture, wherein in the primed position the needle is aligned to pass through the needle opening.

According to some embodiments of the invention, in the shielding position the needle is misaligned with the needle opening.

According to some embodiments of the invention, in the primed position the shield is flush with the frame.

According to some embodiments of the invention, the needle protection system further comprises: a pharmaceutical reservoir in fluid communication with the needle and having a long axis parallel to the skin contact surface.

According to some embodiments of the invention, the sterile needle is rigidly attached to the pharmaceutical reservoir.

According to some embodiments of the invention, a longitudinal axis of the needle at the sharp tip is oriented at an angle of between 30 to 150 degrees with respect to a long axis of the pharmaceutical reservoir.

According to some embodiments of the invention, the pharmaceutical reservoir includes a cylindrical bore and the long axis is the longitudinal axis of the bore.

According to some embodiments of the invention, the skin contact surface includes an adhesive.

According to an aspect of some embodiments of the invention, there is provided a needle protection system for an autoinjector comprising: a frame including a skin contact surface having an aperture; a needle including a sharp tip, a movably connected to the frame for advancing the tip through the aperture; a lock interconnected to the needle for controlling the advancing; a needle protector removably attached to the needle; the needle protector removable from the needle along a trajectory defined by sliding of the needle cap along a axis of the needle; stick protector interconnected with the lock and connected to the frame for movement between two positions: a closed position wherein the stick protector blocks the trajectory for removal of the needle protector; an open position wherein the stick protector secures the lock to prevent the advancing.

According to some embodiments of the invention, the needle protector protrudes through the aperture.

According to some embodiments of the invention, the needle protection system further comprises: a pharmaceutical reservoir in fluid communication with the needle and having a long axis parallel to the skin contact surface.

According to some embodiments of the invention, the needle is rigidly attached to the pharmaceutical reservoir.

According to some embodiments of the invention, a longitudinal axis of the needle at the sharp tip is oriented at an angle of between 30 to 150 degrees with respect to a long axis of the pharmaceutical reservoir.

According to some embodiments of the invention, the pharmaceutical reservoir includes a cylindrical bore and the long axis is the longitudinal axis of the bore.

According to some embodiments of the invention, the needle is sterile and the needle protector protects a sterility of the needle.

According to some embodiments of the invention, the skin contact surface includes an adhesive.

According to an aspect of some embodiments of the invention, there is provided a system for protecting a needle of a wearable pharmaceutical delivery device comprising: an outer surface the pharmaceutical delivery device including a skin contact surface, the skin contact surface including at least a open portion defining an opening; a pharmaceutical reservoir in fluid communication with the needle and having a long axis parallel to at least one surface selected from the open portion of the skin contact surface and another portion of the skin contact surface; a needle driver connected to the needle and movable mounted to the open portion of the skin contact surface for advancing a tip of the needle through the opening and outward from the skin contact surface; a switch interconnected between the needle driver and the open portion of the skin contact surface; the switch enabling the advancing in response to an inward pressure on the outer surface of the device.

According to some embodiments of the invention, during delivery of the pharmaceutical the open portion is flush to the another portion.

According to some embodiments of the invention, the needle is sterile and further comprising: a needle cap protecting a sterility of the needle and blocking the switch and wherein removing the needle cap from the needle enables the switch.

According to some embodiments of the invention, the switch is biased outward from the outer surface of the pharmaceutical device.

According to some embodiments of the invention, the needle is rigidly attached to the pharmaceutical reservoir.

According to some embodiments of the invention, a longitudinal axis of the needle at the tip is oriented at an angle of between 30 to 150 degrees with respect to the long axis of the pharmaceutical reservoir.

According to some embodiments of the invention, the pharmaceutical reservoir includes a cylindrical bore and the long axis is the longitudinal axis of the bore.

According to some embodiments of the invention, the skin contact surface includes an adhesive.

According to an aspect of some embodiments of the invention, there is provided a system a wearable pharmaceutical delivery device comprising: an outer surface the pharmaceutical delivery device including a skin contact surface, the skin contact surface defining an opening; a pharmaceutical reservoir in fluid communication with a needle and having a long axis parallel to the skin contact surface; a needle cap protecting surrounding a tip of the needle of to protect the tip from contamination; a needle driver connected to the needle and movable mounted to the skin contact surface for advancing a tip of the needle through the opening and outward from the skin contact surface; and wherein removing the needle cap from the needle opens a pathway of movement the reservoir for the advancing.

According to some embodiments of the invention, the needle is sterile and the needle cap protecting a sterility of the needle.

According to some embodiments of the invention, the needle is rigidly attached to the pharmaceutical reservoir.

According to some embodiments of the invention, a longitudinal axis of the needle at the tip is oriented at an angle of between 30 to 150 degrees with respect to the long axis of the pharmaceutical reservoir.

According to some embodiments of the invention, the pharmaceutical reservoir includes a cylindrical bore and the long axis is the longitudinal axis of the bore.

According to some embodiments of the invention, the skin contact surface includes an adhesive.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

Overview

The present invention, in some embodiments thereof, relates to a protecting a needle point and, more particularly, but not exclusively, to a shield or sensor for needle protection upon removal of a pharmaceutical delivery device from an injection site.

An aspect of some embodiments of the current invention relates to a needle cap which interferes with deployment of a needle protector of a drug discharge device (sometimes a needle cap is referred to as a rigid needle shield RNS). Optionally, the needle protector may be deployed when the cap is removed. In some embodiments, deploying the needle protector may activate the injector.

An aspect of some embodiments of the current invention relates to a pharmaceutical delivery device (for example a drug delivery device, for example an injector) including needle protector that interferes with removal of a needle cap. For example, when the shield and/or sensor is deployed it may block a trajectory of movement of the cap. Optionally the shield and/or sensor has a non activated position which clears the cap. For example, after the cap is removed from the needle, the shield and/or sensor may move from the non active position to a deployed position.

An aspect of some embodiments of the current invention relates to a needle shield and/or sensor that in a deployed state interfere with replacing a needle cap of the injector. Optionally, when the injector is activated and/or primed the sensor and/or shield is deployed.

An aspect of some embodiments of the current invention relates to a needle shield for a drug injector that moves between three states. For example the needle shield may have an open position (for example a pulled back position). The pulled back position may allow a needle cap and/or a cap removal tool to protrude into and/or out of the injector. Optionally, when the needle cap is removed, the needle shield may move to a shielding position. In the shielding position the shield may block exposure of the needle tip. Alternatively and/or additionally the needle shield may have a primed position. In the primed position an opening in the shield may be aligned with a needle, allowing the needle to protrude from the injector. Optionally before the needle of the injector is deployed, the shield may move from the shielding position to the primed position. For example, the shield may move from the shielding position to the primed position when the injector is placed on the skin of a subject. Optionally when the shield is in the shielding position the needle may be prevented from deploying. Optionally, the needle shield may move from primed position to the shielding position when the injector is removed from the skin of a subject. For example while the needle is deployed the needle shield may move from the primed position to a deployed position (for example the shielding position) by a slight bending (elastic and/or inelastic) of the needle. Once the needle shield is in the shielding position with the needle deployed the shield is optionally prevented from returning to the primed position, for example by being blocked by the needle and/or locked. Alternatively or additionally the needle may retract at the end of injection.

In some embodiments, a needle cap may protect a needle before use of the device. Optionally, the needle protector may prevent a stick hazard after removal of the needle cap. For example, the needle protector may prevent a stick hazard upon removal of the device from an injection site.

In some embodiments a needle protector may include a shield that shields a needle point to prevent a stick hazard. Optionally the shield will extend past the needle tip to prevent the stick hazard. Alternatively or additionally, a needle protector may include a skin sensor that senses when a skin contact surface of an injector is in contact with and next to an injection site. In some embodiments, a shield may also include a skin sensor and/or the skin sensor may also shield the needle tip.

In some embodiments a sensor and/or needle shield may include a skin contact surface. Alternatively or additionally the sensor and/or shield may extend away from a skin contact surface. Optionally, the skin contact surface may include an adhesive for adhering to a skin of a user. For example, the skin contact surface maybe adhered to the skin in the vicinity of a needle insertion location. In some embodiments, a shield and/or sensor may move between positions in response to an interaction with a skin of a user. For example, when a shield is pushed against a skin of a user the shield may move from a shielding position to a primed position. Alternatively or additionally, when an injector is taken away from the skin of a user a shield and/or a sensor may move to a shielding position and/or a deployed position. For example, when a skin contact surface moves away from the skin, the injector may be switched from an active state to a protected state. Alternatively or additionally, when a housing of an injector moves away from a skin contact surface the injector may be switched from an active state to a protected state. Movement of the sensor and/or shield may cause the injector to switch states. In some embodiments, an injector will include a needle with a sharp tip. For example the sharp tip may be connected to a straight portion of the needle. Optionally the needle cap covers and/or surrounds the straight portion of the needle. For example, the needle cap may have an elongated form and/or be mounted coaxial to the straight portion of the needle. Optionally, a proximal end of the straight portion is connected to a reservoir and/or a neck thereof and/or a needle holder. For example, the proximal end of the needle cap may attach and/or seal to the reservoir and/or the neck thereof and/or to the needle holder. In some embodiments, the needle cap may protect the needle and/or a tip thereof from physical damage, from harming others (e.g. a sharp stick hazard) and/or from contamination (for example the cover may preserve sterility of the needle and/or needle tip).

In some embodiments, the needle cap may be removed from the needle by longitudinal movement. Optionally, the needle cap may be pulled away from the needle with a force of no more than 0.5 Kg. Alternatively, the needle cap may be pulled away from the needle with a force ranging between 0.5 Kg to 1.0 Kg force and/or with a force ranging between 1.0 Kg to 2 Kg force and/or no more than with a force ranging between 2.0 Kg to 3 Kg force and/or with a force ranging between 3.0 Kg to 6 Kg force.

In some embodiments, a needle may be extended, and/or inserted into an injection zone along a linear path. Alternatively or additionally a needle may be extended and/or inserted along a curved path. For example, the needle may be extended and/or inserted by rotating around a pivot. Optionally, while pivoting, the needle may move in a longitudinal direction (the change in direction of movement may coincide with changes in direction of the axis of the needle).

In some embodiments, a needle shield and/or a sensor may be biased to a shielding and/or deployed configuration. Optionally, when a needle cap is covering a needle, the cap interferes with the shield and/or sensor, inhibiting movement to the biased position. Optionally, in some positions a deployed needle interferes with movement of the sensor and/or shield. Optionally, removal of a needle cap may activate an injector. Optionally, removal of a needle cap may cause peeling of an adhesive liner from an adhesive. For example, the adhesive liner may be connected to the needle cap and/or a needle cap puller. For example, the adhesive may be connected to a skin contact surface.

In some embodiments a needle shield may include an aperture through which a needle cap is removed. For example the width of the aperture may range between 1 mm to 3 mm and/or between 3 mm to 8 mm and/or between 8 mm to 15 mm. Optionally, the aperture may be round. Alternatively or additionally it may have a different shape. In some embodiments a shield may not have an aperture for a cap. For example, the shield may open and/or clear an aperture in the housing of the device. Optionally, the cap may be removed through the aperture in the housing. Optionally the aperture in the housing may fit the shield. For example the aperture in the housing may have a width and/or length between 1 to 5 mm and/or between 5 to 10 mm and/or between 10 to 20 mm and/or between 20 to 40 mm and/or between 40 to 80 mm and/or between 80 to 160 mm. Optionally the aperture in the housing may be rectangular and/or have a different shape.

In some embodiments a shield and/or a housing may include a needle opening. For example, a needle opening may be smaller than an aperture for a cap. For example, the width of a needle opening may range between 0 to 0.5 mm and/or between 0.5 to 1 mm and/or between 1 to 2 mm and/or between 2 to 4 mm. Alternatively or additionally, a needle may pass through the aperture through which passes the needle cap.

In some embodiments, a drug delivery device (for example an injector) may include a prefilled sterile cartridge including a cylindrical barrel directly connected to a hypodermic needle covered by a sterile needle cap. In some embodiments, the user removes the sterile needle cap from the prefilled sterile syringe before use. Optionally removing the needle cap activates the device and/or peels an adhesive cover and/or triggers deployment of a needle shield from an open position to a shielding position. In some embodiments, placing a base of the device on the skin of a subject moves the needle shield into a primed position.

In some embodiments, the device discharges a drug into the subject with the axis of the prefilled syringe substantially parallel to the base of the device and/or the skin of the subject. Optionally a needle mounted on the cartridge may be inserted into the skin of the subject and/or may serve as a fluid path directly from the cartridge to the subject. Optionally, removing the device from the skin of the subject redeploys the needle shield and/or deactivates the device.

In some embodiments the drug delivery device may include a prefilled syringe and/or reservoir with a needle and/or hub at an angle to the axis of the barrel of the reservoir. For example, the drug delivery device may include a needle shield and/or a needle retraction mechanism. For example, the delivery device may include an asymmetric syringe and/or plunger seal. For example, the delivery device may include a needle cap and/or cover remover.

In some embodiments, a single use drug delivery device (for example an injector for example an auto-injector, a patch injector, and/or a bolus injector; for example an injector may be hand held and/or worn on the body) may come preloaded with a drug. For example the device may include cartridge. Optionally the cartridge includes a syringe with a sterile hub and/or sterile needle mounted at an angle to the axis of the syringe barrel. The syringe is optionally prefilled with a drug. Optionally the device may include a needle shield and/or a status indicator. Optionally the device may include an attachment mechanism, for example an adhesive for attaching to a subject.

In some embodiments a cartridge may be installed to the delivery device before assembly and/or before being shipped to a retailer and/or a health provider and/or a user. Alternatively or additionally the cartridge may be installed into the drug delivery device by a user, for example a health provider (for example a nurse and/or a pharmacist and/or a doctor and/or a health aid) and/or a subject of the injection (e.g. a patient receiving the drug) and/or a caretaker.

In some embodiments the device may have bilateral symmetry. For example, the user interface of the device may have bilateral symmetry.

DETAILED EMBODIMENTS

Method of Delivering a Drug

FIG. 1is a flow chart illustration of a method of delivering a drug and/or shielding a needle in accordance with an embodiment of the current invention. In some embodiments, an injector may include a needle cover that interferes with a needle shield.

In some embodiments, an assembled injector (with the cartridge installed) may be supplied112to a user. Optionally as supplied112to the user, the cartridge and/or hub and/or the needle may be sterile and/or covered with a sterile needle cap. Optionally, the injector may have a needle shield. For example, while the needle cap is in place the needle shield may be in an open position, allowing the access to the needle cap. For example, when the needle shield is in the open position there may be space for the cap and/or a cap remover to protrude out of the injector. For example, in the open position, the needle shield may retract. In some embodiments the needle shield may pivot and/or slide from one position and/or state to another. Alternatively or additionally the cartridge and/or the injector may be supplied112to the user separately and/or may be assembled by the user.

In some embodiments, before use of an injector, the needle cap may be removed114. For example, the needle cap may be pulled off of the cartridge through an aperture in the injector housing. Optionally removing114the needle cap may cause the delivery device to be activated116and/or the needle shield to move to a shielding position. For example, the cap and/or a removal tool may be connected to a switch and/or a battery insulator and/or an adhesive protector. Removing the cap optionally activates the switch and/or causes removal of the battery insulator and/or removal of the adhesive protector. Once activated116, the delivery device optionally indicates that it is ready to be placed on a subject. Optionally, once the needle shield is in the shielding position it may prevent replacement of the needle cap. Optionally, when the needle shield is in the shielding position it may prevent exposure of the needle. For example, in the shielding position, the needle shield may block the needle tip from extending out of the injector. Alternatively or additionally, when the shield is in the shielding position the needle extension mechanism may be locked and/or disabled thereby preventing extension of the needle out of the injector and/or in the shielding position the needle shield may shield an extended needle tip.

In some embodiments, the injector is placed120on the skin of a subject. For example, the delivery device may be placed120on the skin of the subject after activation116. Optionally placement on the skin causes the needle shield to move122to a primed position. For example, the shield may be pushed by the skin of the subject into the primed position. Movement122of the shield into the primed position may cause extension of a needle from the injection device and/or insertion of the needle through the skin of the subject. For example, the shield may collapse inward exposing the needle and/or allowing the needle to enter the subject and/or movement122of the shield may trigger an insertion mechanism. Alternatively or additionally, movement122of the shield into the primed position may open a path for the needle to exit the injector. For example, movement122of the shield into the primed position may align an opening in the shield to the needle allowing the needle to be extended out of the device, for example through the opening in the needle cap. Alternatively or additionally, an additional step may cause insertion of the needle, for example pushing a button and/or pushing a portion of the injector towards the skin of the subject.

After insertion of the needle, a drug may be delivered124into the subject. For example the needle may be hollow and the drug may be delivered124through the needle into the subject. Optionally, once injection has completed the device may indicate that injection is finished and/or that the device may be removed. Optionally when a malfunction occurs (for example an occlusion of the fluid path) an indicator may indicate that a malfunction has occurred and/or that the injector should be removed. In some embodiment, the needle may retract upon completion of injection and/or upon certain malfunctions. Alternatively or additionally, the needle may remain extended after delivery124.

In some embodiments, after delivery124and/or error and/or when indicated to do so, a user may remove128the injector from the skin of the subject. In some embodiments when the injector is removed128, the needle shield may redeploy130. Redeployment130of the needle protector may protect the needle and/or shut down the device. Alternatively or additionally, needle retraction may protect the needle. Alternatively or additionally, the device may shut down and/or be disabled immediately after completion of delivery124and/or upon certain malfunctions. Alternatively or additionally, the device may shut down and/or be disabled after a certain time period after the completion of delivery124and/or upon certain malfunctions.

FIG. 2is a flow chart illustration of a method of protecting a needle in accordance with an embodiment of the present invention. In some embodiments an injector is supplied212to a user with a sterile needle protected by a needle cap. Optionally, removing214the needle cap may facilitate activation, priming222and/or use of the device.

In some embodiments the needle cap may protect a needle from contamination and/or may inhibit priming222, activation and/or use of the device. For example, while the needle cap is in place protecting the needle, the needle cap may interfere with deployment216of a skin sensor. Optionally, until the skin sensor is deployed216a needle driver may be disabled. Alternatively or additionally, the needle cap, while in place over the needle, may interfere with a moving222a sensor to a primed position. For example, the sensor may be triggered by pushing an appendage toward a housing and/or base of the device. For example, when the device is placed220against the skin of a user a sensor and/or shield may be pushed toward the base and/or housing. For example, the needle cap may interfere with movement of the appendage toward the base. In some embodiments, the needle cap may be interconnected to an adhesive liner and/or a battery insulator. Optionally removal of the needle cap may cause peeling of the adhesive liner away from an adhesive and/or removal of the battery insulator. Optionally removal of the needle cap may facilitate adhering the device (for example a base thereof and/or the skin sensor) to an injection site. Alternatively or additionally, removal of the needle cap may activate the device.

In some embodiments, once the needle cap has been removed214, returning the cap may be inhibited. For example, removing214the cap may release a sensor to partially and/or completely block a needle aperture. In some embodiments, partial blockage of the aperture may inhibit returning the cap onto the needle.

In some embodiments, moving222the sensor to a primed position may facilitate use of the device. For example, moving222the sensor to a primed position may unlock a needle insertion switch and/or trigger needle insertion and/or trigger discharge224of a drug.

In some embodiments, removing228the injector from the skin of a user releases and/or redeploys230a skin sensor. Optionally, releasing and/or redeploying230of the skin sensor deactivates230the device and/or locks the device in a neutralized state (for example with a needle protected and/or with drug discharge disabled).

Injector Apparatus

FIG. 3is a block diagram illustrating an apparatus for protecting a needle in accordance with an embodiment of the present invention. In some embodiments, a needle cap interacts with a needle shield and/or a sensor.

In some embodiments, an injector includes a skin contact surface388which is movably connected (for example, via a frame that may be part of for example a housing) to a needle352and/or a shield and/or sensor316.

In some embodiments, the needle includes a sharp tip that which may move through an optionally aperture308in the skin contact surface. Alternatively or additionally, the needle tip may move with respect to surface388across and edge thereof.

In some embodiments, all or part of needle352(for example sharp tip354) may be surrounded and/or protected by a needle cap304. For example, needle cap may protect tip354from physical damage and/or may protect tip354from contamination (for example preserving sterility of tip354). Alternatively or additionally, cap304may inhibit a sharp stick event (a stick hazard) by covering sharp tip354.

In some embodiments, shield and/or sensor316may shield tip354to inhibit a stick hazard. Alternatively or additionally, shield and/or sensor316may trigger and/or inhibit actions of the injector. For example, in some states, a shield/sensor316may inhibit activation of the device. Optionally in some states shield/sensor may facilitate activation and/or use of the device. For example, when shield/sensor316is in an open and/or a deployed state, the device may not function and/or needle352may be locked (for example in a retracted state). Optionally when shield/sensor316is in a primed state the injector may function and/or needle352may be released. In some states shield/sensor316may totally and/or partially block aperture308.

In some embodiments, shield/sensor316may be included in skin contact surface388. For example, in a primed state, an outer surface of shield/sensor316may be flush to skin contact surface388. Optionally, aperture308may pass through shield/sensor316.

In some embodiments, cap304may interact with shield/sensor316. For example, while cap304is in place on needle352, shield/sensor316may blocked and/or interfere with moving shield/sensor316from an open position to a primed and/or deployed position. Optionally or additionally, when sensor/shield316is in the shielding and/or primed position movement of cap304may be inhibited. For example sensor/shield304may prevent removal of cap304and/or reinsertion of cap304after it has been removed.

Needle Shield Latch

FIGS. 4A-4Eare perspective views of a drug delivery device with pivoting needle shield latch in accordance with an embodiment of the current invention. In some embodiments, a needle shield may have a fully open state (for example as illustrated inFIGS. 4A, 4B and 5B) wherein the needle shield is opened far enough out of the way of device aperture as to allow a needle cap and/or a needle cap remover to extend out of the aperture. In some embodiments, a needle shield may have a shielding state (for example as illustrated inFIGS. 4D and 4E) wherein the needle shield for example prevents exposure of needle tip454. In some embodiments, a needle shield may have a primed state (for example as illustrated inFIG. 4C) wherein the needle shield is positioned to allow a needle cap tip454to extend out of the device.

In some embodiments, shield/sensor416in some states may be included as a portion a skin contact surface of the device. Optionally, in the primed state, an outer surface of shield/sensor416is flush an outer surface of base488. For example, in the primed state, the outer surfaces of shield/sensor416and/or base488form a skin contact surface of the device.

In some embodiments, a drug delivery device may include power source, for example including a battery425. In some embodiments, a drug delivery device may include an actuator, for example including DC motor429. In some embodiments, a drug delivery device may include a transmission, for example including a plunger driver484. In some embodiments, a drug delivery device may include circuitry, for example a printed circuit board PCB427. For example, circuit board427may electrically connect a power source to a status indicator and/or actuator according to an operational program. When the power source is electrically connected to motor429, motor429optionally rotates transmission484driving a plunger and/or discharging a drug. Optionally, PCB427may include a processor and/or may be sensitive to one or more sensors. Alternatively or additionally, PCB427may function by a simple order of physical switches. Optionally a medicine cartridge may be installed into the device (for example preinstalled and/or installed by a user). In some embodiments the cartridge may in include barrel442optionally containing a drug and/or plugged at a proximal location with a plunger seal and/or having a hub436and/or needle452protected by a needle cap404. Optionally plunger driver484may also be a part of a cartridge. Alternatively or additionally plunger driver484may be part of the delivery device.

FIGS. 4A and 4Billustrate an exemplary drug delivery device with a pivoting latch which is a needle shield416in an open position. In some embodiments, in the open position, needle shield416is excessively pivoted around a pivot449for example at an angle ranging between 75 and 90 and/or at an angle ranging between 75 to 50 and/or at an angle ranging between 50 to 30 degrees to a skin contact surface on the base488of the device.

In some embodiments, while needle latch416is in the opening position a needle cover and/or a cover remover414surround the needle452(for example needle452is illustrated inFIG. 4E). For example, the cap may seal around a portion of needle452protecting sterility of the needle and/or protecting the needle from contamination. Alternatively or additionally, a cap may protect a needle from physical damage and/or from causing damage to people and/or other objects. Optionally, the needle cover and/or cover remover414may inhibited needle latch416from moving to the shielding position and/or primed position. For example, cover remover414blocks and/or interferes with movement of shield416from the open position to the shielding position. In some embodiments, shield416may be biased to a shielding position. For example a spring461may bias shield416.

In some embodiments, a user may activate the delivery device by pulling needle cap remover414away from base488. For example pulling needle cap remover414may remove a needle cap (for example cap404) from the cartridge and/or may peel an adhesive protector from base488. For example, cap remover414may include a handle415(for example a pull ring) to facilitate removal by a user. Optionally, when needle cap remover414and/or needle cap404are removed, needle shield416may swing into a shielding position while mount482and/or needle tip454remain in the retracted state (for example a retracted state is illustrated inFIG. 8Aand a needle shield in a shielding state is illustrated inFIG. 4D). Optionally, removing needle cap remover and/or removing needle cap404and/or pivoting of needle shield416into the shielding position may trigger a switch, remove a battery insulator and/or trigger a sensor to activate the delivery device and/or a user indicator and/or a processor. For example, in the shielding state, a needle shield may be at an angle ranging between 20 and 30 degrees to base488and/or between 10 and 20 degrees and/or between 5 and 10 degrees and/or between 30 and 50 degrees. In some embodiments, barrel442is held to the device by a clip463.

In some embodiments, when the device is activated and/or needle452is retracted and/or needle shield416is in the shielding position, base488may be placed against the skin of a subject. Placing base488against the skin of a subject optionally pushes shield416in the dorsal direction up against base488and/or into an aperture408in base488. For example shield416may move from the shielding position to a primed position (for example shield416is illustrated in a primed position inFIG. 4C). In the primed position a opening417in shield416may be aligned with needle tip454. Optionally, when shield416is in the primed position and/or base488is against the skin of the subject, moving mount482and/or barrel442and/or needle tip454to the extended state causes needle tip454to extend out of opening417into the subject. For example, a needle may be extended by rotating around a pivot448. Optionally while needle tip454is in the subject a drug is discharged into the subject.

In some embodiments, after the beginning of discharge, when the device is removed from the skin of a subject (for example after discharge is completed and/or upon a malfunction and/or by mistake) shield416pivots back to the shielding state (as illustrated in for example inFIG. 4D). Optionally, in the shielding position, shield416is prevented from returning to the open position by a latch462and/or a lock. For example, when shield416has moved to the shielding position and/or the retracted state and/or the primed state, latch462locks onto an appendage548of shield416.

In some embodiments, a needle shield may be connected to multiple biasing elements. For example, spring461biases shield416to the shield and/or primed position (for example towards base488). Additionally or alternatively, there may be a second biasing element (for example a leaf spring and/or latch462and/or a coil spring in the path of appendage458). The second biasing element optionally engages shield416after it is prevented from returning to the open position (for example after appendage458is locked under latch562). Optionally, the second biasing element biases shield away from base488, for example to the shielding position.

In some embodiments, pivot449is a switch that enables needle tip454to advance through opening417. For example, shield416is biased outward to a shielding position. An inward pressure against shield416causes shield416to rotate around pivot449to the primed position and/or enables needle tip454to pass through opening417.

In some embodiments, when shield416is in the shielding position, opening417is not aligned with needle tip454and/or exposure of needle tip454prevented by shield416. Optionally when shield416is in the shielding position and/or the primed position it completely and/or partially blocks aperture408and/or prevents replacing needle cap404and/or cap remover414. Alternatively or additionally, when shield416returns to the shielding position (for example after being in the primed position) a switch and/or sensor may be triggered setting the device into a post injection state and/or inactivating the device and/or stopping discharge (for example if the device was removed prematurely) and/or activating a warning (for example if the device malfunctioned and/or was removed prematurely). In some embodiment, when needle452is extended, shield416is prevented from returning to the primed position.

FIGS. 5A and 5Bare perspective views of a drug delivery device with an extending latch which is an extending needle shield516in accordance with an embodiment of the current invention. In some embodiment in the open position (for example as illustrated inFIG. 5A) needle shield516is not excessively pivoted around a pivot549. Optionally the angle between shield516and the skin contact surface of base488in the shielding position and the open position are the same. Shield516optionally moves from the open to the shielding state by extending an extension519into an extension path of the needle and/or a path of the needle cap and/or path of the needle and/or a path of the needle cap remover. Once extension519has been extended, it may lock in position and/or prevent exposure of a needle and/or prevent replacing a needle cap and/or prevent replacing needle cap remover414. Optionally shield516has a primed position which allows needle extension. For example, with extension519extended, shield516may be pushed toward base488to the primed position in which a opening is aligned a needle. In some embodiments, with extension519in the extended position, shield516may have the same geometry and/or functionality as described above for example with respect to shield416(for example inFIGS. 4A-4Dand their accompanying description).

Movement of a Needle and/or a Needle Cap

FIGS. 6A-6Dare schematic illustrations of an injector having a non-linear movement and a shield in accordance with an embodiment of the present invention. In some embodiments a needle shield and/or sensor may interfere with movement of a needle and/or a needle cover.

In some embodiments, a trajectory of movement may be linear (for example as a needle652and/or cap604move the longitudinal axis may remain unchanged) or curved (for example as needle652and/or cap604move the direction of the longitudinal axis may change). In some embodiments, the trajectories of cap604and/or needle652may coincide and/or they may differ.

In some embodiments, a first object (for example a needle shield and/or sensor) may interfere with movement of a second object (for example a needle and/or a cap) by occupying a space to which the object is moving [for example inFIG. 5Acap remover414occupies the space to which shield extension519moves in a shielding state for example as illustrated inFIG. 5B]. Alternatively or additionally, a first object (for example a needle shield and/or sensor) may interfere with movement of a second object (for example a needle and/or a cap) by blocking a trajectory of movement. For example, inFIG. 6Aa shield616in a shielding position blocks a trajectory for removal of cap604.

FIG. 6Aillustrates an embodiment of an injector in a non activated state in accordance with an embodiment of the current invention. In some embodiments, an injector includes a drug reservoir642in fluid communication with a hollow needle652(for example as illustrated inFIG. 6B). Optionally, the injector is supplied to a user in a non activated state. For example, in the non activated state needle652may be covered by a cap604. Optionally needle652and/or cap604may be straight and/or axially symmetric. For example, in the covered state, needle652and cap604are coaxial. Optionally, the injector includes a needle shield616initially in a shielding position. In shielding position, the shield616optionally blocks an open end (e.g. the lower face) of an injection zone691(illustrated as a dashed box inFIGS. 6A-6D.

FIGS. 6B and 6Cillustrate an injector in an activated state in accordance with an embodiment of the current invention. For example, a user may activate an injector by moving shield616to an active position (for example as illustrated inFIG. 6B). For example, shield616may be rotated around a pivot648to the active position. Optionally, in the active position, shield616may clear injection zone691and/or a clear a path693(for example illustrated by the dashed arrow inFIG. 6B) for removal of needle cap604. For example, trajectory693may be straight and/or parallel and/or coaxial with the longitudinal axis of needle652. Optionally trajectory693passes through injection zone691. In some embodiments, in the shielding position (for example as illustrated inFIG. 6A), shield616blocks trajectory693and/or interferes with removal of cap604.

In some embodiments, needle652may be inserted into injection zone691. Optionally, a trajectory694of the sharp tip of the needle (for example illustrated by the dashed line inFIG. 6C) may not be along a straight line. For example, needle652may be inserted into injection zone691by rotating around a pivot648. Optionally, the tip of needle652follows a curved trajectory694, for example an arc.

FIG. 6Dillustrates an injector in a locked state after injection in accordance with an embodiment of the current invention. In some embodiments, needle shield616may be returned to the shielding state, for example at the end of drug discharge and/or when the injector in removed from an injection location. For example the shield may be returned to the shielding state to protect needle652from a stick hazard.

FIGS. 7A-7Dare schematic illustrations of an injector having a linear movement and a shield in accordance with an embodiment of the present injections. In some embodiments a needle shield and/or sensor may interfere with movement of a needle and/or a needle cover.

FIG. 7Aillustrates an embodiment of an injector in a non activated state in accordance with an embodiment of the current invention. In some embodiments, an injector includes a drug reservoir742in fluid communication with a hollow needle652(for example as illustrated inFIG. 7B). Optionally, the injector is supplied to a user in a non activated state. Optionally, the injector includes a needle shield716initially in a shielding position. In shielding position, the shield716optionally blocks an open end (e.g. the lower face) of an injection zone691(for example as illustrated by the dashed box inFIGS. 7A-7D).

FIGS. 7B and 7Cillustrate an injector in an activated state in accordance with an embodiment of the current invention. For example, a user may activate an injector by moving shield716to an active position (for example as illustrated inFIG. 7B). For example, shield716may be rotated around a pivot648to the active position. Optionally, in the active position, shield716may clear injection zone691and/or a trajectory793(for example illustrated by the dashed arrow inFIG. 7B) for removal of needle cap604.

In some embodiments, needle652may be inserted into injection zone691. Optionally, a trajectory794of the sharp tip of the needle (for example illustrated by the dashed line inFIG. 7C) may not be along a straight line. In some embodiments, needle652is rigidly connected to reservoir742and/or moves with reservoir742. Alternatively or additionally, a needle may be connected to a reservoir by a flexible member and/or joint and/or may move independently of the reservoir. For example, a needle may be connected to a reservoir by a flexible tube.

FIG. 7Dillustrates an injector in a locked state after injection in accordance with an embodiment of the current invention. In some embodiments, in the locked state, needle shield716may be returned to the shielding state, for example to protect needle652from a stick hazard.

FIGS. 8A-8Eillustrate an injector with a sensor in accordance with an embodiment of the current invention. In some embodiments, a state of an injector may be switched according to a state of a sensor. Optionally, the sensor interacts with a needle cap. For example, a skin sensor may be stimulated and/or moved when an injector is placed on the skin of a user. The needle cap may block stimulation of the sensor and/or interfere with movement of the sensor.

FIGS. 8A and 8Bare perspective and cross sectional views (respectively) of an injector in an initial state in accordance with an embodiment of the current invention. Optionally in the initial state, the device is not activated. In some embodiments, an injector800may include one or more cap puller814that interfere with movement of a skin sensor816. For example, in the non activated state, sensor816may be extended away from a top housing882aand/or a lower housing882bof injector800. Optionally, injector800is primed and/or activated by collapsing sensor816toward housing882a,882b. In some embodiments, cap puller814interferes with movement of sensor816towards housing882a,882b.

In some embodiments, sensor816moves towards housing882a,882bby rotating around a pivot849. Puller814optionally fits to sensor816such that rotation of sensor816moves puller814. In turn, puller814is optionally rigidly attached to a needle cap404and/or a needle452and/or a neck436of a reservoir442and/or housing882awhich may inhibit movement of puller814. Inhibiting movement of puller814optionally inhibits rotation of sensor816and/or inhibits activation, priming and/or user of injector800.

In some embodiments, cap404and/or puller814may move longitudinally with respect to sensor816, for example along an axis of needle452. For example, cap404and/or puller814may fit through a opening (for example opening817ofFIG. 8C) in sensor816. Optionally, cap404and/or puller814are removed by linear movement away from the device. Optionally, removing cap404and/or puller814from injector800may facilitate activation and/or priming of the device. In some embodiments, cap puller814may be connected to a handle, for example a pull ring415. The handle may facilitate a user removing puller814and/or cap404.

In some embodiment sensor may include a skin contact surface. Optionally a skin contact surface may include an adhesive874. For example, adhesive874may attach sensor816to the skin of a user in the vicinity of an injection site. Optionally, handle415and/or pull ring814and/or cap404is attached to an adhesive liner876such that removing cap404peels liner876from adhesive874. In some embodiments, housing882b,882bmay include a skin contact surface and/or an adhesive. Liner876may also protect the adhesive of the housing882a,882band/or be peeled off housing882a,882bwith removal of cap404. Alternatively or additionally, a switch and/or battery isolator may be attached to handle415and/or pull ring814and/or cap404such that removing cap404removes the battery isolator and/or triggers the switch.

FIG. 8Cis a cross sectional illustration of an injector with a needle cap removed in accordance with an embodiment of the current invention. In some embodiments, removing the needle cap includes peeling a liner off an adhesive surface (for example a skin contact surface). Optionally, removal of needle cap404may activate the injector800. For example, a CPU may be started and/or self tests and/or timers may be initiated. For example, inFIG. 8C, in the activated state, sensor816is deployed away from housing882b. Optionally sensor816is interlinked to an activation switch. For example an activation switch may include a needle insertion button870. For example, when sensor816is in the deployed state needle insertion button is locked and/or needle insertion is inhibited.

FIG. 8Dis a cross sectional illustration of an injector with a skin sensor in a collapsed state in accordance with an embodiment of the current invention. In some embodiments, injector800may be primed by collapsing sensor816towards housing882band/or into aperture808. For example, sensor816may be collapsed by placing sensor816against an injection site (for example on the skin of a user) and/or adhering sensor816to the injection site and/or pushing housing882a,882btowards sensor816and/or towards the injection site. Optionally the device is primed when sensor816collapses. Optionally, when the device is primed, needle insertion switch870is unlocked, allowing and/or facilitating needle insertion. Alternatively or additionally, collapsing of sensor816may trigger needle insertion.

FIG. 8Eis a cross sectional illustration of an injector in an active state in accordance with an embodiment of the current invention. For example, while injector800is in a primed state, a user may depress needle insertion button870. Depressing button870optionally triggers an insertion driver. For example, the driver may cause upper housing882ato rotate around pivot848with respect to lower housing. Rotation may insert needle tip454through aperture808in housing882band/or through opening817in sensor816into an injection zone of a skin of the user. Alternatively or additionally a needle may be inserted by a linear motion. Alternatively or additionally a needle insertion driver may be triggered directly by collapse of sensor816. Alternatively or additionally, needle insertion may be manual (for example the pressure that the user puts onto button870and/or upper housing882amay push needle tip454into the skin.

In some embodiments, needle tip454may be protected after drug delivery and/or upon removal of device808from the skin of a user. For example needle452may be retracted into housing882a,882band/or a needle shield may be deployed to shield needle tip454.

In some embodiments, in some states, sensor816is flush with a base of the device and/or forms a part of a skin contact surface of the device. Optionally in the collapsed state the outer surface sensor816is flush with lower housing882b. For example the outer surface of sensor816and lower housing882bmay form a skin contact surface of the device.

In some embodiments, pivot849is a switch that enables needle tip454to advance through opening817. For example, shield816is biased outward to a shielding position. An inward pressure against shield816causes shield816to rotate around pivot849to the primed position and/or enables needle tip854to pass through opening817.

FIGS. 9A-9Care schematic illustrations of a needle shield in accordance with an embodiment of the current invention. In some embodiments, a needle shield may move linearly with respect to an injection needle. Optionally, a needle cap may interfere with movement of the needle shield. For example removing the needle cap may allow, facilitate and/or trigger movement of the shield. In some embodiments, a needle shield may include a large opening sized and shaped for a needle cap to pass therethrough. Alternatively or additionally, when the needle cap is on the needle, the shield maybe moved aside and/or the needle cap may pass by an edge of the shield. In some embodiments a needle cap may include a small opening shaped and sized for a needle to pass therethrough.

FIG. 9Aillustrates a schematic view of an injector with a needle protected by a needle cover in accordance with an embodiment of the current invention. In some embodiments, a needle cover604and/or a cover remover protecting a needle of an injector device may protrude through an aperture917bin a needle shield916of the device. For example, aperture917bmay be sized to allow cover604to pass therethrough. For example, cover604may pass therethough by translating linearly along a longitudinal axis of cover604and/or needle452(as illustrated for example inFIG. 9B). Optionally, in the protecting position, cover604and/or the cover remover interferes with movement of shield916.

In some embodiments shield916may be freed by pulling needle cover604may away from the injector. For example, cover604may be pulled away from the injector in the direction of the arrow inFIG. 9A.

FIG. 9Billustrates a schematic view of an injector with a needle cap removed in accordance with an embodiment of the current invention. Optionally, when cap604is removed, shield916is free to translate. For example, comparingFIG. 9AtoFIG. 9Bit can be seen that shield916has translated sideways so that a smaller aperture917abecomes aligned with needle452and/or the larger aperture917bis no longer aligned with the axis of needle452. Optionally aperture917ais large enough for needle452to pass therethrough, but too small for cap604to pass therethrough.

FIG. 9Billustrates a schematic view of an injector in an active state in accordance with an embodiment of the current invention. For example, in the active state, needle452extends out of aperture917a. Optionally the outer surface of shield916includes a skin contact surface and/or an adhesive to adhere to an injection zone of the user. For example, needle452may project into the skin of the user and/or a drug may be discharged under the skin.

In some embodiments, after discharge of a drug needle452may be protected. For example reservoir742and/or needle452may be retracted behind shield916(e.g. above shield916in theFIG. 9C). Alternatively or additionally, shield916may move outward (e.g. linearly and/or by rotation) to shield needle452.

Exemplary Dimensions of a Drug Delivery Device

In some embodiments the payload of a reservoir (for example a syringe) may include, for example between 0.5 and 2 ml and/or between 2 and 4 ml and/or between 4 and 6 ml and/or between 4 and 10 ml of a drug and/or more. In some embodiments, the injector may discharge the entire payload as a single dose. A drug delivery device may include, for example, a patch injector, and/or an internally powered driver to drive the plunger and/or discharge the payload. For the sake of this application an internally powered injector driver may be defined as a drive mechanism powered by energy stored at least temporarily within the injector. Power may be stored in a power supply, for instance as chemical potential (for example a chemical that produces an expanding gas and/or a battery) and/or mechanical potential (for example stored in an elastic member and/or a spring and/or a pressurized gas). For example the driver may be designed to discharge the payload over a time period ranging between 20 and 120 seconds and/or between 120 and 600 seconds and/or between 600 seconds and an hour and/or between an hour and a day and/or longer.

In some embodiments of an injector, a needle is inserted into a subject by rotating a cartridge rigidly connected to the needle. Optionally a dual movement pivoting assembly keeps the needle insertion point stationary in the plane of the base of the device. For example, a pivot element may slide while pivoting thereby keeping the insertion location on the skin of the patient stationary. Alternatively or additionally the dual movement pivot may include a cam and/or an extending lever arm. For example the pivoting movement may be over an angle of 7 to 9 degrees and/or 4 to 7 degrees and/or 2 to 4 degrees and/or 9 to 15 degrees and/or 15 to 30 degrees. The sliding movement may optionally offset horizontal movement of the needle puncture location in the plane of the skin of the subject due to rotation. For example, horizontal movement of a needle may generate a load over the needle that may cause a leak around the insertion area. Optionally, a dual movement pivoting assembly will inhibit the horizontal movement of the needle and/or the insertion location and/or alleviated the load on the needle. Optionally the longitudinal movement of a needle may range between 7.5 to 8 mm and/or between 6 to 7.5 mm and/or between 2 and 6 mm and/or between 8 to 10 mm and/or between 10 to 15 mm and/or between 15 to 50 mm. In some embodiments, the horizontal movement of the needle insertion may for example range between 0 to 0.4 mm and/or 0.4 to 0.8 mm and/or 0.8 to 2 mm. Horizontal movement of the dual movement pivoting assembly, for example lengthening of cam arm and/or sliding of a pivot point optionally compensates for the horizontal movement. For example the horizontal movement of the dual movement pivoting assembly may be of the same order as the horizontal movement of the needle insertion location, for example ranging between 0 to 0.4 mm and/or 0.4 to 0.8 mm and/or 0.8 to 2 mm. Various mechanisms may be used to keep the needle insertion location stationary in spirit with the invention, for example and extending arm and/or an extending mount and/or an extending lever and/or a track (for example a linear track) and/or a cam.

In some embodiments, the apparatus may be preprogrammed to wait a fixed time delay ranging between 2 to 20 minutes and/or 20 minutes to an hour and/or an hour to 6 hours and/or 6 hours to 2 days after activation before beginning delivery of the substance. Optionally the length of the time delay may be an estimated time for a temperature sensitive component of the apparatus to reach a preferred working temperature. For example, the temperature sensitive component may include the drug and/or a battery.

In some embodiments, discharge may be driven by a driver. An internally powered driver may be powered by various mechanisms including for example a motor (including for example a DC motor, an actuator, a brushless motor) and/or a transmission including for example a telescoping assembly and/or a threaded element and/or a gear and/or a coupling and/or an elastic mechanism (for example a spring and/or a rubber band) and/or an expanding gas and/or a hydraulic actuator).

A drug delivery device in accordance with some embodiments of the current invention may include reservoir. For example a reservoir may include a medicine container and/or a syringe. Optionally a syringe may be preloaded with medicine using standard equipment and/or in an aseptic room. A preloaded syringe may optionally include a proximal opening. A plunger may optionally seal the proximal opening and/or protect the sterility of the contents of the syringe. A sterile needle (for example a hollow needle) may optionally be connected to the syringe barrel. For example, the hollow of the needle may be in fluid communication with the interior of the barrel. The needle may optionally be rigidly attached to the hub at the distal end of the barrel. The sterility of all and/or part of the needle may for example be protected by a sterile cover. The sterile cover may remain on the needle when the syringe is supplied and/or installed into an injector. For example, the medicine container may optionally include a cylindrical barrel rigidly attached to a needle. In some embodiments a plunger may slide axially along the inside of the barrel to discharge a medicine payload. For example, the medicine may be discharged through the hollow needle. The protruding tip of the needle may be oriented at an angle to the axis of the barrel.

An aspect ratio of the base may be defined as the ratio of the length of the longest axis of the base to the shortest axis. Optionally the axis ratio may range between 1 to 1.5 and/or 1.5 to 2 and/or between 2 to 3 and/or greater than 3. In some embodiments, the height of the injector may range between half the length of the short axis of the base to the length of the short axis of the base and/or between the length of the short axis of the base to twice the length of the short axis of the base and/or greater than the twice length of the short axis of the base. The height of the injector may supply leverage for pivoting the adhesive off the skin of a patient after use.

In some embodiments, the force to insert the needle to the skin of a patient may range for example between 0.02 to 0.2 N and/or between 0.2 and 0.5 N and/or between 0.5 to 5 N. Optionally, the force required to inject the drug (for example the force on a syringe plunger) may range for example between 5 to 60 N. For example the force required to inject the drug may depend on the injection rate and/or the viscosity of the drug and/or the syringe geometry and/or the needle dimensions.

In some embodiments a needle protection mechanism may be triggered by a linear force greater than, for example, between 10 to 60 N.

For example, drug delivery device may include an auto-injector. The auto-injector may be activated by manually pushing with enough force to insert the needle. The device may then apply an injection force to inject a drug. Once the entire drug is injected and/or when there is an obstruction and/or occlusion, the injection force may rise until it passes a threshold triggering safeguarding of the needle and/or ending injection.

For example in the event of an occlusion and/or at the end of delivery, the linear force generated by the device may increase to the level of up to 60 N. A needle safeguarding mechanism (for example a needle retraction mechanism) may be sensitive to the force. For example mechanism may include a snap that gives way at 40 N returning the needle to the retracted position.

In some embodiments, the stress to inject a medicine and/or to trigger safeguarding of a needle may include a torque. For example, injection of medicine may be driven by a plunger. The plunger may optionally be driven by a threaded assembly, for example a threaded screw and/or teeth and/or a telescoping assembly. Optionally the pitch of the teeth and/or an associated screw may range for example between 0.5 and 2 mm. The diameter of the screw may range for example between 2.5 and 15 mm. The torque to power injection may range for example between 0.2 and 1.0 N*cm. The trigger torque (the torque at which the needle safeguarding is triggered) may range for example between to 0.5 to 2 and/or from 2 to 4 and/or from 4 to 10 N*cm.

In some embodiments a safety mechanism may include linear movement of the ranging between 5 to 15 mm. For example movement of the safety mechanism may include extension of a needle during insertion and/or retraction of the needle and/or extensions of a safety shield and/or retraction of a safety shield. Optionally a needle insertion length (for example the length of needle inserted into a patient) may range for example between 3 to 12 mm.

During injection, the linear movement of a plunger may range for example between 10-50 mm. The length of movement of the plunger may vary for example with the volume of medicine to be injected that may range for example between 0.5 to 3 ml.

In some embodiments, a safeguarding mechanism may be sensitive to a torque. For example, the needle may be retracted when the mechanism is exposed to a twisting moment. Optionally, discharge may be driven by a torque. For example the driver may apply torque to threaded element pushing a plunger. When the torque on the driver reaches a threshold value, the needle may be released and/or retracted and/or a needle shield may be deployed. Alternatively or additionally the trigger mechanism may require both a torque and a linear force. For example, requiring both a torque and a linear stress may prevent premature activation due to momentary friction.

In some embodiments a time of discharge may range may depend on the fill volume and/or viscosity For example the expected injection speeds may be Injection speed depend on viscosity, for example for viscosity ranging from 1 cp to 15 cp the expected injection rage may range between 30 to 40 sec/1 ml, for example for viscosity ranging from 15 cp to 60 cp the expected injection rate may range between 35 to 60 sec/ml for viscosity above 60 cp the expected injection rate may range between 53 to 67 sec/lml. The maximum and/or minimum expected injection time may for example be the maximum and/or minimum allowed fill volume divided by an injection rate. For example an expected time of discharge may range for example between 24 to 48 seconds (for example for between 0.8 and 1.2 ml of fluid having a viscosity ranging between 1 to 15 cp) and/or between 36 to 68 seconds (for example for between 1.2 and 1.7 ml of fluid having a viscosity ranging between 1 to 15 cp) and/or between 51 to 92 seconds (for example for between 1.7 and 2.3 ml of fluid having a viscosity between 1 to 15 cp) and/or between 70 to 150 seconds (for example for 2.0 to 2.5 ml of fluid having a viscosity of between 15 and 40 cp) and/or between 120 seconds and 3 minutes for larger volumes and/or viscosities. In some embodiments injection times may be longer. The length of the injection time may be determined by considerations other than viscosity and/or volume.

In some embodiments reservoir may have a length ranging for example between 20 to 42 and/or 42 to 48 mm and/or 48 to 80 mm and/or 80 to 200 mm. In some embodiments an internal cylindrical space of a reservoir may have an average width ranging for example between 1 to 3 mm and/or 3 to 10 and/or 10 to 15 mm and/or 15 to 25 mm and/or 25 to 50 mm. Optionally a reservoir may have a circular cross section such that width is the diameter of the circle. In some embodiments a hub may have a straight end portion with a length ranging for example between 1 to 3 mm and/or 3 go 7 mm and/or 7 and 8 and/or 8 to 10 mm and/or 10 to 15 mm and/or 15 to 50 mm. In some embodiments straight portion of a needle extending out of a hub may have a length ranging for example between 1 to 5 mm and/or 5 and 7 mm and/or 7 to 10 mm and/or 10 to 20 mm. In some embodiments hub may have sealing ring for a needle cap. The sealing ring may have a length ranging for example between 0.1 to 0.6 mm and/or 0.6 to 1 mm and/or 1 to 2.5 mm and/or 2.5 to 3 mm and/or 3 to 6 mm and/or 6 to 15 mm. In some embodiments sealing ring may have an internal cavity with a length ranging for example between 0.5 to 1.5 mm and/or 1.5 to 2.5 mm and/or 2.5 to 5 mm and/or 5 to 10 mm. In some embodiments sealing ring may have an external average width which also may be an average outer diameter ranging for example between 1 to 4 mm and/or 4 to 5 mm and/or 5 to 10 mm and/or 10 to 20 mm. In some embodiments sealing ring may have an internal average width which also may be an average inner diameter ranging for example between 1 to 3 mm and/or 3 to 4 mm and/or 4 to 10 mm and/or 10 to 18 mm. In some embodiments, a hub may have a neck (not including the sealing ring) with an average width which may be an average diameter ranging for example between 1 to 3 mm and/or 3 to 4 mm and/or 4 to 8 mm and/or 8 to 16 mm. Optionally the neck may have a non-uniform cross section (for example an I beam and/or cross shaped cross section) and/or a tapered cross section. For a non-uniform cross section that average outer width will be defined as the width of the smallest oval that can enclose the neck averaged over the length of the neck. In some embodiments a fluid path between a hub and a reservoir cavity may include a 27 gauge needle and/or a needle ranging between 25 to 30 gauge and/or a needle ranging between 20 to 25 gauge and/or a needle ranging between 30 to 32 gauge. In some embodiments a needle protruding from a hub may include a 27 gauge needle and/or a needle ranging between 25 to 30 gauge and/or a needle ranging between 20 to 25 gauge and/or a needle ranging between 30 to 32 gauge.

It is expected that during the life of a patent maturing from this application many relevant technologies and/or materials will be developed and the scope of the terms are intended to include all such new technologies and materials a priori.

As used herein the terms “about”, “approximately” and “substantially” refer to ±5%

The term “consisting of” means “including and limited to”.