Patent Publication Number: US-2022218900-A1

Title: Drug delivery device, method of manufacture, and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/071,873, filed Jul. 20, 2018, which is the U.S. national phase of International Patent Application No. PCT/US2017/017627, having an international filing date of Feb. 13, 2017, which claims the priority benefit of each of U.S. Provisional Patent Application No. 62/294,842, filed Feb. 12, 2016, U.S. Provisional Patent Application No. 62/297,718, filed Feb. 19, 2016, and U.S. Provisional Patent Application No. 62/320,438, filed Apr. 8, 2016. The entire contents of each of the foregoing are expressly incorporated by reference herein for all purposes. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure generally relates to drug delivery devices and, more particularly, a drug delivery device capable of being worn by a patient while the drug delivery device delivers a drug to the patient. 
     BACKGROUND 
     Parenteral delivery of various drugs, i.e., delivery by means other than through the digestive track, has become a desired method of drug delivery for a number of reasons. This form of drug delivery by injection may enhance the effect of the substance being delivered and ensure that the unaltered medicine reaches its intended site at a significant concentration. Similarly, undesired side effects associated with other routes of delivery, such as systemic toxicity, can potentially be avoided through parenteral delivery. By bypassing the digestive system of a mammalian patient, one can avoid degradation of the active ingredients caused by the catalytic enzymes in the digestive tract and liver and ensure that a necessary amount of drug, at a desired concentration, reaches the targeted site. 
     Traditionally, manually operated syringes and injection pens have been employed for delivering parenteral drugs to a patient. More recently, parenteral delivery of liquid medicines into the body has been accomplished by administering bolus injections using a needle and reservoir, continuously by gravity driven dispensers, or via transdermal patch technologies. Bolus injections often imperfectly match the clinical needs of the patient, and usually require larger individual doses than are desired at the specific time they are given. Continuous delivery of medicine through gravity-feed systems compromises the patient&#39;s mobility and lifestyle, and limits the therapy to simplistic flow rates and profiles. Another form of drug delivery, transdermal patches, similarly has its restrictions. Transdermal patches often require specific molecular drug structures for efficacy, and the control of the drug administration through a transdermal patch is severely limited. 
     Ambulatory infusion pumps have been developed for delivering liquid medicaments to a patient. These infusion devices have the ability to offer sophisticated fluid delivery profiles accomplishing bolus requirements, continuous infusion and variable flow rate delivery. These infusion capabilities usually result in better efficacy of the drug and therapy and less toxicity to the patient&#39;s system. Currently available ambulatory infusion devices are expensive, difficult to program and prepare for infusion, and tend to be bulky, heavy and very fragile. Filling these devices can be difficult and require the patient to carry both the intended medication as well as filling accessories. The devices often require specialized care, maintenance, and cleaning to assure proper functionality and safety for their intended long-term use, and are not cost-effective for patients or healthcare providers. 
     As compared to syringes and injection pens, pump type delivery devices can be significantly more convenient to a patient, in that doses of the drug may be calculated and delivered automatically to a patient at any time during the day or night. Furthermore, when used in conjunction with metabolic sensors or monitors, pumps may be automatically controlled to provide appropriate doses of a fluidic medium at appropriate times of need, based on sensed or monitored metabolic levels. As a result, pump type delivery devices have become an important aspect of modern medical treatments of various types of medical conditions, such as diabetes, and the like. 
     While pump type delivery systems have been utilized to solve a number of patient needs, manually operated syringes and injection pens often remain a preferred choice for drug delivery as they now provide integrated safety features and can easily be read to identify the status of drug delivery and the end of dose dispensing. However, manually operated syringes and injections pens are not universally applicable and are not preferred for delivery of all drugs. There remains a need for an adjustable (and/or programmable) infusion system that is precise and reliable and can offer clinicians and patients a small, low cost, light weight, simple to use alternative for parenteral delivery of liquid medicines. 
     There is a strong market demand for drug delivery devices which are easy-to-use, cost-efficient, and which include integrated safety features. However, manufacturing of such devices can be cost intensive, which results in higher costs to patients. Much of the manufacturing costs can be attributed to the need to maintain a sterile fluid pathway from the drug container to the needle, prior to introduction of the drug to the patient. Some commercial products seek to maintain the sterility of the device by manufacturing the components in a non-sterile environment and then sterilizing the entire device. A recognized downside of such processes is the need to separately fill the drug container after device sterilization but prior to drug injection, as most pharmaceutical compounds are not capable of withstanding the device sterilization process. Alternatively, the drug delivery device may be manufactured as a pre-filled device, wherein the device is filled with the drug aseptically during assembly. Such manufacturing processes may be costly since the entire process must be kept sterile and because the fill and assembly lines need to be specially-tailored for the device. Accordingly, this adds substantial operating costs to pharmaceutical companies and contract drug-fillers. 
     Drug delivery devices are generally prepared by molding or shaping the various components and then assembling the components. The assembling steps and other processing operations typically produce a device that subsequently must be cleaned to remove particulates adhering to the surfaces to satisfy cleanliness standards for drug delivery devices. After cleaning, conventional drug delivery devices are packaged and sterilized. Such delivery devices have been classified into several general types. The first type is assembled and placed in sterile packaging which can be shipped with a vial or ampoule of a drug or other injectable solution. The delivery device is filled with the drug or other solution at the point of use and injected into the patient. These devices have the disadvantage of increasing the time and difficulty of filling the device at the point of use, increasing the risk of contamination of the delivery device and/or drug solution, and increasing the likelihood of accidental spills of the drug. There is a further risk of glass particles from the ampoules contaminating the drug solution when the ampoules are opened. Furthermore, the healthcare provider and/or patient may be require training to ensure that they fill the device properly 
     Several of these disadvantages are overcome by providing prefilled delivery devices which can be filled with a suitable drug solution prior to use. Prefilled delivery devices, as the term is known in the art, are devices that are filled by the drug manufacturer and shipped to the health care provider or self-administering patient in a condition that is ready for use. The vial or ampoule is generally made of glass or other clear material that does not interfere with the stability of the drug during prolonged storage. Prefilled delivery devices have the advantage of convenience and ease of application with reduced risk of contamination of the drug solution. Prefilled drug delivery devices are generally assembled and packaged in clean rooms to maintain proper cleanliness levels. The clean rooms are equipped with extensive filter assemblies and air control systems to remove particulates and pyrogens from the air in the room and to prevent particulates and pyrogens from entering the room. The operators and other personnel in the clean room are required to wear appropriate protective garments to reduce contamination of the air and the drug delivery devices being manufactured or assembled. As people and equipment enter and leave the clean room, the risk of contamination and introduction of foreign particulates and pyrogens increases. Various operations are able to form clean and sterile drug delivery devices. However, subsequent handling, filling and printing of the drug delivery device can contaminate the device. It is then necessary to clean and sterilize such conventional drug delivery devices before use. Accordingly, there is a continuing need in the industry for an improved system for manufacturing and assembling clean and sterile medical devices and filling such devices. 
     SUMMARY 
     One aspect of the present disclosure provides a wearable drug delivery device including a housing, a container disposed in the housing, a drug disposed in the container, an insertion mechanism disposed in the housing, a fluid pathway connector defining a sterile fluid flowpath between the container and the insertion mechanism, a needle, and a cannula initially disposed around the needle. The drug may include at least one of: a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The fluid pathway connector may include a flexible fluid conduit. The insertion mechanism may include a wall stationarily fixed relative to the housing, a manifold guide movable relative to the wall, an insertion biasing member initially held in an energized state between the wall and the manifold, a hub connected to the needle, a retraction biasing member initially held in an energized state between the hub and the manifold, a flexible clip initially holding the retraction biasing member in the energized state, and a manifold connected to the manifold guide and movable between a first position and a second position. The manifold may have an internal chamber and a septum. The cannula and the flexible fluid conduit may each be in fluid communication with the internal chamber of the manifold. The cannula and the flexible fluid conduit may each be connected to the manifold such that the cannula and the flexible fluid conduit each moves relative to the wall of the insertion mechanism when the manifold moves between the first position and the second position. 
     Another aspect of the present disclosure provides a wearable drug delivery device including a housing, a container disposed in the housing, a drug, a needle, an insertion mechanism, and a fluid pathway connector defining a sterile fluid flowpath between the container and the insertion mechanism. The container may include a barrel, a plunger seal moveable through the barrel, and a pierceable seal. The drug may be disposed in the barrel of the container. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The insertion mechanism may be configured to move the needle from a retracted position to an inserted position. The fluid pathway connector may include a connection hub, a piercing member connected to the connection hub, and a sterile sleeve having a first end connected to the connection hub and a second end connected to the container. The piercing member may be initially retained within the sterile sleeve between the connection hub and the pierceable seal of the container. 
     Yet another aspect of the present disclosure provides a cartridge to be assembled in a drug delivery device. The cartridge may include a container having a longitudinal axis, a drug disposed in the container, a needle, an insertion mechanism, and a fluid pathway connector defining a sterile fluid flowpath between the container and the insertion mechanism. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The insertion mechanism may be configured to move the needle from a retracted position to an inserted position. The fluid pathway connector may have: (i) a first configuration, prior to assembly of the cartridge in the drug delivery device, where the insertion mechanism is aligned with the longitudinal axis, and (ii) a second configuration, after assembly of the cartridge in the drug delivery device, where the insertion mechanism is not aligned with the longitudinal axis. 
     An additional aspect of the present disclosure provides a method of manufacturing a drug delivery device. The method may include: (a) fluidly coupling a container and a needle insertion mechanism with a fluid pathway connector; (b) sterilizing the fluid pathway connector, the container, and the needle insertion mechanism, separately or together, to create a sterile fluid flow path between the container and the needle insertion mechanism; (c) disposing a drug in the container after fluidly coupling the container and the needle insertion mechanism with the fluid pathway connector; and (d) disposing the container, the needle insertion mechanism, and the fluid pathway in a housing of the drug delivery device. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. 
     Another aspect of the present disclosure provides a method of manufacturing a cartridge for a drug delivery device. The method may include: (a) fluidly coupling a container and a needle insertion mechanism with a fluid pathway connector; (b) sterilizing the fluid pathway connector, the container, and the needle insertion mechanism, separately or together, to create a sterile fluid flow path between the container and the needle insertion mechanism; and (c) disposing a drug in the container after fluidly coupling the container and the needle insertion mechanism with the fluid pathway connector. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. 
     Another aspect of the present disclosure provides a method of drug administration. The method may include: (a) providing a wearable drug delivery device including a container, a needle and a drug disposed in the container; (b) removably attaching the wearable drug delivery device to a patient&#39;s skin; and (c) activating the wearable drug delivery device to insert a pointed end of the needle into the patient to define an injection site and discharging the drug from the container into the patient at the injection site. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. 
     An additional aspect of the present disclosure provides a method of operating a wearable drug delivery device. The method may include: (a) displacing an activation mechanism to disengage one or more lockout pins from corresponding lockout windows of an insertion mechanism housing, wherein such disengagement permits an insertion biasing member to expand in a distal direction substantially along a longitudinal axis of the insertion mechanism housing, wherein such expansion drives insertion of a needle and a cannula into the body of a patient; (b) disengaging one or more release surfaces of a clip from engagement with a hub retained within a manifold guide within the insertion mechanism housing, wherein such disengagement permits a retraction biasing member to expand in a proximal direction substantially along the longitudinal axis of the insertion mechanism housing, wherein such expansion drives retraction of the needle while retaining the cannula in the body of the patient; (c) establishing fluid communication between a fluid pathway connector having a piercing member and a container having a pierceable seal, wherein a drug is disposed in the container; and (d) activating a drive mechanism to force the drug through the fluid pathway connector, the cannula, and into the body of the patient. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. 
     Another aspect of the present disclosure provides a wearable drug delivery device including a container, a drug disposed in the container, and a drive mechanism. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The drive mechanism may include: a drive housing having an axial aperture, a contact sleeve slidably mounted to the drive housing through the axial aperture of the drive housing, a status switch interconnect, a drive biasing member, and a piston. The contact sleeve may have a contact sleeve proximal end, a contact sleeve distal end, and sleeve hooks at the contact sleeve distal end. The piston may have a piston proximal end, a piston distal end, an interface surface, and a contact protrusion near the piston proximal end. The sleeve hooks may be caused to contact the piston between the interface surface and the contact protrusion during operation of the wearable drug delivery device. The drive biasing member may be configured to bear upon the interface surface of the piston. 
     Another aspect of the present disclosure provides a wearable drug delivery device including a container, a drug, a needle, an insertion mechanism configured to move the needle from a retracted position to an inserted position; and a fluid pathway connector defining a sterile fluid flowpath between the container and the insertion mechanism. The container may include a barrel, a plunger seal moveable through the barrel, and a pierceable seal. The pierceable seal may include a first internal chamber accessible through a first aperture formed in the pierceable seal. The drug may be disposed in the barrel of the container. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The fluid pathway connector may include: a connection hub having a second internal chamber accessible through a second aperture formed in the connection hub; a first film attached to the connection hub to cover the second aperture and maintain sterility of the second internal chamber; a second film attached to the container to cover the first aperture and maintain sterility of the first internal chamber; and a piercing member at least partially disposed in the second internal chamber and configured to pierce the first film and the second film in response to activation of the wearable drug delivery device. 
     Yet another aspect of the present disclosure provides a wearable drug delivery device including a container, a drug disposed in the container, a needle, an insertion mechanism configured to move the needle from a retracted position to an inserted position, and a fluid pathway connector defining a sterile fluid flowpath between the container and the insertion mechanism. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The insertion mechanism includes: a housing having an internal chamber, a shell disposed in the internal chamber, a rotational biasing member initially held in an energized state with at least a portion of the rotational biasing member engaged with the housing, a hub connected to a proximal end of the needle, and a retraction biasing member initially held in an energized state between the hub and the shell. 
     An additional aspect of the present disclosure provides a wearable drug delivery device including a container, a drug, and a drive mechanism. The container may include a barrel, a plunger seal configured to move axially within the barrel, and a pierceable seal. The drug may be disposed in the barrel of the container. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The drive mechanism may include: an actuator; a gear assembly; a piston connected to the plunger seal and configured to move axially within the barrel, a biasing member initially retained in an energized state; and a tether. The biasing member may be configured to expand to impart axial movement to the piston when released from the energized state. The tether may have a first end and a second end connected to, respectively, the piston and the gear assembly. The tether may be configured to restrain expansion of the biasing member when the biasing member is released from the energized state, such that the tether restrains axial movement of the piston within the barrel. 
     An additional aspect of the present disclosure provides a drug delivery device including an insertion mechanism, a drive mechanism, a sterile fluid pathway, and a drug container comprising a drug. The device may be configured to delivery to a human patient about 2 mL of the drug at a flow rate of up to about 12 mL per minute. The drug may include at least one of a sclerostin antibody or a calcitonin gene-related peptide (CGRP) antibody. 
     Another aspect of the present disclosure provides a drug delivery device including a means for delivering a drug to a patient of about 2 mL at a flow rate of up to about 12 mL per minute. The drug includes at least one of a sclerostin antibody or a calcitonin gene-related peptide (CGRP) antibody. 
     Yet another aspect of the present disclosure provides a method of administering a drug including: (a) contacting a human patient with a drug delivery device configured to deliver about 2 mL of a drug at a flow rate of up to about 12 mL per minute, wherein the drug comprises at least one of a sclerostin antibody or a calcitonin gene-related peptide (CGRP) antibody; and (b) actuating the drug delivery device to deliver the drug to the patient. 
     Another aspect of the present disclosure provides a wearable drug delivery device including a container, a drug, a needle, an activation member manually operable by a patient, an insertion mechanism, a fluid pathway connector, a locking assembly, and a selector. The drug may be disposed in the container. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The insertion mechanism may be configured to move the needle between a retracted position and an inserted position. The insertion mechanism may a rotatable housing and a rotational biasing member initially held in an energized state. The fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. The locking assembly may have a lock configuration, where the locking assembly engages the rotatable housing to inhibit rotation of the rotatable housing, and an unlock configuration, where the locking assembly disengages the rotatable housing to permit rotation of the rotatable housing. The selector may have a first configuration, where the selector operatively decouples the activation member and the locking assembly, and a second configuration, where the selector operatively couples the activation member and the locking assembly to allow the activation member to change the locking assembly from the lock configuration to the unlock configuration. 
     An additional aspect of the present disclosure provides a wearable drug delivery device including a main housing, a container, a drug, a window, an introducer needle, a cannula, a drive mechanism, an insertion mechanism, a fluid pathway connector, a button, and a trigger assembly. The container may be disposed in the main housing. The container may include a barrel, a plunger seal moveable through the barrel, and a first pierceable seal controlling access to an interior of the barrel. The drug may be disposed in the barrel. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The window may cover an opening in the main housing. At least a portion of the container may be visible through the window. The introduce needle may have a proximal end and a distal end. The cannula may be initially disposed around the distal end of the introducer needle. The drive mechanism may be disposed in the main housing. The drive mechanism may include: a drive housing, a piston moveable relative to the drive housing and configured to impart movement to the plunger seal, a piston biasing member disposed between the drive housing and the piston, and a first retainer. The piston biasing member may be initially retained in a piston biasing member energized state. The piston biasing member may be configured to move the piston as the piston biasing member de-energizes. The first retainer may be moveable between: (i) a first retainer retaining position, where the first retainer retains the piston biasing member in the piston biasing member energized state, and (ii) a first retainer releasing position, where the first retainer allows the piston biasing member to de-energize. The fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. The fluid pathway connector may include a tubular conduit, a container access needle, and a connection hub. The tubular conduit may have a first end and a second end. The container access needle may be configured to pierce the first pierceable seal to establish fluid communication between the between the barrel and the tubular conduit during drug delivery. The connection hub may be connected to the container access needle and the first end of the tubular conduit. The connection hub may have a connection hub interior chamber providing fluid communication between the container access needle and the tubular conduit during drug delivery. The insertion mechanism may be disposed in the main housing. The insertion mechanism may include an insertion mechanism a manifold, a second pierceable seal, an insertion biasing member, a second retainer, a hub, a retraction biasing member, and a third retainer. The manifold may be moveable relative to the insertion mechanism housing. The manifold may be connected to the cannula and the second end of the tubular conduit, the manifold having a manifold internal chamber providing fluid communication between the tubular conduit and the cannula during drug delivery. The second pierceable seal may be connected to the manifold and control access to the manifold internal chamber. The distal end of the introducer needle may be disposed through the second pierceable seal. The insertion biasing member may be disposed between the insertion mechanism housing and the manifold. The insertion biasing member may be initially retained in an insertion biasing member energized state. The insertion biasing member may be configured to move the manifold in a distal direction as the insertion biasing member de-energizes. The second retainer may be moveable between: (i) a second retainer retaining position, where the second retainer retains the insertion biasing member in the insertion biasing member energized state, and (ii) a second retainer releasing position, where the second retainer allows the insertion biasing member to de-energize. The hub may be connected to the proximal end of the introducer needle. The retraction biasing member may be disposed between the hub and the manifold. The retraction biasing member may be initially retained in a retraction biasing member energized state. The retraction biasing member may be configured to move the hub in a proximal direction as the retraction biasing member de-energizes. The third retainer may be moveable between: (i) a third retainer retaining position, where the third retainer retains the retraction biasing member in the retraction biasing member energized state, and (ii) a third retainer releasing position, where the third retainer allows the retraction biasing member to de-energized. The button may protrude from the main housing and may be manually displaceable by a user. The trigger assembly may be configured to, in response to displacement of the button by the user, move: (i) the first retainer from the first retainer retaining position to the first retainer releasing position, and (ii) the second retainer from the second retainer retaining position to the second retainer releasing position. 
     Another aspect of the present disclosure provides a wearable drug delivery device including a main housing, a container, a drug, a window, an introducer needle, a cannula, a drive mechanism, an insertion mechanism, a fluid pathway connector, a button, and a trigger assembly. The container may be disposed in the main housing. The container may include a barrel, a plunger seal moveable through the barrel, and a first pierceable seal controlling access to an interior of the barrel. The drug may be disposed in the barrel. The drug may include at least one of: a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. The window may cover an opening in the main housing, and at least a portion of the container may be visible through the window. The introducer needle may have a hollow interior, a proximal end, and a distal end. The drive mechanism may be disposed in the main housing. The drive mechanism may include a drive housing, a piston moveable relative to the drive housing and configured to impart movement to the plunger seal, a gear assembly, an electrical actuator, a gear interface, a piston biasing member, and a tether. The gear interface may be rotatable by the electrical actuator. Rotation of the gear interface may cause the gear interface to selectively engage the gear assembly to prevent or allow rotation of the gear assembly. The piston biasing member may be disposed between the drive housing and the piston. The piston biasing member may be initially retained in a piston biasing member energized state. The piston biasing member may be configured to move the piston as the piston biasing member de-energizes. The tether may be connected at opposite ends to the gear assembly and the piston. The tether may initially retain the piston biasing member in the piston biasing member energized state. Rotation of the gear assembly may create slack in the tether which allows the piston biasing member to de-energize. The a fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. The fluid pathway connector may include a tubular conduit having a first end and a second end. The second end of the tubular conduit may be in fluid communication with the hollow interior of the introducer needle during drug delivery. The container access needle may be configured to pierce the first pierceable seal to establish fluid communication between the between the barrel and the tubular conduit during drug delivery. The connection hub may be connected to the container access needle and the first end of the tubular conduit. The connection hub may provide fluid communication between the container access needle and the tubular conduit during drug delivery. The insertion biasing mechanism may be disposed in the main housing. The insertion biasing mechanism may include a base, an insertion mechanism housing rotatable relative to the base, a rotational biasing member connected to the insertion mechanism housing, a first retainer, a hub, a retraction biasing member, and a second retainer. The rotational biasing member may be initially retained in a rotational biasing member energized state, the rotational biasing member being configured to rotate the insertion mechanism housing as the rotational biasing member de-energizes. The first retainer may be moveable between: (i) a first retainer retaining position, where the first retainer retains the rotational biasing member in the rotational biasing member energized state, and (ii) a first retainer releasing position, where the first retainer allows the rotational biasing member to de-energize. The hub may be connected to the proximal end of the introducer needle. The hub may be configured to translate relative to the insertion mechanism housing. The retraction biasing member may be disposed between the hub and the base. The retraction biasing member may have a retraction biasing member energized state. The retraction biasing member may be configured to translate the hub in a proximal direction as the retraction biasing member de-energizes. The second retainer may be moveable between: (i) a second retainer retaining position, where the second retainer retains the retraction biasing member in the retraction biasing member energized state, and (ii) a second retainer releasing position, where the second retainer allows the retraction biasing member to de-energize. The button may protrude from the main housing and may be manually displaceable by a user. The trigger assembly may be configured to move the first retainer from the first retainer retaining position to the first retainer releasing position in response to displacement of the button by the user. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings is necessarily to scale. 
         FIG. 1A  shows an isometric view of a drug delivery device having safety integrated insertion mechanisms, according to one embodiment of the present disclosure; 
         FIG. 1B  shows an isometric view of the interior components of the drug delivery device shown in  FIG. 1A ; 
         FIG. 1C  shows an isometric view of the bottom of the drug delivery device shown in  FIG. 1A ; 
         FIG. 2A  shows an isometric view of the patient-initiated fluid pathway connectors to drug containers, according to one embodiment of the present disclosure; 
         FIG. 2B  shows an isometric view of the fluid pathway connector shown in  FIG. 2A  attached to a drug container; 
         FIG. 3A  shows an exploded view of the fluid pathway connector, exploded along a longitudinal axis “A,” according to at least one embodiment of the present disclosure; 
         FIG. 3B  shows a cross-sectional exploded view of the fluid pathway connector shown in  FIG. 3A ; 
         FIG. 4A  shows a cross-sectional view of the fluid pathway connector attached to a drug container, as shown in  FIG. 2B , prior to patient activation; 
         FIG. 4B  shows a cross-sectional view of the fluid pathway connector attached to a drug container, as shown in  FIG. 2B , with the fluid pathway connected by the patient; 
         FIG. 5A  shows an isometric view, from the distal perspective, of a connection hub, according to one embodiment of the present disclosure; 
         FIG. 5B  shows an isometric view, from the proximal perspective, of the connection hub shown in  FIG. 5A ; 
         FIG. 5C  shows a transparent view of the connection hub shown in  FIG. 5B ; 
         FIG. 6A  shows an isometric view, from the distal perspective, of a connection hub, according to another embodiment of the present disclosure; 
         FIG. 6B  shows an isometric view, from the proximal perspective, of the connection hub shown in  FIG. 6A ; 
         FIG. 6C  shows a transparent view of the connection hub shown in  FIG. 6B ; 
         FIG. 7A  shows an isometric view of an insertion mechanism, according to a first embodiment of the present disclosure; 
         FIG. 7B  shows an isometric view of an insertion mechanism, according to another embodiment of the present disclosure; 
         FIG. 8A  shows an exploded view, exploded along an axis “A,” of the insertion mechanism shown in  FIG. 7A ; 
         FIG. 8B  shows a cross-sectional exploded view, exploded along an axis “A,” of the insertion mechanism shown in  FIG. 7A ; 
         FIG. 9  shows a cross-section isometric view of the insertion mechanism housing and manifold guide of the insertion mechanism, according to a first embodiment of the present disclosure; 
         FIG. 10A  shows an isometric view of a clip of the insertion mechanism, according to a first embodiment of the present disclosure; 
         FIG. 10B  shows an isometric view of the manifold guide shown in  FIG. 9 ; 
         FIG. 10C  shows an isometric view of a manifold, a manifold intake, and a fluid conduit of the insertion mechanism, according to a first embodiment of the present disclosure; 
         FIG. 11A  shows a cross-sectional view of an insertion mechanism, according to a first embodiment of the present disclosure, in a locked and ready to use stage; 
         FIG. 11B  shows a cross-sectional view of an insertion mechanism, according to a first embodiment of the present disclosure, in an unlocked and inserted stage; and 
         FIG. 11C  shows a cross-sectional view of an insertion mechanism, according to a first embodiment of the present disclosure, in a retracted stage for drug delivery. 
         FIG. 12  shows an isometric view of a drive mechanism, according to at least one embodiment of the present disclosure; 
         FIG. 13  shows an exploded view, along an axis “A,” of the drive mechanism shown in  FIG. 12 , 
         FIG. 14A  shows a cross-sectional view of the drive mechanism shown in  FIG. 12  in an initial inactive state; 
         FIG. 14B  shows a cross-sectional view of the drive mechanism shown in  FIG. 12  in an actuated state; 
         FIG. 14C  shows a cross-sectional view of the drive mechanism shown in  FIG. 12  in a further actuated state as drug delivery from the mechanism continues; 
         FIG. 14D  shows a cross-sectional view of the drive mechanism shown in  FIG. 12  as the mechanism nears completion of drug delivery; 
         FIG. 14E  shows a cross-sectional view of the drive mechanism shown in  FIG. 12  as the mechanism performs a compliance push to ensure completion of drug delivery; 
         FIG. 15  shows an isometric view of a drive mechanism, according to a second embodiment of the present disclosure; 
         FIG. 16  shows an exploded view, along an axis “A,” of the drive mechanism shown in  FIG. 15 ; 
         FIG. 17  shows a cross-sectional view of the drive mechanism shown in  FIG. 15  in an actuated state; 
         FIG. 18  shows an isometric view of the drive mechanism according to a further embodiment of the present disclosure; 
         FIG. 19A  shows a cross-sectional view of the drive mechanism shown in  FIG. 18  in an initial inactive state; 
         FIG. 19B  shows a cross-sectional view of the drive mechanism shown in  FIG. 18  in an actuated state and as the mechanism nears completion of drug delivery; 
         FIG. 19C  shows a cross-sectional view of the drive mechanism shown in  FIG. 18  as the mechanism completes drug delivery and triggers an end-of-dose signal. 
         FIG. 20A  is an isometric view of yet another embodiment of a drug delivery device having safety integrated insertion mechanisms in accordance with teachings of the present disclosure; 
         FIG. 20B  is an isometric view of the interior components of the drug delivery device shown in  FIG. 20A ; 
         FIG. 20C  is an isometric view of the bottom of the drug delivery device shown in  FIG. 20A ; 
         FIG. 21  is an isometric view of a drive mechanism, according to at the embodiment of  FIGS. 20A-20C ; 
         FIG. 22  is an exploded view, along an axis “A,” of the drive mechanism shown in  FIG. 21 , 
         FIG. 23A  is a cross-sectional view of the drive mechanism shown in  FIG. 21  in an initial inactive state; 
         FIG. 23B  is a cross-sectional view of the drive mechanism shown in  FIG. 21  in an actuated state; 
         FIG. 23C  is a cross-sectional view of the drive mechanism shown in  FIG. 21  at the completion of drug delivery; 
         FIG. 24A  is a cross-sectional view of the drive mechanism taken along line  14 - 14  in  FIG. 21 ; and 
         FIG. 24B  is a cross-sectional view of the drive mechanism similar to  FIG. 24A , but after the activation of the sensor. 
         FIG. 25  is an isometric view of a drug delivery device incorporating an embodiment of a fill-finish cartridge according to aspects of the disclosure; 
         FIG. 26A  is a schematic representation of an exemplary fill-finish cartridge of the present disclosure; 
         FIG. 26B  is a chart of exemplary combinations of components of a fill-finish cartridge according to aspects of the disclosure; 
         FIG. 27  is an exploded isometric view of a fill-finish cartridge, according to an embodiment of the disclosure; 
         FIG. 28  is an enlarged fragmentary isometric cross-sectional view of the fluid pathway connector of the fill-finish cartridge shown in  FIG. 27 , cross-hatching being eliminated for the purposes of clarity; 
         FIG. 29  is an isometric view of the fill-finish cartridge of  FIG. 27  before insertion of a plunger seal, elements of  FIG. 29  being shown in partial transparency; 
         FIG. 30  is an isometric view of the fill-finish cartridge of  FIG. 27  after insertion of a plunger seal, elements of  FIG. 30  being shown in partial transparency; 
         FIG. 31  is an exploded isometric view of a tray which may be utilized to retain a plurality of fill-finish cartridges for use in a fill-finish process, elements of  FIG. 7  being shown in partial transparency;  31   
         FIG. 32  is an isometric view of the a tray of  FIG. 31  in an assembled form and holding a plurality of fill-finish cartridges for use in a fill-finish process; 
         FIG. 33  is a side elevational view of another embodiment of a fill-finish cartridge, wherein the cartridge includes a fully disposable carrier; 
         FIG. 34  is an exploded view of the fill-finish cartridge of  FIG. 33 ; 
         FIG. 35  is a cross-sectional view of the fill-finish cartridge of  FIGS. 33 and 34 , cross-hatching being eliminated for the purposes of clarity; 
         FIG. 36  is a side elevational view of the fill-finish cartridge of  FIGS. 33-35  with the carrier removed; 
         FIG. 37  is an isometric view of a drug delivery device incorporating another embodiment of a fill-finish cartridge according to the disclosure, a portion of a housing of the drug delivery device being removed; 
         FIG. 38  is a side elevational view of the fill-finish cartridge of  FIG. 37  prior to placement in the housing, and including partially disposable carrier; 
         FIG. 39  is a cross-sectional view of the fill-finish cartridge of  FIG. 37 , cross-hatching being eliminated for the purposes of clarity; 
         FIG. 40  is a side elevational view of another embodiment of a fill-finish cartridge in an assembled configuration; 
         FIG. 41  is a cross-sectional view of the fill-finish cartridge of  FIG. 40 , cross-hatching being eliminated for the purposes of clarity; 
         FIG. 42  is a partially exploded view of the fill-finish cartridge of  FIGS. 40 and 41 , showing a fluid conduit in the final configuration; 
         FIG. 43  is an exploded view of the fluid pathway connector of the fill-finish cartridge of  FIGS. 40-42 ; 
         FIG. 44  is a cross-sectional view of the fill-finish cartridge of  FIG. 40  similar to the view of  FIG. 41 , but prior to the coupling of the fluid pathway connector to the needle insertion mechanism, cross-hatching being eliminated for the purposes of clarity; 
         FIG. 45  is a side elevational view of another embodiment of a fill-finish cartridge in an assembled configuration; 
         FIG. 46  is a cross-sectional view of the fill-finish cartridge of  FIG. 41 , cross-hatching being eliminated for the purposes of clarity; 
         FIG. 47  is a cross-sectional view of the fill-finish cartridge of  FIG. 41  similar to the view of  FIG. 42 , but prior to the coupling of the fluid pathway connector to the needle insertion mechanism, cross-hatching being eliminated for the purposes of clarity; 
         FIG. 48A  is an isometric view of an embodiment of a fluid path connection assembly and drug container in an unmounted configuration; 
         FIG. 48B  is an isometric view of the embodiment shown in  FIG. 48A  in a mounted configuration; 
         FIG. 48C  is a cross-sectional isometric view of the embodiment shown in  FIG. 48A  in a mounted configuration; 
         FIG. 49A  is an isometric view of an embodiment of a fluid path connection assembly and a drug container in an unmounted configuration; 
         FIG. 49B  is an isometric view of the embodiment shown in  FIG. 49A  in a mounted configuration; 
         FIG. 49C  is a cross-sectional isometric view of the embodiment shown in  FIG. 49A  in a mounted configuration; 
         FIG. 49D  is a cross-sectional isometric view of the embodiment shown in  FIG. 49A  after connection of the fluid path; 
         FIG. 50A  is a cross-sectional side view of an embodiment of a fluid path connection assembly and a drug container in an mounted configuration; 
         FIG. 50B  is a cross-sectional side view of the embodiment shown in  FIG. 50A  after the first and second films have been pierced; 
         FIG. 50C  is a cross-sectional side view of the embodiment shown in  FIG. 50A  after retraction of the outer piercing member; 
         FIG. 50D  is a cross-sectional side view of the embodiment shown in  FIG. 50A  after connection of the fluid path; 
         FIG. 51A  is a cross-sectional side view of an embodiment of a fluid path connection mechanism and a drug container in an unmounted configuration; 
         FIG. 51B  is a cross-sectional side view of the embodiment shown in  FIG. 51A  after piercing of the first and second films by the outer piercing member; 
         FIG. 51C  is a cross-sectional side view of the embodiment shown in  FIG. 51A  after connection of the fluid path; 
         FIG. 52A  is a cross-sectional side view of an embodiment of a fluid path connection mechanism and a drug container in an unmounted configuration; 
         FIG. 52B  is a cross-sectional side view of the embodiment shown in  FIG. 52A  in a mounted configuration; 
         FIG. 52C  is a cross-sectional side view of the embodiment shown in  FIG. 52A  after piercing of the first and second films by the outer piercing member; 
         FIG. 52D  is a cross-sectional side view of the embodiment shown in  FIG. 52A  after connection of the fluid path; 
         FIG. 53A  is a cross-sectional side view of an embodiment of a fluid path connection mechanism and a drug container in a mounted configuration; 
         FIG. 53B  is a cross-sectional side view of the embodiment of  FIG. 53A  after connection of the fluid path; 
         FIG. 54A  is a cross-sectional side view of an embodiment of a fluid path connection mechanism and a drug container in an unmounted configuration; 
         FIG. 54B  is a cross-sectional side view of the embodiment shown in  FIG. 54A  in a mounted configuration; 
         FIG. 54C  is a cross-sectional side view of the embodiment shown in  FIG. 54A  after connection of the fluid path; 
         FIG. 55A  is a cross-sectional side view of an embodiment of a fluid path connection mechanism and a drug container in an unmounted configuration; 
         FIG. 55B  is a cross-sectional side view of the embodiment shown in  FIG. 55A  in a mounted configuration; 
         FIG. 55C  is a cross-sectional side view of the embodiment shown in  FIG. 55A  during UV sterilization; 
         FIG. 55D  is a cross-sectional side view of the embodiment shown in  FIG. 55A  after connection of the fluid path; 
         FIG. 56  shows a fluid path connection according to at least one embodiment of the present disclosure; 
         FIG. 57A  shows an isometric view of the interior components of a second embodiment of a drug delivery device; 
         FIG. 57B  shows a second view of the interior components of the drug delivery device shown in  FIG. 57A ; 
         FIG. 58A  shows an exploded view, exploded along an axis “A,” of an insertion mechanism according to at least one embodiment of the present disclosure; 
         FIG. 58B  shows a cross-sectional exploded view, exploded along an axis “A,” of an insertion mechanism according to at least one embodiment of the present disclosure; 
         FIG. 59A  shows an isometric view of an insertion mechanism housing according to at least one embodiment of the present disclosure; 
         FIG. 59B  shows a cross-section view of the insertion mechanism housing shown in  FIG. 59A ; 
         FIG. 60  shows an isometric view of a hub according to at least one embodiment of the present disclosure; 
         FIG. 61  shows an isometric view of a sleeve according to at least one embodiment of the present disclosure; 
         FIG. 62  shows an embodiment of a base of an insertion mechanism according to at least one embodiment of the present disclosure; 
         FIG. 63A  shows an isometric view of an insertion mechanism according to at least one embodiment of the present disclosure in an initial configuration; 
         FIG. 63B  shows a cross-sectional view of an insertion mechanism according to at least one embodiment of the present disclosure in an initial configuration; 
         FIG. 64A  shows an isometric view of an insertion mechanism according to at least one embodiment of the present disclosure in a needle inserted configuration; 
         FIG. 64B  shows a cross-sectional view of an insertion mechanism according to at least one embodiment of the present disclosure in a needle inserted configuration; 
         FIG. 65A  shows an isometric view of an insertion mechanism according to at least one embodiment of the present disclosure in a needle retracted configuration; 
         FIG. 65B  shows a cross-sectional view of an insertion mechanism according to at least one embodiment of the present disclosure in a needle retracted configuration; 
         FIG. 66  shows an isometric view of an insertion mechanism according to at least one embodiment of the present disclosure; 
         FIG. 67  shows a cross-sectional side view of the embodiment of  FIG. 66 ; 
         FIG. 68  shows a cross-sectional front view of the embodiment of  FIG. 66 ; 
         FIG. 69A  shows an isometric view of the interior components of a drug delivery device having a multi-function drive mechanism, according to one embodiment of the present disclosure (shown without the adhesive patch); 
         FIG. 69B  shows an isometric view of the interior components of the drug delivery device shown in  FIG. 69A  (shown without the adhesive patch) from another viewpoint; 
         FIG. 69C  shows an isometric view of the interior components of the drug delivery device shown in  FIG. 69A  (shown without the adhesive patch) from yet another viewpoint; 
         FIG. 69D  shows a top view, along an axis “A,” of the interior components of the drug delivery device shown in  FIG. 69A ; 
         FIG. 70A  shows an isometric view of a multi-function drive mechanism, according to at least one embodiment of the present disclosure prior to activation; 
         FIG. 70B  shows an isometric view of a multi-function drive mechanism, according to at least one embodiment of the present disclosure during activation; 
         FIG. 70C  shows an isometric view of a multi-function drive mechanism, according to at least one embodiment of the present disclosure at a later stage during activation; 
         FIG. 70D  shows an isometric view of a multi-function drive mechanism, according to at least one embodiment of the present disclosure near or at completion of drug delivery; 
         FIGS. 71A-71D  show top views which correspond with the stages of operation shown in  FIGS. 70A-70D , respectively; 
         FIG. 72  shows the multi-function drive mechanism, according to at least one embodiment of the present disclosure, in isolation from the drug delivery device; 
         FIGS. 73A-73B  show top and bottom views, respectively, of the multi-function drive mechanism shown in  FIG. 72 ; 
         FIGS. 73C-73D  show front and back perspective views, respectively, of the multi-function drive mechanism shown in  FIG. 72 ; 
         FIG. 74  illustrates a top view of an embodiment of an activation mechanism arranged in a lower housing of a drug delivery device; 
         FIG. 75  depicts an exploded assembly view of the activation mechanism shown in  FIG. 74 ; 
         FIG. 76A  is a cross-sectional view of an embodiment of a fluid pathway connector and drug container prior to drug delivery; 
         FIG. 76B  is a cross-sectional view of the embodiment of a fluid pathway connector and drug container of  FIG. 76A  during drug delivery; 
         FIG. 76C  is a cross-sectional view of the embodiment of a fluid pathway connector and drug container of  FIG. 76A  following completion of drug delivery; 
         FIG. 77  is a schematic illustration of a drug delivery device including a temperature control system, according to one embodiment of the present disclosure; 
         FIG. 78A  illustrates an embodiment of an adhesive patch for a drug delivery device constructed in accordance with principles of the present disclosure; 
         FIG. 78B  illustrates an embodiment of an adhesive patch for a drug delivery device constructed in accordance with principles of the present disclosure; 
         FIG. 79  depicts an embodiment of a non-adhesive patch liner in combination with a drug delivery device constructed in accordance with principles of the present disclosure; 
         FIG. 80A  illustrates an exploded assembly view of an embodiment of an adhesive patch for a drug delivery device constructed in accordance with principles of the present disclosure; 
         FIG. 80B  depicts the adhesive patch of  FIG. 80A  in an assembled form; 
         FIG. 81  illustrates an isometric view of a drug delivery device including an adhesive patch with stiffening members, according to one embodiment of the present disclosure; 
         FIG. 82  illustrates a bottom view an embodiment of a non-adhesive patch liner; 
         FIG. 83A-83C  illustrate a process of attaching the drug delivery device of  FIG. 81  to a patient&#39;s skin; 
         FIG. 84  is a schematic diagram of a drug delivery device in communication with a data processing network according to one embodiment of the present disclosure; 
         FIGS. 85A-85C  are schematic diagrams illustrating the operation of an energy management system according to one embodiment of the present disclosure; 
         FIGS. 86A-86C  are schematic diagrams illustrating the operation of an energy management system according to another embodiment of the present disclosure; 
         FIGS. 87A-87C  are schematic diagrams illustrating the operation of an energy management system according to another embodiment of the present disclosure; 
         FIG. 88  is an isometric view of an energy management system according to another embodiment of the present disclosure; 
         FIG. 89  is an isometric view of an energy management system according to another embodiment of the present disclosure; 
         FIG. 90  is a cross-sectional view of an energy management system according to another embodiment of the present disclosure; 
         FIGS. 91A-91B  are cross-sectional views illustrating the operation of an energy management system according to another embodiment of the present disclosure; 
         FIG. 92  is a bar graph showing delivery times, in seconds (y-axis), for various types of administration (y-axis). tsubQ=Delivery Time, Subcutaneous (SQ) Delivery, With Viscosity Tolerance (Case 1); tsubQvc=Delivery Time, Subcutaneous Delivery, Constant Viscosity (Case 2); tamb=Delivery Time, Ambient Delivery, With Viscosity Tolerance (Case 3); and tambvc=Delivery Time, Ambient Delivery, Constant Viscosity (Case 4). Error bars show min/max error; 
         FIG. 93  is a graph presenting drive system force profiles as a function of drive assembly force (N) (x-axis) over travel distance (mm) (y-axis). In  FIG. 93 , the line having squares indicates a minimum, the line having triangles indicates a maximum, and the lines having diamonds indicates a nominal; 
         FIG. 94  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in subcutaneous Case 1, SQ delivery and viscosity range. The y-axis shows relative time contribution as percent in seconds; 
         FIG. 95  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in Case 2, SQ delivery and viscosity constant. Relative contribution, in seconds, is shown as percent on the y-axis; 
         FIG. 96  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in Case 3, ambient delivery and viscosity range. Relative contribution, in seconds, is shown as percent on the y-axis; 
         FIG. 97  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in Case 4, ambient delivery and viscosity constant. Relative contribution, in seconds, is shown as percent on the y-axis; 
         FIG. 98  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in Case 4, ambient delivery and viscosity constant, by variable groups. Relative contribution, in seconds, is shown as percent on the y-axis; 
         FIG. 99  is a bar graph conveying the contribution (%) to delivery time variation of components (x-axis) in SubQ delivery; 
         FIG. 100A  is an exploded view of an insertion mechanism, according to a first embodiment of the disclosure; 
         FIG. 100B  is a cross-sectional exploded view of the insertion mechanism of  FIG. 100A ; 
         FIG. 101  is an isometric view of an insertion mechanism housing, according to at least one embodiment of the present disclosure; 
         FIG. 102  is an isometric view of an insertion mechanism housing cap, according to at least one embodiment of the present disclosure; 
         FIG. 103  is an isometric view of a clip, according to at least one embodiment of the present disclosure; 
         FIG. 104  is an isometric view of a clip retainer according to at least one embodiment of the present disclosure; 
         FIG. 105  is an isometric view of a manifold guide according to at least one embodiment of the present disclosure; 
         FIG. 106  is an isometric view of a manifold and fluid conduit according to at least one embodiment of the present disclosure; 
         FIG. 107  is an isometric view of a travel limiter according to at least one embodiment of the present disclosure; 
         FIG. 108A  is an isometric view of a needle insertion mechanism in an initial configuration or initial locked configuration according to at least one embodiment of the present disclosure; 
         FIG. 108B  is a cross-sectional view of the needle insertion mechanism of  FIG. 108A ; 
         FIG. 109A  is an isometric view of the needle insertion mechanism of  FIG. 108A  in an administration configuration; 
         FIG. 109B  is a cross-sectional view of the needle insertion mechanism of  FIG. 108A  in an administration configuration; 
         FIG. 110A  is an isometric view of the needle insertion mechanism of  FIG. 108A  in a retracted configuration or unlocked configuration; 
         FIG. 110B  is a cross-sectional view of the needle insertion mechanism of  FIG. 110A  in a retracted configuration or unlocked configuration; 
         FIG. 111A  is an exploded view of an insertion mechanism, according to a second embodiment of the disclosure; 
         FIG. 111B  is a cross-sectional exploded view of the insertion mechanism of  FIG. 111A ; 
         FIG. 112  is an isometric view of an insertion mechanism housing, according to at least one embodiment of the present disclosure; 
         FIG. 113  is an isometric view of a manifold guide according to at least one embodiment of the present disclosure; 
         FIG. 114  is an isometric view of a travel limiter of at least one embodiment of the present disclosure; 
         FIG. 115A  is a cross-sectional view of a needle insertion mechanism in an initial configuration or initial locked configuration according to at least one embodiment of the present disclosure; 
         FIG. 115B  is a cross-sectional view of the needle insertion mechanism of  FIG. 115A  in an administration configuration; 
         FIG. 115C  is a cross-sectional view of the needle insertion mechanism of  FIG. 115A  in a retracted configuration or unlocked configuration; 
         FIG. 116  is an isometric view of a needle retraction release mechanism of at least one embodiment of the present disclosure; 
         FIG. 117  is an isometric view of a pivot of at least one embodiment of the present disclosure. 
         FIG. 118  shows an isometric view of a drug container according to at least one embodiment of the present disclosure; 
         FIG. 119  shows an isometric view of a drug container and a fluid pathway connection according to at least one embodiment of the present disclosure; 
         FIG. 120A  shows an isometric view of the drug container and fluid pathway connection of  FIG. 119  in an unmounted configuration; 
         FIG. 120B  shows a cross-sectional isometric view of the drug container and fluid pathway connection of  FIG. 119  in an initial mounting configuration; 
         FIG. 120C  shows a cross-sectional isometric view of the drug container and fluid pathway connection of  FIG. 119  in an intermediate mounting configuration; 
         FIG. 120D  shows a cross-sectional isometric view of the drug container and fluid pathway connection of  FIG. 119  in a mounted configuration; 
         FIG. 121A  shows an isometric view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 121B  shows a cross-sectional isometric view of the drug container and fluid pathway connection of  FIG. 121A  in a mounted configuration; 
         FIG. 122  shows a detail cross-sectional view of a fluid pathway connection according to at least one embodiment of the present disclosure; 
         FIG. 123  shows a cross-sectional isometric view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 124  shows an isometric view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 125  shows a cross-sectional view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 126  shows a cross-sectional isometric view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 127A  shows an isometric view of an embodiment of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 127B  shows an end view of a drug container; 
         FIG. 127C  shows a cross-sectional view of a drug container and fluid pathway connection in an unmounted configuration; 
         FIG. 127D  shows a cross-sectional view of a drug container and fluid pathway connection in a connected configuration; 
         FIG. 128A  shows an exploded view of a medical device with an integrated stimulant source according to at least one embodiment of the present invention; 
         FIG. 128B  shows the medical device of the embodiment of  FIG. 128A  applied to a patient&#39;s skin and the stimulant source activated; 
         FIG. 128C  shows the medical device of the embodiment of  FIG. 128A  after removal from the patient&#39;s skin; 
         FIG. 129A  shows an exploded view of a medical device with an external stimulant source according to at least one embodiment of the present invention; 
         FIG. 129B  shows the medical device of the embodiment of  FIG. 129A  applied to a patient&#39;s skin; 
         FIG. 129C  shows the medical device of the embodiment of  FIG. 129A  after removal of the body of the medical device and the stimulant source activated; 
         FIG. 129D  illustrates removal of the adhesive from the patient&#39;s skin; 
         FIG. 130  illustrates an isometric view of the interior components of the drug delivery device  10  (shown without the adhesive patch) installed with an embodiment of fluid restriction mechanism; 
         FIG. 131A  shows an isometric view of a fluid restriction mechanism, according to at least one embodiment of the present invention, attached to an integrated sterile fluid pathway connection and drug container; 
         FIG. 131B  shows an exploded isometric view of the fluid restriction mechanism, and integrated sterile fluid pathway connection and drug container, shown in  FIG. 131A ; 
         FIG. 131C  shows a side view of the fluid restriction mechanism shown in  FIG. 131A ; 
         FIG. 132A  shows an isometric view of a fluid restriction mechanism, according to another embodiment of the present invention, attached to a sterile fluid pathway connection which may or may not be integrated within the drug container; 
         FIG. 132B  shows an exploded isometric view of the fluid restriction mechanism, and sterile fluid pathway connection and drug container, shown in  FIG. 131A ; 
         FIG. 132C  shows a side view of the fluid restriction mechanism shown in  FIG. 132A ; 
         FIG. 133A  shows an exploded isometric view of the fluid restriction mechanism shown in  FIGS. 131A-131C ; 
         FIG. 133B  shows another angle of the exploded isometric view of the fluid restriction mechanism shown in  FIG. 133A ; 
         FIG. 133C  shows a cross-sectional view of the fluid restriction mechanism shown in  FIGS. 133A-4B ; 
         FIG. 134A  shows an exploded isometric view of a configurable fluid restriction mechanism, according to another embodiment of the present invention; 
         FIG. 134B  shows a front view of the configurable fluid restriction mechanism shown in  FIG. 134A ; 
         FIG. 135A  shows an isometric view of a stackable fluid restriction mechanism, according to another embodiment of the present invention; 
         FIG. 135B  shows an exploded isometric view of the stackable fluid restriction mechanism shown in  FIG. 135A ; 
         FIG. 136A  shows an isometric view of a fluid restriction mechanism, according to a further embodiment of the present invention; 
         FIG. 136B  shows the isometric view of the fluid restriction mechanism shown in  FIG. 136A , with the top component of the fluid restriction mechanism removed; 
         FIG. 137A  shows an isometric view of a manifold having a vent, according to a first embodiment of the present disclosure; 
         FIG. 137B  shows an isometric view of the components shown in  FIG. 137A , rotated to show the manifold, manifold intake, and a fluid conduit of the insertion mechanism, according to a first embodiment of the present disclosure; 
         FIG. 138A  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, in a locked and ready to use stage; 
         FIG. 138B  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, as fluid passes through a conduit and into the manifold; 
         FIG. 138C  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, as fluid fills the manifold and gas is pushed through the permeable membrane; 
         FIG. 138D  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, in an unlocked and inserted stage; 
         FIG. 138E  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, in a partially retracted stage as fluid begins exiting the manifold through the cannula; 
         FIG. 138F  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, in a retracted stage for drug delivery; 
         FIGS. 139A-139C  show cross-sectional views of an insertion mechanism having a vented fluid pathway, according to another embodiment of the present disclosure, as it progresses through the various stages of insertion, venting, and drug delivery; 
         FIG. 140A  is an isometric view of an integrated sterile fluid pathway connection and drug container, according to an embodiment; and  FIG. 140B  is a sectional isometric view of the integrated sterile fluid pathway connection and drug container shown in  FIG. 140A ; 
         FIG. 141A  is an exploded, side view of the components of an embodiment of an integrated sterile fluid pathway connection and drug container, exploded along a longitudinal axis; and  FIG. 141B  is a sectional exploded view of the embodiment of  FIG. 141A ; 
         FIG. 142A  is a sectional view of an integrated sterile fluid pathway connection and drug container, as shown in  FIG. 140A , prior to user activation;  FIG. 142B  is a sectional view of the embodiment with the fluid pathway connected; and  FIG. 142C  is a sectional view of the embodiment at the end of drug delivery; 
         FIG. 143A  is an isometric perspective view, of the integrated sterile fluid pathway connection according to an embodiment of the present invention; and  FIG. 143B  is an exploded, perspective view of the components of the integrated sterile fluid pathway connection shown in  FIG. 143A ; 
         FIG. 144A  is a sectional view of an embodiment of an integrated sterile fluid pathway connection, having a piercing member guide and drug container, prior to user activation;  FIG. 144B  shows an isometric perspective view of the piercing member guide and piercing member of the embodiment shown in  FIG. 144A ; and  FIG. 144C  is an isometric view of the piercing member guide, piercing member, and connector hub of the embodiment of  FIG. 144A ; 
         FIG. 145  is a cross-sectional view of an integrated sterile fluid pathway connection and drug container according to an embodiment prior to user activation, in which the drug container comprises more than one drug chamber, each drug chamber separated from the next by a pierceable membrane; 
         FIG. 146A  to  FIG. 146E  are sectional views of an embodiment of a sterile fluid connector in which the pierceable seal is configured to maintain different positions within the connector in response to pneumatic and/or hydraulic pressure; 
         FIG. 147A  to  FIG. 147H  are sectional and isometric sectional views of an embodiment of a sterile fluid connector in which the pierceable seal, in response to pneumatic and/or hydraulic pressure, engages or disengages a sensor mechanism that is capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector; 
         FIG. 148A  to  FIG. 148G  are perspective and sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector; 
         FIG. 149A  to  FIG. 149D  are sectional and isomeric sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector, showing more specific configurations of a sensor in the open and closed positions; 
         FIG. 150A  to  FIG. 150D  are perspective and sectional views of an embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector, illustrating the unpressurized ( FIG. 150B ), pressurized ( FIG. 150C ), and end-of-delivery ( FIG. 150D ) positions of components of a sterile fluid connector; 
         FIG. 151A  to  FIG. 151C  are perspective and sectional views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector; 
         FIG. 152A  is a sectional view; and  FIG. 152B  is an isometric sectional view of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector; 
         FIG. 153A  and  FIG. 153B  are sectional isometric views of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector, in which the pierceable seal comprises a conductive material or coating; 
         FIG. 154  is a sectional isometric view of another an embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector, in which signal is mediated using an conductive elastomeric film; 
         FIG. 155  is a sectional isometric view of another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector, in which signal is mediated using a dome switch; 
         FIG. 156  is an isometric view of a drive mechanism, according to yet another embodiment of the present invention; 
         FIG. 157A  is a cross-sectional view of the drive mechanism taken along line  15 - 15  in  FIG. 156 ; and 
         FIG. 157B  is a cross-sectional view of the drive mechanism similar to  FIG. 157A , but after the activation of the sensor. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure provides drug delivery devices having advantageous insertion mechanisms, drive mechanisms, sterile fluid pathway assemblies, status indicators, safety features, and other advantageous components. Such drug delivery devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The drug delivery devices described herein incorporate features which make activation, operation, and lock-out of the drug delivery device simple for even untrained patients. The drug delivery devices of the present disclosure provide these desirable features without various problems associated with known prior art devices. Furthermore, the sterile fluid pathway assemblies of the present disclosure may filled with pharmaceutical treatments using standard filling equipment and systems. This advantage is enabled by the fill-finish cartridges of the present disclosure which function to maintain the sterility of the fluid pathway assemblies and allow them to nest, mount, or otherwise be removably inserted into trays for standard fill-finish processes, as discussed is more detail below. 
     As discussed in more detail below, the drug delivery devices of the present disclosure may contain a drug, which may also be also be referred to as a medication or a medicament. The drug may be, but is not limited to, various biologicals (e.g., peptides, peptibodies, or antibodies), biosimilars, large-molecule drugs (e.g., a drug with a molecular weight of greater than or equal to approximately 900 Daltons), small-molecule drugs (e.g., a drug with a molecular weight of less than or equal to approximately 900 Daltons), high viscosity drugs, low viscosity drugs, drugs exhibiting non-Newtonian fluid characteristics such as shear thinning, and/or drugs exhibiting Newtonian fluid characteristics. The drug may be in a fluid or liquid form, although the disclosure is not limited to a particular state (e.g., no differentiation is intended between a solution, a gel, or a lyophilized product for example). 
     One perceived disadvantage of certain known drug delivery devices is their inability to deliver highly viscous drugs such as certain biologics in a timely manner and/or with little patient discomfort. High viscosity drugs typically require more time for injection than low viscosity drugs. Patients may find it difficult and/or undesirable to hold an autoinjector or a syringe against their skin for the amount of time necessary to inject a high viscosity drug. While the injection time can be decreased by increasing the force of the drive mechanism, a more powerful drive mechanism increases the risk of breakage of the drug container and other internal components of the device. Also, a more powerful drive mechanism increases the possibility that the patient will experience an impulse or mechanical shockwave that may disturb or surprise the patient. As a result, the patient may attempt to pull the drug delivery device away from skin, which can compromise complete dosing. 
     Long injection times are more likely to be tolerated by patients if the drug is administered via a wearable drug delivery device. Unlike a syringe or an autoinjector, a wearable drug delivery device does not have to be held in place by the patient during drug delivery. Therefore, the patient can resume physical activities after the wearable drug delivery device has been placed on the skin and initiated or otherwise not burdened by holding the drug delivery device in place. 
     Certain aspects of wearable drug delivery devices, however, have discouraged their adoption in the field of high viscosity drugs. In order to achieve a compact design with a low profile that does not significantly protrude from the patient&#39;s body, wearable drug delivery devices oftentimes include a drug container that is offset and orthogonal to an insertion mechanism. This arrangement usually requires a tubular conduit with one of more turns to fluidly couple the drug container and the insertion mechanism. Therefore, as compared to syringes and autoinjectors, the internal fluid flowpath of wearable drug delivery devices tend to be relatively long and tortuous. 
     For drugs that behave as Newtonian fluids (i.e., fluids for which shear rate is directly proportional to flow rate), a longer flow path can result in a slower flow rate. Thus, wearable drug delivery devices, due to their long internal flowpaths, have the potential to exacerbate the injection problems associated with high viscosity drugs. The force of the drive mechanism can be increased to compensate for the reduction in flow rate, but a more powerful drive mechanism increases the risk of drug container breakage and therefore is typically considered undesirable. For at least these reasons, wearable drug delivery devices were viewed by some as not being particularly well suited for the delivery of high viscosity drugs. 
     The inventors of the present disclosure found that various high viscosity drugs (e.g., PCSK9 specific antibodies, G-CSFs, sclerostin antibodies, and CGRP antibodies) exhibit non-Newtonian fluid characteristics when injected via a wearable drug delivery device. One such characteristic is shear thinning, which is the ability of a non-Newtonian fluids to exhibit decreased viscosity when subjected to shear strain. Shear thinning reduces the viscosity of a fluid as it is pushed through a conduit. Accordingly, the force needed to push the fluid through a conduit is less than it would be if the fluid was Newtonian. In the context of wearable drug delivery devices, shear shinning mitigates the clogging effect of the device&#39;s long internal flowpath. Therefore, an unexpected benefit of wearable drug delivery devices found by the inventors of the present disclosure is that they are well suited for delivering high viscosity drugs having non-Newtonian characteristics such as shear thinning. The inventors of the present disclosure found that shear thinning oftentimes occurs in drugs such as biologics which have relatively large protein molecules with a molecular weight greater than or equal to approximately (e.g., ±10%) 900 daltons. Any of the wearable drug delivery devices described herein may have a drug container filled with a high viscosity drug having shear thinning capabilities, and therefore realize the unexpected benefits of shear thinning on the operation and use of the device. 
     Certain non-limiting embodiments of the drug delivery device and its respective components will now be described with reference to the accompanying figures. 
     As used herein to describe the drive mechanisms, the insertion mechanisms, fluid pathway connectors, drug delivery devices, or any of the relative positions of the components of the present disclosure, the terms “axial” or “axially” refer generally to a longitudinal axis “A” around which a component is preferably positioned, although not necessarily symmetrically there-around. The term “radial” refers generally to a direction normal to axis A. The terms “proximal,” “rear,” “rearward,” “back,” or “backward” refer generally to an axial direction in the direction “P”. The terms “distal,” “front,” “frontward,” “depressed,” or “forward” refer generally to an axial direction in the direction “D”. As used herein, the term “glass” should be understood to include other similarly non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass, including but not limited to certain non-reactive polymers such as cyclic olefin copolymers (COC) and cyclic olefin polymers (COP). The term “plastic” may include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be re-softened to their original condition by heat; thermosetting polymers cannot. As used herein, the term “plastic” refers primarily to moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, that also typically contain other ingredients such as curatives, fillers, reinforcing agents, colorants, and/or plasticizers, etc., and that can be formed or molded under heat and pressure. As used herein, the term “plastic” is not meant to include glass, non-reactive polymers, or elastomers that are approved for use in applications where they are in direct contact with therapeutic liquids that can interact with plastic or that can be degraded by substituents that could otherwise enter the liquid from plastic. The term “elastomer,” “elastomeric” or “elastomeric material” refers primarily to cross-linked thermosetting rubbery polymers that are more easily deformable than plastics but that are approved for use with pharmaceutical grade fluids and are not readily susceptible to leaching or gas migration under ambient temperature and pressure. As used herein, “fluid” refers primarily to liquids, but can also include suspensions of solids dispersed in liquids, and gasses dissolved in or otherwise present together within liquids inside the fluid-containing portions of drug delivery devices. According to various aspects and embodiments described herein, reference is made to a “biasing member”, such as in the context of one or more biasing members for insertion or retraction of the needle, trocar, and/or cannula. It will be appreciated that the biasing member may be any member that is capable of storing and releasing energy. Non-limiting examples include a spring, such as for example a coiled spring, a compression or extension spring, a torsional spring, and a leaf spring, a resiliently compressible or elastic band, or any other member with similar functions. In at least one embodiment of the present disclosure, the biasing member is a spring, preferably a compression spring. Also, as used herein, the term “drug delivery device” is intended to include any number of devices which are capable of dispensing a fluid to a patient upon activation. Such drug delivery devices include, for example, wearable drug delivery devices, on-body injectors, off-body injectors, autoinjectors, infusion pumps, bolus injectors, and the like. Furthermore, as used herein, the term “wearable drug delivery device” is intended to include any number of devices which are capable dispensing a fluid to a patient upon activation and capable of being attached to the patient&#39;s skin or clothing. Such wearable drug delivery devices include, for example, on-body injectors and off-body injectors. 
     I. Drug Delivery Device 
       FIGS. 1A-1C  show an exemplary drug delivery device  10  according to at least one embodiment of the present disclosure. The drug delivery device  10  may be utilized to administer delivery of a drug treatment into a body of a patient. As shown in  FIGS. 1A-1C , the drug delivery device  10  includes a housing  12 . The housing  12  may include one or more housing subcomponents which are fixedly engageable to facilitate easier manufacturing, assembly, and operation of the drug delivery device  10 . For example, drug delivery device  10  includes the housing  12  which includes an upper housing  12 A and a lower housing  12 B. The drug delivery device  10  may further include an activation mechanism  14 , a status indicator  16 , and a window  18 . Window  18  may be any translucent or transmissive surface through which the operation of the drug delivery device  10  may be viewed. In at least one embodiment, the window  18  may be configured to connect and hold together the upper housing  12 A and the lower housing  12 B. As shown in  FIG. 1B , drug delivery device  10  further includes assembly platform  20 , sterile fluid conduit  30 , drive mechanism  100  having drug container  50 , insertion mechanism  200 , fluid pathway connector  300 , and power and control system  400 . One or more of the components of the drug delivery device  10  may be modular in that they may be, for example, pre-assembled as separate components and configured into position onto the assembly platform  20  of the drug delivery device  10  during manufacturing. 
     The housing  12  may contain some or all of the device components. In some embodiments, the housing  12  may provide a means of removably attaching the drug delivery device  10  to the skin or clothing of the patient, thereby rending the drug delivery device  10  a wearable drug delivery device. In some embodiments, a layer of adhesive may be applied to an exterior surface of the housing  12 , such as the surface through which a cannula protrudes during operation, for releasably attaching the drug delivery device  10  to a patient&#39;s skin. 
     The housing  12  also provides protection to the interior components of the drug delivery device  10  against environmental influences. The housing  12  is ergonomically and aesthetically designed in size, shape, and related features to facilitate easy packaging, storage, handling, and use by patients who may be untrained and/or physically impaired. Furthermore, the external surface of the housing  12  may be utilized to provide product labeling, safety instructions, and the like. Additionally, as described above, housing  12  may include certain components, such as status indicator  16  and window  18 , which may provide operation feedback to the patient. 
     The container  50  may be configured to contain variety of different drug dose volumes, including drug dose volumes in a range of approximately (e.g., ±10%) 0.5-20 mL, or 1-10 mL, or 2-10 mL, or 2-8 mL, or 2-6 mL, or 2-4 mL, or 0.5-2 mL, or 0.5-1 mL, or 3.5 mL. The container  50  may be completely or partially filled with the drug. 
     In at least one embodiment, the drug delivery device  10  provides an activation mechanism that is displaced by the patient to trigger a start command to a power and control system  400 . In a preferred embodiment, the activation mechanism is a start button  14  that is located through the housing  12 , such as through an aperture between the upper housing  12 A and the lower housing  12 B, and which contacts a control arm  40  of the power and control system  400 . In at least one embodiment, the start button  14  may be a push button, and in other embodiments, may be an on/off switch, a toggle, or any similar activation feature known in the art. The housing  12  also provides a status indicator  16  and a window  18 . In other embodiments, one or more of the activation mechanism  14 , the status indicator  16 , the window  18 , and combinations thereof may be provided on the upper housing  12 A or the lower housing  12 B such as, for example, on a side visible to the patient when the drug delivery device  10  is placed on the body of the patient. Housing  12  is described in further detail hereinafter with reference to other components and embodiments of the present disclosure. 
     The drug delivery device  10  may be configured such that, upon activation by a patient by depression of the activation mechanism, the drug delivery device  10  is initiated to: insert a fluid pathway into the patient; enable, connect, or open necessary connections between a drug container, a fluid pathway, and a sterile fluid conduit; and force drug fluid stored in the drug container through the fluid pathway and fluid conduit for delivery into a patient. One or more optional safety mechanisms may be utilized, for example, to prevent premature activation of the drug delivery device  10 . For example, an optional on-body sensor  24  (shown in  FIG. 1C ) may be provided in one embodiment as a safety feature to ensure that the power and control system  400 , or the activation mechanism, cannot be engaged unless the drug delivery device  10  is in contact with the body of the patient. In one such embodiment, the on-body sensor  24  is located on the bottom of lower housing  12 B where it may come in contact with the patient&#39;s body. Upon displacement of the on-body sensor  24 , depression of the activation mechanism is permitted. Accordingly, in at least one embodiment the on-body sensor  24  is a mechanical safety mechanism, such as for example a mechanical lock out, that prevents triggering of the drug delivery device  10  by the activation mechanism  14 . In another embodiment, the on-body sensor may be an electro-mechanical sensor such as a mechanical lock out that sends a signal to the power and control system  400  to permit activation. In still other embodiments, the on-body sensor can be electrically based such as, for example, a capacitive- or impedance-based sensor which must detect tissue before permitting activation of the power and control system  400 . In at least one embodiment, such an electrically based on-body sensor may incorporate a resistor with an impedance of approximately (e.g., ±10%) 1 MΩ. These concepts are not mutually exclusive and one or more combinations may be utilized within the breadth of the present disclosure to prevent, for example, premature activation of the drug delivery device  10 . In a preferred embodiment, the drug delivery device  10  utilizes one or more mechanical on-body sensors. Additional integrated safety mechanisms are described herein with reference to other components of the drug delivery device  10 . 
     II. Power and Control System 
     The power and control system  400  includes a power source, which provides the energy for various electrical components within the drug delivery device  10 , one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnects. Other components commonly used in such electrical systems may also be included, as would be appreciated by one having ordinary skill in the art. The one or more feedback mechanisms may include, for example, audible alarms such as piezo alarms and/or light indicators such as light emitting diodes (LEDs). The microcontroller may be, for example, a microprocessor. The power and control system  400  controls several device interactions with the patient and interfaces with the drive mechanism  100 . In one embodiment, the power and control system  400  interfaces with the control arm  40  to identify when the on-body sensor  24  and/or the activation mechanism  14  have been activated. The power and control system  400  may also interface with the status indicator  16  of the housing  12 , which may be a transmissive or translucent material which permits light transfer, to provide visual feedback to the patient. The power and control system  400  interfaces with the drive mechanism  100  through one or more interconnects to relay status indication, such as activation, drug delivery, and end-of-dose, to the patient. Such status indication may be presented to the patient via auditory tones, such as through the audible alarms, and/or via visual indicators, such as through the LEDs. In a preferred embodiment, the control interfaces between the power and control system and the other components of the drug delivery device  10  are not engaged or connected until activation by the patient. This is a desirable safety feature that prevents accidental operation of the drug delivery device  10  and may additionally maintain the energy contained in the power source during storage, transportation, and the like. 
     The power and control system  400  may be configured to provide a number of different status indicators to the patient. For example, the power and control system  400  may be configured such that after the on-body sensor and/or trigger mechanism have been pressed, the power and control system  400  provides a ready-to-start status signal via the status indicator  16  if device start-up checks provide no errors. After providing the ready-to-start status signal and, in an embodiment with the optional on-body sensor, if the on-body sensor remains in contact with the body of the patient, the power and control system  400  will power the drive mechanism  100  to begin delivery of the drug treatment through the fluid pathway connector  300  and sterile fluid conduit  30 . In a preferred embodiment of the present disclosure, the insertion mechanism  200  and the fluid pathway connector  300  may be caused to activate directly by patient operation of the activation mechanism  14 . During the drug delivery process, the power and control system  400  is configured to provide a dispensing status signal via the status indicator  16 . After the drug has been administered into the body of the patient and after the end of any additional dwell time, to ensure that substantially the entire dose has been delivered to the patient, the power and control system  400  may provide an okay-to-remove status signal via the status indicator  16 . This may be independently verified by the patient by viewing the drive mechanism  100  and drug dose delivery through the window  18  of the housing  12 . Additionally, the power and control system  400  may be configured to provide one or more alert signals via the status indicator  16 , such as for example alerts indicative of fault or operation failure situations. 
     Other power and control system configurations may be utilized with the drug delivery device of the present disclosure. For example, certain activation delays may be utilized during drug delivery. As mentioned above, one such delay optionally included within the system configuration is a dwell time which ensures that substantially the entire drug dose has been delivered before signaling completion to the patient. Similarly, activation of the drug delivery device  10  may require a delayed depression (i.e., pushing) of the activation mechanism  14  of the drug delivery device  10 . Additionally, the system may include a feature which permits the patient to respond to the end-of-dose signals and to deactivate or power-down the drug delivery device  10 . Such a feature may similarly require a delayed depression of the activation mechanism, to prevent accidental deactivation of the device. Such features provide desirable safety integration and ease-of-use parameters to the drug delivery device  10 . An additional safety feature may be integrated into the activation mechanism to prevent partial depression and, therefore, partial activation of the drug delivery device. For example, the activation mechanism and/or power and control system may be configured such that the device is either completely off or completely on, to prevent partial activation. Such features are described in further detail hereinafter with regard to other aspects of the drug delivery device  10 . 
     III. Fluid Pathway Connector 
     The present disclosure provides patient-initiated fluid pathway connectors providing fluid communication with drug containers, and drug delivery devices which utilize fluid pathway connectors capable of maintaining the sterility of the fluid pathway before, during, and after operation of the drug delivery device, and which enable active safety controls for the device. In one embodiment, a fluid pathway connector  300  includes a sterile fluid conduit  30 , a piercing member  330 , a connection hub  310 , and a sterile sleeve  320 , as shown in  FIGS. 2A and 2B . The fluid pathway connector  300  may, optionally, further include one or more flow restrictors. Upon proper activation of the drug delivery device  10  by the patient, the fluid pathway connector  300  is connected to a drug container  50 , thereby enabling fluid flow from the drug container (as may be forced by the drive mechanism  100 ), through the fluid pathway connector  300 , the fluid conduit  30 , the insertion mechanism  200  and into the body of the patient. Such connection between the fluid pathway connector  300  and the drug container  50  may be facilitated by a piercing member  330 , such as a needle, penetrating a pierceable seal  56  (shown in  FIGS. 3A, 3B, 4A, and 4B ) of the drug container  50 . The sterility of this connection may be maintained by performing the connection within a flexible sterile sleeve  320 . Upon substantially simultaneous activation of the insertion mechanism  200 , the fluid pathway between drug container  50  and insertion mechanism  200  is complete to permit drug delivery into the body of the patient. 
     In at least one embodiment of the present disclosure, the piercing member  330  of the fluid pathway connector  300  is caused to penetrate the pierceable seal  56  of the drug container  50  of the drive mechanism  100  by direct action of the patient, such as by depression of the activation mechanism  14  by the patient. For example, the activation mechanism  14  itself may bear on the fluid pathway connector  300  such that displacement of the activation mechanism  14  from its original position also causes displacement of the fluid pathway connector  300 . In a preferred embodiment, this connection is enabled by the patient depressing the activation mechanism  14  and, thereby, driving the piercing member  330  through the pierceable seal  56 . Because the fluid pathway connector  300  is not connected to the drug container  50  until activation by the patient, fluid flow from the drug container  50  is prevented until desired by the patient. This provides an important safety feature to the patient while also maintaining the container integrity of the drug container  50  and sterility of the fluid pathway. In such an embodiment, a collapsible or compressible sterile sleeve  320  may be fixedly attached between a cap  52  of the drug container  50  and the connection hub  310  of the fluid pathway connector. The piercing member  330  may reside within the sterile sleeve  320  until a connection between the fluid pathway connector  300  and the drug container  50  is desired. The sterile sleeve  320  may be sterilized to ensure the sterility of the piercing member  330  and the fluid pathway prior to activation of the device and connection between the fluid pathway connector  300  and the drug container  50 . 
     As shown in  FIG. 2A , the fluid pathway connector  300  may be attached to a drug container  50  and mounted, by a number of known methods, either fixedly or removably to an assembly platform  20  and/or the housing  12  of the drug delivery device  10 . The assembly platform may be a separate component from the housing, or may be a unified component of the housing such a pre-formed mounting aspect on the interior surfaces of the housing. In one embodiment, the drug container  50  may be mounted, connected, or otherwise attached to a fixed aspect of the assembly platform  20  or housing, while the fluid pathway connector  300  is mounted, connected, or otherwise attached to a movable guide  390  that is capable of being translated upon patient translation of the activation mechanism  14 . In an alternative embodiment, this configuration can be reversed such that the drug container  50  is attached to a movable guide  390  and the fluid pathway connector  300  is attached to a fixed aspect of the assembly platform  20  or housing. In either configuration, the sterility of the fluid pathway is maintained, the pathway for fluid flow is not connected until desired by the patient, and patient-initiated activation causes the connection of the drug container and the fluid pathway connector. While the former configuration is preferred, the latter configuration may be desired in certain embodiments such as, for example, those which utilize cartridge-style drug containers. Patient translation or similar displacement of the activation mechanism  14  causes displacement, either directly or indirectly, of the guide  390  to enable a connection between the fluid pathway connector and the drug container. Such displacement of the guide  390  may optionally be assisted, for example to reduce the activation force needed by the patient acting upon the activation mechanism  14 , by a number of different biasing members including compression springs, extension springs, elastic bands, or the like. 
       FIG. 2B  shows the fluid pathway connector  300  and the drug container  50  apart from the housing, assembly platform, and other components of the drug delivery device  10 . As stated above, drug container  50  may include barrel  58  having a plunger seal  60  at one end and a cap  52  at another end. The fluid pathway connector  300  may be mounted, connected, or otherwise attached to the drug container  50  at the cap  52 . At least in an initial configuration, a piercing member  330  is maintained within a sterile sleeve  320  with a distal end adjacent to, or contacting, a pierceable seal of the drug container  50 . The piercing member  330  may be a number of cannulas or conduits, such as rigid needles, and may be comprised of a number of materials, such as steel. In at least one embodiment, the piercing member  330  is a rigid steel needle. The sterile sleeve  320  is a compressible or collapsible membrane positioned between the drug container  50  and the connection hub  310  and provides a sterile environment within which the piercing member  330  may reside. The sterile sleeve  320  may be comprised of a number of materials which are compressible or collapsible, but preferably is an elastomeric membrane. The sterile sleeve  320  may be a number of different shapes or configurations, including cones, pyramids, ellipsoids, ovoids, spheres, octahedron (diamond-shaped), and the like, which are capable of being compressed, collapsed, or otherwise deformed to permit two adjacent components to become closer together while maintaining sterility of an interior environment within the sleeve. Similarly, the sterile sleeve  320  may have one or more aspects, such as longitudinal (i.e., axial) and/or latitudinal (i.e., radial) groove striations, ridges, valleys, accordion folds, and the like, which promote compressibility or collapsibility. Such aspects may be positioned equidistant or non-equidistant, and in a myriad of configurations including along the inner surface, the outer surface, or both surfaces of the sterile sleeve.  FIG. 2B  shows an embodiment having longitudinal grooves which are equidistant along the circumferential exterior surface of the sterile sleeve  320 . 
     The piercing member  330  is maintained in a sterile environment within the sterile sleeve  320 . This sterile environment is maintained between the connection hub  310  and the cap  52  of the drug container  50 .  FIG. 3A  shows an exploded view of the arrangement of the components of the fluid pathway connector, according to at least one embodiment of the present disclosure, while  FIG. 3B  shows a cross-sectional exploded view. These figures include certain components of the drug container, specifically the pierceable seal  56  and the optional connection mount  54 , as they relate to the connection of the fluid pathway connector  300 . As shown, a sleeve interface surface  320 A of the sterile sleeve  320  is caused to contact a seal interface surface  56 A of pierceable seal  56  upon assembly. These corresponding interface surfaces may be retained in position and/or connection by cap  52 , as shown in  FIGS. 4A and 4B , such that a distal end of the sterile sleeve  320  may be held fixed within the cap  52  while the remainder of the sterile sleeve  320  is outside the cap  52 . When utilized, the optional connection mount  54  may reside within a seal recess  56 B of the pierceable seal  56 , and within the sterile interior environment of the sterile sleeve  320 . Alternatively, the pierceable seal  56  and the sterile sleeve  320  may be two aspects of a single pre-formed component (i.e., a unified component having two or more functions). In such a configuration, the cap  52  may similarly be utilized to hold the components in place at a proximal end of the drug container  50  (and attached to the proximal end of the barrel  58 ). In either of these embodiments, the sterile sleeve  320  may have a container connection opening  320 B at a distal end through which the piercing member  330  may translate to pierce the pierceable seal  56  and enable the fluid flow connection with the drug container  50 . Alternatively, the connection opening  320 B may be a closed surface and function as a pierceable sealing membrane between the fluid pathway and the drug container. However, in at least a preferred embodiment of the present disclosure, pierceable seal  56  has a seal barrier  56 C that would be pierced to open the drug container to the fluid pathway. In an initial position, the distal end of the piercing member  330  may reside adjacent to, or in contact with, the seal barrier  56 C of the pierceable seal  56  to, for example, minimize the distance of translation of the fluid pathway connector  300  to pierce the pierceable seal  56  and open the drug container to the fluid pathway. In one particular embodiment, the distal end of the piercing member  330  may reside at least partially within the seal barrier  56 C of the pierceable seal  56 , yet not fully passing there-through until activation of the device by the patient. When an optional connection mount  54  is utilized, for example to ensure axial piercing of the pierceable seal  56 , the piercing member  330  may pass through a piercing member recess  54 A of the connection mount  54 . 
     The sterile sleeve  320  is connected at a proximal end to a connection hub  310 . In one embodiment, this connection is facilitated by engagement between hub connectors  320 C of sterile sleeve  320  and corresponding sleeve connectors  310 C of connection hub  310 . This engagement can be a snap-fit, interference fit, screw fit, or a number of other connective linkages. The piercing member  330  passes through the connection hub  310  and is held in place at the piercing member connection aperture  310 A. As described further below, in one embodiment the connection hub  310  is configured to accept a bent piercing member  330  such that the piercing member passes through and is held in place at both the piercing member connection aperture  310 A and the conduit connection aperture  310 B. The fluid conduit  30  is connected to the proximal end of the piercing member  330  at the conduit connection aperture  310 B. As would be readily appreciated by an ordinary skilled artisan, a number of glues or adhesives, or other connection methods such as snap-fit, interference fit, screw fit, fusion joining, welding, ultrasonic welding, and the like may optionally be utilized to engage one or more of the components described herein.  FIGS. 5A-5C , show a connection hub  310  according to one embodiment of the present disclosure, with a fluid conduit  30  and a piercing member  330  attached.  FIGS. 5A and 5B  show that the piercing member  330  may pass through the connection hub  310 .  FIG. 5C  provides a transparent view of the connection hub  310 , in an embodiment having a bent piercing member  330  which connects to the fluid conduit  30  as described above. 
     One or more optional flow restrictors may be utilized within the configurations of the fluid pathway connector described herein. For example, a flow restrictor may be utilized at the connection between the piercing member  330  and the fluid conduit  30 . The drug delivery device  10  is capable of delivering a range of drugs with different viscosities and volumes. The drug delivery device  10  is capable of delivering a drug at a controlled flow rate (speed) and/or of a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow restrictors within the fluid pathway connector and/or the sterile fluid conduit. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery conduit, varying the speed at which a component of the drive mechanism advances into the drug container to dispense the drug therein, or combinations thereof. 
     In one embodiment of the present disclosure, the connection hub itself may be utilized as part of the fluid path and may, optionally, function as a flow restrictor.  FIGS. 6A and 6B  show such an embodiment, where connection hub  3310  has a piercing member  3330  and a fluid conduit  3030  connected at opposite ends of an internal aperture  3310 D of the connection hub  3310  (visible in the transparent view shown in  FIG. 6C ). Accordingly, the internal aperture  3310 D functions as part of the fluid path and may be utilized to restrict or otherwise modify the flow of fluid from the drug container  50  to the insertion mechanism  200  for delivery of the drug fluid to the body of the patient. For example, the internal aperture  3310 D may have a smaller diameter than the fluid conduit  30  to restrict the fluid flow through the fluid pathway connector  300 . Additionally or alternatively, the internal aperture  3310 D may be configured to extend the length of the fluid path to prolong the time it takes for drug to flow from the drug container to the patient. For example, while the embodiment shown in  FIG. 6C  shows a straight, short distance internal aperture  3310 D, the internal aperture may be a circuitous or tortuous path within the connection hub which extends the fluid pathway and/or provides further flow restriction to the system. By utilizing one or more non-reactive materials and/or non-reactive polymers to form the connection hub  3310 , the container integrity and sterility of the fluid path may be maintained. 
     Referring now to  FIGS. 4A and 4B , upon displacement by the patient of the activation mechanism  14  (in the direction of the solid arrow) the piercing member  330  is caused to penetrate the pierceable seal  56  (through the seal barrier  56 C) to open the fluid path from the drug container  50  to the fluid pathway connector  300 . As described above, because the piercing member  330  is maintained in a sterile environment within the sterile sleeve  320 , the sterility of the fluid path is not compromised. The compressible or collapsible sterile sleeve  320  is deformed to permit the translation or displacement of the fluid pathway connector  300  upon patient initiation.  FIG. 4A  shows an embodiment of the present disclosure which utilizes a sterile sleeve  320  and a pierceable seal  56  as separate components, attached to the proximal end of a barrel  58  of the drug container  50  by a cap  52 . As described above, however, sterile sleeve  320  and pierceable seal  56  may be a unified component that provides two or more functions. An optional connection mount  54  is also shown to guide the piercing member  330  upon activation. In this embodiment, the sterile sleeve  320  is shown to deform radially as it is compressed in the axial direction. However, in other embodiments the sterile sleeve  320  may be caused to collapse upon itself in the axial direction such as in, for example, an accordion-style sterile sleeve  320 . By keeping the fluid path disconnected until use by the patient, the sterility of the fluid pathway and the drug container are maintained. This novel configuration also provides an additional safety feature to the patient which prevents drug flow until desired, and actively initiated, by the patient. 
     As described herein, the fluid pathway connector, and specifically a sterile sleeve of the fluid pathway connector, may be connected to the cap and/or pierceable seal of the drug container upon patient-initiated activation of the device. A fluid conduit may be connected at one end to the fluid pathway connector and at another end to the insertion mechanism such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connector, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a patient. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device  10 , as shown in  FIG. 1B . 
     Certain optional standard components or variations of sterile pathway connection  300  or drug delivery device  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIG. 1A , to enable the patient to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the patient for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug delivery device  10  to the body of the patient. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the patient. Removal of the patch liner  28  may further remove the sealing membrane  254  of the insertion mechanism  200 , opening the insertion mechanism to the body of the patient for drug delivery (as shown in  FIG. 1C ). In some embodiments, removal of the patch liner  28  may also wake-up onboard electronics (e.g., the power and control system  400 ) by supplying them with electricity from an onboard battery. Furthermore, as described above, a number of flow restrictors may be optionally utilized to modify the flow of fluid within the fluid pathway connector. 
     Similarly, one or more of the components of fluid pathway connector  300  and drug delivery device  10  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. Similarly, while sterile sleeve  320  is shown as a separate component from pierceable seal  56 , it may be a unified component pre-formed as part of pierceable seal. As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the fluid pathway connector and/or drug delivery device to each other. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the fluid pathway connectors and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The present disclosure provides container connections which are patient-initiated and which maintain the sterility of the fluid pathway, and drug delivery devices which incorporate such sterile fluid pathway connectors to drug containers. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The devices described herein incorporate features which make activation, operation, and lock-out of the device simple for even untrained patients. Because the fluid path is disconnected until drug delivery is desired by the patient, the sterility of the fluid pathway connector, the drug container, the drug fluid, and the device as a whole is maintained. These aspects of the present disclosure provide highly desirable storage, transportation, and safety advantages to the patient. Furthermore, the novel configurations of the fluid pathway connectors and drug devices of the present disclosure maintain the sterility of the fluid path through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, housing and other components of the drug delivery device may readily be configured to accept and operate connection hub  310 , connection hub  3310 , or a number of other variations of the components described herein. 
     Assembly and/or manufacturing of fluid pathway connector  300 , drug delivery device  10 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization and/or lubrication fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The fluid pathway connector may be assembled in a number of methodologies. In one method of assembly, the drug container  50  may be assembled and filled with a volume of a fluid for delivery to the patient. The fluid may be one of the drugs described below, such as a granulocyte colony-stimulating factor (G-CSF) or a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, for example. In one method of assembly, after being filling with a drug, the drug container  50  may not be subjected to sterilization (e.g., radiation sterilization), so that the drug is not damaged by the high-energy rays typically used in sterilization. The drug container  50  includes a cap  52 , a pierceable seal  56 , a barrel  58 , and a plunger seal  60 . The pierceable seal  56  may be fixedly engaged between the cap  52  and the barrel  58 , at a distal end of the barrel  58 . The barrel  58  may be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal  60  from the proximal end of the barrel  58 . An optional connection mount  54  may be mounted to a distal end of the pierceable seal  56 . The connection mount  54  to guide the insertion of the piercing member of the fluid pathway connector into the barrel  58  of the drug container  50 . The drug container  50  may then be mounted to a distal end of drive housing  130 . The sterile sleeve  320  may be connected to the pierceable seal  56  and held in fixed contact by the cap  52 , as described above. The connection hub  310 , fluid conduit  30 , and piercing member  330  may be assembled together and then attached to the proximal end of the sterile sleeve  320  by engagement between hub connectors  320 C of sterile sleeve  320  and corresponding sleeve connectors  310 C of connection hub  310 , as shown in  FIG. 4A . The drive mechanism  100  may be attached to the distal end of the drug container  50 . The insertion mechanism  200  may be assembled and attached to the other end of the fluid conduit  30 . This entire sub-assembly, including drive mechanism  100 , drug container  50 , fluid pathway connector  300 , fluid conduit  30 , and insertion mechanism  200  may be sterilized, as described above, before assembly into the drug delivery device  10 . Certain components of this sub-assembly may be mounted to the assembly platform  20  or directly to the interior of the housing  12 , while other components are mounted to the guide  390  for activation by the patient. 
     Manufacturing of the drug delivery device  10  may further include the step of attaching both the fluid pathway connector  300  and the drug container  50 , either separately or as a combined component, to the assembly platform  20  or the housing  12  of the drug delivery device  10 . This step may be performed in a sterile or a non-sterile environment. It may be possible to perform this step in a non-sterile environment because the sterile fluid pathway from the drug container  50  to the insertion mechanism  200  may be been previously established. Accordingly, more flexibility may exist in choosing the manufacturing site for installing the combined assembly of the fluid pathway connector  300 , the container  50 , and the insertion mechanism  200  in the housing  12  of the drug delivery device  10 . The method of manufacturing further includes attachment of the drive mechanism  100 , container  50 , and insertion mechanism  200  to the assembly platform  20  or housing  12 . The additional components of the drug delivery device  10 , as described above, including the power and control system  400 , the activation mechanism  14 , and the control arm  40  may be attached, preformed, or pre-assembled to the assembly platform  20  or housing  12 . An adhesive patch and/or an patch liner may be attached to the exterior housing surface of the drug delivery device  10  that contacts the patient during operation of the device. 
     IV. Insertion Mechanism 
     The insertion mechanism  200  includes an insertion mechanism housing  202  having one or more lockout windows  202 A, a base  252 , and a sterile boot  250 , as shown in  FIG. 7A . Base  252  may be connected to assembly platform  20  to integrate the insertion mechanism into the drug delivery device  10  (as shown in  FIG. 1B ). The connection of the base  252  to the assembly platform  20  may be, for example, such that the bottom of the base is permitted to pass-through a hole in the assembly platform to permit direct contact of the base to the body of the patient. In such configurations, the bottom of the base  252  may include a sealing membrane  254  that, at least in one embodiment, is removable prior to use of the drug delivery device  10 . Alternatively, the sealing membrane  254  may remain attached to the bottom of the base  252  such that the needle  214  pierces the sealing membrane  254  during operation of the drug delivery device  10 . As shown in  FIGS. 8A and 8B , the insertion mechanism  200  may further include an insertion biasing member  210 , a hub  212 , a needle  214 , a retraction biasing member  216 , a clip  218 , a manifold guide  220 , a septum  230 , a cannula  234 , and a manifold  240 . The manifold  240  may connect to sterile fluid conduit  30  to permit fluid flow through the manifold  240 , cannula  234 , and into the body of the patient during drug delivery, as will be described in further detail herein. 
     The manifold guide  220  may include an upper chamber  222  and a lower chamber  226  separated by a manifold guide ring  228 . The upper chamber  222  may include a clip interface slot  220 A for engageable retention of clip  218 . The upper chamber  222  may have an inner upper chamber  222 A, within which the retraction biasing member  216 , the clip  218 , and the hub  212  may reside during an initial locked stage of operation, and an outer upper chamber  222 B, which interfaces with the insertion biasing member  210 . In at least one embodiment, the insertion biasing member  210  and the retraction biasing member  216  are springs, preferably compression springs. The hub  212  may be engageably connected to a proximal end of needle  214 , such that displacement or axial translation of the hub  212  causes related motion of the needle  214 . 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as a “trocars.” In a preferred embodiment, the needle is a 27 gauge solid core trocar and in other embodiments, the needle may be any size needle suitable to insert the cannula  234  for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. Upon assembly, the proximal end of needle  214  is maintained in fixed contact with hub  212 , while the remainder of needle  214  is permitted to pass-through retraction biasing member  216 , an aperture  218 C of clip  218  (shown in  FIG. 10A ), and manifold guide  220 . The needle  214  may further pass-through septum  230 , cannula  234 , manifold  240  through manifold header  242 , sterile boot  250 , and base  252  through base opening  252 A. The manifold header  242  may include an internal chamber defined by an interior wall of the manifold  240 . The cannula  234  may be configured in fluid communication with the internal chamber of the manifold header  242 . Septum  230 , cannula  234 , and manifold  240  may reside within lower chamber  226  of manifold guide  220  and within sterile boot  250  until operation of the insertion mechanism. In this position, the cannula  234  may reside over a distal portion of the needle  214  and held in place within the manifold header  242  of manifold  240  by a ferrule  232 . Ferrule  232  ensures that cannula  234  remains substantially fixed and in sealed engagement within the manifold  240  to, for example, maintain the sterility of the manifold header  242 . Similarly, septum  230  resides substantially fixed and in sealed engagement within the upper portion of the manifold  240  to maintain the sterility of the manifold header  242 . 
     Sterile boot  250  is a collapsible or compressible sterile membrane that is in fixed engagement at a proximal end with the manifold  240  and at a distal end with the base  252 . In at least on embodiment, the sterile boot  250  is maintained in fixed engagement at a distal end between base  252  and insertion mechanism housing  202 , as shown in  FIGS. 11A-116C . Base  252  includes a base opening  252 A through which the needle and cannula may pass-through during operation of the insertion mechanism, as will be described further below. Sterility of the cannula and needle are maintained by their initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle  214  and cannula  234  are maintained in the sterile environment of the manifold header  242  and sterile boot  250 . The base opening  252 A of base  252  may be closed from non-sterile environments as well, such as by for example a sealing membrane  254 . 
       FIGS. 8A-8B, 9, and 10A-10C  show the components of the insertion mechanism, according to at least a first embodiment, in greater detail. As shown in  FIG. 9 , insertion mechanism housing  202  may be a substantially cylindrical component having an inner chamber with guide protrusions  204 . The guide protrusions  204  may be a pre-formed aspect on the interior of insertion mechanism housing  202 , or may be a separate guide protrusion sleeve fixedly engaged to the interior proximal end of the insertion mechanism housing  202 . The guide protrusions  204  slidably engage manifold guide  220  at pass-throughs  224  on manifold guide ring  228 . The insertion biasing member  210  initially resides in an energized state between the guide protrusions  204  and inner surface of insertion mechanism housing  202  and between the interior proximal end of the insertion mechanism housing  202  and the manifold guide ring  228  of manifold guide  220 . Therefore upon activation by the patient, as described further hereinafter, the insertion biasing member  210  is caused to bear against and exert force upon manifold guide ring  228  of manifold guide  220  as the insertion biasing member  210  decompresses and/or de-energizes, causing axial translation in the distal direction of the manifold guide  220  and the components retained within its lower chamber  226 . Prior to activation, the insertion biasing member  210  is maintained substantially above locking windows  202 A in a compressed, energized state. 
     In an alternative embodiment of the insertion mechanism shown in  FIG. 7B , the insertion mechanism  2000  may include two insertion biasing members  2210  A, B. Insertion mechanism  2000  further includes insertion mechanism housing  2202  (shown in transparent view), manifold guide  2220 , sterile boot  2250 , base  2252 , and other components similar to those described above with reference to insertion mechanism  200 . In the two insertion biasing members embodiment of the insertion mechanism shown in  FIG. 7B , manifold guide ring includes two circular platforms upon which insertion biasing member  2210  A, B may bear. Insertion mechanism  2000  may function identically to insertion mechanism  200 , but may provide additional insertion force through the use of multiple insertion biasing members  2210  A, B. The components and functions of the insertion mechanisms will be described further herein with the understanding that similar or identical components may be utilized for insertion mechanism  200 , insertion mechanism  2000 , and all reasonably understood variations thereof. 
       FIG. 10A  shows a clip  218 , according to one embodiment of the present disclosure. Clip  218  includes aperture  218 C on platform  218 E through which needle  214  may pass, and release surfaces  218 A and lockout surfaces  218 B of arms  218 D. Clip  218  may be made of any number of resilient materials that are capable of flexing and returning to substantially their original form. In an original form, clip  218  may flex outwards such that anus  218 D are not perpendicular with platform  218 E. Clip  218  resides within clip interface slot  220 A of manifold guide  220  such that clip  218  is in fixed engagement with manifold guide  220  but arms  218 D are permitted to flex. In an initial locked stage, retraction biasing member  216  and hub  212  (with connected needle  214 ) are retained between release surfaces  218 A and platform  218 E of clip  218 , and within inner upper chamber  222 A of manifold guide  220  (shown in  FIG. 9  and  FIG. 10B ). The needle may pass through aperture  218 C of clip  218  and manifold guide  220  into septum  230  and manifold  240 . Septum  230  resides within manifold  240 , as shown in  FIG. 10C . Manifold  240  further includes a manifold intake  240 A at which the sterile fluid conduit  30  may be connected. The manifold intake  240 A may lead to the internal chamber of the manifold header  242  such that connecting the sterile fluid conduit  30  to the manifold intake  240 A provides fluid communication between the sterile fluid conduit  30  and the internal chamber of the manifold head  242 . Furthermore, the connection between the manifold intake  240 A and the sterile fluid conduit  30  is such that the sterility is maintained from the drug container  50  of the drive mechanism  100 , through the fluid pathway connector  300  and the sterile fluid conduit  30 , into sterile manifold header  242  of manifold  240  and sterile boot  250  to maintain the sterility of the needle  214 , cannula  234 , and the fluid pathway until insertion into the patient for drug delivery. 
     The operation of the insertion mechanism is described herein with reference to the above components, in view of  FIGS. 11A-11C .  FIG. 11A  shows a cross-sectional view of the insertion mechanism, according to at least one embodiment of the present disclosure, in a locked and ready to use stage. Lockout pin(s)  208  are initially positioned within lockout windows  202 A of insertion mechanism housing  202 . In this initial position, manifold guide ring  228  of manifold guide  220 , clip  218 , and hub  212  are retained above lockout windows  202 A and locking pin(s)  208 . In this initial configuration, insertion biasing member  210  and retraction biasing member  216  are each retained in their compressed, energized states. 
     As shown in  FIG. 11B , the lockout pin(s)  208  (not visible) may be directly displaced by patient depression of the activation mechanism  14 . As the patient disengages any safety mechanisms, such as an optional on-body sensor  24  (shown in  FIG. 11C ), the activation mechanism  14  may be depressed to initiate the drug delivery device. Depression of the activation mechanism  14  may directly cause translation or displacement of control arm  40  and directly or indirectly cause displacement of lockout pin(s)  208  from their initial position within locking windows  202 A of insertion mechanism housing  202 . Displacement of the lockout pin(s)  208  permits insertion biasing member  210  to decompress and/or de-energize from its initial compressed, energized state. Accordingly, the lockout pin(s)  208  may function as a second retainer having: a second retainer retaining position ( FIG. 11A ), where the second retainer retains the insertion biasing member  210  in the energized state; and a second retainer releasing position ( FIG. 12B ), where the second retainer allows the insertion biasing member  210  to de-energize. 
     As shown in  FIG. 11A , hub ledges  212 A maintain retraction biasing member  216  in a compressed, energized state between hub  212  and manifold guide  220  within inner upper chamber  222 A. The hub  212  fixedly engages proximal end of needle  214  at hub recess  212 B. Prior to operation, sealing member  254  may be removed from bottom of base  252  and base  252  is placed in contact with the target injection site on the body of the patient. As lockout pin(s)  208  are displaced by the activation mechanism, as described above, and insertion biasing member  210  is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in  FIG. 11A ), manifold ring guide  228  is forced by the decompression and/or de-energizing of the insertion biasing member  210  to translate axially in the distal direction to insert the needle  214  and cannula  234  into the body of the patient. The axial translation of the manifold guide is directed, and maintained in rotational alignment, by interaction between the guide protrusions  204  of the insertion mechanism housing  202  and corresponding pass-throughs  224  of the manifold guide  220 . Release surfaces  218 A of clip  218  engage hub  212  and retain the retraction biasing member  216  in a compressed, energized state while the manifold guide  220  travels axially in the distal direction until the clip  218  reaches the end of the guide protrusions  204  where the clip  218  is permitted to elastically flex outwards, as will be described further below. 
       FIG. 11B  shows a cross-sectional view of an insertion mechanism in a needle inserted stage. As shown, sterile boot  250  is permitted to collapse as the insertion biasing member  210  expands and inserts the needle  214  and cannula  234  into the body of the patient. During expansion of the insertion biasing member  210 , the manifold  240  moves in the distal direction, and because the cannula  234  and the sterile fluid conduit  30  are fixedly connected to the manifold  240 , the cannula  234  and the sterile fluid conduit  30  also move in the distal direction, as seen in  FIGS. 11A and 11B . At this stage, as illustrated in  FIG. 11B , needle  218  is introduced into the body of the patient to place the cannula  234  into position for drug delivery. As shown in  FIG. 11C , upon needle  214  and cannula  234  insertion by operation of the insertion biasing member  210  as described above, the needle  214  is retracted back (i.e., axially translated in the proximal direction) into the insertion mechanism housing  202 . Manifold guide  220 , clip  218 , and guide protrusions  204  are dimensioned such that, as the manifold  240  substantially bottoms-out on base  252 , i.e., reaches its full axial translation in the distal direction, the clip  218  escapes the guide protrusions  204  and is permitted to elastically flex outwards (i.e., in the direction of the hollow arrows shown in  FIG. 11B ) to disengage release surfaces  218 A from hub  212 . Upon disengagement of the release surfaces  218 A from hub  212 , retraction biasing member  216  is permitted to expand axially in the proximal direction (i.e., in the direction of hatched arrow in  FIG. 11C ) from its initial compressed, energized state. The clip  218  is prevented from retracting or axial translation in the proximal direction by contact between the lockout surfaces  218 B and the distal ends of the guide protrusions  204 , as shown in  FIG. 11C . This lockout also prevents axial translation in the proximal direction of the manifold guide  220  and insertion mechanism components that are distal to (i.e., below) the manifold guide ring  228 . Thus, the clip  218  may function as a third retainer having: a third retainer retaining position ( FIGS. 11A and 11B ), where the third retainer retains the retraction biasing member  216  in its energized state; and a third retainer releasing position ( FIG. 11C ), where the third retainer allows the retraction biasing member  216  to de-energize. 
     Expansion of the retraction biasing member  216  translates hub  212 , and needle  214  to which it is connected, axially in the proximal direction. Ferrule  232  retains cannula  234  inserted within the body of the patient through base opening  252 A. Upon retraction of the needle  214  from cannula  234 , the fluid pathway from manifold header  242  to the body of the patient through the cannula  234  is opened. As the fluid pathway connector is made to the drug container and the drive mechanism is activated, the fluid drug treatment is forced from the drug container through the fluid pathway connector and the sterile fluid conduit into the manifold header  242  and through the cannula  234  for delivery into the body of the patient. Accordingly, activation of the insertion mechanism inserts the needle  214  and cannula  234  into the body of the patient, and sequentially retracts the needle  214  while maintaining the cannula  234  in fluid communication with the body of the patient. Retraction of the needle  214  also opens up the fluid pathway between the manifold header  242  and the body of the patient through the cannula  234 . At the end of the drug dose delivery, the cannula  234  may be removed from the body of the patient by removal of the drug delivery device from contact with the patient. 
     In some embodiments, the cannula  234  is made of a relatively soft, flexible material (e.g., rubber or plastic), and the needle  214  may be constructed of a relatively hard, rigid material (e.g., metal). In some embodiments, the cannula  234  may be made of a more flexible material than the needle  214 . The rigidity of the needle  214  may facilitate piercing the patient&#39;s skin, and the flexibility of the cannula  234  may facilitate patient comfort when the cannula  234  is disposed in the patient&#39;s body. Accordingly, the combination of the needle  214  and the cannula  234  may be effective in providing subcutaneous delivery of a drug over a duration of time (e.g.,  10  of seconds, minutes, hours, or even days) with little or no patient discomfort, and without impeding the patient&#39;s physical activity. 
     A method of operating an insertion mechanism  200  according to one embodiment of the present disclosure includes: removing one or more of the lockout pins  208  from corresponding one or more locking windows  202 A of the insertion mechanism housing  202 , wherein removal of said lockout pins  208  permits the insertion biasing member  210  to expand from its initially energized state; driving, by expansion of the insertion biasing member  210 , a manifold guide  220  axially in the distal direction to force the needle  214  and the cannula  234  at least partially out of the insertion mechanism  200  and into the body of the patient; permitting outwards flexion of the clip  218  retained in an upper chamber of the manifold guide  220 , wherein said clip  210  initially retains the hub  212  and the retraction biasing member  216  in an energized state and wherein flexion disengages one or more release surfaces  218 A of the clip  210  from contact with a hub  212  thereby permitting expansion of the retraction biasing member  216  axially in the proximal direction; and retracting the needle  214  upon retraction of the hub  212  through a fixed connection between the needle  214  and the hub  212 , while maintaining the cannula  234  inserted into the body of the patient for fluid delivery. 
     Certain optional standard components or variations of insertion mechanism  200  or drug delivery device  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIGS. 1A-1C , to enable the patient to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the patient for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug delivery device to the body of the patient. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the patient. Adhesive patch  26  may optionally include a protective shroud that prevents actuation of the optional on-body sensor  24  and covers base opening  252 A. Removal of the patch liner  28  may remove the protective shroud or the protective shroud may be removed separately. Removal of the patch liner  28  may further remove the sealing membrane  254  of the insertion mechanism  200 , opening the insertion mechanism to the body of the patient for drug delivery. In some embodiments, removal of the patch liner  28  may also wake up onboard electronics (e.g., the power and control system  400 ) by supplying them with electricity from an onboard battery. 
     Similarly, one or more of the components of insertion mechanism  200  and drug delivery device  10  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. Similarly, while guide protrusions  204  are shown as a unified pre-formed component of insertion mechanism housing  202 , it may be a separate component fixedly attached to the interior surface of the insertion mechanism housing  202 . As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the insertion mechanism and/or drug delivery device to each other. Alternatively, one or more components of the insertion mechanism and/or drug delivery device may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the insertion mechanisms and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide integrated safety features; enable direct patient activation of the insertion mechanism; and are configured to maintain the sterility of the fluid pathway. As described above, the integrated safety features include optional on-body sensors, redundant lock-outs, automated needle insertion and retraction upon patient activation, and numerous patient feedback options, including visual and auditory feedback options. The novel insertion mechanisms of the present disclosure may be directly activated by the patient. For example, in at least one embodiment the lockout pin(s) which maintain the insertion mechanism in its locked, energized state are directly displaced from the corresponding lockout windows of the insertion mechanism housing by patient depression of the activation mechanism. Alternatively, one or more additional components may be included, such as a spring mechanism, which displaces the lockout pin(s) upon direct displacement of the activation mechanism by the patient without any intervening steps. 
     Furthermore, the novel configurations of the insertion mechanism and drug delivery devices of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control aim, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, housing and other components of the drug delivery device may readily be configured to accept and operate insertion mechanism  200 , insertion mechanism  2000 , or a number of other variations of the insertion mechanism described herein. 
     Assembly and/or manufacturing of insertion mechanism  200 , drug delivery device  10 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The insertion mechanism may be assembled in a number of methodologies. In one method, a hub is initially connected to a proximal end of a needle. The hub and needle are inserted into an inner upper chamber of a manifold guide, wherein a retraction biasing member is maintained in an energized state between the manifold guide and the hub. The hub, needle, and retraction biasing member are held in this alignment by a clip, wherein the clip is fixedly and flexibly connected to the manifold guide at a clip interface. A cannula is inserted into a manifold and held in place by a ferrule. A septum is inserted into the manifold at an end opposing the cannula to create a manifold header there-between. The manifold, septum, cannula, and ferrule are inserted into a lower chamber of the manifold guide such that the needle pierces through the septum and resides within the cannula. The needle extends beyond the distal end of the cannula to provide a piercing tip. A sterile boot is connected to the manifold, wherein the needle and cannula reside within the sterile boot when the latter is in an expanded configuration. 
     An insertion spring is inserted into insertion mechanism housing between the housing and one or more guide protrusions extending into the interior of the housing from the proximal end. The manifold guide, having the components attached thereto as described herein, is inserted into the insertion mechanism housing such that the guide protrusions extend through corresponding pass-throughs on a manifold guide ring aspect of the manifold guide. As the manifold guide is translated in the proximal direction, the insertion biasing member is caused to contact the manifold guide ring and become energized. As translation of the manifold guide and compression of the insertion biasing member reach a point above one or more lockout windows of the insertion mechanism housing, one or more corresponding lockout pin(s) may be inserted to retain the manifold guide in this position and the insertion biasing member in the compressed, energized state. 
     The distal end of the sterile boot may be positioned and held in fixed engagement with the distal end of the insertion mechanism housing by engagement of the housing with a base. In this position, the sterile boot is in an expanded configuration around the needle and cannula and creates an annular volume which may be sterile. A fluid conduit may be connected to the manifold at a manifold intake such that the fluid pathway, when open travels directly from the fluid conduit, through the manifold intake, into the manifold header, and through the cannula upon retraction of the needle. A fluid pathway connector may be attached to the opposite end of the fluid conduit. The fluid pathway connector, and specifically a sterile sleeve of the fluid pathway connector, may be connected to a cap and pierceable seal of the drug container. The plunger seal and drive mechanism may be connected to the drug container at an end opposing the fluid pathway connector. A sealing membrane may be attached to the bottom of the base to close of the insertion mechanism from the environment. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removable to an assembly platform or housing of the drug delivery device. 
     Manufacturing of a drug delivery device  10  includes the step of attaching the base of the insertion mechanism  200  to the assembly platform  20  or housing  12  of the drug delivery device  10 . In at least one embodiment, the attachment is such that the base of the insertion mechanism  200  is permitted to pass-through the assembly platform  20  and/or housing  12  to come in direct contact with the body of the patient. The method of manufacturing may further include attachment of the fluid pathway connector  300 , drug container  50 , and drive mechanism  100  to the assembly platform  20  or housing  12 . The additional components of the drug delivery device, as described above, including the power and control system  400 , the activation mechanism  14 , and the control arm  40  may be attached, preformed, or pre-assembled to the assembly platform  20  or housing  12 . An adhesive patch and/or patch liner may be attached to an exterior surface of the housing  12  that contacts the patient during operation of the drug delivery device  10 . 
     A method of operating the drug delivery device  10  includes the steps of: activating, by a patient, the activation mechanism  14 ; displacing a control arm to actuate an insertion mechanism  200 ; displacing a guide to translate a fluid pathway connector  300 ; and actuating the power and control system  400  to activate the drive mechanism  100  to drive fluid drug flow through the drug delivery device  10 , wherein translating the fluid pathway  300  connector causes the piercing member  330  to penetrate the pierceable seal  56  thereby opening a fluid path from the drug container  50  to the fluid pathway connector  300 . The method may further include the step of engaging an optional on-body sensor prior to activating the activation mechanism  14 . Furthermore, the method of operation may include translating the plunger seal  60  within the drive mechanism  100  to force the fluid drug to flow through the drug container  50 , the fluid pathway connector  300 , the sterile fluid conduit  30 , and the insertion mechanism  200  for delivery of the fluid drug to the body of a patient. The method of operation of the drug delivery device  10  may be appreciated with reference to  FIGS. 4A-4B and 11A-11C , as described above. 
     V. Drive Mechanism 
     With reference to the embodiments shown in  FIGS. 12 and 13 , the drive mechanism  100  includes a drive housing  130 , a status switch interconnect  132 , and the drug container  50  having the cap  52 , the pierceable seal  56 , the barrel  58 , and the plunger seal  60 . The drug container  50  may contain a drug fluid, within the barrel between the pierceable seal and the plunger seal, for delivery through the insertion mechanism and drug delivery device  10  into the body of the patient. The seals described herein may be comprised of a number of materials but are, in a preferred embodiment, comprised of one or more elastomers or rubbers. The drive mechanism may further include a connection mount  54  to guide the insertion of the piercing member of the fluid pathway connector into the barrel  58  of the drug container  50 . The drive mechanism  100  may further contain one or more drive biasing members, one or more release mechanisms, and one or more guides, as are described further herein. The components of the drive mechanism function to force a fluid from the drug container out through the pierceable seal, or preferably through the piercing member of the fluid pathway connector, for delivery through the fluid pathway connector, sterile fluid conduit, and insertion mechanism into the body of the patient. 
     The drive mechanism may further include one or more contact surfaces located on corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electro-mechanical contact surfaces. Such surfaces may initially be in contact and caused to disengage, or initially be disconnected and caused to engage, to permit a signal to be sent to and/or from the power control system  400 . In at least one embodiment, as described further herein, the contact surfaces may be electrical contact surfaces which are initially disconnected and caused to come into engagement whereby, upon such engagement, contact surfaces are capable of continuing an energy pathway or otherwise relaying a signal to the power and control system  400 . In another embodiment of the present disclosure, the contact surfaces are mechanical contact surfaces which are initially in contact and caused to disengage whereby, upon such disengagement, such disengagement is communicated to the power and control system  400 . Such signals may be transferred across one or more interconnects  132  to the power and control system  400  or by mechanical action to the power and control system  400 . Such components may be utilized within the drive mechanism to measure and relay information related to the status of operation of the drive mechanism, which may be converted by the power and control system  400  into tactile, auditory, and/or visual feedback to the patient. Such embodiments are described further herein. Regardless of the electrical or mechanical nature of the contact surfaces, the motion of the components which permits transmission of a signal to the power control system  400  is enabled by a biasing member  122  axially translating a contact sleeve  140  in the distal direction during operation of the device. 
     In one particular embodiment, the drive mechanism  100  employs one or more compression springs as the biasing member(s). Upon activation of the drug delivery device  10  by the patient, the power and control system may be actuated to directly or indirectly release the compression spring(s) from an energized state. Upon release, the compression spring(s) may bear against and act upon the plunger seal to force the fluid drug out of the drug container. The fluid pathway connector may be connected through the pierceable seal prior to, concurrently with, or after activation of the drive mechanism to permit fluid flow from the drug container, through the fluid pathway connector, sterile fluid conduit, and insertion mechanism, and into the body of the patient for drug delivery. In at least one embodiment, the fluid flows through only a manifold and a cannula of the insertion mechanism, thereby maintaining the sterility of the fluid pathway before and during drug delivery. Such components and their functions are described in further detail hereinafter. 
     Referring now to the embodiment of the drive mechanism shown in  FIG. 13 , the drive mechanism  100  includes a drug container  50  having a cap  52 , a pierceable seal  56 , a barrel  58 , and a plunger seal  60 , and optionally a connection mount  54 . The drug container  50  is mounted to a distal end of a drive housing  130 . Compressed within the drive housing  130 , between the drug container  50  and the proximal end of the housing  130 , are a drive biasing member  122  and a piston  110 , wherein the drive biasing member  122  is configured to bear upon an interface surface  110 C of the piston  110 , as described further herein. Optionally, a cover sleeve  120  may be utilized between the drive biasing member  122  and the interface surface  110 C of the piston  110  to, for example, promote more even distribution of force from the drive biasing member  122  to the piston  110 , prevent buckling of the drive biasing member  122 , and/or hide biasing member from patient view. Interface surface  110 C of piston  110  is caused to rest substantially adjacent to, or in contact with, a proximal end of seal  60 . 
     The drive mechanism  100  further includes, mounted at a distal end, a status switch interconnect  132 . A contact sleeve  140  is slidably mounted to the drive housing  130  through an axial aperture of the housing  130 , such that sleeve hooks  140 B at a distal end of the contact sleeve  140  are caused to contact the piston  110  between interface surface  110  and a contact protrusion  110 B near the proximal end of the piston  110 . Piston  110  also includes a locking groove  110 A, between contact protrusion  110 B and the proximal end of the piston  110 . Contact sleeve  140  has a radially extending ring  140 C at its proximal end, upon which resides one or more flex prongs  140 A. An electrical contact  134  may be connected, mounted, printed, or otherwise mounted to ring  140 C which, during operation of the drive mechanism, may come in contact with corresponding status switch interconnect  132  to complete an electrical circuit or otherwise permit a transmission to the power and control system to provide feedback to the patient. 
     The components of the drive mechanism  100 , upon activation, may be used to drive axial translation in the distal direction of the plunger seal  60  of the drug container  50 . Optionally, the drive mechanism  100  may include one or more compliance features which enable additional axial translation of the plunger seal  60  to, for example, ensure that substantially the entire drug dose has been delivered to the patient and make sure that the feedback contact mechanisms have connected. For example, in one embodiment of the present disclosure, the sleeve hooks  140 B are flex aims which may permit, upon sufficient application of force by the drive biasing member  122  on the piston  110 , to allow interface surface  110 C to translate axially beyond sleeve hooks  140 B to drive further axial translation of the plunger seal  60  for a compliance push of drug fluid from the drug container. Additionally or alternatively, the plunger seal  60 , itself, may have some compressibility permitting a compliance push of drug fluid from the drug container. 
     In at least one embodiment of the present disclosure, a compliance push of drug fluid from the drug container is enabled by a piston extension  102 . In such embodiments, the drive mechanism  100  further includes a piston extension  102  slidably mounted at a distal end and within an axial pass-through of piston  110 . The piston extension  102  may be retained within piston  110  by interaction between extension arms  102 B of the piston extension  102  and connection slots  110 D of piston  110 , as shown in  FIGS. 14A-14E . Piston extension may be driven by a piston extension biasing member  106 , which is mounted within the axial pass-through of piston  110  and initially compressed between piston extension  102  and piston  110 . An optional piston biasing member support  104  may be utilized between piston extension biasing member  106  and piston extension  102  to, for example, promote more uniform distribution of force from piston extension biasing member  106  to piston extension  102 . The function of the optional piston extension is described in further detail hereinafter. 
     The novel drive mechanisms of the present disclosure integrate status indication into the drug dose delivery. By use of one or more status switch interconnects and one or more corresponding electrical contacts, the status of the drive mechanism before, during, and after operation can be relayed to the power and control system to provide feedback to the patient. Such feedback may be tactile, visual, and/or auditory, as described above, and may be redundant such that more than one signals or types of feedback are provided to the patient during use of the device. For example, the patient may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the patient. At completion of drug delivery, the drive mechanism and drug delivery device  10  may provide an end-of-dose indication. As the end-of-dose indication is tied to the piston reaching the end of its axial translation, the drive mechanism and drug delivery device  10  provide a true end-of-dose indication to the patient. 
     In at least one embodiment, as shown in  FIG. 12  and  FIG. 13 , an end-of-dose status indication may be provided to the patient once the status switch interconnect  132  is caused to contact electrical contact  134  at the end of axial travel of the piston  110  and plunger  60  within the barrel  58  of the drug container  50 . In a further embodiment, incremental status indication relaying various stages of drug delivery can be communicated to the patient during operation. In one such embodiment, sleeve hooks  140 B of cover sleeve  120  may have one or more interconnects which come into contact with one or more electrical contacts on the outer surface of piston  110  during operation. As piston  110  translates axially in the distal direction to push plunger seal  60  distally, thereby pushing fluid out of the drug container through the pierceable seal end, the electrical contacts of the piston  110  may sequentially contact the interconnect on the sleeve hooks  140 B to relay the incremental status of operation. Depending on the number of electrical contacts located on the outer surface of the piston  110 , the frequency of the incremental status indication may be varied as desired. The location of the contacts and interconnects may be interchanged or in a number of other configurations which permit completion of an electrical circuit or otherwise permit a transmission between the components. 
     In another embodiment of the drive mechanism  500 , shown in  FIGS. 15 and 16 , incremental status indication may be measured and relayed by a separate incremental status stem  650  and a corresponding stem interconnect  652 . The stem interconnect  652  may be mounted, affixed, printed, or otherwise attached to incremental status stem  650 . Incremental status stem  650  may be a static component, i.e., it does not move or translate, that is mounted to the distal end of contact sleeve  640  and/or the distal end of drive housing  630  such that the incremental status stem  650  resides within an axial pass-through of contact sleeve  640  and drive housing  630 . The incremental status stem  650  further resides within an axial pass-through of piston  610 . In such embodiments of the present disclosure, one or more contacts may be located on an inner surface of the piston  610  such that they sequentially interface with one or more corresponding interconnects on the incremental status stem  650 . As piston  610  translates axially in the distal direction to push plunger seal  60  distally, thereby pushing fluid out of the drug container through the pierceable seal end, the electrical contacts of the piston  610  may sequentially contact the interconnect on the incremental status stem  650  to relay the incremental status of operation. Depending on the number of electrical contacts, the frequency of the incremental status indication may be varied as desired. The location of the contacts and interconnects may be interchanged or in a number of other configurations which permit completion of an electrical circuit or otherwise permit a transmission between the components. 
       FIG. 17  shows a cross-sectional view of the embodiment of the drive mechanism shown in  FIG. 15  during operation of the drive mechanism. As shown, incremental status stem  650  may be a static component that is mounted to the distal end of contact sleeve  640  and/or the distal end of drive housing  630  such that the incremental status stem  650  resides within an axial pass-through of contact sleeve  640  and drive housing  630 . As piston  610  translates axially in the distal direction (i.e., in the direction of the solid arrow) to push plunger seal  60  distally, the electrical contacts of the piston  610  may sequentially contact the interconnect on the incremental status stem  650  to relay the incremental status of operation through stem interconnect  652 . Accordingly, incremental status of the drive mechanism, and therefore status of drug delivery, may be conveyed to the patient during use of the device. 
     Returning now to the embodiment shown in  FIGS. 12 and 13 , further aspects of the novel drive mechanism will be described with reference to  FIGS. 14A-14E . One or more of these aspects may similarly be utilized in the embodiment shown in  FIG. 15 , or any other variation captured by the embodiments described herein.  FIG. 14A  shows a cross-sectional view of the drive mechanism, according to at least a first embodiment, during its initial locked stage. A fluid, such as a drug fluid, may be contained within barrel  58 , between plunger seal  60  and pierceable seal  56 , for delivery to a patient. Upon activation by the patient, a fluid pathway connector may be connected to the drug container through the pierceable seal  56 . As described above, this fluid connection may be facilitated by a piercing member of the fluid pathway connector which pierces the pierceable seal and completes the fluid pathway from the drug container, through the fluid pathway connector, the fluid conduit, the insertion mechanism, and the cannula for delivery of the drug fluid to the body of the patient. Initially, one or more locking mechanisms (not shown) may reside within the locking grooves  110 A of piston  110 . Directly or indirectly upon activation of the device by the patient, the locking mechanism may be removed from the locking grooves  110 A of piston  110 , to permit operation of the drive mechanism. Such a locking mechanism may function as a first retainer having: a first retainer retaining position, where the first retainer retains the drive biasing member  122  in the energized state; and a first retainer releasing position, where the first retainer allows the drive biasing member  122  to de-energize. The first retainer may be structurally and functionally similar to the clip  2115  illustrated in  FIGS. 22 and 23A  and described in more detail below. 
     As shown in  FIG. 14A , the piston extension biasing member  106  and drive biasing member  122  are both initially in a compressed, energized state. The drive biasing member  122  may be maintained in this state until activation of the device between internal features of drive housing  130  and interface surface  110 C of piston  110 . As the locking mechanism is removed from the locking groove  110 A of piston  110 , drive biasing member  122  is permitted to expand (i.e., decompress) axially in the distal direction (i.e., in the direction of the solid arrow). Such expansion causes the drive biasing member  122  to act upon and distally translate interface surface  110 C and piston  110 , thereby distally translating plunger  60  to push drug fluid out of the barrel  58 . Distal translation of the piston  110  causes distal translation of the piston extension biasing member  106  and piston extension  102 , when such optional features are incorporated into the device. As shown in  FIG. 14B , such distal translation of the piston  110  and plunger seal  60  continues to force fluid flow out from barrel  58  through pierceable seal  56 . Status switch interconnect  132  is prevented from prematurely contacting electrical contact  134  by one or more flex prongs  140 A, as shown in  FIG. 14C . Alternatively, low force springs or other resistance mechanisms may be utilized in addition to or alternatively from flex prongs  140 A to achieve the same functions. During distal translation of the piston  110 , sleeve hooks  140 B may slidably contact the outer surface of piston  110 . As described above, interconnects and electrical contacts may be located on these components to provide incremental status indication during operation of the drive mechanism. 
     As the drive mechanism  100  nears or reaches end-of-dose, flex prongs  140 A may be caused to flex outwards (i.e., in the direction of the hollow arrows) by the decompression force of drive biasing member  122 . Such flexion of the flex prongs  140 A may permit status switch interconnect  132  to contact electrical contact  134 , completing a circuit or otherwise permitting a transmission to the power and control system to provide feedback to the patient. At this stage, one or more delivery compliance mechanisms may be utilized to ensure that the status switch interconnect  132  has contacted electrical contact  134  and/or that substantially the entire drug dose has been delivered. For example, in one embodiment of the present disclosure, the sleeve hooks  140 B are flex arms which may permit, upon sufficient application of force by the drive biasing member  122  on the piston  110 , to allow interface surface  110 C to translate axially beyond sleeve hooks  140 B to drive further axial translation of the plunger seal  60  for a compliance push of drug fluid from the drug container. Additionally or alternatively, the plunger seal  60 , itself, may have some compressibility permitting a compliance push of drug fluid from the drug container. For example, when a pop-out plunger seal is employed, i.e., a plunger seal that is deformable from an initial state, the plunger seal may be caused to deform or “pop-out” to provide a compliance push of drug fluid from the drug container. 
     In at least one embodiment of the present disclosure, a compliance push of drug fluid from the drug container is enabled by a piston extension  102 . In such embodiments, the drive mechanism  100  further includes a piston extension  102  slidably mounted at a distal end and within an axial pass-through of piston  110 . The piston extension  102  may be retained within piston  110  by interaction between extension arms  102 B of the piston extension  102  and connection slots  110 D of piston  110 , as shown in  FIG. 14D . Piston extension may be driven by a piston extension biasing member  106 , which is mounted within the axial pass-through of piston  110  and initially compressed between piston extension  102  and piston  110 . An optional piston biasing member support  104  may be utilized between piston extension biasing member  106  and piston extension  102  to, for example, promote more uniform distribution of force from piston extension biasing member  106  to piston extension  102 . 
     As the piston  110  reaches its end of travel within barrel  58 , piston extension  102  may be permitted to axially travel in the distal direction by the force exerted by piston extension biasing member  106 . At this stage, the piston extension biasing member  106  is permitted to expand (i.e., decompress) axially in the distal direction such that extension arms  102 B of the piston extension  102  may translate distally (i.e., in the direction of the solid arrow) within connection slots  110 D of piston  110 , as shown in 
       FIG. 14D . As shown in  FIG. 14E , such distal translation (i.e., in the direction of the hatched arrow) of the piston extension  102  enables a compliance push (shown by dimension “C” in  FIG. 14E ) of drug fluid from the drug container. Piston extension  102  may be configured such that extension arms  102 B may contact and apply force upon a distal end of connections slots  110 D to distally translate piston  110  further (i.e., in the direction of the hatched arrow). This further distal translation of the piston  110  may be utilized to ensure that status switch interconnect  132  has engaged contact  134 . 
     As described above, the novel drive mechanisms of the present disclosure integrate status indication into the drug dose delivery. Through integration of the end-of-dose status indication mechanisms to the axial translation of the piston, and thereby the plunger seal, true and accurate end-of-dose indication may be provided to the patient. By use of one or more contact surfaces on corresponding components, the status of the drive mechanism before, during, and after operation can be relayed to the power and control system to provide feedback to the patient. Such feedback may be tactile, visual, and/or auditory, as described above, and may be redundant such that more than one signals or types of feedback are provided to the patient during use of the device.  FIGS. 14A-14E  above show an arrangement which provide end-of-dose status indication to the patient once the status switch interconnect  132  is caused to contact electrical contact  134  at the end of axial travel of the piston  110  and plunger  60  within the barrel  58  of the drug container  50 . As described above, the novel devices described herein may additionally provide incremental status indication to relay various stages of drug delivery to the patient during operation. In one such embodiment, sleeve hooks  140 B of cover sleeve  120  may have one or more interconnects which come into contact with one or more electrical contacts on the outer surface of piston  110  during operation. A redundant end-of-dose indication may be utilized upon contact between sleeve hooks  140 B of contact sleeve  140  and contact protrusion  110 B of piston  110 . Electrical contacts or interconnects along piston  110  may sequentially contact the corresponding interconnects or contacts on the sleeve hooks  140 B to relay the incremental status of operation. Depending on the number of electrical contacts located on the outer surface of the piston  110 , the frequency of the incremental status indication may be varied as desired. The location of the contacts and interconnects may be interchanged or in a number of other configurations which permit completion of an electrical circuit or otherwise permit a transmission between the components. 
     In another embodiment of the drive mechanism  500 , shown in  FIGS. 15-17 , incremental status indication may be measured and relayed by a separate incremental status stem  650  and a corresponding stem interconnect  652 . As shown in  FIG. 17 , incremental status stem  650  may be a static component that is mounted to the distal end of contact sleeve  640  and/or the distal end of drive housing  630  such that the incremental status stem  650  resides within an axial pass-through of contact sleeve  640  and drive housing  630 . As piston  610  translates axially in the distal direction (i.e., in the direction of the solid arrow) to push plunger seal  60  distally, the electrical contacts of the piston  610  may sequentially contact the interconnect on the incremental status stem  650  to relay the incremental status of operation through stem interconnect  652 . Depending on the number of electrical contacts, the frequency of the incremental status indication may be varied as desired. The location of the contacts and interconnects may be interchanged or in a number of other configurations which permit completion of an electrical circuit or otherwise permit a transmission between the components. Accordingly, incremental status of the drive mechanism, and therefore status of drug delivery, may be conveyed to the patient during use of the device. 
     In a further embodiment of the drive mechanism, shown in  FIGS. 18 and 19A-19C , drive mechanism  1000  may be similar to mechanism  100  or mechanism  500 , and incorporate the respective components and functions of such embodiments, but utilize mechanical contact surfaces instead of electrical contact surfaces, as described above.  FIG. 18  shows an isometric view of the drive mechanism  1000  according to a further embodiment of the present disclosure.  FIGS. 19A-19C  show cross-sectional views of the drive mechanism shown in  FIG. 18  in an initial inactive state, an actuated state and as the mechanism nears completion of drug delivery, and as the mechanism completes drug delivery and triggers an end-of-dose signal. In such embodiments, the status switch interconnect is a mechanical trigger  1150  and the contact surface is a pin  1140 P. As shown in  FIG. 19A , the optional piston extension biasing member  1106  and drive biasing member  1122  are both initially in a compressed, energized state. The drive biasing member  1122  may be maintained in this state until activation of the device between internal features of drive housing  1130  and interface surface  1110 C of piston  1110 . As the locking mechanism is removed from the locking groove  1110 A of piston  1110 , drive biasing member  1122  is permitted to expand (i.e., decompress) axially in the distal direction (i.e., in the direction of the solid arrow). Such expansion causes the drive biasing member  1122  to act upon and distally translate interface surface  1110 C and piston  1110 , thereby distally translating plunger  1060  to push drug fluid out of the barrel  1058 . Distal translation of the piston  1110  causes distal translation of the piston extension biasing member  1106  and piston extension  1102 , when such optional features are incorporated into the device. 
     As shown in  FIG. 19B , such distal translation of the piston  1110  and plunger seal  1060  continues to force fluid flow out from barrel  1058  through pierceable seal  1056 . As described above, interconnects and electrical contacts may be located on these components to provide incremental status indication during operation of the drive mechanism. As shown in  FIG. 19C , as the drive mechanism  1000  reaches end-of-dose, pin  1140 P disengages from mechanical trigger  1150  to permit a transmission to the power and control system  400  to provide feedback to the patient. In one such embodiment, disengagement of the pin  1140 P from the mechanical trigger  1150  permits the trigger to rotate as it is biased by a biasing member, such as a constant-force spring  1170 . Initially, the constant-force spring  1170  biases the mechanical trigger  1150  against the pin  1140 P. Upon axial translation of the pin  1140 P, as described above, pin  1140 P disengages from mechanical trigger  1150  which then rotates or is otherwise displaced to permit transmission of feedback to the patient. At this stage, one or more delivery compliance mechanisms, as described above, may be utilized to ensure that the pin  1140 P has disengaged mechanical trigger  1150  and/or that substantially the entire drug dose has been delivered. 
     Assembly and/or manufacturing of drive mechanism  100 , drug delivery device  10 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization and/or lubrication fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The drive mechanism may be assembled in a number of methodologies. In one method of assembly, the drug container  50  may first be assembled and filled with a fluid for delivery to the patient. The drug container  50  includes a cap  52 , a pierceable seal  56 , a barrel  58 , and a plunger seal  60 . The pierceable seal  56  may be fixedly engaged between the cap  52  and the barrel  58 , at a distal end of the barrel  58 . The barrel  58  may be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal  60  from the proximal end of the barrel  58 . An optional connection mount  54  may be mounted to a distal end of the pierceable seal  56 . The connection mount  54  to guide the insertion of the piercing member of the fluid pathway connector into the barrel  58  of the drug container  50 . The drug container  50  may then be mounted to a distal end of drive housing  130 . 
     One or more switch status interconnects  132  may be mounted to a proximal end of drive housing  130 . A contact sleeve  140 , having one or more sleeve hooks  140 B at a distal end and a ring  140 C at a proximal end having an electrical contact  134  thereon, may be mounted to the drive housing  130  through an axial pass-through from the proximal end of the drive housing  130 . A drive biasing member  122  may be inserted into a distal end of the drive housing  130 . Optionally, a cover sleeve  120  may be inserted into a distal end of the drive housing  130  to substantially cover biasing member  122 . A piston may be inserted into the distal end of the drive housing  130  and through an axial pass-through of contact sleeve  140 , such that a contact protrusion  110 B of piston  110  is proximal to the sleeve hooks  140 B of contact sleeve  140 . The piston  110  and drive biasing member  122 , and optional cover sleeve  120 , may be compressed into drive housing  130 . Such assembly positions the drive biasing member  122  in an initial compressed, energized state and preferably places a piston interface surface  110 C in contact with the proximal surface of the plunger seal  60  within the proximal end of barrel  58 . When a piston extension  102  is employed, the piston extension  102  and piston extension biasing member  106 , and optional piston biasing member support, may be compressed into an axial pass-through of piston  110 . The piston, piston biasing member, contact sleeve, and optional components, may be compressed and locked into the ready-to-actuate state within the drive housing  130  prior to attachment or mounting of the drug container  50 . 
     When one or more interconnects or contacts are utilized for status indication, such components may be mounted, connected, printed, or otherwise attached to their corresponding components prior to assembly of such components into the drive mechanism  100 . When a separate incremental status stem  650  and a corresponding stem interconnect  652  are utilized for such incremental status indication, the stem interconnect  652  may be mounted, affixed, printed, or otherwise attached to incremental status stem  650 . The incremental status stem  650  and stem interconnect  652  to the proximal end of the contact sleeve  640  and/or the proximal end of the drive housing  630  in a manner such that the incremental status stem  650  resides within an axial pass-through of contact sleeve  640  and drive housing  630 . The incremental status stem  650  is further mounted to reside within an axial pass-through of piston  610 . 
     It will be appreciated that the end-of-dose indicator or interconnects/contact may include any appropriate arrangement, including, for example, mechanical, electrical, electromechanical, ultrasonic, capacitive or magnetic arrangements. Similarly, the drive mechanism may be of any appropriate design. 
     Alternate arrangements of both the drive mechanism and end-of-dose indicator or interconnects/contact are illustrated, for example, in  FIGS. 20A-24B . For the sake of clarity, the reference numbers utilized in  FIGS. 20A-24B  are similar to those of the embodiment of  FIGS. 1A-11C , only preceded by the number “2” or “20” as appropriate to provide a reference number having four digits, i.e., 2XXX. For example, the drug delivery device  10  and drive mechanism of  FIGS. 20A-24B  will be designated by the numbers  2010  and  2100 , respectively, as opposed to the drug delivery device  10  and drive mechanism  100  of  FIGS. 1A-11C . This correlation, however, should not be taken as an indication that the components of  FIGS. 20A-24B  with reference numbers similar to those of the embodiment of  FIGS. 1A-11C  are exactly the same as the respective components of  FIGS. 1A-11C . 
     As shown in  FIGS. 20A-20C , the drug delivery device  2010  includes a drive mechanism  2100  for receiving a drug container  2050 , an insertion mechanism  2200 , a fluid pathway connector  2300  including a fluid conduit  2030 , and a power and control system  2400 , all residing within a housing  2012 , and an activation mechanism  2014  actuatable by a patient from the outside of the housing  2012 . The housing  2012  may take any number of configurations and be facilitated by any number of components, such as a single-body or multi-component housing  2012 . Certain other components, such as electronics for power and signaling, activation buttons, and safety sensors are also omitted for clarity, but are understood to be standard components within such drug delivery device  10  devices. While the housing  2012 , insertion mechanism  2200 , fluid pathway connector  2300 , and power and control system  2500 , as well as the activation mechanism  2014  are not discussed in detail, those of skill in the art will appreciate that they may be the same or similar to the components and systems discussed in detail with regard to the other embodiments disclosed herein. 
     The drive mechanism  2100 , primary drug container  2050 , and a portion of the fluid pathway connector  2300  are shown isometrically in  FIG. 21  and exploded form in  FIG. 22 .  FIGS. 23A-23C  illustrate the drive mechanism  2100  in cross-section as it progresses through several stages of operation.  FIGS. 24A-24B  illustrate a lateral cross-section of the drive mechanism  2100  at several stages of operation. 
     The primary drug container  2050  retains the drug treatment that is to be injected or infused into the patient, and may be a vial or similar container from which a drug treatment can be dosed. To provide a sterile environment for the drug treatment, the drug container  2050  may include a cylindrical barrel  2058  with a pierceable seal  2056  disposed in a distal end and a plunger seal  2060  disposed within a proximal end. The pierceable seal  2056  and plunger seal  2060  may be formed of a number of materials, such as one or more elastomeric materials, and are sized and formulated to maintain a seal with the barrel  2058 . 
     The portion of the fluid pathway connector  2300  illustrated in  FIGS. 21-23C  includes a connection mount  2054 , a sterile boot  2310 , and a piercing assembly  2320 . The piercing assembly  2320  includes a piercing member  2322  extending from a hub  2324  which supports the piercing member  2322 , and provides a fluid connection  2326  (see  FIG. 21 ) to which the fluid conduit  2030  or other fluid connector may be fluidly coupled to fluidly couple the drug container  2050  to the insertion mechanism  2200 . The connection mount  2054  is disposed adjacent the pierceable seal  2056  and includes an aperture adapted to guide the insertion of the piercing member  2322  of the fluid pathway connector into the pierceable seal  2056  of the drug container  2050 . The sterile boot  2310  is disposed about the piercing assembly  2320  and provides a sterile environment for the completion of the fluid coupling of the fluid pathway connector  2300 . A collar  2052  may be provided in order to secure a flange of the sterile boot  2310 , the connection mount  2054 , the pierceable seal, and the barrel  2058  in fixed relation to one another. 
     Referring to  FIGS. 20A and 20B , in operation, when a patient activates the activation mechanism  2014 , as by depressing the illustrated start button, an arm  2015  coupled to the activation mechanism  2014  exerts an axial force on the piercing assembly  2320  to move the piercing member  2322  axially to pierce the pierceable seal  2056 . The drive mechanism  2100  is adapted for use in cooperation with the proximal end of the drug container  2050  to axially advance the plunger seal  2060  within the barrel  2058  to dispense the drug treatment through the fluid pathway connector  2300  once the pierceable seal  2056  has been pierced by the piercing member  2322 . 
     The drive mechanism  2100  includes a drive housing  2130  having an axis that is coincident with the axis A of the drive mechanism  2100  (see  FIG. 21 ). The axis A may be disposed in coincident with axes in the container  2050  and the plunger seal  2060 . A piston  2110  is at least partially disposed within the drive housing  2130  for longitudinal movement along the axis of the drive mechanism  2100 . It will be appreciated that the term “axis” when used in connection with the drive housing  2130  is not intended to require the axis to be in a central location of the drive housing  2130  or that the drive housing  2130  be round. 
     The piston  2110  is mounted to move between a retracted first position (illustrated in  FIG. 23A ), wherein the piston  2110  is at least partially disposed within the drive housing  2130 , and an extended second position (illustrated in  FIGS. 23B and 23C ), wherein the piston  2110  extends axially outward from drive housing  2130 . The piston  2110  includes an interface surface  2110 C that is disposed to either directly confront the plunger seal  2060  when assembled with a drug container  2050 , or to otherwise transmit an actuating force to the plunger seal  2060 . In other words, the piston  2110  of the drive mechanism  2100  of  FIGS. 20A-24B  is adapted to exert a dispensing force on the plunger seal  2060  of the drug container  2050  and to translate outward from a distal end of a housing  2012  to advance the plunger seal  2060  within the drug container  2050  to dispense the drug. While the initial position shown in  FIG. 23A  illustrates the interface surface  2110 C of the piston  2110  as disposed substantially adjacent the distal end of the housing  2012 , it will be appreciated that, in alternate embodiments, the piston may be initially disposed in a position extending outside of the drive housing  2130 . In such an arrangement, in initial assembly of the drive mechanism  2100  with a drug container  2050 , the piston  2110  may be initially at least partially disposed within proximal end of the drug container  2050 . 
     In order to impart axial movement to the piston  2010 , the drive mechanism  2100  further includes a plurality of piston biasing members  2106 ,  2122  disposed to move from an energized first position when the piston  2110  is in the retracted first position to a de-energized second position when the piston  2110  is in an extended second position. It will be appreciated that, for the purposes of this disclosure and the accompanying claims, the term “de-energized second position” is a relative term. That is, the piston biasing members  2106 ,  2122  in the “de-energized second position” have less energy than the piston biasing members  2106 ,  2122  in the “energized first position.” That is not to say, however, that the piston biasing members  2106 ,  2122  in the “de-energized second position” are necessarily completely de-energized or storing no energy. 
     So long as the piston  2110  is maintained in the retracted first position, biasing members  2106 ,  2122  are maintained in their energized first position (see  FIG. 23A ). The piston  2110  is maintained in the retracted first position by a retaining element or clip  2115 . While any appropriate arrangement may be utilized to retain the piston  2110  in the retracted first position, the clip  2115  may bear against an outside surface of the drug delivery device  10  housing  2012  and be received in a locking groove  2110 A of the piston  2110 .  FIG. 23A  illustrates the clip  2115  disposed in such a retaining first position. It will thus be appreciated by those of skill in the art that the engagement of the retaining element or clip  2115  to maintain the piston  2110  in its retracted first position with the biasing members  2106 ,  2122  in their energized first position, allows the drive mechanism  2100  to be handled as a self-contained unit such that it may be assembled into the drug delivery device  2010  or in cooperation with a drug container  2050 . In operation, however, once the clip  2115  is removed or moved to a releasing second position (see  FIGS. 22B and 23C ), the piston biasing members  2106 ,  2122  exert an axial dispensing force on the piston  2110  as they move to a de-energized second position and the piston moves to its extended second position. In at least one embodiment, clip  2115  may be removed through an action caused, directly or indirectly, by movement of the activation mechanism  2014 . The action removing clip  2115  can be achieved in a number of ways. For example, with reference to  FIG. 22 , the action removing clip  2114  is a linear, perpendicular movement relative to the axis “A” of the drug container  2050 . 
     In accordance with an aspect of the disclosure as illustrated in the embodiment of  FIGS. 20A-24B , the drive mechanism  2100  is small in size and/or device footprint, yet capable of providing the dispensing force needed to push a drug fluid from a drug container  2050  through a fluid conduit  2030  for drug delivery via an insertion mechanism  2200 . In this embodiment of the drive mechanism  2100 , the piston biasing members  2106 ,  2122  are disposed in parallel, in contrast to the series disposal of the embodiments of  FIGS. 1A-11C . It will thus be appreciated by those of skill in the art that the drive mechanism  2100  of  FIGS. 20A-24B  yields a significantly smaller footprint than prior art devices or even the drive mechanisms  100 ,  500 ,  1000  of the other embodiments herein. 
     For the purposes of this disclosure and its claims, when used in connection with biasing members, be it a specific embodiment of biasing members, such as springs, or the general use of the term “biasing members,” the terms “parallel” are to be interpreted as they would by those of skill in the art. That is, the terms “series,” “in series,” or “disposed in series” is to be interpreted as springs disposed and operating as they would when connected end to end, and the terms “parallel,” “in parallel,” or “disposed in parallel” is to be interpreted as springs disposed and operating as they would in a side-by-side relationship. 
     Those of skill in the art will appreciate that for biasing members disposed in series, the inverse of equivalent spring constant will equal the sum of the respective inverses of the spring constants of the individual biasing members. In contrast, the equivalent spring constant of biasing members  2106 ,  2122  in a parallel relationship will be the sum of the spring constants of the individual biasing members. Similarly, the dispensing force exerted by the biasing members  2106 ,  2122  in a parallel relationship will be the sum of the forces exerted by the biasing members  2106 ,  2122  individually. As a result, the use of biasing members  2106 ,  2122  disposed in parallel provides the desired dispensing force in a substantially more compact package, allowing the drive mechanism  2100  to be more compact than the embodiments of  FIGS. 1A-11C . By extension, the use of biasing members  2106 ,  2122  disposed in parallel may allow the entire drug delivery device  2010  to be substantially more compact than an arrangement wherein the biasing members are disposed in series. 
     In this embodiment, the biasing members  2106 ,  2122  are in the form of a pair of concentrically disposed compression springs. In some embodiments, the biasing members  2106 ,  2122  may be wound in opposite directions, thereby balancing any lateral forces created by the biasing members  2106 ,  2122 . Alternate arrangements are also envisioned, however. For example, one or more of the biasing members could alternately, for example, be tension springs, depending upon the structure of the components of the drive mechanism. Moreover, in the illustrated drive mechanism  2100 , the biasing members  2106 ,  2122  are disposed concentrically with respect to each other and the piston  2100 . In an alternate embodiment, however, the biasing members may be alternately disposed, as, by way of example only, in a side by side arrangement, or on opposite sides of the piston. In still further embodiments, three or more biasing members could be provided and disposed in parallel in any appropriate configuration. It will further be appreciated, that an additional biasing member may be provided and disposed in series with one or more of the parallelly disposed biasing members. For example, in an embodiment where the piston includes an extension, similar to the piston extension  102  of the embodiment of  FIGS. 1A-11C , for example, an additional biasing member may be provided to engage the piston extension. 
     Returning now to the embodiment of  FIGS. 20A-24B , the drive mechanism  2100  includes an end-of-dose indicator  2133 . The end-of-dose indicator  2133  includes a switch interconnect  2132  and a contact sleeve assembly  2120  adapted for movement with the piston  2110 . Piston  2110  has an interface surface  2112  that is capable of contacting or otherwise bearing upon plunger seal  2060  to force drug fluid out of barrel  2058  through the fluid pathway connector  2300  for delivery to a patient. In order to provide access of the end-of-dose indicator  2133  to the interior of the drive housing  2130  includes an access window  2131 , the significance of which will be described further below. 
     The contact sleeve assembly  2120  of the embodiment illustrated in  FIGS. 21-23C  includes a pair of telescoping sleeves  2124 ,  2126 . The first sleeve  2124  is adapted for movement with the piston  2110  as the piston biasing members  2106 ,  2122  are de-energized. A distal, generally radially extending flange  2124 A of the first sleeve  2124  is disposed subjacent the head  2111  of the piston  2110 . In this way, one or both of the biasing members  2106 ,  2122  bear against the flange  2124 A, which bears against the piston head  2111  to impart axial movement to the piston  2110 . The second sleeve  2126  is slidably coupled to the first sleeve  2124 , the first sleeve  2124  sliding distally outward from the second sleeve  2126 . In order to permit the second sleeve  2126  to travel with the first sleeve  2124  when the first sleeve  2124  is fully extended from the second sleeve  2126 , a coupling structure is provided. In the illustrated embodiment the sleeves  2124 ,  2126  include respective flanges  2124 B,  2126 A that engage as the proximal end of the first sleeve  2124  approaches the distal end of the second sleeve  2126  (see  FIG. 23A ) to cause the second sleeve  2126  to likewise move in an axial direction with the piston  2110  (see  FIG. 23C ). 
     It will be appreciated, however, that alternate arrangements are envisioned. By way of example only, the first sleeve  2124  could alternatively be integrally formed with the piston  2110 . In this way, the first sleeve  2124  formed with the piston  2110  would telescope outward from a second sleeve  2126  in a manner similar to that described above. Moreover, while the sleeve assembly  2120  has been described as including a pair of telescoping sleeves, alternate numbers of sleeves may be used, such as three or more telescoping sleeves. The number of sleeves may be dependent upon the cooperative structures, however, such as the relative dimensions of the drive housing  2130 , and the travel of the piston  2110 . For example, in an embodiment utilizing a smaller drive housing, but having a similar piston travel, three or more telescoping sleeves may be desirable. In some embodiments where multiple sleeves are provided about the biasing members  2106 ,  2122 , and the biasing members  2106 ,  2122  are in the form of compression springs, such as shown in the illustrated embodiment, the springs in a compressed, energized state may have a length equal to the untelescoped sleeves  2124 ,  2126 , yet have an uncompressed, de-energized length that is equal to the length of the telescoped sleeves. Further, while the end-of-dose indicator  2133  is described in connection with a drive mechanism  2100  including a plurality of biasing members disposed in parallel, those of skill in the art will appreciate that the end-of-dose indicator  2133  could also be utilized in connection with a drive mechanism including a single biasing device or a plurality of biasing members disposed in series and/or parallel. 
     As the sleeve assembly  2120  moves axially outward, the proximal end  2126 B of the sleeve assembly  2120  passes the window  2131  of the drive housing  2130 . In the illustrated embodiment in particular, as the second sleeve  2126  moves axially outward, the proximal end  2126 B of the second sleeve  2126  passes the window  2131  of the drive housing  2130 . 
     The switch interconnect  2132  includes a sensor  2134  and an electronic coupling  2136  to the power and control system  2400 . At least a portion of the sensor  2134  is disposed adjacent the window  2131 , and is adapted to identify a change in the presence of the contact sleeve assembly  2120  proximal to the window  2131  within the drive housing  2130 . For example, in the illustrated embodiment, the sensor  2134  may read that the sleeve assembly  2120  is no longer present proximal to the window  2131 . 
     In order to better illustrate the relationship of the sensor  2134  and the sleeve assembly  2120  during movement of the sleeve assembly  2120 , portions of the sleeve assembly  2120  are broken away in  FIGS. 23A-23B ; in  FIGS. 24A-24B , the housing  2130 , sleeve  2126 , biasing members  2106 ,  2122 , and end-of-dose indicator  2133  are shown in cross-section taken along line  14 - 14  in  FIG. 11 . In the illustrated embodiment, the sleeve assembly  1120  is disposed adjacent the window  2131  when the piston  2110  is in the retracted first position (see  FIG. 23A ), and as the sleeve assembly  1120  begins to telescope outward with the piston  2110  (see  FIGS. 23B and 24A ). Conversely, the sleeve assembly  1120  is not disposed adjacent the window  2131  when the piston  2110  is in a fully extended second position (see  FIGS. 23C and 24B ). As the proximal end  2126 B of the second sleeve  2126  passes the window, the switch interconnect  2132  identifies that the sleeve assembly has passed the window  2131 , and that the end of dose has occurred, and provides that information to the power and control system  2400 . The electronic coupling  2136  may be of any appropriate design. In the illustrated embodiment, for example, the sensor  2134  connects directly to a PCB board  2138 . 
     The switch interconnect  2132  illustrated includes a mechanical sensor  2134  in the form of a pivotably mounted trigger  2135 , in essence, an on/off mechanical switch. The trigger  2135  is disposed in a first position in contact with the sleeve assembly  2120  when the piston  2110  is in a retracted first position. As the piston  2110  moves outward from the drive housing  2130 , the trigger  2135  slides along the telescoping sleeve assembly  2120  until such time as the proximal end  2126 B of the second sleeve  2126  passes the window  2131 , that is, the trigger  2135 . As the second sleeve  2126  passes the trigger  2135 , the trigger  2135  moves to a second position. The movement of the trigger  2135  to the second position results in the electronic coupling  2135  providing a signal indicating the end of dose to the power and control system  2400 . 
     The switch interconnect  2132  may be of any appropriate design, however. For example, the switch interconnect  2132  may include a sensor of an electromechanical nature, such as the one illustrated in  FIGS. 20A-24B , or a sensor of an electrical nature, such as, for example, an optical reader or sensor. Additionally or alternatively, the switch interconnect  2132  may utilize an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or a number of other types of sensors. Accordingly, the sensor may not require physical contact with the corresponding reference component. In an embodiment including an optical sensor, the sensor may read when the presence or absence of the sleeve assembly  2120 , for example, reading the interior of the drive housing  2130  opposite the window  2131 . The sensor may be configured to additionally or alternatively identify at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rate or change of rate of motion. 
     Although illustrated as an electromechanical arrangement that reads the position of a telescoping sleeve, any appropriate arrangement may be provided to read the relative position of any appropriate component, the end-of-dose indicator providing a signal to the power and control system to indicate that all of the drug has been administered. Additionally, the switch interconnects and corresponding contacts and/or reference component may be utilized to provide incremental status indication in addition to an end-of-dose indication. For example, in the switch interconnect arrangement described above with reference to  FIGS. 20A-23C , the switch interconnect  2132  may be an electromechanical sensor configured to recognize a number of bumps, ridges, or grooves, in the corresponding sleeve  2126  or any other reference component, the contact with which permits the switch interconnect to signal an incremental status indication (e.g., delivery initiation, amount of volumes delivered, duration of plunger travel, etc.) and a final end-of-dose indication. As described herein, similar incremental status indication may be provided in this configuration by utilizing a different type of sensor arrangement. For example, the switch interconnect  2132  may be an optical sensor configured to recognize a number of markings on the corresponding sleeve  2126  or any other reference component. As the optical sensor recognizes the number of markings, it permits the switch interconnect to signal an incremental status indication (e.g., delivery initiation, amount of volumes delivered, duration of plunger travel, etc.) and a final end-of-dose indication. Any appropriate arrangement may be provided to read the relative position of a number of markings, ridges, grooves, or respective indicators on any appropriate reference component, and recognition of such indicators by the switch interconnect permits it to provide a signal to the power and control system to indicate the incremental status of drug delivery, including the final status that all of the drug has been administered. As would be appreciated by an ordinarily skilled artisan in the relevant arts, the indicators may not necessarily be defined aspects on a reference component, and the switch interconnects may be configured to recognize the actual travel of the reference component itself. The switch interconnects may thus be configured to recognize the rate of change, the distance of travel, or other related measurements in the actual travel of the reference components and enable a signal to the power and control system to provide the patient with such information or feedback. 
     It will be appreciated by those of skill in the art that the embodiments of the present disclosure provide the necessary drive force to push a plunger seal and a drug fluid within a drug container, while reducing or minimizing the drive mechanism and overall device footprint. Accordingly, the present disclosure provides a drive mechanism which may be utilized within a more compact drug delivery device. The embodiments of the present disclosure may similarly be utilized to provide additional force, as may be needed for highly viscous drug fluids or for larger volume drug containers. 
     The embodiments shown and detailed herein disclose only a few possible variations of the present disclosure; other similar variations are contemplated and incorporated within the breadth of this disclosure. 
     The drive mechanism may further include one or more contact surfaces located on corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electro-mechanical contact surfaces. Such surfaces may initially be in contact and caused to disengage, or initially be disconnected and caused to engage, to permit a signal to be sent to and/or from the power control system  2400 . 
     A fluid pathway connector, and specifically a sterile sleeve of the fluid pathway connector, may be connected to the cap and/or pierceable seal of the drug container. A fluid conduit may be connected to the other end of the fluid pathway connector which itself is connected to the insertion mechanism such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connector, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a patient. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device, as shown in  FIG. 1B . 
     Certain optional standard components or variations of drive mechanism  100  or drug delivery device  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIG. 1A , to enable the patient to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the patient for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug delivery device  10  to the body of the patient. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the patient. Removal of the patch liner  28  may further remove the sealing membrane  254  of the insertion mechanism  200 , opening the insertion mechanism to the body of the patient for drug delivery (as shown in  FIG. 1C ). In some embodiments, removal of the patch liner  28  may also wake up onboard electronics (e.g., the power and control system  400 ) by supplying them with electricity from an onboard battery. 
     Similarly, one or more of the components of drive mechanism  100  and drug delivery device  10  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. Similarly, while electrical contact  134  is shown as a separate component from contact sleeve  140 , it may be a unified component printed onto the ring surface of the contact sleeve  140 . As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the drive mechanism and/or drug delivery device  10  to each other. Alternatively, one or more components of the drive mechanism and/or drug delivery device  10  may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the drive mechanisms and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide integrated status indication to provide feedback to the patient. The novel drive mechanisms of the present disclosure may be directly or indirectly activated by the patient. For example, in at least one embodiment the lockout pin(s) which maintain the drive mechanism in its locked, energized state are directly displaced from the corresponding lockout grooves of the piston  110  by patient depression of the activation mechanism. Furthermore, the novel configurations of the drive mechanism and drug delivery devices of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device  10  do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, housing and other components of the drug delivery device may readily be configured to accept and operate drive mechanism  100 , drive mechanism  500 , or a number of other variations of the drive mechanism described herein. 
     Manufacturing of a drug delivery device  10  includes the step of attaching both the drive mechanism and drug container, either separately or as a combined component, to an assembly platform or housing of the drug delivery device. The method of manufacturing further includes attachment of the fluid pathway connector, drug container, and insertion mechanism to the assembly platform or housing. The additional components of the drug delivery device, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug delivery device  10  that contacts the patient during operation of the device. 
     VI. Fill Finish Cartridge 
     The sterile fluid pathway assemblies described above may be filled with pharmaceutical treatments, such as the drugs described below, using standard filling equipment and systems. This advantage is enabled by the fill-finish cartridges described below which function to maintain the sterility of the fluid pathway assemblies and allow them to nest, mount, or otherwise be removably inserted into trays for standard fill-finish processes, as discussed further below. The drive mechanisms, fluid pathway connectors, insertion mechanisms, and other components and sub-components of the drug delivery devices described below in connection with  FIGS. 25-47  may be implemented in any of the drug delivery devices described above in connection with  FIGS. 1A-24B . Furthermore, any of the methods of manufacture and methods of use described below may be applied to the drug delivery devices described above in connection with  FIGS. 1A-24B . 
     Turning to  FIG. 25 , there is illustrated a schematic representation of an example of a drug delivery device  10  incorporating aspects of the disclosure. The device  10  includes a housing  612  having an activation mechanism  614 . For ease of understanding, the housing  612  is shown schematically. In accordance with the disclosure, the device further includes a fill-finish cartridge  616 . The fill-finish cartridge  616  includes a drug container  618 , a fluid pathway assembly  620  including a fluid pathway connector  622  and a needle insertion mechanism  624 . The fluid pathway assembly  620  may include further structure that facilitates disposition of various components, including, for example, a fluid conduit  26 . The fluid pathway connector  622  is disposed substantially adjacent a distal end  628  of the drug container  618 , and the needle insertion mechanism  624  is disposed substantially adjacent a distal end  630  of the fluid pathway connector  622 . In the illustrated embodiment, the drug container  618  is generally horizontally positioned and perpendicular from a vertically positioned needle insertion mechanism  624 . It will be appreciated, however, that the components may be positioned in any appropriate manner. 
     Administration of a drug contained in the drug container  618  may be initiated by the activation mechanism  614 . The activation mechanism  614  may include, for example, activation mechanisms that are manually actuated by a patient, or that are automatically actuated by, for example, a power and control module  632  that may include, by way of further example, a microprocessor or other automatic administration arrangement with appropriate connections. In this embodiment, the activation mechanism  614  is a button  634  that may be disposed, for example, along an outer surface of the housing  612 , and may be selectively depressed by the patient. It will be appreciated that the drug delivery device  10  as well as the activation mechanism  614  may be of any appropriate design. 
     The power and control module  632 , if included, may include a power source, which provides the energy for various electrical components within the drug delivery device, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnects. Other components commonly used in such electrical systems may also be included, as would be appreciated by one having ordinary skill in the art. The one or more feedback mechanisms may include, for example, audible alarms such as piezo alarms and/or light indicators such as light emitting diodes (LEDs). The microcontroller may be, for example, a microprocessor. The power and control module  632  controls several device interactions with the patient and may interface with one or more other components of the drug delivery device  10 . In one embodiment, the power and control module  632  may identify when an on-body sensor and/or the activation mechanism  614  have been activated. The power and control module  632  may also interface with a status indicator, which may be a transparent or translucent material which permits light transfer, to provide visual feedback to the patient. The power and control module  632  may interface with a drive mechanism and/or the integrated sterile fluid pathway connector and drug container  618  through one or more interconnects to relay status indication, such as activation, drug delivery, and/or end-of-dose, to the patient. Such status indication may be presented to the patient via tactile feedback, such as vibration; auditory tones, such as through the audible alarms; and/or via visual indicators, such as through the LEDs. In a preferred embodiment, the control interfaces between the power and control system and the other components of the drug delivery device are not engaged or connected until activation by the patient. This is a desirable safety feature that prevents accidental operation of the drug delivery device and may also maintain the energy stored in the power source during storage, transport, and the like. 
     The power and control module  632  may be configured to provide a number of different status indicators to the patient. For example, the power and control module  632  may be configured such that after the on-body sensor and/or trigger mechanism have been pressed, the power and control module  632  provides a ready-to-start status signal via the status indicator if device start-up checks provide no errors. After providing the ready-to-start status signal and, in an embodiment with the optional on-body sensor, if the on-body sensor remains in contact with the body of the patient, the power and control module  632  will power the drive mechanism to begin delivery of the drug treatment through the integrated sterile fluid pathway connector  622  and sterile fluid conduit  26 . In a preferred embodiment of the present disclosure, the insertion mechanism  624  and the drive mechanism may be caused to activate directly by patient operation of the activation mechanism  614 . The integrated sterile fluid pathway connector is connected (i.e., the fluid pathway is opened) by the pneumatic force of the drug fluid within the drug container  618  created by activation of the drive mechanism, as is detailed further herein. During the drug delivery process, the power and control module  632  is configured to provide a dispensing status signal via the status indicator. After the drug has been administered into the body of the patient and after the end of any additional dwell time, to ensure that substantially the entire dose has been delivered to the patient, the power and control module  632  may provide an okay-to-remove status signal via the status indicator. This may be independently verified by the patient by viewing the drive mechanism and delivery of the drug dose within the drug container through a window of the housing  612 . Additionally, the power and control module  632  may be configured to provide one or more alert signals via the status indicator, such as for example alerts indicative of fault or operation failure situations. 
     Other power and control system configurations may be utilized with the novel drug delivery devices of the present disclosure. For example, certain activation delays may be utilized during drug delivery. As mentioned above, one such delay optionally included within the system configuration is a dwell time which ensures that substantially the entire drug dose has been delivered before signaling completion to the patient. Similarly, activation of the device may require a prolonged depression (i.e., pushing) of the activation mechanism  614  of the drug delivery device  10  prior to drug delivery device activation. Additionally, the system may include a feature which permits the patient to respond to the end-of-dose signals and to deactivate or power-down the drug delivery device. Such a feature may similarly require a delayed depression of the activation mechanism, to prevent accidental deactivation of the device. Such features provide desirable safety integration and ease-of-use parameters to the drug delivery devices. An additional safety feature may be integrated into the activation mechanism to prevent partial depression and, therefore, partial activation of the drug delivery devices. For example, the activation mechanism and/or power and control system may be configured such that the device is either completely off or completely on, to prevent partial activation. Such features are described in further detail hereinafter with regard to other aspects of the novel drug delivery devices. 
     When included, the power and control module  632  may include a processor (not shown) and a memory component (not shown). The processor may be microprocessors or other processors as known in the art. In some embodiments the processor may be made up of multiple processors. The processor may execute instructions for generating administration signal and controlling administration of a drug contained in the drug container  618 . Such instructions may be read into or incorporated into a computer readable medium, such as the memory component or provided external to processor. In alternative embodiments, hard-wired circuitry may be used in place of or in combination with software instructions to implement drug administration. Thus, embodiments are not limited to any specific combination of hardware circuitry and software. 
     The term “computer-readable medium” as used herein refers to any medium or combination of media that participates in providing instructions to processor for execution. Such a medium may take many forms. The memory component may include any form of computer-readable media as described above. The memory component may include multiple memory components. 
     The power and control module  632  may be enclosed in a single housing. In alternative embodiments, the power and control module  632  may include a plurality of components operably connected and enclosed in a plurality of housings. 
     The power and control module  632  may be configured to generate an administration signal as a function of patient actuation, preprogrammed actuation or remote actuation. The power and control module  632  may be communicatively coupled to fill-finish cartridge  616 , and/or the drug container  618 , the fluid pathway connector  622 , and/or the needle insertion mechanism  624  individually. 
     In accordance with an aspect of embodiments of the disclosure, in the illustrated embodiment, actuation of the activation mechanism  614 , here, depression of the button  634 , results in engagement of the fluid pathway connector  622 , as will be discussed in greater detail below. This same action by the patient may trigger the needle insertion mechanism  624  to inject a needle or cannula into the patient, as will likewise be explained in greater detail below. Thus, actuation of activation mechanism  614  results in the completion of a drug pathway from the drug container  618  through the fluid pathway connector  622 , the fluid conduit  26 , and the needle insertion mechanism  624  to the patient (not shown). Actuation of the activation mechanism  614  may also result in a drive mechanism acting upon structure associated with the drug container  618  to force fluid through the sterile pathway. In an embodiment of the present disclosure, the needle insertion mechanism  624  may be triggered to retract the needle from the patient, giving a clear end of dose delivery indication upon completion of drug delivery. The housing  612  may additionally include, for example, a window through which the drug container  618  may be viewed to confirm drug delivery. 
     According to an aspect of embodiments of the disclosure, the fill-finish cartridge  616  is constructed and filled prior to assembly into the housing  612  of the drug delivery device  10 . In this regard, the fill-finish cartridge  616  is sufficiently robust to withstand procedures for sterilizing the fill-finish cartridge  616 , in some embodiments prior to fill, and in some embodiments after fill. After the sterile construction and filling of the fill-finish cartridges  616 , the device may be positioned as needed within a drug delivery device  10 . In any event, the sterility of the fluid pathway assembly  620  and the drug container  618  are maintained through aspects of the assembly, filling, and manufacturing processes. Final assembly of the drug delivery device  10  can thus be performed outside of a sterile environment. Because only the components of the sterile fluid pathway assembly  620  need to be, and have been, sterilized, the remainder of the drug delivery device  10  does not need sterilization (i.e., terminal sterilization). This provides a number of advantages. Novel embodiments of the present disclosure may also alleviate the need to fill the drug delivery device at time-of-use, although some embodiments of the present disclosure may be utilized in devices configured for time-of-use filling as well. 
     According to another aspect of embodiments of the disclosure, various embodiments of individual components of the fill-finish cartridge  616  may be assembled in various configurations to provide various embodiments of the fill-finish cartridge  616 . The following disclosures disclose exemplary structures of individual elements that may be incorporated into the fill-finish cartridge  616 , and are incorporated herein by reference for everything disclosed therein: U.S. application Ser. No. 13/600,114 filed Aug. 30, 2012; U.S. application Ser. No. 13/599,727 filed Aug. 30, 2012; U.S. application Ser. No. 13/612,203 filed Sep. 12, 2012; and Ser. No. 13/796,156 filed Mar. 12, 2013.  FIG. 26B  is a chart of examples of variables for possible structures of connections between individual components that may yield various configurations of embodiments of fill-finish cartridges  616 , while  FIG. 26A  shows an example of a fill-finish cartridge  616  identifying aspects referenced in  FIG. 26A . For ease of understanding, the same reference numbers are utilized as in  FIG. 25 . The individual components, as well as the interactions and connections between the individual components may have various designs. For example, the needle insertion mechanism  624  may be of any suitable design. Similarly, the container  618  and the fluid pathway connector  622  may each be of any appropriate design. 
     Likewise, the interactions between the components may be of any appropriate design. For example, the engagement of the fluid pathway connector  622  with the drug container  618  may include a threaded or snap connection, an interference fit, or an external support or other arrangement, so long as a tight seal is obtained. Similarly, the engagement of the fluid pathway connector  622  with the needle insertion mechanism  624  may include a threaded or snap connection, an interference fit, a tongue and groove arrangement, an external support, or some other arrangement including, but not limited to, utilizing a fluid conduit between the fluid pathway connector  622  and the needle insertion mechanism  624  for the connection. Moreover, in some embodiments, the engagement of the fluid pathway connector  622  with the needle insertion mechanism  624  may be disassembled following the fill-finish process in order to permit the needle insertion mechanism  624  to be oriented other than axially with the remainder of the fill-finish cartridge  616 , so long as the sterile fluid connection is maintained. 
     In various embodiments, the fill-finish cartridge  616  may be maintained with the components in axial alignment during the fill-finish process, as well as in use with a drug delivery device  10 . That is, for example, the needle insertion mechanism  624  may be disposed axially with the remainder of the fill-finish cartridge  616  during both the fill-finish process, such as is shown in  FIG. 26B , and in use in a drug delivery. In other embodiments, the fill-finish cartridge  616  may be maintained with the components in axial alignment during the fill-finish process, such as is illustrated in  FIG. 26B , while the components may be maintained in other than axial alignment in use with a drug delivery device  10 . For example, as illustrated in  FIG. 25 , the needle insertion mechanism  624  is disposed spaced from the fluid pathway connector  622  and the drug container  618 , and at a 90.degree. orientation. In other embodiments, the fill-finish cartridge may be maintained with the components in other than axial alignment during the fill-finish process, yet be axially aligned in use with a drug delivery device  10 . In other embodiments, the fill-finish cartridge  616  may be maintained with the components in other than axial alignment during both the fill-finish process and in use with a drug delivery device  10 . 
     Further, while not included in all embodiments, in order to provide added structural integrity to the fill-finish cartridge  616 , a carrier may be provided, as will be explained in more detail below. Such a carrier may be integrated with the structure of the fill-finish cartridge  616  such that it is maintained about or along at least a portion of the fill-finish cartridge  616  in the drug delivery device  10 , or such a carrier may be fully or partially disposable. A carrier may perform a number of functions, such as, the maintenance of the relative positions of various of the fill-finish cartridge components during assembly, a fill-finish process, or other operations performed on the fill-finish cartridge or a drug delivery device incorporating the same; a carrier or a portion of a carrier may be utilized in the interaction of the fill-finish cartridge with a drug delivery device  10 , such as, in attachment of the fill-finish cartridge  616  into a drug delivery device  10  or in connection with operation of a drug delivery device  10 . More detailed explanations of various examples of such structures in varied configurations follow; it is not the intention to limit the structures to those particular configurations. Rather, the individual arrangements explained are provided as examples of various possible configurations and structures within the purview of this disclosure. 
       FIG. 27  shows an exploded view of one embodiment of the fill-finish cartridge  716  of the present disclosure. For ease of understanding, the number utilized in  FIG. 25  are utilized in further examples of embodiments of the disclosure with numerical prefixes; in this embodiment, 1XX will be utilized. The fill-finish cartridge  716  of this embodiment includes a fluid pathway assembly  720  connected to a drug container  718 . 
     The fluid pathway assembly  720  includes a needle insertion mechanism  724  coupled to a fluid pathway connector  722  by a fluid conduit  726 . A proximal end of the needle insertion mechanism  724  is connected to a distal end of a fluid conduit  726 , which is connected at its proximal end to the fluid pathway connector  722 . 
     The needle insertion mechanism  724  may be of any appropriate design so long as it may be sterilized prior to the placement of the fill-finish cartridge  716  in a drug delivery device. Examples of such needle insertion mechanisms  724  for implants and liquid drugs and are disclosed in U.S. application Ser. No. 13/599,727 filed Aug. 30, 2012, is incorporated herein by reference for everything disclosed therein. It will be noted that the needle insertion mechanism  724  of  FIG. 27  includes an axial structure, such that the administration needle (not visible in  FIG. 27 ) extends axially from a distal end of the fill-finish cartridge  716  for administration. It will be appreciated, however, that a needle insertion mechanism  724  that is disposed at an angle to an axis of the fluid pathway connector  722  and/or drug container  718  could alternately be utilized. 
     The components of the fluid pathway assembly  720 , including the needle insertion mechanism  724 , the fluid pathway connector  722 , and the fluid conduit  726  are formed of materials that may be sterilized by conventional sterilization techniques and machinery. The fluid conduit  726  may be formed of any appropriate material, for example, a length of flexible tubing, such as plastic tubing. It will be appreciated, however, that fluid pathway connector  722  and the needle insertion mechanism  724  may be directly attached in some embodiments (not illustrated in  FIGS. 27 and 28 ). 
     The components of the fluid pathway assembly  720  may be sterilized in advance of such connections, or may be connected prior to sterilization as a unified component. If sterilized in advance of such connections, the fluid pathway assembly  720  may include an additional seal at the fluid pathway connector  722 , such as a permeable seal that may be pierced during assembly or actuation (not illustrated). 
     The drug container  718  of this and each of the embodiments may be of any appropriate material and of any appropriate shape and size, and may include a seal to maintain the integrity and sterility of a drug contained therein. For example, the drug container  718  may be formed of glass, plastic, or other appropriate material. The drug container  718  of this and each of the embodiments may include structure that facilitates handling, mounting within a drug delivery device, sterilization, and/or interface with other components of the fill-finish cartridge  716 . For example, a flange  719  may be provided at any appropriate location along the drug container  716 . Such a flange  719  may be integrally formed with the drug container  718  or may be a separate element that is secured to the drug container. In the illustrated embodiment, the flange  719  is a separate component that is coupled to a proximal end of the drug container  718 . 
     It will be appreciated that any appropriate drive mechanism may be provided for moving the medication from the drug container  718  to the fluid pathway assembly  720  in embodiments of the disclosure. For example, U.S. application Ser. No. 13/600,114 filed Aug. 30, 2013, discloses an embodiment of a drive mechanism associated with a drug container, and is incorporated herein by reference for everything disclosed in that application. 
     In order to facilitate both filling the drug container  718  and administering medication from the drug delivery container, the drug container  718  may include openings  718   a ,  718   b  at the proximal and distal ends  6127 ,  728 , respectively. In order to seal the drug container  718 , a permeable seal  150  may be provided at a distal end  728  of the drug container  718 . In this way, once filled, a drug contained within the drug container  718  may be maintained in a sterile environment until such time as the seal  150  is pierced by the fluid pathway connector  722  to complete the fluid pathway. The permeable seal  150  may be of any appropriate design and material. 
     The distal end  728  of the drug container  718  may be assembled with the fluid pathway assembly  720  for sterilization prior to or after fill, as will be explained in greater detail below.  FIG. 28  shows an enlarged cross-sectional view of the fluid pathway connector  722  and the permeable seal  150  of  FIG. 28 , after these components are assembled and ready for sterilization. While the permeable seal  150  may be a single thin membrane  762  or the like across the opening  718   b  at the distal end  728  of the drug container  718 , the permeable seal  150  may include further structure that facilitates connection with the drug container  718  and/or the fluid pathway connector  722 . As shown, in at least one embodiment of the present disclosure, the permeable seal  150  is in the form of a container tip which caps the drug container  718 , as well as provides support for the fluid pathway connector  722 . In this embodiment, the permeable seal  150  may include a portion  152  that rests inside the drug container  718 , providing a mating surface to mount the permeable seal  150  to the drug container  718 . To assist in maintaining the connection of the seal  150  with the drug container  718  a cap  151  may be provided about portions of the permeable seal  150  and the drug container  718 , such as around a lip on the drug container  718 . Such a cap  151  may be of any appropriate material, such as a foil. While the drug container  718  necks in at the interface with the permeable seal  150 , it will be appreciated that alternate designs may likewise be provided. 
     The permeable seal  150  may also have an extension  153  which facilitates mounting with the fluid pathway connector  722 . In the embodiment shown in  FIG. 28 , the fluid pathway connector  722  includes a hub  154  through which a cannula  158  may extend. It will be appreciated by those of skill in the art that, as used herein the term “cannula”  158  includes a needle or a cannula that may be operative to provide the required fluid connection. The fluid conduit  726  is fluidly connected to the cannula  158  as it extends from a surface of the hub  154 . The hub  154  of the fluid pathway connector  722  may be employed, as shown here, to mount, attach, or otherwise connect with the extension  153  of the permeable seal  150 , the proximal end of the cannula  158  being disposed within a bore  760  of the extension  153 . Prior to the completion of a fluid pathway between the drug container  718  and the fluid conduit  726 , the cannula  158  is held in position as illustrated in  FIG. 28 . 
     The permeable seal  150  has a portion that acts as a membrane  762  that may be pierced by the cannula  158 . In the embodiment of  FIGS. 27 and 28 , the membrane  762  is disposed generally perpendicular to the cannula  158  to close off the drug container  718  from the fluid pathway connector  722 , thereby blocking the fluid pathway from the drug container  718  to the fluid conduit  726 . Upon activation by the patient, a portion of the permeable seal  150  blocking the drug container  718 , here, membrane  762 , is caused to be pierced by the cannula  158  of the fluid pathway connector  722 , thereby completing the fluid pathway and permitting drug fluid to pass from the container  718  to the cannula  158  and the fluid conduit  726 , and on to the needle insertion mechanism  724 . In order to facilitate piercing, the extension  153  of the permeable seal  150  may bow outward in response to sufficient axial pressure, for example, to allow the cannula  158  to pierce the membrane  762  to complete the fluid pathway. 
     Accordingly to another aspect of embodiments of the disclosure, the drug container  718 , fluid pathway connector  722 , and the needle insertion mechanism  724  of the fill-finish cartridge  716  exhibit sufficient structural integrity to be utilized in a fill-finish process and to be assembled into a housing of a drug delivery device. It will be appreciated that any appropriate fluid pathway connector  722  may be incorporated into embodiments of the disclosure. For example, a mounted fluid pathway connector, such as is disclosed, for example, in U.S. application Ser. No. 13/612,203 filed Sep. 12, 2012, may be utilized. Likewise, an integrated fluid pathway connector, such as is disclosed, for example, in U.S. application Ser. No. 13/796,156 filed Mar. 12, 2013, and may be utilized. Both of these applications are incorporated herein by reference. 
     Similarly, it will be appreciated that any appropriate connection may be provided between the fluid pathway connector  722  and the needle insertion mechanism  724 . While examples of some connections are disclosed in detail herein, it is not the applicant&#39;s intention to limit the disclosure. Such a connection may include, for example, a snap connection (see  FIGS. 45-47 ), a threaded connection (see  FIGS. 40-44 ), an interference connection, a tongue and groove connection, an external support (see  FIG. 27 ), or other appropriate connection. 
     Returning to  FIG. 27 , In order to provide further structural integrity to such an interface between the fluid pathway connector  722  and the permeable seal  150 , and/or between the fluid pathway connector  722  and the needle insertion mechanism  724 , a carrier  742  may be provided. The carrier  742  of this embodiment includes a connection collar  740  and a barrel  6141 . For manufacturing purposes, the connection collar  740  may itself include multiple components, as illustrated in  FIG. 27 , that may be coupled together about the fluid pathway connector  722 , the permeable seal  150 , and a portion of the drug container  718  by any appropriate mechanism. It will be appreciated, however, that a unitary connection collar  740  could alternately be provided. It will further be appreciated that the connection collar  740  may not be required or desirable in all embodiments, and that such a connection collar  740  may be provided as an integrated part of the design, or may be fully or partially disposable during the assembly or sterilization processes. 
     Further structural integrity may be provided by the barrel  6141 , which may support the fluid pathway assembly  720  during the sterilization and assembly processes. While any appropriate coupling may be provided, the connection collar  740  may facilitate coupling of the barrel  6141  about the fluid pathway assembly  720 . In the illustrated embodiment, the connection collar  740  includes a pair of protrusions  744  (only one being visible in  FIG. 27 ) that mate with a pair of recesses  746  in the barrel  6141 . As with the connection collar  740 , it will further be appreciated that the barrel  6141  may not be required or desirable in all embodiments, and that such a barrel  6141  may be provided as an integrated part of the design, or may be fully or partially disposable during the assembly or sterilization processes. In order to permit the needle insertion mechanism  724  to operate to administer medication, the barrel  6141  may include an opening  6   741   a  through which an administration needle may extend during use. 
     For operational efficiency, the needle insertion mechanism  724  may be coupled to the fluid pathway connector  722 , and the fluid pathway connector  722  may be connected to the permeable seal  150  with the needle insertion mechanism  724  maintained in the non-piercing configuration through the sterilization, filling, and assembly processes. In this way, the fill-finish cartridge  716  may appear as shown in  FIG. 29 , with the fluid pathway assembly  720  residing entirely hidden from the external environment by the carrier  742 . Once the drug container  718  is filled with a pharmaceutical treatment, a seal  764  may be provided in the proximal end  6127  of the drug container  718  to provide a closed fill-finish cartridge  716  that may be inserted into an appropriate drug delivery device. In the embodiment illustrated in  FIGS. 29-30 , an elastomeric plunger seal  764  is inserted into the proximal end  6127  of the drug container  718 . It will be appreciated, however, that other appropriate sealing arrangement may be provided. In  FIGS. 29 and 30 , the arrangement of the fluid pathway connector  722 , the container  718 , and the insertion mechanism  724  relative to each other may be considered to be a first configuration. The first configuration may facilitate the manufacturing process, for example, by enabling the use of standard filling equipment and systems. While the first configuration shown in  FIGS. 29 and 30  involves the axial alignment of the container  718  and the insertion mechanism  724 , in other embodiments, the first configuration may involve a non-axial alignment of the container  718  and the insertion mechanism  724 , or any other relative positioning of the container  718  and the insertion mechanism  724 . Subsequently, when assembled in the drug delivery device  610 , as illustrated in  FIG. 25 , the fluid pathway connector  722 , the container  718 , and the insertion mechanism  724  may be arranged relative to each other such they have a second configuration. The second configuration may involve the non-alignment of the container  718  and the insertion mechanism  724  as illustrate in  FIG. 25 , or, in alternative embodiments, the axial alignment of the container  718  and the insertion mechanism  724 , or any other relative positioning of the container  718  and the insertion mechanism  724 . In some embodiments, the first configuration is different from the second configuration. 
     According to another aspect of the disclosure, the fluid pathway assemblies may be maintained in a sterile condition and the drug containers of each assembly may be filled with a pharmaceutical compound aseptically using processes similar to those known in the art. After a pharmaceutical treatment is filled into the drug container and the container is sealed, for example with the plunger seal  764  of the embodiment of  FIGS. 27-30 , the fill-finish cartridge  716  may be removed from the sterile filling environment without comprising the sterility or container integrity of the drug container  718 , fluid pathway assembly  720 , or their individual components. 
     Alternatively, the fill-finish process may be such that the plunger seal  764  is inserted to the proximal end of the drug container  718  prior to filling the container  718  with a pharmaceutical treatment. In such an embodiment, the pharmaceutical treatment may be filled from the distal end  728  of the drug container  718  prior to insertion and connection of the fluid pathway connector  722  and the fluid pathway assembly  720 . Accordingly, the fill-finish cartridges of the present disclosure enable the fluid pathway assemblies of the present disclosure to be filled with pharmaceutical treatments in standard fill-finish processes, greatly reducing the complexities associated with manufacturing and operation of the components and the drug delivery devices in which they are incorporated. 
     According to another aspect of the disclosure, embodiments of the fill-finish cartridges of the present disclosure may enable the fluid pathways assemblies to be filled in standard fill-finish processes. In this regard, the fill-finish cartridges may utilize existing or standardized fill-finish equipment. A plurality of fill-finish cartridges  716 , such as is illustrated in  FIGS. 27-30 , for example, may be removably mounted, mated, inserted, or otherwise placed into a standard fill-finish tray  770 , such as illustrated in  FIGS. 31-32 , for filling with pharmaceutical treatments. As explained above, the flange  719  of the drug container  718  may assist in placement and handling of the fill-finish cartridges  716 . The fill-finish tray  770  illustrated in  FIGS. 31-32  is configured to hold thirty-six drug containers, here, fill-finish cartridges  716 , but trays of any configuration or capable of holding any number of containers may be utilized. 
     According to another aspect of the disclosure, fill-finish cartridges may be configured to be fixed cartridges or adjustable cartridges. For example, the cartridges may have a flexible or adjustable portion that enables them to bend, rotate, expand, or contract to fit a number of different fluid pathway assemblies or to mate with fill-finish processing trays of different dimensions. 
     According to yet another aspect of the disclosure, components of some embodiments of the fill-finish cartridges may be incorporated into the drug delivery devices, while in other embodiments, components of the fill-finish cartridges may be utilized for the fill-finish process and then discarded upon mounting the fluid pathway assembly and drug container into a drug delivery device. For example, in an embodiment such as is illustrated in  FIGS. 27-30  is utilized as shown in  FIG. 25 , by removing the barrel, the connection collar may be utilized to mount and/or brace the drug container into position within the drug delivery device, while the needle insertion mechanism is mounted remotely from and 90.degree. to the drug container. 
     In the embodiment of  FIGS. 33-35 , there is illustrated a fill-finish cartridge  816  that includes a carrier  842  that may be disposed of after the fill-finish process, that is prior to insertion into a drug delivery device. The fill-finish cartridge  816  of this embodiment includes a fluid pathway assembly  820  connected to a drug container  818 . The fluid pathway assembly  820  includes a needle insertion mechanism  824  coupled to a fluid pathway connector  822  by a fluid conduit  826 . A proximal end of the needle insertion mechanism  824  is connected to a distal end of a fluid conduit  826 , which is connected at its proximal end to the fluid pathway connector  822 . In order to provide further support to the fill-finish cartridge  816 , the illustrated carrier  842  is disposed about portions of the drug container  818  and the fluid pathway assembly  820 , that is, the fluid pathway connector  822 , the fluid conduit  826 , and a portion of the needle insertion mechanism  824 . 
     The carrier  842  is generally an elongated tubular structure that may be fabricated in multiple components to facilitate assembly and disassembly, if desired. In the illustrated embodiment, one portion of the carrier  842  includes circumferentially extending arms  843  having protrusions  844 , while a mating portion of the carrier  842  includes recesses or openings  846  through which the protrusions  844  may extend when assembled about the fill-finish cartridge  816 . 
     In order to assist in maintaining the components of the fill-finish cartridge  816  in their relative positions, the carrier  842  may further include one or more radially projecting flanges  848   a ,  848   b ,  848   c . As will be apparent from the explanation below, flanges  848   a  and  848   b  may be disposed to further secure aspects of the fluid pathway connector  822  and the drug container  818  in their relative positions. Further, as will likewise be apparent from the explanation below, flanges  848   b  and  848   c  may be disposed to maintain the fill-finish cartridge  816  in an un-actuated position during filling, and, optionally, placement within a drug delivery device. In order to permit actuation of the device, the carrier  842  may be removed from the fill-finish cartridge  816  and discarded. The carrier  842  may further include a removable brace  840 . The removable brace  840  may have a generally U-shaped structure and surfaces that confront the surfaces of the fill-finish cartridge  816  to prevent premature completion of the fluid pathway from the drug container  818  to the fluid pathway connector  822 . The removable brace  840  may remain with the fill-finish cartridge  816  as it is assembled into a housing of a drug delivery device; in some embodiments, structure within the housing of the drug delivery device may confront one or more surfaces of the removable brace  840  to cause the removable brace  840  to disengage from the fill-finish cartridge  816  as it is assembled into the housing. 
     The drug container  818  is an elongated, generally annular structure, although the drug container  818  may be of an alternate design. For example, a flange  819  may be provided at any appropriate location along the drug container  818 . Such a flange  819  may be integrally formed with the drug container  818  or may be a separate element that is secured to the drug container  818 . In the illustrated embodiment, the flange  819  is a separate component that is coupled to a proximal end  827  of the drug container  818 . In an embodiment, the flange  819  may interface with a wall of a housing of a drug delivery device incorporating the fill-finish cartridge  816 . Further, in this embodiment, a flange  817  is provided at the distal end  828  of the drug container  818 . As illustrated in  FIG. 35 , the flange  817  may engage with flange  848   a  of the carrier  842  to facilitate the maintenance of the relative positions of the components of the fill-finish cartridge  816  during the fill-finish process and handling. 
     In order to seal the drug container  818 , a permeable seal  850  may be provided at the distal end  828  of the drug container  818 . In this way, a drug contained within the drug container  818  may be maintained in a sterile environment until such time as the seal  850  is pierced by the fluid pathway connector  822  to complete the fluid pathway. The drug container  818  may be assembled with the permeable seal  850  and the fluid pathway assembly  820  for sterilization prior to or after fill. The permeable seal  850  may be of any appropriate design and material. The permeable seal  850  includes a thin membrane  862  or the like that may be pierced in order to complete the fluid pathway from the drug container  818  through the fluid pathway connector  822  and fluid conduit  826  to the needle insertion assembly  824 . 
     The permeable seal  850  may include structure that facilitates connection with the drug container  818  and/or the fluid pathway connector  822 . For example, the permeable seal  850  may include a portion  852  that rests inside the drug container  818 , providing a mating surface to mount the permeable seal  850  to the drug container  818 . 
     The fluid pathway connector  822  maybe of any appropriate design. Such piercing arrangements are disclosed, for example, in U.S. application Ser. No. 13/612,203, and in U.S. application Ser. No. 13/796,156, both of which are incorporated herein by reference. 
     Referring to  FIG. 35 , the illustrated fluid pathway connector  822  includes a cannula  858  that is disposed to pierce the membrane  862  of the permeable seal  850  during actuation, the cannula  858  being spaced from the permeable seal  850  in the un-actuated position (see  FIG. 35 ), and progressing respectively axially in a proximal direction to confront and pierce the membrane  862  as a result of actuation. In the embodiment shown in  FIG. 35 , the fluid pathway connector  822  includes a hub  854  through which the cannula  858  extends. A pathway from the cannula  858  secured within the hub  854  extends from the lumen of the cannula  858  to a lumen of the fluid conduit  826 . Accordingly, when the cannula  858  pierces the membrane  862  of the permeable seal  850 , the fluid pathway is provided between the drug container  818 , the fluid conduit  826  and the needle  825  of the needle insertion mechanism  824 . 
     In order to maintain the hub  854  and, therefore, the cannula  858  in a desired position relative to the permeable seal  850  closing the drug container  818 , the fluid pathway connector  822  further includes a boot  853  formed of collapsible material, such as an elastomeric material. A distal end of the boot  853  includes a generally axially extending bore  853   a  that is disposed about a portion of the hub  854 , while a proximal end of the boot  853  includes a generally radially extending flange  853   b . The permeable seal  850  may also include a flange  849  that may be sandwiched between the flange  853   b  of the boot  853  of the fluid pathway connector  822  and the flange  817  at the distal end  828  of the drug container  818 . As with the embodiment illustrated in  FIGS. 27-30 , a retaining structure, such as a cap  851  may be provided about the periphery of the flanges  817 ,  849 ,  853   b.    
     The fluid pathway connector  822  of the fill-finish cartridge  816  may be caused to pierce the membrane  862  of the permeable seal  850  to complete the fluid pathway, for example, by manual depression of the proximal end  827  of the drug container  818  or by an alternate arrangement. During actuation, the boot  853  bows outward to allow relative axial movement between the hub  854  and the permeable seal  850  such that the cannula  858  pierces the membrane  862  of the permeable seal  850  to fluidly connect the drug container  818  to the delivery needle  825  of the needle insertion mechanism  824  via the fluid conduit  826 . 
     In order to inhibit inadvertent activation of the fluid pathway connector  822  once the carrier  842  is removed, the removable brace  840  may be provided about a portion of the circumference of the sterile boot  853  and/or between surfaces that inhibit axial movement of the hub  854  relative to the drug container  818 . The removable brace  840  may be a relatively rigid structure that confronts opposing surfaces  840   a ,  840   b , for example, on a surface of the hub  854 , and the flange  853   b  of the sterile boot  853  or, as here the cap  851  along the flange  853   b ; as a result, the removable brace  840  inhibits axial movement of hub  854  relative to the seal  850 . The removable brace  840  illustrated also closely follows at least a portion of the periphery of the sterile boot  853 ; as a result, the removable brace  840  likewise prevents the sterile boot  853  from bowing outward as the cannula  858  moves axially to pierce the seal  850 . In this embodiment, the removable brace  840  may be slid out of position on the sterile boot  853  by the patient prior to assembling the fill-finish cartridge  816  into the drug delivery device or by the action of placement into the drug delivery device, for example, as the removable brace  840  engages confronting surfaces of the housing of the delivery device (not illustrated). 
     The needle insertion mechanism  824  may be of any appropriate design. The needle insertion mechanism  824  illustrated in connection with the embodiment of  FIGS. 33-36  likewise includes a needle retraction mechanism, and is shown and explained in greater detail in U.S. application Ser. No. 13/599,727, which is incorporated by reference. 
     The insertion mechanism  824  includes an insertion mechanism housing  865  having one or more lockout windows  865   a , a base  866 , and a sterile boot  879 . The base  866  includes an opening to passage of the needle  825  and may include a sealing membrane  867  that, at least in one embodiment, is removable prior to use of the fill-finish cartridge  816 . Alternatively, the sealing membrane  867  may remain attached to the bottom of the base  866  such that the needle  825  pierces the sealing membrane  867  during operation of the fill-finish cartridge  816  within the drug delivery device incorporating the same. 
     The insertion mechanism  824  may further include an insertion biasing member  868 , a hub  869 , a needle  825 , a refraction biasing member  871 , a clip  872 , a manifold guide  873 , a septum  874 , a cannula  875 , and a manifold  876 . As illustrated in  FIG. 35 , both the insertion and retraction biasing members  868 ,  871  are held in energized states. The manifold  876  may connect to sterile fluid conduit  826  to permit fluid flow through the manifold  876 , cannula  875 , and into the body of the patient during drug delivery, as will be described in further detail herein. 
     As used herein, “needle  825 ” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles often referred to as “trocars.” In an embodiment, the needle  825  may be a 27 gauge solid core trocar and in other embodiments, the needle may be any size needle suitable to insert the cannula for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. 
     Upon assembly, the proximal end of needle  825  is maintained in fixed contact with hub  869 . The needle  825  may be positioned to move through a cannula  875 , if provided, in order to further control movement of the needle  825 . The hub  869 , and therefore the needle  825 , is maintained in selective contact with the manifold guide  873  by the clip  872 . While biasing members  868  and  871  bear on the manifold guide  873 , the manifold guide  873  is maintained in position by at least one lockout pin  878 , which extends through window  865   a  of the housing  865 . 
     Actuation of the needle insertion  824  device results from removal of the lockout pin  878 . The lockout pin  878  may be removed from the window  865   a  either directly or indirectly as a result of actuation of the fill-finish cartridge  816 . Upon removal of the lockout pin  878 , the manifold guide  873  carrying the hub  869  and needle  825  is permitted to move axially under the biasing force of the injection biasing member  868 . That is, the needle  825  moves into the injection position. As the hub  869  and needle  825  move to the injection position, the sterile boot  879  collapses. 
     In at least some embodiments, such as the embodiment shown in  FIG. 35 , the needle insertion mechanism  824  further includes a refraction mechanism that retracts the needle  825  following injection. Such a retraction mechanism may be of any appropriate design. As the manifold guide  873  moves axially in the distal direction, the clip  872  releases the hub  869 . Upon release, the biasing force of the retraction biasing member  871  causes hub  869  and the associated needle  825  to retract. 
     As with the embodiment of  FIGS. 27-30 , the needle insertion mechanism  824  of  FIGS. 33-36  includes an axially aligned structure, such that the administration needle  825  extends axially from a distal end of the fill-finish cartridge  816  during administration. It will be appreciated that the components may be secured together by any appropriate structure and method. The relative positions of the fluid pathway connector  822  and the needle insertion mechanism  824  may be maintained by, for example, a bracket  880 , as may be seen in  FIGS. 34-36 . The illustrated bracket  880  extends between the hub  854  of the fluid pathway connector  822  and the insertion mechanism housing  865 , as may best be seen in  FIG. 35 . The bracket  880  may perform additional functions such as, for example, management of the fluid conduit  826 . 
     It will be appreciated that in some embodiments wherein the bracket  880  is removed from its connection with either of the fluid pathway connector  822  or the needle insertion mechanism  824 , or wherein the fill-finish cartridge does not include the bracket  880 , the fluid conduit  826  may provide a flexible fluid connection between the fluid pathway connector  822  and the needle insertion mechanism  824 , allowing the needle insertion mechanism  824  and the fluid pathway connector  822  to be placed other than in axial alignment. Such embodiments are illustrated, for example, in  FIG. 25  or  FIGS. 37-40 . 
     Referring to  FIG. 37 , there is illustrated another embodiment of a drug delivery device  910  according to teachings of the disclosure. A portion of the housing  912  of the drug delivery device  910  is broken away in order to illustrate the relative positions of the components contained therein. The fill-finish cartridge  916  includes a drug container  918  to which a fluid pathway assembly  920  is coupled. The fluid pathway assembly  920  includes a fluid pathway connector  922 , fluidly coupled to a needle insertion mechanism  924  by a fluid conduit  926 . It will be appreciated that, in this embodiment, while they remain fluidly coupled, the needle insertion mechanism  924  is decoupled from the fluid pathway connector  922  of the fill-finish cartridge  916  when assembled into the housing  912 . As shown in  FIGS. 38 and 39 , during the fill-finish process, the components are aligned to allow the fill-finish cartridge  916  to be readily placed in a tray, such as are illustrated in  FIGS. 31 and 32 . It is noted, however, that the components are not in axial alignment in the fill-finish cartridge  916  during the fill-finish process inasmuch as the axis of the needle insertion mechanism  924  extends perpendicular to the axis of the drug container  918  and fluid path connection  922 . As may be best seen in  FIG. 38 , the needle insertion mechanism  924  may include a sealing membrane  967  that, at least in one embodiment, is removable prior to use of the fill-finish cartridge  916  within the drug delivery device to allow passage of a needle from the needle insertion mechanism  924 . Alternatively, the sealing membrane  967  may remain attached to the bottom of the needle insertion mechanism  924  such that the needle pierces the sealing membrane  967  during operation of the fill-finish cartridge  916  within the drug delivery device  910  incorporating the same. 
     Referring to  FIG. 38 , there is illustrated the fill-finish cartridge  916  along with a carrier  942  that partially surrounds the assembled fill-finish cartridge  916  during the fill-finish process. As may be seen in  FIG. 38 , the carrier  942  substantially surrounds a distal portion of the drug container  918 , the fluid pathway connector  922 , and the needle insertion mechanism  924 . The carrier  942  of this embodiment includes three separate sections, although a greater or lesser number may be provided. In this embodiment, a portion of the carrier  942  is disposable prior to placement of the fill-finish cartridge  916  into the housing  912  of the drug delivery device  910 , while a portion remains on the fill-finish cartridge  916  when disposed in the housing  912 , and may be utilized in operation of the device  910 . 
     As may be seen in  FIGS. 14 and 15 , the carrier  942  includes a first barrel section  941   a  and a second barrel section  941   b . The first and second barrel sections  941   a ,  941   b  may be selectively coupled together by any appropriate mechanism. In the illustrated embodiment, a coupling arrangement similar to that illustrated in  FIGS. 33-35  is utilized such that the first and second sections  941   a ,  941   b  may be decoupled and removed prior to placement into the housing  912  of the drug delivery device  910 . The carrier  942  further includes a collar  940  that, when assembled to the fill-finish cartridge  916 , completes the barrel. 
     The fluid pathway connector  922  and the needle insertion mechanism  924  may be of any appropriate design. The illustrated fluid pathway connector  922 , for example, is as explained with regard to  FIGS. 33-36 , and the needle insertion mechanism  924  may likewise be as described with regard to  FIGS. 33-36 . Referring to  FIG. 39 , in short, a permeable seal  950  is disposed between the drug container  918  and a sterile boot  953  of the fluid pathway connector  922 . A cannula  958  extending from a hub  954  is axially disposed within the sterile boot  953 . Continued relative axial, proximal movement of the cannula  958  toward the permeable seal  950  results in a piercing of the permeable seal  950 , and completion of the fluid pathway to the needle insertion mechanism  924 . 
     In assembly of the filled fill-finish cartridge  916  into the drug delivery device housing  912 , the collar  940  remains coupled to the fluid pathway connector  922 , as illustrated in  FIG. 37 . In some embodiments of the disclosure, the carrier, or a portion of the same such as the collar  940  here, may be utilized in the operation or actuation of the fill-finish cartridge  916 . In this embodiment, an activation mechanism  914 , such as a button, may be provided along an outer surface of the drug delivery device housing  912  in order to permit the patient to selectively provide medication. In this embodiment, the activation mechanism  914  asserts an axial, proximally directed force on the collar  940 . The collar  940  further asserts an axial, proximally directed force on the hub  954 , causing the cannula  958  to pierce the permeable seal  950  of the fluid pathway connector  922  to complete the fluid pathway from the drug container  918  to the needle insertion mechanism  924 . The needle insertion mechanism  924  may be actuated by any appropriate operation. For example, the movement of a portion of the collar  940  may cause the dislodgement of the lockout pin, causing actuation of the needle insertion mechanism  924 , as explained in greater detail with regard to the embodiment illustrated in  FIGS. 33-36 . 
     Turning now to the embodiment of  FIGS. 40-46 , the fill-finish cartridge  1116  includes a drug container  1118  having proximal and distal ends  1127 ,  1128 . The proximal end  1127  may include a flange  1119  and is adapted to receive a plug or plunger seal  1164 , while the distal end  1128  may include a flange  1117  and is adapted to receive a permeable seal  1150  in conjunction with a fluid pathway assembly  1120 . The fluid pathway assembly  1120  includes a fluid pathway connector  1122  and a needle insertion mechanism  824  fluidly coupled by a fluid conduit  1126 . 
     In this embodiment, the fluid pathway connector  1122  is integrated with the permeable seal of the drug container  1118 . The fluid pathway connector  1122  may best be seen in the cross-sectional view of  FIG. 41  and the exploded view of  FIG. 43 . The fluid pathway connector  1122  includes a hub assembly  1156  having a hub  1154  and a cap  1155 . A cannula  1158  is secured to the hub  1154  to provide a fluid path therethrough. The fluid conduit  1126  may be coupled to the cannula  1158  by any appropriate structure. In this embodiment, the fluid conduit  1126  is coupled to a nipple  1159  that is fluidly open to the cannula  1158 . 
     In order to maintain the hub assembly  1156  along with the associated cannula  1158  in position relative to the permeable seal  1150 , a seal mount  1130  is provided. While the seal mount  1130  may be coupled to the permeable seal  1150  by any appropriate structure, in the illustrated embodiment, the permeable seal  1150  and the seal mount  1130  include mating structure in the form of respective interlocking flanges  1131 ,  1132 . 
     While the hub assembly  1156  may be assembled with the seal mount  1130  and permeable seal  1150  for coupling to the drug container  1118 , the permeable seal  1150  and seal mount  1130  are slidably disposed relative to the hub assembly  1156 . In order to allow this sliding, yet coupled relationship, the hub  1154  includes one or more resilient posts  1154   a  that present surfaces that interlock with a complimentarily disposed bore  1160  in the seal mount  1130 . As shown in  FIG. 41 , the when assembled together, the cannula  1158  is disposed subjacent the membrane  1162  of the permeable seal  1150 . In this way, the permeable seal  1150 , the seal mount  1130  and the coupled hub assembly  1156  form an integrated fluid pathway connector  1122  that may be assembled into the distal end  1128  of the container  1118 . 
     In order to further facilitate assembly of the fluid pathway connector  1122  to the container  1118 , a cap  1151  may be provided. One or more gaskets  1133  may be provided between adjacent surfaces of the fluid pathway connector  1122  and, for example, the flange  1117  of the drug container  1118 . One such gasket  1133  is illustrated in  FIG. 41 , although additional gaskets may be provided. 
     The needle insertion mechanism  1124  may be of any appropriate design, such as, for example, the needle insertion mechanism  1124  illustrated in  FIG. 35 . The cannula  1158  of the fluid pathway connector  1122  is fluidly connected to the needle  425  of the needle insertion mechanism  1124  by way of the fluid conduit  1126 . 
     In this embodiment the fluid pathway connector  1122  and the needle insertion mechanism  1124  are coupled, for example by mechanical coupling, by way of complimentary threads  1134 ,  1135 . In the illustrated embodiment, fluid pathway connector  1122 , here, the hub  1154 , includes external threads  1134 , while the needle insertion mechanism  1124 , here, a bore  436  of an extension  1137  of the insertion mechanism housing  1165 , includes complimentary internal threads  1135 . It will be appreciated that alternate arrangements are envisioned. For example, the threading arrangement could be reversed, the fluid pathway connector  1122  including internal threads and the needle insertion mechanism  1124  including external threads. Alternately, a threaded collar, or the like, could be provided to couple the components together. 
     Moreover, although the fluid pathway connector  1122  and the needle insertion mechanism  1124  are coupled in axial alignment in the fill-finish cartridge  1116  for the fill process, the components could be alternately disposed. For example, the axis of the needle insertion mechanism  1124  could be disposed at a right angle to the axis of the fluid pathway connector  1122  and the drug container  1118 . 
     According to another aspect of the disclosure, the fill-finish cartridge  1116  provides controlled management of the fluid conduit  1126 . In this embodiment, the threaded coupling of the needle insertion mechanism  1124  and the fluid pathway connector  1122  may provide controlled placement of the fluid conduit  1126 . The uncoupled needle insertion mechanism  1124  and fluid pathway connector  1122  are illustrated in  FIG. 44 . As the needle insertion mechanism  1124  and the fluid pathway connector  1122  are threaded together to the positions illustrated in  FIGS. 40 and 41 , the fluid conduit  1126  winds about the housing  1165  of the needle insertion mechanism  1124 . While the needle insertion mechanism  1124  and the fluid pathway connector  1122  are illustrated in a disassembled configuration with the fluid pathway connector  1122  being assembled to the container  1118  in  FIG. 44 , it will be appreciated that the components may be assembled in any order. For example, the needle insertion mechanism  1124  and the fluid pathway connector  1122  may be assembled together prior to coupling the fluid pathway connector  1122  to the container  1118  to form the fill-finish cartridge  1116 . 
     Turning to the embodiment illustrated in  FIGS. 45-47 , the fill-finish cartridge  1216  illustrated is similar in operation to the fill-finish cartridge  1116  of  FIGS. 40-44 . The fill-finish cartridge  1216  of  FIGS. 45-47  differs, however, in that the fluid pathway connector  1222  is coupled to the needle insertion mechanism  1224  by way of a snap connection  1238 , the needle insertion mechanism  1224  and the fluid pathway connector  1222  including complementary structure that allow the components to snap together. For example, the housing  1265  of the needle insertion mechanism  1224  may include an extension  1237  having a recess or bore  1236 , or female portion, adapted to receive a corresponding male portion  1234  of the fluid pathway connector  1222 . In order to ensure axial alignment of the extension  1237  and male portion  1234 , each may present one or more confronting shoulders. For example, the recess  1236  of the may include shoulders  1282 ,  1284  against which one or more outwardly extending shoulders  1283 ,  1285  of the fluid pathway connector  1222  seat. To facilitate connection, the hub  1254  of the fluid pathway connector  1222  may include one or more resilient fingers  586  extending from the hub  1254 . During assembly, the fingers  586  may flex such that the shoulders  1283  may move generally radially inward as the fingers  586  are moved through the recess or bore  1236 , and snap outward into engagement with shoulders  1282  when the fluid pathway connector  1222  and the needle insertion mechanism  1224  are in their final assembled axial positions. It will be appreciated, however, that the snap connection  1238  may have alternate structure as, for example if the fluid pathway connector  1222  included a shouldered recess and the needle insertion mechanism  1224  included mating outwardly extending shoulders. 
     As with the embodiment of  FIGS. 40-44 , the embodiment of  FIGS. 45-47  allows for controlled management of fluid conduit  1226  fluidly connecting the fluid pathway connector  1222  and the needle insertion mechanism  1224 . For example, the conduit may be wound around the periphery of the housing  1265  of needle insertion mechanism  1224 , as illustrated in  FIG. 47 , before, after, or during the engagement of the snap connection  1238 . 
     While a threaded connection has been described with regard to  FIGS. 40-44 , and a snap connection with regard to  FIGS. 45-47 , it will be appreciated that alternate mechanical connections may be utilized to provide sufficient structural integrity to the cartridge to facilitate filling the container in a conventional fill-finish process. For example, a tongue and groove type connection may be utilized. Alternately, or additionally, an external support, such as the bracket  880  of  FIGS. 33-36  may be utilized, or the relative positions may be maintained by way of a carrier, such as the carrier  742  of  FIGS. 27-30 . Other mechanical coupling arrangements are likewise within the purview of the disclosure. 
     It will thus be appreciated that the inventive arrangement described herein provide varied designs of components that may be assembled in various configurations to provide various designs of fill-finish cartridges that may be sterilized and filled in conventional fill finish processes. 
     As a further benefit, because the embodiments of the present disclosure enable the manufacture of pre-filled infusion or injection pumps, these pumps may be configured to be single-use or reusable pumps. For example, the fluid pathway assemblies and/or fill-finish cartridge of the present disclosure may be configured to be cartridges which can be replaced within reusable pump devices. 
     Some embodiments of the present disclosure enable the drug container to be filled in a standard fill-finish process, without the need to expose the drug treatment to the sterilization environment or conditions. Some drug treatments, however, are capable of withstanding the sterilization conditions without degrading, losing efficacy, or the like. Accordingly, in at least one embodiment of the present disclosure, sterilization of the fluid pathway assembly and/or the fill-finish cartridge may occur after the components have been assembled and the drug container has been filled with a pharmaceutical treatment. This method of manufacturing, filling, and using the novel embodiments of the present disclosure still may provide the benefit of being adaptable to a standard fill-finish process. Additionally, this method enables drug delivery device manufacturers and fillers the benefit of only needing to sterilize the components of the fluid pathway (i.e., components which may come in contact with the drug fluid). The fill-finish cartridges, fluid pathway assemblies, and individual components of the present disclosure may be sterilized prior to their integration in a drug delivery device. As such, the other components of the drug delivery device which generally never contact the drug fluid do not need to be sterilized because of the advantages offered by the present disclosure. Accordingly, the embodiments of the present disclosure enable more complex geometries and more standard materials, for example, to be employed for the manufacture of advanced drug delivery devices. 
     The novel configurations of the fluid pathway assemblies and the fill-finish cartridges of the present disclosure may provide substantial benefits in the marketplace. Embodiments of the present disclosure can readily be manufactured in a sterile environment, integrated into standard drug filling (e.g., fill-finish) process lines for aseptic filling of pharmaceutical treatments, and utilized for cost-effective assembly into drug delivery devices. Each of these advantages has substantial benefits over existing methodologies. 
     For example, because the fluid pathway assemblies themselves can be sterilized and maintained in a sterile condition during the filling and device assembly processes, the resulting drug delivery device does not need to be sterilized after assembly (i.e., terminally sterilized). This avoids a number of known challenges faced by existing methodologies for the manufacture of drug delivery devices. 
     Conventional drug delivery devices often require filling at time-of-use because the terminal sterilization of the device cannot be completed with the pharmaceutical drug within the drug container. Various pharmaceutical drugs cannot withstand the temperatures, pressures, and other conditions necessary for sterilization of the device after assembly. In other words, because existing manufacturing processes require sterilization of the entire device, the drug cannot be “pre-filled” into the device prior to sterilization. This adds a complex step after final assembly of the device, which often requires costly additional equipment, handling of separate drug containers, and/or training of the patient to perform the filling step themselves prior to injection. Instead, the embodiments of the present disclosure enable the manufacture, assembly, and use of pre-filled drug delivery devices which maintain the sterility of the fluid pathway assembly through the various manufacturing steps. 
     Additionally, because the drug delivery devices which incorporate the novel embodiments of the present disclosure do not need to be terminally sterilized, the components of the devices may comprise of other, often less expensive, materials which would not normally withstand the sterilization environment. For example, less expensive plastics may be utilized for certain device components because they do not need to be sterilized after assembly. 
     In other words, the embodiments of the present disclosure may allow the manufacturer to sterilize only the components which will be in contact with the drug fluid and/or which are necessary to maintain sterile fluid pathways. These embodiments may also allow the pharmaceutical filler to maintain the sterility of these components during the filling and finishing steps associated with the assembly of the drug delivery devices. Similarly, drug delivery devices which incorporate the fluid pathway assemblies of the present disclosure may have smaller or more efficient geometries as the device does not have to be configured for sterilization after assembly. 
     Additionally, the embodiments of the present disclosure allow for the utilization of standard fill-finish processes to fill the drug container. This greatly simplifies the manufacturing processes used to build drug delivery devices. Standard fill-finish processes utilize trays which hold multiple drug containers, such as syringes. The embodiments of the present disclosure enable a drug delivery device manufacturer, pharmaceutical company, or contract drug filler to fill the drug containers for infusion or injection pumps using the same standard fill-finish processes. These drug containers can be filled aseptically, as is common industry practice, in a cost-efficient manner that preserves the sterility of the fluid pathway assembly. After mounting of the fluid pathway connector mechanism, the combined assembly can then be mated into a drug delivery device without requiring the remainder of the device components to be sterilized. Accordingly, embodiments of the present disclosure may provide novel components which enable the fluid pathway assemblies to be sterilized, assembled, filling, and incorporated into drug delivery devices in a cost-efficient and streamlined process. 
     Additionally, the fluid pathway assemblies of the present disclosure utilize materials that are substantially non-reactive with therapeutic fluids or drugs, and are suitable for use in pharmaceutical grade applications. The novel fluid pathway assemblies and fill-finish cartridges are configured to minimize or eliminate the possibility of contact or interaction between degradable materials, such as certain plastics, with the therapeutic fluids or drugs. The fluid pathway assemblies, with adaptable needle injection and retraction mechanisms, also may provide fluid conduits from the drug container to the patient, through the needle or cannula, which are substantially absent of degradable materials. Such configurations, when integrated into the fill-finish cartridges or drug delivery devices, may provide increased stability and shelf-life parameters to the drug and drug delivery devices. These characteristics are thought to be highly desirable for generally all pharmaceutical treatments, but perhaps especially of value in drug delivery devices for use with biologics and other complex therapies. 
     One or more embodiments of the present disclosure may further include certain standard components. For example, the fill-finish cartridge configurations and drug delivery devices of the present disclosure may include one or more membranes. In at least one embodiment, one or more permeable membranes are employed to seal the drug container and/or to ensure a sterile environment and container integrity within the drug chamber. Similarly, the drug container may include a flange. The flange may be pre-formed along any portion of the container, or may be a separate component that is connected to or affixed to the container. In at least one embodiment, the flange is a removable connected component that is connected at the proximal end of the drug container. The flange may be configured to allow the fill-finish cartridge and drug container to rest within a fill-finish tray, for filling with a pharmaceutical compound within a standard fill-finish process. The position, shape, number, and materials for such components may vary, as would be readily appreciated by a skilled artisan, to meet any number of desired characteristics. 
     Similarly, while the components of the fill-finish cartridge and the fluid pathway assembly are described herein as separate components, it is within the contemplation of the present disclosure that certain groups of these components may be combined to form a single component capable of performing the functions of the individual components. In at least one embodiment the needle insertion and needle retraction mechanisms may be one unified component that may provide a dual function. Additionally, as would be appreciated by one having ordinary skill in the art, the components of the devices may be manufactured as individual components or as single components. For example, the flange may be a component that is pre-formed, during the manufacturing process, as a part of the drug container itself. Accordingly, in at least one embodiment, the flange may be a glass flange extension of the container. Furthermore, while the components of the fill-finish cartridge and fluid pathway assembly are described herein as separate components, they may be unified components having multiple functions. The configuration of the components and their assembly may vary based on the assembly process, the device parameters, and other desired characteristics. 
     Embodiments of the present disclosure may provide fluid pathway assemblies, fill-finish cartridges, methods of manufacturing such cartridges, and their methods of use. The fill-finish cartridges and fluid pathway assemblies may be utilized in a number of different configurations and may themselves comprise of one or more components. Such modifications are contemplated by and encompassed in the embodiments of the present disclosure. Other components may similarly be single components, unified components, or multi-purpose components, as described in the embodiments discussed above. Thus, it is intended that the present disclosure covers the modifications and variations of this disclosure, provided they come within the scope of the appended claims and their equivalents. 
     VII. Activation Mechanism 
     Described below in connection with  FIGS. 74 and 75  is an activation mechanism  9000  enabling a user (e.g., a self-administering patient) to activate one or more mechanisms or subsystems of a drug delivery device disclosed herein (e.g., the drug delivery device  10 ,  910 ,  2010 ,  6000 , or  8000 ). The activation mechanism  9000  may be configured to activate, simultaneously or sequentially, one or more of: a drive mechanism (e.g., the drive mechanism  100 ,  500 ,  1000 , or  2100 ); a needle insertion mechanism (e.g., the needle insertion mechanism  200 ,  624 , or  724 ); a fluid pathway connector (e.g., the fluid pathway connector  300 ,  622 ,  722 ,  822 ,  922 , or  2300 ); and/or a power and control system (e.g., the power and control system  400  or  2400 ). 
       FIGS. 74 and 75  illustrate that the activation mechanism  9000  may include a button  9010 , which may correspond to the start button  14  or  2014 , and a trigger assembly  9020 . The button  9010  may protrude from the housing  12 , such as through an opening between the upper housing  12 A and the lower housing  12 B, and may be manually displaceable by a user, such that the button  9010  can be depressed into the housing  12  by the user. In at least one embodiment, the button  9010  may be configured to slide back-and-forth in a linear direction that is orthogonal to an exterior surface of the housing  12  from which the button  9010  protrudes. 
     In general, the trigger assembly  9020  may be configured to transfer, convert, and/or transmit motion of the button  9010  into motion that activates one or more of a drive mechanism, a needle insertion mechanism, a fluid pathway connector, and/or a power and control system. In at least one embodiment, in response to displacement of the button  9010  by the user, the trigger assembly  9020  may be configured to simultaneously or sequentially: (1) activate a needle insertion mechanism (e.g., the needle insertion mechanism  200 ,  624 , or  724 ) so that the needle insertion mechanism inserts a needle (e.g., the needle  214 ) and/or a cannula (e.g., cannula  234 ) into a patient; (2) activate a fluid pathway connector (e.g., the fluid pathway connector  300 ,  622 ,  722 ,  822 ,  922 , or  2300 ) to establish fluid communication between a drug container (e.g., the container  50 ,  618 ,  718 ,  818 ,  918 ,  1118 , or  2050 ) and the insertion mechanism; (3) activate a drive mechanism (e.g., the drive mechanism  100 ,  500 ,  1000 , or  2100 ) to force a drug (e.g., a PCSK9 specific antibody, a G-CSFs, a sclerostin antibody, a CGRP antibody, etc.) stored in the drug container through the fluid pathway connector and the insertion mechanism and ultimately into the patient. In at least one embodiment, displacement of the button  9010  by the user may also activate a power and control system (e.g., the power and control system  400  or  2400 ), either simultaneously or sequentially with the activation of the needle insertion mechanism, the fluid pathway connector, and/or the drive mechanism. Accordingly, the trigger assembly  9020  may permit a user to activate multiple mechanisms and/or subsystems with a single push of the button  9010 , thereby simplifying operation of the drug delivery device for the user. 
     As shown in the exploded assembly view of  FIG. 75 , the trigger assembly  9020  may include a plurality of interconnected and/or cooperating components including a trigger arm  9030 , a first control arm  9032 , a second control arm  9034 , a button spring  9036 , a main slide spring  9038 , and a latch  9040 . The trigger arm  9030  may be connected directly to the button  9010  such that the trigger arm  9030  and the button  9010  move together as a single unit. The button spring  9036  may be disposed between the trigger arm  9030  and the first control arm  9032 ; and the main slide spring  9038  may be disposed between the first control arm  9032  and the housing  12 . In at least one embodiment, the button spring  9036  and the main slide spring  9038  may be arranged in series and parallel to each other, with the first control arm  9032  arranged therebetween. The main slide spring  9038  may have a stiffness that is greater than the button spring  9036 . Accordingly, initial displacement of the button  9010  by the user may cause the button spring  9036  to compress between the trigger arm  9030  and the first control arm  9032 ; however, due to its greater stiffness, the main slide spring  9038  may not compress between the first control arm  9032  and the housing  12  during the initial displacement of the button  9010 . Further displacement of the button  9010  by the user may cause the individual coils of the button spring  9036  to contact each other, thus rendering additional compression of the button spring  9036  extremely difficult or impossible. Thus, further displacement of the button  9010  may cause the main slide spring  9038  to compress between the first control arm  9032  and the housing  12 . Accordingly, the first control arm  9032  may move in response to displacement of the button  9010  only after the button spring  9036  has been sufficiently compressed. The interaction between the button spring  9036  and the main slide spring  9038 , and the resulting movement of the first control arm  9032 , may be referred to as a “point-of-no-return” feature of the button  9010 . 
     The delay provided by the point-of-no-return feature of the button  9010  gives the user time to affirm his or her intent to activate the drug delivery device. Furthermore, the point-of-no-return feature of the button  9010  reduces the risk of accidental activation, and provides the user with tactile feedback that informs the user that he or she is approaching activation as the button spring  9036  becomes increasingly compressed. 
     The first control arm  9032  may be slidably connected to the housing  12  such that linear displacement of the button  9010  causes linear displacement of the first control arm  9032 . The second control arm  9034  may be rotatably connected to the first control arm  9032  and rotatably connected to the housing  12  such that linear displacement of the first control arm  9032  causes rotation of the second control arm  9032  relative to the first control arm  9032  and the housing  12 . 
     The first control arm  9032  may be configured to interact with and activate both the fluid pathway connector and the needle insertion mechanism. The first control arm  9032  may include a main body  9042  extending along a longitudinal axis A, and a first protrusion  9044  and a second protrusion  9046  extending from opposite sides of the main body  9042  away from the longitudinal axis A. During operation, the first control arm  9032  may slide in a direction that is parallel to the longitudinal axis A. In at least one embodiment, the first protrusion  9044  and the second protrusion  9046  each may extend orthogonally to the longitudinal axis A. By arranging the first and second protrusions  9044  and  9046  on opposite sides of the main body  9042 , the first and second protrusions  9044  and  9046  can be used to activate mechanisms located on opposite sides of the drug delivery device. Accordingly, the first and second protrusions  9044  and  9046  may facilitate an arrangement that reduces the overall size of the drug delivery device. 
     The first protrusion  9044  of the first control arm  9032  may be configured to contact and move a portion of a fluid pathway connector such that fluid communication is established between a drug container and an insertion mechanism. For example, the first protrusion  9044  may be configured to contact and move the connection hub  310  of the fluid pathway connector  300  toward the drug container  50  in response to displacement of the button  9010 . Consequently, the piercing member  330  mounted on the connection hub  310  may pierce the pierceable seal  56  and access the interior of the drug container  50 , thereby establishing fluid communication between the drug container  50  and the needle insertion mechanism  200  via the fluid pathway connector  300 . An example of linear movement imparted to the connection hub  310  by the first protrusion  9044  is illustrated by  FIGS. 4A and 4B . 
     The second protrusion  9046  of the first control arm  9032  may be configured to contact and move a portion of a needle insertion mechanism such that the needle insertion mechanism inserts a needle and/or a cannula into the patient. For example, the second protrusion  9046  may be configured to contact and move lockout pin(s)  208  (i.e., the second retainer) so that they no longer occupy the retaining position illustrated in  FIG. 11A . As a result, the insertion biasing member  210  may be allowed to de-energize and insert the needle  214  and the cannula  234  into the patient, as depicted in  FIG. 11B . 
     The second control arm  9034  may be configured to contact and move a portion of a drive mechanism such that the drive mechanism discharges a drug from the container. For example, rotation of the second control arm  9034  caused by linear displacement of the first control arm  9032  may result in the second control arm  9034  to displace the clip  2115  (i.e., the first retainer) from its retaining position illustrated in  FIG. 23A . Consequently, the piston biasing members  2106 ,  2122  may be allowed to de-energize and move the plunger seal  2060  to discharge drug from the distal end of the drug container  2050  and ultimately to the patient. In the embodiment illustrated in  FIG. 74 , linear movement of the first control arm  9032  away from the side of the housing  12  having the button  9010  may cause clockwise rotation of the second control arm  9034 . A radial protrusion  9048  extending from a center portion  9050  of the control arm  9034  may be connected to the clip  2115  (not illustrated) such that the clockwise rotation of the radial protrusion  9048  moves the clip  2115  from its retaining position to its releasing position. 
     Still referring to  FIGS. 74 and 75 , the activation mechanism  9000  may incorporate one or more safety features to prevent premature and/or inadvertent activation of the drug delivery device. In at least one embodiment, the activation mechanism  9000  may include a body contact sensor  9052  to detect contact between the lower housing  12 B and the patient&#39;s skin. In at least one embodiment, the body contact sensor  9052  may correspond to the on-body sensor  24  illustrated in  FIG. 1C . The body contact sensor  9052  may include an interlock  9054  rotationally connected to the lower housing  12 B and interlock spring  9056  configured to bias a portion of the interlock  9054  through an opening  9058  in the lower housing  12 B. Contact between the lower housing  12 B and the patient&#39;s skin may cause the interlock  9054  to retract into the housing  12  against the biasing force of the interlock spring  9056 . When the interlock  9054  protrudes from the housing  12 B through the opening  9058 , the interlock  9054  may occupy a lock position in which the interlock  9054  obstructs linear displacement of the trigger arm  9030 , as illustrated in  FIG. 74 . Accordingly, a user may be unable to depress the button  9010  when the interlock  9054  occupies its lock position. When the interlock  9054  retracts into the housing  12  due to contact with the patient&#39;s skin, the interlock  9054  may move to an unlock position in which the interlock  9054  does not obstruct movement of the trigger arm  9030 . Accordingly, when the interlock  9054  occupies its unlock position, the user may be able to depress the button  9010  and activate, via the trigger assembly  9020 , one or more of the drive mechanism, the needle insertion mechanism, the fluid pathway connector, and/or the power and control system. 
     While the body contact sensor  9052  functions primarily as a mechanical lockout mechanism, alternative embodiments may incorporate a body contact sensor that is electrically based such as, for example, a capacitive- or impedance-based sensor which must detect tissue before permitting activation of a power and control system. In at least one embodiment, such an electrically based on-body sensor may incorporate a resistor with an impedance of approximately (e.g., ±10%) 1 MΩ. 
     VIII. Additional Embodiments of Fluid Pathway Connector 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-47, 74, 75, and 77-91B , may be configured to incorporate the embodiments of the fluid pathway connector described below in connection with  FIGS. 48-56 and 76A-76C . 
     In the processes of filling drug containers and other drug delivery devices, it is sometimes necessary to connect two or more sterile components or subassemblies. For example, wearable injectors or drug pumps may include a drug container which may be filled with a fluid drug using standard pharmaceutical fill-finish processes. After filling of the drug container, it may be necessary to connect the drug container to one or more additional components or subassemblies such that a fluid communication may be established between the drug container and these components. Maintaining the fluid path in an aseptic condition is critical, preventing the introduction of harmful microbes to the drug and/or fluid pathway. The connection of two or more aseptic components or subassemblies is typically performed in an aseptic environment, such as a clean room, thereby ensuring that no harmful microbes are introduced to the assembly. This, however, may lead to increased cost to manufacture the drug delivery devices 
     Embodiments of the present disclosure allow aseptic connections to be made between two or components or subassemblies in a septic environment. As seen in  FIGS. 48A-48C , the connection hub  310  of the fluid pathway connector may be connected to the drug container  350 .  FIG. 48A  shows these components prior to connection. A first film  318  is in place on connection hub  312 . First film  318  covers aperture  312 B of connection hub  312  and prevents microbes from entering cavity  312 A through aperture  312 B, thereby maintaining cavity  312 B and piercing member  316  in an aseptic condition. Piercing member  316  is partially disposed in cavity  312 A and at least partially disposed in retainer  314 . The piercing member may be a hollow needle. Retainer  314  is engaged with connection hub  312  and may be configured for translation with respect to the connection hub in a direction parallel to the long axis of piercing member  316 . The retainer may include one or more locking arms  314 A which may engage one or more first recesses  312 C in connection hub  312 . The locking arms may include protrusions at their lower end, which in the locked position are at least partially disposed in the upper recesses. The engagement of the flex arms maintains the spatial relationship of the retainer and the connection hub. 
     The drug container  350  may include a crimp cap  324  that maintains a connection between a pierceable seal  326  and a barrel (not shown). The pierceable seal maintains the fluid drug within the barrel and prevents microbes and other substances from entering the drug chamber. A recess  328  is formed by the geometry of the pierceable seal. A second film  322  is affixed to the drug container such that it encloses recess  328 , thereby maintaining recess  328  in an aseptic condition. The first and second films may be constructed of any material capable of providing the barrier properties required to maintain the aseptic condition of the associated surfaces. In a preferred embodiment, the films are constructed from a foil material. Alternatively, the films may be any type of sterilizable membrane, film, or foil. Additionally, the film may be removable and/or pierceable as well as breathable and/or permeable. 
     An adhesive may be applied to the exterior surfaces of both first film  318  and second film  322  prior to joining the fluid pathway connector and the drug container  312 . The adhesive may contain antimicrobial, antibacterial, and antiviral compounds to limit or reduce the number of such substances on the surface of the seals. During connection, flex arms  312 E may engage crimp cap  324  or another portion of the drug container  312 , thereby limiting axial translation of the fluid pathway connector with respect to the drug container  312 . In this position, first film  318  and second film  322  are in contact with, or in close proximity to, one another. If an adhesive is present on the faces of one or more of the films the films may be bonded together. 
     After the fluid pathway connector and drug container  312  are joined, the retainer  314  may be translated axially with respect to the connection hub. Translation of the retainer causes locking arms  314 A to flex and become disengaged from first recess  312 C. Translation of the retainer causes needle  316  to also translate. This translation causes the needle to pierce first film  318  and second film  322 . After translation of the retainer, the piercing member is at least partially disposed in recess  328  of pierceable seal  326 . The retainer may be further translated, leading to the piercing of pierceable seal  326  by piercing member  316 . After piercing of the pierceable seal a fluid path is established from the drug container and through the needle. The needle may also be in fluid communication with a conduit, the conduit being configured to carry the fluid contents to a delivery mechanism such as an insertion mechanism for delivery to a patient. Piercing of the first and second films may occur at the time of assembly. Alternatively, the piercing of the films may occur at or near the time-of-use of the drug delivery device. Piercing of the pierceable seal at or near the time-of-use may be initiated, by the patient, by interaction with an activation mechanism. 
     In some embodiments, the end of the piercing member may remain disposed within cavity  328  until time-of-use. The pierceable seal may be configured such that, in response to hydraulic and/or pneumatic pressure within the drug chamber, it deforms and is caused to come into contact with the piercing member. This deformation of the pierceable seal leads to the piercing of the seal by the piercing member. 
       FIGS. 49A-49D  show an embodiment in which a connection hub  1312  of a fluid pathway connector is connected to a drug container such that the long axis of the piercing member  1316  is orthogonal to the long axis of the drug barrel  1330  of the drug container. As seen in  FIG. 49B , flex arms  1312 E engage a portion of cap  1324  to securely attach the fluid pathway connector to the drug container. The fluid pathway connector may further include insert  1332  disposed within connection hub  1312 . Extension  1314 D of retainer  1314  may be sealingly engaged with insert  1332  and be configured for axial translation with respect to the insert. Protrusions  1314 B of retainer  1314  are initially disposed in first recesses  1312 C of connection hub  1312 . In this position, the piercing end of piercing member  1316  is disposed within insert  1332 .  FIG. 49C  shows a cross-sectional view of the drug container and fluid pathway connector after assembly and before connection of the fluid path. As seen in the cross-section, cap  1324  may contain side port  1324 A which allows the piercing member to access the pierceable seal. Also shown in  FIG. 49C  is conduit port  1314 C which may be configured to allow a conduit to be connected to the retainer. This conduit may provide a fluid path that connects the drug container to a delivery mechanism for delivery of the fluid drug to the patient.  FIG. 49D  is a cross-section showing the assembly in an open fluid path configuration. As shown, retainer  1314  has been displaced toward the center axis of the drug container. Protrusions  1314 B of flex arms  1314  have disengaged from first recesses  1312 C and have engaged second recesses  1312 D. Piercing member  1316  has pierced first film  1318 , second film  1322 , and pierceable seal  1326 . The piercing of each of these may occur at time of use upon patient initiation. Alternatively, the first and second film may be pierced at time of assembly. This creates a fluid path from the drug container, through the piercing member, conduit, and insertion mechanism for delivery to the patient. The connection of the fluid pathway connector such that the long axis of the piercing member is orthogonal to the long axis of the drug container may allow for more compact packaging in a drug delivery device. 
     In other embodiments, shown in  FIGS. 50A-50D , the piercing member includes an inner piercing member  2316 A and an outer piercing member  2316 B. The inner piercing member  2316 A is disposed within the hollow outer piercing member  2316 B. After connection of the connection hub  2312  to the drug container  2330 , the outer piercing member  2316 B pierces the first film  2318  covering terminal end of the connection hub  2312  and the second film  2318  covering the terminal end of the drug container  2330 , while maintaining the inner piercing member  2316 A within its hollow inner cavity. The piercing may be caused by joint motion of the piercing members  2316 A and  2316 B toward the drug container or, alternatively, may be caused by the drug container displacing the connection hub, thereby exposing the outer piercing member  2316 B. Because the inner piercing member  2316 A does not contact the first and second films  2318  and  2322 , any contaminants present on the surface of the films  2318  and  2322  are not in contact with the inner piercing member  2316 A. After piercing the films  2318  and  2322  the outer piercing member is retracted, thereby exposing the inner piercing member  2316 A. In this position, shown in  FIG. 50C , the end of the inner piercing member  2316 A is disposed in the cavity  2328  created by the pierceable seal  2326 . In response to increased hydraulic and/or pneumatic pressure within the drug container the pierceable seal  2326  may deform, as shown in  FIG. 50D . The deformation of the pierceable seal  2326  causes the inner piercing member  2316 A to pierce the pierceable seal  2326 , thereby creating a fluid path from the drug container  2330  through the inner piercing member  2316 A for delivery to the patient. 
     As shown in the alternative embodiment of  FIGS. 51-52 , the fluid pathway connector may include an elastomeric component  3334 . At least a portion of the outer piercing member  2316 B may be embedded in the elastomeric component  3334 . The outer piercing member  2316 B may be embedded in the elastomeric component  334  while in an aseptic environment. The aseptic condition of the embedded portion of the outer piercing member  2316 B is maintained when the fluid path connection mechanism is transferred to a septic environment due to the sealing engagement of the outer piercing member  2316 B with the elastomeric component  3334 . Hence, after mounting the fluid pathway connector to the drug container, the fluid pathway connector may be transformed to the open configuration by initially piercing of the first and second films  2318  and  2322  with the outer piercing member  2316 B, and then piercing the pierceable seal  3324  with the inner piercing member  2316 A by moving the inner piercing member  2316 A relative to the outer piercing member  2316 B while keeping the outer piercing member  2316 B stationary. In this way, the inner piercing member  2316 A is not contaminated by touching the non-sterile exterior surfaces of the first and second foils  2318  and  2322 . In alternative embodiments, the outer piercing member  2316 B may be the sole piercing member and/or may pierce the pierceable seal  3324  in addition to the first and second films  2318  and  2322 . As seen in the further alternative embodiment of  FIGS. 52A-D , the first film  2318  and/or the second film  2322  may further include an adhesive containing antimicrobial agents as described above. Initially, the antimicrobial adhesive of the first film  2318  may be covered by a removable liner  2319  and the antimicrobial adhesive of the second film  2322  may be covered by a removable liner  2323 . Prior to assembling the first film  2318  in engagement with the second film  2322 , the removable liners  2319  and  2323  may be removed. This presence of the antimicrobial adhesive on the exterior surfaces of the first and second films  2318  and  2322  inhibits or prevents contamination of those surfaces if this step of the assembly is performed in a non-sterile environment. 
     In some embodiments, as shown in  FIGS. 53A-B , an additional film or seal  4336  may be present on the outer piercing member  4316 B which further isolates the inner cavity of the outer piercing member  4316 B and hence the inner piercing member  4316 A. This seal  4336  may remain intact as the outer piercing member pierces first film  4318  and second film  4322 . This may prevent any microbes that are present on the surfaces of the seals from coming in contact with the inner piercing member. After piercing the first and second films  4318  and  4322  the translation of the outer piercing member  4318 B may be restricted prior to the outer piercing member piercing the piercable seal  4326 . The inner piercing member  4316 A continues to translate toward the drug container  2330  and pierces the first and second films  4318  and  4322  and the pierceable seal  4326 , thereby opening the fluid path. Furthermore, in the embodiment shown in  FIGS. 53A-B , an antimicrobial adhesive  4325  may initially cover the exterior surface(s) of the first film  4318  and/or the second film  4322 . 
     In other embodiments, shown in  FIGS. 54A-C , the first and second films are removed from the fluid pathway connector and drug container just prior to mounting of the fluid pathway connector. Prior to removal of the films, their placement maintains the sterility of the pierceable seal of the drug container and the face of the elastomeric component of the fluid pathway connector. Except for the removal of the first and second films prior to connection of the fluid pathway connector and the drug container and the omission of the outer piercing member  2316 B, the embodiment shown in  FIGS. 54A-C  includes same or similar elements as the embodiment shown in  FIGS. 51A-C . Thus, same reference numerals are used to indicate same or similar elements in both sets of figures. It is noted that the outer piercing member  2316 B of the embodiment shown in  FIGS. 51A-C  can be implemented in an alternative version of the embodiment shown n  FIGS. 54A-C . Also, it is noted that the elastomeric component  3334  of the  FIGS. 54A-C  embodiment, unlike the elastomeric component  3334  of the  FIGS. 51A-C  embodiment, includes a recess or cavity  2327  configured to receive and form a tight fit (e.g., an airtight interference or press fit) with a distal end  2329  of the drug container  2330 . This tight fit may prevent the ingress of contaminants and thereby maintain sterility of the interface between the drug container and the fluid pathway connector. In some embodiments, the distal end  2329  of the drug container  2330  may be inserted into the recess  2327  and the elastomeric component  3334  under non-sterile or aseptic conditions so that contaminants are not trapped between distal end  2329  of the drug container  2330  and the elastomeric component  3334  as the result of assembly. 
     As shown in the alternative embodiment of  FIGS. 55A-D , the fluid pathway connector may also be mounted to the drug container  2330  using a glass tube  2335 . After mounting, the glass tube  2335  and the surfaces of the elastomeric piercing member retainer or component  3334  and pierceable seal  3324  may be sterilized using UV sterilization (see  FIG. 55C ). The glass tube may be in sealing engagement (e.g., an airtight seal) with both the drug container  2330  and the elastomeric component  3334  of the fluid pathway connector such that after sterilization microbes and other foreign elements are unable to enter the glass tube, thereby maintaining the aseptic condition of the interior of the glass tube  2335 . Except for the omission of the first and second foils  2318  and  2322  and the inclusion of the glass tube  2335 , the embodiment shown in  FIGS. 55A-D  may include the same or similar elements as the embodiment shown in  FIGS. 54A-C . Therefore, same reference numerals are used to indicate same or similar elements in both sets of figures. 
     The embodiment shown in  FIG. 56  shows a connection which is made orthogonal to the long axis of the drug container. In this embodiment, a first film  5318  is initially in place over and maintaining the sterility of a cavity  5312 A of the connection hub  5312 . During connection, the first film  5318  is pierced by an insert  5340  of the drug container. The pierced portion is retained within the concave portion  5342  of the insert after piercing. By retaining this pierced portion within the concave portion the non-aseptic surface of the first film is isolated and any substances present thereon are prevented from contaminating the drug fluid or fluid path. A second film  5322  is initially in place over an aperture  5340 A in the insert  5340 , maintaining the aseptic condition of the aperture. The second film  5322  may be a rigid or elastomeric component which is in tight conformity to the insert such that it prevents microbes and other contaminants from entering the aperture. Upon mounting of the connection hub to the drug container the second film may be displaced from its initial position, thereby allowing a fluid path to be established from the drug container through the fluid pathway connector. After mounting of the connection hub to the drug container the aperture  5340 A in the insert  5340  is aligned with an aperture  5312 B in the connection hub  5312 . A pierceable seal may be in place over one or more of the apertures which may be pierced by a piercing member to establish a fluid path. One or more snap arms may retain the insert in position in relation to the drug barrel. The snap arms may connect to the drug barrel itself or another component of the drug container. 
     While many of the above-described embodiments of the fluid pathway connector incorporate a piercing member which moves to access the drug container upon activation of the drug delivery device, alternative embodiments of the fluid pathway connector, such as the embodiment illustrated in  FIGS. 76A-76C , may include a piercing member that remains stationary throughout drug delivery. In such alternative embodiments, the drug container may move toward the stationary piercing member upon activation of the drug delivery device. The movement of the drug container may result in the stationary piercing member accessing the drug container through the pierceable seal located at the distal end of the drug container. 
       FIGS. 76A-76C  illustrate a subassembly of a drug delivery device (e.g., the drug delivery device  10 ,  910 ,  2010 ,  6000 , or  8000 ) including a drug container  10050  (which may be substituted for one or more the drug containers  50 ,  618 ,  718 ,  818 ,  918 ,  1118 ,  2050 , or  6050 ), a drive mechanism  10100  (which may be substituted for one or more of the drive mechanisms  100 ,  500 ,  1000 , or  2100 ) and a fluid pathway connector  10300 . The drug container  10050  may include a barrel  10058 , a plunger seal  10060  moveable through the barrel  10058 , and a pierceable seal  10056  covering an open distal end of the barrel  10058  and controlling access to the interior of the barrel  10058 . 
     The drive mechanism  10100  may include a drive housing  10130 , a piston  10110  moveable relative to the drive housing  10130  and configured to impart movement to the plunger seal  10060 , and a piston biasing member  10106  disposed between the drive housing  10130  and the piston  10110 . Prior to delivery, the piston biasing member  10106  may be retained in a piston biasing member energized state, as depicted in  FIG. 76A . When the piston biasing member  10106  is released and consequently de-energizes (as seen in  FIGS. 76B and 76C ), the piston biasing member  10106  may move the piston  10110  and/or the plunger seal  10060  toward the fluid pathway connector  10300 . 
     The fluid pathway connector  10300  may define a sterile fluid flowpath between the drug container  10050  and an insertion mechanism (e.g., the needle insertion mechanism  200 ,  624 , or  724 ). The fluid pathway connector  10300  may include a connection hub  10310 , a tubular conduit (not illustrated) providing fluid communication between the connection hub  10310  and the insertion mechanism, a piercing member  10330  (e.g., a container access needle) configured to pierce the pierceable seal  10056  to establish fluid communication between the between the barrel  10058  and the tubular conduit during drug delivery, a barrel connector  10332 , and a flexible sealing member  10334 . In some embodiments, the tubular conduit may be a single, unitary tube made of a flexible material and may extend directly between the connection hub  10310  and the insertion mechanism. In other embodiments, depending on the need to regulate or modify the fluid pressure, fluid flow rate, or other characteristic of the drug, the tubular conduit may include one or more flow restrictors made of a relatively rigid material and connected at opposite ends via flexible tubes to the connection hub  10310  and the insertion mechanism, respectively. 
     Still referring to  FIGS. 76A-76C , the flexible sealing member  10334  may define a sterile chamber  10062  with a collapsible volume between the distal end of the barrel  10058  and the connection hub  10310 . In at least one embodiment, the flexible sealing member  10334  may have a generally conical shape and function as a flexible bellows. A proximal end of the flexible sealing member  10334  may be clamped between the barrel connector  10332  and a distal end surface of the barrel  10058 . At its distal end, the flexible sealing member  10334  may be connected to the connection hub  10310 . 
     The barrel connector  10332  may have a tubular body portion  10335  configured to fit snugly around a circumferential surface of the barrel  10058 , and first and second radially inwardly depending annular protrusions  10336 ,  10338  at opposite ends of the tubular body portion  10335 . The first annular protrusion  10336  may grip a neck of the barrel  10058 , and the second annular protrusion  10338  may clamp the proximal end of the flexible sealing member  10334  against the distal end surface of the barrel  10332 . 
     The connection hub  10310  may be fixed relative to a housing (e.g., the housing  12 ) of the drug delivery device such that the connection hub  10310  is prevented from moving relative to the housing of the drug delivery device. A distal end of the piercing member  10330  may be rigidly connected to the connection hub  10310  so that the piercing member  10330  is also fixed relative to the housing of the drug delivery device. The barrel  10058  may be slidably connected to the housing of the drug delivery device such that the barrel  10058  can move (e.g., translate in a linear direction) relative to the housing of the drug delivery device. As the barrel  10058  moves toward the connection hub  10310 , the flexible sealing member  10334  may elastically or in-elastically deform such that the volume of the sterile chamber  10062  decreases, as illustrated in  FIGS. 76B and 76C . 
     In a pre-delivery state ( FIG. 76A ), a proximal end of the piercing member  10330  may be disposed within the sterile chamber  10062  defined by the flexible sealing member  10334 . Upon release of the piston biasing member  10106 , the piston biasing member  10106  may begin to de-energize and thereby cause the piston  10110  and the plunger seal  10060  to move toward the piercing member  10330 . Friction between the plunger seal  10060  and the inner wall of the barrel  10058  may cause the barrel  10058 , which is slidably connected to the housing, to initially move in a distal direction together with the plunger seal  10060 . The movement of the barrel  10058  causes the pierceable seal  10056  to be pierced by the piercing member  10330 . As a result, the piercing member  10330  may access the interior of the barrel  10058  and establish fluid communication between the barrel  10058  and the connection hub  10310 . 
       FIG. 76B  shows that the barrel  10058  continues to move in the distal direction until it contacts a stopping member, which in the present embodiment corresponds to the connection hub  10310 . The reaction force exerted on the barrel  10058  by the stopping member overcomes the frictional force between the plunger seal  10060  and the inner wall of the barrel  10058 , thereby allowing the plunger seal  10060  to move relative to the barrel  10058  and discharge the drug from the barrel  10058  via the piercing member  10330 .  FIG. 76C  shows that movement of the plunger seal  10060  is halted, thereby ending drug delivery, when the plunger seal  10060  impacts a portion of the inner wall of the barrel  10058  at the neck of the barrel  10058 . 
     The combination of the fluid pathway connector  10300  having a stationary piercing member  10330  and the drug container  10050  having a moveable barrel  10058  removes the need for a separate mechanism to establish fluid communication with the interior of the barrel  10058  upon activation of the drug delivery device. Instead, the force of the piston biasing member  10106  is utilized to move the pierceable seal  10056  into the stationary piercing member  10330  to establish fluid communication with the interior of the barrel  10058 . Accordingly, the design and manufacture of the drug delivery device may be simplified, and the overall size of the drug delivery device may be reduced. 
     IX. Motor-Driven Drug Delivery Device 
     Another embodiment of a drug delivery device  6000  is shown in  FIGS. 57A-57B . The drug delivery device  6000  may include a container  6050  filled with a volume of a fluid(s) for delivery to a patient. The fluid(s) may include one or more of the drugs described below, such as, for example, a granulocyte colony-stimulating factor (G-CSF), a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. In drug delivery device  6000 , one or more of an insertion mechanism, fluid pathway connector, and drug delivery drive mechanism are controlled by the rotation of a motor  6207 . Additionally, or alternatively, an escapement mechanism may be used to control the rate of rotation of one or more gears. One of the gears may be engaged with teeth  6208  of an insertion mechanism housing  6202 . As such, the rotation of the gear train controls the rotation of the insertion mechanism housing and, thereby, the insertion of the needle into the skin of the patient. The operation of the insertion mechanism will be described further herein. 
     X. Additional Embodiments of Insertion Mechanism 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-57B , may be configured to incorporate the embodiments of the insertion mechanism described below in connection with  FIGS. 58A-68 . 
     In one embodiment, the insertion mechanism  6200  includes an insertion mechanism housing  6202  having one or more extension arms  6202 A, a base  6252 , and a sterile boot  6250 , as shown in the exploded view of  FIGS. 58A and 58B . Base  6252  may be connected to assembly platform  20  to integrate the insertion mechanism into the drug delivery device  10  (as shown in  FIG. 1B ) or the or the drug delivery device  6000 . The connection of the base  6252  to the assembly platform  20  may be, for example, such that the bottom of the base is permitted to pass-through a hole in the assembly platform to permit direct contact of the base to the body of the patient. In such configurations, the bottom of the base  6252  may include a sealing membrane  6254  that, at least in one embodiment, is removable prior to use of the drug delivery device  10  or the drug delivery device  6000 . Alternatively, the sealing membrane  6254  may remain attached to the bottom of the base  6252  such that the needle  6214  pierces the sealing membrane  6254  during operation of the drug delivery device  10  or the drug delivery device  6000 . As shown in  FIGS. 58A and 58B , the insertion mechanism  6200  may further include a rotational biasing member  6210 , a needle hub  6212 , a needle  6214 , a retraction biasing member  6216 , a sleeve  6220 , and a conduit  6218 . The conduit  6218  may connect to sterile fluid conduit  30  or to sterile access connection  300  to permit fluid flow through the conduit  6218 , needle  6214 , and into the body of the patient during drug delivery, as will be described in further detail herein. 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles. Upon assembly, the proximal end of needle  6214  is maintained in fixed contact with hub  6212 , while the remainder of needle  6214  is preferably located within sterile boot  6250 . The needle  6214  may further pass-through base opening  6252 E. 
     Sterile boot  6250  is a collapsible or compressible sterile membrane that is in fixed engagement at a proximal end with the hub  6212  and at a distal end with the sleeve  6220  and/or base  6252 . The term “sterile boot” is used to describe a boot within which certain internal components may reside, at one or more stages of operation, in a sterile condition. The boot need not be sterile through the entire operation of the mechanism or drug delivery device and, in fact, may not be initially sterile until assembly and sterilization of certain components has occurred. Additionally, the term “boot” is not intended to mean any specific shape or configuration, but is instead utilized to describe a component that can provide an interior space within which other components may reside at one or more stages of operation. In at least one embodiment, the sterile boot  6250  is maintained in fixed engagement at a distal end between base  6252  and sleeve  6220 . In other embodiments sterile boot  6250  is maintained in fixed engagement at a distal end between base  6252  and insertion mechanism housing  6202 . Base  6252  includes a base opening  6252 E through which the needle may pass during operation of the insertion mechanism, as will be described further below. Sterility of the needle is maintained by its initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle  6214  is maintained in the sterile environment of the sterile boot  6250 . The base opening  6252 E of base  6252  may be closed from non-sterile environments as well, such as by for example a sealing membrane  6254 . 
       FIGS. 59A-59B and 60-62  show the components of the insertion mechanism, according to at least a first embodiment, in greater detail. As shown in  FIGS. 59A-59B , insertion mechanism housing  6202  may be a substantially cylindrical component having an inner chamber within which conduit  6218 , hub  6212 , needle  6214 , sleeve  6220 , retraction biasing member  6216 , and sterile boot  6250  are substantially disposed in an initial configuration. Guide surfaces  6204  (as best seen in  FIG. 59B ) are located on the inner surface of housing  6202  and are configured to interact with extension arms  6212 A of hub  6212 . As will be described in further detail hereinafter rotation of housing  6202  is transferred to axial movement of hub  6212  by interaction of guide surfaces  6204  with extension arms  6212 A of hub  6212 . Housing  6202  may further include one or more protrusions  6202 A. Protrusion  6202 A is configured to engage a proximal end of rotational biasing member  6210 . Protrusion  6202 A may form recess  6202 B in which the proximal end of rotational biasing member  6210  may be disposed. In this way, unwinding and/or de-energizing of rotational biasing member  6210  causes rotation of housing  6202  about axis A. Rotational biasing member  6210  may be located on the outside of housing  6202  in a substantially concentric relationship. The distal end of the rotational biasing member may be engaged with base  6252  or another feature of the drug delivery device  10  or the drug delivery device  6000  such that movement of the distal end of rotational biasing member  6210  is restricted. Protrusion  6202 A, or another feature, may further contact a portion of the sterile access connection during rotation of housing  6202 . This contact, in conjunction with rotation of housing  6202 , may be used to initiate the piercing of the pierceable seal and thereby allow the contents of the drug container to flow through the conduit. 
     Hub  6212 , as seen in  FIG. 60 , includes extension arms  6212 A as described above. It further includes aperture  6212 B configured to receive a portion of conduit  6218 . Aperture  6212 B allows conduit  6218  to be in fluid communication with needle  6214  for delivery of the fluid drug to the patient. Needle  6214  is securely engaged with hub  6212  by bonding, press-fit or other means known to one skilled in the art. 
     Sleeve  6220 , as shown in  FIG. 61 , includes slots  6220 A within which extension arms  6212 A of hub  6212  are at least partially disposed during operation of the insertion mechanism. These slots restrict the ability of hub  6212  to rotate. Sleeve  6220  further includes one or more apertures  6220 B which are configured to interface with flex arms  6252 A of base  6252 . During assembly, flex arms  6252 A engage apertures  6220 B, thereby restricting movement of sleeve  6220  with respect to base  6252 . Base  6252 , as shown in  FIG. 62 , may further include one or more lower alignment members  6252 C configured to engage one or more alignment notches  6220 C of sleeve  6220 . This engagement aligns sleeve  6220  to base  6252  and limits rotation of sleeve  6220  with respect to base  6252 . Base  6252  may also include one or more upper alignment members  6252 D configured to engage face  206  of housing  6202  during installation, thereby positioning housing  6202  with respect to base  6252 . 
     The operation of the insertion mechanism is described herein with reference to the above components, in view of  FIGS. 63-65 .  FIG. 63A  shows an isometric view and  FIG. 63B  shows a cross-sectional view of the insertion mechanism, according to at least one embodiment of the present disclosure, in a locked and ready to use stage. The proximal end of rotational biasing member  6210  is disposed in recess  6202 B of housing  6202  and rotational biasing member  6210  is in an energized state. In this initial position, hub  6212  is in a retracted, proximal position such that needle  6214  does not extend past opening  6252 E of base  6252 . Sterile boot  6250  is in an extended configuration with one end engaged with hub  6212  and the other engaged with shell  6220  and base  6252 . Retraction biasing member  6216  is in a relatively decompressed and/or de-energized state. Extension arms  6212 A of hub  6212  are located within or substantially adjacent to proximal portion  6204 A of guide surfaces  6204 . Coiled fluid conduit  6218  may be located proximally to hub  6212 . Fluid conduit  6218  may be connected at one end to hub  6212 , allowing fluid drug contents to pass from the drug container  50  to needle  6214  for delivery to the patient. 
     Insertion mechanism  6200  may be held in this initial configuration by interaction with other components of the drug delivery device  10  or the drug delivery device  6000 . By way of example, activation member  14  may be engaged with a slide which, in an initial configuration, prevents rotation of housing  6202  by interaction with extension arm  6202 A. Depression of trigger member  14  may displace the slide, disengaging the slide from the extension arm  6202 A of housing  6202 , thereby allowing rotation of housing  6202 . In an alternative embodiment, shown in  FIGS. 57A-57B , a portion of housing  6202  may have gear teeth  6208  configured to interact with a gear  6209  which prevents rotation of the housing. In this configuration, the gear may be connected to a motor  6207  which controls the rotation of the gear and therefore the housing. The housing may be able to be disengaged from the gear, thereby allowing free rotation of the housing in response to de-energizing of the rotational biasing member. Gear  6209  may be connected to motor  6207  through a gear train, the gear train controlling the relationship between rotation of motor  6207  and gear  6209 . Additionally, or alternatively, an escapement mechanism may be used to control rotation of the gear train. 
       FIG. 64A  shows an isometric view and  FIG. 64B  shows a cross-sectional view of an insertion mechanism in a needle inserted stage. As shown in  FIG. 63A  unwinding and/or de-energizing of rotational biasing member  6210  causes housing  6202  to rotate about axis A. As housing  6202  rotates contact of guide surfaces  6204  with extension arms  6212 A of hub  6212  causes hub  6212  to translate in the distal direction. Hub  6212  is prevented from rotating by interaction between extension arms  6212 A and slots  6220 A of sleeve  6220 . Sleeve  6220  is connected to base  6252  by engagement of flex arms  6252 B with apertures  6220 B. As shown, sterile boot  6250  is permitted to collapse as housing  6202  rotates and hub  6212  translates in the distal direction and inserts the needle  6214  into the body of the patient. At this stage, shown in  FIG. 63B , needle  6214  is introduced into the body of the patient for drug delivery. Due to the distal translation of hub  6212 , retraction biasing member  6216  is compressed or energized. Rotation of housing  6202  is preferably limited or stopped at a position in which guide surfaces  6204  retain hub  6212  in a distal position. Rotation of housing  6202  may be stopped at this position by interaction between protrusion  6202 A and a stop component of the drug delivery device  10  or the drug delivery device  6000 . Alternatively, a stop component may interact with another portion of housing  6202 . Upon insertion of the needle  6214 , the fluid pathway from the conduit to the body of the patient through the needle  6214  is opened. As the fluid pathway connector is made to the drug container and the drive mechanism is activated, the fluid drug treatment is forced from the drug container through the fluid pathway connector and the sterile fluid conduit into the needle  6214  for delivery into the body of the patient. 
     As shown in  FIGS. 65A and 65B , upon completion of drug delivery, the needle  6214  is retracted back (i.e., axially translated in the proximal direction) into the insertion mechanism housing  6202 . Continued rotation of housing  6202  aligns the proximal portion  6204 A of guide surfaces  6204  with extension arms  6212 A of hub  6212  such that proximal translation of hub  6212  is no longer restricted. In this position, retraction biasing member  6216  is able to decompress or de-energize. Expansion of the retraction biasing member  6216  translates hub  6212 , and needle  6214  to which it is connected, axially in the proximal direction. Accordingly, activation of the insertion mechanism inserts the needle  6214  into the body of the patient, and sequentially retracts the needle  6214  after completion of drug delivery or upon some other retraction initiation mechanism. 
       FIGS. 11-13  show another embodiment of an insertion mechanism. As shown in  FIG. 66 , one end of the rotational biasing member  7210  is disposed in a recess  7202 B formed in the housing  7202  of the insertion mechanism. By engaging the housing in this way the requirement for a protrusion extending outwardly from the housing is eliminated, thereby allowing the overall size of the insertion mechanism to be reduced. Further, as shown in  FIG. 67  the sterile boot  7250  may be configured in an “accordion” configuration, which may allow the diameter of the sterile boot to be less than the sterile boot shown in previous embodiments. It may also be seen in  FIG. 67  that platform  7020  may have upwardly extending boss  7020 A that aids in locating and retaining the needle insertion mechanism. The rotational biasing member  7210  may be positioned around the outside of boss  7020 A. The needle insertion mechanism may also include cap  7222 . The cap may engage the shell  7220  and act to retain the components of the needle insertion mechanism in place. Specifically, the cap may retain the conduit in position within housing  7202 . The cap may include one or more circumferential flex arms  7222 A which, during installation, may flex outward in response to contact with protrusions of the shell  7220 . The flex arms may then return to their natural position and thereby be retained in place with respect to the shell as seen best in the cross-section view of  FIG. 68 . Also seen in  FIG. 68 , one or more flex arms  7020 B of platform  7020  may engage apertures  7220 B of the housing  7220 . This engagement retains and positions the insertion mechanism with respect to platform  7020 . The platform  7020  of the drug delivery device may further include locking arms  7020 B which are configured to engage apertures  7220 B of the shell. This engagement retains the insertion mechanism in position with respect to the drug delivery device. The stages of operation of this embodiment may be substantially similar to those described above (i.e., de-energizing of the rotational biasing member leads to insertion of the needle and de-energizing of the retraction biasing member leads to retraction of the needle). 
     In some embodiments, retraction is activated upon removal of the drug delivery device from the patient&#39;s body. In other embodiments, retraction is activated if it is determined that an error has occurred in the delivery of the substances to the patient. For example, an occlusion of the drug delivery pathway which prevents the flow of medicament may be detected by a sensing function of the drug delivery device. Upon the sensing of the occlusion an electrical or mechanical input may be used to initiate retraction of the needle. 
     Activating retraction of the needle may be accomplished through many mechanisms. For example, a button may be provided on the outside of housing  12  which, when depressed by the patient, activates retraction of the needle from the patient&#39;s body. For example, in one embodiment, depressing the button may allow housing  6202  to rotate, hence allowing retraction biasing member  6216  to expand and retract needle  6214 . Actuation of the button may be spring assisted such that the travel and/or force required to depress the button is reduced. Alternatively, or additionally, upon drive mechanism  100  reaching end-of-dose an electrical or mechanical actuator may cause activation of retraction. For example, upon end-of-dose, an electrical connection may be made such that a current is applied to a nitinol component. Upon application of the current the nitinol component&#39;s temperature rises. Because of nitinol&#39;s shape memory characteristics this component may be configured, upon an increase in temperature, to transform from a first configuration to a second configuration. In this second configuration, the nitinol component may allow or cause the actuation of the retraction of the needle by, for example, allowing rotation of housing  6202 . 
     Alternatively, or additionally, a sensor such as on-body sensor  24  may, when drug delivery device  10  is removed from the patient&#39;s body, cause or allow activation of the retraction of the needle. For example, when drug delivery device  10  is installed on the patient the position of on-body sensor  24  may prevent rotation of housing  6202  to the retraction position. Upon removal from the patient a change in configuration of on-body sensor  24  may allow rotation. In another embodiment, a light sensor may be placed on drug delivery device  10  near to base opening  6252 . When drug delivery device  10  is in place on the patient&#39;s body light would be substantially blocked from entering the light sensor. Upon removal of drug delivery device  10  from the patient&#39;s body light may be sensed by the light sensor and the light sensor may trigger an electromechanical actuator to allow or cause activation of retraction. In other embodiments, a pin-type press-fit interconnect is used to initiate retraction of the needle. The pin may be biased to at least partially protrude from housing  12  and be displaced upon placement of drug delivery device  10  on the patient. When displaced, the pin may engage a female hole on a PCB which may be a part of power and control system  400 . Upon removal of drug delivery device  10  from the patient, the biased pin disengages the female PCB hole, thereby causing a signal to activate the retraction of the needle. 
     Certain optional standard components or variations of insertion mechanism  6200  or the drug delivery devices  10  or  6000  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIGS. 1A-1C , to enable the patient to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the patient for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug delivery device to the body of the patient. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the patient. Adhesive patch  26  may optionally include a protective shroud that prevents actuation of the optional on-body sensor  24  and covers base opening  6252 E. Removal of the patch liner  28  may remove the protective shroud or the protective shroud may be removed separately. Removal of the patch liner  28  may further remove the sealing membrane  6254  of the insertion mechanism  6200 , opening the insertion mechanism to the body of the patient for drug delivery. 
     Similarly, one or more of the components of insertion mechanism  6200  and the drug delivery devices  10  and  6000  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the insertion mechanism and/or drug delivery device to each other. Alternatively, one or more components of the insertion mechanism and/or drug delivery device may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the insertion mechanisms and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide integrated safety features; enable direct patient activation of the insertion mechanism; and are configured to maintain the sterility of the fluid pathway. As described above, the integrated safety features include optional on-body sensors, redundant lock-outs, automated needle insertion and retraction upon patient activation, and numerous patient feedback options, including visual and auditory feedback options. The novel insertion mechanisms of the present disclosure may be directly activated by the patient. For example, in at least one embodiment the rotation prevention feature, whether it is a stop component configured to engage protrusion  6202 A or a gear engaged with teeth of housing  6202 , which maintain the insertion mechanism in its locked, retracted state is directly displaced from its locked position by patient depression of the activation mechanism. Alternatively, one or more additional components may be included, such as a spring mechanism, which displaces the rotation prevention feature upon direct displacement of the activation mechanism by the patient without any intervening steps. In at least one configuration, rotation of a motor causes or allows rotation of a gear, thereby allowing rotation of the housing of the insertion mechanism. 
     Furthermore, the novel configurations of the insertion mechanism and drug delivery devices of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, the housing and other components of the drug delivery device may readily be configured to accept and operate insertion mechanism  6200  or a number of other variations of the insertion mechanism described herein. 
     Assembly and/or manufacturing of insertion mechanism  6200 , drug delivery devices  10  or  6000 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     In a further embodiment, the present disclosure provides a method of assembling the insertion mechanism including the steps of: connecting a hub to a proximal end of a needle; connecting a conduit to the hub; connecting a sterile boot to the hub; inserting a retraction biasing member into a sleeve of the needle insertion mechanism; inserting the hub, needle, conduit, and sterile boot into the sleeve (in this position, the retraction biasing member is constrained between the hub at one end and the shell at the other end); placing a housing around the sleeve; inserting a retraction biasing member into the sleeve; and connecting a base to the sleeve by engagement of flex arms with apertures in the housing. A rotational biasing member may be placed around the housing such that a portion of the rotational biasing member is engaged with a portion of the housing, thereby coupling de-energizing of the biasing member with rotation of the housing. 
     The distal end of the sterile boot may be positioned and held in fixed engagement with the distal end of the insertion mechanism housing by engagement of the housing with a base. In this position, the sterile boot is in an expanded configuration around the needle and creates an annular volume which may be sterile. A fluid conduit may be connected to the hub such that the fluid pathway, when open, travels directly from the fluid conduit, through the hub, and through the needle. A fluid pathway connector may be attached to the opposite end of the fluid conduit. The fluid pathway connector, and specifically a sterile sleeve of the fluid pathway connector, may be connected to a cap and pierceable seal of the drug container. The plunger seal and drive mechanism may be connected to the drug container at an end opposing the fluid pathway connector. A sealing membrane may be attached to the bottom of the base to close off the insertion mechanism from the environment. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device. 
     Manufacturing of a drug delivery device includes the step of attaching the base of the insertion mechanism to an assembly platform or housing of the drug delivery device. In at least one embodiment, the attachment is such that the base of the insertion mechanism is permitted to pass-through the assembly platform and/or housing to come in direct contact with the body of the patient. The method of manufacturing further includes attachment of the fluid pathway connector, drug container, and drive mechanism to the assembly platform or housing. The additional components of the drug delivery device, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug delivery device that contacts the patient during operation of the device. 
     A method of operating the drug delivery device may include the steps of: activating, by a patient, the activation mechanism; displacing a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a drive control mechanism to drive fluid drug flow through the drug delivery device. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. The method similarly may include the step of: establishing a connection between a fluid pathway connector to a drug container. Furthermore, the method of operation may include translating a plunger seal within the drive control mechanism and drug container to force fluid drug flow through the drug container, the fluid pathway connector, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to the body of a patient. 
     XI. Drug Delivery Device with Multi-Function Drive Mechanism 
     Another embodiment of a drug delivery device  8000  is illustrated in  FIGS. 69A-73D . Various aspects, components, mechanisms, assemblies, methods of manufacture, and methods of use associated with the drug delivery devices described in connection with  FIGS. 1-68  may be incorporated into and/or applied to the drug delivery device  8000  to the extent they do not conflict with aspects, components, mechanisms, assemblies, methods of manufacture, and methods of use associated with the drug delivery device  8000 , and vice versa. Furthermore, the drug delivery device  8000  may include a container  8050  filled with a volume of a fluid for delivery to a patient. The fluid may be one or more of the drugs described below, such as, for example, a granulocyte colony-stimulating factor (G-CSF), a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. 
     The present disclosure provides multi-function drive mechanisms for the controlled delivery of drug substances, controlled drug delivery pumps with such drive mechanisms, the methods of operating such devices, and the methods of assembling such devices. Notably, the multi-function drive mechanisms of the present disclosure enable or initiate several functions, including: (i) controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container; (ii) triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a patient; and (iii) connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. The novel embodiments of the present disclosure thus are capable of delivering drug substances at variable rates. The drive mechanisms of the present disclosure may be pre-configurable or dynamically configurable, such as by control by the power and control system, to meet desired delivery rates or profiles, as explained in detail below. Additionally, the drive mechanisms of the present disclosure provide integrated status indication features which provide feedback to the patient before, during, and after drug delivery. For example, the patient may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the patient. At completion of drug delivery, the drive mechanism and drug delivery device may provide an end-of-dose indication. Because the end-of-dose indication is related to the physical end of axial translation and/or travel of one or more components of the drive mechanism, the drive mechanism and drug delivery device provide a true end-of-dose indication to the patient. Through these mechanisms, confirmation of drug dose delivery can accurately be provided to the patient or administrator. Accordingly, the novel devices of the present disclosure alleviate one or more of the problems associated with prior art devices, such as those referred to above. 
     In a first embodiment, the present disclosure provides a multi-function drive mechanism which includes an actuator, a gear assembly including a main gear, a drive housing, and a drug container having a cap, a pierceable seal (not visible), a barrel, and a plunger seal. The main gear may be, for example, a star gear disposed to contact multiple secondary gears or gear surfaces. A drug chamber, located within the barrel between the pierceable seal and the plunger seal, may contain a drug fluid for delivery through the insertion mechanism and drug delivery device into the body of the patient. A piston, and one or more biasing members, wherein the one or more biasing members are initially retained in an energized state and is configured to bear upon an interface surface of the piston, may also be incorporated in the multi-function drive mechanism. The piston is configured to translate substantially axially within a drug container having a plunger seal and a barrel. A tether is connected at one end to the piston and at another end to a winch drum/gear of a regulating mechanism, wherein the tether restrains the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon. The drug container may contain a drug fluid within a drug chamber for delivery to a patient. Optionally, a cover sleeve may be utilized between the biasing member and the interface surface of the piston to hide the interior components of the barrel (namely, the piston and the biasing member) from view during operation of the drive mechanism. The tether is configured to be released from a winch drum/gear of a regulating mechanism of the multi-function drive mechanism to meter the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon. 
     In at least one embodiment of the present disclosure, the regulating mechanism is gear assembly driven by an actuator of the multi-function drive mechanism. The regulating mechanism retards or restrains the distribution of tether, only allowing it to advance at a regulated or desired rate. This restricts movement of piston within barrel, which is pushed by one or more biasing members, hence controlling the movement of plunger seal and delivery of the drug contained in chamber. As the plunger seal advances in the drug container, the drug substance is dispensed through the sterile pathway connection, conduit, insertion mechanism, and into the body of the patient for drug delivery. The actuator may be a number of power/motion sources including, for example, a motor (e.g., a DC motor, AC motor, or stepper motor) or a solenoid (e.g., linear solenoid, rotary solenoid). In a particular embodiment, the actuator is a rotational stepper motor with a notch that corresponds with the gear teeth of the main/star gear. 
     The regulating mechanism may further include one or more gears of a gear assembly. One or more of the gears may be, for example, compound gears having a small diameter gear attached at a shared center point to a large diameter gear. The gear assembly may include a winch gear coupled to a winch drum/gear upon which the tether may be releasably wound. Accordingly, rotation of the gear assembly initiated by the actuator may be coupled to winch drum/gear (i.e., through the gear assembly), thereby controlling the distribution of tether, the rate of expansion of the biasing members and the axial translation of the piston, and the rate of movement of plunger seal within barrel to force a fluid from drug chamber. The rotational movement of the winch drum/gear, and thus the axial translation of the piston and plunger seal, are metered, restrained, or otherwise prevented from free axial translation by other components of the regulating element, as described herein. Notably, the regulating mechanisms of the present disclosure do not drive the delivery of fluid substances from the drug chamber. The delivery of fluid substances from the drug chamber is caused by the expansion of the biasing member from its initial energized state acting upon the piston and plunger seal. The regulating mechanisms instead function to provide resistance to the free motion of the piston and plunger seal as they are pushed by the expansion of the biasing member from its initial energized state. The regulating mechanism does not drive the delivery but only controls the delivery motion. The tether limits or otherwise restrains the motion of the piston and plunger seal, but does not apply the force for the delivery. 
     In addition to controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container (thereby delivering drug substances at variable rates and/or delivery profiles); the multi-function drive mechanisms of the present disclosure may concurrently or sequentially perform the steps of: triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a patient; and connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. In at least one embodiment, initial motion by the actuator of the multi-function drive mechanism causes rotation of main/star gear. In one manner, main/star gear conveys motion to the regulating mechanism through gear assembly. In another manner, main/star gear conveys motion to the needle insertion mechanism through gear. As gear is rotated by main/star gear, gear engages the needle insertion mechanism to initiate the fluid pathway connector into the patient, as described in detail above. In one particular embodiment, needle insertion mechanism is a rotational needle insertion mechanism. Accordingly, gear is configured to engage a corresponding gear surface of the needle insertion mechanism. Rotation of gear causes rotation of needle insertion mechanism through the gear interaction between gear of the drive mechanism and corresponding gear surface of the needle insertion mechanism. Once suitable rotation of the needle insertion mechanism occurs, the needle insertion mechanism may be initiated to create the fluid pathway connector into the patient, as described in detail herein. 
     In at least one embodiment, rotation of the needle insertion mechanism in this manner may also cause a connection of a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. Ramp aspect of needle insertion mechanism is caused to bear upon a movable connection hub of the sterile fluid pathway connector. As the needle insertion mechanism is rotated by the multi-function drive mechanism, ramp aspect of needle insertion mechanism bears upon and translates movable connection hub of the sterile fluid pathway connector to facilitate a fluid connection therein. In at least one embodiment, the needle insertion mechanism may be configured such that a particular degree of rotation enables the needle/trocar to retract as detailed above. Additionally or alternatively, such needle/trocar retraction may be configured to occur upon a patient-activity or upon movement or function of another component of the drug delivery device. In at least one embodiment, needle/trocar retraction may be configured to occur upon end-of-drug-delivery, as triggered by, for example, the regulating mechanism and/or one or more of the status readers as described herein. 
     In yet another embodiment, the drive mechanism may include a status reader configured to read or recognize one or more corresponding status triggers. The status triggers may be incrementally spaced on the tether, wherein, during operation of the drive mechanism, interaction between the status reader and the status triggers transmit a signal to a power and control system to provide feedback to a patient. The status reader may be an optical status reader and the corresponding status triggers are optical status triggers, an electromechanical status reader and the corresponding status triggers are electromechanical status triggers, or a mechanical status reader and the corresponding status triggers are mechanical status triggers. 
     In a further embodiment, the present disclosure provides a drug delivery pump with controlled drug delivery. The drug delivery pump having a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connector, a power and control system, and a controlled delivery drive mechanism may be mounted, said drive mechanism having a drive housing, a piston, and a biasing member, wherein the biasing member is initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate substantially axially within a drug container having a plunger seal and a barrel. A tether is connected at one end to the piston and at another end to a winch drum/gear of a delivery regulating mechanism, wherein the tether restrains the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon. The drug container may contain a drug fluid within a drug chamber for delivery to a patient. Optionally, a cover sleeve may be utilized between the biasing member and the interface surface of the piston to hide the interior components of the barrel (namely, the piston and the biasing member) from view during operation of the drive mechanism. The tether is configured to be released from a winch drum/gear of the delivery regulating mechanism to meter the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon. 
     In another embodiment, the drug delivery device further includes a gear assembly. The gear assembly may include a winch gear connected to a winch drum/gear upon which the tether may be releasably wound, rotation of the winch drum/gear releases the tether from the winch drum/gear to meter the free expansion of the biasing member from its initial energized state and the free axial translation of the piston upon which the biasing member bears upon. The metering of the tether controls the rate or profile of drug delivery to a patient. The piston may be one or more parts and connects to a distal end of the tether. The winch drum/gear is coupled to a regulating mechanism which controls rotation of the winch drum/gear and hence metering of the translation of the piston. 
     In yet another embodiment, the drug delivery device may include a status reader configured to read or recognize one or more corresponding status triggers. The status triggers may be incrementally spaced on the tether, wherein, during operation of the drive mechanism, interaction between the status reader and the status triggers transmit a signal to a power and control system to provide feedback to a patient. The status reader may be an optical status reader and the corresponding status triggers are optical status triggers, an electromechanical status reader and the corresponding status triggers are electromechanical status triggers, or a mechanical status reader and the corresponding status triggers are mechanical status triggers. 
     In another embodiment, the power and control system of the drug delivery device is configured to receive one or more inputs to meter the release of the tether by the winch drum/gear and thereby permit axial translation of the piston by the biasing member to translate a plunger seal within a barrel. The one or more inputs may be provided by the actuation of the activation mechanism, a control interface, and/or a remote control mechanism. The power and control system may be configured to receive one or more inputs to adjust the restraint provided by the tether and winch drum/gear on the free axial translation of the piston upon which the biasing member bears upon to meet a desired drug delivery rate or profile, to change the dose volume for delivery to the patient, and/or to otherwise start, stop, or pause operation of the drive mechanism. 
     The novel embodiments of the present disclosure provide drive mechanisms which are capable of metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container and, thereby, controlling the rate of delivery of drug substances. The novel control delivery drive mechanisms are additionally capable of providing the incremental status of the drug delivery before, during, and after operation of the device. Throughout this specification, unless otherwise indicated, “comprise,” “comprises,” and “comprising,” or related terms such as “includes” or “consists of,” are used inclusively rather than exclusively, so that a stated integer or group of integers may include one or more other non-stated integers or groups of integers. As will be described further below, the embodiments of the present disclosure may include one or more additional components which may be considered standard components in the industry of medical devices. For example, the embodiments may include one or more batteries utilized to power the motor, drive mechanisms, and drug delivery devices of the present disclosure. The components, and the embodiments containing such components, are within the contemplation of the present disclosure and are to be understood as falling within the breadth and scope of the present disclosure. 
     The present disclosure provides multi-function drive mechanisms for the controlled delivery of drug substances and drug delivery pumps which incorporate such multi-function drive mechanisms. The multi-function drive mechanisms of the present disclosure enable or initiate several functions, including: (i) controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container; (ii) triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a patient; and (iii) connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. The drive mechanisms of the present disclosure control the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container and, thus, are capable of delivering drug substances at variable rates and/or delivery profiles. Additionally, the drive mechanisms of the present disclosure provide integrated status indication features which provide feedback to the patient before, during, and after drug delivery. For example, the patient may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the patient. At completion of drug delivery, the drive mechanism and drug delivery device may provide an end-of-dose indication. 
     The novel devices of the present disclosure provide drive mechanisms with integrated status indication and drug delivery pumps which incorporate such drive mechanisms. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The devices described herein incorporate features which make activation, operation, and lock-out of the device simple for even untrained patients. The novel devices of the present disclosure provide these desirable features without any of the problems associated with known prior art devices. Certain non-limiting embodiments of the novel drug delivery pumps, drive mechanisms, and their respective components are described further herein with reference to the accompanying Figures. 
       FIGS. 1A-1C  show an exemplary drug delivery device according to at least one embodiment of the present disclosure with the top housing removed so that the internal components are visible. The drug delivery device may be utilized to administer delivery of a drug treatment into a body of a patient. As shown in  FIGS. 69A-69C , the drug delivery device  8000  includes a pump housing  8012 . Pump housing  8012  may include one or more housing subcomponents which are fixedly engageable to facilitate easier manufacturing, assembly, and operation of the drug delivery device. For example, drug delivery device  8000  includes a pump housing  8012  which may include an upper housing and a lower housing (not shown for ease of viewing internal components). The drug delivery device may further include an activation mechanism, a status indicator, and a window. Window may be any translucent or transmissive surface through which the operation of the drug delivery device may be viewed. As shown in  FIG. 69B , drug delivery device  8000  further includes assembly platform  8020 , sterile fluid conduit  8030 , drive mechanism  8100  having drug container  8050 , insertion mechanism  8200 , fluid pathway connector  8300 , and a power and control system (not shown). One or more of the components of such drug delivery devices may be modular in that they may be, for example, pre-assembled as separate components and configured into position onto the assembly platform  8020  of the drug delivery device  8000  during manufacturing. 
     The pump housing  8012  contains all of the device components and provides a means of removably attaching the device  8000  to the skin of the patient. The pump housing  8012  also provides protection to the interior components of the device  8000  against environmental influences. The pump housing  8012  is ergonomically and aesthetically designed in size, shape, and related features to facilitate easy packaging, storage, handling, and use by patients who may be untrained and/or physically impaired. Furthermore, the external surface of the pump housing  8012  may be utilized to provide product labeling, safety instructions, and the like. Additionally, as described above, housing  8012  may include certain components, such as one or more status indicators and windows, which may provide operation feedback to the patient. 
     In at least one embodiment, the drug delivery device  8000  provides an activation mechanism that is displaced by the patient to trigger the start command to the power and control system. In a preferred embodiment, the activation mechanism is a start button that is located through the pump housing  8012 , such as through an aperture between upper housing and lower housing, and which contacts either directly or indirectly the power and control system. In at least one embodiment, the start button may be a push button, and in other embodiments, may be an on/off switch, a toggle, or any similar activation feature known in the art. The pump housing  8012  also provides one or more status indicators and windows. In other embodiments, one or more of the activation mechanism, the status indicator, the window, and combinations thereof may be provided on the upper housing or the lower housing such as, for example, on a side visible to the patient when the drug delivery device  8000  is placed on the body of the patient. Housing  8012  is described in further detail hereinafter with reference to other components and embodiments of the present disclosure. 
     Drug delivery device  8000  is configured such that, upon activation by a patient by depression of the activation mechanism, the multi-function drive mechanism is activated to: insert a fluid pathway into the patient; enable, connect, or open necessary connections between a drug container, a fluid pathway, and a sterile fluid conduit; and force drug fluid stored in the drug container through the fluid pathway and fluid conduit for delivery into a patient. In at least one embodiment, such delivery of drug fluid into a patient is performed by the multi-function drive mechanism in a controlled manner. One or more optional safety mechanisms may be utilized, for example, to prevent premature activation of the drug delivery device. For example, an optional on-body sensor (not visible) may be provided in one embodiment as a safety feature to ensure that the power and control system, or the activation mechanism, cannot be engaged unless the drug delivery device  8000  is in contact with the body of the patient. In one such embodiment, the on-body sensor is located on the bottom of lower housing where it may come in contact with the patient&#39;s body. Upon displacement of the on-body sensor, depression of the activation mechanism is permitted. Accordingly, in at least one embodiment the on-body sensor is a mechanical safety mechanism, such as for example a mechanical lock out, that prevents triggering of the drug delivery device  8000  by the activation mechanism. In another embodiment, the on-body sensor may be an electro-mechanical sensor such as a mechanical lock out that sends a signal to the power and control system to permit activation. In still other embodiments, the on-body sensor can be electrically based such as, for example, a capacitive- or impedance-based sensor which must detect tissue before permitting activation of the power and control system. In at least one embodiment, such an an electrically based on-body sensor may incorporate a resistor with an impedance of approximately (e.g., ±10%) 1 MΩ. These concepts are not mutually exclusive and one or more combinations may be utilized within the breadth of the present disclosure to prevent, for example, premature activation of the drug delivery device. In a preferred embodiment, the drug delivery device  8000  utilizes one or more mechanical on-body sensors. Additional integrated safety mechanisms are described herein with reference to other components of the novel drug delivery devices. 
     XI.A. Power and Control System 
     The power and control system may include a power source, which provides the energy for various electrical components within the drug delivery device, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnects. Other components commonly used in such electrical systems may also be included, as would be appreciated by one having ordinary skill in the art. The one or more feedback mechanisms may include, for example, audible alarms such as piezo alarms and/or light indicators such as light emitting diodes (LEDs). The microcontroller may be, for example, a microprocessor. The power and control system controls several device interactions with the patient and interfaces with the drive mechanism  8100 . In one embodiment, the power and control system interfaces either directly or indirectly with the on-body sensor  24  to identify when the device is in contact with the patient and/or the activation mechanism to identify when the device has been activated. The power and control system may also interface with the status indicator of the pump housing  8012 , which may be a transmissive or translucent material which permits light transfer, to provide visual feedback to the patient. The power and control system interfaces with the drive mechanism  8100  through one or more interconnects to relay status indication, such as activation, drug delivery, and end-of-dose, to the patient. Such status indication may be presented to the patient via auditory tones, such as through the audible alarms, and/or via visual indicators, such as through the LEDs. In a preferred embodiment, the control interfaces between the power and control system and the other components of the drug delivery device are not engaged or connected until activation by the patient. This is a desirable safety feature that prevents accidental operation of the drug delivery device and may additionally maintain the energy contained in the power source during storage, transportation, and the like. 
     The power and control system may be configured to provide a number of different status indicators to the patient. For example, the power and control system may be configured such that after the on-body sensor and/or trigger mechanism have been pressed, the power and control system provides a ready-to-start status signal via the status indicator if device start-up checks provide no errors. After providing the ready-to-start status signal and, in an embodiment with the optional on-body sensor, if the on-body sensor remains in contact with the body of the patient, the power and control system will power the drive mechanism  8100  to begin delivery of the drug treatment through the fluid pathway connector  8300  and sterile fluid conduit  8030  (not shown). 
     Additionally, the power and control system may be configured to identify removal of the drug delivery device from its packaging. The power and control system may be mechanically, electronically, or electro-mechanically connected to the packaging such that removal of the drug delivery device from the packaging may activate or power-on the power and control system for use, or simply enable the power and control system to be powered-on by the patient. In such an embodiment, without removal of the drug delivery device from the packaging the drug delivery device cannot be activated. This provides an additional safety mechanism of the drug delivery device and for the patient. In at least one embodiment, the drug delivery device or the power and control system may be electronically or electro-mechanically connected to the packaging, for example, such as by one or more interacting sensors from a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal between components to identify the location there-between. Additionally or alternatively, the drug delivery device or the power and control system may be mechanically connected to the packaging, such as by a pin and slot relationship which activates the system when the pin is removed (i.e., once the drug delivery device is removed from the packaging). 
     In a preferred embodiment of the present disclosure, once the power and control system has been activated, the multi-function drive mechanism is initiated to actuate the insertion mechanism  8200  and the fluid pathway connector  8300 , while also permitting the drug fluid to be forced from the drug container. During the drug delivery process, the power and control system is configured to provide a dispensing status signal via the status indicator. After the drug has been administered into the body of the patient and after the end of any additional dwell time, to ensure that substantially the entire dose has been delivered to the patient, the power and control system may provide an okay-to-remove status signal via the status indicator. This may be independently verified by the patient by viewing the drive mechanism and drug dose delivery through the window of the pump housing  8012 . Additionally, the power and control system may be configured to provide one or more alert signals via the status indicator, such as for example alerts indicative of fault or operation failure situations. 
     The power and control system may additionally be configured to accept various inputs from the patient to dynamically control the drive mechanisms  8100  to meet a desired drug delivery rate or profile. For example, the power and control system may receive inputs, such as from partial or full activation, depression, and/or release of the activation mechanism, to set, initiate, stop, or otherwise adjust the control of the drive mechanism  8100  via the power and control system to meet the desired drug delivery rate or profile. Similarly, the power and control system may be configured to receive such inputs to adjust the drug dose volume; to prime the drive mechanism, fluid pathway connector, and fluid conduit; and/or to start, stop, or pause operation of the drive mechanism  8100 . Such inputs may be received by the patient directly acting on the drug delivery device  8000 , such as by use of the activation mechanism  8014  or a different control interface, or the power and control system may be configured to receive such inputs from a remote control device. Additionally or alternatively, such inputs may be pre-programmed. 
     Other power and control system configurations may be utilized with the novel drug delivery devices of the present disclosure. For example, certain activation delays may be utilized during drug delivery. As mentioned above, one such delay optionally included within the system configuration is a dwell time which ensures that substantially the entire drug dose has been delivered before signaling completion to the patient. Similarly, activation of the device may require a delayed depression (i.e., pushing) of the activation mechanism of the drug delivery device  8000  prior to drug delivery device activation. Additionally, the system may include a feature which permits the patient to respond to the end-of-dose signals and to deactivate or power-down the drug delivery device. Such a feature may similarly require a delayed depression of the activation mechanism, to prevent accidental deactivation of the device. Such features provide desirable safety integration and ease-of-use parameters to the drug delivery devices. An additional safety feature may be integrated into the activation mechanism to prevent partial depression and, therefore, partial activation of the drug delivery devices. For example, the activation mechanism and/or power and control system may be configured such that the device is either completely off or completely on, to prevent partial activation. Such features are described in further detail hereinafter with regard to other aspects of the novel drug delivery devices. 
     XI.B. Insertion Mechanism 
     A number of insertion mechanisms may be utilized within the drug delivery devices of the present disclosure. The pump-type delivery devices of the present disclosure may be connected in fluid flow communication to a patient or patient, for example, through any suitable hollow tubing. A solid bore needle may be used to pierce the skin of the patient and place a hollow cannula at the appropriate delivery position, with the solid bore needle being removed or retracted prior to drug delivery to the patient. As stated above, the fluid can be introduced into the body through any number of means, including but not limited to: an automatically inserted needle, cannula, micro-needle array, or infusion set tubing. A number of mechanisms may also be employed to activate the needle insertion into the patient. For example, a biasing member such as a spring may be employed to provide sufficient force to cause the needle and cannula to pierce the skin of the patient. The same spring, an additional spring, or another similar mechanism may be utilized to retract the needle from the patient. In a preferred embodiment, the insertion mechanism may generally be as described in International Patent Application No. PCT/US2012/53174, which is included by reference herein in its entirety for all purposes. Such a configuration may be utilized for insertion of the drug delivery pathway into, or below, the skin (or muscle) of the patient in a manner that minimizes pain to the patient. Other known methods for insertion of a fluid pathway may be utilized and are contemplated within the bounds of the present disclosure, including a rigid needle insertion mechanism and/or a rotational needle insertion mechanism as described by the present disclosure. 
     In at least one embodiment, the insertion mechanism  8200  includes an insertion mechanism housing having one or more lockout windows, and a base for connection to the assembly platform and/or pump housing (as shown in  FIG. 69B  and  FIG. 69C ). The connection of the base to the assembly platform  8020  may be, for example, such that the bottom of the base is permitted to pass-through a hole in the assembly platform to permit direct contact of the base to the body of the patient. In such configurations, the bottom of the base may include a sealing membrane that is removable prior to use of the drug delivery device  8000 . The insertion mechanism may further include one or more insertion biasing members, a needle, a retraction biasing member, a cannula, and a manifold. The manifold may connect to sterile fluid conduit  8030  to permit fluid flow through the manifold, cannula, and into the body of the patient during drug delivery. 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as “trocars.” In a preferred embodiment, the needle is a 27 gauge solid core trocar and in other embodiments, the needle may be any size needle suitable to insert the cannula for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. A sterile boot may be utilized within the needle insertion mechanism. The sterile boot is a collapsible sterile membrane that is in fixed engagement at a proximal end with the manifold and at a distal end with the base. In at least on embodiment, the sterile boot is maintained in fixed engagement at a distal end between base and insertion mechanism housing. Base includes a base opening through which the needle and cannula may pass-through during operation of the insertion mechanism, as will be described further below. Sterility of the cannula and needle are maintained by their initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle and cannula are maintained in the sterile environment of the manifold and sterile boot. The base opening of base may be closed from non-sterile environments as well, such as by for example a sealing membrane (not visible). 
     According to at least one embodiment of the present disclosure, the insertion mechanism is initially locked into a ready-to-use stage by lockout pin(s) which are initially positioned within lockout windows of the insertion mechanism housing. In this initial configuration, insertion biasing member and retraction biasing member are each retained in their compressed, energized states. Displacement of the lockout pin(s), by one or more methods such as pulling, pushing, sliding, and/or rotation, permits insertion biasing member to decompress from its initial compressed, energized state. This decompression of the insertion biasing member drives the needle and, optionally, the cannula into the body of the patient. At the end of the insertion stage or at the end of drug delivery (as triggered by the multi-function drive mechanism), the retraction biasing member is permitted to expand in the proximal direction from its initial energized state. This axial expansion in the proximal direction of the retraction biasing member retracts the needle. If an inserter needle/trocar and cannula configuration are utilized, retraction of the needle may occur while maintaining the cannula in fluid communication with the body of the patient. Accordingly, the insertion mechanism may be used to insert a needle and cannula into the patient and, subsequently, retract the needle while retaining the cannula in position for drug delivery to the body of the patient. 
     XI.C. Fluid Pathway Connector 
     A number of fluid pathway connectors may be utilized within the embodiments of the present disclosure. Generally, a suitable fluid pathway connector includes a sterile fluid conduit, a piercing member, and a sterile sleeve attached to a drug container or a sliding pierceable seal integrated within a drug container. The fluid pathway connector may further include one or more flow restrictors. Upon proper activation of the device  8000 , the fluid pathway connector  8300  is enabled to connect the sterile fluid conduit  8030  to the drug container of the drive mechanism  8100 . Such connection may be facilitated by a piercing member, such as a needle, penetrating a pierceable seal of the drug container of the drive mechanism  8100 . The sterility of this connection may be maintained by performing the connection within a flexible sterile sleeve. Upon substantially simultaneous activation of the insertion mechanism, the fluid pathway between drug container and insertion mechanism is complete to permit drug delivery into the body of the patient. In one such embodiment, the fluid pathway connector may be substantially similar to that described in International Patent Application No. PCT/US2012/054861, which is included by reference herein in its entirety for all purposes. In such an embodiment, a compressible sterile sleeve may be fixedly attached between the cap of the drug container and the connection hub of the fluid pathway connector. The piercing member may reside within the sterile sleeve until a connection between the fluid connection pathway and the drug container is desired. The sterile sleeve may be sterilized to ensure the sterility of the piercing member and the fluid pathway prior to activation. 
     Alternatively, the fluid pathway connector may be integrated into a drug container as described in International Patent Applications No. PCT/US2013/030478 or No. PCT/US2014/052329, for example, which are included by reference herein in their entirety for all purposes. According to such an embodiment, a drug container may have a drug chamber within a barrel between a pierceable seal and a plunger seal. A drug fluid is contained in the drug chamber. Upon activation of the device by the patient, a drive mechanism asserts a force on a plunger seal contained in the drug container. As the plunger seal asserts a force on the drug fluid and any air/gas gap or bubble, a combination of pneumatic and hydraulic pressure builds by compression of the air/gas and drug fluid and the force is relayed to the sliding pierceable seal. The pierceable seal is caused to slide towards the cap, causing it to be pierced by the piercing member retained within the integrated sterile fluid pathway connector. Accordingly, the integrated sterile fluid pathway connector is connected (i.e., the fluid pathway is opened) by the combination pneumatic/hydraulic force of the air/gas and drug fluid within the drug chamber created by activation of a drive mechanism. Once the integrated sterile fluid pathway connector is connected or opened, drug fluid is permitted to flow from the drug container, through the integrated sterile fluid pathway connector, sterile fluid conduit, and insertion mechanism, and into the body of the patient for drug delivery. In at least one embodiment, the fluid flows through only a manifold and a cannula and/or needle of the insertion mechanism, thereby maintaining the sterility of the fluid pathway before and during drug delivery. 
     In a preferred embodiment, the sterile fluid pathway connector is initiated by movement of the needle insertion mechanism, which itself is initiated by the multi-function drive mechanism. Additionally or alternatively, the sterile fluid pathway connector is initiated by movement directly of the multi-function drive mechanism. For example, the multi-function drive mechanism may include a rotational gear, such as the star gear described in detail herein, that acts concurrently or sequentially to control the rate of drug delivery, to actuate the needle insertion mechanism, and/or initiate the sterile fluid pathway connector. In one particular embodiment, shown in  FIGS. 69A-69C , the multi-function drive mechanism performs all of these steps substantially concurrently. The multi-function drive mechanism rotates a gear that acts upon several other components. The gear acts on a gear assembly to control the rate of drug delivery, while also contacting a needle insertion mechanism to introduce a fluid pathway into the patient. As the needle insertion mechanism is initiated, the sterile fluid connection is made to permit drug fluid flow from the drug container, through the fluid conduit, into the needle insertion mechanism, for delivery into the patient as the gear and gear assembly of the multi-function drive mechanism control the rate of drug delivery. 
     Regardless of the fluid pathway connector utilized by the drug delivery device, the drug delivery device is capable of delivering a range of drugs with different viscosities and volumes. The drug delivery device is capable of delivering a drug at a controlled flow rate (speed) and/or of a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow restrictors within the fluid pathway connector and/or the sterile fluid conduit. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery conduit, varying the speed at which a component of the drive mechanism advances into the drug container to dispense the drug therein, or combinations thereof. Still further details about the fluid pathway connector  8300  and the sterile fluid conduit  8030  are provided hereinafter in later sections in reference to other embodiments. 
     XI.D. Multi-Function Drive Mechanism 
     The multi-function drive mechanisms of the present disclosure enable or initiate several functions, including: (i) controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container; (ii) triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a patient; and (iii) connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. With reference to the embodiments shown in  FIGS. 70A-70D and 71A-71D , multi-function drive mechanism  8100  includes an actuator  8101 , a gear assembly  8110  including a main gear  8102 , a drive housing  8130 , and a drug container  8050  having a cap  8052 , a pierceable seal (not visible), a barrel  8058 , and a plunger seal  8060 . The main gear  8102  may be, for example, a star gear disposed to contact multiple secondary gears or gear surfaces. A drug chamber  8021 , located within the barrel  8058  between the pierceable seal and the plunger seal  8060 , may contain a drug fluid for delivery through the insertion mechanism and drug delivery device into the body of the patient. The seals described herein may be comprised of a number of materials but are, in a preferred embodiment, comprised of one or more elastomers or rubbers. The drive mechanism  8100  may further contain one or more drive biasing members, one or more release mechanisms, and one or more guides, as are described further herein. The components of the drive mechanism function to force a fluid from the drug container out through the pierceable seal, or preferably through the piercing member of the fluid pathway connector, for delivery through the fluid pathway connector, sterile fluid conduit, and insertion mechanism into the body of the patient. 
     In one particular embodiment, the drive mechanism  8100  employs one or more compression springs as the biasing member(s). Upon activation of the drug delivery device by the patient, the power and control system may be actuated to directly or indirectly release the compression spring(s) from an energized state. Upon release, the compression spring(s) may bear against and act upon the plunger seal to force the fluid drug out of the drug container. The compression spring may bear against and act upon a piston which, in turn, acts upon the plunger seal to force the fluid drug out of the drug container. The fluid pathway connector may be connected through the pierceable seal prior to, concurrently with, or after activation of the drive mechanism to permit fluid flow from the drug container, through the fluid pathway connector, sterile fluid conduit, and insertion mechanism, and into the body of the patient for drug delivery. In at least one embodiment, the fluid flows through only a manifold and a cannula of the insertion mechanism, thereby maintaining the sterility of the fluid pathway before and during drug delivery. Such components and their functions are described in further detail herein. 
     Referring now to the embodiment of the multi-function drive mechanism shown in  FIGS. 70A-70D and 70A-70D , multi-function drive mechanism  8100  includes an actuator  8101 , a gear assembly  8110  including a main gear  8102 , a drive housing  8130 , and a drug container  8050  having a cap  8052 , a pierceable seal (not visible), a barrel  8058 , and a plunger seal  8060 . The main gear  8102  may be, for example, a star gear disposed to contact multiple secondary gears or gear surfaces. A drug chamber  8021 , located within the barrel  8058  between the pierceable seal and the plunger seal  8060 , may contain a drug fluid for delivery through the insertion mechanism and drug delivery device into the body of the patient. Compressed within the drive housing  8130 , between the drug container  8050  and the proximal end of the housing  8130 , are one or more drive biasing members  8122  and a piston  8110 , wherein the drive biasing members  8122  are configured to bear upon an interface surface  8110 C of the piston  8110 , as described further herein. Optionally, a cover sleeve (not shown) may be utilized between the drive biasing members  8122  and the interface surface  8110 C of the piston  8110  to, for example, promote more even distribution of force from the drive biasing member  8122  to the piston  8110 , prevent buckling of the drive biasing members  8122 , and/or hide biasing members  8122  from patient view. Interface surface  8110 C of piston  8110  is caused to rest substantially adjacent to, or in contact with, a proximal end of seal  8060 . Although the embodiments shown in  FIGS. 70A-70D and 71A-71D  show a singular biasing member it is also contemplated that one or more biasing members disposed to act in parallel may be used. 
     As best shown in  FIG. 70D  and  FIG. 71D , the piston  8110  may be comprised of two components  8110 A and  8110 B and have an interface surface  8110 C to contact the plunger seal. A tether, ribbon, string, or other retention strap (referred to herein as the “tether”  8525 ) may be connected at one end to the piston  8110 A,  8110 B. For example, the tether  8525  may be connected to the piston  8110 A,  8110 B by retention between the two components of the piston  8110 A,  8110 B when assembled. The tether  8525  is connected at another end to a winch drum/gear  8520  of a delivery control mechanism  8500 . Through the use of the winch drum/gear  8520  connected to one end of the tether  8525 , and the tether  8525  connected at another end to the piston  8110 A,  8110 B, the regulating mechanism  8500  functions to control, meter, provide resistance, or otherwise prevent free axial translation of the piston  8110 A,  8110 B and plunger seal  8060  utilized to force a drug substance out of a drug container  8050 . Accordingly, the regulating mechanism  8500  is a portion of the gear assembly  8116  aspect of the multi-function drive mechanism, which together function to control the rate or profile of drug delivery to the patient. 
     As shown in  FIGS. 70A-70D and 71A-71D , and in isolation in  FIGS. 72 and 73A-73B , in the embodiments of the present disclosure, the regulating mechanism  8500  is gear assembly driven by an actuator  8101  of the multi-function drive mechanism  8100 . The regulating mechanism retards or restrains the distribution of tether  8525 , only allowing it to advance at a regulated or desired rate. This restricts movement of piston  8110  within barrel  8058 , which is pushed by one or more biasing members  8122 , hence controlling the movement of plunger seal  8060  and delivery of the drug contained in chamber  8021 . As the plunger seal  8060  advances in the drug container  8050 , the drug substance is dispensed through the sterile pathway connection  8300 , conduit  8030 , insertion mechanism  8200 , and into the body of the patient for drug delivery. The actuator  8101  may be a number of power/motion sources including, for example, a solenoid, a stepper motor, or a rotational drive motor. In a particular embodiment, the actuator  8101  is a rotational stepper motor with a notch that corresponds with the gear teeth of the main/star gear  8102 . Commonly, such a rotational stepper motor may be referred to as a Pac-Man′ motor. In at least one embodiment, the Pac-Man motor has a gear interface within which one or more teeth of the main gear may partially reside during operation of the system. This is more clearly visible in  FIGS. 73A-73B . When the gear interface  8101 A of the Pac-Man motor  8101  is in alignment with a tooth  8102 A of the main gear  8102 , rotational motion of the Pac-Man motor  8101  causes gear interface rotation of the main gear  8102 . When the Pac-Man motor  8101  is between gear teeth of the main gear, it may act as a resistance for, for example, back-spinning or unwinding of the gear assembly  8116 . Further detail about the gear assembly  8116 , regulating mechanism  8500 , and multi-function drive mechanism  8100  are provided herein. 
     In a particular embodiment shown in  FIGS. 73A-73B , the regulating element  8500  further includes one or more gears  8511 ,  8512 ,  8513 ,  8514 , of a gear assembly  8516 . One or more of the gears  8511 ,  8512 ,  8513 ,  8514  may be, for example, compound gears having a small diameter gear attached at a shared center point to a large diameter gear. Gear  8513  may be rotationally coupled to winch drum/gear  8520 , for example by a keyed shaft, thereby coupling rotation of gear assembly  8516  to winch drum/gear  8520 . Compound gear  8512  engages the small diameter gear  8513  such that rotational movement of the compound gear aspect  8512 B is conveyed by engagement of the gears (such as by engagement of corresponding gear teeth) to gear  8513 . Compound gear aspect  8512 A, the rotation of which is coupled to gear aspect  8512 B, is caused to rotate by action of compound gear aspect  8102 B of the main/star gear  8102 . Compound gear aspect  8102 B, the rotation of which is coupled to main/star gear  8102 , is caused to rotate by interaction between main/star gear  8102 A and interface  8101 A of the actuator  8101 . Thus, rotation of main/star gear  8102  is conveyed to winch drum/gear  8520 . Accordingly, rotation of the gear assembly  8516  initiated by the actuator  8101  may be coupled to winch drum/gear  8520  (i.e., through the gear assembly  8516 ), thereby controlling the distribution of tether  8525 , and the rate of movement of plunger seal  8060  within barrel  8058  to force a fluid from drug chamber  8021 . The rotational movement of the winch drum/gear  8520 , and thus the axial translation of the piston  8110  and plunger seal  8060 , are metered, restrained, or otherwise prevented from free axial translation by other components of the regulating element  8500 , as described herein. As described above, the actuator  8101  may be a number of known power/motion sources including, for example, a motor (e.g., a DC motor, AC motor, or stepper motor) or a solenoid (e.g., linear solenoid, rotary solenoid). 
     Notably, the regulating mechanisms  8500  of the present disclosure do not drive the delivery of fluid substances from the drug chamber  8021 . The delivery of fluid substances from the drug chamber  8021  is caused by the expansion of the biasing member  8122  from its initial energized state acting upon the piston  8110 A,  8110 B and plunger seal  8060 . The regulating mechanisms  8500  instead function to provide resistance to the free motion of the piston  8110 A,  8110 B and plunger seal  8060  as they are pushed by the expansion of the biasing member  8122  from its initial energized state. The regulating mechanism  8500  does not drive the delivery but only controls the delivery motion. The tether limits or otherwise restrains the motion of the piston  8110  and plunger seal  8060 , but does not apply the force for the delivery. According to a preferred embodiment, the controlled delivery drive mechanisms and drug delivery devices of the present disclosure include a regulating mechanism indirectly or directly connected to a tether metering the axial translation of the piston  8110 A,  8110 B and plunger seal  8060 , which are being driven to axially translate by the biasing member  8122 . The rate of drug delivery as controlled by the regulating mechanism may be determined by: selection of the gear ratio of gear assembly  8516 ; selection of the main/star gear  8102 ; selection of the diameter of winding drum/gear  8520 ; using electromechanical actuator  8101  to control the rate of rotation of the main/star gear  8102 ; or any other method known to one skilled in the art. By using electromechanical actuator  8101  the rate of rotation of the main/star gear  8102  it may be possible to configure a drug delivery device to provide a variable dose rate (i.e., the rate of drug delivery is varied during a treatment). 
     In another embodiment, the power and control system of the drug delivery device is configured to receive one or more inputs to meter the release of the tether  8525  by the winch drum/gear  8520  and thereby permit axial translation of the piston  8110  by the biasing member  8122  to translate a plunger seal  8060  within a barrel  8058 . The one or more inputs may be provided by the actuation of the activation mechanism, a control interface, and/or a remote control mechanism. The power and control system may be configured to receive one or more inputs to adjust the restraint provided by the tether  8525  and winch drum/gear  8520  on the free axial translation of the piston  8110  upon which the biasing member  8122  bears upon to meet a desired drug delivery rate or profile, to change the dose volume for delivery to the patient, and/or to otherwise start, stop, or pause operation of the drive mechanism. 
     The components of the drive mechanism  8100 , upon activation, may be used to drive axial translation in the distal direction of the plunger seal  8060  of the drug container  8050 . Optionally, the drive mechanism  8100  may include one or more compliance features which enable additional axial translation of the plunger seal  8060  to, for example, ensure that substantially the entire drug dose has been delivered to the patient. For example, the plunger seal  8060 , itself, may have some compressibility permitting a compliance push of drug fluid from the drug container. 
     The novel controlled delivery drive mechanisms of the present disclosure may optionally integrate status indication into the drug dose delivery. By use of one or more status triggers and a corresponding status reader, the status of the drive mechanism before, during, and after operation can be relayed to the power and control system to provide feedback to the patient. Such feedback may be tactile, visual, and/or auditory, as described above, and may be redundant such that more than one signal or type of feedback is provided to the patient during use of the device. For example, the patient may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the patient. At completion of drug delivery, the drive mechanism and drug delivery device may provide an end-of-dose indication. As the end-of-dose indication is tied to the piston reaching the end of its axial translation, the drive mechanism and drug delivery device provide a true end-of-dose indication to the patient. 
     The tether  8525  may have one or more status triggers, such as electrical contacts, optical markings, or electromechanical pins or recesses, which are capable of contacting or being recognized by a status reader. In at least one embodiment, an end-of-dose status indication may be provided to the patient once the status reader contacts or recognizes the final status trigger positioned on the tether  8525  that would contact the status reader at the end of axial travel of the piston  8110 A,  8110 B and plunger  8060  within the barrel  8058  of the drug container  8050 . The status reader may be, for example, an electrical switch reader to contact the corresponding electrical contacts, an optical reader to recognize the corresponding optical markings, or a mechanical or electromechanical reader configured to contact corresponding pins, holes, or similar aspects on the tether. The status triggers may be positioned along the tether  8525  to be read or recognized at positions which correspond with the beginning and end of drug delivery, as well as at desired increments during drug delivery. As the drug delivery device is activated and drug delivery is begun by release of the biasing member  8122  and the resulting force applied to the piston  8110 A,  8110 B and plunger seal  8060 , the rate or profile of drug delivery to the patient is controlled by the regulating mechanism  8500 , gear assembly  8516 , and winch drum/gear  8520  releasing the tether  8525  and permitting expansion of the biasing member  8122  and axial translation of the piston  8110 A,  8110 B and plunger seal  8060 . As this occurs, the status triggers of the tether  8525  are contacted or recognized by the status reader and the status of the drive mechanism before, during, and after operation can be relayed to the power and control system to provide feedback to the patient. Depending on the number of status triggers located on the tether  8525 , the frequency of the incremental status indication may be varied as desired. As described above, a range of status readers may be utilized depending on the status triggers utilized by the system. 
     In a preferred embodiment, the status reader may apply a tensioning force to the tether  8525 . When the system reaches end-of-dose, the tether  8525  goes slack and the status reader  8544  is permitted to rotate about a fulcrum. This rotation may operate an electrical or electromechanical switch, for example a switch, signaling slack in the tether  8525  to the power and control system. Additionally, a gear  8511  of gear assembly  8516  may act as an encoder along with a sensor. The sensor/encoder combination is used to provide feedback of gear assembly rotation, which in turn can be calibrated to the position of piston  8110  when there is no slack in the tether  8525 . Together, the status reader and sensor/encoder may provide positional feedback, end-of-dose signal, and error indication, such as an occlusion, by observing slack in the tether  8525  prior to reaching the expected number of motor rotations as counted by the sensor/encoder. 
     Referring back to  FIGS. 70A-70D and 71A-71D , in addition to controlling the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container (thereby delivering drug substances at variable rates and/or delivery profiles); the multi-function drive mechanisms of the present disclosure may concurrently or sequentially perform the steps of: triggering a needle insertion mechanism to provide a fluid pathway for drug delivery to a patient; and connecting a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. In at least one embodiment, as shown in  FIGS. 70A-70D and 71A-71D , initial motion by the actuator  8101  of the multi-function drive mechanism  8100  causes rotation of main/star gear  8102 . Main/star gear  8102  is shown as a compound gear with aspects  8102 A and  8102 B (see  FIG. 72 ). In one manner, main/star gear  8102  conveys motion to the regulating mechanism  8500  through gear assembly  8516 . In another manner, main/star gear  8102  conveys motion to the needle insertion mechanism  8200  through gear  8112 . As gear  8112  is rotated by main/star gear  8102 , gear  8112  engages the needle insertion mechanism  8200  to initiate the fluid pathway connector into the patient, as described in detail above. In one particular embodiment, needle insertion mechanism  8200  is a rotational needle insertion mechanism. Accordingly, gear  8112  is configured to engage a corresponding gear surface  8208  of the needle insertion mechanism  8200 . Rotation of gear  8112  causes rotation of needle insertion mechanism  8200  through the gear interaction between gear  8112  of the drive mechanism  8100  and corresponding gear surface  8208  of the needle insertion mechanism  8200 . Once suitable rotation of the needle insertion mechanism  8200  occurs, for example rotation along axis ‘R’ shown in  FIG. 70B-70C , the needle insertion mechanism may be initiated to create the fluid pathway connector into the patient, as described in detail above. 
     As shown in  FIGS. 70A-70D and 71A-71D , rotation of the needle insertion mechanism  8200  in this manner may also cause a connection of a sterile fluid pathway to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the patient. Ramp aspect  8222  of needle insertion mechanism  8200  is caused to bear upon a movable connection hub  322  of the sterile fluid pathway connector  8300 . As the needle insertion mechanism  8200  is rotated by the multi-function drive mechanism  8100 , ramp aspect  8222  of needle insertion mechanism  8200  bears upon and translates movable connection hub  322  of the sterile fluid pathway connector  8300  to facilitate a fluid connection therein. Such translation may occur, for example, in the direction of the hollow arrow along axis ‘C’ shown in  FIGS. 70B and 71B . In at least one embodiment, the needle insertion mechanism  8200  may be configured such that a particular degree of rotation upon rotational axis ‘R’ (shown in  FIGS. 70B-70C ) enables the needle/trocar to retract as detailed above. Additionally or alternatively, such needle/trocar retraction may be configured to occur upon a patient-activity or upon movement or function of another component of the drug delivery device. In at least one embodiment, needle/trocar retraction may be configured to occur upon end-of-drug-delivery, as triggered by, for example, the regulating mechanism  8500  and/or one or more of the status readers as described above. During these stages of operation, delivery of fluid substances from the drug chamber  8021  may be initiated, on-going, and/or completed by the expansion of the biasing member  8122  from its initial energized state acting upon the piston  8110 A,  8110 B and plunger seal  8060 . As described above, the regulating mechanisms  8500  function to provide resistance to the free motion of the piston  8110 A,  8110 B and plunger seal  8060  as they are pushed by the expansion of the biasing member  8122  from its initial energized state. The regulating mechanism  8500  does not drive the delivery but only controls the delivery motion. The tether limits or otherwise restrains the motion of the piston  8110  and plunger seal  8060 , but does not apply the force for the delivery. This is visible through the progression of the components shown in  FIGS. 70A-70D and 71A-71D . The motion of the piston  8110 A,  8110 B and plunger seal  8060  as they are pushed by the expansion of the biasing member  8122  from its initial energized state are shown in the direction of the solid arrow along axis ‘A’ from proximal or first position ‘F’ to the distal or second position ‘D’, as shown in the transition of  FIGS. 70A-70D and 71A-71D . 
     Further aspects of the novel drive mechanism will be described with reference to  FIG. 72  and  FIGS. 73A-73B .  FIG. 4  shows a perspective view of the multi-function drive mechanism, according to at least a first embodiment, during its initial locked stage. Initially, the tether  8525  may retain the biasing member  8122  in an initial energized position within piston  8110 A,  8110 B. Directly or indirectly upon activation of the device by the patient, the multi-function drive mechanism  8100  may be activated to permit the biasing member to impart a force to piston  8110  and therefore to tether  8525 . This force on tether  8525  imparts a torque on winding drum  8520  which causes the gear assembly  8516  and regulating mechanism  8500  to begin motion. As shown in  FIG. 73A , the piston  8110  and biasing member  8122  are both initially in a compressed, energized state behind the plunger seal  8060 . The biasing member  8122  may be maintained in this state until activation of the device between internal features of drive housing  8130  and interface surface  8110 C of piston  8110 A,  8110 B. As the drug delivery device  8000  is activated and the drive mechanism  8100  is triggered to operate, biasing member  8122  is permitted to expand (i.e., decompress) axially in the distal direction (i.e., in the direction of the solid arrow shown in  FIGS. 70A-70D  and  FIGS. 71A-71D ). Such expansion causes the biasing member  8122  to act upon and distally translate interface surface  8110 C and piston  8110 , thereby distally translating plunger seal  8060  to push drug fluid out of the drug chamber  8021  of barrel  8058 . In at least one embodiment, an end-of-dose status indication may be provided to the patient once the status reader contacts or recognizes a status trigger positioned on the tether  8525  to substantially correspond with the end of axial travel of the piston  8110 A,  8110 B and plunger seal  8060  within the barrel  8058  of the drug container  8050 . The status triggers may be positioned along the tether  8525  at various increments, such as increments which correspond to certain volume measurement, to provide incremental status indication to the patient. In at least one embodiment, the status reader is an optical status reader configured to recognize the corresponding optical status triggers on the tether. As would be understood by an ordinarily skilled artisan, such optical status triggers may be markings which are recognizable by the optical status reader. In another embodiment, the status reader is a mechanical or electromechanical reader configured to physically contact corresponding pins, holes, or similar aspects on the tether. Electrical contacts could similarly be utilized on the tether as status indicators which contact or are otherwise recognized by the corresponding electrical status reader. The status triggers may be positioned along the tether  8525  to be read or recognized at positions which correspond with the beginning and end of drug delivery, as well as at desired increments during drug delivery. As shown, tether  8525  passes substantially axially through the drive mechanism housing  8130 , the biasing member  8122 , and connects to the piston  8110 A,  8110 B to restrict the axial translation of the piston  8110 A,  8110 B and the plunger seal  8060  that resides adjacent thereto. 
     The novel embodiments of the present disclosure may be utilized to meter, restrain, or otherwise prevent free rotational movement of winding drum  8520  and, thus, axial translation of the components of the controlled delivery drive mechanism  8100 . Accordingly, the regulating mechanism  8500  only controls the motion of the drive mechanism, but does not apply the force for the drug delivery. One or more additional biasing members  8122 , such as compression springs, may be utilized to drive or assist the driving of the piston  8110 . For example, a compression spring may be utilized within the drive housing  8130  for this purpose. The regulating mechanism  8500  only controls, meters, or regulates such action. The controlled delivery drive mechanisms and/or drug delivery devices of the present disclosure may additionally enable a compliance push to ensure that substantially all of the drug substance has been pushed out of the drug chamber  8021 . The plunger seal  8060 , itself, may have some compressibility permitting a compliance push of drug fluid from the drug container. For example, when a pop-out plunger seal is employed, i.e., a plunger seal that is deformable from an initial state, the plunger seal may be caused to deform or “pop-out” to provide a compliance push of drug fluid from the drug container. Additionally or alternatively, an electromechanical status switch and interconnect assembly may be utilized to contact, connect, or otherwise enable a transmission to the power and control system to signal end-of-dose to the patient. This configuration further enables true end-of-dose indication to the patient. 
     In at least one embodiment, incremental status indication may be provided to the patient by reading or recognizing the rotational movement of one or more gears of gear assembly  8516 . As the gear assembly  8516  rotates, a status reader may read or recognize one or more corresponding status triggers on one of the gears in the gear assembly to provide incremental status indication before, during, and after operation of the variable rate controlled delivery drive mechanism. A number of status readers may be utilized within the embodiments of the present disclosure. For example, the drive mechanism may utilize a mechanical status reader which is physically contacted by gear teeth of one of the gears of the gear assembly. As the status reader is contacted by the status trigger(s), which in this exemplary embodiment may be the gear teeth of one of the gears (or holes, pins, ridges, markings, electrical contacts, or the like, upon the gear), the status reader measures the rotational position of the gear and transmits a signal to the power and control system for status indication to the patient. Additionally or alternatively, the drive mechanism may utilize an optical status reader. The optical status reader may be, for example, a light beam that is capable of recognizing a motion and transmitting a signal to the power and control system. For example, the drive mechanism may utilize an optical status reader that is configured to recognize motion of the gear teeth of one of the gears in the gear assembly (or holes, pins, ridges, markings, electrical contacts, or the like, upon the gear). Similarly, the status reader may be an electrical switch configured to recognize electrical contacts on the gear. In any of these embodiments, the sensor may be utilized to then relay a signal to the power and control system to provide feedback to the patient. 
     As would be appreciated by one having ordinary skill in the art, optical status readers and corresponding triggers, electromechanical status readers and corresponding triggers, and/or mechanical status readers and corresponding triggers may all be utilized by the embodiments of the present disclosure to provide incremental status indication to the patient. While the drive mechanisms of the present disclosure are described with reference to the gear assembly and regulating mechanism shown in the Figures, a range of configurations may be acceptable and capable of being employed within the embodiments of the present disclosure, as would readily be appreciated by an ordinarily skilled artisan. Accordingly, the embodiments of the present disclosure are not limited to the specific gear assembly and regulating mechanism described herein, which is provided as an exemplary embodiment of such mechanisms for employment within the controlled delivery drive mechanisms and drug delivery pumps. 
     Assembly and/or manufacturing of controlled delivery drive mechanism  8100 , drug delivery drug delivery device  8000 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization and/or lubrication fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The drive mechanism may be assembled in a number of methodologies. In one method of assembly, the drug container  8050  may first be assembled and filled with a fluid for delivery to the patient. The drug container  8050  includes a cap  8052 , a pierceable seal  8056 , a barrel  8058 , and a plunger seal  8060 . The pierceable seal  8056  may be fixedly engaged between the cap  8052  and the barrel  8058 , at a distal end of the barrel  8058 . The barrel  8058  may be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal  8060  from the proximal end of the barrel  8058 . An optional connection mount  854  may be mounted to a distal end of the pierceable seal  8056 . The connection mount  854  may guide the insertion of the piercing member of the fluid pathway connector into the barrel  8058  of the drug container  8050 . The drug container  8050  may then be mounted to a distal end of drive housing  8130 . 
     One or more drive biasing members  8122  may be inserted into a distal end of the drive housing  8130 . Optionally, a cover sleeve  8140  may be inserted into a distal end of the drive housing  8130  to substantially cover biasing member  8122 . A piston may be inserted into the distal end of the drive housing  8130  such that it resides at least partially within an axial pass-through of the biasing member  8122  and the biasing member  8122  is permitted to contact a piston interface surface  8110 C of piston  8110 A,  8110 B at the distal end of the biasing member  8122 . An optional cover sleeve  8140  may be utilized to enclose the biasing member  8122  and contact the piston interface surface  8110 C of piston  8110 A,  8110 B. The piston  8110 A,  8110 B and drive biasing member  8122 , and optional cover sleeve  8140 , may be compressed into drive housing  8130 . Such assembly positions the drive biasing member  8122  in an initial compressed, energized state and preferably places a piston interface surface  8110 C in contact with the proximal surface of the plunger seal  8060  within the proximal end of barrel  8058 . The piston, piston biasing member, contact sleeve, and optional components, may be compressed and locked into the ready-to-actuate state within the drive housing  8130  prior to attachment or mounting of the drug container  8050 . The tether  8525  is pre-connected to the proximal end of the piston  8110 A,  8110 B and passed through the axial aperture of the biasing member  8122  and drive mechanism  8130 , and then wound through the interior of the drug delivery device with the other end of the tether  8525  wrapped around the winch drum/gear  8520  of the regulating mechanism  8500 . 
     A fluid pathway connector, and specifically a sterile sleeve of the fluid pathway connector, may be connected to the cap and/or pierceable seal of the drug container. A fluid conduit may be connected to the other end of the fluid pathway connector which itself is connected to the insertion mechanism such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connector, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a patient. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device, as shown in  FIG. 69B . 
     Certain optional standard components or variations of drive mechanism  8100  or drug delivery device  8000  are contemplated while remaining within the breadth and scope of the present disclosure. For example, the embodiments may include one or more batteries utilized to power a motor or solenoid, drive mechanisms, and drug delivery devices of the present disclosure. A range of batteries known in the art may be utilized for this purpose. Additionally, upper or lower housings may optionally contain one or more transparent or translucent windows  18  to enable the patient to view the operation of the drug delivery device  8000  or verify that drug dose has completed. Similarly, the drug delivery device  8000  may contain an adhesive patch  8026  and a patch liner  8028  on the bottom surface of the housing  8012 . The adhesive patch  8026  may be utilized to adhere the drug delivery device  8000  to the body of the patient for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  8026  may have an adhesive surface for adhesion of the drug delivery device to the body of the patient. The adhesive surface of the adhesive patch  8026  may initially be covered by a non-adhesive patch liner  8028 , which is removed from the adhesive patch  8026  prior to placement of the drug delivery device  8000  in contact with the body of the patient. Removal of the patch liner  8028  may further remove the sealing membrane  254  of the insertion mechanism  8200 , opening the insertion mechanism to the body of the patient for drug delivery (as shown in  FIG. 69C ). In some embodiments, removal of the patch liner  8028  may also wake-up onboard electronics (e.g., the power and control system  2400 ) by supplying them with electricity from an onboard battery. 
     Similarly, one or more of the components of controlled delivery drive mechanism  8100  and drug delivery device  8000  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  8000  is shown as two separate components upper housing  8012 A and lower housing  8012 B, these components may be a single unified component. As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the controlled delivery drive mechanism and/or drug delivery device to each other. Alternatively, one or more components of the controlled delivery drive mechanism and/or drug delivery device may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the controlled delivery drive mechanisms and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide drive mechanisms for the controlled delivery of drug substances and drug delivery pumps which incorporate such controlled delivery drive mechanisms. The drive mechanisms of the present disclosure control the rate of drug delivery by metering, providing resistance, or otherwise preventing free axial translation of the plunger seal utilized to force a drug substance out of a drug container and, thus, are capable of delivering drug substances at variable rates and/or delivery profiles. Additionally, the drive mechanisms of the present disclosure may provide integrated status indication features which provide feedback to the patient before, during, and after drug delivery. For example, the patient may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the patient. At completion of drug delivery, the drive mechanism and drug delivery device may provide an end-of-dose indication. The novel controlled delivery drive mechanisms of the present disclosure may be directly or indirectly activated by the patient. Furthermore, the novel configurations of the controlled delivery drive mechanism and drug delivery devices of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. 
     Manufacturing of a drug delivery device includes the step of attaching both the controlled delivery drive mechanism and drug container, either separately or as a combined component, to an assembly platform or housing of the drug delivery device. The method of manufacturing further includes attachment of the fluid pathway connector, drug container, and insertion mechanism to the assembly platform or housing. The additional components of the drug delivery device, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug delivery device that contacts the patient during operation of the device. 
     A method of operating the drug delivery device includes the steps of: activating, by a patient, the activation mechanism; displacing a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a controlled delivery drive mechanism to drive fluid drug flow through the drug delivery device according to a controlled rate or drug delivery profile. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. The method similarly may include the step of: establishing a connection between a fluid pathway connector to a drug container. Furthermore, the method of operation may include translating a plunger seal within the controlled delivery drive mechanism by the expansion of the biasing member acting upon a piston within a drug container to force fluid drug flow through the drug container, the fluid pathway connector, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to the body of a patient, wherein a regulating mechanism acting to restrain the distribution of a tether is utilized to meter the free axial translation of the piston. The method of operation of the drive mechanism and the drug delivery device may be better appreciated with reference to  FIGS. 70A-70D  and  FIGS. 71A-71D , as described above. 
     XII. Temperature Control System 
     For some drugs, temperature is an important consideration both during and prior to patient delivery. Biologic drugs, for example, oftentimes require refrigeration or frozen storage prior to patient delivery. While cold temperatures may help extend the shelf life of the drug, they can result in an increased viscosity of the drug. A more viscous drug may take longer to inject and/or require additional injection force. Furthermore, injecting a cold drug can be uncomfortable, and potentially even painful, for some patients. Therefore, a drug which has been stored in a cold state usually is allowed to warm to near room temperature prior to patient delivery. This warming up period can take upwards of 30 minutes, which can be inconvenient to the patient and consequently have an adverse impact on patient compliance rates. 
     The drug delivery devices of the present disclosure can be configured to include a temperature control system for monitoring and/or controlling the temperature of the drug within the device. One embodiment of a drug delivery device, denoted by reference numeral  11010 , incorporating a temperature control system  11600  according to principles of the present disclosure is illustrated by  FIG. 77 . While the temperature control system  11600  is described in conjunction with particular elements and features of the drug delivery device  11010 , the temperature control system  11600  can be implemented, where appropriate, in any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 . Various elements of the drug delivery device  11010  are similar in structure and/or function to those previously described in connection with the drug delivery device  10 . These elements are assigned reference numbers similar to those previously provided with the addition of the two-digit suffix “11,” and, for the sake of brevity, are not described in detail below. For example, the drug delivery device  11010  includes a needle insertion mechanism  11200  which bears at least some similarities in structure and/or function to the needle insertion mechanism  200  of the drug delivery device  10 . It should be noted, however, that the temperature control system  11600  is not limited to being used in conjunction with elements of the drug delivery device  10 , and can be implemented in any one of the drug delivery devices disclosed herein, where appropriate. 
     Turning to  FIG. 77 , the drug delivery device  11600  may include a start button  11014 , a drug container  11050 , a drive mechanism  11100 , a needle insertion mechanism  11200 , a fluid pathway connector  11300 , a power and control system  11400 , and a temperature control system  11600 . The drug container  11050  may include a barrel  11058  and a plunger seal  11060  moveable through the barrel  11058  to discharge a drug from the barrel  11058 , and a pierceable seal (not illustrated) controlling access to an interior of the barrel  11058 . The drive mechanism  11100  may include a drive housing  11130 , a piston  11110  moveable relative to the drive housing  11130  and configured to impart movement to the plunger seal  11060 , and a piston biasing member  11106  disposed between the drive housing  11130  and the piston  11110 . The fluid pathway connector  11300  may define a sterile fluid flowpath between the drug container  11050  and the insertion mechanism  11200 . The fluid pathway connector  11300  may include a connection hub  11310 , a tubular conduit  11030  providing fluid communication between the connection hub  11310  and the insertion mechanism  11200 , and a piercing member (not illustrated) configured to pierce the pierceable seal to establish fluid communication between the between the barrel  11058  and the tubular conduit  11030  during drug delivery. 
     The tubular conduit  11030  may include a first flexible tube  11032 , a second flexible tube  11034 , and a rigid tube  11036  connected and providing fluid communication between the first and second flexible tubes  11032  and  11034 . The first flexible tube  11032  may fluidly connect the connection hub  11310  with a proximal end  11037  of the rigid tube  11036 , and the second flexible tube  11032  may fluidly connect the needle insertion mechanism  11200  with a distal end  11038  of the rigid tube  11036 . The first and second flexible tubes  11032  and  11034  each may be made of a material that is more flexible than the material used to construct the rigid tube  11036 . In at least one embodiment, the first and second flexible tubes  11032 ,  11034  are made of a polymeric material, and the rigid tube  11036  is made of metal. As described below, the material used to construct the rigid tube  11036  may possess a relatively high thermal conductivity such that heat can be transferred from a heating element to a drug flowing through the rigid tube  11036  during delivery. 
     An inner diameter of the rigid tube  11036  may be less than an inner diameter of the first flexible tube  11032  and/or the second flexible tube  11034 . Accordingly, the rigid tube  11036  may serve as a flow restrictor that reduces and/or regulates the flow rate of the drug during delivery. The rigid tube  11036  may be replaced with other rigid tubes having different inner diameters depending on the target flow rate. Furthermore, the inclusion of a flow restrictor may provide broadened design space when coupled with other contributing elements such as a drive spring. In an alternative embodiment, the rigid tube  11036  may have an inner diameter that is equal to that of the first flexible tube  11032  and/or the second flexible tube  11034 . 
     Still referring to  FIG. 77 , the temperature control system  11600  may include a heating element  11602 , a first temperature sensor  11604 , and a second temperature sensor  11606 . In the illustrated embodiment, the heating element  11602  includes an electrically-conductive coil that is wrapped around and contacts an exterior of the rigid tube  10036 . The heating element  11602  may be electrically connected to the power and control system  11400 , such that the heating element  11602  is supplied with electricity from the power and control system  11400  in a controlled manner. The impedance of the material used to construct the heating element  11602  may cause the heating element  11602  to convert at least some of the electricity it is supplied with into heat. Due to the contact or close proximity of the heating element  11602  to the rigid tube  11036 , the heat generated by the heating element  11602  may warm the rigid tube  11036 , and due to the thermal conductivity of the rigid tube  11036 , warm a drug flowing through the rigid tube  11036 . 
     The inclusion of the heating element  11602  may eliminate the need for a pre-delivery warming period in the case where the drug delivery device  11010  has been removed from cold storage. Furthermore, heat transfer from the heating element  11602  to the drug may be relatively efficient, because the volume of drug per unit length of the rigid tube  11036  is relatively small. Therefore, it may be possible to warm the drug to a target temperature without reducing the flow rate or increasing the length of the flow path. Accordingly, it may be possible to heat the drug during delivery without altering the duration of delivery. Moreover, the heating element  11602  can be installed with little or no modifications to a pre-existing fluid pathway connector, thereby reducing manufacturing and/or design costs. 
     In some embodiments, the heating element  11602  may be dynamically controlled based on real-time drug temperature measurements to ensure that the drug is delivered to the patient at a desired temperature. As shown in  FIG. 77 , the first temperature sensor  11604  may be connected to the proximal end  11037  of the rigid tube  11036  so that the first temperature sensor  11604  can measure the temperature of the drug flowing into the rigid tube  11036 . The second temperature sensor  11606  may be connected to the distal end  11038  of the rigid tube  11036  so that the second temperature sensor  11606  can measure the temperature of the drug flowing out of the rigid tube  11036 . In some embodiments, the first and second temperature sensors  11604  and  11606  may not directly measure the temperature of the drug. Rather, the first and second temperatures sensors  11604  and  11060  may measure the temperature of, respectively, the inlet and outlet portions of the rigid tube  11036  (or other portions of the drug delivery device proximate to the drug). These temperatures measurements could be used to extrapolate the temperature of the drug based on heat transfer characteristics of the material used to construct the rigid tube  11036  (or the other portions of the drug delivery device proximate to the drug). 
     The first and second temperature sensors  11604  and  11606  may be output their temperature measurements to the power and control system  11400 , which may analyze the temperature measurements to determine an amount of electricity that must be supplied to the heating element  11602  to achieve a target drug temperature. Additionally, the temperature measurements of the first and second temperature sensors  11604  and  11606  may be analyzed by the power and control system  11400  according to thermal dilution techniques in order to determine the flow rate of the drug. Furthermore, in an embodiment where the drug delivery device incorporates a motor-controlled regulating mechanism to control the expansion of the piston biasing member (e.g., akin to the drug delivery device  6000  or  8000 ), the power and control system  11400  may control the motor based on the output of the first and second temperature sensors  11604  and  11606  to reduce the flow rate if the drug has not been sufficiently warmed by the heating element  11602 , so that the patient does not experience a painful injection due to cold temperatures. Furthermore, input from the first and second temperature sensors  11604  and  11606  may be used to determine if the drug has been overheated by the heating element  11602  and therefore no longer suitable for injection, in which case the drive mechanism  11100  may be locked out. Additional temperature sensors may be included to monitor the temperature of the drug in the container during, for example, storage to determine if the drug has been stored at an appropriate temperature. If not, the power and control system  11400  may lockout the device and/or alert the patient that the drug is no longer viable. 
     The temperature control system  11600  may additionally include temperature indicators (e.g., lights, sounds, graphical displays, etc.) for informing the user of the drug temperature and/or whether the drug temperature is suitable for injection. 
     While the embodiment of the tubular conduit illustrated in  FIG. 77  incorporates two flexible tubes and a rigid tube connected therebetween, alternative embodiments may forgo the rigid tube so that the tubular conduit is formed by a single, unitary flexible tube. In such an embodiment, the heating element  11602  may be wrapped around the single, unitary flexible tube. 
     In one alternative embodiment, the power and control system  11400  may serve as the heating element  11602 , or as a supplemental heating element. The power and control system  11400  may include a circuit board and/or other electronics that heat up while performing their data processing functions. By positioning the circuit board and/or other electronics immediately adjacent to the tubular conduit  11030  (e.g., immediately above the tubular conduit  11030 ), the heat generated by the circuit board and/or other electronics can be used to warm the drug as it flows through the tubular conduit  11030 . Also, in some embodiments, it may be desirable that the heat generated by the power and control system  11400  is not permitted to warm the drug. In such embodiments, the power and control system  11400  may include a heat sink that is remote from the drug container, the fluid pathway connector, and/or the insertion mechanism, so that the heat sink can draw heat away from regions of the drug delivery device including the drug. 
     While the heating element  11602  described above generates heat primarily through electrical resistance, other embodiments of the heating element may generate heat through other means, including, but not limited to, induction, the Peltier effect, and/or a chemical reaction. 
     Furthermore, other embodiments of the temperature control system  11600  may include a cooling system (not illustrated) for lowering the temperature of the drug while it is disposed in the container  11050  and/or flows through the tubular conduit  11030 . Such a cooling system may employ a fan which draws in cool air from outside the drug delivery device and/or expels warm air from inside the drug delivery device. Alternatively, or additionally, the cooling system may employ the following to reduce the temperature of the drug: a thermoelectric cooling element the exploits the Peltier effect and/or a chemical reaction. 
     XIII. Skin Attachment 
     The drug delivery devices of the present disclosure may be configured for temporary attachment to a patient&#39;s body tissue (e.g., the patient&#39;s skin) while the drug is delivered. The drug delivery device may be attached to the tissue of the patient&#39;s abdomen, thigh, arm or some other portion of the patient&#39;s body. As described above, an adhesive patch (e.g., the adhesive patch  26 ) may be disposed on or over a base of the housing to adhere the drug delivery device to the patient&#39;s body tissue. The adhesive surface of the adhesive patch may initially be covered by a non-adhesive patch liner (e.g., the non-adhesive patch liner  28 ), which is removed from the adhesive patch  26  prior to placement of the drug delivery device in contact with the patient&#39;s body tissue. 
     Disengaging the adhesive from the patient&#39;s body tissue may cause to patient discomfort, particularly if the adhesive engages a large surface area of the patient&#39;s body tissue. Therefore, to reduce the amount of body tissue in contact with adhesive, only a limited portion of drug delivery device&#39;s base may be covered with adhesive.  FIGS. 78A and 78B  illustrate, respectively, adhesive patches  12000  and  12100  which reduce the amount body tissue in contact with adhesive, yet still provide adequate adhesion to secure the drug delivery device to the patient&#39;s body tissue during drug delivery. The adhesive patches  12000  and  12100  each may be applied to the base of any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 . 
       FIG. 78A  shows that the adhesive patch  12000  includes a pattern of adhesive dots  12002  with non-adhesive regions  12004  located therebetween. The illustrated pattern is symmetric and includes equally-spaced rows and columns of circular adhesive dots  12202 . Alternative embodiments may have a non-symmetric pattern and/or non-circular adhesive dots. The adhesive patch  12000  includes a base  12006  having a first side (not illustrated) for attachment to the drug delivery device and an opposite second side  12006  including the pattern of adhesive dots  12002 . In alternative embodiments, the base  12006  may be omitted, and the pattern of adhesive dots  12002  may be applied directly to an exterior surface of the drug delivery device. 
     Instead of adhesive dots, the adhesive patch  12100  shown in  FIG. 78B  includes a plurality of adhesive strips  12102 , with non-adhesive regions  12104  located therebetween. The adhesive strips  12102  are equally-spaced and extend lengthwise across the adhesive patch  12100 . Alternative embodiments may have non-linear (e.g., curved) adhesive strips and/or the adhesive strips may extend widthwise across the adhesive patch  12100 . The adhesive patch  12100  includes a base  12106  having a first side (not illustrated) for attachment to the drug delivery device and an opposite second side  12106  including the adhesive strips  12102 . In alternative embodiments, the base  12106  may be omitted, and the pattern of adhesive strips  12102  may be applied directly to an exterior surface of the drug delivery device. A non-adhesive patch liner (e.g., the non-adhesive patch liner  28 ) may be used to cover the adhesive sides of each of the adhesive patches  12100  and  12200  prior to use. 
       FIG. 79  illustrates an embodiment of a non-adhesive patch liner, denoted by reference numeral  12300 , including stiffening members  12310  for imparting rigidity to the non-adhesive patch liner  12300  as well as an adhesive patch (e.g., the adhesive patch  28 ,  12100 , or  12200 ) covered by the non-adhesive patch liner  12300 . A body  12312  of the non-adhesive patch liner  12300  may be co-extensive with the adhesive patch to prevent unintended adhesion prior to use of the drug delivery device. The stiffening members  12310  may each be made of a more rigid material (e.g., metal or hardened plastic) than the body  12312  of the non-adhesive patch liner  12300 . Additionally, as shown in  FIG. 79 , each of the stiffening members  12310  may have a tapered shape, with a width that narrows as the stiffening member  12310  approaches the outer peripheral edge of the body  12312 . The rigidity imparted by the stiffening members  12300  to the outer peripheral edge of the adhesive patch, which may extend beyond the outer edge of the body of the drug delivery  12340  device as shown in  FIG. 79 , renders the outer peripheral edge of the adhesive patch less likely to experience curling. Accordingly, the stiffening members  12310  may help the adhesive patch retain its planar shape so that the patient can press the adhesive patch flushly against the patient&#39;s body tissue upon removal of the non-adhesive patch liner  12300 . 
     While the embodiment of the non-adhesive patch liner illustrated in  FIG. 79  includes stiffening members located at discrete points around the periphery of the non-adhesive patch liner, other embodiments of the non-adhesive patch liner may include a stiffening member that extends continuously around the periphery of the non-adhesive patch liner.  FIG. 80A  illustrates an exploded assembly view of a non-adhesive patch liner  12400 , an adhesive patch  12500 , and a base  12600  of a drug delivery device. The adhesive patch  12500  may be similar to one of the adhesive patches disclosed herein, including, but not limited to, any one of the adhesive patches  28 ,  12100 , or  12200 . The non-adhesive patch liner  12400  may include a central body portion  12402  and a ring-shaped stiffening portion  12404  positioned around the periphery of the central body portion  12402  (as seen in the assembled view shown in  FIG. 80B ). The central body portion  12402  may cover a central portion of the adhesive patch  12500 , leaving an outer peripheral edge of the adhesive patch  12500  exposed. The ring-shaped stiffening portion  12404  may be used to cover this exposed outer peripheral edge of the adhesive patch  12500 , thereby preventing it from curling. In some embodiments, the ring-shaped stiffening portion  12404  may cover and contact each of: an outer peripheral edge of the central body portion  12402 , an outer peripheral edge of the adhesive patch  12500 , and a portion of the base  12600  of the drug delivery device surrounding the adhesive patch  12500 . In such an embodiment, the underside of the ring-shaped stiffening portion  12404  may be include an adhesive for adhering the ring-shaped stiffening portion  12404  directly to the base  12600  of the drug delivery device and the central body portion  12402 . As such, removing the central body portion  12402  (e.g., by pulling a tab extending from the central body  12402 ) may disengage the ring-shaped stiffening portion  12404  from the base  12600  of the drug delivery device as well as the adhesive patch  12500 . 
     While the stiffening members described above may be attached to or integrally formed with the non-adhesive patch liner, alternative embodiments of the stiffening members may be attached to or integrally formed with the adhesive patch.  FIG. 81  illustrates a drug delivery device  12710  (which may correspond to any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 ) including a housing  12712 , an adhesive patch  12726  attached to the underside of the housing  12712 , and a non-adhesive patch liner  12728  removably attached to the underside of the adhesive patch  12726 . 
     The adhesive patch  12726  may include a base  12730  and a plurality of stiffening members  12732 . The base  12730  may have an upper surface  12734  rigidly attached to the underside of the housing  12712  and a lower surface (hidden in  FIG. 81 ) covered with a skin adhesive. The base  12730  may have a larger footprint than the housing  12712  such that an outer peripheral portion  12736  of the base  12730  forms a skirt that extends beyond the outer edge of the housing  12712 . 
     Still referring to  FIG. 81 , the stiffening members  12732  may be formed in the outer peripheral portion  12736  of the base  12730 . In the illustrated embodiment, the stiffening members  12732  and the base  12730  are integrally formed such that the stiffening members  12732  and the base  12730  form a single, unitary structure made of a single material. Alternatively, the stiffening members  12732  may be distinct structures from the base  12730 . As illustrated in  FIG. 81 , the stiffening members  12732  may be designed as a plurality of equally spaced ribs located at discrete locations around the periphery of the base  12730 . Furthermore, the stiffening members  12732  may protrude upwardly from the upper surface  12734  of the outer peripheral portion  12736  of the base  12730 . Nevertheless, the height of the stiffening members  12732  may be such that the tops of the stiffening members  12732  are located below the bottom surface of the housing  12712 . 
     The stiffening members  12732  may impart rigidity to the adhesive patch  12726  so that the adhesive patch  12726  can retain its generally planar shape. Accordingly, the periphery of the adhesive patch  12726  is less likely to fold over on itself, or experience, curling when the drug delivery device  12710  is being applied to the patient&#39;s skin or when the non-adhesive patch liner  12728  is being removed. 
     Referring to  FIG. 82 , in at least one embodiment, the non-adhesive patch liner  12728  may be comprised of separate first and second sections  12740  and  12742  covering respective portions of the underside of the adhesive patch  12726 . The first section  12740  may have a first tab  12744  which protrudes outwardly from a side of the adhesive patch  12726 , and the second section  12742  may have a second tab  12746  which protrudes outwardly from an opposite side of the adhesive patch  12726 . The first and second sections  12740  and  12742  may be removed separately by pulling, respectively, on the first and second tabs  12744  and  12746 , as described below with reference to  FIGS. 83A-83C . 
     In at least one embodiment, the process of attaching the drug delivery device  12710  to the patient&#39;s skin  12750  may involve the following steps. Initially, the non-adhesive patch liner  12728  may be disposed against the patient&#39;s skin  12750 . Next, while the user or patient pushes down on a first end  12752  of the housing  12712  (opposite to the first tab  12744 ), the first tab  12744  may be pulled outwardly to remove the first section  12740  of the non-adhesive patch liner  12728  from the adhesive patch  12726 , as illustrated in  FIG. 83A . Subsequently, while the user or patient pushes down on a second end  12754  of the housing  12712  (opposite to the second tab  12746 ), the second tab  12746  may be pulled outwardly to remove the second section  12742  of the non-adhesive patch liner  12728  from the adhesive patch  12726 , as seen in  FIG. 83B . This will result in the adhesive patch  12726  being flush with the patient&#39;s skin  12750 , as shown in  FIG. 83C . 
     In some embodiments, such as the one illustrated in  FIGS. 83A-83C , the first tab  12744  may be formed by a portion of the first section  12740  of the non-adhesive patch liner  12728  that is folded back on itself. More particularly, the first section  12740  may have a first end  12760  in contact with the adhesive patch  12726  and a second end  12762  folded over the first end  12760  and configured to initially contact the patient&#39;s skin  12750 . The second end  12762  may include the first tab  12744 . By pulling the first tab  12744  outwardly, the first end  12760  of the first section  12740  may unroll such that it is peeled away from the adhesive patch  12726 . This configuration of the first section  12740  of the non-adhesive patch liner  12728  may facilitate the removal of the first section  12740  from the adhesive patch  12726  despite the drug delivery device  12710  being push against the patient&#39;s skin  12750 , as shown in  FIG. 83A . 
     Similarly, the second tab  12746  may be formed a portion of the second section  12742  of the non-adhesive patch liner  12728  that is folded back on itself. More particularly, the second section  12742  may have a first end  12770  in contact with the adhesive patch  12726  and a second end  12772  folded over the first end  12770  and configured to initially contact the patient&#39;s skin  12750 . The second end  12772  may include the second tab  12746 . By pulling the second tab  12746  outwardly, the second end  12770  of the second section  12746  may unroll such that it is peeled away from the adhesive patch  12726 . Like the first section  12740 , this configuration of the second section  12742  of the non-adhesive patch liner  12728  may facilitate the removal of the second section  12742  from the adhesive patch  12728  despite the drug delivery device  12710  being push against the patient&#39;s skin  12750 , as shown in  FIG. 83B . 
     Attachment of the drug delivery devices disclosed herein to the patient&#39;s body tissue is not limited to adhesive means. Instead of an adhesive patch, or as a supplement to an adhesive patch, the drug delivery device may incorporate a pneumatic system for temporarily attaching the drug delivery device to the patient&#39;s body tissue. Such a pneumatic system may include at least one pressure communication channel or aperture which extends through a base of the drug delivery device and distributes a negative fluid pressure across the base that draws body tissue against the base. Embodiments of such adhesive and/or pneumatic systems for temporarily attaching a drug delivery device to body tissue are described in U.S. Provisional Patent Application No. 62/117,420 entitled “DRUG DELIVERY DEVICE WITH VACUUM ASSISTED SECUREMENT AND/OR FEEDBACK”, which is hereby incorporated by reference in its entirety for all purposes. Any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 , may be configured to incorporate one or more of the embodiments of the adhesive and/or pneumatic systems for temporarily attaching a drug delivery device to body tissue as described in U.S. Provisional Patent Application No. 62/117,420. 
     In yet still further embodiments, the drug delivery devices disclosed herein may be temporarily attached to a patient&#39;s soft body tissue by way of a mechanism (e.g., a strap) that clamps or squeezes the drug delivery device between the patient&#39;s soft body tissue and bones or other more rigid anatomical structures behind the soft body tissue. 
     XIV. Connectivity Aspects 
     The drug delivery devices of the present disclosure may be configured to include various data processing functionalities and/or operate within various data processing networks. Embodiments of such data processing functionalities and networks related to drug delivery devices are disclosed in International Patent Application Publication No. WO/2015/187793, International Patent Application Publication No. WO/2015/187797, International Patent Application Publication No. WO/2015/187799, International Patent Application Publication No. WO/2015/187802, and International Patent Application Publication No. WO/2015/187805, each of which is hereby incorporated by reference in its entirety for all purposes. Any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 , may be configured to incorporate one or more of the data processing functionalities and/or operate within one or more of the data processing networks disclosed in International Patent Application Publication No. WO/2015/187793, International Patent Application Publication No. WO/2015/187797, International Patent Application Publication No. WO/2015/187799, International Patent Application Publication No. WO/2015/187802, and International Patent Application Publication No. WO/2015/187805. 
     The presently-disclosed drug delivery devices, or data processing systems in communication with the presently-disclosed drug delivery devices, may be configured to determine of one or more states of the drug delivery device, which states may be determined through the use of one or more sensors in combination with one or more controllers. The sensors may rely on mechanical, electrical or chemical sensing mechanisms, and the controllers may be mechanical, electrical, and/or electro-mechanical. By way of example and not by way of limitation, the states may relate to the operation of the drug delivery device, and/or to the condition of the drug delivery device. The drug delivery device, or data processing system in communication with the drug delivery device, may use the state determination to control the operation of the drug delivery device, and/or may communicate the state determination to other devices, such as third-party servers that may collect, process, and/or further disseminate the state determinations received from the drug delivery device. In at least one embodiment, the drug delivery device may communicate the state determination to one or more local computing devices, such as a mobile computing device (e.g., smartphone, smartwatch, tablet, laptop, etc.). 
     In at least one embodiment, a drug delivery device according to the present disclosure may communicate data related to the device or the patient to a social support network. For example, the drug delivery device may monitor a patient&#39;s use of the device with sensors or other means, and link the patient to a support group who can encourage the patient to comply with a treatment regimen (e.g., a therapeutic regimen). In this way, the drug delivery device may leverage the capabilities of social networking services (e.g., Facebook, Twitter, etc.) to identify a support group whose advice the patient is likely to follow, thereby increasing the likelihood of the patient&#39;s compliance with his or her treatment regimen. 
       FIG. 84  illustrates an embodiment of a data processing network  13000  in communication with a drug delivery device  13100  corresponding to any one of the other drug delivery device disclosed herein (including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 ). The drug delivery device  13100  is associated with a patient  13102  who may use the drug delivery device  13100  to inject a drug as part of a treatment regime. The drug delivery device  13100  may communicate with a server  13104  via one or more intermediate computing devices and/or one or more networks. In turn, the server  13104  may communicate with the drug delivery device  13100 , the patient  13102 , and one or more computing devices (with their associated parties) via one or more intermediate computing devices and/or one or more networks. As is also illustrated in  FIG. 84 , the server  13104  may communicate directly and/or wirelessly with the wearable drug delivery device  13100 , using a 4G antenna for example. 
     Still referring to  FIG. 84 , the drug delivery device  13100  is illustrated as communicating with a mobile computing device  13110  (e.g., a smartphone) via a first communication link  13112 , and with a computing device (e.g., a personal computer or dedicated hub)  13114  via a second communication link  13116 . Both links  13112  and  13116  may operate according to a near field communication protocol, such as Bluetooth, for example. The mobile computing device  13110  may communicate with a cellular network  13118  via a communication link  13120 , while the computing device  13114  may communicate with a hard-wired network (e.g., local area network or wide area network)  13122  via a communication link  13124 . These networks  13118  and  122  may also communicate with the server  13104 . 
     The networks  13118  and  13122  may facilitate communication between the server  13104  and one or more parties associated with the patient  13102 , such as his or her caregiver  13130 , support giver  13132 , and healthcare provider  13134 , via their mobile computing devices (e.g., smartphones). The server  13104  may also be in communication with one or more computing devices (e.g., servers) associated with one or more additional parties associated with the patient  13102 . For example, a healthcare system server  13140 , a payment server  13142 , a pharmacy server  13144 , a distributor server  13146 , and a governmental agency server  13148  are illustrated in communication with the server  13104  via the network  13122 . It will also be recognized that the networks  13118  and  13122  may be in communication with each other. 
     In at least one embodiment, the mobile computing device  13110  may include a processor (e.g., microprocessor) and a memory (e.g., a random access memory (RAM), a non-volatile memory such as a hard disk, a flash memory, a removable memory, a non-removable memory, etc.) for storing computer-executable instructions to be executed by the processor. In some embodiments, the computer-executable instructions may be included in a software application (e.g., a mobile software application, also commonly referred to as a “mobile app”) stored in the memory of the mobile computing device  13110 . The software application may be installed on the mobile computing device  13110  as one or more downloaded files, such as an executable package installation file downloaded from a suitable application store via a connection to the Internet. Examples of package download files may include downloads via the iTunes store, the Google Play Store, the Windows Phone Store, downloading a package installation file from another computing device, etc. The software application may be developed for a mobile operating system such as Android™ or iOS®, developed by Google and Apple, respectively. In some embodiments, the application may be initiated by a user selecting an icon shown on a home screen of a display (e.g., a touchscreen) of the mobile computing device  13110 . Various displays, including those having informational prompts and/or instructional prompts similar to those shown in the figures of International Patent Application Publication No. WO/2015/187797, may be generated in the software application and displayed to a user and/or patient via the display of the mobile computing device  13110 . 
     XV. Energy Management 
     As described above, the drug delivery devices of the present disclosure may incorporate a drive mechanism including one or more springs to provide energy for moving a plunger seal to expel a drug from a container. The use of springs can offer benefits of simplicity and low cost, but can have certain limitations. 
     There is a linear relationship between force and displacement in spring actuators. To provide sufficient energy for drug delivery at the end of the stroke of the plunger seal, an excessive amount of energy may be input to the system as drug delivery commences. 
     Further, as higher viscosity drugs are delivered via drug delivery devices, requisite spring forces can increase. Springs with higher spring constants transmit more force to the drug product and container. Because kinetic energy is proportional to velocity squared, even incremental increases in the spring constant can result in large changes in the net kinetic energy applied to the drug and container. 
     The patient may feel this excessive energy as a “slap” or similar physical “bump”, as the spring-driven piston impacts the plunger seal of the container storing the drug. It is known that such mechanical bumps can also be distracting or disturbing to users of the injectors and can therefore prevent proper dose completion. It is therefore desirable to eliminate such disturbances. 
     Accordingly, a need exists for a drug delivery device with an energy management system which can maintain the intended spring force load of the drive mechanism while reducing the transmitted force and resultant energy to the drug product, thereby reducing the potential for structural damage to the container or other components of the drug delivery device. Such a drug delivery device may be potentially more comfortable and safer to use, and applicable to a greater range of drugs. 
     The drug delivery devices of the present disclosure may be configured to include an energy management system that maintains the intended spring force load of the drive mechanism while reducing the transmitted force and resultant energy to the drug product. Embodiments of such energy management systems are disclosed in International Patent Application No. PCT/US15/29485 entitled “AUTOINJECTOR WITH SHOCK REDUCING ELEMENTS” and International Patent Application Publication No. WO/2016/003813, International Patent Application Publication No. WO/2015/187799, each of which is hereby incorporated by reference in its entirety for all purposes. Any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 , may be configured to incorporate one or more of aspects, features, and/or functionalities of the energy management systems disclosed in International Patent Application No. PCT/US15/29485 and International Patent Application Publication No. WO/2015/187799. 
       FIGS. 85A-85C, 86A-86C, and 87A-87C  illustrate, respectively, assemblies  14000   a ,  14000   b ,  14000   c , each of which includes a drug container  14050  (which may correspond to, but is not limited to, any one of the containers  50 ,  618 ,  718 ,  818 ,  918 ,  1118 , or  2050 ), a drive mechanism  14100  (which may correspond to, but is not limited to, any one of the drive mechanisms  100 ,  500 ,  1000 , or  2100 ), a fluid pathway connector  14300  (which may correspond to, but is not limited to, any one of the fluid pathway connector  300 ,  622 ,  722 ,  822 ,  922 , or  2300 ), and a drive damper mechanism  14170   a ,  14170   b , or  14170   c  that functions as an energy management system. The assemblies  14000   a ,  14000   b , and  14000   c  each may be implemented in any one of the drug delivery devices disclosed herein, including, but not limited to, any one of the drug delivery devices  10 ,  910 ,  2010 ,  6000 , or  8000 . 
     The drug container  14050  may include a barrel  14058  and a plunger seal  14060  moveable through the barrel  14058  to discharge a drug  14038  from the barrel  14058 , and a pierceable seal (not illustrated) controlling access to an interior of the barrel  14058 . The drive mechanism  14100  may include a drive housing  14130 , a piston  14110  moveable relative to the drive housing  14130  and configured to impart movement to the plunger seal  14060 , and a piston biasing member  14106  disposed between the drive housing  14130  and the piston  14110 . The piston  14110  may include a head member  14148  disposed at its distal end. 
     The drive damper mechanism  14170  reduces the velocity of the piston  14110  while retaining the intended force of the drive mechanism  14100 , before the piston  14110  begins to move the plunger seal  14060  distally through the barrel  14058 . By reducing the velocity of the piston  14110 , the damper mechanism  14170  essentially operates as a shock reducing element, as it reduces the kinetic energy applied to the drug  14038  and the drug container  14050 . The damper mechanism  14170  can be adapted to reduce the velocity of the piston  14110  to ensure that pressure delivered to the system does not induce syringe breakage, pressure delivered to the system prevents appreciable “slap” or discomfort to the patient, and/or pressure delivered to the drug  14038  prevents shear forces from damaging the drug  14038 . 
     In some embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by less than 1%. In other embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 1-5%. In further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 5-10%. In further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 10-15%. In further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 15-20%. In further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 20-30%. In still further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 30-50%. In yet further embodiments, the drive damper mechanism can be adapted to reduce the velocity of the piston by about 51%-100%. The reduction in velocity provided by the drive damper mechanism can be selected to prevent a physical disturbance and/or discomfort to the patient by preventing appreciable “slap”, and/or reduce breakage of the drug storage device, and/or reduce drug product damage caused by shear load, and/or allow the injection device to be used for injecting drugs with higher viscosities. 
     As shown in  FIGS. 85A-85C , the damper mechanism  14170  can be disposed inline between the plunger seal  14060  of the drug container  14050  and the plunger head  14148  of the piston  14110  to minimize the size of the assembly  14000   a  and to more effectively damp the motion of piston  14110  at the plunger head/stopper interface. In other embodiments, as shown in  FIGS. 86A-86C , the drive damper mechanism can be disposed inline between the proximal end of the piston  14110  of the drive mechanism and the main housing of the drug delivery device. In further embodiments, the drive damper mechanism can be integrated into the piston. 
     In accordance with various embodiments of the assembly  14000   a , the damper mechanism  14170  may comprise a dashpot. The dashpot uses viscous friction to resist the motion of the piston  14110 , thereby reducing the velocity of the piston  14110 .  FIGS. 85A-85C  depict an exemplary embodiment of a linear dashpot  14172  that can be used in the assembly  14000   a . As shown, the linear dashpot  14172  includes a drive damping mechanism housing  14174 , a working fluid  14178  contained inside the housing  14174 , and a piston assembly  14176  movably disposed within the housing  14174 . The housing  14174  can comprise a cylindrical sidewall  14174   sw  that is closed at each of its first and second ends by an end wall  14174   ew . In some embodiments, the housing  14174  can be made of a rigid material, such as a plastic or a metal. The working fluid  14178  contained within the housing  14174  can comprise, without limitation, oil (e.g., mineral oil), silicone material, water or air. 
     As shown in  FIGS. 85A-85C , the piston assembly  14176  may comprise a piston  14180  and a rod  14184  for pushing the piston  14180  through the housing  14174 . In other embodiments, such as shown in  FIGS. 86A-86C , the piston rod can be configured and adapted to pull the piston through the dashpot housing  14174 . As shown in  FIGS. 85A-85C , the piston  14180  can comprise a single disc-like structure or member  14182  (piston disc member  14182 ) having leading and trailing surfaces  141821  and  14182   t , respectively. The piston rod  14184  extends through an aperture  14174   a  in one of the end walls  14174   ew  of the housing  14174  and can have one end attached to or unitary with the leading surface  141821  or trailing surface  14182   t  of the piston disc member  14182 , depending upon whether it pushes (see  FIGS. 85A-85C ) or pulls ( FIGS. 86A-86C ) the piston disc member  14182  in the damping stroke. The free end of the piston rod  14184 , which is typically disposed external to the housing  14174 , can be attached to the plunger head  14148 , as shown in  FIGS. 85A-85C . A seal, such as an O-ring (not visible), may be provided in or adjacent to the aperture  14174   a  to prevent the working fluid  14178  from leaking out of the housing  14174  between the piston rod  14184  and the aperture  14174   a  in the end wall  14174   ew  of the housing  14174 . In some embodiments, the piston assembly  14176  can be made of a rigid material, such as a plastic or a metal. In other embodiments, the piston assembly  14176  can be made of a resilient material, such as a natural or synthetic polymer. In still further embodiments, the piston assembly  14176  can be made of a porous, rigid material. 
       FIGS. 85A-85C  depict one exemplary mode of operation of the dashpot  14172 . As shown in  FIG. 85A , upon the actuation of the drive triggering mechanism, the energy source (e.g., piston biasing member  14106 ) of the drive mechanism  14100  advances the piston  14110  toward plunger seal  14060  disposed in the barrel  14058  of the drug container  14050 . Once the linear dashpot  14172  contacts the plunger seal  14060 , as shown in  FIG. 85B , the load from the piston biasing member  14106  begins to be transmitted to the linear dashpot  14172 , thereby causing the working fluid  178  located in front of the dashpot piston disc member  14182  to be pushed or displaced through one or more constrictions to a location behind the piston disc member  14182  as the piston disc member  14182  moves from one end of the housing  14174  to the other. The flow of the working fluid  14178  through the one or more constrictions generates a viscous friction, which resists the movement of the piston disc member  14182 , thereby damping plunger motion. In some embodiments in which the piston disc member  14182  is made of a rigid material, the constriction(s) can comprise a small gap (not shown) between the peripheral edge of the piston disc member  14182  and the sidewall  174   sw  of the dashpot housing  14174 . In other embodiments, the constriction(s) further or alternatively comprise one or more grooves  14186  provided in the peripheral edge of the piston disc member and/or one or more openings extending through the piston disc member  14182  through which the working fluid  178  flows as it is displaced from in front of the piston disc member  14182 , to behind the piston disc member  14182 . In other embodiments in which the piston disc member  14182  is made of a resilient material, the peripheral edge of the piston disc member  14182  can bend backwards enough to generate a narrow gap or constriction between the peripheral edge of the piston disc member  14182  and the sidewall  174   sw  of the dashpot housing  14174  (not shown) so that the working fluid  178  can flow therethrough. In other embodiments in which the piston disc member  14182  is made of a porous material, the working fluid  178  will flow through the pores (constrictions) of the piston disc member  14182 . In each of these embodiments, the one or more constrictions of the linear dashpot  14172  provide a velocity-dependent resistance to the force of the energy source  144  (e.g., piston biasing member  14106 ) acting on the piston  14110 . This resistance, when coupled to the piston  14110 , reduces the velocity of the piston  14110  while maintaining the force of the energy source  144  (e.g., piston biasing member  14106 ) before the piston  14110  starts to move the plunger seal  14060 . The size, number and type of constrictions, the type of working fluid  178  used in the linear dashpot  14172 , the configuration of the housing  14174  and piston assembly  14176 , and any combination thereof, can be adjusted and/or selected to allow the damping characteristics of the damper mechanism  14170  to be tuned to properly damp the shock characteristics of the drive mechanism  14100 . 
     As shown in  FIG. 85C , the piston disc member  14182  engages the leading one of the end walls of the dashpot housing  14174 , and the force of the piston biasing member  14106  moves the plunger seal  14060 , linear dashpot  14172  and piston  14110  distally through the barrel  14058  of the drug container  14050  at a reduced velocity, to expel the drug  14038  from the barrel  14058 . 
       FIGS. 86A-86C  depict one exemplary mode of operation of a dashpot  14192  disposed inline between the proximal end  14146   pe  of the piston rod  14146  of the injection drive mechanism and the main housing of the drug delivery device. In this embodiment, the dashpot housing  14194  can be retained in a tubular support member  14122  of the main housing by a detent  14123  integrally formed with the tubular support member  14122 . Such an arrangement can be provided on a cantilever spring  14125  defined in the tubular support member  14122 . The end of the piston rod  14204  disposed within the dashpot housing  14194  can be attached to the leading surface  142021  of the piston disc member  14202  and the free end of the piston rod  14204  can be attached to the proximal end  14146   pe  of the piston rod  14146  such that as the piston rod  14146  is driven distally by the energy source (e.g., piston biasing member  14106 ). The piston rod  14204  pulls the piston disc member  14202  through the dashpot housing  14194 . 
     As shown in  FIGS. 86A-86C , upon the actuation of the drive triggering mechanism, the energy source (e.g., piston biasing member  14106 ) of the injection drive mechanism begins to advance the piston  14110  toward the plunger seal  14060  disposed in the barrel  14058  of the drug container  14050 . The load applied by the piston biasing member  14106  to the piston  14110  can be transmitted to the dashpot  14192 . The working fluid  194  located in front of the piston disc member  14202  is pushed or displaced through the one or more constrictions to a location behind the piston disc member  14202 , as the piston disc member  14202  is pulled from one end of the dashpot housing  14194  to the other. The resistance generated by the working fluid  14198  flowing through the one or more constrictions maintains the force of the piston biasing member  14106  while reducing the velocity of the piston  14110  before the head member of the piston  14110  impacts the plunger seal  14060 . The head member of the piston  14110  impacts the plunger seal  14060  at the reduced velocity, and the force of the energy source (e.g., piston biasing member  14106 ) begins to move the plunger seal  14060  and piston  14110  distally through the barrel  14058  of the drug container  14050 , to expel the drug  14038  from the barrel  14058 . At about the same time, the piston disc member  14202  of the dashpot  14192  reaches the end of its stroke and engages the leading end wall  194   ew  of the dashpot housing  14194 . The energy source (e.g., piston biasing member  14106 ) can be selected to apply enough energy to the piston  14110  to overcome the detent and cantilever arrangement  123 / 125  so that it releases the dashpot  14192  from the tubular support member  14122  to allow for movement of the piston  14110  as the energy source (e.g., piston biasing member  14106 ) drives the piston  14110 , plunger seal  14060 , and drug  14038  through the barrel  14058  of the drug container  14050 . The release of the dashpot  14192  from the tubular support member  14122  reduces the duration of engagement, which allows the overall length of the injection device to be reduced. 
       FIGS. 87A-87C  depict an exemplary mode of operation of dashpot  14212  that is integrated into piston  14242 . As shown in  FIGS. 87A-87C , the integrated dashpot  14212  includes a housing  14214  formed by a tubular wall  14214   t  and plunger head  14248 , which closes the open distal end of the tubular wall  14214   t . The dashpot  14212  further includes a piston formed by a distal end wall  14220  of hollow plunger rod  14246 , which is initially disposed in the open proximal end of the tubular wall  14214   t  of the dashpot housing  14214 . The working fluid  14218  of the dashpot  14212  is initially provided in the dashpot housing  14214 , in front of the distal end wall  14220  of the plunger rod  14246 . As shown in  FIG. 87A , upon actuation of the drive triggering mechanism (not shown), the energy source (e.g., spring  14244   s ) of the injection drive mechanism applies a force to the plunger rod  14246  and advances the piston  14242  toward plunger seal  14060  disposed in the barrel  14058  of the drug container  14050 . Once the plunger head  14248  makes contact with the plunger seal  14060 , as shown in  FIG. 87B , the load from the spring  14244   s  is transmitted to the dashpot  14212  integrally formed in the piston  14242 . The working fluid  14218  located in front of the end wall  220  of the plunger rod  14246  is pushed or displaced through one or more constrictions (as previously described) provided in the end wall  220  and into the space defined by the hollow plunger rod  14246 , behind the end wall  220  as it moves distally into the dashpot housing  14214 . The resistance or damping provided by dashpot  14212  reduces the velocity of the plunger rod  14246  before the plunger rod  14246  engages the plunger head  14248  to move the plunger seal  14060 , and performs the damping while maintaining the force of the spring  14244   s.    
     As shown in  FIG. 87C , the end wall  220  of the plunger rod  14246  engages the plunger head  14248 , which marks the end of the damping stroke of the dashpot. The spring  14244   s  then propels or forces the plunger rod  14246  and plunger head  14248  as a single component (i.e., the plunger) against the plunger seal  14060  to drive the plunger seal  14060  distally through the barrel  14058  of the drug container  14050 , to expel the drug  14038  from the barrel  14058 . 
       FIG. 88  shows another exemplary embodiment of the dashpot. The dashpot  14270  is substantially similar to the dashpots previously described except that the piston of the piston assembly  14276  comprises two or more disc members  14282  spaced apart from one another along the piston rod  14284 . The two or more piston disc members  14282  and the previously described constrictions, which may be associated with each piston disc member  14282 , provide a series of resistances to piston movement, where each of the resistances can be the same and/or different. The series resistance of the dashpot  14270  allows the velocity of the plunger to be reduced in stages or increments while maintaining the force of the energy source (e.g. spring  14144   s ). In some embodiments, the multi-disc piston assembly  14276  can be made of a rigid material, such as a plastic or a metal. In such embodiments, the constriction(s), which control or define the resistance provided by each piston disc member  14282 , can comprise a small gap (not shown) between the peripheral edge of one or more of the piston disc members  14282  and the sidewall  14274   sw  of the dashpot housing  14274 . In other such embodiments, the constriction(s) can comprise one or more grooves provided in the peripheral edge of one or more of the piston disc members  14182  or one or more openings  14188  extending through the one or more piston disc members  14182 , forming one or more of the piston disc members as porous discs, and any combination thereof. In other embodiments, the multi-disc piston assembly  14276  can be made of a resilient material, such as a natural or synthetic elastomer, such that the marginal peripheral edge of each piston disc member  14282  can bend backwards enough to generate a narrow gap or constriction between the peripheral edge of the piston disc members  14282  and the sidewall  14274   sw  of the dashpot housing  14274  so that the working fluid can flow therethrough. If air is used as the working fluid, the resilient piston disc members  282  of the piston assembly  276  may be used to create a squeeze-film damping effect. Any of the dashpots described above with respect to  FIGS. 85A-85C, 86A-86C, and 87A-87C , can utilize the piston assembly  14276  of  FIG. 88 . 
       FIG. 89  shows an exemplary embodiment of the dashpot of the present disclosure. The dashpot  14370  comprises a housing  14374  and a piston assembly  14376  comprising a hollow piston rod  14384  and a piston configured as a bellows-like structure (bellows piston structure) attached to an end of the piston rod  14384  disposed within the housing  14374 . The hollow piston rod  14384  may have an aperture  14384   a  for exhausting working fluid (not shown) flowing through the hollow piston rod  14384  outside of the dashpot housing  14374 . The bellows piston structure can comprise one or more collapsible lobes that contain the working fluid, which fluid can be air or any other suitable working fluid. An opening  14386  (constriction) can be provided in the portions of the lobe walls connecting each adjacent pair lobes of the bellows piston structure to one another and to the hollow piston rod  14384 . The openings  14386  allow the working fluid contained in the lobes to flow from one lobe to another, thereby functioning as constrictions. The dashpot  14370  provides damping when the bellows piston structure is pushed or pulled into the end wall  14374   ew  of the dashpot housing  14374  and collapsed by the force acting on the plunger  14142  supplied by the energy source (e.g., spring  14144   s ) of the drive plunger mechanism. The damping action is provided as the working fluid contained inside the lobes flows through the openings  14386 , the hollow piston rod  14384  and the rod aperture  14384   a  as the lobes of the bellows piston structure are collapsed. Any of the dashpots embodiments described above with respect to  FIGS. 85A-85C, 86A-86C, and 87A-87C , can utilize the piston assembly  14376  of  FIG. 89 . 
     Turning to  FIG. 90 , illustrated is the drive mechanism  100  and drug container  50  of  FIG. 14A , outfitted with an energy management system  15000 . The energy management system  15000  includes a plurality of damping members  15010   a - e . The damping members  15010   a - e  may be made of a shock absorbing material such as rubber, plastic, or any other suitable material. The damping member  15010   a  is positioned at the interface between the piston extension  102  and the plunger seal  60 . The damping members  15010   b  and  15010   c  are disposed on the exterior of the neck of the barrel  58 . In an alternative embodiment, the damping members  15010   b  and  15010   c  are replaced with a single ring-shaped damping member disposed around the neck of the barrel  58 . The damping members  15010   d  and  15010   e  are disposed on the distal end surface of the cap  52 . In an alternative embodiment, the damping members  15010   d  and  15010   e  are replaced with a single ring-shaped damping member disposed on the distal end surface of the cap  52 . In use, the damping members  15010   a - e  may dampen a shockwave created when the when the piston  110  impacts the plunger seal  60 , thereby reducing the likelihood of the barrel  58  shattering and/or the user experiencing a discomforting mechanical bump or slapping sound. 
     Looking to  FIGS. 91A and 91B , illustrated is the drive mechanism  2100 , drug container  2150 , and the fluid pathway connector  2300  of  FIGS. 23A and 23B , outfitted with an energy management system  16000 . The energy management system  16000  includes a plurality of damping members  16010   a - c . The damping members  16010   a - c  may be made of a shock absorbing material such as rubber, plastic, or any other suitable material. The damping member  16010   a  is positioned at the interface between the piston  2110  and the plunger seal  2060 . The damping members  16010   b  and  16010   c  are disposed on the distal end surface of the cap  23152 . In an alternative embodiment, the damping members  16010   b  and  16010   c  are replaced with a single ring-shaped damping member disposed on the distal end surface of the cap  2052 . In use, the damping members  16010   a - c  may dampen a shockwave created when the when the piston  2110  impacts the plunger seal  2060 , thereby reducing the likelihood of the barrel  2058  shattering and/or the user experiencing a discomforting mechanical bump or slapping sound. 
     XVI. Viscosity Modeling 
     At least some embodiments described above or below may provide delivery devices capable of delivering a viscous fluid dosage form to a subject. At least some of these embodiments provide for subcutaneous (SQ) injection of a large volume dose (e.g., 2 mL to 2.5 mL, or 2 mL to 3 mL) of a fairly viscous fluid with a tolerable level of pain to a subject. Accordingly, at least some of the embodiments disclosed herein can administer the large volume viscous dosage form at a rate such that pain does not negatively impact compliance with the prescribed dosing regimen. Furthermore, at least some embodiments disclosed herein provide delivery devices capable of delivering a fluid dosage form (including a large-volume dosage form) comprising an antibody, protein, peptide, or nucleic acid, for example. 
     At least one embodiment provides a delivery device comprising an insertion mechanism, a drive mechanism, and a sterile fluid pathway, wherein said device is configured to deliver to a human patient from about 1.0 mL to about 2.5 mL, inclusive, of a viscous dosage form at rate of up to about 12 mL per minute. In certain embodiments, the delivery is SQ injection. In at least one embodiment, the drug delivery device is an on-body or wearable device. In particular embodiments, the device is preloaded with a dosage form. In some embodiments, the dosage form comprises a biologic, such as an antibody, or antigen-binding portion thereof. In some embodiments, the dosage form comprises about 50 mg to about 400 mg, inclusive, of a biologic. In some aspects, the drug is administered at a fixed dose. In specific aspects, the drug is administered at a fixed dose selected from about 50 mg to about 400 mg, inclusive; such as a fixed dose of about 50 mg, about 100 mg, about 150 mg, about 175 mg, about 200 mg, about 300 mg, or about 325 mg drug/dose. In some aspects, the drug is administered in two or more doses. In other aspects, the drug is administered weekly, biweekly, or monthly. In certain aspects, the drug is administered biweekly. In some embodiments, the device is configured for SQ delivery of about 2 mL of a dosage form comprising about 300 mg drug. In some embodiments, the device is configured for delivery of the dosage form once-daily, twice a week (semiweekly), once-weekly, biweekly (fortnightly), once monthly, twice monthly (semimonthly), every two months (bimonthly), or at a frequency determined by a health care professional. In some embodiments, the delivery device is configured to deliver the dosage form at a preselected flow rate from, the rate chosen from a range of about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. In some embodiments, the device is disposable. 
     At least one embodiment provides a drug delivery device comprising means for delivering to a human subject a volume of about 1 mL to about 2.5 mL, inclusive, of a viscous dosage form at a flow rate of up to about 12 mL per minute. In certain embodiments, the delivery is SQ injection. In some embodiments, the dosage form comprises a biologic. The biologic may be an antibody. In some embodiments, the dosage form comprises about 100 mg to about 400 mg, inclusive, of a biologic. In particular embodiments, the device is preloaded with a dosage form comprising a biologic, such as an antibody. In some embodiments, the device is configured for SQ delivery of about 2 mL of a drug. In some embodiments, the device is configured for delivery of the dosage form on a once-daily basis. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate ranging from about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. 
     At least one embodiment provides for a method for administering to a human subject in need thereof a dosage form comprising a viscous pharmaceutical dosage form, comprising contacting a human patient with a drug delivery device configured to deliver from about 1.0 mL to about 2.5 mL, inclusive, of a viscous dosage form at a flow rate of up to about 12 mL per minute, and actuating said device to deliver said dosage form. In certain embodiments, the delivery is SQ injection. In some embodiments, the viscous dosage form comprises a biologic, such as an antibody. In some embodiments, the device is configured for SQ delivery of about 2 mL of a dosage form. In some embodiments, the device is actuated once daily. In some embodiments, the delivery (administration) rate is from a range of about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery rate is about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. 
     At least one embodiment provides for a delivery device comprising an insertion mechanism, a drive mechanism, and a sterile fluid pathway, wherein said device is configured to deliver to a human patient about 2 mL of a dosage form comprising a drug at a flow rate of up to about 12 mL per minute. In certain embodiments, the delivery is subcutaneous injection. In particular embodiments, the device is preloaded with a dosage form comprising a drug. In some embodiments, the dosage form comprises about 300 mg of a drug. In some embodiments, the device is configured for delivery of the dosage form comprising a drug on a once-daily basis. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate ranging from about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. 
     At least one embodiment provides for a drug delivery device comprising a means for delivering a dosage form to a human patient of about 2 mL, comprising a drug, at a flow rate of up to about 12 mL per minute. In certain embodiments, the delivery is subcutaneous injection. In some embodiments, the dosage form comprises about 300 mg of a drug. In particular embodiments, the device is preloaded with a dosage form comprising a drug. In some embodiments, the device is configured for delivery of the dosage form comprising a drug on a once-daily basis. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate ranging from about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. 
     At least one embodiment provides for a method for administering to a human patient in need thereof a dosage form comprising a drug comprising contacting a human patient with a drug delivery device configured to deliver about 2 mL of a dosage form comprising a drug at a flow rate of up to about 12 mL per minute, and actuating said device to deliver said dosage form. In certain embodiments, the delivery is subcutaneous injection. In some embodiments, the device is actuated once daily. In some embodiments, the dosage form comprises about 300 mg of a drug. In some embodiments, the device is configured for delivery of the dosage form comprising a drug on a once-daily basis. In some embodiments, the delivery (administration) rates ranges from about 0.167 mL per minute to about 12 mL per minute, inclusive. In some embodiments, the delivery rate is about 12 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 2 mL per minute. In some embodiments, the delivery device is configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. 
     As used herein, “viscosity” refers in general to the state of being thick, sticky, and semifluid in consistency, corresponding to the informal concept of “thickness.” In particular, however, “viscosity” of a fluid is a measure of its resistance to gradual deformation by shear stress or tensile stress. Viscosity can be expressed as the magnitude of force needed to overcome internal friction, for example, as measured by the force per unit area resisting a flow, in which parallel layers a unit distance apart have a unit speed relative to one another. The viscosity of a Newtonian fluid is dependent only on temperature, and not on shear rate and time. The viscosity of non-Newtonian fluids, time dependent, depends on temperature, shear rate and time; depending on how viscosity changes with time the fluid behavior can be characterized as thixotropic (time thinning, i.e., viscosity decreases with time), rheopetic (time thickening, i.e., viscosity increases with time), or rheomaiaxis (time thinning correlates with breakdown of structure). The viscosity of Non-Newtonian fluids, time independent, depends not only on temperature but also on shear rate. Viscosity may be measured as centipoise (cps), in which water is the standard at 1 cps. Blood has an approximate viscosity of 10 cps; maple syrup 150 cps to 200 cps; motor oil SAE60 1000 cps to 2000 cps; ketchup 50,000 cps to 70,000 cps; peanut butter 150,000 csp to 250,000 cps; caulking compound 5,000,000 cps to 10,000,000 cps. 
     As noted above, temperature can be a factor in viscosity fluid mechanics, but for the purposes of the analytical modeling discussed herein, temperature is assumed to be ambient and remain substantially so for the course of drug delivery. Those of skill in the art armed with this specification can adjust configuration of a drug delivery device to control, manage, or harness changes in viscosity attributed to temperature. The viscous liquid as envisioned herein may be in liquid form or reconstituted from lyophilized form. Non-limiting examples of viscous fluids include those with at least about 10 cps or about 100 cps at a shear rate of 0.1/second. An example viscosity can in the range of from about 80,000 cps to about 300,000 cps, inclusive, or the viscosity be in the range of from about 140,000 cps to about 280,000 cps, inclusive, at a shear rate of 0.1/second at 25° C., or a viscosity range from about 100 cps to about 1,000 cps, inclusive, ata shear rate 0.1/second at 25° C. Viscosity can be measured by a rheometer. 
     The embodiments described herein provide for a drug delivery device capable of SQ delivery of a 2 mL dosage form comprising 300 mg of a drug with acceptable pharmacokinetics and tolerability. In some embodiments, the pharmacokinetics and tolerability of the 2 mL injection are comparable with two 150 mg drug/1 mL SQ injections. Tolerability factors include local injection site pain and injection site pruritus post-injection; local injection site reactions (e.g., erythema, bleeding, rash, etc.) post-injection; presence of fluid leakage immediately post-injection; and incidence of treatment-emergent adverse events including clinically significant changes in vital signs, physical examinations, and laboratory parameters. Additionally, biomarkers relevant to the mechanism of action of a drug, and the presence of anti-drug antibodies may be found acceptable relative to the two-injection regimen. Thus, the present embodiments provide for drug delivery devices that allow for a reduction in the number of injections by the administration of a larger dose volume of a rather viscous dosage form over longer injection times, still satisfying pharmacokinetic requirements as well as patient tolerance of pain. 
     Analytical models for delivery time (i.e., speed), drive system forces, and primary container pressures can be useful in implementing some of the embodiments described herein. For instance, in fluid mechanics, the Reynolds number is a dimensionless quantity that is used to help predict similar flow patterns in different fluid flow situations. The Reynolds number is defined as the ratio of momentum forces (or inertial forces) to viscous forces, and quantifies the relative importance of these two types of forces for given flow conditions. Reynolds numbers are useful when performing scaling of fluid dynamics modeling, and as such can be used to determine dynamic similitude between two different cases of fluid flow. This and other equations relating to such analytical models include the following formulae: 
     
       
         
           
             
               
                 
                   
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     in which td is delivery time and Rg is geometrical fluid resistance. Apc is the primary container area in m2; kds is event spring constant in N/m; Z1subQ is grouping term 1 “SubQ delivery,” in mm; Tf is travel in final position (end of dose) in mm; Ti is travel at initial delivery (after bubble compression) in mm. 
     
       
         
           
             
               
                 
                   
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     in which Z1subQ is grouping term 1 “SubQ delivery,” in mm; Fo is loaded housing force in N; Ffg is glide force in N; ND is tissue back-pressure in psi; Apc is the primary container area in m2; and kds is event spring constant in N/m. 
     
       
         
           
             
               
                 
                   
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     in which Rg is geometrical fluid resistance; Ln is needle length in mm; Lt is tubing length; Lfr is flow restrictor length in mm; Lc is cannula length in mm; Dn is needle diameter in mm; Dt is tubing diameter in mm; Dfr is flow restrictor diameter in mm; and Dc is cannula diameter in mm. 
     
       
         
           
             
               
                 
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     in which Re is Reynolds number; Q is the flow rate in mL per minute; p is fluid density in kg/m3; μ is dynamic viscosity in cP (may also be calculated in Pa·s, N·s/m 2 , or kg/(m·s)); and D is the hydraulic diameter in mm (the “wetted perimeter,” total perimeter of all the channels in contact with the flow [the inside pipe diameter]). It may be convenient to assume the fluid has a density of 1.0 g/mL. Flow is laminar if the value is &lt;2300. 
     Charts and bar graphs depicting variables, components, and delivery times per example embodiments are shown in  FIG. 92  to  FIG. 99 . For example,  FIG. 98  shows the contribution to delivery time of groups of component parts that have been described in more detail above. Further data related to the delivery time, described in the tables above for four models (see Output: Delivery Time, Case 1 to Case 4), appears as a bar graph in  FIG. 92 . The relationship between drive system force and the travel distance of the fluid delivered is shown in  FIG. 93 . The four models are further analyzed for component contribution to the time of delivery in  FIG. 94  (Case 1),  FIG. 95  (Case 2),  FIG. 96  (Case 3),  FIG. 97  (Case 4), and  FIG. 99  (Case 1).  FIG. 94  and  FIG. 99  allow comparison of component contribution in the delivery of fluids with different viscosities. 
     In one aspect of the present disclosure, a drug delivery device comprises an insertion mechanism, a drive mechanism, a sterile fluid pathway, and a drug container comprising a dosage form comprising a drug, wherein said device is configured to deliver to a human patient about 2 mL of the dosage form at a flow rate of up to about 12 mL per minute. Additionally, the drug delivery device may configured for subcutaneous delivery. In addition, the drug delivery device may be configured to deliver about 300 mg of a drug. In addition, the drug delivery device may be configured for delivery of the dosage form comprising a drug on a once-daily basis. In addition, the drug delivery device may be configured to deliver the dosage form at a flow rate ranging from about 0.167 mL per minute to about 12 mL per minute, inclusive. In addition, the drug delivery device may be configured deliver the dosage form at a flow rate of about 12 mL per minute. In addition, the drug delivery device may be configured to deliver the dosage form at a flow rate of about 2 mL per minute. In addition, the drug delivery device may be configured to deliver the dosage form at a flow rate of about 0.167 mL per minute. In addition, the drug delivery device may include a means for delivering a dosage form to a human patient of about 2 mL, comprising a drug, at a flow rate of up to about 12 mL per minute. 
     In another aspect of the present disclosure, a method includes administering to a human subject in need thereof a dosage form comprising a drug comprising contacting a human patient with a drug delivery device configured to deliver about 2 mL of a dosage form comprising a drug at a flow rate of up to about 12 mL per minute, and actuating said device to deliver said dosage form. Additionally, the method may have the delivery administer a dosage form comprising about 300 mg of a drug. Additionally, the method have the delivery be a subcutaneous injection. Additionally, the actuating step of the method may be carried out on a once-daily basis. Additionally, the delivery rate of the method may be from about 0.167 mL per minute to about 12 mL per minute, inclusive. Additionally, the delivery rate of the method may be about 12 mL per minute, about 2 mL per minute, or about 0.167 mL per minute. 
     XVII. Additional Embodiments of Insertion Mechanism 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-56, 74-91B and 118-127D , may be configured to incorporate the embodiments of the insertion mechanism described below in connection with  FIGS. 100A-117 . The embodiments of the insertion mechanism described below in connection with  FIGS. 100A-117  may be used to replace, in its entirety or partially, the above-described insertion mechanism  200 , the insertion mechanism  2000 , or any other insertion mechanism described herein, where appropriate. 
     In one embodiment, the insertion mechanism  17200  includes an insertion mechanism housing  17202 , a housing cap  17203 , a base  17252 , and a sterile boot  17250 , as shown in  FIG. 100A . Base  17252  may be connected to assembly platform  1720  to integrate the insertion mechanism into the drug delivery device  10  (as shown in  FIG. 1A-1C ). The connection of the base  17252  to the assembly platform  1720  may be, for example, such that the bottom of the base is permitted to pass through a hole in the assembly platform to permit direct contact of the base to the target. In such configurations, the bottom of the base  17252  may include a sealing membrane  17254  that, at least in one embodiment, is removable prior to use of the drug delivery device  10 . Alternatively, the sealing membrane  17254  may remain attached to the bottom of the base  17252  such that the hollow needle  17214  pierces the sealing membrane  17254  during operation of the drug delivery device  10 . As shown in  FIGS. 100A and 100B , the insertion mechanism  17200  may further include an insertion biasing member  17210 , a hub  17212 , a needle  17214 , a retraction biasing member  17216 , a clip  17218 , a clip retainer  17219 , a manifold guide  17220 , septa  17230 A and  17230 B, and a manifold body  17240 . The manifold  17240  may connect to sterile fluid conduit  30  to permit fluid flow through the manifold  17240 , into an interior of the hollow needle  17214 , and into the target during drug delivery, as will be described in further detail herein. 
       FIGS. 101-117  show the components of the insertion mechanism, according to at least a first embodiment, in greater detail. As shown in  FIG. 101 , insertion mechanism housing  17202  may be a substantially cylindrical component having an inner chamber within which the components of the insertion mechanism are substantially housed. Housing  17202  further includes axial slot  17202 B within which protrusion  17219 H of clip retainer  17219  slidably translates during insertion as will be described in greater detail hereinafter. Housing  17202  may further include circumferential slot  17202 C which allows protrusion  17219 H to be rotated to allow retraction biasing member  17216  to retract needle  17214 . Housing  17202  may further include axial slot  17202 D within which sterile fluid conduit  30  may translate during needle insertion. Housing  17202  further includes one or more lockout windows  17202 A which are configured to engage lockout pins  17208  in an initial, locked configuration. Lockout pins  17208  may pass through windows  17202 A to the interior of housing  17202  such that manifold guide ring  17220 C may rest upon lockout pins  17208  in an initial, locked configuration. Housing  17202  may additionally include limiter slots  17202 F and aperture  17202 E which are configured to accept and engage travel limiter  17229 . Alternatively, the protrusion  17219 H may be replaced by a manual button or the like, or an automated or automatic mechanism that responds to a timer or other control system or method (not shown). 
     Housing cap  17203 , shown in  FIG. 102 , contains guide protrusions  17204 . Guide protrusions  17204  may, alternatively, be a pre-formed aspect on the interior of insertion mechanism housing  17202 . The guide protrusions  17204  slidably engage clip retainer  17219  at pass throughs  17219 D and may slidably engage manifold guide  17220  at pass-throughs  17220 D on manifold guide ring  17220 C. The insertion biasing member  17210  initially resides in an energized state between the guide protrusions  17204  and inner surface of insertion mechanism housing  17202  and between the interior proximal end of the insertion mechanism housing cap  17203  and the flange  17219 E of clip retainer  17219 . Therefore upon activation by the user, as described further hereinafter, the insertion biasing member  17210  is caused to bear against and exert force upon flange  17219 E of clip retainer  17219  as the insertion biasing member  17210  decompresses and/or de-energizes, causing axial translation in the distal direction of the clip retainer  17219 , clip  17218 , hub  17212 , retraction biasing member  17216 , manifold guide  17220  and the components retained within manifold guide lower chamber  17220 E. Prior to activation, the insertion biasing member  17210  is maintained substantially above locking windows  17202 A in a compressed, energized state. Housing cap  17203  may be mounted to housing  17202  by any means known to one skilled in the art such as threading, bonding, ultrasonic welding, press-fit, snap-fit, etc. 
       FIG. 103  shows a clip  17218 , according to one embodiment of the present disclosure. Clip  17218  includes aperture  17218 C through face  17218 E through which needle  17214  may pass, and release surfaces  17218 A and lockout surfaces  17218 B of arms  17218 D. Clip  17218  further includes prongs  17218 F. Clip  17218  may be made of any number of resilient materials that are capable of flexing and returning to substantially their original form. In an original form, clip  17218  may flex outwards such that arms  17218 D are not perpendicular with face  17218 E. Clip  17218  resides within clip retainer  17219  such that clip  17218  is in fixed engagement with clip retainer  17219  but arms  17218 D are permitted to flex within slots  17219 A. Prongs  17218 F are configured to engage slots  17219 F of clip retainer  17219 , thus coupling rotation of clip  17218  and clip retainer  17219 . In an initial locked stage, retraction biasing member  17216  and hub  17212  (with connected needle  17214 ) are retained between release surfaces  17218 A and face  17218 E of clip  17218 , and within inner chamber  17219 B of clip retainer  17219 . The needle may pass through aperture  17218 C of clip  17218 , through aperture  17219 G of clip retainer  17219 , and through manifold guide  17220  into septa  17230  and manifold  17240 . Septa  17230  reside within manifold  17240 , as shown in  FIG. 106 . Manifold  17240  further includes a manifold body  17240 B having a manifold intake  17240 A at which the sterile fluid conduit  30  may be connected. This connection is such that the sterility is maintained from the drug container  50  of the drive mechanism  100 , through the fluid pathway connection  300  and the sterile fluid conduit  30 , into sterile manifold header  17242  of manifold  17240  and sterile boot  17250  to maintain the sterility of the needle  17214 , and the fluid pathway until insertion into the target for drug delivery. 
     The clip retainer  17219 , shown in  FIG. 104  may include a clip interface slot  17219 A for engageable retention of clip  17218 , shown in  FIG. 103 . Flexible extensions  17219 G may be configured to flex outward during installation of clip  17218  into clip interface slot  17219 A and, upon clip insertion, return to their natural positions. Hence, the clip  17218  is substantially retained in axial position with respect to clip retainer  17219 . The clip retainer  17219  may have an inner chamber  17219 B, within which the retraction biasing member  17216 , the clip  17218 , and the hub  17212  may reside during an initial locked stage of operation, and an outer upper chamber  17219 C, which interfaces with the insertion biasing member  17210 . In at least one embodiment, the insertion biasing member  17210  and the retraction biasing member  17216  are springs, preferably compression springs. The hub  17212  may be engageably connected to a proximal end of needle  17214 , such that displacement or axial translation of the hub  17212  causes related motion of the needle  17214 . 
     The manifold guide  17220 , shown in  FIG. 105 , may include an upper protrusion  17220 A and a lower chamber  17220 B separated by a manifold guide ring  17220 C. Upper protrusion  17220 A is configured to engage manifold  17240 . Manifold guide ring  17220 C is configured to be supported by lockout pins  17208  in an initial, locked stage of operation. 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as a “trocars.” The needle  17214  may include at least one side port  17214 A for admitting fluid into the hollow interior thereof. While one such side port  17214 A is illustrated, it will be appreciated that a plurality of side ports may be provided for admitting fluid into the hollow interior of the needle  17214 . The needle may be any size needle suitable for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. 
     Upon assembly, the proximal end of needle  17214  is maintained in fixed contact with hub  17212 ; the proximal end of the needle may be filled with a plug (e.g., a plastic plug, a plug of bonding agent) or may be encapsulated within hub  17212 . By plugging the proximal end of needle  17214  fluid is prevented from flowing out of the needle in this direction during drug delivery. The remainder of needle  17214  is permitted to pass through retraction biasing member  17216 , an aperture  17218 C of clip  17218 , clip retainer  17219 , and manifold guide  17220 . The needle  17214  may further pass through septa  17230 , manifold body  17240 B through manifold header  17242 , sterile boot  17250 , and base  17252  through base opening  17252 A. Septa  17230  and manifold body  17240 B may reside within lower chamber  17220 B of manifold guide  17220  and within sterile boot  17250  until operation of the insertion mechanism. Similarly, septum  17230 A resides substantially fixed and in sealed engagement within the upper portion of the manifold body  17240 B and septum  17230 B resides substantially fixed and in sealed engagement within the lower portion of the manifold body  17240 B to maintain the sterility of the manifold header  17242 . Upon insertion of needle  17214  into the target, port  17214 A is located within manifold  17220  between the upper and lower septa. This allows fluid to pass into the needle for delivery into the target. 
     Sterile boot  17250  is a collapsible or compressible sterile membrane that is in fixed engagement at a proximal end with the manifold  17240  and at a distal end with the base  17252 . In at least on embodiment, the sterile boot  17250  is maintained in fixed engagement at a distal end between base  17252  and insertion mechanism housing  17202 , as shown in  FIGS. 108C, 109C, and 110C . Base  17252  includes a base opening  17252 A through which the needle may pass through during operation of the insertion mechanism, as will be described further below. Sterility of the needle is maintained by their initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle  17214  is maintained in the sterile environment of the manifold header  17242  and sterile boot  17250 . The base opening  17252 A of base  17252  may be closed from non-sterile environments as well, such as by for example a sealing membrane  17254 . 
       FIG. 107  shows a travel limiter  17229 , according to at least one embodiment of the present disclosure. Travel limiter  17229  includes prongs  17229 A and arms  17229 C. Travel limiter  17229  is configured to engage housing  17202  such that arms  17229 C are at least partially disposed within one or more lower circumferential slots  17202 F of housing  17202 . Prongs  17229 A are configured to engage aperture  17202 E of housing  17202 . Prongs  17229 A flex inward during insertion through aperture  17202 E due to interference with the walls of aperture  17202 E. After protrusions  17229 D fully pass through aperture  17202 E prongs  17229 A flex outward, thereafter substantially fixing travel limiter  17229  in place with respect to housing  17202 . One or more proximal faces  17229 B are used to restrict the movement of manifold guide  17220  and/or clip retainer  17219  as will be described in more detail hereinafter. 
     The operation of the insertion mechanism is described herein with reference to the above components, in view of  FIGS. 108-110 .  FIG. 108A  shows an isometric view and  FIG. 108B  shows a cross-sectional view of the insertion mechanism, according to at least one embodiment of the present disclosure, in a locked and ready to use stage. Lockout pin(s)  17208  are initially positioned within lockout windows  17202 A of insertion mechanism housing  17202 . In this initial position, manifold guide ring  17220 C of manifold guide  17220 , clip retainer,  17219 , clip  17218 , and hub  17212  are retained above lockout windows  17202 A and locking pin(s)  17208 . In this initial configuration, insertion biasing member  17210  and retraction biasing member  17216  are each retained in their compressed, energized states. Protrusion  17219 H is located within slot  17202 B of housing  17202 . 
     As shown in  FIG. 1B , the lockout pin(s)  17208  (not visible) may be directly displaced by user depression of the activation mechanism  14 . As the user disengages any safety mechanisms, such as an optional sensor  24  (shown in  FIG. 1C ), the activation mechanism  14  may be depressed to initiate the drug pump. Depression of the activation mechanism  14  may directly cause translation or displacement of control arm  40  and directly or indirectly cause displacement of lockout pin(s)  17208  from their initial position within locking windows  17202 A of insertion mechanism housing  17202 . Displacement of the lockout pin(s)  17208  permits insertion biasing member  17210  to decompress and/or de-energize from its initial compressed, energized state. 
     As shown in  FIG. 108B , hub ledges  17212 A maintain retraction biasing member  17216  in a compressed, energized state between hub  17212  and clip retainer  17219  within chamber  17219 B. The hub  17212  fixedly engages proximal end of needle  17214  at hub recess  17212 B, positioning the hub  17212  and needle  17214  in an initial position. Prior to operation, sealing member  17254  may be removed from bottom of base  17252  and base  17252  is placed in contact with the target injection site on the target. As lockout pin(s)  17208  are displaced by the activation mechanism, as described above, and insertion biasing member  17210  is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in  FIG. 108B ), flange  17219 E is forced by the decompression and/or de-energizing of the insertion biasing member  17210  to translate axially in the distal direction to insert the needle  17214  into the target. The axial translation of the clip retainer and manifold guide is directed, and maintained in rotational alignment, by interaction between the guide protrusions  17204  of the insertion mechanism housing cap  17203  and corresponding pass-throughs  17219 D and  17220 D of the clip retainer  17219  and manifold guide  17220 . Release surfaces  17218 A of clip  17218  engage hub  17212  and retain the retraction biasing member  17216  in a compressed, energized state while the manifold guide  17220  travels axially in the distal direction. 
       FIG. 109A  shows an isometric and  FIG. 109B  shows a cross-sectional view of an insertion mechanism in an administration configuration, that is, with the needle  17214  and hub  17212  in an administration position. In this position, manifold guide  17220  is in contact with proximal surfaces  17229 B of travel limiter  17229 . As shown, sterile boot  17250  is permitted to collapse as the insertion biasing member  17210  expands and inserts the needle  17214  into the target. At this stage, shown in  FIG. 109 , needle  17214  is introduced into the target for drug delivery. As the fluid pathway connection is made to the drug container and the drive mechanism is activated, the fluid drug treatment is forced from the drug container through the fluid pathway connection and the sterile fluid conduit into the manifold header  17242  and through the needle  17214  for delivery into the target. Accordingly, activation of the insertion mechanism inserts the needle  17214  into a target or the target placing the fluid pathway in communication with the target. As can be seen in  FIG. 109B  arms  17218 D are flexed inward due to contact with guide protrusions  17204 . Hence, release surfaces  17218 A maintain contact with hub  17212  and prevent retraction biasing member  17216  from decompressing or de-energizing. 
     As shown in  FIG. 110A-110B , needle  17214  is retracted back (i.e., axially translated in the proximal direction) into the insertion mechanism housing  17202 .  FIG. 110A  shows an isometric view of the insertion mechanism in this configuration and  FIG. 110B  shows a cross-sectional view. The plane of cross-section in  FIG. 110B  is not the same as that of  FIG. 108B  and  FIG. 109B  but is rotated with respect to the cross-sectional plane of those views. This retraction may be triggered by user activation, automatic retraction at completion of dose delivery, failure or fault of the drive mechanism, or upon activation by one or more sensors. Upon full distal displacement of insertion biasing member  17210 , protrusion  17219 H is substantially aligned with circumferential slot  17202 C of housing  17202  and arms  17218 D are constrained by guide protrusions  17204  as shown in  FIGS. 11A-11B  (position A). In this position clip retainer  17219  is able to rotate with respect to housing  17202 , housing cap  17203 , and guide protrusions  17204  to a position B as shown in  FIGS. 110A-B . The rotation of clip retainer  17219  is transmitted to clip  17218 . In position B, arms  17218 D of clip  17218  are no longer restrained by guide protrusions  17204 , hence, arms  17218 D flex radially outward (i.e., in the direction of the hollow arrows shown in  FIG. 109B ) due to their outward bias. This causes release surfaces  17218 A to disengage from hub  17212 . Upon disengagement of the release surfaces  17218 A from hub  17212 , retraction biasing member  17216  is permitted to expand axially in the proximal direction (i.e., in the direction of hatched arrow in  FIG. 110B ) from its initial compressed, energized state. The clip  17218  is prevented from retracting or axial translation in the proximal direction by contact between the lockout surfaces  17218 B and the distal ends of the guide protrusions  17204 , as shown in  FIG. 110B . This lockout also prevents axial translation in the proximal direction of the clip retainer  17219 , manifold guide  17220  and insertion mechanism components that are distal to (i.e., below) the manifold guide ring  17220 C. In this configuration, needle  17214  is no longer exposed, therefore making pump  10  safe to handle. 
     In a second embodiment, shown in  FIG. 111 , the insertion mechanism  172200  includes an insertion mechanism housing  172202 , a base  172252 , and a sterile boot  172250 , as shown in  FIGS. 111A and 111B . Base  172252  may be connected to assembly platform  1720  to integrate the insertion mechanism into the drug delivery device  10  (as shown in  FIGS. 1A-1C ). The connection of the base  172252  to the assembly platform  1720  may be, for example, such that the bottom of the base is permitted to pass through a hole in the assembly platform to permit direct contact of the base to the target. In such configurations, the bottom of the base  172252  may include a sealing membrane  172254  that, at least in one embodiment, is removable prior to use of the drug pump  10 . Alternatively, the sealing membrane  172254  may remain attached to the bottom of the base  172252  such that the needle  172214  pierces the sealing membrane  172254  during operation of the drug pump  10 . As shown in  FIGS. 111A  and  111 B, the insertion mechanism  172200  may further include an insertion biasing member  172210 , a hub  172212 , a needle  172214 , a retraction biasing member  172216 , a clip  172218 , a manifold guide  172220 , a travel limiter  172229 , and a manifold  172240  including a manifold body  172240 B, septa  172230 A and  172230 B. The manifold  172240  may connect to sterile fluid conduit  30  to permit fluid flow through the manifold  172240 , needle  172214 , and into the target during drug delivery, as will be described in further detail herein. 
     As shown in  FIG. 112 , insertion mechanism housing  172202  may be a substantially cylindrical component having an inner chamber within which the components of the insertion mechanism are substantially housed. Housing  172202  may further include axial slot  172202 D within which sterile fluid conduit  30  may translate during needle insertion as will be described hereinafter. Housing  17202  further includes one or more lockout windows  172202 A which are configured to engage lockout pins  17208  in an initial, locked configuration. Lockout pins  17208  may pass through windows  172202 A to the interior of housing  172202  such that manifold guide ring  172220 C may rest upon lockout pins  17208  in an initial, locked configuration. Housing  172202  may additionally include limiter slots  172202 F which are configured to accept and engage travel limiter  172229 . 
     Housing  172202  may additionally include guide protrusions  172204 . Guide protrusions  172204  may, alternatively, be a portion of a separate component located within housing  172202 . The guide protrusions  172204  slidably engage manifold guide  172220  at pass-throughs  172220 D on manifold guide ring  172220 C. The insertion biasing member  172210  initially resides in an energized state between the guide protrusions  172204  and inner surface of insertion mechanism housing  172202  and between the interior proximal end of the insertion mechanism housing  172202  and the manifold guide ring  172220 C. Therefore upon activation by the user, as described further hereinafter, the insertion biasing member  172210  is caused to bear against and exert force upon manifold guide ring  172220 C as the insertion biasing member  172210  decompresses and/or de-energizes, causing axial translation in the distal direction of the manifold guide  172220  and the components retained within manifold guide  172220 . Prior to activation, the insertion biasing member  172210  is maintained substantially above locking windows  172202 A in a compressed, energized state. 
     The manifold guide  172220 , shown in  FIG. 113 , may include an upper, clip retainer or clip retaining portion  172219  and a lower chamber  172220 B separated by a guide ring  172220 C. The clip retainer or clip retaining portion  172219  may include a clip interface slot  172219 A for engageable retention of clip  172218 . Flexible extensions  172219 G may be configured to flex outward during installation of clip  172218  into clip interface slot  172219 A and, upon clip insertion, return to their natural positions. Hence, the clip  172218  is substantially retained in axial position with respect to manifold guide  172220 . The clip retainer or clip retaining portion  172219  may have an inner chamber  172219 B, within which the retraction biasing member  172216 , the clip  172218 , and the hub  172212  may reside during an initial locked stage of operation, and an outer upper chamber  172219 C, which interfaces with the insertion biasing member  172210 . In at least one embodiment, the insertion biasing member  172210  and the retraction biasing member  172216  are springs, preferably compression springs. The hub  172212  may be engageably connected to a proximal end of needle  172214 , such that displacement or axial translation of the hub  172212  causes related motion of the needle  172214 . Manifold guide ring  172220 C is configured to be supported by lockout pins  17208  in an initial, locked stage of operation. 
     Travel limiter  172229 , shown in  FIG. 114 , may be configured to include a living hinge  172229 D which allows arms  172229 C of travel limiter  172229  to transform from a “closed” position in which proximal faces  172229 B restrict axial movement of manifold guide  172220  to an “open” position in which travel limiter  172229  allows additional axial movement of manifold guide  172220 , thereby allowing needle retraction. Travel limiter  172229  is configured to be at least partially within the interior of housing  172202  in an initial, installed configuration. After transformation to its “open” position travel limiter  172229  may be positioned substantially outside of housing  172202  or may remain partially within housing  172202  but allow additional distal movement of manifold guide  172220 . Alternatively, transformation from the “closed” position to the “open” position may be performed by translating travel limiter  172229  in a direction perpendicular to axis A such that proximal faces  172229 B allow additional movement of manifold guide  172220 . 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as a “trocars.” The needle may be any size needle suitable for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. As with the needle  17214  of the first embodiment, the needle  172214  may include at least one side port  172214 A for admitting fluid into the hollow interior thereof. While one such side port  172214 A is illustrated, it will be appreciated that a plurality of side ports may be provided for admitting fluid into the hollow interior of the needle  172214 . Upon assembly, the proximal end of needle  172214  is maintained in fixed contact with hub  172212 ; the proximal end of the needle may be filled with a plug (e.g., a plastic plug, a plug of bonding agent) or may be encapsulated within hub  172212 . By plugging the proximal end of needle  172214  fluid is prevented from flowing out of the needle in this direction during drug delivery. The remainder of needle  172214  is permitted to pass through retraction biasing member  172216 , an aperture  172218 C of clip  172218  and manifold guide  172220 . The needle  172214  may further pass through septa  172230 , manifold body  172240 B through manifold header  172242 , sterile boot  172250 , and base  172252  through base opening  172252 A. Septa  172230  and manifold body  172240 B may reside within lower chamber  172220 B of manifold guide  172220  and within sterile boot  172250  until operation of the insertion mechanism. Similarly, septum  172230 A resides substantially fixed and in sealed engagement within the upper portion of the manifold body  172240 B and septum  172230 B resides substantially fixed and in sealed engagement within the lower portion of the manifold body  172240 B to maintain the sterility of the manifold header  172242 . Upon insertion of needle  172214  into the target, port  172214 A is located within manifold  172220  between the upper and lower septa. This allows fluid to pass into the needle  172214  for delivery into the target. 
     Sterile boot  172250  is a collapsible or compressible sterile membrane that is in fixed engagement at a proximal end with the manifold  172240  and at a distal end with the base  172252 . In at least on embodiment, the sterile boot  172250  is maintained in fixed engagement at a distal end between base  172252  and insertion mechanism housing  172202 , as shown in  FIGS. 115A-C . Base  172252  includes a base opening  172252 A through which the needle may pass through during operation of the insertion mechanism, as will be described further below. Sterility of the needle is maintained by its initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, needle  172214  is maintained in the sterile environment of the manifold header  172242  and sterile boot  172250 . The base opening  172252 A of base  172252  may be closed from non-sterile environments as well, such as by for example a sealing membrane  172254 . 
     The operation of one embodiment of the insertion mechanism is described herein with reference to the above components, in view of  FIGS. 115A-C .  FIG. 115A  shows a cross-sectional view of the insertion mechanism, according to at least one embodiment of the present disclosure, in a locked and ready to use stage. Lockout pin(s)  172208  are initially positioned within lockout windows  172202 A of insertion mechanism housing  172202 . In this initial position, manifold guide ring  172220 C of manifold guide  172220 , clip  172218 , and hub  172212  are retained above lockout windows  172202 A and locking pin(s)  172208 . In this initial configuration, insertion biasing member  172210  and retraction biasing member  172216  are each retained in their compressed, energized states. 
     As shown in  FIG. 1B , the lockout pin(s)  172208  (not visible) may be directly displaced by user depression of the activation mechanism  14 . As the user disengages any safety mechanisms, such as an optional sensor  24  (shown in  FIG. 1C ), the activation mechanism  14  may be depressed to initiate the drug pump. Depression of the activation mechanism  14  may directly cause translation or displacement of control arm  40  and directly or indirectly cause displacement of lockout pin(s)  17208  from their initial position within locking windows  172202 A of insertion mechanism housing  172202 . Displacement of the lockout pin(s)  172208  permits insertion biasing member  172210  to decompress and/or de-energize from its initial compressed, energized state. 
     As shown in  FIG. 115B , hub ledges  172212 A maintain retraction biasing member  172216  in a compressed, energized state between hub  172212  and manifold guide  172220  within chamber  172219 B. The hub  172212  fixedly engages proximal end of needle  172214  at hub recess  172212 B. Prior to operation, sealing member  172254  may be removed from bottom of base  172252  and base  172252  is placed in contact with the target injection site on the target. As lockout pin(s)  172208  are displaced by the activation mechanism, as described above, and insertion biasing member  172210  is permitted to expand axially in the distal direction (i.e., in the direction of the solid arrow in  FIG. 115A ), guide ring  172220 C is forced by the decompression and/or de-energizing of the insertion biasing member  172210  to translate axially in the distal direction to insert the needle  172214  into a target. The axial translation of the manifold guide is directed, and maintained in rotational alignment by interaction between the guide protrusions  172204  of the insertion mechanism housing  172202  and corresponding pass-throughs  172220 D of the manifold guide  172220 . Release surfaces  172218 A of clip  172218  engage hub  172212  and retain the retraction biasing member  172216  in a compressed, energized state while the manifold guide  172220  travels axially in the distal direction.  FIG. 115B  shows a cross-sectional view of an insertion mechanism according to at least one embodiment in an administration configuration, that is, with the needle  172214  and hub  172212  in an administration position. In this position, manifold guide  172220  is in contact with proximal surfaces  172229 B of travel limiter  172229 . As shown, sterile boot  172250  is permitted to collapse as the insertion biasing member  172210  expands and inserts the needle  172214  into the target. At this stage, needle  172214  is introduced into the target for drug delivery. As the fluid pathway connection is made to the drug container and the drive mechanism is activated, the fluid drug treatment is forced from the drug container through the fluid pathway connection and the sterile fluid conduit into the manifold header  172242  and through the needle  172214  for delivery into the target. Accordingly, activation of the insertion mechanism inserts the needle  172214  into the target, which may be a tissue, for example, placing the fluid pathway in communication with the target. As can be seen in  FIG. 115B  arms  172218 D are flexed inward due to contact with guide protrusions  172204 . Hence, release surfaces  172218 A maintain contact with hub  172212  and prevent retraction biasing member  172216  from decompressing or de-energizing. 
     As shown in  FIG. 115C , needle  172214  is retracted back (i.e., axially translated in the proximal direction) into the insertion mechanism housing  172202 . This retraction may be triggered by user activation, automatic retraction at completion of dose delivery, failure or fault of the drive mechanism, or upon activation by one or more sensors. To effect retraction of needle  172214 , travel limiter  172229  is displaced and/or transformed such that manifold guide ring  172220 C is no longer supported by proximal faces  172229 B. Hence, further decompression or de-energizing of insertion biasing member  172210  causes manifold guide  172220  to move in the distal direction (direction of solid arrow in  FIG. 115A ). In this position arms  172218 D of clip  172218  are no longer restrained by guide protrusions  172204 , hence, arms  172218 D flex radially outward (i.e., in the direction of the hollow arrows shown in  FIG. 115B ) due to their outward bias. This causes release surfaces  172218 A to disengage from hub  172212 . Upon disengagement of the release surfaces  172218 A from hub  172212 , retraction biasing member  172216  is permitted to expand axially in the proximal direction (i.e., in the direction of hatched arrow in  FIG. 115C ) from its initial compressed, energized state. The clip  172218  is prevented from retracting or axial translation in the proximal direction by contact between the lockout surfaces  172218 B and the distal ends of the guide protrusions  172204 , as shown in  FIG. 115C . This lockout also prevents axial translation in the proximal direction of the manifold guide  172220  and insertion mechanism components that are distal to (i.e., below) the manifold guide ring  172220 C. In this configuration, needle  172214  is no longer exposed, therefore making pump  10  safe to handle. 
     Activating retraction of the needle may be accomplished through many mechanisms. For example, a retraction activation mechanism such as a button may be provided on the outside of housing  12  which, when depressed by the user, activates retraction of the needle from the target. For example, in one embodiment, depressing the retraction activation mechanism may cause clip retainer  17219  to rotate to position B, hence allowing retraction biasing member  17216  to expand and retract needle  17214 . In another embodiment, depression of the retraction activation mechanism may cause displacement and/or transformation of travel limiter  172229  and allow retraction biasing member  172216  to decompress and retract the needle. Actuation of the retraction activation mechanism may be spring assisted such that the travel and/or force required to depress the retraction activation mechanism is reduced. Alternatively, or additionally, upon drive mechanism  100  reaching end-of-dose an electrical or mechanical actuator may cause activation of retraction. For example, upon end-of-dose, an electrical connection may be made such that a current is applied to a nitinol component. Upon application of the current the nitinol component&#39;s temperature rises. Because of the shape-memory characteristics of nitinol, this component may be configured, upon an increase in temperature, to transform from a first configuration to a second configuration. In this second configuration, the nitinol component may allow or cause the actuation of the retraction of the needle by, for example, rotating clip retainer  17219  or displacing or transforming travel limiter  172229 . 
     Alternatively, or additionally, a sensor such as sensor  24  may, when drug pump  10  is removed from the target, cause or allow activation of the retraction of the needle. For example, when pump  10  is installed on the target the position of sensor  24  may prevent retraction of the needle. Upon removal from the target a change in configuration of sensor  24  may allow retraction. In another embodiment, a light sensor may be placed on drug pump  10  near to base opening  17252 . When drug pump  10  is in place on the target, light would be substantially blocked from entering the light sensor. Upon removal of drug pump  10  from the target, light may be sensed by the light sensor and the light sensor may trigger an electromechanical actuator to allow or cause activation of retraction. In other embodiments, a pin-type press-fit interconnect is used to initiate retraction of the needle. The pin may be biased to at least partially protrude from housing  12  and be displaced upon placement of pump  10  on the target. When displaced, the pin may engage a female hole on a PCB which may be a part of power and control system  400 . Upon removal of pump  10  from the target, the biased pin disengages the female PCB hole, thereby causing a signal to activate the retraction of the needle. 
     Further, the insertion mechanism may be configured such that existence or detection of an unsafe condition, such as displacement of the insertion mechanism with respect to housing  12  or platform  1720 , causes actuation of the retraction of the needle. For example, upon removal of locking pins  17208  from the lockout windows, the needle insertion mechanism may be free to float in a distal direction relative to housing  12  and/or platform  1720 . A biasing member may be used such that the needle insertion mechanism is biased to move in a distal direction with respect to housing  12  and/or platform  1720 . However, when pump  10  is in place on a target, motion is restrained by the target. Upon removal of pump  10  from the target, the biasing member may decompress or de-energize and cause the needle insertion mechanism to move distally with respect to housing  12  and/or platform  1720 . This distal displacement may cause or allow the activation of retraction. Alternatively, or additionally, adhesive may be located on the distal face of the needle insertion mechanism which resists removal from the target and causes the needle insertion mechanism to move distally with respect to the housing  12  or platform  1720 . The safety to the user may be enhanced through the use of one or more of these mechanisms for needle retraction. For example, if drug pump  10  is inadvertently removed from the target after needle insertion, the automatic retraction of the needle by one of the means described above reduces the risk of a needle-stick injury. 
       FIG. 116  shows one embodiment of a retraction activation mechanism. Retraction activation biasing member  64  is connected at the one end to control arm  40  and at the other end to connection arm  78  of pivot  70 . Target contact portion  72  of pivot  70  may extend through lower housing  12 B and its motion may be restrained by contact with the target when pump  10  is installed on the target. Pin  76  of pivot  70  is configured to engage housing  12  or another component of the pump, thereby allowing rotation of pivot  70  about pin  76 . Extension  74  of pivot  70  is configured to contact protrusion  17219 H during operation. Depression of activation mechanism  14  by the user causes displacement of slide  40 , which activates the drug pump to insert the needle into the target by transforming lockout pins  17208 ; depression of the activation mechanism  14  may also activate the drug pump to perform additional actions. Displacement of control arm  40  displaces the first end of retraction activation biasing member  64 , displacement of the second end of retraction activation biasing member is resisted by pivot  70  due to contact between target contact portion  72  of pivot  70  with the target. Upon removal of drug pump  10  from the target, pivot  70  is permitted to rotate and is caused to rotate by the energy stored in retraction activation biasing member  64 . As pivot  70  rotates, extension  74  contacts protrusion  17219 H and imparts rotation to clip retainer  17219 , thereby causing or allowing retraction of the needle from the target. 
     Retraction of the needle may further be initiated upon a failure and/or fault of drive mechanism  100 . For example, the drive mechanism may include a tether which serves to meter or control the rate of delivery of the contents of drug container  50 . The tension applied to, or sustained by, the tether may be monitored by one or more sensors. A reduction in the tension of the tether may be an indication that the tether is not properly metering or controlling the delivery of the medicament. The sensor may be a mechanical component or linkage which is in contact with a portion of the tether, the contact at least partially controlling the position and/or configuration of the sensor. In response to a reduction in tension in the tether, the sensor transforms from a first position to a second position. This transformation may, directly or indirectly, cause retraction of the needle. The retraction may be caused by a purely mechanical action or, alternatively, may involve an electrical signal received and/or generated by power and control system  400 . 
     In other embodiments, the sensor may be a strain gauge, load cell, force sensor or other sensor which is configured to measure and/or monitor the strain, load, or tension present in the tether. In these embodiments, the sensor is at least partially affixed to the tether and generates an electrical signal based on the tension of the tether. The electrical signal may vary in magnitude in proportion to the magnitude of tension in the tether. Alternatively, the signal may be either interrupted or initiated when the tension in the tether falls below or exceeds a specified magnitude. The signal may be monitored by the power and control system which, based on the presence, absence, or magnitude of the signal, may cause or allow the retraction of the needle and/or cannula. 
     In still other embodiments, a mechanical failure of the tether may directly cause an electrical signal to be initiated or interrupted. For example, the tether may be constructed, at least partially, from a conductive material. The tether may be in electrical communication with the power and control system. The mechanical failure of the tether may interrupt a current path through the tether and cause a change in the flow of current in one or more circuits. This change may initiate or allow the retraction of the needle. 
     Additionally, or alternatively, the position and/or velocity of one or more features of the drive system may be monitored by a sensor such as: an optical sensor, such as an encoder; a potentiometer; or a transducer. If the position and/or velocity of the monitored feature exceeds or falls below a specified threshold, the power and control system may initiate and/or allow retraction of the needle. 
     A similar mechanism may be used to transform travel limiter  172229  from a configuration in which it restricts axial motion of manifold guide  172220  to a configuration in which it allows manifold guide  172220  to axially translate in the distal direction, thereby allowing for retraction of the needle from the target. For example, travel limiter  172229  may be caused to flex at living hinge feature  172229 D, causing travel limiter  172229  to transform to its “open” position. 
     A method of operating an insertion mechanism according to the present disclosure includes: removing one or more lockout pins from corresponding one or more locking windows of an insertion mechanism housing, wherein removal of said lockout pins permits an insertion biasing member to expand from its initially energized state; driving, by expansion of the insertion biasing member, a clip retainer and manifold guide axially in the distal direction to force a needle at least partially out of the insertion mechanism and into a target; maintain the needle in an administration position, as it would be when inserted into the target for fluid delivery; rotating a clip retainer and a clip; permitting outwards flexion of a clip retained in a chamber of a clip retainer, wherein said clip initially retains a hub and a retraction biasing member in an energized state and wherein flexion disengages one or more release surfaces of the clip from contact with a hub thereby permitting expansion of the retraction biasing member axially in the proximal direction; and retracting the needle upon retraction of the hub through a fixed connection between the needle and the hub. 
     In another embodiment, a method of operating an insertion mechanism according to the present disclosure includes: removing one or more lockout pins from corresponding one or more locking windows of an insertion mechanism housing, wherein removal of said lockout pins permits an insertion biasing member to expand from its initially energized state; driving, by expansion of the insertion biasing member, a manifold guide axially in the distal direction to force a needle at least partially out of the insertion mechanism and into the target; maintain the needle in an administration position for fluid delivery; transforming or displacing a travel limiter, permitting additional distal displacement of the manifold guide; permitting outwards flexion of a clip retained in a chamber of the manifold guide, wherein said clip initially retains a hub and a retraction biasing member in an energized state and wherein flexion disengages one or more release surfaces of the clip from contact with a hub thereby permitting expansion of the retraction biasing member axially in the proximal direction; and retracting the needle upon retraction of the hub through a fixed connection between the needle and the hub. 
     Certain optional standard components or variations of the insertion mechanism or drug pump  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIGS. 1A-1C , to enable the user to view the operation of the drug pump  10  or verify that drug dose has completed. Additionally, the drug pump  10  may contain an adhesive patch  1726  and a patch liner  1728  on the bottom surface of the housing  12 . The adhesive patch  1726  may be utilized to adhere the drug pump  10  to the target for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  1726  may have an adhesive surface for adhesion of the drug pump to the target. The adhesive surface of the adhesive patch  1726  may initially be covered by a non-adhesive patch liner  1728 , which is removed from the adhesive patch  1726  prior to placement of the drug pump  10  in contact with the target. Adhesive patch  1726  may optionally include a protective shroud that prevents actuation of the optional sensor  24  and covers the base opening of the insertion mechanism. Removal of the patch liner  1728  may remove the protective shroud or the protective shroud may be removed separately. Removal of the patch liner  1728  may further remove the sealing membrane of the insertion mechanism, opening the insertion mechanism to the target for drug delivery. 
     Similarly, one or more of the components of the insertion mechanism and drug pump  10  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug pump  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. Similarly, while guide protrusions  172204  are shown as a unified pre-formed component of insertion mechanism housing  172202 , it may be a separate component fixedly attached to the interior surface of the insertion mechanism housing  17202 . As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the insertion mechanism and/or drug pump to each other. Alternatively, one or more components of the insertion mechanism and/or drug pump may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the insertion mechanisms and drug pumps disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide integrated safety features; enable direct user activation of the insertion mechanism; and are configured to maintain the sterility of the fluid pathway. As described above, the integrated safety features include optional sensors, redundant lock-outs, automated needle insertion and retraction upon user activation, and numerous user feedback options, including visual and auditory feedback options. The novel insertion mechanisms of the present disclosure may be directly activated by the user. For example, in at least one embodiment the lockout pin(s) which maintain the insertion mechanism in its locked, energized state are directly displaced from the corresponding lockout windows of the insertion mechanism housing by user depression of the activation mechanism. Alternatively, one or more additional components may be included, such as a spring mechanism, which displaces the lockout pin(s) upon direct displacement of the activation mechanism by the user without any intervening steps. 
     Furthermore, the novel configurations of the insertion mechanism and drug pumps of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connection, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug pump do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, housing and other components of the pump drug may readily be configured to accept and operate insertion mechanism  17200 , insertion mechanism  172000 , or a number of other variations of the insertion mechanism described herein. 
     Assembly and/or manufacturing of the insertion mechanism, drug pump  10 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The insertion mechanism may be assembled in a number of methodologies. In one method, a hub is initially connected to a proximal end of a needle. The hub and needle are inserted into an inner chamber of a clip retainer, wherein a retraction biasing member is maintained in an energized state between the clip retainer and the hub. The hub, needle, and retraction biasing member are held in this alignment by a clip, wherein the clip is fixedly and flexibly connected to the clip retainer at a clip interface. One or more septa are inserted into the manifold to create a manifold header. The manifold and septum are inserted into a lower chamber of the manifold guide such that the needle pierces through the septum. A sterile boot is connected to the manifold, wherein the needle resides within the sterile boot when the latter is in an expanded configuration. 
     An insertion spring is inserted into the insertion mechanism housing between the housing and one or more guide protrusions extending into the interior of the housing from the housing cap. The manifold guide and clip retainer, having the components attached thereto as described herein, is inserted into the insertion mechanism housing such that the guide protrusions extend through corresponding pass-throughs on a clip retainer flange and manifold guide ring aspect of the manifold guide. As the clip retainer and manifold guide is translated in the proximal direction, the insertion biasing member is caused to contact the manifold guide ring and become energized. As translation of the clip retainer and manifold guide and compression of the insertion biasing member reach a point above one or more lockout windows of the insertion mechanism housing, one or more corresponding lockout pin(s) may be inserted to retain the manifold guide in this position and the insertion biasing member in the compressed, energized state. A travel limiter may further be inserted into the housing such that the prongs of the travel limiter engage the aperture of the housing. 
     The distal end of the sterile boot may be positioned and held in fixed engagement with the distal end of the insertion mechanism housing by engagement of the housing with a base. In this position, the sterile boot is in an expanded configuration around the needle and creates an annular volume which may be sterile. A fluid conduit may be connected to the manifold at a manifold intake such that the fluid pathway, when open, travels directly from the fluid conduit, through the manifold intake, into the manifold header, and through the needle. A fluid pathway connection may be attached to the opposite end of the fluid conduit. The fluid pathway connection, and specifically a sterile sleeve of the fluid pathway connection, may be connected to a cap and pierceable seal of the drug container. The plunger seal and drive mechanism may be connected to the drug container at an end opposing the fluid pathway connection. A sealing membrane may be attached to the bottom of the base to close off the insertion mechanism from the environment. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug pump. 
     Manufacturing of a drug pump includes the step of attaching the base of the insertion mechanism to an assembly platform or housing of the drug pump. In at least one embodiment, the attachment is such that the base of the insertion mechanism is permitted to pass through the assembly platform and/or housing to come in direct contact with the target. The method of manufacturing further includes attachment of the fluid pathway connection, drug container, and drive mechanism to the assembly platform or housing. The additional components of the drug pump, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug pump that contacts the target during operation of the device. 
     A method of operating the drug pump includes the steps of: activating, by a user, the activation mechanism; displacing a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a drive control mechanism to drive fluid drug flow through the drug pump. The method may further include the step of: engaging an optional sensor prior to activating the activation mechanism. The method similarly may include the step of: establishing a connection between a fluid pathway connection to a drug container. Furthermore, the method of operation may include translating a plunger seal within the drive control mechanism and drug container to force fluid drug flow through the drug container, the fluid pathway connection, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to the target. The method of operation of the insertion mechanism and the drug pump may be better appreciated with reference to  FIGS. 108-110  and  FIG. 115 , as described above. 
     In at least one embodiment, the present disclosure provides an insertion mechanism for a drug pump, said insertion mechanism including: an insertion mechanism housing having an internal chamber; a manifold guide having an upper chamber and a lower chamber separated by a manifold guide ring; one or more insertion biasing members initially held in an energized state within the internal chamber of insertion mechanism housing between the housing cap and the manifold guide ring; a clip flexibly engaged with the upper chamber of the manifold guide; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having one or more septa, wherein the annular space between the septa defines a manifold header. 
     In at least one embodiment, the insertion mechanism may include two or more insertion biasing members. The manifold has a manifold intake for connection to a fluid conduit. The insertion mechanism further includes a travel limiter, engaged with the housing, at least a portion of which is located within the housing internal chamber. 
     In another embodiment, the present disclosure provides an insertion mechanism for a drug pump, said insertion mechanism including: an insertion mechanism housing having an internal chamber; a housing cap engaged with the housing; a clip retainer including an internal chamber and a flange; a manifold guide having an internal chamber and a manifold guide ring; one or more insertion biasing members initially held in an energized state within the internal chamber of the insertion mechanism housing between the housing cap and the clip retainer flange; a clip flexibly engaged with the internal chamber of the clip retainer; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the clip retainer; and a manifold having one or more septa, wherein the annular space between the septa defines a manifold header. In an alternative embodiment, the insertion mechanism may include two or more insertion biasing members. The manifold has a manifold intake for connection to a fluid conduit. The insertion mechanism further includes a travel limiter, engaged with the housing, at least a portion of which is located within the housing internal chamber. 
     The insertion mechanism may further include a base connected to a distal end of the insertion mechanism housing. A sterile boot may be fixedly connected between the manifold and the base connected to a distal end of the insertion mechanism housing. The term “sterile boot” is used to describe a boot within which certain internal components may reside, at one or more stages of operation, in a sterile condition. The boot need not be sterile through the entire operation of the mechanism or pump and, in fact, may not be initially sterile until assembly and sterilization of certain components has occurred. Additionally, the term “boot” is not intended to mean any specific shape or configuration, but is instead utilized to describe a component that can provide an interior space within which other components may reside at one or more stages of operation. 
     One or more guide protrusions may extend from a proximal end of the insertion mechanism housing or housing cap into the internal chamber. Alternatively, the one or more guide protrusions may be a separate component that is fixed to the insertion mechanism housing. The manifold guide ring and/or clip retainer flange has one or more pass-throughs which correspond with the guide protrusions, wherein the manifold guide and/or the clip retainer is slidably engaged with the housing by interaction between the pass-throughs and the guide protrusions. The interaction between the pass-throughs and the guide protrusions may also function to maintain the rotational alignment of the manifold guide and/or to promote proper assembly of the components. 
     The clip may have one or more arms, with each arm having a release surface and a lockout surface. In an initial locked configuration the release surfaces engage the hub to maintain the retraction biasing member in an energized state; and, in a retracted configuration the release surfaces disengage the hub to permit de-energizing of the retraction biasing member, thereby retracting the hub and the needle. The manifold and manifold guide and clip retainer are maintained in their final positions and prevented from axial translation in the proximal direction by interaction between the lockout surfaces of the clips and the distal ends of the guide protrusions, effectively locking out further motion of these components. In some embodiments, the clip is caused or allowed to transform from the locked configuration to the retracted configuration by transformation of the travel limiter from a first configuration to a second configuration. In the first configuration, the travel limiter restricts distal movement of the manifold guide and prevents the release surfaces of the clip from disengaging from the hub. In the second configuration, the travel limiter allows some additional distal movement of the manifold guide which allows the release surfaces of the clip to disengage the hub. In other embodiments, the clip retainer is rotated from a first position to a second configuration; this rotation is transmitted to the clip. In the first configuration, the release surfaces of the clip are prevented from disengaging the hub. In the second configuration, the release surfaces of the clip are not prevented from disengaging the hub. 
     In another embodiment, the present disclosure provides a drug delivery pump with integrated safety features including a housing and an assembly platform, upon which an activation mechanism, a drive mechanism, a fluid pathway connection, a power control system, and an insertion mechanism for a drug pump may be mounted, said insertion mechanism including: an insertion mechanism housing having an internal chamber; a manifold guide having an upper chamber and a lower chamber separated by a manifold guide ring; one or more insertion biasing members initially held in an energized state within the internal chamber of insertion mechanism housing between the housing cap and the manifold guide ring; a clip flexibly engaged with the upper chamber of the manifold guide; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; a manifold having one or more septa, wherein the annular space between the septa defines a manifold header; a travel limiter engaged with insertion mechanism housing and a base for connection of the insertion mechanism to the assembly platform. 
     In another embodiment, the present disclosure provides a drug delivery pump with integrated safety features including a housing and an assembly platform, upon which an activation mechanism, a drive mechanism, a fluid pathway connection, a power control system, and an insertion mechanism for a drug pump may be mounted, said insertion mechanism including: an insertion mechanism housing having an internal chamber; a housing cap attached to the housing; a clip retainer having an internal chamber and a flange; a manifold guide having an internal chamber and a manifold guide ring; one or more insertion biasing members initially held in an energized state within the internal chamber of the insertion mechanism housing between the housing cap and the manifold guide ring; a clip flexibly engaged with the internal chamber of the clip retainer; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the clip retainer; a manifold having one or more septa, wherein the annular space between the septa defines a manifold header; a travel limiter engaged with the insertion mechanism housing; and a base for connection of the insertion mechanism to the assembly platform. 
     The insertion mechanism of the drug pump may further include a base connected to a distal end of the insertion mechanism housing. The manifold may have a manifold intake for connection to a fluid conduit, wherein the fluid conduit is employable for fluid transfer between the fluid pathway connection and the insertion mechanism. A sterile boot may be fixedly connected between the manifold and the base connected to a distal end of the insertion mechanism housing. These components function to maintain the sterility of the fluid pathway and the needle, prior to insertion into the target. 
     In a further embodiment, the present disclosure provides a method of assembling the insertion mechanism including the steps of: connecting a hub to a proximal end of a needle; inserting the hub and needle into an inner upper chamber of a manifold guide, wherein a retraction biasing member is maintained in an energized state between the manifold guide and the hub, and maintained in the energized state by a clip fixedly and flexibly connected to the manifold guide at a clip interface. The method further includes: inserting one or more septa into the manifold to create a manifold header there-between, and subsequently inserting the manifold and septa into a lower chamber of the manifold guide such that the needle pierces through at least one septum and resides initially at least partially within the manifold header. Furthermore, the method includes: inserting an insertion biasing member into an insertion mechanism housing between the housing and one or more guide protrusions extending into the interior of the housing from a proximal end or from a housing cap; inserting the manifold guide into the insertion mechanism housing such that the guide protrusions extend through corresponding pass-throughs on a manifold guide ring aspect of the manifold guide, wherein as the manifold guide is translated in the proximal direction, the insertion biasing member is caused to contact the manifold guide ring and become energized. 
     In an alternative embodiment, the present disclosure provides a method of assembling the insertion mechanism includes the steps of: connecting a hub to a proximal end of a needle; inserting the hub and needle into an internal chamber of a clip retainer, wherein a retraction biasing member is maintained in an energized state between the clip retainer and the hub, and maintained in the energized state by a clip fixedly and flexibly connected to the clip retainer at a clip interface. The method further includes: inserting one or more septa into the manifold to create a manifold header there-between, and subsequently inserting the manifold and septa into an internal chamber of a manifold guide such that the needle pierces through at least one septum and resides initially at least partially within the manifold header. Furthermore, the method includes: inserting an insertion biasing member into an insertion mechanism housing between the housing and one or more guide protrusions extending into the interior of the housing from a proximal end or from a housing cap; inserting the clip retainer and manifold guide into the insertion mechanism housing such that the guide protrusions extend through corresponding pass-throughs on a flange of the clip retainer and manifold guide ring aspect of a manifold guide, wherein as the clip retainer and manifold guide are translated in the proximal direction, the insertion biasing member is caused to contact the clip retainer flange and become energized. 
     Upon translation of the manifold guide and/or clip retainer and compression of the insertion biasing member to a point above one or more lockout windows of the insertion mechanism housing, the method includes the step of: placing one or more corresponding lockout pin(s) into the lockout windows and in removable engagement with the manifold guide to retain the manifold guide in this position and the insertion biasing member in the energized state. Finally, a base may be attached to the distal end of the insertion mechanism housing to maintain the components in position. The method of assembly may further include the step of: attaching a sterile boot in fixed engagement at a proximal end to the manifold and in a fixed engagement at a distal end to the base. Similarly, the method may include: attaching a fluid conduit to the manifold at a manifold intake. The method of assembly may further include the step of: attaching a travel limiter to the housing such that at least a portion of the travel limiter is located internal to the housing. 
     In yet another embodiment, the present disclosure provides a method of operating the drug delivery pump. The method of operation includes: displacing an activation mechanism to disengage one or more lockout pins from corresponding lockout windows of an insertion mechanism housing, wherein such disengagement permits an insertion biasing member to expand in a distal direction substantially along a longitudinal axis of the insertion mechanism housing from its initial energized state, wherein such expansion drives insertion of a needle into the target; connecting a fluid pathway connection having a piercing member to a drug container having a pierceable seal; and activating a drive mechanism to force a fluid through the fluid pathway connection, the needle, and into the target. The method further includes: disengaging one or more release surfaces of a clip from engagement with a hub retained within a manifold guide or clip retainer within the insertion mechanism housing, wherein such disengagement permits a retraction biasing member to expand in a proximal direction substantially along a longitudinal axis of the insertion mechanism housing from its initial energized state, wherein such expansion drives retraction of the needle. In a preferred embodiment, the method of operation may include: first displacing one or more sensors to permit displacement of the activation mechanism. The method may include one or more additional steps to activate the retraction of the needle. These steps may be performed by the user such as, for example, displacing a second activation member or may be automatically performed by the drug pump upon completion of dose delivery, failure or fault of the drive mechanism, or removal of the drug pump from the target. 
     XVIII. Additional Embodiments of Fluid Pathway Connector 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-47, 74, 75, and 77-117 , may be configured to incorporate the embodiments of the fluid pathway connector described below in connection with  FIGS. 118-127D . The embodiments of the fluid pathway connected described below in connection with  FIGS. 118-127D  may be used to replace, in its entirety or partially, the above-described fluid pathway connector  300 , fluid pathway connector  622 , fluid pathway connector  722 , fluid pathway connector  922 , fluid pathway connector  1122 , fluid pathway connector  2300 , or any other fluid pathway connector described herein, where appropriate. 
     As discussed above, in the processes of filling drug containers and other drug delivery devices, it is sometimes necessary to connect two or more sterile components or subassemblies. For example, wearable injectors or drug pumps may include a drug container which may be filled with a fluid drug using standard aseptic pharmaceutical fill-finish processes. After filling of the drug container, it may be necessary to connect the drug container to one or more additional components or subassemblies such that a fluid communication may be established between the drug container and these components. Maintaining the fluid path in an aseptic condition is critical, preventing the introduction of harmful microbes to the drug and/or fluid pathway. The connection of two or more aseptic components or subassemblies is typically performed in an aseptic environment, thereby ensuring that no harmful foreign matter is introduced to the assembly. This, however, may lead to increased cost to manufacture the drug delivery devices. The fluid pathway connections of the present disclosure may be assembled to the drug container in a non-aseptic environment while maintaining the aseptic condition of the fluid path and drug fluid. 
     As shown in the embodiment of  FIGS. 118-120 , the drug container  1850  may consist of barrel  1858 , cap  1852 , and pierceable seal  1856 . Base  1856 A of pierceable seal  1856  may be in sealing engagement with the inside of barrel  1858 . Cap  1852  may be fixedly engaged to the outside of barrel  1858  and may retain pierceable seal  1856  in position and restrict movement of pierceable seal  1856  with respect to barrel  1858 . Cap  1852  may include one or more locking arms  1852 A which extend from ring  1852 B of cap  1852  substantially parallel to axis A-A and in a distal direction. The locking arms  1852 A may include a radially extending protrusion  1852 C at or near their distal ends. The drug container may further include toroidal seal  1857 . In an initial configuration, shown in  FIG. 118 , the toroidal seal is retained between protrusions  1852 B and proximal circumferential rib  1856 B of pierceable seal  1856 . Pierceable seal  1856  may further include distal circumferential rib  1856 C which further retains toroidal seal  1857 . By placing the toroidal seal in this position when the drug container is in an aseptic environment the portion of pierceable seal  1856  in contact with the inner face of toroidal seal  1857  (i.e., the area between the proximal circumferential rib and the distal circumferential rib) is maintained in an aseptic condition even if the drug container is moved to a septic environment. 
     The fluid pathway connection  18300  includes connection hub  18310 , retainer  18320 , piercing member  18330 , and plug seal  18330 . As shown in  FIG. 120A , plug seal  18330  is initially disposed within bore  18310 A of connection hub  18310 . When the fluid pathway connection is assembled, the plug seal maintains the aseptic condition of at least a portion of the fluid pathway connection by maintaining a sealing engagement with bore  18310 A. The retainer is disposed for sliding translation with respect to connection hub  18310  in a direction parallel to axis B-B (shown in  FIG. 120D ). Initially, translation of retainer  18320  may be restricted. The restriction may be by engagement of flex arms  18320 B with recesses in connection hub  18310 . Piercing member  18330  may be fixedly engaged with retainer  18320  such that translation of retainer  18320  is transferred to the piercing member. The piercing member may be bonded, press-fit, or engaged to the retainer using other appropriate means. The piercing member may initially be at least partially disposed within cavity  18310 D and/or aperture  18310 C of connection hub  18310 . Both cavities  18310 D and  18310 C are maintained in an aseptic condition by plug seal  18340 . Retainer  18320  may further include conduit connection  18320 A to which the sterile fluid conduit  30  (see  FIG. 1B ) may be attached. This provides a sterile fluid path from the sterile fluid pathway connection to the insertion mechanism. Piercing member  18330  may be a hollow needle such that fluids may pass through the hollow interior of the piercing member and into the sterile fluid conduit. 
       FIGS. 120A-D  show the steps of connecting the fluid pathway connection to the drug container. This connection may be performed in a non-aseptic environment. In  FIG. 120A , the plug seal of the fluid pathway connection is substantially aligned with axis A-A (i.e., the plug seal  18340  is aligned with the distal end of the pierceable seal  56 ).  FIG. 120B  shows a cross-section view of the fluid pathway connection  18300  in contact with the drug container. Recesses  18310 B of connection hub  18310  are aligned with locking arms  1852 A, this alignment guides the installation of the fluid pathway connection and prevents rotation of the fluid pathway connection with respect to the drug container. As shown in  FIG. 120C , as the connection hub is translated in the proximal direction along axis A-A the plug seal  18340  is prevented from translating with the connection hub due to contact with pierceable seal  1856 . This causes the plug seal to be displaced from its position within bore  18310 A. Additionally, contact of shoulder  18310 E of connection hub  18310  with toroidal seal  1857  causes the toroidal seal to translate in the proximal direction along axis A-A. As the connection hub is translated along axis A-A only bore  18310 A comes in contact with the portion of the pierceable seal which was previously covered by toroidal seal  1857 . Further, as the connection hub comes into contact with the toroidal seal these components sealingly engage such that microbes and other foreign substances may not come in contact with the sterile portions of the pierceable seal and fluid pathway connection. In this way the aseptic condition of the pierceable seal  1856 , aperture  18310 C, cavity  18310 D, and piercing member  18330  are maintained during installation of the fluid pathway connection. 
     As seen in  FIG. 120D , further proximal translation of the connection hub brings the connection hub into contact with a portion of drug container  1850 , thus preventing further distal translation of the connection hub. In the embodiment shown, the connection hub contacts a portion of cap  1852 . When the connection hub reaches this position, the plug seal may be removed from the assembly and discarded. Snap arms  1852 A may engage one or more aspects of the connection hub and thereby prevent the connection hub from being removed from the drug container. 
     After installation, the piercing member is aligned with the sterile portion of the pierceable seal which was originally engaged with the toroidal seal. The components may be assembled into the drug delivery device  10  (see  FIGS. 1A-1C ) and remain in this configuration until activation of the drug pump by the user. Upon activation, the retainer  18320  is translated in a direction parallel to axis B-B with respect to the connection hub, causing translation of piercing member  18330 . Due to this translation, the piercing member comes in contact with and, subsequently, pierces the pierceable seal  1856 . This opens a fluid pathway from the drug container and through the piercing member. The fluid pathway may further include sterile fluid conduit  30  (see  FIG. 1B ) which is engaged with conduit connection  18320 A of retainer  18320 . In this way a sterile fluid path is provided from the drug container to the insertion mechanism for delivery to the patient. 
       FIGS. 121A-121B  show another embodiment of the present disclosure in which connection hub  181310  includes snap arms  181310 F which may engage cap  181052  of drug container  181050 . Toroidal seal  181057  is initially retained between proximal circumferential rib  181056 B and distal circumferential rib  181056 C of pierceable seal  181056  and is caused to translate in the proximal direction by contact with the connection hub. After mounting of the fluid pathway connection to the drug container, opening of the fluid pathway is substantially similar as that described above. 
       FIG. 122  shows a detail view of the plug seal disposed within the bore of the connection hub. This shows a possible method of retaining the plug seal in position using tabs  181310 G. These tabs control the location of the plug seal in the inner bore. 
       FIGS. 123-125  show additional embodiments of the disclosure illustrating alternative configurations of the cap and pierceable seal. 
     In the embodiment shown in  FIG. 126 , bore  182310 A is enclosed on its distal face by distal film  182350  and on its proximal face by proximal film  182352 . The proximal and distal films may be constructed from any material with barrier properties sufficient to prevent the passage of foreign matter. For example, the films may be constructed from a foil material. The films may be bonded or otherwise securely affixed to the connection hub. In this way, bore  182310 A is maintained in an aseptic condition. 
     As the fluid pathway connection is brought into contact with the drug container, a portion of the drug container pierces, tears, or otherwise removes a portion of proximal film  182352  from the connection hub. For example, as shown in  FIG. 126 , a portion of the cap  182052  contacts the proximal film during installation and disengages a portion thereof from the connection hub. The disengaged portion of proximal seal  182352  may be retained within void  182055  formed by cap  182052  and pierceable seal  182056 , thereby preventing the septic portion of proximal film  182352  from contacting the aseptic portion of pierceable seal  182056 . 
     Also shown in  FIG. 126 , seal  182057  may be configured to maintain the aseptic condition of only a portion of the circumference of pierceable seal  182056 . This portion may be configured to be aligned with aperture  182310 C and piercing member  182330  after installation of fluid pathway connection  182300 . During installation, seal  182057  is displaced by the connection hub as described in reference to other embodiments. Seal  182057  may be retained in position with respect to the pierceable seal by engagement of the seal with slot  182052 D of cap  182052 , proximal circumferential rib  182056 B, and distal circumferential rib  182056 C. During displacement, the seal may translate within slot  182052 D in the proximal direction. 
       FIGS. 127A-127D  show another embodiment of a fluid pathway connection in which the fluid pathway connection includes first rotating disk  183360  and drug container  183050  includes second rotating disk  183051 . First rotating disk  183360  may be configured for rotation with respect to connection hub  183310  about a central axis and further include first opening  183360 A. As shown in  FIG. 127A , the first rotating disk may also include post  183360 B and receptacle  183360 C. Second rotating disk  183051  may include complementary features to allow for alignment of the first opening  183360 A with the second opening  183051 A. Second rotating disk  183051  may be configured for rotation with respect to the drug container and have second opening  183051 A. One or both of the openings may initially be covered by a film such that the film prevents foreign materials from entering the openings. 
     As seen in  FIG. 127C , during installation the first and second rotating disks are brought into contact such that the first and second openings are aligned. The rotating disks may be joined through the use of an adhesive or, alternatively, may be held in contact by features such as the snap arms described previously in relation to other embodiments. Once connected, the disks may be rotated such that they align with chimney  183053  and third opening  183310 F in connection hub  183310 . Chimney  183053  may be biased for axial movement in the distal direction, such as by a spring or other biasing member capable of storing energy. As shown in  FIG. 127D , upon alignment with the first and second opening, the chimney translates in the distal direction, passing through both the first and second opening. The chimney may have a pass-through which allows contents to flow from the drug container. In this way, a sterile fluid path is created between the drug container and the fluid pathway connection. The fluid pathway connection may further include a piercing member which is configured to, upon activation by a user, pass through the chimney and pierce a pierceable seal of the drug container. After the pierceable seal is pierced, drug fluid may pass through the piercing member and be delivered to the patient. The piercing member may be engaged with retainer  183320 . The retainer may also be configured for connection of sterile fluid conduit  30  (see  FIG. 1B ) at conduit connection  183320 A. The translation of the piercing member may be caused by translation of the retainer. 
     In at least one embodiment, the present disclosure provides a user-initiated fluid pathway connection. The fluid pathway connection includes: a connection hub, a piercing member, a piercing member retainer, and a drug container having a cap, a pierceable seal, and a barrel, wherein the piercing member is at least partially disposed in a sterile chamber defined by the connection hub. The fluid pathway connection is configured such that it may be connected to the drug container while maintaining the aseptic condition of a fluid pathway. The drug container may contain a drug fluid for delivery. The fluid pathway connection may further be in fluid communication with a conduit that provides a fluid pathway for delivery of the fluid drug to the patient. Upon initiation by the user, the fluid drug is delivered through the fluid pathway to the body of the user. The pierceable seal includes a seal barrier that may be penetrated, upon user initiation, by the piercing member. 
     In another embodiment, the present disclosure provides a drug delivery pump with integrated sterility maintenance features having a housing and an assembly platform, upon which an activation mechanism, a fluid pathway connection, a power and control system, and a drive mechanism having a drug container may be mounted, said fluid pathway connection including a connection hub, a piercing member, a piercing member retainer, and a drug container having a cap, a pierceable seal, and a barrel, wherein the piercing member is at least partially disposed in a sterile chamber defined by the connection hub. The fluid pathway connection is configured such that it may be connected to the drug container while maintaining the aseptic condition of a fluid pathway. The drug container may contain a drug fluid for delivery. The fluid pathway connection may further be in fluid communication with a conduit that provides a fluid pathway for delivery of the fluid drug to the patient. Upon initiation by the user, the fluid drug is delivered through the fluid pathway connection to the body of the user. The pierceable seal includes a seal barrier that may be penetrated, upon user initiation, by the piercing member. 
     XIX. Additional Embodiments Relating to Skin Attachment 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-127D , may be configured to incorporate the embodiments of the adhesive described below in connection with  FIGS. 128A-129D . 
     The present embodiments disclose adhesives which have bond strengths which are sensitive to the presence of a stimulant. The adhesive may be used to adhere the drug delivery device to the skin of a patient. The introduction of a stimulus may cause the bond strength of the adhesive to decrease such that the device may be more easily removed from the patient&#39;s skin as well as possibly reducing the pain or discomfort to the patient due to the removal. The stimulus may be chosen from any of the group of stimuli that is capable of decreasing the strength of the bond including: light, such as a UV light, heat, and electricity. The stimulant source may be integrated into the medical device or, alternatively, may be independent from the medical device. Methods of use and assembly are also described. 
     As seen in  FIGS. 128A-128C , the drug delivery device  19010  may include a body  19001 , stimulant source  19002 , first adhesive patch  19003 , and second adhesive patch  19004 . Body  19001  may encompass or enclose stimulant source  2  or, alternatively, stimulant source  19002  may be located on the outside of body  19001 . The stimulant source has an inactive state and an active state. In the inactive state the stimulant source does not produce and/or emit a stimulus. In the active state, the stimulant source does produce and emit a stimulus. The bond strength of first adhesive  19003  may be such that it does not decrease in response to activation of stimulant source  19002 . The first adhesive may retain the second adhesive in connection with the medical device. The bond strength of second adhesive  19004  may initially have a first bond strength in the absence of a stimulant and a second bond strength in the presence of a stimulant. The device  190010  may, optionally, include a removable adhesive cover which protects and isolates the adhesive during shipment and prior to application of the medical device to the patient. 
     Prior to initiation of delivery of the medicament, the patient or a medical practitioner may remove the adhesive cover, if equipped. The medical device may then be secured to the patient using the adhesive. The first bond strength of the second adhesive may be such that it securely attaches the device to the patient&#39;s skin, preventing unintentional removal. After delivery of the medicament or, at any other desired time, stimulant source  19002  may be activated. The activation may occur automatically at completion of medicament delivery or may occur in response to an input by the patient. For example, the device may include a stimulant activation mechanism such as a button, switch, or any other mechanism known to one skilled in the art. Activation of the stimulant source causes the bond strength of at least a portion of second adhesive patch  19004  to decrease to the second bond strength. In at least one embodiment, the bond strength of the outer perimeter of the second adhesive may be decreased to the second bond strength, thereby allowing the user to easily engage the edge of the adhesive and thereby remove or peel off the remainder of the adhesive from the patient&#39;s skin. In these embodiments, a stimulant source may be arranged around the outer profile of the device, the position of the stimulant source and the intensity of the stimulant controlling the portion of the second adhesive which is affected. In other embodiments, the bond strength of substantially all of the second adhesive is decreased, thereby allowing easy removal of the device from the patient&#39;s skin. The bond strength of the second adhesive does not need to be decreased uniformly in response to activation of the stimulant source. In other words, the bond strength of some portion of the second adhesive may be decreased to a greater extent than other portions. The cohesive properties of the adhesive may be completely eliminated or, alternatively, may retain some bonding strength. For example, the bond strength of the adhesive, in the presence of the activated stimulant may be sufficient to maintain its adhesion to the patient&#39;s skin until a removal operation is performed by the patient. 
     The stimulant may be a UV light source and be an integral aspect of the device as seen in  FIGS. 128A-128C . The UV light source may be located on the bottom portion of the device such that it is in proximity to the adhesive patch. The UV light source may be in electronic communication with one or more other aspects of the device such that activation of the UV light source may be performed and/or controlled by a PCB or other type of electronic controller. Activation, by the electronic controller, may occur in response to completion of the delivery of a medicament to the patient. The activation may also be triggered by an input by the user, such as by depression of a button. 
     In other embodiments, shown in  FIGS. 129A-129D , the stimulant source  190015  is an external stimulant source (i.e., not physically connected to the medical device). In these embodiments, the stimulant source may be supplied, with the drug delivery device  19020 , to the user or may be supplied separately. The external stimulant source may be used multiple times and for multiple devices. To facilitate application of the stimulant to the adhesive, one or more aspects of the body of the device may be at least partially translucent, thereby allowing a stimulant such as a UV light to pass through. In at least one embodiment, the medical device may have a removable portion  190011 . The removal of this portion of the medical device may expose a translucent portion  190012 . Translucent portion  190012  may be a thin portion of the device thereby allowing the stimulant source to come into close proximity with the adhesive. A first adhesive  190013  may be bonded to translucent portion  190012 . The bond strength of the first adhesive may not be affected by the presence of the stimulant. A second adhesive  190014  may be applied, the bond strength of which is altered by the presence of a stimulant as described previously. The external stimulus may be in the form of a handheld UV light source such that the user may direct the light source toward the adhesive. 
     In another aspect of the invention, the secondary adhesive may be re-useable. Removal of the stimulant may allow the adhesive to return to its first bond strength. After returning to the first bond strength the device may be re-applied to the patient&#39;s skin. This may be useful in applications of re-usable medical devices. 
     In applications in which the bond strength of the adhesive is affected by light, the adhesive may be configured such that it responds only to light of certain wavelengths. This may allow filters to be applied that prevent an inadvertent decrease in bond strength. 
     The bond strength of the adhesive may be immediately decreased in the presence of the stimulant. Alternatively, it may be necessary that the adhesive be exposed to the stimulus for a prolonged period of time in order to decrease the bond strength. The time may be as short as a few seconds to as long as a few minutes. 
     In other embodiments, a method of use is provided. The method of use may include the steps of: applying a medical device to a patient&#39;s skin using an adhesive; initiating operation of the medical device; activating a stimulant source to decrease the bond strength of at least a portion of the adhesive; and removal of the medical device from the patient. The stimulant source may be integral to the medical device or may be independent from the device. The method may optionally also include the step of removing an adhesive patch cover. The method may also include removal of one or more portions of the medical device from one or more other portions of the medical device. 
     In still other embodiments, a method of assembly is provided. The method of assembly may include the steps of: applying a first adhesive to a portion of the medical device; applying a second adhesive at least partially to the second adhesive. The method of assembly may further include assembling a stimulant source into the medical device. 
     XX. Additional Embodiments of Fluid Pathway Connector 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-56, 74-129 , may be configured to incorporate the embodiments of the fluid pathway connector described below in connection with  FIGS. 130-136B . The embodiments of the fluid pathway connected described below in connection with  FIGS. 130-136B  may be used to replace, in its entirety or partially, the above-described fluid pathway connector  300 , fluid pathway connector  622 , fluid pathway connector  722 , fluid pathway connector  922 , fluid pathway connector  1122 , fluid pathway connector  2300 , or any other fluid pathway connector described herein, where appropriate. 
     In general, the present embodiments relate to fluid restriction mechanisms that control the rate of drug delivery by providing resistance and/or increasing the length of the fluid delivery pathway from the drug container to the needle insertion mechanism, for drug delivery into the patient. Additionally, the fluid restriction mechanisms of the present disclosure may be readily replaceable, configurable, and/or stackable to provide a range of fluid pathways and to meet a myriad of drug delivery needs. For example, the manufacturer, drug-filler, assembler, or another member of the production process may select and insert the necessary fluid restriction mechanism to meet the desired drug delivery profile. This selection and insertion may be performed by initial placement or replacement of the fluid restriction mechanism. Additionally or alternatively, this may be performed by adjusting the fluid restriction mechanism, such as by rotation of a configurable fluid restriction mechanism having a plurality of fluid pathway channels or a single pathway with passages that may be opened or closed to modify the fluid pathway prior to assembly. Additionally or alternatively, the fluid delivery profile may be met by utilizing a multitude of fluid restriction mechanisms, at least in part, in a series configuration or in a parallel configuration. Each of these variations of the fluid restriction mechanism may be utilized to meet the desired fluid delivery profile from the drug delivery device. 
     Furthermore, the fluid restriction mechanisms of the present embodiments may include permeable membranes to permit venting of gaseous fluids from the fluid pathway. The pump type drug delivery systems which include such fluid pathway systems and fluid restriction mechanisms are capable of being primed to reduce or eliminate gaseous fluids from the fluid pathway system prior to introduction of a liquid fluid to a patient. When delivering fluid subcutaneously it is important to minimize or eliminate the amount of gaseous fluid that is delivered into the patient. Delivery of gaseous fluids, such as air or inert gases, is correlated to increased perception of pain for patients and may adversely affect absorption profiles of pharmaceutical treatments. As such, it is important to minimize or eliminate such gaseous fluids from the system prior to injection of the drug. The fluid restriction mechanisms are also easily configurable to permit the manufacture of one type of mechanism (e.g., plate, chip, etc.) while enabling customization of the fluid restriction mechanism prior to or during assembly to enable a range of fluid restriction parameters. 
     As described in more detail below, a single restriction mechanism may have a number of selectable fluid pathways or channels with different restriction parameters. Based on the desired fluid flow characteristics, the manufacturer or assembler can select the appropriate fluid pathway and assemble the components such that the desired fluid pathway is utilized. Similarly, the fluid pathways may be opened or closed by the assembler/manufacturer to enable longer or shorter fluid pathways, as may be desired to meet the particular flow characteristics. While these are important and desirable features of drug delivery devices, such features should not be cumbersome or complicated for the user. The present disclosure provides a system which enables the configurability of the fluid restriction mechanisms and also the reduction or elimination of gaseous fluids from the fluid pathway, but yet is easy to use for clinicians and patients. 
     When delivering fluid subcutaneously it is important to control or restrict the flow of fluid that is delivered into the patient. A drug delivery device, such as an infusion pump or a bolus injector, may be needed to deliver a particular amount of drug fluid within a period of time. The flow of drug fluid, however, may need to be restricted as it passes through the system from a drug container to the needle insertion mechanism and into the patient. Some drug delivery device systems may utilize one or more an active fluid restriction mechanisms, one or more passive fluid restriction mechanisms, or a combination of both. The present disclosure provides configurable fluid restriction mechanisms (e.g., plates, chips, etc.) for microfluidic pathways which can be readily integrated into a pump type delivery device within the fluid pathway between the drug container and the needle insertion mechanism. 
     The pump type delivery devices may be connected in fluid flow communication to a patient or user, for example, through any suitable hollow tubing. The hollow tubing may be connected to a hollow needle that is designed to pierce the skin of the patient and to deliver a fluidic medium there-through. Alternatively, the hollow tubing may be connected directly to the patient as through a cannula, or the like. As a further option, a solid bore needle may be used to pierce the skin of the patient and place a hollow cannula at the appropriate delivery position, with the solid bore needle being removed or retracted prior to drug delivery to the patient. As stated above, the fluid can be introduced into the body through any number of means, including but not limited to: an automatically inserted needle, cannula, micro-needle array, or infusion set tubing. The flow of fluid may be initiated by a number of different drive mechanisms which push a plunger seal within a drug container, thereby forcing a drug fluid out of the drug container. In at least one embodiment, the drive mechanism may be a spring-based drive mechanism that utilizes one or more springs to drive or push the plunger seal. The activation of the drive mechanism and the pushing of the plunger seal may occur before or after a fluid connection is completed, or itself may first cause a fluid connection to be made before forcing fluid through the fluid connection. Once the fluid flow is initiated, the fluid restriction mechanisms of the present disclosure may be utilized to control the duration of fluid flow through the drug delivery device. The fluid restriction mechanism may be located between the drug container and the fluid conduit leading to the insertion mechanism, or at one or more locations within the fluid pathway from drug container to patient through the insertion mechanism. 
     In a first embodiment, the present disclosure provides a selectively replaceable fluid restriction mechanism for a drug delivery device. The fluid restriction mechanism includes an aperture residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open; an entry point of a fluid channel configured such that the flow of drug fluid can travel through aperture to the entry point and through the fluid channel to an exit point; and an outlet aperture of a port through which the flow of drug fluid may travel after exiting the exit point, wherein a fluid conduit is connected to the fluid restriction mechanism at the outlet aperture. The selectively replaceable fluid restriction mechanism may further include a vent aperture to vent air or gas from a proximal side of the fluid restriction mechanism to a distal side of the fluid restriction mechanism; and a membrane to facilitate the passage of air or gas in one direction while preventing fluid passage therethrough. The membrane may be a permeable membrane. 
     In another embodiment, the present disclosure provides a configurable fluid restriction mechanism for a drug delivery device which includes an aperture residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open; an entry point configured such that the flow of drug fluid can travel through aperture to the entry point; a plurality of fluid channels, selectable to align with the entry point and an exit point of the fluid restriction mechanism; and an outlet aperture of a port through which the flow of drug fluid may travel after exiting the exit point, wherein a fluid conduit is connected to the fluid restriction mechanism at the outlet aperture. The configurable fluid restriction mechanism may include a vent aperture to vent air or gas from a proximal side of the fluid restriction mechanism to a distal side of the fluid restriction mechanism; and a membrane to facilitate the passage of air or gas in one direction while preventing fluid passage therethrough. The plurality of fluid channels may vary in length to provide different durations of travel for the flow of drug fluid, and/or the plurality of fluid channels may vary in diameter to provide different fluid restrictions to the flow of drug fluid. 
     In at least one embodiment, a plurality of the configurable fluid restriction mechanisms may be connected in series in a stacked configuration, and wherein the aperture of the first fluid restriction mechanism resides adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture when the fluid pathway connection is open, and the fluid conduit is connected to the outlet aperture of the last fluid restriction mechanism in the stacked configuration. In another embodiment, the one or more fluid channels may be selectively opened to permit the flow of drug fluid, and/or selectively closed to prevent the flow of drug fluid. In at least one embodiment, one or more fluid channels may be connected to each other to increase the duration of travel that the drug fluid must flow through. The fluid restriction mechanisms may be in the shape of a disc, a spheroid, a square, a sphere, a cube, a rectangle, or a pyramid. 
     In yet another embodiment, the present disclosure provides a drug delivery device with fluid delivery control which includes a housing, within which an activation mechanism, an insertion mechanism, a drug container having a plunger seal may be mounted, and one or more of the fluid restriction mechanisms described above, wherein the drug container is connected at one end to a drive mechanism and at another end to a fluid pathway connection, and the fluid restriction mechanism is connected at one end to the fluid pathway connection and at the other end to a fluid conduit, and the fluid conduit is connected at another end to the insertion mechanism; such that the fluid restriction mechanism is configured to restrict or control a flow of a drug fluid from the drug container to the insertion mechanism. The fluid restriction mechanism may be a component of the fluid pathway connection mounted to and integrated within the barrel of a drug container, or the fluid restriction mechanism may be a component adjacent to the fluid pathway connection and configured to restrict the flow of drug fluid from the barrel of a drug container through the drug delivery device once the fluid pathway connection is opened. Alternatively, the fluid restriction mechanism may be connected to the fluid pathway connection by a first fluid conduit, and the fluid restriction mechanism is connected to the insertion mechanism by a second fluid conduit, such that the flow of drug fluid is restricted between the drug container and the insertion mechanism by the fluid restriction mechanism. 
     Referring now to  FIG. 130 , illustrated is an embodiment of a fluid restriction mechanism  20500  implemented in the drug delivery device  10 . As described above, the drug delivery device  10  may be utilized to administer delivery of a drug treatment into a body of a user. The drug delivery device  10  includes the pump housing  12 . The pump housing  12  may include one or more housing subcomponents which are fixedly engageable to facilitate easier manufacturing, assembly, and operation of the drug delivery device  10 . For example, the pump housing  12  may includes the upper housing  12 A and the lower housing  12 B. The drug delivery device  10  may further include the activation mechanism  14 , the status indicator  16 , and the window  18 . The window  18  may be any translucent or transmissive surface through which the operation of the drug delivery device may be viewed. As shown in  FIG. 130 , drug delivery device  10  further includes the assembly platform  20 , the sterile fluid conduit  30 , the drive mechanism  100  having the drug container  50 , the insertion mechanism  200 , the fluid pathway connection  300 , and the power and control system  400 . The fluid restriction mechanism  20500  may be connected to the sterile fluid conduit  30 , preferably, between the fluid pathway connection  300  and the insertion mechanism  200 . One or more of the components of such drug delivery devices may be modular in that they may be, for example, pre-assembled as separate components and configured into position onto the assembly platform  20  of the drug delivery device  10  during manufacturing. 
     The fluid restriction mechanisms of the present disclosure may take a number of configurations while remaining within the scope of the presently claimed embodiments. The fluid restriction mechanisms provide a means for fluid delivery control, by restricting the flow of fluid travel and/or by increasing the length of the fluid pathway that the fluid must travel through between the drug container and the insertion mechanism before delivery into the patient. The fluid restriction mechanisms of the present disclosure are readily replaceable, configurable, and/or stackable to enable the drug delivery device to meet the desired drug delivery profile (e.g., delivery duration). The fluid restriction mechanism  20500  may be connected to the sterile fluid conduit  30 , preferably, between the fluid pathway connection  300  and the insertion mechanism  200 . For example, the fluid restriction mechanism  20500  may be connected at the beginning of the fluid conduit  30  (between the sterile fluid pathway connection  300  and the fluid conduit  30 ), at the end of the fluid conduit  30  (between the fluid conduit  30  and the insertion mechanism  200 ), or anywhere in between along the fluid conduit  30 . 
     The fluid restriction mechanism  20500  resides within the housing of the drug delivery device, as shown in  FIG. 130 .  FIG. 131A  shows an isometric view of a fluid restriction mechanism, according to at least one embodiment of the present disclosure, attached to an integrated sterile fluid pathway connection and drug container. In such an embodiment, the fluid restriction mechanism may be a component of the integrated sterile fluid pathway connection and drug container. As shown in  FIG. 131B , the fluid restriction mechanism may be attached to the sterile fluid pathway connection and drug container, such as by retention by cap  52  which may be a cap that is crimped to the barrel  58 . In this configuration, the fluid restriction mechanism may include a piercing member  20510 , such as a needle, that is capable of piercing a seal  56  of the sterile fluid pathway connection  300  to permit fluid flow from the drug chamber  21  of barrel  58  of the drug container  50 . In this configuration, the seal  56  is caused to slide upon, and be pierced by the piercing member  510  upon hydraulic and/or pneumatic pressure of the fluid within the drug chamber  21  that is caused by a drive mechanism  100  acting upon plunger seal  60 . Once the sterile fluid pathway connection  300  is opened, drug fluid may travel through piercing member  510 , through the fluid channel(s) of the fluid restriction mechanism  20500 , out through port  20512  through the fluid conduit  30  to the insertion mechanism  200  for drug delivery to the patient.  FIG. 131C  shows a side view of the fluid restriction mechanism shown in  FIG. 131A . As will be detailed further herein, the fluid restriction mechanism  20500  may also include a membrane  20309 , such as a partially permeable membrane, that is capable of venting air or other gas from the sterile cavity between the fluid restriction mechanism  20500  and the seal  56 . In such a configuration, the fluid restriction mechanism  20500  does not need to move or translate once assembled to barrel  58  of the drug container  50  as the sterile fluid pathway connection  300  occurs integrated within the drug container  50 . This configuration of the fluid restriction mechanism may be preferred for use with the integrated fluid pathway connection and drug container described in International Patent Application No. PCT/US2013/030478, which is hereby incorporated by reference in its entirety. 
       FIG. 132A  shows an isometric view of a fluid restriction mechanism, according to another embodiment of the present disclosure. In this configuration, the fluid restriction mechanism  201500  is attached to a sterile fluid pathway connection which may or may not be integrated within the drug container. In this configuration, the seal  56  may be retained in position at the distal end of the barrel  58  by cap  52 , and the sterile fluid pathway connection  300  may be external (i.e., not integrated) to the barrel  58  of the drug container  50 . This configuration of the fluid restriction mechanism may be preferred for use with the fluid pathway connection and drug container described in International Patent Application No. PCT/US2012/054861, which is hereby incorporated by reference in its entirety. The fluid restriction mechanism  201500  of this embodiment may be attached to the distal end of the sterile fluid pathway connection  300  which is capable of acting upon and piercing the seal  56  retained within barrel  58  of the drug container  50 . In that embodiment, the piercing member  201510  would instead be a conduit or port connected to the distal surface of the fluid pathway connection. Alternatively, a piercing member  201510  may be utilized in this embodiment to function as part of the integrated fluid pathway connection and drug container, and to pierce the seal  56  to permit drug flow from the drug container  50 .  FIG. 132B  shows an exploded isometric view of the fluid restriction mechanism, and sterile fluid pathway connection and drug container, shown in  FIG. 132A .  FIG. 132C  shows a side view of the fluid restriction mechanism shown in  FIG. 132A . 
       FIG. 133A  shows an exploded isometric view of the fluid restriction mechanism shown in  FIGS. 131A-131C . Though the description below provides details with reference to the embodiments shown in  FIGS. 131A-131C , the description with reference to the function of the fluid restriction mechanism may also provide detail to the embodiments shown in  FIGS. 132A-132C .  FIG. 4A  shows the fluid restriction mechanism  20500  as two separate components.  FIG. 133B  shows another angle of the exploded isometric view of the fluid restriction mechanism shown in  FIG. 133A . As would be understood by one having ordinary skill in the relevant art, this is primarily for ease of manufacture and the mechanism  20500  may be a single unified component if manufactured, for example, by injection molding or other suitable means. In this two-part assembly the fluid channel(s) may be imparted, such as by carving or other suitable means of manufacture, onto a first component  20500 B of the fluid restriction mechanism and then closed by attachment of a second component  20500 A. The two components may be affixed and held together by snap arms, adhesives, etc., or other mechanisms which are readily known in the industry to provide a tight seal to the fluid channel(s) of the fluid restriction mechanism. The second component (e.g., cover plate)  20500 A may be fused, molded, or otherwise connected to the first component (e.g., restriction plate)  20500 B. The fluid pathway of each of the fluid channels may be adjusted for pathway thickness, length, curvature, and any number of tortuous path parameters, for example, to produce a fluid restriction of any desired range. The pathway that a drug fluid may travel through the fluid restriction mechanism  20500  is shown with reference to  FIG. 133C , which provides a cross-sectional view of the fluid restriction mechanism shown in  FIGS. 133A-133B . Drug fluid may enter the fluid restriction mechanism  20500  through aperture  20520 A of a piercing member  510 . The drug fluid then enters the fluid channel(s) at entry point  20520 B. The drug fluid is retained in the fluid channel(s)  20520 C because of the tight seal provided by the mating of the second component  20500 A to the first component  20500 B. 
     In the embodiment shown, the fluid channel(s) are in a spiral shape to elongate the length of travel that the fluid must pass (i.e., extending the time or duration of drug delivery). The width of the channel(s) may also be modified and utilized to control the flow parameters through the fluid restriction mechanism. The drug fluid then travels through the fluid channel(s)  20520 C to exit point  20520 D, at which point the drug fluid is caused to travel through outlet aperture  20514  of port  20512  to the fluid conduit  30  (visible in  FIGS. 131A-131C ). The fluid channel(s) may be shortened or lengthened to provide the desired duration of fluid delivery time (i.e., the drug fluid may be caused to travel a longer path or a shorter path through the fluid restriction mechanism). Additionally or alternatively, the fluid channel(s) may restrict the flow of drug fluid by functioning as an orifice. As would be readily understood by an ordinarily skilled artisan in the relevant arts, fluid flow in a pipe or conduit is always accompanied by friction of fluid particles rubbing against one another, and consequently, by loss of energy available for work. In other words, there must be a pressure drop in the direction of flow. Accordingly, the fluid channel(s) of the fluid restriction mechanism may function as an orifice to meter rate of flow, by restricting flow and/or to reduce pressure. For liquid flow, several orifices are sometimes used to reduce pressure in steps so as to avoid cavitation. Concurrently, a vent aperture  20530 A,  20530 B may be utilized to vent the air or gas from the proximal side of the fluid restriction mechanism  20500  to the distal side of the fluid restriction mechanism  20500 . A membrane  20309 , such as a partially permeable membrane, may be utilized for example to facilitate the passage of gas (e.g., air) in one direction while preventing fluid passage therethrough. 
       FIGS. 134A-134B  show a configurable fluid restriction mechanism, according to another embodiment of the present disclosure, in the exploded and front views respectively. In this embodiment, the fluid restriction mechanism  20500  contains more than one fluid channel  20520 C,  20521 C,  20522 C, and  20523 C. Accordingly, the same fluid restriction mechanism  20500  may be utilized in a number of configurations to provide the desired fluid flow parameters. If shorter drug delivery duration is desired, channel  20522 C may be selected and aligned with entry point  20520 B and exit point  20520 D. If more restrictive fluid flow is desired, channel  20523 C may be selected and aligned with entry point  20520 B and exit point  20520 D. Alternatively, channels  20521 C or  20520 C may be selected and aligned with entry point  20520 B and exit point  20520 D to reach the desired drug delivery parameters. This is facilitated, for example during assembly of the device, by identifying the desired drug delivery parameters and the appropriate fluid channel, and rotating and mounting the fluid chip  20550 A into the corresponding recess  20550 B such that the selected fluid channel aligns with entry point  20520 B and exit point  20520 D. This is shown in  FIG. 134B . 
     Any number of distinct channels may be provided and utilized in this embodiment of a configurable fluid restriction mechanism. Additionally, the desired channels may be opened or closed by removing or adding, respectively, barriers between the channels. For example, if an even longer fluid channel is desired, the barriers between channels  20521 C and  20520 C may be modified such that the fluid flows initially into channel  20520 C through entry point  20520 B, then through channel  20521 C, then back through the remainder of channel  20520 C to exit point  20520 D. In a further embodiment, the fluid restriction plate may have a number of sequential or parallel pathways which are configurable to deliver the desired fluid restriction parameters. For example, the fluid restriction plate may have a number of different pathways of different lengths and constraints, and the specifically desired fluid pathway may be selected during assembly to produce the desired fluid restriction for the drug delivery device system. One or more of these pathways may be “opened” or “closed” prior to assembly to enable a range of configurable fluid pathways. While plates are discussed and shown herein, the fluid restrictors may take on a number of different shapes and configurations including, but not limited to, spheres, discs, pucks, semicircles, rectangles, cubes, pyramids, and the like. This configurability provides even more variation to the number of channels or fluid path configurations capable of being employed by the present disclosure. More complex shapes may be utilized which include different fluid pathway channels, and these are only restricted by economically-feasible and known manufacturing methods. For example, more complex shapes and fluid channel configurations may be possible via 3D-printing, or other complex manufacturing methods. Concurrently, a vent aperture  20530 A,  20530 B may be utilized to vent the air or gas from the proximal side of the fluid restriction mechanism  20500  to the distal side of the fluid restriction mechanism  20500 . A membrane  20309 , such as a partially permeable membrane, may be utilized for example to facilitate the passage of gas (e.g., air) in one direction while preventing fluid passage therethrough. 
       FIG. 135A  shows an isometric view of a stackable fluid restriction mechanism, according to another embodiment of the present disclosure.  FIG. 135B  shows an exploded isometric view of the stackable fluid restriction mechanism. The stackable fluid restriction mechanism may utilize any of the fluid restriction arrangement described above with reference to  FIG. 133A  and  FIG. 134A , in the configurations shown in  FIGS. 131A-131C ,  FIGS. 132A-132C , or the other configurations described herein. Accordingly, one or more fluid restriction mechanisms may be utilized in a stacked configuration to provide an additional distance that the drug fluid must travel to prolong the duration of drug delivery. In such a stacked configuration, a spacer plate  20503 B may be utilized between two restriction plates  20503 A and  20500 B, in order to align the fluid entry points and exit points with the corresponding or abutting plates. Any number of these plates may be utilized to reach the desired drug delivery parameters. 
     The fluid restriction mechanisms of the present disclosure are shown primarily in a disc-shaped configuration, though the shape is not a necessary limitation on the present disclosure and any number of known shapes may be utilized. For example,  FIG. 136A  shows an isometric view of a rectangular fluid restriction mechanism, according to a further embodiment of the present disclosure.  FIG. 136B  shows the isometric view of the fluid restriction mechanism  202500  shown in  FIG. 136A , with the top component of the fluid restriction mechanism removed. As shown, the fluid restriction mechanism  202500  may take any number of shapes or dimensions, provided that there is at least one fluid channel therein having at least one entry point and at least one exit point through which the drug fluid may travel. Additionally, the fluid restriction mechanism  202500  may be connected to the sterile fluid conduit  30 , preferably, between the fluid pathway connection  300  and the insertion mechanism  200 . For example, the fluid restriction mechanism  202500  may be connected at the beginning of the fluid conduit  30  (between the sterile fluid pathway connection  300  and the fluid conduit  30 ), at the end of the fluid conduit  30  (between the fluid conduit  30  and the insertion mechanism  200 ), or anywhere in between along the fluid conduit  30  (as shown in  FIG. 136A-136B ). 
     Assembly and/or manufacturing of the above-described embodiments of the fluid restriction mechanism, drug delivery pump  10 , or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components and/or the devices. A number of known adhesives or glues may similarly be employed in the manufacturing process. Additionally, known siliconization and/or lubrication fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     A fluid pathway connection, and specifically a sterile sleeve of the fluid pathway connection, may be connected to the cap and/or pierceable seal of the drug container. The fluid restriction mechanism may be connected to the other end of the fluid pathway connection. A fluid conduit may be connected to the fluid restriction mechanism at one end and the insertion mechanism at the other end, such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connection, fluid restriction mechanism, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a user. As described above, the fluid restriction mechanism may alternatively be located between the sterile pathway connection and the insertion mechanism such that a first fluid conduit is connected directly to the sterile pathway connection and to the fluid restriction mechanism, and then a second fluid conduit is connected to the fluid restriction mechanism and to the insertion mechanism. Regardless of the configuration, or order of components, the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connection, fluid restriction mechanism, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a user. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device, as shown in  FIG. 130 .) 
     XXI. Additional Embodiments of Insertion Mechanism 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-56, 74-136B , may be configured to incorporate the embodiments of the insertion mechanism described below in connection with  FIGS. 137A-139C . The embodiments of the insertion mechanism described below in connection with  FIGS. 137A-139C  may be used to replace, in its entirety or partially, the above-described insertion mechanism  200 , the insertion mechanism  2000 , the insertion mechanism  17200 , the insertion mechanism  172200 , or any other insertion mechanism described herein, where appropriate. 
     When delivering drug fluid to a user, such as by subcutaneous or intramuscular injection, it is important to minimize or eliminate the amount of gaseous fluid that is delivered into the user. Delivery of gaseous fluids, such as air or inert gases, is correlated to increased perception of pain for patients and may adversely affect absorption profiles of pharmaceutical treatments. As such, it is important to minimize or eliminate such gaseous fluids from the system prior to injection of the drug. While this is an important and desirable feature of drug delivery devices, such features should not be cumbersome or complicated for the user. The present embodiments provide a system which enables the reduction or elimination of gaseous fluids from the fluid pathway, but yet is easy to use for clinicians and patients. 
     More particularly, the present embodiments provide insertion mechanisms having vented fluid pathways, and pump-type drug delivery systems which includes such vented fluid pathways, which are capable of being primed to reduce or eliminate gaseous fluids from the fluid pathway system prior to introduction of a liquid fluid to a user. The present embodiments relate to vented fluid pathway systems having a membrane, such as a permeable or semi-permeable membrane, and drug delivery pumps which utilize such vented fluid pathway systems for the parenteral delivery of drug fluids. Such novel components and devices provide a mechanism to prime (e.g., the evacuation or removal of air or other gaseous fluid) the fluid pathway prior to injection and dosing of the drug treatment. The novel systems and devices of the present disclosure can be employed in a number of different configurations, and can be utilized with both pre-filled cartridges and fill-at-time-of-use primary drug containers. 
     In at least one embodiment, the present disclosure provides an insertion mechanism having a vented fluid pathway which includes: one or more insertion biasing members, a hub, a needle, a refraction biasing member, and a manifold having a septum, a cannula, a manifold intake, and a membrane, wherein the annular space within the manifold between the septum, the cannula, the manifold intake, and the membrane defines a manifold header, wherein the manifold is configured to vent a gaseous fluid through the membrane and fill with a liquid fluid for delivery to the user through the cannula. The manifold intake is capable of connection with a fluid conduit. The insertion mechanism may be configured to be internally mounted within a drug pump or externally tethered to a drug pump by a conduit. In at least one embodiment, the vented or ventable insertion mechanism comprises two insertion biasing members. The septum closes the upper portion of the manifold while allowing the needle to pass through it. Another opening from the manifold is at least temporarily blocked by the needle as it resides within the cannula and/or another occlusion element such as a ferrule or plug, prior to operation of the insertion mechanism. The manifold intake receives fluid flow from the fluid conduit. The only remaining opening from manifold is blocked by membrane until operation of the insertion mechanism. 
     The membrane may be a number of filtering membranes which are capable of permitting passage of gaseous fluids but prohibiting passage of liquid fluids. For example, the membrane may be a permeable membrane or a semi-permeable membrane. Additionally, the membrane may be or function as a sterile barrier. In at least one embodiment, the membrane is a permeable membrane selected from the group consisting of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), one or more styrenes, and polyethylene fibers, and the combinations thereof. The membrane may be a separate component or be an integrated portion, such as part of the wall, of the manifold. 
     The insertion mechanism having a vented fluid pathway may further include a sensor. The sensor may be any number of sensors known to an ordinarily skilled artisan, such as those selected from the group consisting of pressure sensors, fluid sensors, optical sensors, mechanical sensors, electrical sensors, and electro-mechanical sensors, and the combinations thereof. 
     In another embodiment, the present disclosure provides a drug delivery pump which includes a housing and an assembly platform, upon which an activation mechanism, a drive mechanism, a fluid pathway connection, a power and control system, and an insertion mechanism having a vented fluid pathway may be mounted. The insertion mechanism having vented fluid pathway may be as described above. In a preferred embodiment, the drug pump utilizes a vented or ventable insertion mechanism having a vented fluid pathway which includes: one or more insertion biasing members, a hub, a needle, a refraction biasing member, and a manifold having a septum, a cannula, a manifold intake, and a membrane, wherein the annular space within the manifold between the septum, the cannula, the manifold intake, and the membrane defines a manifold header, wherein the manifold is configured to vent a gaseous fluid through the membrane and fill with a liquid fluid for delivery to the user through the cannula. The manifold intake is capable of connection with a fluid conduit. The insertion mechanism may be configured to be internally mounted within a drug pump or externally tethered to a drug pump by a conduit. In at least one embodiment, the vented or ventable insertion mechanism comprises two insertion biasing members. 
     In yet another embodiment of the present disclosure, a method of operating the insertion mechanism having a vented fluid pathway includes the steps of: (i.) initially maintaining a needle in a first position wherein fluid passage from a manifold header of a manifold through the cannula is blocked; (ii.) activating the flow of liquid drug fluid from a drug container through a fluid conduit to the manifold header of the manifold; (iii.) venting a gaseous fluid through a membrane within the manifold while prohibiting passage of the liquid drug fluid through the membrane; (iv.) activating an insertion biasing member to translate the needle and the cannula from the first position to a second position within a body of a user; and (v.) activating a retraction biasing member to translate the needle from the second position to a third position, wherein the third position permits passage of the liquid drug fluid from the manifold header of the manifold through the cannula and into the body of the user. In at least one embodiment, the step of activating an insertion biasing member to translate the needle and the cannula from the first position to a second position occurs after the step of venting a gaseous fluid through a membrane within the manifold. In another embodiment, the step of activating an insertion biasing member to translate the needle and the cannula from the first position to a second position may occur before the step of venting a gaseous fluid through a membrane within the manifold such that venting through the membrane is permitted only once the needle is in the second position. In such an embodiment, the step of activating an insertion biasing member to translate the needle and the cannula from the first position to a second position may cause the removal of a covering element from the membrane outside of the manifold to permit venting of any gaseous fluid from the fluid pathway. The covering element may be, for example, a cover, sheath, or sleeve. In either embodiment, however, the passage of the liquid drug fluid is permitted to occur only after the venting step and upon translation of the needle from the second position to a third position, wherein the third position permits passage of the liquid drug fluid from the manifold header of the manifold through the cannula and into the body of the user. In yet another embodiment, the method further includes, prior to the step of activating a retraction biasing member to translate the needle from the second position to a third position, the step of: measuring by a sensor the substantial completion of venting the gaseous fluid through the membrane. 
     Turning to the figures, the pump-type drug delivery devices of the present disclosure may be connected in fluid flow communication to a patient or user, for example, through any suitable hollow tubing. A solid bore needle may be used to pierce the skin of the patient and place a hollow cannula at the appropriate delivery position, with the solid bore needle being removed or retracted prior to drug delivery to the patient. As stated above, the fluid can be introduced into the body through any number of means, including but not limited to: an automatically inserted needle, cannula, micro-needle array, or infusion set tubing. A number of mechanisms may also be employed to activate the needle insertion into the patient. For example, a single spring insertion mechanism (as shown in  FIG. 7A ) or a dual spring insertion mechanism (as shown in  FIG. 7B ) may be employed to provide sufficient force to cause the needle and cannula to pierce the skin of the patient. The same spring, an additional spring, or another similar mechanism may be utilized to retract the needle from the patient. In at least one embodiment, the insertion mechanism may generally be as described in International Patent Application No. PCT/US2012/53174, which is hereby incorporated by reference herein in its entirety. Such a configuration may be utilized for insertion of the drug delivery pathway into, or below, the skin (or muscle) of the patient in a manner that minimizes pain to the patient. Other known methods for insertion of a fluid pathway may be utilized and are contemplated within the bounds of the present disclosure. 
     In a first embodiment, the present disclosure provides a fluid pathway system that allows a tube, conduit, or other fluid channel to be evacuated of air (or another gaseous fluid) prior to operation. In one such embodiment, the ventable fluid pathway system is integrated into an insertion mechanism  200 . The insertion mechanism includes an insertion mechanism housing  202  having one or more lockout windows  202 A, a base  252 , and a sterile boot  250 , as shown in  FIG. 8A . Base  252  may be connected to assembly platform  20  to integrate the insertion mechanism into the drug delivery pump  10  (as shown in  FIG. 1B ). The connection of the base  252  to the assembly platform  20  may be, for example, such that the bottom of the base is permitted to pass-through a hole in the assembly platform to permit direct contact of the base to the body of the user. In such configurations, the bottom of the base  252  may include a sealing membrane  254  that, at least in one embodiment, is removable prior to use of the drug delivery pump  10 . Alternatively, the sealing membrane  254  may remain attached to the bottom of the base  252  such that the needle  214  pierces the sealing membrane  254  during operation of the drug delivery pump  10 . As shown in  FIGS. 8A and 8B , the insertion mechanism  200  may further include an insertion biasing member  210 , a hub  212 , a needle  214 , a retraction biasing member  216 , a clip  218 , a manifold guide  220 , a septum  230 , a cannula  234 , and a manifold  240 . The manifold  240  may connect to fluid conduit  30  to permit fluid flow through the manifold  240 , cannula  234 , and into the body of the user during drug delivery, as described below in more detail. 
     The manifold guide  220  may include an upper chamber  222  and a lower chamber  226  separated by a manifold guide ring  228 . The upper chamber  222  may have an inner upper chamber  222 A, within which the retraction biasing member  216 , the clip  218 , and the hub  212  may reside during an initial locked stage of operation, and an outer upper chamber  222 B, which interfaces with the insertion biasing member  210 . In at least one embodiment, the insertion biasing member  210  and the refraction biasing member  216  are springs, preferably compression springs. The hub  212  may be engageably connected to a proximal end of needle  214 , such that displacement or axial translation of the hub  212  causes related motion of the needle  214 .  FIGS. 137A and 137B  show isometric views of the fluid conduit  30  connected to the manifold  240  at the manifold intake  240 A.  FIGS. 137A and 137B  show an embodiment of the present disclosure in which the membrane  21233  is located in a portion of the manifold  240  substantially opposite the manifold intake  240 A; however, the membrane could be located in any number of positions within the manifold  240 . Septum  230  closes the top portion of the manifold  240  from the environment and/or the inside of the pump housing, while permitting a pass-through for the needle or trocar. 
     As used herein, “needle” is intended to refer to a variety of needles including but not limited to conventional hollow needles, such as a rigid hollow steel needles, and solid core needles more commonly referred to as a “trocars.” In a preferred embodiment, the needle is a 27 gauge solid core trocar and in other embodiments, the needle may be any size needle suitable to insert the cannula for the type of drug and drug administration (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. Upon assembly, the proximal end of needle  214  is maintained in fixed contact with hub  212 , while the remainder of needle  214  is permitted to pass-through retraction biasing member  216 , an aperture of clip  218 , and manifold guide  220 . The needle  214  may further pass-through septum  230 , cannula  234 , manifold  240  through manifold header  242 , sterile boot  250 , and base  252  through base opening  252 A. Septum  230 , cannula  234 , and manifold  240  may reside within lower chamber  226  of manifold guide  220  and within sterile boot  250  until operation of the insertion mechanism. In this position, the cannula  234  may reside over a distal portion of the needle  214  and held in place within the manifold header  242  of manifold  240  by a ferrule  232 . Ferrule  232  ensures that cannula  234  remains substantially fixed and in sealed engagement within the manifold  240  to, for example, maintain the sterility of the manifold header  242  until operation of the device. As described above, the ferrule  232  may also function as a restriction or occlusion element to restrict, at least partially, the flow of liquid fluid from the manifold  240  through the cannula  234 . Similarly, septum  230  resides substantially fixed and in sealed engagement within the upper portion of the manifold  240  to maintain the sterility of the manifold header  242 . These aspects and components may be more clearly visible in the cross-sectional view shown in  FIG. 138A . 
     As would be appreciated by one having ordinary skill in the art, the restriction of fluid flow from the manifold header to the user through the cannula may be adjusted to reach the desired fluid flow characteristics. In at least one embodiment, the fluid flow is substantially entirely prevented until it is desirable and permitted by the removal of the restriction. In other embodiments, however, the restriction (e.g., the needle, the plug, or other occlusion element that prevents or reduces fluid flow) does not entirely prevent fluid flow but instead may be used to reduce or meter the fluid flow through the cannula. This may be desirable, for example, when the fluid flow is initially low volume and then increased at a later time as operation of the device progresses. Similarly, one or more restrictions or occlusion elements may be utilized separately or concurrently. For example, as described further herein, the ferrule may be utilized to restrict fluid flow from the manifold through the cannula to the user. 
     Similar to the insertion mechanism  200  described in connection with  FIGS. 7A and 8A-8B , the insertion mechanism  21200  of  138 A- 138 F may have a vented fluid pathway and may utilize a single insertion biasing member  210 . In an alternative embodiment of the insertion mechanism  2121200  having a vented fluid pathway, as shown in  FIG. 7B , the insertion mechanism  21200  may include two insertion biasing members  210  A, B. Insertion mechanism  21200  further includes insertion mechanism housing  202  (shown in transparent view), manifold guide  220 , sterile boot  250 , base  252 , and other components similar to those described above with reference to insertion mechanism  21200 . In the two insertion biasing members embodiment of the insertion mechanism shown in  FIG. 7B , manifold guide ring includes two circular platforms upon which insertion biasing member  2210  A, B may bear. Insertion mechanism  21200  may function identically to insertion mechanism  21200 , but may provide additional insertion force and/or facilitate different packaging configurations through the use of multiple insertion biasing members  210  A, B. The components and functions of the insertion mechanisms will be described further herein with the understanding that similar or identical components may be utilized for insertion mechanism  21200 , insertion mechanism  22200 , and all reasonably understood variations thereof. Regardless of the single or multiple insertion biasing member configuration, the insertion mechanisms of the present disclosure incorporate a vented fluid pathway capable of permitting priming (e.g., evacuation or expulsion of the gaseous fluid) of the drug container, the fluid conduit, and manifold prior to delivery of the drug fluid to the patient. This is enabled, at least in part, by the location of the membrane  21233  in the manifold  240  and the function of the insertion mechanism  21200  during the insertion and refraction stages of operation. 
     The operation of the insertion mechanism having a vented fluid pathway is described herein with reference to the above components, in view of  FIGS. 138A-138F .  FIG. 138A  shows a cross-sectional view of the insertion mechanism  21200  having a vented fluid pathway, according to at least one embodiment of the present disclosure, in a locked and ready to use stage. In this initial configuration, insertion biasing member  210  and retraction biasing member  216  are each retained in their compressed, energized states. As shown, the needle  214  may pass through an aperture of clip  218  and manifold guide  220  into septum  230  and manifold  240 . Septum  230  resides within manifold  240 . Manifold  240  further includes a manifold intake  240 A at which the fluid conduit  30  may be connected. This connection is such that the sterility is maintained from the drug container  50  of the drive mechanism  100 , through the fluid pathway connection  300  and the fluid conduit  30 , into sterile manifold header  242  of manifold  240  and sterile boot  250  to maintain the sterility of the needle  214 , cannula  234 , and the fluid pathway until insertion into the user for drug delivery. The fluid conduit  30  connects the fluid path from the drug container  50  (visible in  FIG. 1B ) to the insertion mechanism  21200  at manifold intake  240 A and into manifold header  242 . As described earlier, septum  230  closes the upper portion of the manifold  240  while allowing the needle  214  to pass through it. Another opening from the manifold  240  is at least temporarily blocked by the needle  214  as it resides within the cannula  234 , and/or by another occlusion element such as the ferrule  232 , prior to operation of the insertion mechanism  21200 . The only remaining opening from manifold  240  is blocked by membrane  21233 . As would be readily understood by an ordinarily skilled artisan, membrane  21233  may be any number of permeable or semi-permeable membranes which are capable of permitting passage of gaseous fluids while prohibiting passage through the membrane  21233  of liquid fluids. In at least one embodiment of the present disclosure, this is accomplished by utilizing a permeable membrane, such as a hydrophobic permeable membrane, that is permeable to a gaseous fluid but not a liquid fluid, such as the liquid drug treatment. In at least one embodiment of the present disclosure, it may be beneficial to utilize a permeable membrane that is also a sterile barrier. For example, the membrane  21233  may be a polymeric filter made of polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE), a number of types of styrene, and/or a high-density polyethylene fiber (such as that sold under the trade name TYVEK by DuPont), among many other types of suitable medical-grade gas filtering membranes. Accordingly, because the desired fluid pathway from the manifold  240  to the user through the cannula  234  is blocked by the needle  214 , the only available pathway for any gaseous fluid is through the membrane  21233 . 
     As shown in  FIG. 138B , as the drug pump is activated and liquid drug fluid (shown as a hatched area) is permitted to pass through the fluid conduit  30 , any gaseous fluid in the fluid pathway is caused to enter into the manifold header  242  of the manifold  240 . As the pressure of the liquid drug fluid continues to build in the fluid conduit  30 , it pushes the gaseous fluid out of the manifold header  242  through the membrane  21233  (shown as solid arrows). As stated above, this is possible because the fluid pathway to the user through the cannula  234  remains blocked by the needle  214 .  FIG. 138C  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway as liquid drug fluid fills the manifold and gaseous fluid is substantially fully pushed through the permeable membrane (as shown by the hatched area nearly reaching the membrane  21233  and filling the entire manifold header  242 ). Through the stages of operation of the insertion mechanism having a vented fluid pathway shown in  FIGS. 138A-138C , the needle  214  remains at substantially a first position, e.g., a blocking position, within the insertion mechanism  21200 . In this first position, the needle  214  blocks the fluid pathway through the cannula  234  to the user. As the drug container, fluid conduit  30 , and manifold header  242  are vented of gaseous fluid, such as air or inert gas, the needle insertion mechanism may be unlocked and activated to move the needle  214  to a second position, e.g., an inserted position.  FIG. 138D  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway, according to a first embodiment of the present disclosure, in an unlocked and inserted stage with the needle  214  in the second position. In this second position, the needle  214  and cannula  234  are inserted (in the direction of the solid arrow in  FIG. 138D ) into the body of the user. 
     The timing of the activation of the insertion mechanism  21200  to move the needle  214  from the first position to the second position may be coordinated by a timing mechanism controlled by, for example, the power and control system or by a mechanical delay directly from user activation of the drug pump. Additionally or alternatively, a number of sensors may be utilized to identify when the gaseous fluid has been substantially entirely expelled from the fluid pathway and the fluid pathway is primed for delivery of liquid drug fluid to the user. For example, pressure sensors may be utilized to monitor back-pressure (e.g., pressure build-up) in the fluid pathway resulting from the liquid fluid substantially filling the manifold header  242  and expulsion of any gaseous fluid from the drug container, fluid conduit  30 , and manifold  240 . Similarly, the rate of fluid flow may be actively controlled or passively controlled. For example, in at least one embodiment of the present disclosure, tubing or other fluid conduits with a controlled diameter or geometry, orifice, or other limiting mechanism may be utilized to control the rate of flow. Such mechanisms may provide means for passive control of the rate of delivery. The orifice or tubing can be used to passively modulate flow when coupled with an induced pressure in the primary drug container, i.e., the pressure exerted by the pump mechanism on the liquid fluid as it is forced out of the primary drug container. In some embodiments, the device may be configured to actively control the flow of delivery by an electrical means, a mechanical means, or a combination of both. For example, one or more solenoids may be utilized to actively control the flow of delivery by closing and/or opening the fluid pathway. 
     Additionally or alternatively, one or more timing mechanisms may be utilized which are directly coupled to the drive mechanism which subsequently brake or meter the delivery rate or total time to deliver a volume of liquid fluid from the primary drug container. It is to be understood that the mechanisms, methods, and devices of the present disclosure may be used control the total time of drug delivery, the static rate of delivery during the entire time of delivery, a dynamic rate of delivery during any interval period of the entire time of delivery, or any combination of the above. For example, the device may be configured to provide drug delivery which, start to finish, completes in a specified amount of time, for example 5 minutes. This could be configured to be irrespective of the rate of delivery, such that: (a) the rate of delivery may be initially high and then later low; (b) a constant rate during the entire time of delivery; or (c) constant rates that vary at different intervals within the entire time of delivery; (d) or any combination of these delivery methodologies. The insertion of the blocking needle and activation of the liquid fluid (e.g., drug treatment) flow may similarly be controlled to ensure there is enough time for the system to vent (i.e., prime the fluid pathway) prior to introduction of the liquid fluid to the user. After substantially all of the gaseous fluid has been expelled from the drug container, fluid conduit, and manifold, and the insertion mechanism has moved the needle from the first position to the second position, the fluid pathway is ready to permit delivery of the drug fluid to the user. 
       FIG. 138D  shows a cross-sectional view of an insertion mechanism in the second, e.g., needle inserted, position. As shown, sterile boot  250  is permitted to collapse as the insertion biasing member  210  expands and inserts the needle  214  and cannula  234  into the body of the user. At this stage, needle  214  is introduced into the body of the user to place the cannula  234  into position for drug delivery. As shown in  FIG. 138E , upon needle  214  and cannula  234  insertion by operation of the insertion biasing member  210  as described above, the needle  214  is retracted back (i.e., axially translated in the proximal direction) into the housing of the insertion mechanism  21200 . Manifold guide  220  and clip  218  (shown in  FIGS. 8A and 8B ), and guide protrusions  204 , are dimensioned such that, as the manifold  240  substantially bottoms-out on base  252 , i.e., reaches its full axial translation in the distal direction, the clip  218  escapes the guide protrusions  204  and is permitted to flex outwards to disengage from hub  212 . Upon such disengagement, retraction biasing member  216  is permitted to expand axially in the proximal direction (i.e., in the direction of solid arrow in  FIG. 138E ) from its initial compressed, energized state. A suitable lockout mechanism prevents axial translation in the proximal direction of the manifold guide  220  and insertion mechanism components that are distal to (i.e., below) the manifold guide ring  228 . Expansion of the retraction biasing member  216  translates hub  212 , and needle  214  to which it is connected, axially in the proximal direction from the second position to a third position, i.e., a needle retracted position. Ferrule  232  retains cannula  234  inserted within the body of the user through base opening  252 A. Upon retraction of the needle  214  from cannula  234 , the fluid pathway from manifold header  242  to the body of the user through the cannula  234  is opened and fluid may begin to pass-through the cannula  234 , as shown in  FIG. 138E . As the fluid pathway connection to the user is completed, the fluid drug treatment is forced from the drug container through the fluid pathway connection and the sterile fluid conduit into the manifold header  242  and through the cannula  234  for delivery into the body of the user. Accordingly, activation of the insertion mechanism inserts the needle  214  and cannula  234  into the body of the user from a first position to a second position, and sequentially retracts the needle  214  from the second position to a third position, i.e., the retracted position, while maintaining the cannula  234  in fluid communication with the body of the user.  FIG. 138F  shows a cross-sectional view of an insertion mechanism having a vented fluid pathway in the third retracted position for drug delivery. As shown, the needle  214  does not need to be fully retracted from septum  230 , though this may be desirable and permissible in other embodiments of the present disclosure, so long as the fluid pathway through the cannula  234  to the body of the user is opened. At the end of the drug dose delivery, the cannula  234  may be removed from the body of the user by removal of the drug pump from contact with the user. 
     In another embodiment of the present disclosure, the fluid pathway may be blocked by a plug, stopper, cork, or other removable occlusion element. For example, during the venting stage a removable plug or stopper may be utilized to block the portion of the fluid pathway that is in connection with the user. The plug, stopper, or other similar occlusion element is retracted or removed from the pathway after venting has substantially completed, enabling the liquid fluid to be delivered into the user. This may be desirable in configurations which use, for example, a rigid needle in fluid connection with the patient. For example, in at least one embodiment of the present disclosure, a rigid hollow needle may be utilized in place of the solid core trocar needle described above. In such an embodiment, the needle and, optionally, a cannula are inserted from a first position to a second position into the user. The needle and optional cannula are then retained within the body of the user. Instead of retracting the needle, the needle remains in the second position and a plug, stopper, or other similar occlusion element is removed or retracted from the needle to a third position, after the venting stage, to open the fluid pathway for drug delivery to the user. 
     A method of operating an insertion mechanism having a vented fluid pathway according to the present disclosure includes: initially maintaining a needle in a first position within a cannula and thereby blocking fluid passage from a manifold header of a manifold through the cannula; activating the flow of liquid drug fluid from a drug container through a fluid conduit to the manifold header of the manifold; venting a gaseous fluid through a membrane within the manifold while prohibiting passage of the liquid drug fluid through the membrane; activating an insertion biasing member to translate the needle and the cannula from the first position to a second position within a body of a user; and activating a retraction biasing member to translate the needle from the second position to a third position, wherein the third position permits passage of the liquid drug fluid from the manifold header of the manifold through the cannula and into the body of the user. In at least one embodiment of the present disclosure, the step of activating an insertion biasing member to translate the needle and the cannula from the first position to a second position occurs after the step of venting a gaseous fluid through a membrane within the manifold. In an alternative embodiment, however, the step of activating an insertion biasing member to translate the needle and the cannula from the first position to a second position may occur before the step of venting a gaseous fluid through a membrane within the manifold such that venting through the membrane is permitted only once the needle is in the second position. Such an embodiment of a needle insertion mechanism  22200  is shown in  FIGS. 139A-139C . In this embodiment, the fluid pressure in the fluid conduit may build and force any gaseous fluid in the fluid pathway into the manifold for venting through the membrane, as shown in  FIG. 139A . Once the fluid pathway has been suitably pressurized in this way, the insertion biasing member may be triggered to translate the needle and the cannula from the first position to a second position, thereby opening, uncovering, or otherwise unblocking the membrane to evacuate the gaseous fluid from the manifold. This is visible in  FIG. 139B . A blocking or covering element  22263  such as a sleeve, cover, sheath, or other similar component may be utilized outside of the manifold adjacent the membrane to initially cover or block the membrane in the first position and to uncover or unblock the membrane in the second position to permit venting, as shown in  FIG. 139C . In either embodiment, however, passage of the liquid drug fluid is permitted to occur only after the venting step and upon translation of the needle from the second position to a third position, wherein the third position permits passage of the liquid drug fluid from the manifold the manifold header of the manifold through the cannula and into the body of the user. The method may further include, prior to the step of activating a retraction biasing member to translate the needle from the second position to a third position, the step of: measuring by a sensor the substantial completion of venting the gaseous fluid through the membrane. 
     Certain optional standard components or variations of insertion mechanism  21200  or drug delivery device  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIGS. 1A-1C , to enable the user to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the user for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug pump to the body of the user. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the user. Adhesive patch  26  may optionally include a protective shroud that prevents actuation of the optional on-body sensor  24  and covers base opening  252 A. Removal of the patch liner  28  may remove the protective shroud or the protective shroud may be removed separately. Removal of the patch liner  28  may further remove the sealing membrane  254  of the insertion mechanism  21200 , opening the insertion mechanism to the body of the user for drug delivery. 
     Similarly, certain components of the present disclosure may be unified components or separate components while remaining within the breadth and scope of the described embodiments. For example, the membrane is shown as a component of the manifold of the insertion mechanism. The membrane may be a separate component or may comprise a wall of the manifold, as would readily be appreciated by one having ordinary skill in the art. In an alternative embodiment, the membrane may be located at the distal end of the fluid conduit or be a distal portion of the fluid conduit itself. The vent location enabled by the membrane determines the degree to which the system may be primed, however. To reduce dead volume within the fluid pathway and reduce the gaseous fluid that may be delivered to the user, it may be desirable to have the membrane as close as possible to the end of the fluid pathway. Accordingly, the membrane is preferably an integrated aspect of the manifold of the needle insertion mechanism. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure.) 
     XXII. Additional Embodiments of Fluid Pathway Connector 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-139C , may be configured to incorporate the embodiments of the fluid pathway connector described below in connection with  FIGS. 140A-155 . The embodiments of the fluid pathway connector described below in connection with FIGS.  140 A- 155  may be used to replace, in its entirety or partially, the above-described fluid pathway connector  300 , fluid pathway connector  622 , fluid pathway connector  722 , fluid pathway connector  922 , fluid pathway connector  1122 , fluid pathway connector  2300 , or any other fluid pathway connector described herein, where appropriate. 
     In general, the present embodiments provide for container connections that maintain the sterility of a fluid pathway and are integrated into a fluid container; drug delivery devices that incorporate such sterile fluid pathway connectors to fluid containers; methods of operating such devices; and methods of assembling such devices. The fluid pathway connectors of the present embodiments provide integrated safety features that ensure the sterility of the fluid pathway before, during, and after fluid delivery. In one aspect, the fluid pathway remains disconnected from the fluid container until the device has been initiated by the operator. In another aspect, the fluid pathway maintains the sterility of a piercing member prior to connection with the fluid container within a sterile cavity prior to activation by the operator. Upon activation by the operator, at least a portion of a pierceable seal is translated, such as by pneumatic and/or hydraulic pressure or force within the fluid, towards a substantially fixed piercing member such that the pierceable seal is pierced and the fluid pathway is connected or opened to enable fluid flow through the fluid pathway for fluid delivery from the device. 
     A drug delivery device, such as an infusion pump or a bolus injector, may be needed to deliver a particular amount of fluid within a period of time. For example, when delivering a drug fluid subcutaneously it is important to control the flow of fluid that is delivered into the patient and to maintain the sterility of the fluid container and fluid pathway prior to activation or operation of the fluid delivery device. It may be desired that the fluid pathway connector remains disconnected, for container integrity, sterility, and other purposes, until the user has activated the device and initiated fluid flow from a container. Some drug delivery devices may utilize one or more active fluid pathway control mechanisms to prevent premature fluid pathway connector or drug delivery. Other drug delivery devices are configured such that fluid pathway connector is made upon manufacture, and fluid delivery is blocked until desired by the user. Such designs do not provide the beneficial advantages associated with maintaining container integrity and sterility of the internal components of the drug delivery device. The present embodiments provide an integrated fluid pathway connector mechanism for sterile drug delivery devices. These novel embodiments provide both a connection mechanism to open or connect a sterile fluid pathway between a fluid container and a fluid conduit, without adding unnecessary steps for the user. This is enabled by activation of the drive mechanism and translation of the plunger seal, resulting in pneumatic and/or hydraulic pressure within the fluid that forces translation of at least a portion of a pierceable seal, causing it to impact upon a substantially stationary piercing member, thus opening a sterile fluid pathway between the fluid container and the fluid conduit. 
     Accordingly, the embodiments of the present disclosure provide a sterile fluid pathway connector that is integrated into a fluid container and opened, connected, activated, or otherwise enabled by the operation of the device and drive mechanism. The activation of the drive mechanism and the force transferred from the drive mechanism to the plunger seal is, itself, used to open a sterile fluid pathway between the fluid container and the fluid conduit. Accordingly, container integrity and sterility of the fluid container may be maintained prior to and during operation of the device. This novel configuration also automates the sterile fluid pathway connector step, greatly reducing the complexity of the device and operational steps needed to be performed by the device or the user. The novel embodiments of the present disclosure also permit flexibility in device component configurations, and reduce the layout or overall footprint of the device because no separate sterile fluid pathway connector mechanism is needed on the cap-side of the fluid container. The present embodiment may also be implemented fully or utilized in standard production of sterile fluids, including drug fill-finish processes, including applications that require the pulling of a vacuum. Additionally, the present embodiments may also integrate a number of different status indication mechanisms into the device, including utilizing the piercing member or the plunger seal as parts of an indication mechanism that relates status of fluid transfer from the sterile fluid container to the connector. For example, when the fluid container is a drug container, such components and devices provide an end-of-dose indication coupled to the actual travel and drug delivery status of the plunger seal. 
     At least one embodiment provides for a sterile fluid pathway connector that includes a piercing member, a connector hub, and a pierceable seal. More specifically, at least one embodiment provides for sterile fluid connector comprising a first portion configured to connect a sterile fluid pathway and a second portion comprising a housing configured to mount a sterile fluid container; a connector hub; a pierceable seal disposed at least partially between the connector hub and the sterile fluid container and forming a sterile fluid chamber between the connector hub and the pierceable seal; and a piercing member disposed within the connector hub capable of providing a sterile fluid communication between the sterile fluid chamber and the sterile fluid pathway; wherein at least a portion of the pierceable seal is configured to transform from a non-activated state in which the pierceable seal is intact, to an activated state in which the pierceable seal is disrupted by the piercing member to create a sterile fluid communication between the sterile fluid container and the sterile fluid pathway. The housing may be further configured to recess a portion of the connector within the sterile fluid container. The connector hub may further comprise at least one port or vent. The sterile fluid pathway may also include at least one sensor configured to indicate the status of fluid transfer from the sterile fluid container to the connector. Additionally, the sterile fluid pathway connector may include one or more flow restrictors. In at least one embodiment, the connector hub may at least partially function as a fluid conduit or flow restrictor. In at least one embodiment, the fluid pathway connector further includes a filter. A number of known filters may be utilized within the embodiments of the present disclosure, which would readily be appreciated by an ordinarily skilled artisan. For example, the filter may comprise a permeable membrane, semi-permeable membrane or porous membrane, which encloses the sterile cavity from the outside environment. 
     The piercing member is initially retained in a substantially fixed position within a sterile cavity between the connector hub and the pierceable seal. Upon activation by the operator (e.g., a patient), at least a portion of the pierceable seal is caused to move to a second position in which the pierceable seal is penetrated by the piercing member. Force, such as pneumatic and/or hydraulic force, applied on the pierceable seal on the side opposing the sterile cavity, causes translation of at least a portion of the pierceable seal towards the piercing member. The translation of the pierceable seal causes it to impact upon the substantially stationary or fixed piercing member to open a fluid pathway through the pierceable seal. Accordingly, at least a portion of the pierceable seal is configured to move from the first position to the second position by force applied by a fluid on the pierceable seal. Penetration by the piercing member of the pierceable seal upon movement of a portion of the pierceable seal from the first position to the second position opens a fluid pathway through the pierceable seal and the piercing member to a fluid conduit. 
     In at least one embodiment, the pierceable seal comprises a seal barrier that can be penetrated by the piercing member. The piercing member may initially be in contact with, or adjacent to, the seal barrier. 
     The fluid pathway connector may further include a piercing member guide, wherein the piercing member guide is capable of engaging with or translating upon the connector hub. The piercing member guide may function to ensure that the pierceable seal, or at least a portion thereof such as a seal barrier, properly contacts the piercing member and translates thereupon to become pierced and open the fluid pathway through the pierceable seal and piercing member to a fluid conduit. 
     The piercing member may be configured to pass into the connector hub and connect to a fluid conduit. In another embodiment, the connector hub may connect the piercing member to the fluid conduit, and the fluid conduit may be at least partially a part of the connector hub. In at least one embodiment, the fluid conduit passes into the connector hub at a port in the connector hub. 
     In at least one embodiment, the sterile fluid connector includes at least one sensor configured to indicate the status of fluid transfer from the sterile fluid container to the connector. For example, the sterile fluid pathway connector may further include one or more interconnects and, optionally, one or more corresponding contacts, to transmit a signal to the user. For example, the interconnect(s) may be within or at least partially proximal to a plunger seal translatable within a fluid container such that the piercing member is capable of penetrating the plunger seal and acting as a contact(s) for the interconnect(s) to transmit a signal to the user. Additionally or alternatively, the interconnect(s) or the contact(s) is within or at least partially proximal to a plunger seal translatable within a drug container and the other is within or at least partially distal to the pierceable seal to transmit a signal to the user when the plunger seal and the pierceable seal are substantially in contact. Additionally or alternatively, the interconnect(s) and contact(s) are within the sterile cavity between the connector hub and pierceable seal such that release of pneumatic and/or hydraulic pressure at the end of fluid transfer releases interconnection to transmit or cease transmission of a signal to the user. A number of known interconnects and contacts may be utilized within the embodiments of the present disclosure, which would readily be appreciated by an ordinarily skilled artisan. For example, a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal to the user may be utilized for such purposes. 
     Another embodiment provides for an integrated fluid pathway connector and drug container having a piercing member, a connector hub, and a pierceable seal integrated at least partially within a drug container having a barrel and a plunger seal. The pierceable seal is translatable upon a substantially stationary piercing member, and the pierceable seal is configured to move from a first position, where the piercing member is positioned within a sterile cavity between the connector hub and the pierceable seal, to a second position, where the pierceable seal has been penetrated by the piercing member. The fluid container contains a fluid chamber between the pierceable seal and the plunger seal to initially retain a fluid, and the pierceable seal is configured to move from the first position to the second position by a force applied by the fluid on the pierceable seal. In at least one embodiment, the pierceable seal has a seal barrier that can be penetrated by the piercing member, and the piercing member is initially in contact with, or adjacent to, the seal barrier. 
     The integrated fluid pathway connector may further include a piercing member guide piece attached to the connector hub or piercing member, wherein the piercing member guide slidably engages the connector hub or piercing member to permit translation of the pierceable seal, or a portion thereof, in the direction of fluid exit from the connector. Translation of the pierceable seal in the direction of the fluid container may be prevented by retention of a portion of the pierceable seal by, for example, a housing, such as a crimped cap, mounted to the fluid container barrel that retains the connector hub, piercing member, and pierceable seal in position during operation. Such a configuration may be used to permit the fluid chamber of the fluid container to be evacuated, such as by vacuum, prior to filling with a fluid without compromising the function of the sterile fluid pathway connector. 
     In at least one embodiment, the connector hub has a header with a conduit port, a chamber, and a vacuum port with a channel that leads into the chamber such that the sterile cavity may be evacuated through the channel. The conduit port may have a membrane or seal that permits fluid flow out of the chamber, and may be capable of being plugged. Similarly, the vacuum port may be capable of being plugged, such as by a polymeric plug. Such configurations allow, for example, the sterile cavity to be evacuated to maintain both sterility and pressure equilibrium between the sterile cavity and the opposing side of the pierceable seal, or otherwise assist in maintaining the relative positions of the components prior to or during operation of the device by the user. 
     In at least one embodiment, the pierceable seal, or at least a portion thereof, is translatable upon the piercing member and the pierceable seal is further configured to move from the second position, where the pierceable seal has been penetrated by the piercing member, to a third position wherein at least one sensor indicates the status of fluid transfer from the sterile fluid container to the connector. For example, in a third position, one or more interconnects and one or more corresponding contacts are permitted to transmit a signal to the user. In one such embodiment, the interconnect(s) or the contact(s) is upon an aspect of a drive mechanism and the other is within or at least partially proximal to the plunger seal to transmit a signal to the user when the plunger seal and the pierceable seal are substantially in contact. Alternatively, the interconnect(s) or the contact(s) is within or at least partially distal to the pierceable seal and the other is proximal to the connector hub to transmit a signal to the user when the plunger seal and the pierceable seal are substantially in contact. Additionally or alternatively, the interconnect(s) and contact(s) are within the sterile cavity between the connector hub and pierceable seal such that release of pneumatic and/or hydraulic pressure at end of dose releases interconnection to transmit or cease transmission of a signal to the user. A number of known interconnects and contacts may be used with the present embodiments, which would readily be appreciated by a skilled artisan. For example, a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal to the user may be utilized for such purposes. 
     Yet another embodiment provides a drug delivery device with integrated sterility maintenance features comprising a housing within which an activation mechanism, an insertion mechanism, and a fluid container having a plunger seal may be mounted. The fluid container is connected at one end to a drive mechanism and at another end to a fluid pathway connector. The fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal, wherein the piercing member is retained within a sterile cavity between the connector hub and the pierceable seal, and wherein the pierceable seal is configured to move from a first position to a second position in which the pierceable seal has been penetrated by the piercing member. The fluid container contains a fluid chamber between the pierceable seal and the plunger seal to initially retain a fluid, and wherein the pierceable fluid seal is configured to move from the first position to the second position by a force applied by the fluid on the pierceable seal. In at least one embodiment, the pierceable seal has a seal barrier that can be penetrated by the piercing member, and the piercing member is initially in contact with, or adjacent to, the seal barrier. 
     The drug delivery device may further include a piercing member guide engaged with the connector hub or piercing member, wherein the piercing member guide slidably engages the connector hub or piercing member to permit translation of the pierceable seal, or a portion thereof, in the distal direction (i.e., towards the fluid conduit from where fluid exits the connector). Translation of the pierceable seal in the proximal direction may be prevented by retention of the pierceable seal, or a portion thereof, by, for example, a housing such as a crimped cap mounted to the barrel, which housing retains the connector hub, piercing member, and pierceable seal in position during operation. Such a configuration may be used to permit the drug chamber of the drug container to be evacuated, such as by vacuum, prior to filling with a fluid without compromising the function of the sterile fluid pathway connector. In at least one embodiment, the connector hub has a header with a conduit port, a chamber, and a vacuum port with a channel that leads into the chamber such that the sterile cavity may be evacuated through the channel. The conduit port may have a filter, membrane or seal to permit or restrict fluid flow out of the chamber. Similarly, the vacuum port may be capable of being plugged, such as by a polymeric plug. Such configurations may allow, for example, the sterile cavity to be evacuated to maintain sterility, the maintenance of pressure equilibrium between the sterile cavity and the opposing side of the pierceable seal, or assist in maintaining the relative positions of the components prior to or during operation of the device by a user. 
     In at least one embodiment, the pierceable seal is translatable upon the piercing member or an aspect of the connector hub and is further configured to move from the second position, where the pierceable seal has been penetrated by the piercing member, to a third position where one or more interconnects and one or more corresponding contacts are permitted to transmit a signal to the user. The interconnect(s) and the corresponding contact(s) are configured such that, for example: (a) the interconnect(s) or the contact(s) is positioned upon an aspect of the drive mechanism and the other is positioned within or at least partially proximal to the plunger seal, to transmit a signal to the user when the plunger seal and the pierceable seal are substantially in contact; (b) the interconnect(s) or the contact(s) is positioned within or at least partially distal to the pierceable seal and the other is positioned proximal to the connector hub, to transmit a signal to the user when the plunger seal and the pierceable seal are substantially in contact; (c) the interconnect(s) and the contact(s) are situated within the sterile cavity between the connector hub and the pierceable seal, such after the seal is pierced, continued pressure within the drug chamber causes interconnection which transmits a signal to the user, which signal is terminated once pressure inside the drug chamber drops and interconnection is lost, i.e., at end of dose. A number of known interconnects and contacts may be utilized within the embodiments of the present disclosure, which would readily be appreciated by an ordinarily skilled artisan. For example, a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal to the user may be utilized for such purposes. 
     Additionally, the fluid pathway connectors may include one or more flow restrictors. In at least one embodiment, the connector hub may at least partially function as a fluid conduit or flow restrictor. In at least one embodiment, the fluid pathway connector further includes a filter. A number of known filters can be utilized within the embodiments of the present disclosure, which would readily be appreciated by an ordinarily skilled artisan. For example the filter may be a permeable membrane, semi-permeable membrane, or porous membrane, which encloses the sterile cavity from the outside environment. 
     The novel devices of the present embodiments provide container fluid pathway connectors that maintain the sterility of the fluid pathway and that are integrated into the fluid container, and drug delivery devices that incorporate such integrated sterile fluid pathway connectors to fluid containers. Because the fluid path is disconnected until fluid delivery is desired by the operator, the sterility of the fluid pathway connector, the fluid container, the fluid, and the interior of the device as a whole is maintained. Furthermore, the novel configurations of the fluid pathway connectors and drug delivery devices of the present disclosure maintain the sterility of the fluid path through operation of the device. Because the path that the fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the fluid container of the drive mechanism, the fluid pathway connector, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present embodiments do not require terminal sterilization upon completion of assembly. A further benefit of the present embodiments is that the components described herein are designed to be modular such that, for example, the fluid pathway connector and other components of the device may be integrated into a housing and readily interface to function as a drug delivery device. 
     A further embodiment provides a method of assembly of an integrated sterile fluid pathway connector and fluid container. The sterile fluid pathway connector may first be assembled and then attached, mounted, connected, or otherwise integrated into fluid container such that at least a portion of the pierceable seal is contained within the drug container. The fluid container can then be filled with a fluid for delivery to the user and plugged with a plunger seal at an end opposite the pierceable seal. The barrel can be filled with a fluid through the open proximal end prior to insertion of the plunger seal from the proximal end of the barrel. A drive mechanism can then be attached to the proximal end of the fluid container such that a component of the drive mechanism is capable of contacting the plunger seal. An insertion mechanism can be assembled and attached to the other end of the fluid conduit. This entire sub-assembly, including drive mechanism, drug container, fluid pathway connector, fluid conduit, and insertion mechanism can be sterilized, as described above, before assembly into a drug delivery device. Certain components of this sub-assembly may be mounted to an assembly platform within the housing or directly to the interior of the housing, and other components may be mounted to a guide, channel, or other component or aspect for activation by the user. A method of manufacturing a drug delivery device includes the step of attaching both the fluid pathway connector and fluid container, either separately or as a combined component, to an assembly platform or housing of the drug delivery device. The method of manufacturing further includes attachment of the drive mechanism, fluid container, and insertion mechanism to the assembly platform or housing. The additional components of the drug delivery device, as described herein, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. In the instance in which the fluid is a drug, and the drug delivery device is an ambulatory infusion device, an adhesive patch and patch liner may be attached to the housing surface of the drug delivery device that contacts the user during operation of the device. 
     A method of operating the drug delivery device includes one or more of the following steps: activating, by a user, the activation mechanism; displacing a control arm to actuate an insertion mechanism; activating a drive control mechanism to push the plunger seal, connect the sterile fluid pathway connector, and drive fluid flow through the drug delivery device; wherein the pushing of the plunger seal translates the fluid and thus causes a pierceable seal to deform in the direction of the fluid conduit and be pierced by a piercing member, to thereby open a fluid path from the fluid container to the fluid conduit. The drive control mechanism may be activated by actuating a power and control system. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. Furthermore, the method of operation may include translating a plunger seal within the drive control mechanism and fluid container to force fluid flow through the fluid container, the fluid pathway connector, the fluid conduit, and the insertion mechanism for delivery of the fluid to the desired target, e.g., to the body of a patient. 
     The novel devices of the present embodiments provide container connections which maintain the sterility of the fluid pathway and which are integrated into the fluid container, and drug delivery devices which incorporate such integrated sterile fluid pathway connectors to fluid containers. For example, such devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. 
     In at least one embodiment, the presently disclosed sterile fluid pathway connector includes a piercing member, a connector hub, and a pierceable seal; wherein at least a portion of the pierceable seal is configured to move from a first position in which the piercing member is retained within a sterile cavity between the pierceable seal and the connector hub, to a second position in which the pierceable seal has been penetrated by the piercing member. A filter may be utilized to enclose the sterile cavity from the outside environment. Such fluid pathway connectors may be integrated into a fluid container having a barrel and a plunger seal. The components of the fluid pathway connector may further be capable of transmitting a signal to the user upon completion of fluid delivery, for example, upon contact between the plunger seal and the pierceable seal. A fluid delivery pump includes such integrated fluid pathway connectors and fluid containers. 
     The novel embodiments presented herein provide integrated sterile fluid pathway connectors and fluid containers, and drug delivery devices that utilize such connections, configured to maintain the sterility of the fluid pathway before, during, and after operation of the device, and that enable active safety controls for the device. Integration of the fluid pathway connector into a portion of the fluid container helps ensure container integrity and sterility of the fluid pathway. Additionally, by integrating the sterile fluid pathway connector into a portion of the fluid container, the connection for fluid transfer can be controlled by the user (i.e., is user-activated) and enabled by the function of the drive mechanism. Accordingly, user-activation steps and the internal operation of the drug delivery device can be greatly simplified by the novel integrated sterile fluid pathway connectors of the present embodiments. 
     The novel embodiments provide container connections that maintain the sterility of the fluid pathway and are integrated into the fluid container, and drug delivery devices that incorporate such integrated sterile fluid pathway connectors to fluid containers. The present embodiments also further integrate the sterile pathway connector into the fluid container, to reduce the necessary components or to provide easier and more efficient operation of the connection and drug delivery devices. The connector, the sterile fluid pathway assembly, and the infusion pump disclosed here are not limited to medical applications, but may include any application, including industrial uses, where sterile or uncontaminated fluid delivery may be desired. When the fluid is a drug, the present embodiments provide for devices that are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The embodiment described herein incorporate features which make activation, operation, and lock-out of the device simple for even untrained users. One or more of the components of the present embodiments may be modular in that they can be, for example, pre-assembled as separate components and configured into position within the housing of the drug delivery device during manufacturing. 
       FIG. 140A  and  FIG. 140B  show an initial configuration of an embodiment of a sterile fluid pathway connector  23030  integrated with fluid container  23050  having fluid chamber  23021  and plunger seal  23060 . In some embodiments, the fluid pathway connector  23030  and the fluid container  23050  may be substituted, partially or entirely, for the fluid pathway connector  30  and the fluid container  50  illustrated in  FIG. 1B  of the present application. Fluid pathway connector  23030  may be mounted, connected or otherwise attached, permanently or removably, to fluid container  23050  at an end opposite plunger seal  23060 . As shown in the embodiment of  FIG. 140A  and  FIG. 140B , fluid container  23050  has mutable fluid chamber  23021  within barrel  23058 , defined by the position of pierceable seal  23056  and plunger seal  23060 . The seals described herein can be made of a number of materials, but are typically made of one or more elastomers or rubbers. Fluid chamber  23021  may contain a fluid for delivery through the integrated sterile fluid pathway connector  23030 . In the embodiment of  FIG. 140A  and  FIG. 140B , the fluid pathway connector  23030  includes sterile fluid conduit  23035 , piercing member  23033 , connector hub  23031 , and pierceable seal  23056 . Fluid pathway connection  23030  includes piercing member guide  37  engaged with connector hub  23031 , upon which pierceable seal  23056  may interface with piercing member  23033  of connector hub  23031  during operation. A permeable, semi-permeable, or porous membrane, such as filter  23039 , may be used to allow venting of air from within the fluid pathway connector  23030  during operation of the device, such as through port or vent  23031 B in connector hub  23031 . Filter  23039  may be attached, mounted, bonded, over-molded, co-molded, pre-formed, or otherwise connected to enclose sterile cavity  23032  between the exterior of connector hub  23031  and pierceable seal  23056 . The term “enclose” or “enclosure” is used herein to define at least a semi-permeable or porous confined area that is capable of being sterilized, evacuated by vacuum, and vented, but is not penetrable by microorganisms, contaminants, or other undesirable environmental factors. For example, filter  23039  can be over-molded at least partially within connector hub  23031  to separate the sterile cavity  23032  from the outside environment. In some embodiments, the filter is a membrane, e.g., a semi-permeable membrane, which allows the venting of air during the actuation of pierceable seal  23056 , fluid pathway connection  23030 , and the pump device. Filter  23039  may be sterilized by methods well-known to one having skill in the art, thus the filter can maintain a sterile barrier to prevent exposure of the piercing member  23033  to microorganisms, contaminants, or other undesirable environmental factors. 
     As shown in  FIG. 140B , piercing member  23033  is retained within the integrated sterile fluid pathway connection  23030 , at or near seal barrier  23056 C of pierceable seal  23056 . Piercing member  23033  may be an aspect of fluid conduit  23035  or may be a separate component from fluid conduit  23035 , as would readily be appreciated by one having skill in the art. Additionally, fluid pathway connector  23030  may optionally include one or more gaskets, O-rings, or other sealing members, compressed to seal between barrel  23058 , particularly at lip  23058 A, connector hub  23031 , and housing  23052 . In at least one embodiment, sealing aspect  23056 A of the pierceable seal  23056  may be configured as a seal between barrel lip  23058 A, connector hub  23031 , and housing  23052 . Housing  23052  may be a separate component, such as a crimp cap, or may be an aspect of connector hub  23031  capable of mounting to barrel  23058 . The housing or cap could also have screw threads configured to complement screw threads in a fluid container, or use other impermanent means for connecting the fluid container to the sterile fluid pathway connector. As shown in  FIG. 140A  and  FIG. 140B , the sterile fluid pathway connector  23030  may be attached to (i.e., integrated with) fluid container  23050 ; which in turn can be mounted, by a number of known methods, either fixedly or removably to an assembly platform or housing of a fluid pump, such as the drug delivery device  10  as shown in  FIGS. 1A-1C . The assembly platform may be a separate component from the housing, or may be a unified component of the housing such as a pre-formed mounting aspect on the interior surfaces of the housing. In such configurations, the sterility of the fluid pathway is maintained, the pathway for fluid flow is not connected until desired by the user, and user-initiated activation causes the connection of the fluid chamber and the fluid pathway connection. The fluid pathway connection may, optionally, further include one or more separate flow restrictors or one or more of piercing member  23033  and fluid conduit  23035  may additionally function as flow restrictors. 
     The integrated fluid connection of the present embodiments is further illustrated with reference to a drive mechanism, as shown in  FIG. 141A  and  FIG. 141B . The embodiment comprises fluid conduit  23035 , engaged with piercing member  23033  at engagement  23038 , connector hub  23031  that includes vent  23031 B, filter  23039  which is housed against connector hub  23031 , and pierceable seal  23056 , which sealing portion  23056 A abuts connector hub  23031  and the end of barrel  23058 , all of which are housed in cap  23052 . Barrel  23058  comprises mutable fluid chamber  23021 , and houses plunger seal  23060  which is slidably disposed therein and in contact with a drive mechanism (e.g., the drive mechanism  50  illustrated in  FIG. 1B ), which includes biasing member  23099 .  FIG. 141A  is an exploded side view of components of an integrated sterile fluid pathway connector and fluid container according to at least one embodiment.  FIG. 141B  shows a sectional exploded view of the same embodiment. Sterile fluid pathway connector  23030  may be integrated at least partially within fluid container  23050  at an end opposite of plunger seal  23060 . An exemplary drive mechanism  23090  is shown in these figures to clarify the orientation of these components. The components of the novel sterile fluid pathway connection  23030  may be pre-assembled (see, e.g.,  FIG. 143A ) and subsequently attached, mounted, connected or otherwise mated, permanently or removably, with a fluid container such as fluid container  23050 . 
     A number of drive mechanisms may be utilized to force fluid from a fluid container for delivery. In one such embodiment, the drive mechanism  23090  may be substantially similar to that described in WO 2013/023033467 (PCT/US2012/023052303241). The components of the drive mechanism upon activation, may be used to drive axial translation in the distal direction (i.e., toward housing  23052  of  FIG. 140 ) of the plunger seal of the fluid container. Optionally, the drive mechanism may include one or more compliance features that enable additional axial translation of the plunger seal to ensure, for example, that substantially the entire drug dose has been delivered to the user and that the feedback contact mechanisms have connected or interconnected. Furthermore, the drive mechanism may include one or more safety mechanisms, such as premature activation prevention mechanisms, to enhance the safety and usability of the mechanism and the device. 
     In a particular embodiment, drive mechanism  23090  employs one or more compression springs  23099  as biasing member(s), as shown in  FIG. 141B . Upon activation of the fluid pump by the user, the power and control system is actuated to directly or indirectly release the compression spring(s) from an energized state. Upon release, the compression spring(s) may bear against and act upon the plunger seal  23060  to force the fluid out of the mutable fluid chamber  23021  of drug container  23050  as further described with reference to  FIG. 142A-142C . 
       FIG. 142A  to  FIG. 142C  illustrate the features of an embodiment before use, upon piercing of the pierceable seal, and upon completion of fluid delivery. More specifically, in the configuration shown in  FIG. 142A , piercing member  23033  is maintained within sterile cavity  23032  with a first end (a proximal end) adjacent to, or contacting, pierceable seal  23056  of fluid pathway connector  23030 . The sterility of cavity  23032  and piercing member  23033  is maintained, for example, by filter  23039  disposed between sterile cavity  23032  and the outside environment. In at least one embodiment, as shown in  FIG. 142 , filter  23039  is connected to, engaged with, or part of connector hub  23031 , and encloses sterile cavity  23032  from the outside environment. Sterile cavity  23032  can be vented via vent or port  23031 B within hub connection  23031 . Accordingly, fluid pathway connector  23030 , in at least one embodiment, is mounted to and integrated with fluid container  23050 , for example by housing (cap)  23052  engaged with lip  23058 A of barrel  23058 . The piercing member may be a number of cannulas or conduits, such as rigid needles, and may be comprised of a number of materials, such as steel. In at least one embodiment, piercing member  23033  is a rigid steel needle. Pierceable seal  23056  may have sealing aspect  23056 A that permits pierceable seal  23056  to be mounted directly to or otherwise be held in position between barrel  23058 , connector hub  23031 , and cap  23052 . Connector hub  23031  includes an internal seal mount  23034  that further stabilizes the position of more stationary aspects of pierceable membrane  23056 . At least a portion of pierceable seal  23056 , such as seal barrier  23056 C, is translatable upon connector hub  23031 , as described herein, to rupture against piercing member  23033  and enable the fluid pathway connection to sterile fluid conduit  23035 . Advantageously, such an arrangement permits pierceable seal  23056  to translate towards cap  23052  but not towards the plunger seal  23060 . This is a desirable feature that permits the mutable fluid chamber  23021  of the fluid container  23050  to be evacuated, such as by vacuum, prior to filling with a fluid without compromising the function of sterile fluid pathway connector  23030 . 
     In an initial position the proximal end of piercing member  23033  may reside adjacent to, or in contact with, seal barrier  23056 C of pierceable seal  23056  to, for example, minimize the distance of translation of the seal barrier  23056 C to become pierced and open fluid container  23050  to fluid pathway connector  23030 . In a particular embodiment, proximal end of the piercing member  23033  may reside at least partially within seal barrier  23056 C of pierceable seal  23056 , yet not fully passing there-through, until activation of the device by a user. 
     As shown in  FIG. 142B , once the pump device is activated and the drive mechanism pushes plunger seal  23060 , plunger seal  23060  asserts a force on fluid chamber  23021 , and pneumatic and/or hydraulic pressure builds by compression of the fluid in chamber  23021 . As pneumatic and/or hydraulic pressure builds within fluid chamber  23021 , the force is relayed to pierceable seal  23056 , causing barrier seal  23056 C to transform. This transformation may include a shift, inversion, translation, flexion, deformation, pop, snap, or any other functionally equivalent change, such that a portion of pierceable seal  23056 , such as seal barrier  23056 C, impinges against the substantially fixed position of piercing member  23033  and causes piercing member  23033  to pierce pierceable seal  23056  at seal barrier  23056 C, as shown in  FIG. 142B , thereby opening or otherwise connecting the fluid pathway between mutable fluid chamber  23021 , piercing member  23033 , and fluid conduit  23035 . 
     Accordingly, integrated sterile fluid pathway connector  23030  is connected (i.e., the fluid pathway is opened) by the pneumatic and/or hydraulic force of the fluid within the fluid chamber  23021  created by activation of the drive mechanism. Once integrated sterile fluid pathway connection  23030  is connected or opened, fluid is permitted to flow from the fluid container  23050 , through integrated sterile fluid pathway connection  23030  and sterile fluid conduit  23035 . In aspects in which the fluid pump is an ambulatory drug infusion pump, fluid drug then flows through the insertion mechanism and into the body of the user for drug delivery. In at least one embodiment, a number of flow restrictors may be optionally utilized to modify the flow of fluid within the fluid pathway connection. In at least one embodiment, the fluid flows through only a manifold and a cannula or needle of the insertion mechanism, thereby maintaining the sterility of the fluid pathway before and during fluid delivery. 
     Additionally or alternatively, plunger seal  23060  or the pierceable seal  23056  may have some compressibility permitting a compliance push of fluid from drug container  23050 . Additionally, the drive mechanism, plunger seal  23060 , connector hub  23031 , pierceable seal  23056 , or a combination thereof, may include one or more sensors or status indication mechanisms, such as interconnects and contacts, to measure and communicate the status of drug delivery drive before, during, and after operation of the device to deliver fluid. 
       FIG. 142C  shows the components of fluid container  23050  and sterile fluid pathway connector  23030  after substantially all of the fluid has been pushed out of the fluid container  23050 . In particular, plunger seal  23060  is in the most-distal position in barrel  23058 . In the embodiment of  FIG. 142C , the connector hub-side (e.g., distal end) of plunger seal  23060  is configured with an optional protrusion and cavity aspect  23069 , which structure minimizes residual volume left in fluid chamber  23021 , now collapsed. Alternatively, plunger seal may be a flat-faced plunger seal (e.g., plunger seal  23160  in  FIG. 144A  and  FIG. 145 ), or may have any number of other configurations as would be readily appreciated by one having skill in the art. In the embodiment shown in  FIG. 142 , plunger seal  23060  further comprises interconnect/contact  23061 ; and connector hub  23031  further comprises interconnect/contact  62 . At end-of-delivery, interconnect/contact  61  of plunger seal  23060  and interconnect/contact  62  of connector hub  23031  interconnect and transduce a signal that may be perceived by a user. As described herein, numerous sensors and signal transducing means can be incorporated or adapted for use in the present embodiments. 
     Because of the novel design of the fluid pathway connector of the present embodiments and their integration at least partially within fluid containers, sterility of the fluid pathway is maintained throughout transport, storage, and operation of the device; user-activation of the device is simplified; and the fluid pathway is only connected when desired by the user. The sterility of the fluid pathway connection is initially maintained by performing the connection within a sterile cavity  23032  between connector hub  23031 , pierceable seal  23056 , and piercing member guide  23037 . In at least one embodiment, the sterility of cavity  23032  is maintained by filter  23039  that abuts, is engaged with or part of, connector hub  23031 . Filter  23039  may be, for example, a semi-permeable membrane that allows the venting of air through vent  23031 B of connector hub  23031  during the actuation and translation of pierceable seal  23056 . Filter  23039  may be sterilized by typical sterilization methods, which would readily be appreciated by one having skill in the art, and may be used to maintain a sterile barrier that prevents exposing piercing member  23033  to microorganisms, contaminants, or other undesirable environmental factors. For example, upon substantially simultaneous activation of the insertion mechanism, the fluid pathway between mutable fluid chamber  23021  and insertion mechanism is complete to permit drug delivery into the body of the user. Because fluid pathway connector  23030  is not in fluid connection or communication with fluid chamber  23021  until activation of the fluid pump and drive mechanism, fluid flow from the fluid container  23050  is prevented until desired by the user. This provides an important safety feature to the user and also maintains the container integrity of the fluid container and sterility of the fluid pathway. 
     The drive mechanism that translates the plunger seal  23060  may contain one or more drive biasing members (e.g., as shown in  FIG. 141B ). The components of the drive mechanism function to force a fluid from the mutable fluid chamber  23021  through pierceable seal  23056  and through the piercing member  23033  or sterile fluid conduit  23035 , for delivery through fluid pathway connector  23030 . Further regarding the drive mechanism, a number of drive mechanisms may be utilized to force fluid from a drug container for delivery into the body of a user. In one such embodiment, the drive mechanism  23090  may be substantially similar to that described in WO 2013/023033467 (PCT/US2012/023052303241), which is hereby incorporated by reference in its entirety. The components of the drive mechanism, upon activation, drive axial translation in the distal direction of the plunger seal of the drug container. Optionally, drive mechanism may include one or more compliance features which enable additional axial translation of the plunger seal to, for example, ensure that substantially the entire fluid dose has been delivered to the user and make sure that the feedback contact mechanisms have connected. Furthermore, the drive mechanism may include one or more safety mechanisms, such as premature activation prevention mechanisms, to enhance the safety and usability of the mechanism and the device. 
     At least one embodiment provides for a modular fluid pathway connection.  FIG. 143A  and  FIG. 143B  detail an embodiment of a modular fluid pathway connector that comprises connector hub  23031 , which abuts filter  23039  and pierceable seal  23056  at sealing member  23056 A. Connector hub  23031 , filter  23039  and pierceable seal  23056  are housed within cap  23052 , as shown in  FIG. 143A . Connector hub  23031  further comprises header  23031 C, which forms a junction for fluid conduit  23035  and piercing member  23033 . As shown in  FIG. 143A  and  FIG. 143B , fluid conduit  23035  may be connected directly to piercing member  23033 . Alternatively, as shown in  FIG. 144A  fluid conduit  223035  may be connected via conduit port  223038 . Nevertheless, a modular fluid pathway connection can be adapted for use with a number of alternative barrel and drive configurations, and used within a variety of ambulatory infusion devices. The components of the novel sterile fluid pathway connector  23030  may be pre-assembled, to appear as exemplified in  FIG. 143A , and subsequently attached, mounted, connected, or otherwise mated with a fluid container such as fluid container  23050 . Alternatively, the components of sterile fluid pathway connector  23030  may be assembled directly into drug container  23050 . As would be readily appreciated by one skilled in the art, a number of glues or adhesives, or other connection methods such as snap-fit, interference fit, screw fit, fusion joining, welding, ultrasonic welding, laser welding, and mechanical fastening, and the like, can be used to engage one or more of the components described herein in permanent or impermanent connection as desired for a particular use. For example, glue can be used between distal end of barrel  23058 , sealing member  23056 A, or connector hub  23031 A. Additionally or alternatively, the components of the sterile fluid pathway connector  23030  may be mounted to barrel  23058  and held in place crimping cap  23052  to distal aspect of barrel  23058 , such as to a flanged aspect or lip of barrel  23058 A. 
     In at least one embodiment, as shown in  FIG. 144A  to  FIG. 144C , piercing member guide  230237  may be utilized to guide pierceable seal  23056  and to slidably engage the connector hub  230231 . Additionally or alternatively, piercing member guide  230237  may be utilized to ensure that piercing member  230233  remains substantially centered on the axis so as to pierce pierceable seal  23056  at the desired portion of seal barrier  23056 C. The embodiment of  FIG. 144A  shows fluid container comprising barrel  23058  and forming mutable fluid chamber  23021  between plunger seal  230260  and pierceable seal  56 . As shown in  FIG. 144A , plunger seal  230260  is a flat plunger seal, but a variety of plunger seal shapes can be adapted for use with the fluid connection and infusion pumps of the present embodiments. The embodiment of  FIG. 144A  further comprises filter  23039 , which abuts connector hub  230231  and is used to maintain sterility of sterile chamber  23032  between connector hub  230231  and pierceable seal  23056 . Connector hub  230231  also includes seal mount  230234  that abuts pierceable seal  23056 ; and flange  230231 A that abuts seal member  23056 A of seal  23056 , and that, in turn, abuts the distal lip  23058 A of barrel  23058 . The meeting surfaces of connector hub  230231 A, sealing member  23056 A and barrel lip  23058 A are positioned in place and secured within the rims of cap  23052 . Connector hub  230231  also houses piercing member  230233 , which connects to fluid conduit  230235 . Connector hub  230231  also has vacuum port  230231 B, a filtered channel that leads into sterile chamber  23032 . Connector hub  230231  is also configured with conduit port  230231 D, which provides exit from sterile fluid connector  230230  to the rest of the infusion device (e.g., injection means), such as via sterile fluid conduit  23035  (not shown). Conduit port  230231 D and vacuum port  230231 B may contain a membrane or seals, such as one-way seals, which permit fluid flow out of chamber  23032  through the respective ports but do not permit fluid flow into the chamber  23032  through these ports. Additionally, or alternatively, conduit port  230231 D and vacuum port  230231 B may be plugged at certain points of assembly or operation. For example, vacuum port  230231 B may be used to evacuate sterile cavity  23032  during manufacturing, assembly, or at any point prior to operation of the device; and then vacuum port  230231 B can be plugged after the evacuation has been completed. 
     Further regarding piercing member guide  230237 , this component may be slidably attached to connector hub  230231 . A number of means known in the art may be used to facilitate this slidable attachment such as, for example, engagement between a connector prong  230237 D and leg  230237 A of piercing member guide  230237  with complementary cavity  230236  in connector hub  230231 . These components are more clearly visible in  FIG. 144A  and  FIG. 144B .  FIG. 144B  shows the orientation of piercing member  230233  within piercing member guide  230237 , which emerges from piercing member guide  230237  at header  230237 C; and  FIG. 144C  shows the orientation of piercing member  23033  and piercing member guide  230237  within connector hub  230231 . Such an arrangement permits the pierceable seal  23056  and piercing member guide  230237  to translate towards housing  23052  together, at least for a portion of the translation of seal barrier  23056 C. Additionally, pierceable seal  23056  may be removably attached to piercing member guide  230237  by a number of means known in the art such as, for example, removable snap-fit engagement or it may be configured to enable contact between the components to guide the translation of the seal barrier  23056 C upon the piercing member  230233 . When a piercing member guide is used, such as piercing member guide  230237  in  FIG. 144A , the piercing member guide may translate with pierceable seal  23056 , for at least a portion of the translation, to ensure that the seal barrier  23056 C contacts and is pierced by the piercing member  230233 . Once the fluid pathway is opened or connected, translation of plunger seal  230160  in the distal direction by the drive mechanism causes fluid within drug chamber  23021  to be forced through the sterile fluid connector. In some embodiments, a needle insertion mechanism, as described herein, may be connected at the other end of the fluid conduit  23035  to insert a needle into the body of the user to facilitate fluid transfer to the user. 
     The embodiment shown in  FIG. 144A  also comprises plunger seal  260 , which may be used as a part of the status indication mechanism along with piercing member guide  237 . More specifically, in this embodiment plunger seal  260  includes interconnect/contact  261  and the corresponding interconnect/contact  262  is located on piercing member guide  237 . When plunger seal  260  and piercing member guide  237  reach proximity at end-of-delivery (e.g., as in  FIG. 144C ), interconnect/contact  261  and interconnect/contact  261  interconnect and transduce a perceptible signal to the user. 
     The novel embodiments presented herein provide integrated sterile fluid pathway connections and fluid containers, and fluid pumps that utilize such connections, that are configured to maintain the sterility of the fluid pathway before, during, and after operation of the device, and that enable active safety controls for the device. Integration of the fluid pathway connector into a portion of the fluid container helps ensure container integrity and sterility of the fluid pathway. Additionally, by integrating the sterile fluid pathway connector into a portion of the fluid container, the connection for fluid transfer can be controlled by the user (i.e., user-activated) and enabled by the function of the drive mechanism. Accordingly, user-activation steps and the internal operation of the fluid pump can be greatly simplified by the novel integrated sterile fluid pathway connections of the present embodiments. 
     In another embodiment, the fluid container comprises at least two mutable internal compartments, wherein each compartment-compartment interface comprises a distinct pierceable seal capable of being disrupted by the piercing member of the sterile fluid pathway connector to create a sterile fluid communication between the sterile fluid pathway and that compartment of the sterile fluid container. As shown in  FIG. 145 , container  23050  may utilize one or more seals in addition to plunger seal  230160  and pierceable seal  230156 . This may be applicable, for example, when multiple fluid substances are desired to be delivered by the container and the infusion pump device.  FIG. 145  shows one such embodiment that utilizes two additional seals,  230163  and  230165 , to create compartments or chambers  230121 A,  230121 B and  230121 C, within which one or more fluid substances may be stored for delivery. The embodiment of  FIG. 145 , pierceable seal  230156  includes seal barrier  230156 C and base  230156 A, which base  230156 A abuts barrel lip  23058 A on its distal side and connector hub  230131 A on its proximal side, which abutments are held within housing  23052 . Connector hub  230151  further includes vacuum port  230131 B, with a channel that leads into sterile chamber  23032 . Connector hub  230131  is also configured with conduit port  230131 D, which provides exit from sterile fluid connector  230130  to the rest of the infusion device (e.g., an injection mechanism). Conduit port  230131 D and vacuum port  230131 B may each contain a membrane, filter or seals, such as one-way seals, which permit fluid flow out of chamber  23032  through the respective ports but do not permit fluid flow into the chamber  23032  through said ports. Additionally, or alternatively, conduit port  230131 D and vacuum port  230131 B may be plugged at certain points of assembly or operation. For example, vacuum port  230131 B may be used to evacuate sterile cavity  32  during manufacturing, assembly, or at any point prior to operation of the device; and then vacuum port  230131 B can be plugged after the evacuation has been completed. 
     Upon activation of the fluid pump, pressure at interface  230168  of plunger seal  230160  causes distal translation of plunger seal  230160  towards housing  23052 . The pneumatic and/or hydraulic pressure within the fluid substance(s) held in drug chambers  230121 A,  230121 B and  230121 C relays the force to, and causes distal translation of, chamber seal  230163 , chamber seal  230165 , and pierceable seal  230156 , causing seal barrier  230156 C to translate towards housing  23052  and become pierced by piercing member  230133 . This causes the sterile fluid pathway connection to be made or opened, as described herein. Upon further translation of plunger seal  160 , the fluid substance held in mutable drug chamber  230121 A is dispensed through conduit  230135 . Upon further translation of the fluids and seals, seal  230165  may be then be pierced by piercing member  230133 , thereby permitting the fluid substance in mutable fluid chamber  230121 B to be dispensed from the fluid pathway connector. If further compartments or chambers are desired, more seals and chambers (such as seal  230163  and mutable chamber  230121 C) may be configured, and subsequently engaged in the same manner until plunger seal  230160  has been fully translated towards housing  23052 . This configuration may offer advantages over single-compartment fluid containers. For example, a diluent may be stored in mutable fluid chamber  230121 A and a therapeutic drug may be stored in mutable fluid chamber  230121 B, such that the sterile fluid pathway is first purged by the diluent prior to delivery of the drug therapy to the patient. When drug combinations are desired for delivery, multiple therapeutic agents may be stored and delivered using the configuration provided by this embodiment. Any number of seals and drug chambers may be utilized in such a configuration provided that the piercing member  230133 , the drive mechanism, and other components of the embodiments are configured appropriately for such delivery. 
     The novel integrated sterile fluid pathway connectors of the present invention may additionally incorporate status indication into the fluid delivery mechanisms. Such status indication features may be incorporated into the drive mechanism  23090 , as described in WO 2013033467. Additionally or alternatively, status indication features may be incorporated into the components of the sterile fluid pathway connectors. In one embodiment, one or more interconnects are contained within, or proximal of, the plunger seal. At the end of fluid delivery, the piercing member may be utilized to contact the, or as a contact for, interconnect to open, close, or otherwise create a signal to the power and control system to provide feedback to the user. In another embodiment, one of either interconnects/contacts are contained within, or proximal of the plunger seal, while the other is contained within or distal of the pierceable seal, such as in or on a seal mount or guide piece. At the end of fluid delivery, interconnects and corresponding contacts are close enough to permit a signal to be sent to the power and control system to provide feedback to the user. 
     In another embodiment, the surface of the connector hub sequestered in sterile chamber  23032  may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism. For example, an end-of-delivery signal can be provided using a leaf/flex arm or spring style switch mechanism contained within sterile compartment  23032 , engaged with the surface of the connector hub and connected through the hub to the appropriate electronics. In this arrangement, in the unpressurized state (before device activation), the switch rests in the open position, and there is no contact/interconnect or signal transduced. When the device is activated, i.e., when the drive engages the plunger seal within the drug container, pneumatic and/or hydraulic pressure causes the pierceable seal to translate into the piecing member, thus disrupting the pierceable seal and allowing fluid to flow through the sterile fluid connector. Pneumatic and/or hydraulic pressure further causes the septum of the pierceable seal to press against the switch mechanism until it interconnects with its complementary contacts, which closes the circuit and allows a signal to transduce to the user, indicating that drug delivery has started. At end-of-delivery, the pneumatic and/or hydraulic pressure within the sterile chamber is released and the switch re-opens, breaking the circuit and providing an end-of-delivery signal to the user. 
     Such a configuration, in which the surface of the connector hub sequestered in the sterile chamber of the sterile fluid pathway connector may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism, may be facilitated by a configuration of the pierceable seal. For example, as shown in  FIG. 146A  to  FIG. 146E , fluid chamber  23058  comprises plunger seal  230160 , configured to engage a drive mechanism that forces plunger seal  230160  towards sterile fluid connector  230130 . In the initial position (i.e., before the drive is engaged), pierceable seal  230356  maintains sterile chamber  23032  within the space defined by pierceable seal  230356  and connector hub  230131 , particularly as partially maintained by seal mount  230134 , as shown in  FIG. 146A . Connector hub  230131  further includes piercing member  23033 , and vacuum port or vent  131 B in which sterility of chamber  23032  is maintained by filter  23039 . Connector hub base  230131 A, sealing member  230356 A of pierceable member  230356 , and barrel lip  23058 A are all secured in housing  23052 , which housing can be a cap such as a crimp cap. Connector hub  230131  also includes exit port  230131 D, which provides an exit passage for fluid conduit  23035  from the sterile fluid pathway connector. Once a pump drive is activated and plunger seal  230160  is forced toward piercing member  23033 , pneumatic and/or hydraulic pressure within mutable fluid chamber  23021  forces seal barrier  230356 C of pierceable seal  230356  into piercing member  23033 , which pierces seal barrier  230356 C and opens the sterile fluid pathway. Continued pneumatic and/or hydraulic pressure within mutable chamber  23021  forces at least a portion of pierceable seal  230356  to contact at least a portion of connector hub  230131  within sterile chamber  23032 , as shown in  FIG. 146B . This continued pneumatic and/or hydraulic pressure, as long as the drive is activated and fluid remains in mutable chamber  23021 , maintains the contact between seal  230356  and connector hub  230131 , as shown in  FIGS. 146C and 146D . When fluid has been pumped out of mutable fluid chamber  23021 , such that this chamber essentially no longer exists, pneumatic and/or hydraulic pressure against seal  230356  is released, and seal  230356  returns to a non-pressurized state within chamber  23032 , in which there is no longer contact between seal  230356  and hub  230131 , as shown in  FIG. 146E . 
     This aspect of the embodiments is advantageous for a number of devices and configurations useful to provide the sterile fluid pathway connector with at least one sensor configured to indicate the status of fluid transfer from the sterile fluid container to the connector. An example of such a sensor is a “switch” mechanism contained within the sterile chamber in the sterile fluid connector. For example, in the embodiment shown in  FIG. 147A  to  FIG. 147H , fluid container  230350  includes barrel  230358 , which houses fluid chamber  230321  and plunger seal  230360 , configured to engage a drive mechanism that forces plunger seal  230360  and fluid in mutable fluid chamber  230321  toward sterile fluid connector  230330 . Pierceable seal  230356  maintains sterile chamber  230332  within the space defined by pierceable seal  230356  and connector hub  230331 , as shown in  FIG. 147A  and  FIG. 147B , in which the fluid pathway is “closed.” Connector  230330  further includes connector hub  230331 , which further vacuum port  230331 B, in which sterility of chamber  230332  is maintained by filter  230339 ; exit port  230331 D, which provides an exit passage for fluid conduit  230335  from sterile fluid pathway connector  230330 ; and engages piercing member  333 . Connector hub base  230331 A, pierceable seal  230356  sealing member  230356 A, and barrel lip  230358 A are secured in housing  230352 . Connector hub  230331  further houses, in sterile chamber  230332 , stamped ring  230391  fitted on seal mount  230334  of connector hub  230331 ; contact  230392 ; spring  230393 ; and interconnects  230362  which are in communication with flexible power strip  230394  (flex). As shown in  FIG. 147A  and  FIG. 147B , in the initial state before activation of the drive, spring  230393  rests in a non-compressed state, and contact  230392  is held between spring  230393  and stamped ring  230391  in a position in which there is no contact between interconnects  230362  and contact  230392 . Contact  230392  is further stabilized within sterile chamber  230332  by the position of piercing member  230333  that passes through contact  230392  through passage  230392 C. 
     As shown in  FIG. 147C  and  FIG. 147D , once the drive mechanism is activated and plunger seal  230360  is forced toward piercing member  230333 , as indicated by the arrow, pneumatic and/or hydraulic pressure within mutable fluid chamber  230321  forces seal barrier  230356 C of pierceable seal  230356  into piercing member  230333 , thereby piercing seal barrier  230356 C and opening the sterile fluid pathway such that fluid can pass to sterile fluid conduit  230335 . This pneumatic and/or hydraulic pressure within mutable chamber  230321  also forces at least a portion of barrier seal  230356 C against at least a portion of contact  230392 , such that spring  230393  is compressed until contact  230392  meets with interconnects  230362  within sterile chamber  230332 , forming an interconnection. A signal can then be transduced via contact  230392 , interconnect  230362 , and flex  230394 . Continued pneumatic and/or hydraulic pressure (see arrow), as long as the drive is activated and fluid remains in mutable chamber  230321 , compresses spring  230393  and maintains the contact between seal  230356 , contact  230392  and interconnect  230362 , such that interconnection continues, as shown in  FIG. 147E  to  FIG. 147F . When fluid has been pumped out of mutable fluid chamber  230321 , such that this chamber essentially no longer exists and flow through the sterile fluid connector  230330  has ceased, as shown in  FIG. 147G  and  FIG. 147H  (the latter is a different sectional view of the sterile fluid pathway connector showing the position of interconnects  230362  within connector hub  230331 ), pneumatic and/or hydraulic pressure against seal  230356  is released, and spring  230393  returns to the non-compressed state, pushing contact  230362  back toward stamped ring  230391  and breaking interconnection between contact  230392  and interconnect  230362 . Once this interconnection is broken, signal can no longer be transduced via flex  230394 . 
     Other switch mechanisms can be designed that use the position of the membrane in pressured and unpressurized states to facilitate transduction of a signal to indicate the status of fluid transfer from the sterile fluid container to the connector. For example, as shown in  FIG. 148A  to  FIG. 148G , connector hub  230331  can house components of a switch comprising a leaf/flex arm contacts  395 .  FIG. 148B ,  FIG. 148D  and  FIG. 148E  show the sterile fluid pathway connector in the pre-use position, in which pierceable seal  230356  is unpierced and intact. In this position, contacts  230395  are not touching (or in close enough proximity with) interconnects  230362 , and no signal can be transduced.  FIG. 148C ,  FIG. 148F  and  FIG. 148G  show the sterile fluid pathway connector in the activated, pressurized position, in which pneumatic and/or hydraulic pressure from the fluid chamber has deformed barrier seal  230356 C against piercing member  230333 , piercing pierceable seal  230356  and opening the fluid pathway. In this position, barrier seal  230356 C has further been forced against contacts  230395 , such that contacts  230395  meet (or become in close enough proximity) with interconnects  230362 , such that interconnection forms a signal that can be transduced via flex  230394 .  FIGS. 148D and 10F  are perspectives (in which the barrel and housing are not shown), that illustrate the positions of pierceable seal  230356 , connector hub  230331 , and piercing member  230333  in pre-use and pressurized positions, respectively.  FIGS. 148E and 148G  are perspectives in which the barrel, housing and pierceable seal are not shown, to illustrate the positions of contacts  230395  and interconnects  230362  in pre-use (no interconnection) and pressurized (interconnected) positions, respectively. 
       FIG. 149A  to  FIG. 149D  further illustrate an embodiment in which leaf/arm contacts  230395  do not form interconnection with interconnects  362  until and unless, as shown in  FIG. 149B  and  FIG. 149D , pneumatic and/or hydraulic pressure force seal barrier  230356 C onto connects  230395 , which force then transferred to place contacts  230395  in contact with interconnects  230362 , which then allows signal flow via flex  230394 . Additionally, as shown in the embodiment of  FIG. 149A  to  FIG. 149D , connector hub  230331  further includes internal post  230334 A, a structure that limits position of contacts  230395  and membrane  230356  to avoid an over-center position that might interfere with fluid passage through the sterile fluid pathway connector. 
       FIG. 12A  to  FIG. 12D  further illustrate an embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector.  FIG. 150B  illustrates the position of components of a sterile fluid connector  230330  in an unpressurized state, while  FIG. 150C  illustrates the pressurized state and  FIG. 150D  illustrates an end-of-delivery state. Interconnect(s)  230362  and contact(s)  230395  are situated within sterile chamber  230332  between connector hub  230331  and pierceable seal  230356 , such that after pierceable seal  230356  is pierced, continued pressure within drug chamber  230321  causes interconnection between one or more interconnect(s)  230362  and one or more contact(s)  230395 , which transmits a signal to the user, and which signal is terminated once pressure inside the drug chamber  321  drops and interconnection is lost, i.e., at end-of-delivery. A number of known interconnects and contacts may be used with the present embodiments, which would readily be appreciated by a skilled artisan. For example, a range of: Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear travel, LVDT, linear resistive, or radiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal to the user may be utilized for such purposes.  FIG. 151A  to  FIG. 151C  illustrate another embodiment of a sterile fluid connector capable of transmitting a signal indicating the status of fluid transfer from the sterile fluid container to the connector. 
     Yet another switch mechanism is shown in  FIG. 152A  and  FIG. 152B , which show sectional and sectional isometric views of a sterile fluid pathway connector (barrel not shown). In this embodiment, sterile chamber  230332 , defined in part by the position of pierceable seal  230356  seal mount  230334  and hub connection  230331 . Connector hub also holds piercing member  230333  and interconnects  230362  within the sterile chamber  230332 . The switch mechanism includes interconnects  230362 , first compression spring  230393 , contact  230392 , and second compression spring  230396 . In this embodiment, shown in the un-activated, depressurized state, both compression springs  230393  and  396  compress in order for contact  230392  to form an interconnection with interconnects  230362 . Before and upon release of pneumatic and/or hydraulic pressure against seal barrier  230356 , compression springs  230393  and  230396  decompress and interconnection is broken. 
     Another embodiment of a switch mechanism is shown in  FIG. 153A  and  FIG. 153B . In this embodiment, pierceable seal  230456  comprises a conductive material or coating. Connector hub  230431  includes rib  434 A, a structure that ensures that continuity between conductive pierceable seal  230456  and contacts  230462  is broken when system pressure drops at the end of fluid delivery. More specifically, as shown in  FIG. 151B , in the pressurized system in which pneumatic and/or hydraulic pressure has caused conductive pierceable membrane  230456  to have been ruptured by piercing member  230433 , conductive pierceable membrane  230456  must deform further proximal to rib  230434  in order to meet interconnects  230462 . Once pneumatic and/or hydraulic pressure ceases, i.e., at the end of fluid delivery, conductive pierceable membrane  230456  is naturally released from interconnection by proximal to rib  230434   
     Yet another embodiment of a switch mechanism is shown in  FIG. 154 . In this embodiment, connector hub  230531  comprises conductive elastomer  230597  held in sterile chamber  230532  between connector hub  230531  and pierceable membrane  230556 . In this embodiment, at least a portion of conductive elastomer  230597  is affixed to or otherwise engaged with seal mount  230534 , and is configured with a centrally located aperture to allow barrier seal  230556 C to be forced into contact with piercing member  230533  upon activation of the pump and creation of pneumatic and/or hydraulic pressure against pierceable membrane  230556 . Conductive elastomer  230597  is “springy” in nature and can deform (i.e., stretch) in response to distal force from pierceable seal  230556 , thereby deformed into meeting interconnects  230362  under pressure from pierceable seal  230356 . The elastomeric nature of conductive elastomer  230597  allows it to return to the pre-deformed state, in which there is no interconnection, in an unpressurized environment. Therefore, once pneumatic and/or hydraulic pressure ceases, i.e., at end-of-delivery, conductive elastomer film  230597  is passively released from contact with interconnections  230562 , and signal is interrupted. 
     In another embodiment, shown in  FIG. 155 , the sterile fluid pathway connector includes a sensor mechanism comprising dome switch  230666 , which dome is made or of includes conductive material such that dome switch  230666  can act as a contact to create a signal when dome switch  230666  meets with, or moves sufficiently close to, interconnects  230662  to complete the circuit. Dome switch  230666  is configured with at least one outer portion  230666 A that resists deformation and engages with or bears against the inner wall of connector hub seal mount  230634 . Alternatively, the outer deformation-resistant portion of the dome switch can be a radial ring, or any structure that will stabilize the position of the dome within the sterile fluid pathway connector. The conductive portion of the dome switch may comprise shape-memory alloy that “remembers” its dome shape, but can be deformed into a more flattened shape under pressure, then return to the dome shape once pressure is relieved. In the embodiment of  FIG. 155 , dome switch  230666  further comprises aperture  230666 C through which piercing member  230633  can pass as dome switch  230666  is pressed in the direction of interconnects  230662 . More specifically, when the pump device is actuated and pneumatic and/or hydraulic pressure builds against the pierceable membrane (not shown), the pierceable membrane is forced onto piercing member  230633  and ruptured to open the fluid pathway. Dome switch  230666  is similarly deformed by the pneumatic and/or hydraulic pressure or by the distal pressure of the deformed portion of the pierceable seal bearing against it, and dome switch  666  flattens towards interconnects  230662  to allow a signal to be transduced. Once the pneumatic and/or hydraulic pressure stops, i.e., at end-of-delivery, the dome switch returns to its pre-deformed dome shape and interconnection ceases. As shown in  FIG. 155 , dome switch  230666  is configured for placement under the pierceable seal (not shown), within the sterile cavity of the fluid pathway connector. The dome switch could, however, be configured to “ride” on top of the pierceable seal, and upon pressurization would be pushed in close enough proximity with interconnects  230662  to generate a signal. Alternatively, the dome switch could be made of evenly deformable/resistant shape-memory material with the conductive portion of the dome switch configured in the outer portions or rim of the dome, and be placed “upside down” (as a bowl shape) in the sterile chamber of the fluid pathway connector. In this configuration, the pneumatic and/or hydraulic pressure against the pierced pierceable membrane would sufficiently flatten the dome until the outer conductive part of the dome made sufficient contact with interconnects positioned in the connector hub to allow a signal. Upon cessation of pressure, i.e., at end-of-delivery, the dome would pop back to its remembered dome shape, and thereby remove the connective contacts from interconnection. 
     As should be clear from the preceding discussions, a number of known interconnects and contacts, or similar components, are known in the art and may be utilized within the novel embodiments disclosed herein. As would readily be appreciated by one having skill in the art, a vast range of magnets, sensors, coils, and the like may be utilized to connect, transmit, or relay a signal for user feedback. Generally, any RLC circuit systems having a resistor, an inductor, and a capacitor, connected in series or in parallel, may be utilized for this purpose. For example, Hall effect sensors; giant magneto resistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; or linear travel, LVDT, linear resistive, or radiometric linear resistive sensors may be utilized as interconnects and corresponding contacts used to permit a signal to be sent to the power and control system to provide feedback to the user. The location of the contacts and interconnects may be interchanged or in a number of other configurations which permit completion of an electrical circuit or otherwise permit a transmission between the components. By use of one or more status switch interconnects and one or more corresponding electrical contacts, the status of the drive mechanism before, during, and after operation can be relayed to the power and control system to provide feedback to the user. Such feedback may be tactile, visual or auditory, and may be redundant such that more than one signals or types of feedback are provided to the user during use of the device. 
     Additionally, the embodiments of the present invention provide end-of-delivery compliance to ensure that substantially the entire fluid volume has been delivered and that the status indication features have been properly contacted to provide accurate feedback to the user. Through these mechanisms, confirmation of fluid delivery can accurately be provided to the user or administrator. Accordingly, the novel devices of the present invention alleviate one or more of the problems associated with prior art devices. Optionally, the drive mechanism may include one or more compliance features that enable additional axial translation of the plunger seal to, for example, ensure that substantially the entire fluid volume has been delivered and make sure that the feedback contact mechanisms have connected. For example, in one embodiment of the present invention, the drive mechanism may be configured to drive further axial translation of at least a portion of the plunger seal for a compliance push of the plunger seal, or of fluid, from the fluid container. Additionally or alternatively, the plunger seal, itself, may have some compressibility permitting a compliance push. For example, when a pop-out plunger seal is employed, i.e., a plunger seal that is deformable from an initial state, the plunger seal may be caused to deform or “pop-out” to provide a compliance push. Similarly, the plunger seal may be porous, compressible, deformable, or the like to itself be capable of providing a compliance push. 
     As described above, the location of the contacts and interconnects may be interchanged or in a number of other configurations that permit completion of an electrical circuit or otherwise permit a transmission between the components. In one embodiment, the plunger seal may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism (e.g.,  61  in  FIG. 142C ). In one embodiment, the seal mount may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism (e.g.,  62  in  FIG. 142C ). In one embodiment, a guide piece may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism (e.g.,  232  in  FIG. 144A ). In another embodiment, the proximal surface of the connector hub sequestered in sterile chamber  32  may incorporate, or itself be utilized as, a contact or interconnect for the status indication mechanism (e.g.,  FIG. 147  to  FIG. 155 ). 
     Other components of the sterile fluid pathway connection may similarly be utilized for multiple functions. Alternatively, other optional components may be utilized within the novel embodiments of the present invention. For example, one or more optional flow restrictors may be utilized within the configurations of the fluid pathway connection described herein. In at least one embodiment, a flow restrictor may be utilized at the connection between the piercing member and the fluid conduit. The fluid pump is capable of delivering a range of fluid with different viscosities and volumes. The fluid pump is capable of delivering a fluid at a controlled flow rate (speed) or of a specified volume. In one embodiment, the fluid delivery process is controlled by one or more flow restrictors within the fluid pathway connection and/or the sterile fluid conduit. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery conduit, varying the speed at which a component of the drive mechanism advances into the fluid container to dispense the fluid therein, or combinations thereof. In at least one embodiment of the present invention, the connector hub itself may be utilized as part of the fluid path and may, optionally, function as a flow restrictor. 
     It will be appreciated from the above description that the fluid pathway connections and fluid pumps disclosed herein provide an efficient and easily-operated system for automated fluid delivery from a fluid container. The novel devices of the present invention provide container connections which maintain the sterility of the fluid pathway and which are integrated into the fluid container, and fluid delivery pumps that incorporate such integrated sterile fluid pathway connections to fluid containers. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing for self-administering patients. The devices described herein incorporate features which make activation, operation, and lock-out of the device simple for even untrained users. Because the fluid path is disconnected until fluid delivery is desired by the operator, the sterility of the fluid pathway connection, the fluid container, the fluid, and the device as a whole is maintained. These aspects of the present embodiments provide highly desirable storage, transportation, and safety advantages to the operator. Furthermore, the novel configurations of the fluid pathway connections and drug pumps of the present invention maintain the sterility of the fluid path through operation of the device. Because the path that the fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the fluid container of the drive mechanism, the fluid pathway connection, the sterile fluid conduit, and, when the fluid is a drug, the insertion mechanism. In at least one embodiment of the present invention, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the fluid pump do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present invention do not require terminal sterilization upon completion of assembly. A further benefit of the present embodiments is that the components described herein are designed to be modular such that, for example, the fluid pathway connection and other components of the device may be integrated into a housing and readily interface to function as a fluid pump. 
     Assembly or manufacturing of fluid pathway connection  23030  or any of the individual components may utilize a number of known materials and methodologies in the art. For example, a number of known cleaning fluids such as isopropyl alcohol and hexane may be used to clean the components or the devices. A number of known adhesives may similarly be employed in the manufacturing process. Additionally, known siliconization or lubrication fluids and processes may be employed during the manufacture of the novel components and devices. Furthermore, known sterilization processes may be employed at one or more of the manufacturing or assembly stages to ensure the sterility of the final product. 
     The fluid pathway connection may be assembled in a number of methodologies. In one method of assembly, the sterile fluid pathway connection may be assembled, e.g., as shown in  FIG. 143A  and  FIG. 143B , and then attached, mounted, connected, or otherwise integrated into fluid container  23050  such that at least a portion of the pierceable seal  23056  is contained within the fluid container  23050 . The fluid container  23050  may then be filled with a fluid and plugged with a plunger seal  23060  at an end opposite the pierceable seal  23056 . The barrel  23058  may be filled with a fluid through the open proximal end prior to insertion of the plunger seal  23060  from the proximal end of the barrel  23058 . The drive mechanism  23090  may then be attached to the proximal end of the fluid container  23050  such that a component of the drive mechanism  23090  is capable of contacting the plunger seal  23060 . The insertion mechanism  23070  may be assembled and attached to the other end of the fluid conduit  23035 . This entire sub-assembly, including drive mechanism  23090 , fluid container  23050 , fluid pathway connection  23030 , fluid conduit  23035 , and insertion mechanism  23070 , may be sterilized by known techniques before assembly into the drug delivery device  230100 . Certain components of this sub-assembly may be mounted to an assembly platform within the housing  12 A,  12 B or directly to the interior of the housing  12 A,  12 B, while other components may be mounted to a guide, channel, or other component or aspect for activation by the user. 
     Manufacturing of a fluid pump includes the step of attaching both the fluid pathway connection and fluid container, either separately or as a combined component, to an assembly platform or housing of the drug pump. The method of manufacturing further includes attachment of the drive mechanism, fluid container, and insertion mechanism to the assembly platform or housing. The additional components of the fluid pump, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug pump that contacts the user during operation of the device. 
     A method of operating the fluid pump includes one or more of the following steps: activating, by a user, the activation mechanism; displacing a control arm to actuate an insertion mechanism; activating a drive control mechanism to push the plunger seal, connect the sterile fluid pathway connection, and drive fluid flow through the fluid pump, wherein translating the fluid pathway connection causes a pierceable seal to be pierced by a piercing member thereby opening a fluid path from the fluid container to the fluid pathway connection. The drive control mechanism may be activated by actuating a power and control system. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. Furthermore, the method of operation may include translating a plunger seal within the drive control mechanism and fluid container to force fluid drug flow through the fluid container, the fluid pathway connection, a sterile fluid conduit, and, optionally the insertion mechanism for delivery of the fluid to the body of a user. 
     XXIII. Additional Embodiments of Drive Mechanism 
     At least some of the drug delivery devices described in this application, including at least those described in connection with  FIGS. 1-56 and 74-157B , may be configured to incorporate the embodiments of the drive mechanism described below in connection with  FIGS. 156-157B . The embodiments of the drive mechanism described below in connection with  FIGS. 156-157B  may be used to replace, in its entirety or partially, the above-described drive mechanisms  100 ,  500 ,  1000 ,  2100 ,  10100 , or any other drive mechanism described herein, where appropriate. 
     In general, the present embodiments provide drive mechanisms with integrated status indication, drug delivery devices which incorporate such drive mechanisms, the methods of operating such devices, and the methods of assembling such devices. The drive mechanisms of the present disclosure provide integrated status indication features which provide feedback to the user before, during, and after drug delivery. For example, the user may be provided an initial feedback to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more drug delivery status indications to the user. At completion of drug delivery, the drive mechanism and drug delivery device may provide an end-of-dose indication. As the end-of-dose indication is tied to the piston reaching the end of its axial translation, the drive mechanism and drug delivery device provide a true end-of-dose indication to the user. Additionally, the embodiments of the present disclosure provide end-of-dose compliance to ensure that substantially the entire drug dose has been delivered to the user and that the status indication features have been properly contacted to provide accurate feedback to the user. Through these mechanisms, confirmation of drug dose delivery can accurately be provided to the user or administrator. 
     In at least one embodiment, the present disclosure provides a drive mechanism having integrated status indication which includes: a drive housing, a status switch interconnect, a drive biasing member, a piston, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal. The drive biasing member may be configured to bear upon an interface surface of the piston. The drug container may preferably contain a drug fluid for delivery to the user. The drive mechanism may further include a connection mount attached to the pierceable seal. A cover sleeve may be utilized between the drive biasing member and the interface surface of the piston to, for example, provide more even distribution of force from the biasing member to the piston. A contact sleeve may be slidably mounted to the drive housing through an axial aperture of the drive housing, such that sleeve hooks at a distal end of the contact sleeve are caused to contact the piston between interface surface and a contact protrusion near the proximal end of the piston. The piston may also include a locking groove, between contact protrusion and the proximal end of the piston. The contact sleeve may have a radially extending ring at its proximal end, upon which reside one or more flex prongs. 
     The drive mechanism may further include one or more contact surfaces located on corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electro-mechanical contact surfaces. Such surfaces may initially be in contact and caused to disengage, or initially be disconnected and caused to engage, to permit a signal to be sent to and/or from the power control system. In at least one embodiment, as described further herein, the contact surfaces may be electrical contact surfaces which are initially disconnected and caused to come into engagement whereby, upon such engagement, contact surfaces are capable of continuing an energy pathway or otherwise relaying a signal to the power and control system. In another embodiment of the present disclosure, the contact surfaces are mechanical contact surfaces which are initially in contact and caused to disengage whereby, upon such disengagement, such disengagement is communicated to the power and control system. Such signals may be transferred across one or more interconnects to the power and control system or by mechanical action to the power and control system. Such components may be utilized within the drive mechanism to measure and relay information related to the status of operation of the drive mechanism, which may be converted by the power and control system into tactile, auditory, and/or visual feedback to the user. Regardless of the electrical or mechanical nature of the contact surfaces, the motion of the components which permits transmission of a signal to the power control system is enabled by a biasing member axially translating a contact sleeve in the distal direction during operation of the device. 
     The drive mechanism may include a piston extension slidably mounted at a distal end and within an axial pass-through of piston; a piston extension biasing member, which is mounted within the axial pass-through of piston and initially compressed between piston extension and piston; and, optionally, a piston biasing member support between piston extension biasing member and piston extension. The piston extension is retained within piston by interaction between one or more extension arms of the piston extension and one or more corresponding connection slots of piston. The piston extension may be utilized to perform a compliance push of drug fluid from the drug container. Additionally or alternatively, the drive mechanism may utilize a compressible plunger seal, wherein such compression capacity or distance permits a compliance push of drug fluid from the drug container. Other compliance features are described further herein. 
     In another embodiment of the present disclosure, a drive mechanism having integrated incremental status indication includes a drive housing, a drive biasing member, a piston, an incremental status stem having a stem interconnect mounted, affixed, printed, or otherwise attached thereon, and a drug container having a cap, a pierceable seal, a barrel, and a plunger seal, wherein the incremental status stem resides within axial pass-throughs of the drive housing and the piston. The incremental status stem may have one or more interconnects which contact one or more contacts on the piston to provide incremental status feedback to the user. The incremental status embodiment may similarly utilize the electrical, mechanical, or electro-mechanical interconnects and contacts, and/or one or more of the compliance features, described above. 
     In a further embodiment, the present disclosure provides a drug delivery device with integrated status indication. The drug delivery device includes a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and a drive mechanism having a drug container may be mounted. The drive biasing member may be configured to bear upon an interface surface of the piston. The drug container may preferably contain a drug fluid for delivery to the user. The drive mechanism may further include a connection mount attached to the pierceable seal. A cover sleeve may be utilized between the drive biasing member and the interface surface of the piston to, for example, provide more even distribution of force from the biasing member to the piston. A contact sleeve may be slidably mounted to the drive housing through an axial aperture of the drive housing, such that sleeve hooks at a distal end of the contact sleeve are caused to contact the piston between interface surface and a contact protrusion near the proximal end of the piston. The piston may also include a locking groove, between contact protrusion and the proximal end of the piston. The contact sleeve may have a radially extending ring at its proximal end, upon which reside one or more flex prongs. The drive mechanism may further include one or more contact surfaces located on corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electro-mechanical contact surfaces. Such surfaces may initially be in contact and caused to disengage, or initially be disconnected and caused to engage, to permit a signal to be sent to and/or from the power control system. In at least one embodiment, as described further herein, the contact surfaces may be electrical contact surfaces which are initially disconnected and caused to come into engagement whereby, upon such engagement, contact surfaces are capable of continuing an energy pathway or otherwise relaying a signal to the power and control system. In another embodiment of the present disclosure, the contact surfaces are mechanical contact surfaces which are initially in contact and caused to disengage whereby, upon such disengagement, such disengagement is communicated to the power and control system. Regardless of the electrical or mechanical nature of the contact surfaces, the motion of the components which permits transmission of a signal to the power control system is enabled by a biasing member axially translating a contact sleeve in the distal direction during operation of the device. 
     In yet another embodiment, the present disclosure provides a drug delivery device with incremental status indication. The drug delivery device includes a housing and an assembly platform, upon which an activation mechanism, an insertion mechanism, a fluid pathway connection, a power and control system, and a drive mechanism having a drug container may be mounted, and further includes an incremental status stem having a stem interconnect mounted, affixed, printed, or otherwise attached thereon, wherein the incremental status stem resides within axial pass-throughs of the drive housing and the piston, and wherein the incremental status stem has one or more interconnects which contact one or more contacts on the piston to complete an transmission to the power and control system to provide incremental feedback to the user. The drug delivery device with incremental status indication may similarly utilize the electrical, mechanical, or electro-mechanical interconnects and contacts, and/or one or more of the compliance features, described above. 
     The present disclosure further provides a method of assembly. The drug container may first be assembled and filled with a drug fluid. The drug container includes a cap, a pierceable seal, a barrel, and a plunger seal. The pierceable may be fixedly engaged between the cap and the barrel, at a distal end of the barrel. The barrel may be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal from the proximal end of the barrel  58 . An optional connection mount may be mounted to a distal end of the pierceable seal. The connection mount to guide the insertion of the piercing member of the fluid pathway connection into the barrel of the drug container. The drug container may then be mounted to a distal end of drive housing. 
     Prior to mounting the drug container to the housing, a switch status interconnect may be mounted to a proximal end of drive housing. A contact sleeve, having one or more sleeve hooks at a distal end and a ring at a proximal end having an electrical contact thereon, may be mounted to the drive housing through an axial pass-through from the proximal end of the drive housing. A drive biasing member may be inserted into a distal end of the drive housing. Optionally, a cover sleeve may be inserted into a distal end of the drive housing to substantially cover biasing member. A piston may be inserted into the distal end of the drive housing and through an axial pass-through of contact sleeve, such that a contact protrusion of piston is proximal to the sleeve hooks of contact sleeve. The piston and drive biasing member, and optional cover sleeve, may be compressed into the drive housing. Such assembly positions the drive biasing member in an initial compressed, energized state and preferably places a piston interface surface in contact with the proximal surface of the plunger seal within the proximal end of barrel. When a piston extension is employed, the piston extension and piston extension biasing member, and optional piston biasing member support, may be compressed into an axial pass-through of piston prior to compression of the components. Prior to, or after, installing these components into the drive mechanism housing, the primary container may be attached. 
     When one or more interconnects or contacts are utilized for status indication, such components may be mounted, connected, printed, or otherwise attached to their corresponding components prior to assembly of such components into the drive mechanism. When a separate incremental status stem and a corresponding stem interconnect are utilized for such incremental status indication, the stem interconnect may be mounted, affixed, printed, or otherwise attached to incremental status stem prior to assembly of the incremental status stem to the proximal end of the contact sleeve and/or the proximal end of the drive housing in a manner such that the incremental status stem resides within an axial pass-through of contact sleeve and drive housing. The incremental status stem is further mounted to reside within an axial pass-through of piston. 
     The disclosure describes, in one aspect, a drug delivery device drive mechanism for use in cooperation with a drug container including a plunger seal. The drive mechanism has an axis and includes a drive housing, a piston adapted to impart movement to the plunger seal within the drug container, a plurality of biasing members disposed in parallel, and a retainer. The piston is disposed for movement from a retracted first position along the axis to an extended second position. The biasing members are adapted to move from an energized first position to a deenergized second position as a result of the release of energy. The biasing members are disposed to cause movement of the piston from the retracted first position to the extended second position as the biasing members move from the energized first position to the deenergized second position. The retainer is disposed to maintain the biasing members in the energized first position when the retainer is in a retaining first position, and to release the biasing members from the first energized position when the retainer moves to a releasing second position. 
     In at least one embodiment, the plurality of biasing members includes at least one of a tension spring or a compression spring. In at least one embodiment, the plurality of biasing members includes a pair of springs, in at least one embodiment of which the springs are compression springs. In at least embodiment, the compression springs are concentrically disposed, and disposed about at least a portion of the piston. In at least one embodiment, the retainer engages at least a portion of the piston to retain the piston in its retracted position when the retainer is in its retaining first position. At least one embodiment further includes a sleeve assembly disposed about at least one of the plurality of biasing members. In at least one embodiment, the sleeve assembly includes a plurality of telescoping sleeves, and the sleeve assembly is disposed to move to axially with the piston. At least one embodiment further includes at least one window and at least a portion of the sleeve assembly is visible through the window with at least a portion of the sleeve assembly being visible through said window until the piston is in the extended second position. At least one embodiment further includes an end-of-dose indicator disposed substantially adjacent the window, the end-of-dose indicator being adapted to identify at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window, the relative motion of the sleeve assembly with reference to the window or another reference component, the stoppage of such motion, and the rate or change of rate of motion. In at least one embodiment, the end-of-dose indicator includes a sensor disposed to sense at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window. In at least one embodiment, the sensor is a mechanical sensor, an electrical sensor, an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or an optical sensor. In at least one embodiment, the sensor is a mechanical sensor disposed to bear against the sleeve assembly when the sleeve assembly is disposed subjacent the window. 
     In another aspect of the disclosure, there is provided a drug delivery device drive mechanism for use in cooperation with a drug container including a plunger seal; the drive mechanism has an axis and includes a drive housing, a piston adapted to impart movement to the plunger seal within the drug container, at least one biasing member, a retainer, a sleeve assembly, and an end-of-dose indicator. The piston is disposed for movement from at least a retracted first position to an extended second position along said axis. The at least one biasing member is disposed and adapted to move from an energized first position to a deenergized second position as a result of the release of energy. The biasing member is disposed to cause movement of the piston from the retracted first position to the extended second position as the biasing member moves from the energized first position to the deenergized second position. The retainer disposed to maintain the biasing member in the energized first position when the retainer is in a retaining first position, and to release the biasing member from the first energized position when the retainer moves to a releasing second position. The sleeve assembly is adapted to move along the axis with the piston. The sleeve assembly is disposed at least partially within the drive housing, and at least a portion of the sleeve assembly being visible through a window in the housing when the piston is one of the retracted first position or the extended second position. The sleeve assembly is not visible through said window when the piston is in the other of the retracted first position or the extended second position. The end-of-dose indicator is disposed substantially adjacent the window. The end-of-dose indicator is adapted to identify at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window. 
     In at least one embodiment, the sleeve assembly is disposed about the at least one biasing member and includes a plurality of telescoping sleeves. In an embodiment, the sleeve assembly is disposed about the biasing member(s). In at least one embodiment, the at least one biasing member includes a plurality of biasing members. A particular embodiment includes at least two compression springs disposed in parallel. In at least on embodiment, the end-of-dose indicator includes a sensor disposed to sense at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window. In at least one embodiment, the sensor is at least one of a mechanical sensor, a mechanical sensor, an electrical sensor, an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or an optical sensor. In a particular embodiment, the sensor is a mechanical sensor disposed to bear against the sleeve assembly when the sleeve assembly is disposed subjacent the window. In some embodiments, at least a portion of a distal end of the piston is adapted to be disposed within the drug container when the piston is disposed in the retracted first position and the drug delivery device drive mechanism is disposed for use in cooperation with the drug container. 
     At least some embodiments of the present disclosure provide the necessary drive force to push a plunger seal and a drug fluid within a drug container, while reducing or minimizing the drive mechanism and overall device footprint. Accordingly, the present disclosure may provide a drive mechanism which may be utilized within a more compact drug delivery device. Some embodiments of the present disclosure may similarly be utilized to provide additional force, as may be needed for highly viscous drug fluids or for larger volume drug containers. 
     According to another aspect of the disclosure, there is provided a drug delivery device drive mechanism for use in cooperation with a drug container that includes a plunger seal and a power and control system. The drive mechanism includes a drive housing, a piston, at least one biasing member, a retainer, sleeve assembly, and an end-of-dose indicator. The drive housing includes an axis, the housing further includes at least one window. The piston is disposed for movement from at least a retracted first position to an extended second position along the axis. The piston is also adapted to impart movement to the plunger seal within the drug container. The at least one biasing member is disposed and adapted to move from an energized first position to a deenergized second position as a result of the release of energy. The biasing member is also disposed to cause movement of the piston from the retracted first position to the extended second position as the biasing member moves from the energized first position to the deenergized second position. The retainer is moveable between a retaining first position and a releasing second position. The retainer is disposed to maintain the biasing member in the energized first position when the retainer is in the retaining first position, and to release the biasing member from the first energized position when the retainer moves to the releasing second position. The sleeve assembly is disposed at least partially within the drive housing. At least a portion of the sleeve assembly is adapted to move along the axis with the piston. At least a portion of the sleeve assembly is visible through the window when the piston is one of the retracted first position or the extended second position, and the sleeve assembly is not visible through the window when the piston is in the other of the retracted first position or the extended second position. The end-of-dose indicator includes at least one switch interconnect, at least a portion of which is disposed substantially adjacent the window and adapted to identify at least one of when the sleeve assembly is disposed subjacent the window and when the sleeve assembly is not disposed subjacent the window. The switch interconnect includes a mechanical trigger adapted to engage the sleeve assembly through the window. The switch interconnect is further adapted to selectively engage the power and control system as a result of the engagement or disengagement end of the trigger. 
     The novel embodiments of the present disclosure provide drive mechanisms with integrated status indication, which are capable of provide incremental status of the drug delivery before, during, and after operation of the device, and provides means for ensuring drug dose compliance, i.e., ensuring substantially the entire drug dose has been delivered to the user. Throughout this specification, unless otherwise indicated, “comprise,” “comprises,” and “comprising,” or related terms such as “includes” or “consists of,” are used inclusively rather than exclusively, so that a stated integer or group of integers may include one or more other non-stated integers or groups of integers. As will be described further below, the embodiments of the present disclosure may include one or more additional components which may be considered standard components in the industry of medical devices. The components, and the embodiments containing such components, are within the contemplation of the present disclosure and are to be understood as falling within the breadth and scope of the present disclosure. 
       FIGS. 156 and 157A-157B  illustrate an embodiment of the drive mechanism  3100  which includes an end-of-dose indicator  3133 . The end-of-dose indicator  3133  includes a switch interconnect  3132  and a contact sleeve assembly  3120  adapted for movement with the piston. As described above with reference to the embodiments shown in  FIGS. 20A-24B , the piston has an interface surface that is capable of contacting or otherwise bearing upon plunger seal to force drug fluid out of barrel through the fluid pathway connection for delivery to a patient. In order to provide access of the end-of-dose indicator  3133  to the interior of the drive housing  3130 , the drive housing  3130  includes an access window  3131 . In at least one embodiment, the drive housing  3130  includes more than one access window  3131  to permit pass-through of more than one switch interconnect, sensor and/or trigger to, for example, interface with the sleeve assembly  3120 . In order to better illustrate the relationship of the end-of-dose indicator  3133  and the sleeve assembly  3120  during movement of the sleeve assembly  3120 ,  FIGS. 157A and 157B  show the housing  3130 , sleeve  3126 , biasing members  3106 ,  3122 , and end-of-dose indicator  3133  in cross-section taken along line  15 - 15  in  FIG. 156 , before and after actuation, respectively. The PCB board  3138  is included in this view of the drive mechanism  3100  to show the interaction between the end-of-dose indicator  3133  and the PCB board  3138 . 
     The end-of-dose indicator  3133  illustrated includes a sensor  3134  that includes a mechanical, pivotably mounted trigger  3135 , in essence, an on/off mechanical switch. In at least one embodiment, the end-of-dose indicator  3133  has more than one trigger  3135  mounted through more than one corresponding window  3131  of the drive mechanism  3100 , for functional redundancy and/or operational robustness. Each of the triggers  3135  is disposed in a first position in contact with the sleeve assembly  3120 , particularly the sleeve  3126  thereof, when the piston  3110  is in a retracted first position, illustrated in  FIG. 157A . As the piston  3110  moves outward from the drive housing  3130 , the triggers  3135  slide along the telescoping sleeve assembly  3120  until such time as the proximal end of the second sleeve  3126  passes the windows  3131 , that is, the triggers  3135 . As the second sleeve  3126  passes at least one of the triggers  3135 , the trigger  3135  moves to a second position, illustrated in  FIG. 157B . The movement of the trigger  3135  to the second position results in the transmission of a signal indicating the end of dose to the power and control system. In this configuration, movement of at least one trigger  3135  will cause the transmission of the signal to occur. 
     Those of skill in the art will appreciate that in some configurations, there is the possibility that the disposal of the spring  3122  subjacent the window  3131  following axial movement of the sleeve  3126  may inhibit actuation of the sensor  3134  of the switch interconnect  3132 , for example, by inhibiting movement of the trigger  3135  to an actuated position. Although the sensor  3134 , or trigger  3135 , may be prevented from actuation only temporarily, such delay may result in a corresponding delay in the indication of the end of the dose. Accordingly, the inclusion of two or more sensors  3134  or triggers  3135  may provide a desirable redundancy. Moreover, the windows  3131  and sensors  3134  may be positioned to maximize the opportunity for actuation of at least one of the triggers  3135  concurrently with the end of the dose delivery. Because more than one trigger  3135  is utilized in this configuration, the end-of-dose indicator  3133  provides functional redundancy to ensure that an accurate signal is transmitted to the power and control system. 
     For the purposes of this disclosure and the appended claims, the transmission of a signal means the provision of an indication that the end of dose has occurred. That transmission may be associated with a mechanical movement, for example, the engagement or disengagement, or an electrical signal, for example, the provision of an electrical signal or connection, or the discontinuation of an electrical signal or connection, or a combination of such transmissions. 
     In at least one embodiment of the configuration shown in  FIGS. 156-157B , the switch interconnects  3132  directly engage with a PCB board  3138  to permit transmission of a signal to the power control system. The switch interconnects  3132  may further be configured to initially be connected (e.g., a closed or complete circuit) or disconnected (e.g., an open or broken circuit) from a PCB board  3138 , though the embodiment shown in  FIGS. 157A-157B  shows the switch interconnects  3132  initially connected to the PCB board  3138 , that is, prior to the end of dose. As the second sleeve  3126  passes at least one of the triggers  3135 , as shown in the transition from  FIG. 157A  to  FIG. 157B , the trigger  3135  moves to a second position, namely, a distance shown as ‘D 1 ’ in  FIG. 157B . The movement of the trigger  3135  to the second position results, in at least one embodiment, in a disconnection of the switch interconnect  3132  from the PCB board  3138  and the resulting transmission of a signal indicating the end of dose to the power and control system. While the illustrated design shows the switch interconnect  3132  directly engaged with the PCB board  3138 , it will be appreciated that the switch interconnect  3132  could alternatively or additionally engage one or more intermediate conductive or nonconductive structures. 
     The end-of-dose indicator  3133 , triggers  3135 , and PCB board  3138  may alternatively be configured, as would be readily appreciated by an ordinarily skilled artisan, to cause a connection there-between upon the movement of the trigger  3135  to the second position. By way of example only, a trigger may be toggled such that the switch interconnect is not in communication with the PCB board prior to the end of dose, movement of the trigger at the end of dose yielding a connection directly with or conveyed to the PCB board. Additionally, as described below, the connection and disconnection (or vice versa) between the switch interconnects  3132  and the PCB board may be utilized to provide incremental status indication. 
     The end-of-dose indicator  3133  may be of any appropriate design and formed of any appropriate material or materials and by any appropriate fabrication method. The illustrated switch interconnect  3132  may be formed in whole or in part of a conductive material, for example. In an arrangement wherein an electrical connection occurs when the trigger  3135  is in the position illustrated in  FIG. 157A  and electrical connection is discontinued when the trigger  3135  is in the position illustrated in  FIG. 157B , for example, at least a portion of the switch interconnect  3132  disposed to engage with the PCB board  3138  may be formed of or coated with a conductive material. Conversely, in an arrangement wherein no electrical connection occurs when the trigger  3135  is in the position illustrated in  FIG. 157A  and electrical connection occurs when the trigger  3135  is in the position illustrated in  FIG. 157B , for example, at least a portion of the switch interconnect  3132  disposed to engage with the PCB board  3138  may be formed of or coated with an insulative material. 
     Although illustrated as an electromechanical arrangement that reads the position of a telescoping sleeve, any appropriate arrangement may be provided to read the relative position of any appropriate component, the end-of-dose indicator providing a signal to the power and control system to indicate that all of the drug has been administered. Additionally, the switch interconnects and corresponding contacts and/or reference component may be utilized to provide incremental status indication in addition to an end-of-dose indication. For example, in the switch interconnect arrangement described above with reference to  FIGS. 20A-24B  or  FIGS. 156-157B , the switch interconnect  2132 ,  3132  may be an electromechanical sensor configured to recognize a number of bumps, ridges, or grooves, in the corresponding sleeve  2126 ,  3126  or any other reference component, the contact with which permits the switch interconnect to signal an incremental status indication (e.g., delivery initiation, amount of volumes delivered, duration of plunger travel, etc.) and a final end-of-dose indication. As described herein, similar incremental status indication may be provided in this configuration by utilizing a different type of sensor arrangement. For example, the switch interconnect  2132 ,  3132  may be an optical sensor configured to recognize a number of markings on the corresponding sleeve  2126 ,  3126  or any other reference component. As the optical sensor recognizes the number of markings, it permits the switch interconnect to signal an incremental status indication (e.g., delivery initiation, amount of volumes delivered, duration of plunger travel, etc.) and a final end-of-dose indication. Any appropriate arrangement may be provided to read the relative position of a number of markings, ridges, grooves, or respective indicators on any appropriate reference component, and recognition of such indicators by the switch interconnect permits it to provide a signal to the power and control system to indicate the incremental status of drug delivery, including the final status that all of the drug has been administered. As would be appreciated by an ordinarily skilled artisan in the relevant arts, the indicators may not necessarily be defined aspects on a reference component, and the switch interconnects may be configured to recognize the actual travel of the reference component itself. The switch interconnects may thus be configured to recognize the rate of change, the distance of travel, or other related measurements in the actual travel of the reference components and enable a signal to the power and control system to provide the user with such information or feedback. 
     It will be appreciated by those of skill in the art that the embodiments of the present disclosure provide the necessary drive force to push a plunger seal and a drug fluid within a drug container, while reducing or minimizing the drive mechanism and overall device footprint. Accordingly, the present disclosure provides a drive mechanism which may be utilized within a more compact drug delivery device. The embodiments of the present disclosure may similarly be utilized to provide additional force, as may be needed for highly viscous drug fluids or for larger volume drug containers. 
     The embodiments shown and detailed herein disclose only a few possible variations of the present disclosure; other similar variations are contemplated and incorporated within the breadth of this disclosure. 
     The drive mechanism may further include one or more contact surfaces located on corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electro-mechanical contact surfaces. Such surfaces may initially be in contact and caused to disengage, or initially be disconnected and caused to engage, to permit a signal to be sent to and/or from the power control system  2400 . 
     A fluid pathway connection, and specifically a sterile sleeve of the fluid pathway connection, may be connected to the cap and/or pierceable seal of the drug container. A fluid conduit may be connected to the other end of the fluid pathway connection which itself is connected to the insertion mechanism such that the fluid pathway, when opened, connected, or otherwise enabled travels directly from the drug container, fluid pathway connection, fluid conduit, insertion mechanism, and through the cannula for drug delivery into the body of a user. The components which constitute the pathway for fluid flow are now assembled. These components may be sterilized, by a number of known methods, and then mounted either fixedly or removably to an assembly platform or housing of the drug delivery device  10 , as shown in  FIG. 1B . 
     Certain optional standard components or variations of drive mechanism  100  or drug delivery device  10  are contemplated while remaining within the breadth and scope of the present disclosure. For example, upper or lower housings may optionally contain one or more transparent or translucent windows  18 , as shown in  FIG. 1A , to enable the user to view the operation of the drug delivery device  10  or verify that drug dose has completed. Additionally, the drug delivery device  10  may contain an adhesive patch  26  and a patch liner  28  on the bottom surface of the housing  12 . The adhesive patch  26  may be utilized to adhere the drug delivery device  10  to the body of the user for delivery of the drug dose. As would be readily understood by one having ordinary skill in the art, the adhesive patch  26  may have an adhesive surface for adhesion of the drug delivery device to the body of the user. The adhesive surface of the adhesive patch  26  may initially be covered by a non-adhesive patch liner  28 , which is removed from the adhesive patch  26  prior to placement of the drug delivery device  10  in contact with the body of the user. Removal of the patch liner  28  may further remove the sealing membrane  254  of the insertion mechanism  200 , opening the insertion mechanism to the body of the user for drug delivery (as shown in  FIG. 1C ). 
     Similarly, one or more of the components of drive mechanism  100  and drug delivery device  10  may be modified while remaining functionally within the breadth and scope of the present disclosure. For example, as described above, while the housing of drug delivery device  10  is shown as two separate components upper housing  12 A and lower housing  12 B, these components may be a single unified component. Similarly, while electrical contact  134  is shown as a separate component from contact sleeve  140 , it may be a unified component printed onto the ring surface of the contact sleeve  140 . As discussed above, a glue, adhesive, or other known materials or methods may be utilized to affix one or more components of the drive mechanism and/or drug delivery device to each other. Alternatively, one or more components of the drive mechanism and/or drug delivery device may be a unified component. For example, the upper housing and lower housing may be separate components affixed together by a glue or adhesive, a screw fit connection, an interference fit, fusion joining, welding, ultrasonic welding, and the like; or the upper housing and lower housing may be a single unified component. Such standard components and functional variations would be appreciated by one having ordinary skill in the art and are, accordingly, within the breadth and scope of the present disclosure. 
     It will be appreciated from the above description that the drive mechanisms and drug delivery devices disclosed herein provide an efficient and easily-operated system for automated drug delivery from a drug container. The novel embodiments described herein provide integrated status indication to provide feedback to the user. The novel drive mechanisms of the present disclosure may be directly or indirectly activated by the user. For example, in at least one embodiment the lockout pin(s) which maintain the drive mechanism in its locked, energized state are directly displaced from the corresponding lockout grooves of the piston  110  by user depression of the activation mechanism. Furthermore, the novel configurations of the drive mechanism and drug delivery devices of the present disclosure maintain the sterility of the fluid pathway during storage, transportation, and through operation of the device. Because the path that the drug fluid travels within the device is entirely maintained in a sterile condition, only these components need be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid pathway connection, the sterile fluid conduit, and the insertion mechanism. In at least one embodiment of the present disclosure, the power and control system, the assembly platform, the control arm, the activation mechanism, the housing, and other components of the drug delivery device do not need to be sterilized. This greatly improves the manufacturability of the device and reduces associated assembly costs. Accordingly, the devices of the present disclosure do not require terminal sterilization upon completion of assembly. A further benefit of the present disclosure is that the components described herein are designed to be modular such that, for example, housing and other components of the drug delivery device may readily be configured to accept and operate drive mechanism  100 , drive mechanism  500 , or a number of other variations of the drive mechanism described herein. 
     Manufacturing of a drug delivery device includes the step of attaching both the drive mechanism and drug container, either separately or as a combined component, to an assembly platform or housing of the drug delivery device. The method of manufacturing further includes attachment of the fluid pathway connection, drug container, and insertion mechanism to the assembly platform or housing. The additional components of the drug delivery device, as described above, including the power and control system, the activation mechanism, and the control arm may be attached, preformed, or pre-assembled to the assembly platform or housing. An adhesive patch and patch liner may be attached to the housing surface of the drug delivery device that contacts the user during operation of the device. 
     A method of operating the drug delivery device includes the steps of: activating, by a user, the activation mechanism; displacing a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a drive control mechanism to drive fluid drug flow through the drug delivery device. The method may further include the step of: engaging an optional on-body sensor prior to activating the activation mechanism. The method similarly may include the step of: establishing a connection between a fluid pathway connection to a drug container. Furthermore, the method of operation may include translating a plunger seal within the drive control mechanism and drug container to force fluid drug flow through the drug container, the fluid pathway connection, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to the body of a user. The method of operation of the insertion mechanism and the drug delivery device may be better appreciated with reference to  FIGS. 14A-14E , as described above.) 
     XXIV. Drug Information 
     The above description describes various systems and methods for use with various drug delivery devices. It should be clear that the systems, drug delivery devices or methods can further comprise use of a medicament listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting. The medicament will be contained in a reservoir (e.g., container  50 , container  618 , container  718 , container  818 , container  918 , container  1118 , container  2050 , container  6050 , container  8050 ). In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the medicament. The primary container can be a cartridge or a pre-filled syringe. Additionally, in some instances, the reservoir may be a primary container that is pre-loaded. 
     For example, the drug delivery device or more specifically the reservoir of the device may be filled 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 drug delivery device may be used with various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form. An ESA is any molecule that stimulates erythropoiesis, such as 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® (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 the molecules or variants or analogs thereof as disclosed in the following patents or patent applications, each of which is herein incorporated by reference in its entirety: U.S. Pat. Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,986,047; 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. 
     An ESA can be an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, 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, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in U.S. Publication Nos. 2003/0215444 and 2006/0040858, the disclosures of each of which is incorporated herein by reference in its entirety) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications, which are each herein incorporated by reference in its entirety: U.S. Pat. Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086; 6,310,078; 6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369; 7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002/0155998; 2003/0077753; 2003/0082749; 2003/0143202; 2004/0009902; 2004/0071694; 2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824; 2004/0229318; 2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834; 2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564; 2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822; 2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211; 2005/0202538; 2005/0227289; 2005/0244409; 2006/0088906; and 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 2004/033651; 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; WO 2005/025606; WO 2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO 2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO 2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO 2006/29094. 
     Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, TNF-receptor/Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, 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 a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose. The pharmaceutical product may be in liquid form, or reconstituted from lyophilized form. 
     Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: 
     OPGL specific antibodies, peptibodies, and related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies, including but not limited to the antibodies described in PCT Publication No. WO 03/002713, which is incorporated herein in its entirety as to OPGL specific antibodies and antibody related proteins, particularly those having the sequences set forth therein, particularly, but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1; and 22B3, including the OPGL specific antibodies having either the light chain of SEQ ID NO:2 as set forth therein in  FIG. 2  and/or the heavy chain of SEQ ID NO:4, as set forth therein in  FIG. 4 , each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; 
     Myostatin binding proteins, peptibodies, and related proteins, and the like, including myostatin specific peptibodies, particularly those described in U.S. Publication No. 2004/0181033 and PCT Publication No. WO 2004/058988, which are incorporated by reference herein in their entirety particularly in parts pertinent to myostatin specific peptibodies, including but not limited to peptibodies of the mTN8-19 family, including those of SEQ ID NOS:305-351, including TN8-19-1 through TN8-19-40, TN8-19 con1 and TN8-19 con2; peptibodies of 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 those of SEQ ID NOS:615-631, each of which is individually and specifically incorporated by reference herein in their entirety fully as disclosed in the foregoing publication; 
     IL-4 receptor specific antibodies, peptibodies, and related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and/or IL-13 to the receptor, including those described in PCT Publication No. WO 2005/047331 or PCT Application No. PCT/US2004/37242 and in U.S. Publication No. 2005/112694, which are incorporated herein by reference in their entirety particularly in parts pertinent to IL-4 receptor specific antibodies, particularly such antibodies as are described therein, particularly, and without limitation, those designated therein: 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 herein in its entirety fully as disclosed in the foregoing publication; 
     Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in U.S. Publication No. 2004/097712, which is incorporated herein by reference in its entirety in parts pertinent to IL1-R1 specific binding proteins, monoclonal antibodies in particular, especially, without limitation, those designated therein: 15CA, 26F5, 27F2, 24E12, and 10H7, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the aforementioned publication; 
     Ang2 specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in PCT Publication No. WO 03/057134 and U.S. Publication No. 2003/0229023, each of which is incorporated herein by reference in its entirety particularly in parts pertinent to Ang2 specific antibodies and peptibodies and the like, especially those of sequences described therein and including but not limited to: 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 1K; Con4-L1 (N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies and formulations such as those described in PCT Publication No. WO 2003/030833 which is incorporated herein by reference in its entirety as to the same, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK; AbG1D4; AbGC1E8; AbH1C12; AblA1; AbIF; AbIK, AbIP; and AbIP, in their various permutations as described therein, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; 
     NGF specific antibodies, peptibodies, and related proteins, and the like including, in particular, but not limited to those described in U.S. Publication No. 2005/0074821 and U.S. Pat. No. 6,919,426, which are incorporated herein by reference in their entirety particularly as to NGF-specific antibodies and related proteins in this regard, including in particular, but not limited to, the NGF-specific antibodies therein designated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; 
     CD22 specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Pat. No. 5,789,554, which is incorporated herein by reference in its entirety as to CD22 specific antibodies and related proteins, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, for instance, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa-chain, including, but limited to, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; 
     IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like, such as those described in PCT Publication No. WO 06/069202, which is incorporated herein by reference in its entirety as to IGF-1 receptor specific antibodies and related proteins, including but not limited to the IGF-1 specific antibodies therein designated L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, 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, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; 
     Also among non-limiting examples of anti-IGF-1R antibodies for use in the methods and compositions of the present disclosure are each and all of those described in: 
     (i) U.S. Publication No. 2006/0040358 (published Feb. 23, 2006), 2005/0008642 (published Jan. 13, 2005), 2004/0228859 (published Nov. 18, 2004), including but not limited to, for instance, antibody 1A (DSMZ Deposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC 2589), antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 as described therein; 
     (ii) PCT Publication No. WO 06/138729 (published Dec. 28, 2006) and WO 05/016970 (published Feb. 24, 2005), and Lu et al. (2004), J. Biol. Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12, and IMC-A12 as described therein; 
     (iii) PCT Publication No. WO 07/012614 (published Feb. 1, 2007), WO 07/000328 (published Jan. 4, 2007), WO 06/013472 (published Feb. 9, 2006), WO 05/058967 (published Jun. 30, 2005), and WO 03/059951 (published Jul. 24, 2003); 
     (iv) U.S. Publication No. 2005/0084906 (published Apr. 21, 2005), including but not limited to antibody 7C10, chimaeric antibody C7C10, antibody h7C10, antibody 7H2M, chimaeric antibody *7C10, antibody GM 607, humanized antibody 7C10 version 1, humanized antibody 7C10 version 2, humanized antibody 7C10 version 3, and antibody 7H2HM, as described therein; 
     (v) U.S. Publication Nos. 2005/0249728 (published Nov. 10, 2005), 2005/0186203 (published Aug. 25, 2005), 2004/0265307 (published Dec. 30, 2004), and 2003/0235582 (published Dec. 25, 2003) and Maloney et al. (2003), Cancer Res. 63:5073-5083, including but not limited to antibody EM164, resurfaced EM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, and huEM164 v1.3 as described therein; 
     (vi) U.S. Pat. No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos. 2005/0244408 (published Nov. 30, 2005) and 2004/0086503 (published May 6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073, e.g., antibody CP-751,871, including but not limited to each of the antibodies produced by the hybridomas having the ATCC accession numbers 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, as described therein; 
     (vii) U.S. Publication Nos. 2005/0136063 (published Jun. 23, 2005) and 2004/0018191 (published Jan. 29, 2004), including but not limited to antibody 19D12 and an antibody comprising a heavy chain encoded by a polynucleotide in plasmid 15H12/19D12 HCA (γ4), deposited at the ATCC under number PTA-5214, and a light chain encoded by a polynucleotide in plasmid 15H12/19D12 LCF (κ), deposited at the ATCC under number PTA-5220, as described therein; and 
     (viii) U.S. Publication No. 2004/0202655 (published Oct. 14, 2004), including but not limited to 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, as described therein; each and all of which are herein incorporated by reference in their entireties, particularly as to the aforementioned antibodies, peptibodies, and related proteins and the like that target IGF-1 receptors; 
     B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1,” also is referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP-specific fully human monoclonal IgG2 antibodies, particularly fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, especially those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells in particular, especially, in all of the foregoing regards, those disclosed in U.S. Publication No. 2008/0166352 and PCT Publication No. WO 07/011941, which are incorporated herein by reference in their entireties as to such antibodies and related proteins, including but not limited to antibodies designated therein as follow: 16H (having light chain variable and heavy chain variable sequences SEQ ID NO:1 and SEQ ID NO:7 respectively therein); 5D (having light chain variable and heavy chain variable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H (having light chain variable and heavy chain variable sequences SEQ ID NO:3 and SEQ ID NO:10 respectively therein); 43H (having light chain variable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO:14 respectively therein); 41H (having light chain variable and heavy chain variable sequences SEQ ID NO:5 and SEQ ID NO:13 respectively therein); and 15H (having light chain variable and heavy chain variable sequences SEQ ID NO:4 and SEQ ID NO:12 respectively therein), each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication; 
     IL-15 specific antibodies, peptibodies, and related proteins, and the like, such as, in particular, humanized monoclonal antibodies, particularly antibodies such as those disclosed in U.S. Publication Nos. 2003/0138421; 2003/023586; and 2004/0071702; and U.S. Pat. No. 7,153,507, each of which is incorporated herein by reference in its entirety as to IL-15 specific antibodies and related proteins, including peptibodies, including particularly, for instance, but not limited to, HuMax IL-15 antibodies and related proteins, such as, for instance, 14687; 
     IFN gamma specific antibodies, peptibodies, and related proteins and the like, especially human IFN gamma specific antibodies, particularly fully human anti-IFN gamma antibodies, such as, for instance, those described in U.S. Publication No. 2005/0004353, which is incorporated herein by reference in its entirety as to IFN gamma specific antibodies, particularly, for example, the antibodies therein designated 1118; 1118*; 1119; 1121; and 1121*. The entire sequences of the heavy and light chains of each of these antibodies, as well as the sequences of their heavy and light chain variable regions and complementarity determining regions, are each individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication and in Thakur et al. (1999), Mol. Immunol. 36:1107-1115. In addition, description of the properties of these antibodies provided in the foregoing publication is also incorporated by reference herein in its entirety. Specific antibodies include those having the heavy chain of SEQ ID NO:17 and the light chain of SEQ ID NO:18; those having the heavy chain variable region of SEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; those having the heavy chain of SEQ ID NO:19 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:10 and the light chain variable region of SEQ ID NO:12; those having the heavy chain of SEQ ID NO:32 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:30 and the light chain variable region of SEQ ID NO:12; those having the heavy chain sequence of SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; those having the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:16; those having the heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; and those having the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:31, as disclosed in the foregoing publication. A specific antibody contemplated is antibody 1119 as disclosed in the foregoing U.S. publication and having a complete heavy chain of SEQ ID NO:17 as disclosed therein and having a complete light chain of SEQ ID NO:18 as disclosed therein; 
     TALL-1 specific antibodies, peptibodies, and the related proteins, and the like, and other TALL specific binding proteins, such as those described in U.S. Publication Nos. 2003/0195156 and 2006/0135431, each of which is incorporated herein by reference in its entirety as to TALL-1 binding proteins, particularly the molecules of Tables 4 and 5B, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publications; 
     Parathyroid hormone (“PTH”) specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Pat. No. 6,756,480, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind PTH; 
     Thrombopoietin receptor (“TPO-R”) specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Pat. No. 6,835,809, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TPO-R; 
     Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, and related proteins, and the like, including those that target the HGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonal antibodies that neutralize hepatocyte growth factor/scatter (HGF/SF) described in U.S. Publication No. 2005/0118643 and PCT Publication No. WO 2005/017107, huL2G7 described in U.S. Pat. No. 7,220,410 and 0A-5d5 described in U.S. Pat. Nos. 5,686,292 and 6,468,529 and in PCT Publication No. WO 96/38557, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind HGF; 
     TRAIL-R2 specific antibodies, peptibodies, related proteins and the like, such as those described in U.S. Pat. No. 7,521,048, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TRAIL-R2; 
     Activin A specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2009/0234106, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind Activin A; 
     TGF-beta specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Pat. No. 6,803,453 and U.S. Publication No. 2007/0110747, each of which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TGF-beta; 
     Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in PCT Publication No. WO 2006/081171, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind amyloid-beta proteins. One antibody contemplated 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 foregoing publication; 
     c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2007/0253951, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind c-Kit and/or other stem cell factor receptors; 
     OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2006/0002929, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind OX40L and/or other ligands of the OX40 receptor; and 
     Other exemplary proteins, including Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); 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® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); 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 Ilb/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® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri® (natalizumab, anti-α4integrin mAb); Valortim® (MDX-1303, anti- B. anthracis  protective antigen mAb); ABthrax™; Vectibix® (panitumumab); Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG1 and the extracellular domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); 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); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatumumab; 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 C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxinl 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-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10 Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513; anti-Mannose Receptor/hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFß 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 #1; and NVS Antibody #2. 
     Also included can be a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis). Further included can be therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA. Additionally, included in the device can be a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9). Such PCSK9 specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab), as well as molecules, variants, analogs or derivatives thereof as disclosed in the following patents or patent applications, each of which is herein incorporated by reference in its entirety for all purposes: U.S. Pat. Nos. 8,030,547, 8,563,698, 8,829,165, 8,859,741, 8,871,913, 8,871,914, 8,883,983, 8,889,834, 8,981,064, 9,056,915, 8,168,762, 9,045,547, 8,030,457, 8,030,457, 8,829,165, 8,981,064, 8,030,457, U.S. 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. Patent Application Publication No. 2015/0031870, U.S. Patent Application Publication No. 2013/0085265, U.S. Patent Application Publication No. 2013/0079501, U.S. Patent Application Publication No. 2012/0213797, U.S. Patent Application Publication No. 2012/0251544, U.S. Patent Application Publication No. 2013/0072665, U.S. Patent Application Publication No. 2013/0058944, U.S. Patent Application Publication No. 2013/0052201, 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. 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 Ser. No. 14/777,371, International Patent Application No. PCT/US2013/048714, International Patent Application No. PCT/US2015/040211, International Patent Application No. PCT/US2015/056972, International Patent Application Publication No. WO/2008/057457, International Patent Application Publication No. WO/2008/057458, International Patent Application Publication No. WO/2008/057459, International Patent Application Publication No. WO/2008/063382, International Patent Application Publication No. WO/2008/133647, International Patent Application Publication No. WO/2009/100297, International Patent Application Publication No. WO/2009/100318, International Patent Application Publication No. WO/2011/037791, International Patent Application Publication No. WO/2011/053759, International Patent Application Publication No. WO/2011/053783, International Patent Application Publication No. WO/2008/125623, International Patent Application Publication No. WO/2011/072263, International Patent Application Publication No. WO/2009/055783, International Patent Application Publication No. WO/2012/0544438, International Patent Application Publication No. WO/2010/029513, International Patent Application Publication No. WO/2011/111007, International Patent Application Publication No. WO/2010/077854, International Patent Application Publication No. WO/2012/088313, International Patent Application Publication No. WO/2012/101251, International Patent Application Publication No. WO/2012/101252, International Patent Application Publication No. WO/2012/101253, International Patent Application Publication No. WO/2012/109530, and International Patent Application Publication No. WO/2001/031007, International Patent Application Publication No. WO/2009/026558, International Patent Application Publication No. WO/2009/131740, International Patent Application Publication No. WO/2013/166448, and International Patent Application Publication No. WO/2014/150983. 
     Also included can 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). 
     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 or and is present in the extracellular matrix; it inhibits all the major cartilage-degrading metalloproteases, and may play a role in 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 a DNA that encodes TIMP-3, are disclosed in U.S. Pat. No. 6,562,596, issued May 13, 2003, the disclosure of which is incorporated by reference herein. Description of TIMP mutations can be found in U.S. Publication No. 2014/0274874 and PCT Publication No. WO 2014/152012. 
     Also included are antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecule that target the CGRP receptor and other headache targets. Further information concerning these molecules can be found in PCT Application No. WO 2010/075238. 
     Additionally, a bispecific T cell engager antibody (BiTe), e.g. Blinotumomab can be used in the device. Alternatively, included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in PCT Publication No. WO 2014/099984. 
     In certain embodiments, the medicament comprises a therapeutically effective amount of an 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. 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 particularly preferred embodiments, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within U.S. Pat. No. 7,982,016. 
     XXV. Additional Aspects 
     The drug delivery devices, assemblies, mechanisms, components, features, functionalities, methods of manufacture, and methods of use described above may incorporate various aspects of the drug delivery devices, assemblies, mechanisms, components, features, functionalities, methods of manufacture, and methods of use described in the following documents, each of which is incorporated in its entirety for all purposes: U.S. Pat. No. 8,939,935; U.S. Patent Application Publication No. 2013/0060233; U.S. Patent Application Publication No. 2013/0066274; U.S. Patent Application Publication No. 2013/0237916; U.S. Patent Application Publication No. 2014/0200510; U.S. Patent Application Publication No. 2014/0288511A1; U.S. Patent Application Publication No. 2015/0290390; U.S. Patent Application Publication No. 2015/0374919A1; U.S. Patent Application Publication No. 2015/0209505; U.S. Patent Application Publication No. 2015/0297827; U.S. Patent Application Publication No. 2015/0359965; U.S. Patent Application Publication No. 2015/0190588; U.S. Patent Application Publication No. 2015/0217045; U.S. Patent Application Publication No. 2015/0057613; U.S. Patent Application Publication No. 2014/0296787; U.S. Provisional Patent Application No. 62/094,395 entitled “DRUG DELIVERY DEVICE WITH PROXIMITY SENSOR”; U.S. Provisional Patent Application No. 62/114,200 entitled “ROTATIONALLY BIASED INSERTION MECHANISM FOR A DRUG DELIVERY PUMP”; U.S. Provisional Patent Application No. 62/117,420 entitled “DRUG DELIVERY DEVICE WITH VACUUM ASSISTED SECUREMENT AND/OR FEEDBACK”; U.S. Provisional Patent Application No. 62/127,021 entitled “DEVICE AND METHOD FOR MAKING ASEPTIC CONNECTIONS”; U.S. Provisional Patent Application No. 62/130,318 entitled “MULTI-FUNCTION DRIVE MECHANISMS FOR CONTROLLED DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/266,788 entitled “DRUG DELIVERY STORAGE DEVICE AND SYSTEM”; U.S. Provisional Patent Application No. 62/293,556 filed on Feb. 10, 2016 entitled “DRUG DELIVERY DEVICE”; U.S. Provisional Patent Application No. 62/133,690 entitled “ROTATIONALLY BIASED INSERTION MECHANISM FORA DRUG DELIVERY PUMP”; U.S. Provisional Patent Application No. 62/201,456 entitled “MULTI-FUNCTION DRIVE MECHANISMS FOR CONTROLLED DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/147,435 entitled “MULTI-FUNCTION DRIVE MECHANISMS FOR CONTROLLED DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/134,226 entitled “MULTI-FUNCTION DRIVE MECHANISMS FOR CONTROLLED DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/147,403 entitled “ROTATIONALLY BIASED INSERTION MECHANISM FORA DRUG DELIVERY PUMP”; U.S. Provisional Patent Application No. 62/220,754 entitled “CONTROLLED DELIVERY DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/290,064 entitled “ASEPTIC CONNECTIONS FOR DRUG DELIVERY DEVICES”; U.S. Provisional Patent Application No. 62/201,468 entitled “DRUG DELIVERY PUMPS HAVING MULTIPLE CHAMBERS”; U.S. Provisional Patent Application No. 62/262,666 entitled “SYSTEMS FOR THE CONTROL OF DRUG DELIVERY PUMPS BASED ON INPUT DATA”; U.S. Provisional Patent Application No. 62/241,906 entitled “FILL-FINISH CARRIERS FOR DRUG CONTAINERS”; U.S. Provisional Patent Application No. 62/262,683 entitled “SYSTEMS AND METHODS FOR CONTROLLED DRUG DELIVERY PUMPS”; U.S. Provisional Patent Application No. 62/204,866 entitled “AUTOMATIC DRUG INJECTORS AND ASSOCIATED DEVICES INCORPORATING DATA RECORDING, TRANSMISSION, AND RECEIVING”; U.S. Provisional Patent Application No. 62/239,116 entitled “AUTOMATIC INJECTORS FOR INJECTABLE CARTRIDGES INCORPORATING SIMPLIFIED LOADING OF CARTRIDGES”; U.S. Provisional Patent Application No. 62/206,503 entitled “ARCUATE DRIVE MECHANISMS FOR AUTOMATIC INJECTORS”; U.S. Provisional Patent Application No. 62/278,028 entitled “MEDICAL DEVICE INCORPORATING ADHESIVE WITH STIMULANT SENSITIVE BONDING STRENGTH”; International Patent Application Publication No. WO/2015/061386; International Patent Application Publication No. WO/2015/061389; International Patent Application Publication No. WO/2015/187793; International Patent Application Publication No. WO/2015/187797; International Patent Application Publication No. WO/2015/187799; International Patent Application Publication No. WO/2015/187802; International Patent Application Publication No. WO/2015/187805; International Patent Application Publication No. WO/2016/003813; International Patent Application No. PCT/US2016/017534 entitled “ROTATIONALLY BIASED INSERTION MECHANISM FORA DRUG DELIVERY PUMP”; International Patent Application No. PCT/US2016/017534 entitled “ROTATIONALLY BIASED INSERTION MECHANISM FORA DRUG DELIVERY PUMP”; International Patent Application No. PCT/US2015/052311 entitled “CONCENTRIC BARREL DRUG CONTAINERS AND DRUG DELIVERY PUMPS THAT ALLOW MIXING AND DELIVERY”; International Patent Application No. PCT/US2015/052367 entitled “SEQUENTIAL CHAMBER DRUG DELIVERY PUMPS FOR DRUG MIXING AND DELIVERY”; International Patent Application No. PCT/US2015/047487 entitled “SKIN SENSORS FOR DRUG DELIVERY DEVICES”; International Patent Application No. PCT/US2015/052815 entitled “RIGID NEEDLE INSERTION MECHANISM FORA DRUG DELIVERY PUMP”; International Patent Application No. PCT/US2015/047503 entitled “SENSOR SYSTEMS FOR DRUG DELIVERY DEVICES”; International Patent Application No. PCT/US2016/021585 entitled “DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS”; International Patent Application No. PCT/US2016/020486 entitled “DEVICE AND METHOD FOR MAKING ASEPTIC CONNECTIONS”; International Patent Application No. PCT/US15/29485 entitled “AUTOINJECTOR WITH SHOCK REDUCING ELEMENTS”. Furthermore, the drug delivery devices, assemblies, mechanisms, components, features, functionalities, methods of manufacture, and methods of use described in any of the above-listed-incorporated-by-reference disclosures may include a container filled partially or entirely with one or more of the drugs described above, including, for example, a PCSK9 specific antibody, a G-CSF, a sclerostin antibody, or a CGRP antibody. 
     Throughout the specification, the aim has been to describe the preferred embodiments of the disclosure without limiting the disclosure to any one embodiment or specific collection of features. Various changes and modifications may be made to the embodiments described and illustrated without departing from the present disclosure. The disclosure of each patent and scientific document, computer program and algorithm referred to in this specification is incorporated by reference in its entirety.