Drug delivery device with container access system and related method of assembly

Abstract

To provide a drug delivery device and a related method of assembly.SOLUTION: A drug delivery device may include a container including a wall with an interior surface, and a seal member with an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir filled with a drug. A fluid pathway assembly may be connected to the container and include an overmold member which covers a length of a container access needle and which defines an enclosed space with the seal member. The overmold member may be moveable relative to the seal member to carry the container access needle between a storage position, where a point of the container access needle is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 536,909, filed July 25, 2017, the entire contents of which are expressly incorporated by reference herein.

[0002] The present disclosure relates generally to drug delivery devices and, more particularly, but not necessarily limited to, enabling a sterile fluid flow path between a drug container assembled within the drug delivery device and a patient. [Background technology]

[0003] Drug delivery devices, such as injectors, are used to deliver liquid medication to patients. Upon activation, the drug delivery device expels the drug stored in an internal reservoir through a needle, cannula, or other delivery member to the patient. Some drug delivery devices are manufactured with an empty reservoir, and the patient or healthcare provider (e.g., a doctor, nurse, medical assistant, etc.) fills the reservoir with drug at the time of use. Typically, this requires the patient or healthcare provider to manipulate a syringe to inject the drug into the empty reservoir through an inlet port formed in the drug delivery device. Prior to this filling procedure, the inlet port should be sterilized, for example, by wiping its external surface with an alcohol wipe. Alternatively, some drug delivery devices have a prefilled drug container attached by the patient or healthcare provider at the time of use. Before attaching the prefilled drug container, the mating connectors located on the prefilled drug container and the fluid pathway assembly in the device, respectively, should be sterilized, for example, by wiping them with an alcohol wipe. In either case, the drug delivery device must be prepared by the patient or healthcare provider before use.

[0004] More recently, drug delivery devices have become available that are pre-assembled with a pre-filled drug container. This eliminates the need for the patient or healthcare provider to add drugs to the drug delivery device at the time of treatment. In such drug delivery devices, a sterile fluid flow path is provided between the pre-filled drug container and a fluid pathway assembly upon activation of the device. Typically, this involves accessing the interior of the drug container with a container access needle so that the drug can be expelled from the container through the container access needle. Prior to activation of the device, the container access needle should be maintained in a sterile state so that the container access needle does not introduce contaminants into the container upon activation of the device. Existing assemblies for enabling sterile access of the drug container through the container access needle tend to be bulky, difficult to assemble, and / or very complex in design.

[0005] The present disclosure describes a drug delivery device and associated assembly methods that embody advantageous alternatives to existing drug delivery devices and assembly methods and that can address one or more of the problems or needs discussed above, as well as provide other benefits and advantages. Summary of the Invention [Means for solving the problem]

[0006] One aspect of the disclosure provides a drug delivery device including a container, a seal member, and a fluid pathway assembly connected to the container. The container may have a wall having an interior surface, and the seal member may have an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir to be filled with the drug. The fluid pathway assembly may include a container access needle having a tip, and an overmold member. The overmold member may cover a length of the container access needle and may define an enclosed space between the overmold member and the seal member. The overmold member may be movable relative to the seal member to carry the container access needle between a stored position in which the tip of the container access needle is disposed outside the reservoir, and a delivery position in which the tip of the container access needle extends through the end surface of the seal member into the reservoir.

[0007] Another aspect of the present disclosure provides a method of assembly that includes: (a) providing a fluid pathway assembly including a container having a wall with an interior surface, a container access needle having a tip, and an overmold member covering a length of the container access needle with the tip protruding out of the overmold member; (b) covering a first opening formed in the wall of the container with the seal member such that an end surface of the seal member and an interior surface of the container wall define a reservoir; and (c) positioning the overmold member to define an enclosed space between the overmold member and the seal member.

[0008] The present disclosure will be more fully understood when the following description is taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by omitting selected elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily indicate the presence or absence of the particular element in any of the illustrative embodiments, unless expressly described in the corresponding written specification. Additionally, none of the drawings are necessarily drawn to scale. [Brief description of the drawings]

[0009] [Figure 1] 1 shows a schematic cross-sectional view of one embodiment of a drug delivery device according to the principles of the present disclosure. [Figure 2A] 2 shows an exploded cross-sectional view of the container, seal member, and fluid pathway assembly shown in FIG. 1. [Figure 2B] 2B shows a cross-sectional assembled view of the container, seal member, and fluid path assembly shown in FIG. 2A in a stored state. [Figure 2C] 2B shows an assembled cross-sectional view of the container, seal member, and fluid pathway assembly shown in FIG. 2A in a delivery state. [Figure 3A] 13 shows an exploded cross-sectional view of another embodiment of a container, a seal member, and a fluid path assembly. [Figure 3B] 3B shows a cross-sectional assembled view of the container, seal member and fluid path assembly shown in FIG. 3A in a stored state. [Figure 3C] 3B shows an assembled cross-sectional view of the container, seal member and fluid pathway assembly shown in FIG. 3A in a delivery state. [Figure 4] 1 illustrates one embodiment of a carrier assembly according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present disclosure generally relates to a sterile fluid flow path between a drug container assembled in a drug delivery device and a patient. The drug delivery device may include a fluid pathway assembly that establishes fluid communication between a reservoir of the drug container and other components or assemblies of the device in response to an actuation or control signal of the device. Prior to activation, a reservoir access needle of the fluid pathway assembly may be disposed outside the reservoir. Upon activation, a tip of the reservoir access needle may be inserted through a seal member, such as a pierceable septum, to provide fluid communication with the drug in the reservoir. If the tip of the reservoir access needle is carrying microorganisms or other contaminants, the reservoir access needle may introduce contaminants into the reservoir. To reduce the possibility of such contamination, certain embodiments of the present disclosure store the tip of the reservoir access needle in an enclosed clean space prior to activation of the drug delivery device. The enclosed clean space may be defined between a seal member and an overmolded member that covers a length of the reservoir access needle. In some embodiments, the overmolded member may be received within a recess formed in the seal member to define the enclosed clean space. In other embodiments, the overmolded member may be received within an annular clip member attached to the seal member to define an enclosed clean space. Creating an enclosed clean space with an overmolded member may facilitate a more compact design of the fluid pathway assembly, which may allow for a smaller overall size of the drug delivery device. Additionally, the relative simplicity of this design may improve the manufacturability of the drug delivery device, among other benefits.

[0011] Each of the aforementioned components of the drug delivery device and the method of assembly of such a device will now be described in more detail.

[0012] FIG. 1 is a schematic diagram of one embodiment of a drug delivery device 10 constructed according to the principles of the present disclosure. The drug delivery device 10 may be operated to deliver a drug to a patient subcutaneously or transdermally. In the illustrated embodiment, the drug delivery device 10 is configured as a wearable drug delivery device, such as an on-body injector or a portable infusion pump, and is removably attached to the patient's tissue 11 (e.g., the patient's skin). In other embodiments (not shown), the drug delivery device 10 may be configured as a pen injector, such as an autoinjector or an injection pen, that is temporarily pressed against the patient's tissue 11 for the course of an injection. The drug delivery device 10 may be configured to automatically deliver a fixed or patient / operator settable dose of a drug over a controlled or selected time period. Additionally, the drug delivery device 10 may be for self-administration by the patient or may be operated by medical personnel or other caregivers formally trained to administer injections.

[0013] In general, the drug delivery device 10 may include an insertion mechanism 12, a reservoir 14, a fluid path assembly 22, a drive mechanism 24, and a controller 26, each of which may be disposed within an interior space of a main housing 29. An actuator 28 (e.g., a user-depressible button, a touch screen, a microphone, etc.) may protrude from or be disposed on an exterior surface of the housing 29 and may be configured to initiate operation of the drug delivery device 10 by activating the insertion mechanism 12, the fluid path assembly 22, the drive mechanism 24, the controller 26, and / or other mechanisms and / or electronics by mechanical and / or electrical means (shown in dashed lines in FIG. 1). In embodiments in which the actuator 28 is a button that is pressed or otherwise physically operated by a user or patient, the actuator 28 may be configured to exert the motive force necessary to activate the insertion mechanism 12, the fluid path assembly 22, the drive assembly 24, the controller 26, and / or other mechanisms. In such embodiments, the actuator 28 may be physically connected, either directly or indirectly via a mechanical linkage, to the insertion mechanism 12, the drive mechanism 24, the fluid path assembly 22, and / or other mechanisms such that manually pushing or otherwise interacting with the actuator 28 provides the motive force necessary to activate the insertion mechanism 12, the drive mechanism 24, the fluid path assembly 22, and / or other mechanisms. For example, in some embodiments, manually pushing the actuator 28 may move the fluid path assembly 22 toward the fixed container 14, or move the container 14 toward the fixed fluid path assembly 22, thereby causing the container access needle to pierce the seal member and enter the reservoir or interior volume of the container 14. Additionally or alternatively, the actuator 28 may operate as an input device that transmits electrical and / or mechanical signals to the controller 26, which may further execute programmable instructions to control the operation of the insertion mechanism 12, the drive mechanism 24, the fluid path assembly 22, and / or other mechanisms.In such embodiments, the controller 26 may include a processor (e.g., a microprocessor) and a non-transitory memory for storing programmable instructions executed by the processor. Additionally, in such embodiments, the drug delivery device 10 may include internal actuators (e.g., electric motors, pneumatic or hydraulic pumps, and / or pressurized gas or liquid sources) separate from the actuators 28 that apply the motive force necessary to activate the insertion mechanism 12, the drive mechanism 24, the fluid path assembly 22, and / or other mechanisms in response to electrical control signals received from the controller 26.

[0014] 1 , the housing 29 may include a bottom wall 25 configured to be removably attached (e.g., adhered by an adhesive) to the patient's tissue 11, and a top wall 27 including one or more visual indicators 42 (e.g., lights, graphical displays, etc.) and / or a window 35 for viewing the container 14 and the drug 32 contained therein. The one or more visual indicators 42 may be used to communicate information to a user regarding the operational status of the drug delivery device 10 and / or the status of the drug 32. An opening 31 may be formed in the bottom wall 25, and optionally a pierceable sterile barrier 33, such as a pierceable septum, may extend across the opening 31 to seal the interior of the housing 29 prior to use. In some embodiments, the pierceable sterile barrier 33 may be omitted, and instead a removable sealing member (not shown) may cover and seal close the opening 31 prior to use.

[0015] More specifically, with regard to the window 35, this element may be constructed from a transparent or translucent material and may be generally aligned with the container 14 to allow the patient or user of the drug delivery device 10 to see the drug 32 in the container 14 and / or to confirm completion of administration. Suitable materials for constructing the window 35 include, but are not limited to, glass and / or plastic. Placing the window 35 on the outside of the drug delivery device 10 may expose the drug 32 to ambient light, including sunlight. Some drugs may be sensitive to certain wavelengths of light and may undergo undesirable molecular changes when exposed to such wavelengths of light. For example, some drugs may be sensitive to wavelengths of light in the ultraviolet (UV), visible, and / or infrared ranges. To protect drugs that are primarily sensitive to light in the UV and / or infrared ranges, the window 35 may be dark-tinted and / or sized to cover a relatively small surface area of ​​the housing 29. For drugs that are primarily sensitive to light in the visible range, it may not be necessary to add a dark tint to the window 35 and / or reduce the size of the window 35. Instead, the window 35 may be constructed with a polarizing filter. In some embodiments, the polarizing filter may be a film or other coating applied to the window 35. In other embodiments, the polarizing filter may be directly incorporated into the material of the window 35. The polarizing filter may allow for observation and identification of the drug 32 within the container 14 while blocking approximately (e.g., ±10%) up to and including 50% of light in the visible range. In some embodiments, the portion of visible light blocked by the window 35 may be within the range of approximately (e.g., ±10%) 0-50%, or 10-50%, or 20-50%, or 25-50%, or 0-40%, or 0-30%, or 0-25%, depending on the photosensitivity of the drug 32 and / or the acuity of the patient population for the drug 32, among other considerations. Instead of adding a dark tint to window 35 and / or reducing the size of window 35, adding a polarizing filter to window 35 advantageously protects drug 35 from visible light without substantially impairing the ability of a patient or user of drug delivery device 10 to see drug 32.

[0016] After the bottom wall 25 of the housing 29 is attached to the patient's tissue 13, the insertion mechanism 12 may be actuated to move the delivery member from a retracted position within the housing 29 to a deployed position extending outside the housing 29. In this embodiment, this may include the insertion mechanism 12 inserting the trocar 21 and the hollow cannula 23 surrounding the trocar 21 through a pierceable sterile barrier 33 into the patient's tissue 11, as shown in FIG. 1. Immediately thereafter, or shortly thereafter, the insertion mechanism 12 may automatically retract the trocar 21, leaving the distal open end of the cannula 23 inside the patient for subcutaneous delivery of the drug 32. The trocar 21 may be solid and have a sharp end for piercing the patient's skin 11. Additionally, the trocar 21 may be made of a more rigid material than the cannula 23. In some embodiments, the trocar 21 may be made of metal and the cannula 23 may be made of plastic or another polymer. The relative flexibility of the cannula 23 may allow the cannula 23 to be subcutaneously positioned within the patient's tissue 11 for a period of time without causing pain or significant discomfort to the patient. In other embodiments (not shown), the trocar 21 and cannula 23 may be omitted, and instead the insertion mechanism 12 may insert only a stiff hollow needle into the patient for subcutaneous delivery of the drug 32.

[0017] In some embodiments, the insertion mechanism 12 may include one or more springs (e.g., coil springs, torsion springs, etc.) that are initially held in a biased state and released upon depression of the actuator 28 to insert the trocar 21 and cannula 23 or hollow needle into the patient. Additionally, retraction of the trocar 21 may be accomplished by automatic release of another spring after the trocar 21 and cannula 23 are inserted into the patient. Other power sources for insertion and / or retraction are also contemplated, including, for example, an electric motor, a hydraulic or pneumatic pump, or a canister that releases pressurized gas or liquid to provide the actuation energy.

[0018] Continuing to refer to FIG. 1 , the container 14, which may be referred to in some contexts as a primary container, may include a wall 38 having an interior surface 43 and an exterior surface 47 that define a reservoir 30 into which the drug 32 is loaded. In some embodiments, the reservoir 30 may be preloaded with the drug 32 by the drug manufacturer prior to mounting the container 14 on the drug delivery device 10. In some embodiments, the container 14 may be rigidly connected to the housing 29 such that the container 14 cannot move relative to the housing, while in other embodiments, the container 14 may be slidably connected to the housing 29 such that the container 14 can move relative to the housing 29 during operation of the drug delivery device 10. The container 14 may have an elongated barrel-like or cylindrical shape extending along a longitudinal axis A. In embodiments in which the drug delivery device 10 is configured as an on-body injector, the longitudinal axis A of the container 14 may be perpendicular, or substantially perpendicular, or non-parallel to the direction in which the insertion mechanism 12 inserts a delivery member, such as the cannula 23, into the patient. This configuration may allow the on-body injector to have a generally flat, low-profile shape that may be worn by a patient without impeding patient movement. Initially, a stopper 34 or other piston member may be disposed within the reservoir 30 at a proximal end 36 of the container 14. The stopper 34 may sealingly and slidably engage an interior surface 43 of a wall 38 of the container 14 and may be movable relative to the wall 38 of the container 14.

[0019] The amount of drug 32 contained within reservoir 30 prior to delivery can be any amount within the range of about (e.g., ±10%) 0.5-20 mL, or any amount within the range of about (e.g., ±10%) 0.5-10 mL, or any amount within the range of about (e.g., ±10%) 1-10 mL, or any amount within the range of about (e.g., ±10%) 1-8 mL, or any amount within the range of about (e.g., ±10%) 1-5 mL, or any amount within the range of about (e.g., ±10%) 1-3.5 mL, or any amount within the range of about (e.g., ±10%) 1-3 mL, or any amount within the range of about (e.g., ±10%) 1-3 mL, or For example, the reservoir 30 may be filled completely or partially with a drug 32. The drug 32 may be one or more of the drugs described below, such as, for example, a granulocyte colony stimulating factor (G-CSF), a PCSK9 (human proprotein convertase subtilisin / kexin type 9) specific antibody, a sclerostin antibody, or a calcitonin gene-related peptide antibody (CGRP).

[0020] During operation of the drug delivery device 10, the drive mechanism 24 may push the stopper 34 along the longitudinal axis A from the proximal end 36 of the container 14 to the distal end 37 of the container 14 to expel the drug 32 from the container 14. In some embodiments, the drive mechanism 24 may include one or more springs (e.g., coil springs, torsion springs, etc.) that are initially held in a biased state and released upon pressing the actuator 28. After their release, the springs may expand or contract to move the stopper 34 within the reservoir 30 along the longitudinal axis A from the proximal end 36 of the container 14 to the distal end 37 of the container 14. In other embodiments, the drive mechanism 24 may include an electric motor (not shown) that rotates a gear mechanism, including, for example, one or more sprocket gears, to cause axial movement of the stopper 34 within the reservoir 30. In yet other embodiments, the drive mechanism 24 may include both an electric motor and a spring, with the electric motor adjusting the extension of the spring via a tether or pulley system. In yet another embodiment, the drive mechanism 24 may include a canister that releases pressurized gas or liquid to provide the actuation energy.

[0021] At the distal end 37 of the container 14, an opening 45 (see FIG. 2A) may be formed in a distal surface 72 (see FIG. 2A) of the wall 38. The distal surface 72 may define a portion of the exterior surface 47 of the wall 38. At least prior to operation of the drug delivery device 10, the opening 45 may be covered and hermetically closed by a sealing member 40, such as a pierceable septum, connected to the distal end 37 of the container 14. The sealing member 40 may include a proximal surface 73 and a distal surface 75. The proximal surface 73 of the sealing member 40 and the interior surface 43 of the wall 38 of the container 14 may define the reservoir 30. Additionally, in some embodiments, the distal surface 39 of the stopper 34 may define the reservoir 30.

[0022] In general, the seal member 40 may be configured to selectively allow access to the reservoir 30. In operation, the seal member 40 may be physically altered (e.g., pierced) to allow fluid communication with the drug 32 in the reservoir 30. In some embodiments, the seal member 40 may be constructed of a flexible or elastically deformable material, such as, for example, rubber, that can be penetrated or pierced by the sharp end or tip 63 of the container access needle 60 of the fluid pathway assembly 22. In some embodiments, the seal member 40 may be fastened or secured to the tip surface 72 of the wall 38 by a fastener 91 (see FIGS. 2B and 2C) and / or may be directly attached to the tip surface 72.

[0023] With further reference to FIG. 1 , the fluid path assembly 22 may be configured to establish fluid communication between the container 14 and the insertion mechanism 12 via a sterile fluid path during operation of the drug delivery device 10. Prior to use of the drug delivery device 10, the fluid path assembly 22 may not be in fluid communication with the container 14. During setup of the drug delivery device 10 or during an initial stage of operation of the drug delivery device 10 prior to drug delivery, the necessary connections may be enabled, connected, or opened manually by a user or automatically by the drug delivery device 10 to establish fluid communication between the container 14 and the fluid path assembly 22. The drive mechanism 24 may then move the stopper 34 distally to push the drug 32 stored in the container 14 through the sterile fluid path of the fluid path assembly 22 and into the cannula 23 or needle or other delivery member of the insertion mechanism 12 for subcutaneous delivery to a patient.

[0024] In some embodiments, the fluid path assembly 22 can be rigidly connected to the housing 29 such that the fluid path assembly 22 cannot move relative to the housing, while in other embodiments, the fluid path assembly 22 can be slidably or movably connected to the housing 29 such that the fluid path assembly 22 can move relative to the housing 29 during operation of the drug delivery device 10. In the former embodiment, the container 14 can be slidably or movably connected to the housing 29 such that the seal member 40 can be moved toward and pierced by the tip 63 of a fixedly positioned container access needle 60 of the fluid path assembly 22. In the latter embodiment, the container 14 can be fixedly positioned while the fluid path assembly 22 is moved toward the container 14 to pierce the tip 63 of the container access needle 60 through the seal member 40 to access the reservoir 30.

[0025] The fluid pathway assembly 22 may include a first end 44 connected to the container 14, a second end 48 connected to the insertion mechanism 12, and a fluid pathway 50 extending between the first end 44 and the second end 48. As described in more detail below, in some embodiments, the first end 44 of the fluid pathway assembly 22 may be connected to the container 14 by a clip member 53. The fluid pathway 50 may be sterile and may be made partially or completely from a flexible tube 52. Initially, there may be slack in the flexible tube 52 to allow the fluid pathway assembly 22 to move relative to the housing 29 and / or to allow the components of the insertion mechanism 12 to which the fluid pathway assembly 22 is attached to move relative to the housing 29. In some embodiments, the fluid pathway 50 may include a rigid fluid-restricting element (not shown) in addition to the flexible tube 52. The fluid-restricting element may have an inner diameter smaller than the inner diameter of the flexible tube 52 to regulate the flow rate of the drug 32 as it passes through the fluid pathway assembly 22. Additionally, the fluid restricting element may be made from a stiffer material than the flexible tube 52. For example, the fluid restricting element may be made from a metal and the flexible tube 52 may be made from a polymeric material such as plastic.

[0026] 1, the first end 44 of the fluid pathway assembly 22 may include a vessel access needle 60 and an overmold member 62. Generally, the overmold member 62 may act as a mounting member or connection hub for the vessel access needle 60 and may provide an enlarged outer dimension, such as an enlarged outer diameter, to a portion of the vessel access needle 60 that does not access the reservoir 30. The vessel access needle 60 may have a sharpened end, or tip 63, corresponding to a proximal end of the vessel access needle 60 and a tip 64 in fluid communication with the fluid passageway 50. In the illustrated embodiment, the vessel access needle 60 has a bend such that the tip 63 of the vessel access needle 60 may be axially aligned with the longitudinal axis A of the vessel 14, while the tip 64 of the vessel access needle 60 may be perpendicular or non-parallel to the longitudinal axis A of the vessel 14. The overmolded member 62 may cover a length of the vessel access needle 60, including the bend, with a distal end 63 of the vessel access needle 60 protruding outwardly from a proximal end 65 of the overmolded member 62. As shown in FIG. 1, a distal end 66 of the overmolded member 62 may include an aperture or opening that allows the end of the flexible tube 52 to be inserted into the overmolded member 62. In another embodiment, the distal end 66 of the overmolded member 62 may be inserted into an opening formed in the end of the flexible tube 52.

[0027] Reservoir access needle 60 may have a hollow tubular shape with one or more openings at each of tip 63 and tip 64. Reservoir access needle 60 may be constructed from a rigid material including, but not limited to, metal (e.g., stainless steel) and / or plastic. In some embodiments, overmold member 62 may be constructed from a different material than reservoir access needle 60 such that overmold member 62 and reservoir access needle 60 are separate, rigidly connected components. In some embodiments, overmold member 62 may be constructed from a rigid plastic material while reservoir access needle 60 is constructed from metal. In other embodiments, overmold member 62 and reservoir access needle 60 may be made from the same material such that they form a single, integral structure.

[0028] Generally, the overmold member 62 may have a sleeve-like or tubular shape that surrounds a length of the vessel access needle 60. The overmold member 62 may be fixedly or rigidly connected to the needle 60 such that the overmold member 62 and the needle 60 can move together as a single unit or structure. In other words, the overmold member 62 may be fixedly or rigidly connected to the vessel access needle 60 to prevent the needle 60 from moving relative to the overmold member 62. In some embodiments, the fixed or rigid connection between the overmold member 62 and the vessel access needle 60 may be achieved by bonding the material of the overmold member 62 to the material of the vessel access needle 60. Such bonding may be achieved by forming the overmold member 62 around the vessel access needle 60 by an overmolding or insert molding process. In some such embodiments, the vessel access needle 60 may be placed in a mold, after which molten plastic or other molten material may be poured or injected into the mold and allowed to solidify to form the overmold member 62. Other processes are possible for manufacturing overmolded member 62. In another embodiment, overmolded member 62 may be formed with a through hole or passageway extending between proximal end 65 and distal end 66, into which vessel access needle 60 may then be inserted. In such an embodiment, vessel access needle 60 may be secured to overmolded member 62 by, for example, an interference fit connection, adhesive, and / or fasteners.

[0029] At least the proximal end 65 of the overmolded member 62 may be flush over a length of the vessel access needle 60 with no gap therebetween. As seen in FIG. 1, there may be a gap between the distal end 66 of the overmolded member 62 and the vessel access needle 60 to form an aperture or opening for receiving the flexible tubing 52. In another embodiment, no aperture or opening may be formed in the distal end 66 of the overmolded member 62 such that no gap exists between the distal end 66 of the overmolded member 62 and the vessel access needle 60.

[0030] As shown in FIG. 1 and described in more detail below with reference to FIGS. 2A-2C, prior to activation of the drug delivery device 10 (e.g., in the stored state), the overmold member 62 may define an enclosed clean space 68 between the overmold member 62 and the seal member 40. In some embodiments, the enclosed clean space 68 may be an empty space that may or may not be evacuated, which is sterile. In other embodiments, the enclosed clean space may be a space filled with a gas or liquid sterilant. In the embodiment shown in FIGS. 1-2C, the boundary (e.g., a sterile boundary) of the enclosed clean space 68 may be defined simply by the outer surface 77 of the overmold member 62 and the inner surface 79 of the seal member 40. However, the boundary of the enclosed clean space 68 should not be limited to the surfaces of the overmold member 62 and the seal member 40. In some embodiments, an O-ring (not shown) may be disposed about the proximal end 65 of the overmolded member 62 such that the boundary of the enclosed clean space 68 is defined by the outer surface of the O-ring in addition to the outer surface 77 of the overmolded member 62 and the inner surface 79 of the seal member 40. In yet another embodiment as shown in FIGS. 3A-3C , the boundary of the enclosed clean space 68 may be defined by the inner surface of the clip member 53, an O-ring disposed about the proximal end 65 of the overmolded member 62, and the distal surface 75 of the seal member 40. Although other configurations for defining the boundary of the enclosed clean space 68 are possible, at a minimum, the boundary of the enclosed clean space 68 may be defined by the surface of the overmolded member 62 and the surface of the seal member 40.

[0031] As shown in FIGS. 1, 2B, and 3B, prior to activation of the drug delivery device 10, the reservoir access needle 60 may be disposed in a retracted position with its tip 63 disposed outside the reservoir 30. In some embodiments, in the retracted position, the tip 63 of the reservoir access needle 60 may be disposed within the enclosed clean space 68, thereby reducing or preventing contamination of the tip 63 of the reservoir access needle 60. In other embodiments, in the retracted position, the tip 63 of the reservoir access needle 60 may be disposed partially within the seal member 40 such that the tip 63 is embedded within the material of the seal member 40. Embedding the tip 63 within the material of the seal member 40 may reduce or prevent contamination of the tip 63. In such an embodiment, the enclosed clean space 68 may be filled with a gas or liquid sterilant such that the tip 63 is sterilized by the gas or liquid sterilant when the tip 63 is inserted through the enclosed clean space 68 during manufacturing.

[0032] The clip member 53 may frictionally engage an exterior surface 77 of the overmold member 62 to restrain the reservoir access needle 60 in a retracted position prior to activation of the drug delivery device 10. The clip member 53 may thus inhibit movement of the overmold member 62 toward and / or away from the seal member 40. A more detailed description of the clip member 53 will now be provided.

[0033] 2C and 3C, upon activation of the drug delivery device 10, the reservoir access needle 60 may move from the retracted position to the delivery position with the tip 63 disposed through the proximal surface 73 of the seal member 40 and into the reservoir 30, thereby establishing fluid communication with the drug 32. In some embodiments, the actuator 28 may be mechanically coupled or connected, directly or indirectly, to the reservoir access needle 60 such that manual depression of the actuator 28 provides the motive force necessary to move the reservoir access needle 60 from the retracted position to the delivery position 62. In other embodiments, as described above, an energized actuator (including, for example, an electric motor, a pneumatic or hydraulic pump, and / or a source of pressurized gas or liquid) may be activated in response to a user pressing the actuator 28 and may provide the motive force necessary to move the reservoir access needle 60 from the retracted position to the delivery position.

[0034] Where appropriate, any of the above subassemblies, features, components, features, functions, methods of manufacture, methods of use, and other aspects of drug delivery device 10 may be substituted and / or combined with any of the subassemblies, features, components, features, functions, methods of manufacture, methods of use, and other aspects of drug delivery devices described in any or all of the following documents, which are incorporated herein by reference in their entirety for all purposes: U.S. Patent No. 9,061,097; U.S. Patent Application Publication No. 2017 / 0124284; U.S. Patent Application Publication No. 2017 / 0119969; U.S. Patent Application Publication No. 2017 / 0098058; U.S. Patent Application Publication No. 2017 / 0124285; U.S. Patent Application Publication No. 2017 / 0103186; U.S. Provisional Patent Application No. 62 / 460,501 entitled "INSERTION MECHANISM FOR DRUG DELIVERY DEVICE"; "INSERTION MECHANISM FOR DRUG DELIVERY DEVICE"; and U.S. Provisional Patent Application No. 62 / 460,501 entitled "INSERTION MECHANISM FOR DRUG DELIVERY DEVICE"; No. 62 / 469,226, entitled "INSERTION MECHANISM AND METHOD OF INSERTING A NEEDLE OF A DRUG DELIVERY DEVICE"; U.S. Provisional Patent Application No. 62 / 468,190, entitled "DRUG DELIVERY DEVICE WITH STERILE FLUID FLOWPATH AND RELATED METHOD OF ASSEMBLY"; U.S. Provisional Patent Application No. 62 / 460,559, entitled "DRUG DELIVERY DEVICE WITH STERILE FLUID FLOWPATH AND RELATED METHOD OF ASSEMBLY"; U.S. Provisional Patent Application No. 62 / 294,842, entitled "DRUG DELIVERY DEVICE, METHOD OF MANUFACTURE, AND METHOD OF USE"; No. 62 / 297,718, entitled "DRUG DELIVERY DEVICE, METHOD OF MANUFACTURE, AND METHOD OF USE"; U.S. Provisional Patent Application No. 62 / 320,438, entitled "DRUG DELIVERY DEVICE, METHOD OF MANUFACTURE, AND METHOD OF USE";International Application No. PCT / US2017 / 017627, entitled "DRUG DELIVERY DEVICE, METHOD OF MANUFACTURE, AND METHOD OF USE"; and International Application No. PCT / US2017 / 026524, entitled "DRUG DELIVERY DEVICE, METHOD OF MANUFACTURE, AND METHOD OF USE".

[0035] 2A-2C, there is shown an enlarged view of the container 14, the seal member 40, and the fluid pathway assembly 22 of the drug delivery device 10 shown in FIG. The container 14 may have a generally cylindrical shape having an inner diameter D1. At the distal end 37 of the container 14, the wall 38 may project radially outward to define a container flange 70. The container flange 70 may extend partially or entirely around the distal end 37 of the container 14. The container flange 70 may define a distal surface 72 of the container 14 that is perpendicular or non-parallel to the longitudinal axis A of the container 14 and faces generally in a distal direction. An opening 45 may be formed in the distal surface 72 and may communicate with the reservoir 30 of the container 14. In some embodiments, the container flange 70 may be omitted such that the distal surface 72 does not project radially outward from the remainder of the container 14. The wall 38 at the proximal end 36 of the container 14 may include a proximal surface 78 that is perpendicular or non-parallel to the longitudinal axis A of the container 14 and faces generally proximally. An opening 99 may be formed in the proximal surface 89 and may communicate with the reservoir 30. After the container 14 is filled with the drug 32, the stopper 34 may be inserted into the container 14 through the opening 99. The container 14 may be constructed of glass, plastic, or any other suitably inert material that will not chemically interact with the drug 32.

[0036] 2A, when the seal member 40 is inserted into the container 14, the seal member 40 may be centrally aligned with the longitudinal axis A of the container 14 such that the seal member 40 and the container 14 share the same longitudinal axis A. The seal member 40 may be divided into a proximal (or lower) end 81 and a distal (or upper) end 83 by an imaginary plane perpendicular to the longitudinal axis A. As shown in FIG. 2A, the proximal end 81 and the distal end 83 may each have a generally cylindrical shape and may have an outer diameter D2 and an outer diameter D3, respectively. The distal end 83 may be expanded relative to the proximal end 81 such that the outer diameter D3 (or other outer dimension) of the distal end 83 is greater than the outer diameter D2 (or other outer dimension) of the proximal end 81. A flange 84 of the seal member 40 is defined by an outer peripheral (e.g., perimeter) portion of the distal end 83 of the seal member 40 disposed radially outward of the proximal end 81 of the seal member 40.

[0037] 2B and 2C, when the seal member 40 is installed in the container 14, the proximal end 81 of the seal member 40 may be inserted through the opening 45 into the reservoir 30 and the flange 84 may directly contact and sealingly engage the distal surface 72 of the container 14. In some embodiments, the proximal end 81 of the seal member 40 may include one or more radially outwardly projecting annular ribs 100 for sealingly engaging the inner surface 43 of the wall 38 of the container 14. The annular ribs 100 may provide a secondary barrier to prevent ingress contaminants from breaching the seal between the flange 84 of the seal member 40 and the distal surface 72 of the container 70. In embodiments including the annular ribs 100, the outer diameter D2 of the proximal end 81 of the seal member 40 may be equal to or less than the inner diameter D1 of the container 14. In other embodiments, the annular rib 100 may be omitted (see FIGS. 3A and 3B), and the outer diameter D2 of the proximal end 81 of the seal member 40 may be slightly larger than the inner diameter D1 of the container 14 to provide a snug fit and seal. In yet other embodiments, the annular rib 100 may be omitted, and the outer diameter D2 of the proximal end 81 of the seal member 40 may be smaller than the inner diameter D1 of the container 14, such that no seal is formed between the proximal end 81 of the seal member 40 and the container 14.

[0038] 2A, a recess or depression 80 may be formed in the seal member 40 and dimensioned to receive the proximal end 65 of the overmold member 62. The recess 80 may originate from the distal surface 75 of the seal member 40 and extend into the seal member 40 to a location that is distal to the proximal surface 73 of the seal member 40. The recess 80 may thus define a blind hole having a depth X1. The recess 80 may be defined by an inner surface 79 of the seal member 40. In some embodiments, the recess 80 may receive the overmold member 62 by an interference fit connection (also referred to as a press fit connection) such that the inner surface 79 of the seal member 40 sealingly engages the outer surface 77 of the overmold member 62 to prevent or inhibit the ingress of microorganisms and other contaminants. The interference fit connection may be achieved by constructing the proximal end 65 of the overmold member 62 with an outer diameter D4 (or other outer dimension) that is equal to or greater than the inner diameter D5 (or other inner dimension) of the recess 80. The interference fit connection may provide friction between the inner surface 79 of the seal member 40 and the outer surface 77 of the overmold member 62 that prevents movement of the overmold member 62 relative to the seal member 40. In other embodiments, the outer diameter D4 of the proximal end 65 of the overmold member 62 may be smaller than the inner diameter D5 of the recess 80, and an O-ring (not shown) may be disposed about the proximal end 65 of the overmold member 62 and sealingly engage the inner surface 79 of the seal member 40 to prevent or inhibit the ingress of contaminants.

[0039] 2B , the enclosed clean space 68 may be formed by partially inserting the proximal end 65 of the overmolded member 62 into the recess 80 such that the proximal end 65 of the overmolded member 62 does not extend to the entire depth X1 of the recess 80. The resulting gap between the proximal end 65 of the overmolded member 62 and the bottom of the recess 80 may represent the enclosed clean space 68. In this manner, the enclosed clean space 68 may be defined within the recess 80. In some embodiments, after inserting the proximal end 65 of the overmolded member 62 into the recess 80, the configuration may be exposed to radiation sterilization (e.g., gamma sterilization or electron beam sterilization) to sterilize any residual contaminants trapped within the enclosed clean space 68.

[0040] FIG. 2B shows that at least a portion of the recess 80 may be disposed proximally relative to the tip surface 72 of the container 14. Thus, at least a portion of the recess 80 may be disposed within the container 14. Thus, when inserted into the recess 80, at least a portion of the overmolded member 62 may also be disposed within the container 14. This may reduce the axial length of the overmolded member 62 disposed outside the container 14, which may further save space within the housing 29 of the drug delivery device 10. As a result, the drug delivery device 10 may be able to have a more compact design. Also, the carrier assembly described below in conjunction with FIG. 4 may be able to have a shorter axial length.

[0041] The configuration shown in Figure 2B corresponds to a stored position or state of the reservoir access needle 60 and the overmolded member 62. The overmolded member 62 may be held statically in the stored position for a period of time between completion of assembly of the drug delivery device 10 and actuation of the drug delivery device 10 by a user or patient. As shown in Figure 2B, in the stored position, the tip 63 of the reservoir access needle 60 may be disposed within the enclosed clean space 68 and therefore outside of the reservoir 30. In other embodiments, when disposed in the stored position, the tip 63 of the reservoir access needle 60 may be disposed partially within the seal member 40 such that the tip 63 is embedded within the material of the seal member 40 but is still disposed outside of the reservoir 30, as described above.

[0042] To prevent the tip 63 of the reservoir access needle 60 from piercing the seal member 40 and entering the reservoir 30 too soon, the clip member 53 may frictionally engage the exterior surface 77 of the overmolded member 62. In some embodiments, this may be accomplished by constructing the clip member 53 with a gripping element 90 that, in the stored state, is received in a corresponding groove 92 formed in the exterior surface 77 of the overmolded member 62, as shown in FIG. 2B. The friction between the gripping element 90 and the groove 92 may advantageously inhibit movement of the overmolded member 62, and thus the reservoir access needle 60, toward and / or away from the seal member 40 prior to use of the drug delivery device 10. Upon actuation of the drug delivery device 10, the actuator (e.g., actuator 28 or an internally energized actuator) may be configured to apply a motive force to overcome the frictional force between the grip element 90 and the groove 92, and also any frictional force between the overmold member 62 and the inner surface 79 of the seal member 40 if an interference fit connection exists between the overmold member 62 and the inner surface 79 of the seal member 40, to slide the grip element 90 out of the groove 92 and move the overmold member 62 from the retracted position ( FIG. 2B ) to the delivery position ( FIG. 2C ). As a result, the tip 63 of the container access needle 60 can penetrate the proximal surface 73 of the seal member 40 and enter the reservoir 30, thereby establishing fluid communication with the drug 32.

[0043] In this embodiment, the grip element 90 may be configured as a continuous annular ridge or protrusion. In other embodiments, a plurality of separate grip elements may be formed on the clip member 53, each of which may be received in a corresponding groove formed in the exterior surface 77 of the overmold member 62 in the stored state.

[0044] 2A , clip member 53 may have an interior surface 94 that defines a throughbore 95. Throughbore 95 may extend between a proximal surface 96 and a distal surface 97 of clip member 53. Proximal surface 96 of clip member 53 may be disposed in direct contact with distal surface 75 of seal member 40. As shown in FIGS. 2B and 2C , overmold member 62 may extend entirely within throughbore 95 when assembled to clip member 53. Grip element 90 may be disposed on or formed by interior surface 94 such that grip element 90 extends radially inward into throughbore 95.

[0045] As shown in Figures 2B and 2C, the fastener 91 may be configured to hold or clamp the clip member 53 to the container 14 with the seal member 40 disposed between the clip member 53 and the container 14. In some embodiments, the fastener 91 may take the form of a crimp ring applied to the container 14 and the clip member 53 by a crimping tool. As shown in Figures 2B and 2C, the fastener 91 may include radially inwardly extending flanges 93a and 93b that abut against a proximal facing surface of the container flange 70 (or other exterior surface of the wall 38 of the container 14) and a distal side and surface 97 of the clip member 53, respectively, to tightly clamp or press a proximal surface 90 of the flange 84 of the seal member 40 against a distal surface 72 of the container 70. The clamping force provided by the fastener 94 may help ensure an air-tight and / or fluid-tight seal between the flange 84 of the seal member 40 and the distal surface 72 of the container 70.

[0046] In each of the foregoing embodiments, the enclosed clean space is formed by inserting the overmolded member into a recess in the seal member. However, the enclosed clean space may be achieved by other configurations. Figures 3A-3C show an embodiment in which a clip member defines a portion of the boundary of the enclosed clean space between the overmolded member and the seal member. Elements of the assembly shown in Figures 3A-3C that are similar to those shown in Figures 1-2C are indicated by the same reference numerals, but increased by 100. Descriptions of many of these elements have been omitted or eliminated for the sake of brevity.

[0047] 3A, seal member 140 may be similar in structure to seal member 40 described above, except that seal member 140 does not include a recess formed in its distal surface 175. Rather, distal surface 175 may extend between opposing sides of seal member 140 and may be flat or substantially flat. The absence of a recess formed in distal surface 175 may simplify manufacturing of seal member 140 and / or allow seal member 140 to be used in conjunction with a variety of standard container designs. In another embodiment, seal member 140 may have a recess similar to recess 80 formed in seal member 40. Although seal member 140 may not include a recess formed in its distal surface 175, as shown in FIG. 3A, seal member 140 may have a recess 250 formed in its proximal surface 173 for HUV control.

[0048] 3A , clip member 153 may include an interior surface 194 defining a throughbore 195. Throughbore 195 may extend between a proximal surface 196 and a distal surface 197 of clip member 153. Proximal surface 196 of clip member 153 may be disposed in direct contact with distal surface 175 of seal member 140 and may sealingly engage distal surface 175 of seal member 140 using a clamping force provided by fastener 191.

[0049] In some embodiments, the proximal end 210 of the clip member 153 may include a flange 211 extending radially outwardly of the distal end 212 of the clip member 153 such that the outer diameter (or other outer dimension) of the proximal end 210 is greater than the outer diameter (or other outer dimension) of the distal end 212. Further, in some embodiments, the proximal end 210 of the clip member 153 may have a generally flat disk shape to increase the surface area of ​​the proximal end surface 196 that contacts the distal end surface 175 of the seal member 140 and promote sealing, and the distal end 212 of the clip member 153 may have a generally elongated tubular member shape such that the length of the through hole 195 is sufficient to create an enclosed clean space 168 for receiving the tip 163 of the vessel access needle 160. Thus, the axial length of the distal end 212 of the clip member 153 may be greater than the axial length of the proximal end 210 of the clip member 153. The throughbore 195 may extend as a continuous passageway through the proximal end 210 and the distal end 212 of the clip member 153 .

[0050] 3B , the enclosed clean space 168 may be formed by partially inserting the proximal end 165 of the overmolded member 162 into the through hole 195 of the clip member 153 such that the proximal end 165 of the overmolded member 162 extends into and terminates within the through hole 195. The resulting gap between the proximal end 165 of the overmolded member 162 and the distal surface 175 of the seal member 140 may represent the enclosed clean space 168. In this manner, the enclosed clean space 168 may be defined within the through hole 195. In some embodiments, after the proximal end 165 of the overmolded member 162 is partially inserted into the through hole 195, the configuration may be exposed to a radiation sterilization process (e.g., gamma sterilization or electron beam sterilization) to sterilize any residual contaminants trapped within the enclosed clean space 168.

[0051] 3B, an O-ring 220 may be disposed about the proximal end 165 of the overmolded member 162. The O-ring 220 may be configured to sealingly and slidably engage the inner surface 194 of the through hole 195. Thus, a boundary (e.g., a sterile boundary) of the enclosed clean space 168 may be defined by the outer surface of the O-ring 220, the outer surface 177 of the overmolded member 162, the inner surface 194 of the clip member 153, and the distal surface 175 of the seal member 140. In another embodiment, the O-ring 220 may be omitted and instead the through hole 195 of the clip member 153 may receive the proximal end 165 of the overmolded member 162 via an interference fit connection. In such embodiments, the boundaries of the enclosed clean space 168 may be defined simply by the exterior surface 177 of the overmold member 162, the interior surface 194 of the clip member 153, and the leading surface 175 of the seal member 140. Although other configurations for defining the boundaries of the enclosed clean space 168 are possible, at a minimum, the boundaries of the enclosed clean space 168 may be defined by the exterior surface 177 of the overmold member 162, the interior surface 194 of the clip member 153, and the leading surface 175 of the seal member 140.

[0052] The configuration shown in Figure 3B corresponds to a stored position or state of the reservoir access needle 160 and the overmolded member 162. The overmolded member 162 may be held statically in the stored position for a period of time between completion of assembly of the drug delivery device 10 and actuation of the drug delivery device 10 by a user or patient. As shown in Figure 3B, in the stored position, the tip 163 of the reservoir access needle 160 may be disposed within the enclosed clean space 168 and therefore outside of the reservoir 130. In other embodiments, the tip 163 of the reservoir access needle 160 may be disposed partially within the seal member 140 such that when disposed in the stored position, the tip 163 is embedded within the material of the seal member 140 but is still disposed outside of the reservoir 130.

[0053] To prevent the tip 163 of the reservoir access needle 160 from piercing the seal member 140 and entering the reservoir 130 too soon, the clip member 153 may frictionally engage the exterior surface 177 of the overmolded member 162. In some embodiments, this may be accomplished by constructing the clip member 153 with a gripping element 190 that, in the stored state, is received in a corresponding groove 192 formed in the exterior surface 177 of the overmolded member 162, as shown in FIG. 3B. The gripping element 190 may be disposed on or formed by the interior surface 194 such that the gripping element 190 extends radially inward into the through hole 195. Friction between the gripping element 190 and the groove 192 may inhibit movement of the overmolded member 162, and thus the reservoir access needle 160, towards and / or away from the seal member 140 prior to use of the drug delivery device 10. Upon actuation of the drug delivery device 10, the actuator (e.g., actuator 28 or an internally energized actuator) may be configured to apply a motive force to overcome the frictional force between the gripping element 190 and the groove 192, sliding the gripping element 190 out of the groove 192 and moving the overmold member 162 from the retracted position ( FIG. 3B ) to the delivery position ( FIG. 3C ). As a result, the tip 163 of the container access needle 60 can penetrate the proximal surface 173 of the seal member 140 and enter the reservoir 130, thereby establishing fluid communication with the drug 132.

[0054] In this embodiment, the grip element 190 may be configured as a continuous annular ridge or protrusion. In other embodiments, the grip element 190 may be formed by a plurality of separate grip elements, each of which may be received in a corresponding groove formed in the exterior surface 177 of the overmold member 162 in the storage state. In addition to the grip element 190, the clip member 153 may include a grip element 221 at an axial location located proximally relative to the grip element 190. The grip element 221 may be disposed on or formed by the interior surface 194 such that the grip element 221 extends radially inward into the through hole 195. The grip element 221 may be received in a groove 192 formed in the exterior surface 177 of the overmold member 162 in the delivery state, as shown in FIG. 3C. Friction between the grip element 221 and the groove 192 can advantageously prevent movement of the overmold member 162, and thus the container access needle 160, toward and / or away from the seal member 140 during and after delivery of the medication 132.

[0055] Clip member 53 and clip member 153 may be constructed from any suitable rigid or semi-rigid material including, for example, plastic and / or metal.

[0056] The fluid pathway assembly described in connection with Figures 2A-3C advantageously allows for a thinner construction of the flange (84 or 184) located at the distal end of the seal member, since the distal end of the seal member is not the only element responsible for defining the enclosed clean space for the tip of the container access needle. Rather, the enclosed clean space may be defined by a portion of the seal member located within the container (Figures 2A-2C) and / or by a clip member located outside the seal member (Figures 3A-3C). As a result, the thickness of the flange at the distal end of the seal member may be reduced. This further facilitates sterilization of the interface between the proximal surface of the seal member and the distal surface of the container. A thinner flange means that a proximally directed sterilization beam (e.g., electron beam or gamma radiation) needs to penetrate less seal member material to reach the interface. As a result, a lower energy sterilization beam may be used, reducing the possibility of discoloration of the materials used to construct the container and / or reducing manufacturing costs.

[0057] A method of assembly of the drug delivery device 10 will now be described. The following assembly method will be described in the context of the embodiment shown in Figures 2A-2C, but also applies to the embodiment shown in Figures 3A-3C unless otherwise stated. The assembly process may be performed in at least two separate stages: an initial stage in which a sterile fluid flow path is established between the container 14 and the needle insertion mechanism 12 and the container 14 is filled with the drug 32, and a final assembly stage in which the prefilled container 14 and its pre-attached components are installed within the drug delivery device 10. The initial and final assembly stages may be performed by different manufacturers and / or at different facilities. For example, the initial stage may be performed by a drug manufacturer and the final assembly stage may be performed by a device manufacturer.

[0058] The initial step may include first providing an empty container 14 and covering the opening 45 of the container 14 with the seal member 40. In this step, the proximal end 81 of the seal member 40 may be inserted into the container 14 until the flange 84 abuts the distal surface 72 of the container. The clip member 53 may then be placed over the seal member 40 such that the proximal surface 81 of the seal member 40 directly contacts the distal surface 75 of the seal member 40. A fastener 91 may then be applied to an exterior surface of the clip member 53 and to the exterior surface 47 of the wall 38 of the container 14 to secure the clip member 53 to the container 14 with the seal member 40 disposed between the clip member 53 and the container 14. The clamping force provided by the fastener may form a seal between the seal member 40 and the distal surface 72 of the container and / or between the seal member 40 and the proximal surface 96 of the clip member 53.

[0059] The proximal end 65 of the overmold member 62 may then be inserted into the through hole 95 and partially into the recess 80 of the clip member 53 to define a sealed clean space 68 between the overmold member 62 and the seal member 62. The proximal end 65 of the overmold member 62 may be inserted into the through hole 95 until the gripping elements 90 are received in corresponding grooves 92 formed in the exterior surface 77 of the overmold member 62, thereby frictionally locking the overmold member 62 to the clip member 53. After this step, the distal end 63 of the vessel access needle 60 may either be disposed within the sealed clean space 68 or embedded within the material of the seal member 40. In another embodiment, the proximal end 65 of the overmold member 62 may be inserted into the through hole 95 of the clip member 53 prior to attaching the clip member 53 to the seal member 40. When the clip member 53 is later attached to the seal member 40 , the proximal end 65 of the overmold member 62 may be partially inserted into the recess 80 to define an enclosed clean space 68 between the overmold member 62 and the seal member 62 .

[0060] Assembly of the container 114, overmold member 162, and clip member 153 may be similar to the process described in the previous paragraph, except that the overmold member 162 may be only partially inserted into the through hole 195. As a result, the distal or proximal end 165 of the overmold member 162 may be disposed within the through hole 195.

[0061] Thereafter, as shown in FIG. 4, the container 14 and attached fluid path assembly 22 may be removably connected to the needle insertion mechanism 12 by the carrier assembly 300. This may include inserting the container 114 into the hollow sleeve 310 of the carrier assembly 300 such that the hollow sleeve 310 is disposed in the container, and inserting the needle insertion mechanism 12 into the hollow carrier element 320 such that the carrier element 320 is disposed about the insertion mechanism 12. An end of the carrier element 320 may then be inserted into and removably connected to an interior surface of the sleeve 310. In addition, this process may include connecting a flexible tube 52 (not shown in FIG. 4) to the tip 66 of the overmold member 62 and / or the inlet port of the insertion mechanism 12. When assembled in the carrier assembly 300, the insertion mechanism 12 may have its longitudinal axis aligned or parallel to the longitudinal axis A of the container 14, making the configuration compatible with standard filling and capping machines. The configuration of the carrier assembly 300, container 14, fluid pathway assembly 22, and insertion mechanism 12 may then be exposed to a sterilization process, including but not limited to, a radiation sterilization process (e.g., using gamma radiation, e-beam, and / or e-beam) and / or a gas sterilization process (e.g., using ethylene oxide, ozone, chlorine dioxide, nitrogen dioxide, and / or steam), which may help ensure sterility of the fluid flow path between the container 14 and the insertion mechanism 12.

[0062] After sterilization, the reservoir 30 of the container 14 may be filled with a quantity of drug 32, after which a stopper 34 may be inserted into the opening 99 of the container 14 and the proximal end 36 of the container 14 may be hermetically closed. This filling and capping procedure may be performed in a sterile or aseptic environment. Furthermore, the container 14 may be placed in a carrier assembly 300 throughout this filling and capping procedure. The filled container 14, along with the attached carrier assembly 300, fluid pathway assembly 22, and insertion mechanism 12, may then be packaged and shipped to a facility where final assembly of the drug delivery device 10 will occur.

[0063] At the final assembly facility, the carrier assembly 300 may be removed from the container 14, the fluid pathway assembly 22, and the insertion mechanism 12, and these components may be installed within the housing 29 of the drug delivery device 10 along with other components and subassemblies of the drug delivery device 10. Once the final assembly stages are completed, the drug delivery device 10 may be configured as a preloaded and prefilled drug delivery device.

[0064] Drug Information As mentioned above, the container can be filled with a drug, which can be any one or combination of the drugs listed below, although the following list should not be considered as all-inclusive or limiting.

[0065] For example, the syringe may be loaded with colony stimulating factors such as granulocyte colony stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). In various other embodiments, the syringe may be used with various pharmaceutical agents such as erythropoietin stimulating agents (ESAs), which may be in liquid or lyophilized form.ESAs include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (registered trademark), and cyclosporine. any molecule that stimulates red blood cell production, such as, for example, epoetin zeta, Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as any molecule that stimulates red blood cell production, such as, for example, epoetin zeta, epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as any molecule that stimulates red blood cell production, such as, for example, epoetin zeta, epoetin alfa, epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), ... and the following patents or patent applications, each of which is incorporated herein by reference in its entirety: U.S. Pat. No. 4,703,008; U.S. Pat. No. 5,441,868; U.S. Pat. No. 5,547,933; U.S. Pat. No. 5,618,698; U.S. Pat. No. 5,621,080; U.S. Pat. No. 5,756,349; U.S. Pat. No. 5,767,078; U.S. Pat. No. 5,773,569; U.S. Pat. No. 5,955,422; U.S. Pat. No. 5,986,047. Nos. 6,583,272, 7,084,245, and 7,271,689, and PCT Publication Nos. WO 91 / 05867, WO 95 / 05465, WO 96 / 40772, WO 00 / 24893, WO 01 / 81405, and WO 2007 / 136752, or variants or analogs thereof.

[0066] The ESA may be an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis stimulating proteins include erythropoietin and its variants, analogs, or derivatives that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alpha, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, PEGylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1 / hematide), and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoietin, erythropoietin agonist variants, and peptides or antibodies that bind to and activate the erythropoietin receptor (as well as the compounds reported in U.S. Patent Application Publication Nos. 2003 / 0215444 and 2006 / 0040858, the disclosures of each of which are incorporated herein by reference in their entireties), as well as the following patents or patent applications, the disclosures of which are each incorporated herein by reference in their entireties: U.S. Pat. No. 4,703,008; U.S. Pat. No. 5,441,868; U.S. Pat. No. 5,547,933; U.S. Pat. No. 5,547,933; Patent No. 5,618,698, U.S. Patent No. 5,621,080, U.S. Patent No. 5,756,349, U.S. Patent No. 5,767,078, U.S. Patent No. 5,773,569, U.S. Patent No. 5,955,422, U.S. Patent No. 5,830,851, U.S. Patent No. 5,856,298, U.S. Patent No. 5,986,047, U.S. Patent No. 6,030,086, U.S. Patent No. 6,310,078, U.S. Patent No. 6,391,633, U.S. Patent No. 6,583,272, U.S. Patent No. 6,586,398, U.S. Patent No. 6,900,292,U.S. Patent No. 6,750,369, U.S. Patent No. 7,030,226, U.S. Patent No. 7,084,245, and U.S. Patent No. 7,217,689, U.S. Patent Application Publication No. 2002 / 0155998, U.S. Patent Application Publication No. 2003 / 0077753, U.S. Patent Application Publication No. 2003 / 0082749, U.S. Patent Application Publication No. 2003 / 0143202, U.S. Patent Application Publication No. 2004 / 0009902, U.S. Patent Application Publication No. 2004 / 0071694, U.S. Patent Application Publication No. 2004 / 0091961, U.S. Patent Application Publication No. 2004 / 0143857, U.S. Patent Application Publication No. 2004 / 0157293, U.S. Patent Application Publication No. 2004 / 0175379, U.S. Patent Application Publication No. 2004 / 0175824, U.S. Patent Application Publication No. 2004 / 0229318, U.S. Patent Application Publication No. 2004 / 0248815, U.S. Patent Application Publication No. 2004 / 0266690, U.S. Patent Application Publication No. 2005 / 0019914, U.S. Patent Application Publication No. 2005 / 0026834, US Patent Application Publication No. 2005 / 0096461, US Patent Application Publication No. 2005 / 0107297, US Patent Application Publication No. 2005 / 0107591, US Patent Application Publication No. 2005 / 0124045, US Patent Application Publication No. 2005 / 0124564, US Patent Application Publication No. 2005 / 0137329, US Patent Application Publication No. 2005 / 0142642, US Patent Application Publication No. 2005 / 0143292, US Patent Application Publication No. 2005 / 0153879, US Patent Application Publication No. 2005 / 0158822, U.S. Patent Application Publication No. 2005 / 0158832, U.S. Patent Application Publication No. 2005 / 0170457, U.S. Patent Application Publication No. 2005 / 0181359, U.S. Patent Application Publication No. 2005 / 0181482, U.S. Patent Application Publication No. 2005 / 0192211, U.S. Patent Application Publication No. 2005 / 0202538, U.S. Patent Application Publication No. 2005 / 0227289, U.S. Patent Application Publication No. 2005 / 0244409, U.S. Patent Application Publication No. 2006 / 0088906,and U.S. Patent Application Publication No. 2006 / 0111279, and PCT Publication Nos. WO 91 / 05867, WO 95 / 05465, WO 99 / 66054, WO 00 / 24893, WO 01 / 81405, WO 00 / 61637, WO 01 / 36489, WO 02 / 014356, WO 02 / 19963, WO 02 / 20034, WO 02 / 49673, WO 02 / 085940, WO 03 / 029291, WO 2003 / 055526, WO 2003 / 084477, WO 2003 / 094858, WO 2004 / 002417, WO 2004 / 002424, WO 2004 / 009627, WO 2004 / 024761, WO 2004 / 033 651, WO 2004 / 035603, WO 2004 / 043382, WO 2004 / 101600, WO 2004 / 101606, WO 2004 / 101611, WO 2004 / 106373, WO 2004 / 018667, WO 2005 / 001025, WO 2005 / 001136, WO 2005 / 021579 brochure, International Publication No. 2005 / 025606 pamphlet, International Publication No. 2005 / 032460 pamphlet, International Publication No. 2005 / 051327 pamphlet, International Publication No. 2005 / 063808 pamphlet, International Publication No. 2005 / 063809 pamphlet, International Publication No. 2005 / 070451 pamphlet, International Publication No. 2005 / 081687 pamphlet, International Publication No. 2005 / 084711 pamphlet, International Publication No. 2005 / 103076 pamphlet, International Publication No. 2005 / 100403 pamphlet,The erythropoietin molecules disclosed in WO 2005 / 092369, WO 2006 / 50959, WO 2006 / 02646, and WO 2006 / 29094, or variants or analogs thereof, are included.

[0067] Examples of other pharmaceuticals for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosumab); other biologics such as Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, PEGylated filgastriam, PEGylated G-CSF, PEGylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet). The device may also be used with therapeutic antibodies, polypeptides, proteins, or other chemicals such as iron, e.g., ferumoxytol, iron dextran, ferric gluconate, and ferric oxide. The pharmaceutical agent may be in liquid form or may be reconstituted from a lyophilized form.

[0068] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof.

[0069] and / or a heavy chain of SEQ ID NO:4 as set forth in FIG. 4 of the following publications, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the following publications; with regard to OPGL-specific antibodies and antibody-related proteins, in particular those having sequences as set forth in the following publications, specifically but not limited to those set forth in the following publications (9H7, 18B2, 2D8, 2E11, 16E1, and 22B3), including but not limited to the antibodies described in PCT Publication WO 03 / 002713, which is incorporated herein in its entirety, OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, in particular fully humanized monoclonal antibodies:

[0070] The following publications are individually and specifically incorporated by reference in their entirety as disclosed in the following publications: TN8-19-1 to TN8-19-40, TN8-19 con1, and TN8-19 myostatin binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies, particularly those described in U.S. Patent Application Publication No. 2004 / 0181033 and PCT Publication No. WO 2004 / 058988, which are incorporated by reference in their entireties, particularly with reference in part to myostatin-specific peptibodies, including, but not limited to, the mTN8-19 family of peptibodies, including those of SEQ ID NOs: 305-351, including con2; the mL2 family of SEQ ID NOs: 357-383, the mL15 family of SEQ ID NOs: 384-409, the mL17 family of SEQ ID NOs: 410-438, the mL20 family of SEQ ID NOs: 439-446, the mL21 family of SEQ ID NOs: 447-452, the mL24 family of SEQ ID NOs: 453-454, and the peptibodies of SEQ ID NOs: 615-631;

[0071] IL-4 receptor specific antibodies, including, but not limited to, L1H1, L1H2, L1H3, L1H4, L1H5, L1H6, L1H7, L1H8, L1H9, L1H10, L1H11, L2H1, L2H2, L2H3, L2H4, L2H5, L2H6, L2H7, L2H8, L2H9, L2H10, L2H11, L2H12, L2H13, L2H14, L3H1, L4H1, L5H1, L6H1, each of which is individually and specifically incorporated by reference in its entirety herein, as disclosed in the following publications: Antibodies such as those described in the following publications, particularly those that inhibit the activity mediated by the binding of IL-4 and / or IL-13 to the receptor, including those described in PCT Publication No. WO 2005 / 047331 or International Application No. PCT / US2004 / 37242 and US Patent Publication No. 2005 / 112694, the entireties of which are incorporated herein by reference, with particular reference in part to those set forth in the following publications, including IL-4 receptor-specific antibodies, peptibodies, and related proteins:

[0072] Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, and related proteins, including, but not limited to, those set forth in the following publications, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the following publications: 15CA, 26F5, 27F2, 24E12, and 10H7, in part, IL1-R1 specific binding proteins, particularly those described in U.S. Patent Application Publication No. 2004 / 097712, which is incorporated herein by reference in its entirety, particularly with respect to monoclonal antibodies;

[0073] The sequences of the following publications, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the following publications, in particular those sequences described in the following publications: L1(N), L1(N)WT, L1(N)1K WT, 2xL1(N), 2xL1(N)WT, Con4(N), Con4(N)1K WT, 2xCon4(N)1K, L1C, L1C 1K, 2xL1C, Con4C, Con4C 1K, 2xCon4C Ang2 specific antibodies and peptibodies, including, but not limited to, those described in PCT Publication No. WO 03 / 057134 and U.S. Patent Application Publication No. 2003 / 0229023, each of which is incorporated by reference in its entirety in part with particular reference to Ang2 specific antibodies and peptibodies, including, but not limited to, those described in the following publications ... Ang2 specific antibodies, peptibodies, and related proteins, including anti-Ang2 antibodies and formulations such as those described in PCT Publication WO 2003 / 030833, which is incorporated by reference in its entirety with respect to Ab533, Ab535, Ab536, Ab537, Ab540, Ab543, Ab544, Ab545, Ab546, A551, Ab553, Ab555, Ab558, Ab559, Ab565, AbF1AbFD, AbFE, AbFJ, AbFK, AbG1D4, AbGC1E8, AbH1C12, AblA1, AblF, AblK, AblP, and AblP;

[0074] NGF-specific antibodies, peptibodies, and related proteins, including, but not limited to, those described in U.S. Patent Application Publication No. 2005 / 0074821 and U.S. Patent No. 6,919,426, each of which is individually and specifically incorporated herein by reference in its entirety as disclosed in the following publications, specifically including, but not limited to, the NGF-specific antibodies 4D4, 4G6, 6H9, 7H2, 14D10, and 14D11 set forth in the following publications, each of which is individually and specifically incorporated herein by reference in its entirety:

[0075] Humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, including but not limited to, particularly human CD22 specific IgG antibodies, such as, for example, a dimer of human-mouse monoclonal hLL2 gamma chain disulfide linked to a human-mouse monoclonal hLL2 kappa chain, including, but not limited to, the human CD22 specific fully humanized antibody of epratuzumab (CAS Registry Number 501423-23-0), specifically human CD22 specific antibodies, CD22 specific antibodies, peptibodies, and related proteins, such as those described in U.S. Pat. No. 5,789,554, the entirety of which is incorporated herein by reference with respect to CD22 specific antibodies and related proteins;

[0076] The IGF-1 specific antibodies L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, and the like are set forth in the following publications, each of which is individually and specifically incorporated by reference in its entirety herein: L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L22H22, L23H23, L 24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L3 IGF-1 receptor specific antibodies, peptibodies, and related proteins, such as those described in PCT Publication WO 06 / 069202, which is incorporated by reference in its entirety with respect to IGF-1 receptor specific antibodies and related proteins, including, but not limited to, 4H34, L35H35, L36H36, L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47, L48H48, L49H49, L50H50, L51H51, L52H52, and IGF-1R-binding fragments and derivatives thereof;

[0077] Also among the non-limiting examples of anti-IGF-1R antibodies for use in the methods and compositions of the disclosure are each of those described below.

[0078] (i) antibodies described in U.S. Patent Application Publication No. 2006 / 0040358 (published February 23, 2006), U.S. Patent Application Publication No. 2005 / 0008642 (published January 13, 2005), and U.S. Patent Application Publication No. 2004 / 0228859 (published November 18, 2004), including, but not limited to, antibody 1A (DSMZ Accession No. DSM ACC 2586), antibody 8 (DSMZ Accession No. DSM ACC 2589), antibody 23 (DSMZ Accession No. DSM ACC 2588), and antibody 18;

[0079] (ii) antibodies, including but not limited to, 2F8, A12, and IMC-A12, described in PCT Publication No. WO 06 / 138729 (published December 28, 2006) and PCT Publication No. WO 05 / 016970 (published February 24, 2005), and Lu et al. (2004), J. Biol. Chem. 279:2856-2865;

[0080] (iii) PCT Publication No. 07 / 012614 (published on February 1, 2007), PCT Publication No. 07 / 000328 (published on January 4, 2007), PCT Publication No. 06 / 013472 (published on February 9, 2006), PCT Publication No. 05 / 058967 (published on June 30, 2005), and PCT Publication No. 03 / 059951 (published on July 24, 2003);

[0081] (iv) antibodies described in U.S. Patent Application Publication No. 2005 / 0084906 (published April 21, 2005), including, but not limited to, antibody 7C10, chimeric antibody C7C10, antibody h7C10, antibody 7H2M, chimeric antibody *7C10, antibody GM607, humanized antibody 7C10 version 1, humanized antibody 7C10 version 2, humanized antibody 7C10 version 3, and antibody 7H2HM;

[0082] (v) antibodies EM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, and huEM164 v1.3, as described in U.S. Patent Application Publication No. 2005 / 0249728 (published November 10, 2005), U.S. Patent Application Publication No. 2005 / 0186203 (published August 25, 2005), U.S. Patent Application Publication No. 2004 / 0265307 (published December 30, 2004), and U.S. Patent Application Publication No. 2003 / 0235582 (published December 25, 2003), and Maloney et al. (2003), Cancer Res. 63:5073-5083, including, but not limited to, EM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, and huEM164 v1.3, as described in U.S. Patent Application Publication No. 2005 / 0249728 (published November 10, 2005), U.S. Patent Application Publication No. 2005 / 0186203 (published August 25, 2005), U.S. Patent Application Publication No. 2004 / 0265307 (published December 30, 2004), and U.S. Patent Application Publication No. 2003 / 0235582 (published December 25, 2003), and Maloney et al. (2003), Cancer Res. 63:5073-508

[0083] (vi) U.S. Pat. No. 7,037,498, issued May 2, 2006; U.S. Patent Application Publication No. 2005 / 0244408, published November 30, 2005; and U.S. Patent Application Publication No. 2004 / 0086503, published May 6, 2004; and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073, including, but not limited to, each of the antibodies produced by hybridomas having ATCC Accession Nos. PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, e.g., antibody CP-751,871,

[0084] (vii) including, but not limited to, antibody 19D12, as described in U.S. Patent Application Publication No. 2005 / 0136063, published June 23, 2005, and U.S. Patent Application Publication No. 2004 / 0018191, published January 29, 2004, and an antibody comprising a heavy chain encoded by the polynucleotide of plasmid 15H12 / 19D12 HCA(γ4), deposited with the ATCC under accession number PTA-5214, and a light chain encoded by the polynucleotide of plasmid 15H12 / 19D12 LCF(κ), deposited with the ATCC under accession number PTA-5220;

[0085] (viii) including, but not limited to, the antibodies PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4, PINT-11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4, and PINT-12A5, which are described in U.S. Patent Application Publication No. 2004 / 0202655 (published October 14, 2004), each of which is incorporated herein by reference in its entirety with respect to the aforementioned antibodies, peptibodies, and related proteins that specifically target the IGF-1 receptor;

[0086] B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like ("B7RP-1," also referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP specific fully human monoclonal IgG2 antibodies, particularly fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1, particularly those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1, particularly on activated T cells, and ... as disclosed in the following publications, each of which is individually and specifically incorporated herein in its entirety by reference as disclosed in the following publications: 16H (within which the light and heavy chain variable region sequences have SEQ ID NOs: 1 and 7, respectively), 5D (within which the light and heavy chain variable region sequences have SEQ ID NOs: 1 and 7, respectively), and SEQ ID NOs: 2 and 3, respectively; and SEQ ID NO:9), 2H (having therein light chain variable region sequences and heavy chain variable region sequences, SEQ ID NO:3 and SEQ ID NO:10, respectively), 43H (having therein light chain variable region sequences and heavy chain variable region sequences, SEQ ID NO:6 and SEQ ID NO:14, respectively), 41H (having therein light chain variable region sequences and heavy chain variable region sequences, SEQ ID NO:5 and SEQ ID NO:13, respectively), and 15H (having therein light chain variable region sequences and heavy chain variable region sequences, SEQ ID NO:4 and SEQ ID NO:12, respectively) as disclosed in U.S. Patent Publication No. 2008 / 0166352 and PCT Publication No. WO 07 / 011941, which are incorporated by reference in their entireties with respect to such antibodies and related proteins, including, but not limited to, the antibodies set forth in the following publications:

[0087] IL-15 specific antibodies, peptibodies, and related proteins, particularly antibodies, particularly humanized monoclonal antibodies, such as those disclosed in U.S. Patent Application Publication Nos. 2003 / 0138421, 2003 / 023586, and 2004 / 0071702, and U.S. Patent Application Publication No. 7,153,507, each of which is incorporated herein by reference in its entirety for IL-15 specific antibodies and related proteins, including, inter alia, peptibodies, including, but not limited to, HuMax IL-15 antibody and related proteins, such as 146B7;

[0088] IFNγ-specific antibodies, peptibodies, and related proteins, etc., particularly human IFNγ-specific antibodies, in particular fully human anti-IFNγ antibodies, such as, for example, IFNγ-specific antibodies, in particular, fully human anti-IFNγ antibodies, such as those described in U.S. Patent Application Publication No. 2005 / 0004353, which is incorporated herein by reference in its entirety for the antibodies designated 1118, 1118*, 1119, 1121, and 1121* in the following patent publications: The entire sequences of the heavy and light chains of each of these antibodies, and the sequences of their heavy and light chain variable regions and complementarity determining regions, are each individually and specifically incorporated herein by reference in their entirety as disclosed in the aforementioned publications and in Thakur et al. (1999), Mol. Immunol. 36:1107-1115. In addition, the descriptions of the properties of these antibodies described in the aforementioned publications are also incorporated herein by reference in their entirety. Specific antibodies include those having a heavy chain of SEQ ID NO:17 and a light chain of SEQ ID NO:18, those having a heavy chain variable region of SEQ ID NO:6 and a light chain variable region of SEQ ID NO:8, those having a heavy chain of SEQ ID NO:19 and a light chain of SEQ ID NO:20, those having a heavy chain variable region of SEQ ID NO:10 and a light chain variable region of SEQ ID NO:12, those having a heavy chain of SEQ ID NO:32 and a light chain of SEQ ID NO:20, those having a heavy chain variable region of SEQ ID NO:30 and a light chain variable region of SEQ ID NO:12, those having a heavy chain sequence of SEQ ID NO:21 and a light chain sequence of SEQ ID NO:22, those having a heavy chain variable region of SEQ ID NO:14 and a light chain variable region of SEQ ID NO:16, those having a heavy chain of SEQ ID NO:21 and a light chain of SEQ ID NO:33, and those having a heavy chain variable region of SEQ ID NO:14 and a light chain variable region of SEQ ID NO:31, as disclosed in the aforementioned publications. A specific antibody contemplated is antibody 1119, disclosed in the aforementioned U.S. Patent Application Publication, having a complete heavy chain of SEQ ID NO: 17, disclosed in the aforementioned U.S. Patent Application Publication, and a complete light chain of SEQ ID NO: 18, disclosed in the aforementioned U.S. Patent Application Publication.

[0089] TALL-1 specific antibodies, peptibodies, and related proteins, such as those described in the following publications, each of which is individually and specifically incorporated herein by reference in its entirety, as well as other TALL specific binding proteins, particularly those described in U.S. Patent Application Publication Nos. 2003 / 0195156 and 2006 / 0135431, each of which is incorporated herein by reference in its entirety with respect to the molecules in Tables 4 and 5B:

[0090] Parathyroid hormone ("PTH")-specific antibodies, peptibodies, and related proteins, such as those described in U.S. Pat. No. 6,756,480, which is incorporated by reference in its entirety, with particular reference in part to proteins that bind PTH;

[0091] Thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, and related proteins, such as those described in U.S. Pat. No. 6,835,809, which is incorporated by reference in its entirety, with particular reference in part to proteins that bind TPO-R;

[0092] Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, and related proteins, including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF), as described in U.S. Patent Application Publication No. 2005 / 0118643 and PCT Publication No. WO 2005 / 017107, huL2G7, as described in U.S. Patent No. 7,220,410, and OA-5d5, as described in U.S. Patent Nos. 5,686,292 and 6,468,529, and PCT Publication No. WO 96 / 38557, each of which is incorporated by reference in its entirety with particular reference in part to proteins that bind HGF;

[0093] TRAIL-R2 specific antibodies, peptibodies, related proteins, etc., such as those described in U.S. Pat. No. 7,521,048, which is incorporated by reference in its entirety, with particular reference in part to proteins that bind TRAIL-R2;

[0094] Activin A-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Patent Application Publication No. 2009 / 0234106, which is incorporated by reference in its entirety, with particular reference in part to proteins that bind activin A;

[0095] TGF-β specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Pat. No. 6,803,453 and U.S. Patent Application Publication No. 2007 / 0110747, each of which is incorporated by reference in its entirety, with particular reference in part to proteins that bind TGF-β;

[0096] Amyloid β protein specific antibodies, peptibodies, related proteins, etc., including but not limited to those described in PCT Publication WO 2006 / 081171, which is incorporated by reference in its entirety, particularly in part, with reference to proteins that bind to the amyloid β protein. One contemplated antibody is an antibody having a heavy chain variable region comprising SEQ ID NO:8 and a light chain variable region having SEQ ID NO:6, as disclosed in the aforementioned publication.

[0097] c-Kit specific antibodies, peptibodies, related proteins, etc., including, but not limited to, those described in U.S. Patent Application Publication No. 2007 / 0253951, which is incorporated by reference in its entirety, with particular reference in part to proteins that bind c-Kit and / or other stem cell factor receptors;

[0098] OX40L-specific antibodies, peptibodies, related proteins, and the like, including, but not limited to, those described in U.S. Patent Application Publication No. 2006 / 0002929, which is incorporated herein by reference in its entirety, with particular reference in part to proteins that bind OX40L and / or other ligands of the OX40 receptor;

[0099] Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-alpha4beta7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP), Kineret® (anakinra), Leukine ( LymphoCide® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin ), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCimhR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Neulasta® (PEGylated filgastrim, PEGylated G-CSF, PEGylated hu-Met-G-CSF), Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP lIb / Ilia receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Rituxan® (rituximab, anti-CD20 mAb), Tarceva® (erlotinib), Roferon-A® (interferon alfa-2a), Simulect® (basiliximab), Prexige® (lumib racoxib), Synagis® (palivizumab, 146B7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-α4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Vectibix® (panitumumab), Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein))), VEGF trap (Ig domain of VEGFR1 fused to IgG1 Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2RαmAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23 mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS- ETR1 (mapatuzumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (zalutumumab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-C. difficile toxin A and toxin B CmAbs MDX-066 (CDA-1 and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25mAb (HuMax-TAC), anti-CD3mAb (NI-0401), adecatumumab, anti-CD30mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38mAb (HuMaxCD38), anti-CD40LmAb, anti-Cripto mAb, anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019), anti-CTLA4 mAb, anti-eotaxin 1 mAb, (CAT-213), anti-FGF8 mAb, anti-ganglioside GD2 mAb, anti-ganglioside GM2 mAb, anti-GDF-8 human mAb (MYO-029), anti-GM-CSF receptor mAb (CAM-3001), anti-HepC mAb (HuMax HepC), anti-IFNα mAb (MEDI-545, MDX-1103), anti-IGF1R mAb, anti-IGF-1R mAb (HuMax-Inflam), anti-IL12mAb (ABT-874), anti-IL12 / IL23mAb (CNTO1275), anti-IL13mAb (CAT-354), anti-IL2RamAb (HuMax-TAC) , anti-IL5 receptor mAb, anti-integrin receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), anti-LLY antibody, BMS-66513, anti-mannose receptor / hCGβOther exemplary proteins include mAb (MDX-1307), anti-mesothelin dsFv-PE38 conjugate (CAT-5001), anti-PD1 mAb (MDX-1106 (ONO-4538)), anti-PDGFRα antibody (IMC-3G3), anti-TGFβ mAb (GC-1008), anti-TRAIL receptor-2 human mAb (HGS-ETR2), anti-TWEAK mAb, anti-VEGFR / Flt-1 mAb, anti-ZP3 mAb (HuMax-ZP3), NVS antibody no. 1, and NVS antibody no. 2.

[0100] Sclerostin antibodies, such as, but not limited to, romosozumab, brosozumab, or BPS804 (Novartis), may also be included. Further therapeutic agents may be included, such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX, or XGEVA. Additionally, monoclonal antibodies (IgG) that bind to human proprotein convertase subtilisin / kexin type 9 (PCSK9) may be included in the device. Such PCSK9-specific antibodies include those described in the following patents or patent applications, each of which is incorporated herein by reference in its entirety for all purposes: U.S. Pat. No. 8,030,547, U.S. Pat. No. 8,563,698, U.S. Pat. No. 8,829,165, U.S. Pat. No. 8,859,741, U.S. Pat. No. 8,871,913, U.S. Pat. No. 8,871,914, U.S. Pat. No. 8,883,983, U.S. Pat. No. 8,889,834, U.S. Pat. No. 8,981,064, U.S. Pat. No. 9,056,915, U.S. Pat. No. 8,168,762, U.S. Pat. No. 9,045,547, U.S. Pat. No. 8,030,457, U.S. Pat. No. 8,030,457, U.S. Pat. No. 8,829,165, U.S. Pat. No. 8,981,064, U.S. Pat. No. 8,030,457, U.S. Patent Application Publication No. 2013 / 0064825, U.S. Patent Application Publication No. 2012 / 0093818, U.S. Patent Application Publication No. 2013 / 0079502, U.S. Patent Application Publication No. 2014 / 0357850, U.S. Patent Application Publication No. 2011 / 0027287, U.S. Patent Application Publication No. 2014 / 0357851, U.S. Patent Application Publication No. 2014 / 0357854, U.S. US Patent Application Publication No. 2015 / 0031870, US Patent Application Publication No. 2013 / 0085265, US Patent Application Publication No. 2013 / 0079501, US Patent Application Publication No. 2012 / 0213797, US Patent Application Publication No. 2012 / 0251544, US Patent Application Publication No. 2013 / 0072665, US Patent Application Publication No. 2013 / 0058944, US Patent Application Publication No. 201 3 / 0052201, U.S. Patent Application Publication No. 2012 / 0027765, U.S. Patent Application Publication No. 2015 / 0087819, U.S. Patent Application Publication No. 2011 / 0117011, U.S. Patent Application Publication No. 2015 / 0004174, U.S. Provisional Patent Application No. 60 / 957,668, U.S. Provisional Patent Application No. 61 / 008,965, U.S. Provisional Patent Application No. 61 / 010,630, U.S. Provisional Patent Application No. Application No. 61 / 086,133, U.S. Provisional Patent Application No. 61 / 125,304, U.S. Provisional Patent Application No. 61 / 798,970, U.S. Provisional Patent Application No. 61 / 841,039, U.S. Provisional Patent Application No. 62 / 002,623, U.S. Provisional Patent Application No. 62 / 024,399, U.S. Provisional Patent Application No. 62 / 019,729, U.S. Provisional Patent Application No. 62 / 067,637, U.S. Patent Application No. 14 / 777,371, International Application No. PCT / US2013 / 048714, International Application No. PCT / US2015 / 040211, International Application No. PCT / US2015 / 056972, International Publication No. WO 2008 / 057457, International Publication No. WO 2008 / 057458, International Publication No. WO 2008 / 057459, International Publication No. WO 2008 / 063382, International Publication No. WO 2008 / 133647, International Publication No. 2009 / 100297, International Publication No. 2009 / 100318, International Publication No. 2011 / 037791, International Publication No. 2011 / 053759, International Publication No. 2011 / 053783, International Publication No. 2008 / 125623, International Publication No. 2011 / 072263, International Publication No. 2009 / 055783, International Publication No. 2012 / 0544438 No. WO 2010 / 029513, WO 2011 / 111007, WO 2010 / 077854, WO 2012 / 088313, WO 2012 / 101251, WO 2012 / 101252, WO 2012 / 101253, WO 2012 / 109530, WO 200 Examples of suitable anti-inflammatory agents include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab), and molecules, variants, analogs, or derivatives thereof, as disclosed in WO 1 / 031007, WO 2009 / 026558, WO 2009 / 131740, WO 2013 / 166448, and WO 2014 / 150983.

[0101] Also included may be talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers. Examples of oncolytic HSV include, but are not limited to, talimogene laherparepvec (U.S. Pat. Nos. 7,223,593 and 7,537,924), OncoVEXGALV / CD (U.S. Pat. No. 7,981,669), OrienX010 (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143), G207, 1716, NV1020, NV12023, NV1034, and NV1042 (Vargehes et al. (2002), Cancer Gene Ther., 9(12):967-978).

[0102] Also included are TIMPs. TIMPs are endogenous tissue inhibitors of metalloproteinases (TIMPs) and are important in many natural processes. TIMP-3 is expressed by various cells and / or present in the extracellular matrix, inhibits all major cartilage-degrading metalloproteases, and may play a role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions. The amino acid sequence of TIMP-3 and the nucleic acid sequence of DNA encoding TIMP-3 are disclosed in U.S. Patent No. 6,562,596, issued May 13, 2003, the disclosure of which is incorporated herein by reference. Descriptions of TIMP mutations can be found in U.S. Patent Application Publication No. 2014 / 0274874 and PCT Publication No. WO 2014 / 152012.

[0103] Also included are antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecules targeting the CGRP receptor and other headache targets. Further information regarding these molecules can be found in WO 2010 / 075238.

[0104] In addition, bispecific T cell-inducing antibodies (BiTe), such as blinatumomab, can be used in the device. Alternatively, APJ macromolecular agonists, such as apelin or analogs thereof, can be included in the device. Information regarding such molecules can be found in PCT Publication WO 2014 / 099984.

[0105] In some embodiments, the medicament comprises a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti-TSLP antibodies that may be used in such embodiments include, but are not limited to, those described in U.S. Pat. Nos. 7,982,016 and 8,232,372, and U.S. Patent Publication No. 2009 / 0186022. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in U.S. Pat. No. 8,101,182. In a particularly preferred embodiment, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated A5 in U.S. Pat. No. 7,982,016.

[0106] While the disclosure has been described in connection with various embodiments, it will be understood that the disclosure is capable of further modifications. The disclosure is generally intended to cover any variations, uses, or adaptations of the disclosed subject matter that are in accordance with the principles of the disclosure and that are within known and customary practice within the art to which the disclosure pertains, including departures from the disclosure.

[0107] It should be noted that the structure and configuration of the drug delivery device and its various components and assemblies as shown in the various exemplary embodiments are merely exemplary. Although the present disclosure describes in detail only a few embodiments of the subject matter at issue, those skilled in the art who review the present disclosure will readily appreciate that many modifications (e.g., variations in the size, dimensions, configuration, shape and proportions of the various elements, parameter values, mounting configurations, use of materials, colors, orientations, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter disclosed herein. For example, elements shown as integrally formed may be composed of multiple parts or elements, and vice versa. Also, the positions of elements may be reversed or otherwise changed, and the nature or number of separate elements or positions may be modified or changed. Accordingly, all such modifications are intended to be included within the scope of the present disclosure as defined in the appended claims. Furthermore, the order or sequence of any process or method steps may be changed or rearranged in accordance with alternative embodiments. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangements of the various exemplary embodiments without departing from the scope of the present disclosure.

Claims

1. a container including a wall having an interior surface, and a seal member having an end surface, the interior surface of the wall and the end surface of the seal member defining a reservoir into which a drug is loaded; a fluid pathway assembly connected to the container, a vessel access needle having a tip; an overmold member covering a length of the vessel access needle, the overmold member defining an enclosed space between the overmold member and the seal member, the overmold member being movable relative to the seal member to carry the vessel access needle between a stored position in which the tip is disposed outside the reservoir and a delivery position in which the tip extends past the end surface of the seal member into the reservoir; a fluid path assembly including:

13. A drug delivery device comprising:

2. The drug delivery device of claim 1 , wherein the tip of the reservoir access needle is disposed within the enclosed space when the reservoir access needle is disposed in the retracted position.

3. The drug delivery device of claim 1 or 2, further comprising a recess formed in the seal member for receiving a proximal end of the overmolded member, the sealed space being defined within the recess.

4. The drug delivery device of claim 3 , wherein the recess receives the proximal end of the overmolded member with an interference fit connection.

5. The drug delivery device of claim 4 , wherein the proximal end of the seal member extends into the container such that at least a portion of the recess is disposed within the container.

6. The drug delivery device of any one of claims 1 to 5, comprising a clip member attached to the seal member, frictionally engaging the overmold member and preventing movement of the overmold member relative to the seal member.

7. The drug delivery device of claim 6 , wherein the clip member has an interior surface defining a through hole, the proximal end of the overmold member passing through the through hole and extending into the recess.

8. 8. The drug delivery device of claim 6 or 7, wherein the inner surface of the clip member defines a gripping element, and when the needle is disposed in the retracted position, the gripping element is received within a corresponding groove formed in the overmold member.

9. 9. The drug delivery device of claim 6, further comprising an actuator configured to apply a motive force to overcome frictional forces between the clip member and the overmold member to move the overmold member relative to the seal member such that the container access needle moves from the stored position to the delivery position.

10. A drug delivery device according to any one of claims 6 to 9, comprising a fastener which engages an outer surface of the clip member and an outer surface of the wall of the container to secure the clip member to the container while the sealing member is disposed between the clip member and the container.

11. 3. The drug delivery device of claim 1 or 2, further comprising a clip member attached to the seal member, frictionally engaging the overmolded member and preventing movement of the overmolded member relative to the seal member, the clip member having an inner surface defining a through hole, a base end of the overmolded member extending partially into the through hole, and the sealing gap being defined within the through hole.

12. The drug delivery device of claim 11 including an O-ring disposed about the proximal end of the overmold member and sealingly and slidably engaging the inner surface of the clip member.

13. 13. The drug delivery device of claim 11 or 12, wherein the clip member has a proximal end and a distal end, the proximal end including a mounting flange disposed radially outward of the distal end and adapted to engage the sealing member.

14. A drug delivery device according to any one of claims 11 to 13, wherein the inner surface of the clip member defines a grip element, and when the needle is disposed in the retracted position, the grip element is received within a corresponding groove formed in the overmold member.

15. 15. The drug delivery device of claim 11, further comprising an actuator configured to apply a motive force to overcome frictional forces between the clip member and the overmold member to move the overmold member relative to the seal member such that the reservoir access needle moves from the stored position to the delivery position.

16. A drug delivery device according to any one of claims 11 to 15, comprising a fastener which engages an outer surface of the clip member and an outer surface of the wall of the container to secure the clip member to the container while the sealing member is disposed between the clip member and the container.

17. providing a vessel having a wall with an interior surface; a fluid pathway assembly including a vessel access needle having a tip and an overmold member, the overmold member covering a length of the vessel access needle with the tip protruding out of the overmold member; covering a first opening in the wall of the container with a seal member such that an end surface of the seal member and the interior surface of the wall of the container define a reservoir; disposing the overmold member to define an enclosed space between the overmold member and the seal member; An assembly method comprising:

18. The method of claim 17 including attaching a clip member to the seal member and frictionally engaging the clip member with the overmold member.

19. 20. The method of claim 18, wherein frictionally engaging the clip member and the overmold member includes aligning an inwardly projecting gripping element of the clip member with a corresponding groove formed in the overmold member such that the inwardly projecting gripping element is received within the corresponding groove.

20. 20. The method of claim 17, wherein disposing the overmold member to define an enclosed space between the overmold member and the seal member comprises inserting the overmold member into a recess formed in the seal member.

21. The method of claim 20 , wherein inserting the overmold member into the recess formed in the seal member includes forming an interference fit connection between the overmold member and the seal member.

22. 20. The method of claim 18 or 19, wherein positioning the overmold member to define an enclosed space between the overmold member and the seal member comprises partially inserting the overmold member into the through hole of the clip member such that an end portion of the overmold member is positioned within the through hole.

23. 23. The method of claim 22, wherein positioning the overmold member to define a sealed space between the overmold member and the seal member includes an O-ring disposed about the distal end of the overmold member sealingly engaging an inner surface of the clip member.

24. A method according to any one of claims 17 to 23, comprising filling the reservoir of the container with a drug.

25. 25. The method of claim 24, comprising inserting a stopper into the reservoir through a second opening formed in the wall of the container.

26. 26. The method of any one of claims 17 to 25, comprising applying fasteners to an exterior surface of the clip member and an exterior surface of the wall of the container to secure the clip member to the container while the seal member is disposed between the clip member and the container.

27. A method according to any one of claims 17 to 26, comprising releasably connecting an insertion mechanism and an assembled configuration of the container, the seal member, the clip member and the fluid pathway assembly by a carrier assembly.

28. 28. The method of claim 27, wherein the carrier assembly includes a sleeve disposed around the container and a carrier disposed around the insertion mechanism, the fluid path assembly, and the clip member, an end of the carrier being received within and removably connected to the sleeve.

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