DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS

Abstract

A drive mechanism (100) for use with a drug container (50) in a drug pump, wherein the drug container (50) has a cylinder (58) and a piston seal (60), including a belt, an electric actuator (101), and a gear interface. The rotation of the gear interface is controlled by the actuator (101). A gear assembly is rotatably coupled to the gear interface. The gear assembly includes a main gear and a regulating mechanism. The belt release is calibrated by the gear assembly via the regulating mechanism. A piston (110, 1110, 2110) is connected to the belt and disposed in the cylinder (58) and is configured to travel axially within the container.A deflection member is disposed at least partially within the cylinder (58) and is held in an activated state between the piston (110, 1110, 2110) and the drive housing, where release of the belt controls the free expansion of the deflection member from its activated state and the axial translation of the piston (110, 1110, 2110).

Description

DRIVE MECHANISMS FOR DRUG DELIVERY PUMPS CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 130,318, filed March 9, 2015; U.S. Provisional Application No. 62 / 134,226, filed March 17, 2015; U.S. Provisional Application No. 62 / 147,435, filed April 14, 2015; U.S. Provisional Application No. 62 / 201,456, filed August 5, 2015; and U.S. Provisional Application No. 62 / 242,929, filed October 16, 2015, all of which are hereby incorporated by reference for all purposes in their entireties. FIELD The present invention relates to drug delivery pumps. More particularly, the present invention relates to drive mechanisms for the controlled delivery of pharmacological substances, controlled drug delivery pumps with such drive mechanisms, methods of operating such devices, and methods of assembling such devices. BACKGROUND Parenteral delivery of various drugs, that is, delivery through means that do not involve the digestive tract, has become a desired method of drug delivery for several reasons. This form of drug delivery by injection can enhance the effect of the delivered substance and ensure that the drug reaches its intended site unaltered in a significant concentration. Similarly, unwanted side effects associated with other delivery routes, such as systemic toxicity, can potentially be avoided through parenteral delivery. By bypassing the digestive system, the degradation of active ingredients caused by catalytic enzymes in the digestive tract and liver can be avoided, ensuring that the required amount of drug, at a desired concentration, reaches the intended site. Traditionally, manually actuated syringes and injection pens have been used to deliver parenteral drugs to a patient. More recently, parenteral delivery of liquid medications has been achieved by administering bolus injections with a needle and reservoir, continuously, using gravity-fed dispensers, or through transdermal patch technologies. Bolus injections may not be perfectly tailored to the patient's clinical needs and may require larger individual doses than desired at the specific time they are administered. Continuous delivery of a medication through gravity-fed systems compromises patient mobility and lifestyle and limits therapy to simplistic flow rates and profiles.Similarly, another form of drug delivery, transdermal patches, also has its limitations. Transdermal patches often require specific drug molecular structures to achieve efficacy, and control of drug delivery through a transdermal patch is greatly limited. Ambulatory infusion pumps have been developed to deliver liquid medications to a patient. These infusion devices are capable of delivering sophisticated fluid delivery profiles that meet the requirements of bolus, continuous infusion, and variable flow rate delivery. These infusion capabilities typically result in improved drug and therapy efficacy and reduced toxicity to the patient'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 the intended medication, as well as refill accessories.The devices often require specialized care, maintenance, and cleaning to ensure safety and proper functioning for their intended long-term use, and are not cost-effective for patients and healthcare providers. Compared to syringes and injection pens, pump-type delivery devices can be considerably more convenient for a patient, as drug doses can be automatically calculated and delivered to a patient at any time during the day or night. Furthermore, when used in conjunction with metabolic sensors or monitors, pumps can be automatically controlled to provide appropriate doses of a fluid medium at appropriate times of need, based on monitored or detected metabolic levels. Consequently, pump-type delivery devices have become an important aspect of modern medical treatments for various types of medical conditions, such as diabetes and the like. Although pump-type delivery systems have been used to address a number of patient needs, manually actuated syringes and injection pens are still often preferred for drug delivery, as they now provide integrated safety features and can be easily read to identify drug delivery status and dose completion. However, manually actuated syringes and injection pens are not universally applicable and are not preferred for the delivery of all drugs. There remains a need for an adjustable (and / or programmable) infusion system that is accurate and reliable and can offer physicians and patients a small, low-cost, lightweight, and easy-to-use alternative for parenteral delivery of liquid medications. MA / a / zuzz / ui i ozy THE INVENTION The present invention provides drive mechanisms for controlled delivery of drug substances, controlled drug delivery pumps with those drive mechanisms, methods of operating those devices, and methods of assembling those devices.It is worth noting that the drive mechanisms of the present invention allow or enable several functions, including: (i) controlling the rate of drug delivery by sizing, providing resistance, or otherwise preventing free axial translation of the piston seal that is used to force a drug substance out of a drug container; (ii) actuating a needle insertion mechanism to provide a fluid path for delivery of the drug to a target; and (iii) connecting a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target. Thus, novel embodiments of the present invention allow for delivery of drug substances at variable rates.The drive mechanisms of the present invention may allow for pre-configuration or dynamic configuration, for example, through control by the power and control system, to meet desired delivery rates or profiles, as will be explained in detail below. Additionally, the drive mechanisms of the present invention provide integrated status indication elements that provide information to the user before, during, and after drug delivery. For example, initial information may be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may provide one or more drug delivery status indications to the user.Upon completion of drug delivery, the drive mechanism and drug pump may provide a dose completion indication. Since the dose completion indication relates to the physical completion of axial displacement and / or translation of one or more components of the drive mechanism, the drive mechanism and drug pump provide a true indication of dose completion to the user. Through these mechanisms, confirmation of drug dose delivery may be accurately provided to the user or administrator. Accordingly, the novel devices of the present invention overcome one or more of the problems associated with prior art devices, such as those mentioned above. In a first embodiment, the present invention provides a drive mechanism including an actuator, a gear assembly including a main gear, a drive housing, and a drug container with a lid, a pierceable seal (not visible), a cylinder, and a piston seal. The main gear may be, for example, a star-shaped gear arranged to contact multiple secondary gears or gear surfaces. A drug chamber, located within the cylinder between the pierceable seal and the piston seal, may contain a drug fluid for delivery via the insertion mechanism and the drug pump to the target.A piston and one or more biasing members may also be incorporated into the drive mechanism, wherein the biasing member(s) are initially retained in an activated state and configured to exert pressure on an interface surface of the piston. The piston is configured for substantially axial translation within a drug container with a piston seal and a cylinder. A strap is connected at one end to the piston and at another end to a winch assembly of a regulating mechanism, where the strap restricts free expansion of the biasing member from its initial activated state and free axial translation of the piston upon which the biasing member exerts pressure. The drug container may contain a drug fluid within a drug chamber for delivery to a target.Optionally, a cover sleeve may be used between the biasing member and the piston interface surface to conceal the internal components of the cylinder (i.e., the piston and biasing member) from view during operation of the drive mechanism. The strap is configured to be released from a capstan mount of a regulating mechanism of the drive mechanism to calibrate the free expansion of the biasing member from its initial activated state and the free axial translation of the piston against which the biasing member exerts pressure. Alternatively, the present invention provides a drive mechanism for use with a drug container in a drug pump, the drug container including a cylinder and a piston seal, including a belt, an electric actuator, and a gear interface. Rotation of the gear interface is controlled by the electric actuator. A gear assembly is in rotatable engagement with the gear interface and includes a main gear and a timing mechanism, the release of the belt being calibrated by the action of the gear assembly through the timing mechanism. A drive housing is provided. A piston is connected to the belt and is configured to be disposed in the cylinder adjacent the piston seal.The piston is configured for substantially axial translation within the drug container, and a biasing member is configured to be disposed at least partially within the cylinder, where the biasing member is retained in an activated state between the piston and the drive housing. Release of the strap controls the free expansion of the biasing member from its initial activated state and the free axial translation of the piston upon which the biasing member exerts pressure. The present invention further provides a drug delivery pump, including a drive mechanism of any of the described embodiments and a drug container including a cylinder and piston seal, a needle insertion mechanism, and a fluid path connection. The invention may also provide a safety mechanism configured to stop or slow the delivery of the drug fluid through the fluid path connection upon a loss of tension in the belt. In yet another embodiment, the present invention provides a drive mechanism preparable for use with a drug container in a drug pump, the drug container including a cylinder and a piston seal, including a belt, a drive housing, and a capstan drum. A piston is connected to the belt and is configured to be disposed in the cylinder adjacent the piston seal, the piston being configured for substantially axial translation within the drug container, and a biasing member being configured to be disposed at least partially within the cylinder, the biasing member being retained in an activated state between the piston and the drive housing.The strap is arranged and wound around the winch drum and is configured to be released from the winch drum by rotation of the winch drum to calibrate the free expansion of the biasing member from its activated state and the free axial translation of the piston on which the biasing member exerts pressure. In at least one embodiment of the present invention, the regulating mechanism is a gear assembly driven by a drive mechanism actuator. The regulating mechanism retards or restricts the timing of the belt, only allowing it to advance at a regulated or desired speed. This restricts the movement of the piston within the cylinder, which is biased by one or more biasing members, thereby controlling the movement of the piston seal and the delivery of the drug contained in the chamber. As the piston seal advances into the drug container, the drug substance is dispensed through the sterile line connection, the conduit, the insertion mechanism, and to the drug delivery target. The actuator can be any of a number of power / motion sources, including, for example, a motor (e.g., a DC motor, an AC motor, or a stepper motor) or a solenoid (e.g.,, a linear solenoid, a rotary solenoid). In one particular embodiment, the actuator is a rotary stepper motor with a notch corresponding to the gear teeth of the main / star gear. The regulating mechanism may further include one or more gears in a gear assembly. One or more of the gears may be, for example, compound gears with a small diameter gear attached at a shared center point to ML / a / ZUZZ / U 11 oz a large diameter gear. The gear assembly may include a gear coupled to a capstan assembly around which the belt may be removably wrapped. Accordingly, rotation of the gear assembly initiated by the actuator may be coupled to the capstan assembly (i.e., via the gear assembly), thereby controlling belt timing, the expansion rate of the biasing members and axial translation of the piston, and the speed of movement of the piston seal within the cylinder to force fluid out of the drug chamber. As described herein, other components of the regulating element calibrate or restrict the rotary motion of the capstan assembly and thus the axial translation of the piston and piston seal, or otherwise prevent free axial translation.It should be noted that the regulating mechanisms of the present invention do not actuate 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 activated state and its action on the piston and piston seal. Instead, the regulating mechanisms serve the function of providing resistance to the free movement of the piston and piston seal as they are pressured by the expansion of the biasing member from its initial activated state. The regulating mechanism does not actuate the delivery, but merely controls the movement of the delivery. The belt limits or otherwise restricts the movement of the piston and piston seal, but does not apply the force for the delivery. In addition to controlling the drug delivery rate by sizing, resisting, or otherwise preventing free axial translation of a piston seal used to force a drug substance out of a drug container (whereby drug substances are delivered at variable delivery profiles and / or rates); the drive mechanisms of the present invention may simultaneously or sequentially perform the following steps: activating a needle insertion mechanism (NIM) to provide a fluid path for delivery of the drug to a target; and connecting a sterile fluid path to a drug container to permit fluid flow from the drug container to the needle insertion mechanism for delivery to the target.In at least one embodiment, initial movement by the actuator of the drive mechanism causes rotation of the main / star gear. In one manner, the main / star gear transmits motion to the regulating mechanism through the gear assembly. In the other manner, the main / star gear transmits motion to the needle insertion mechanism through a gear. As the main / star gear rotates the gear, the gear causes the needle insertion mechanism to initiate connection of the fluid path to the target, as described in detail above. In a particular embodiment, the needle insertion mechanism is a rotary needle insertion mechanism. Accordingly, the gear is configured to engage a corresponding engagement surface of the needle insertion mechanism.The rotation of the gear causes the needle insertion mechanism to rotate through the interaction between the gears of the drive mechanism gear and the corresponding gear surface of the needle insertion mechanism. Once the needle insertion mechanism has properly rotated, it can be initiated to create the fluid path connection to the target, as described in detail herein. In another embodiment, the drive mechanism may configure a NIM activation mechanism for activation by a user. For example, the NIM activation mechanism may be in an initial configuration in which pressing an activation mechanism actuator does not activate the NIM. Subsequently, the drive mechanism may transform the NIM activation mechanism to a configuration in which actuation of the activation mechanism does activate needle insertion. For example, actuation of the activation mechanism may cause translation of a slide gate. The drive mechanism may cause a selector member to be positioned such that contact between the slide gate and the selector member causes at least a portion of the slide gate to be displaced.This displacement brings the sliding gate into contact with a pull arm, causing the latter to translate with the sliding gate. This translation of the pull arm triggers needle insertion. For example, the pull arm may trigger the displacement of a NIM lock that, in an initial configuration, prevents rotation of a NIM retainer. The NIM retainer initially prevents activation of needle insertion. After translation of the NIM lock, an opening in the NIM lock aligns with a portion of the NIM retainer, allowing rotation of the NIM retainer. This rotation allows activation of needle insertion. In at least one embodiment, rotating the needle insertion mechanism in this manner may also cause a connection of a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target. The ramp aspect of the needle insertion mechanism is caused to exert pressure on a movable connection point of the sterile fluid path connection. As the drive mechanism rotates the needle insertion mechanism, a ramp aspect of the needle insertion mechanism exerts pressure on the movable connection point of the sterile fluid path connection and translates it to facilitate a fluid connection therethrough.In at least one embodiment, the needle insertion mechanism may be configured such that a particular degree of rotation allows the needle / trocar to be withdrawn as detailed above. Additionally or alternatively, such needle / trocar retraction may be configured to occur upon user activity or upon movement or operation of another component of the drug pump. In at least one embodiment, the needle / trocar retraction may be configured to occur upon completion of drug delivery, triggered, for example, by the throttle mechanism and / or one or more of the status readers as described herein. In yet another embodiment, the drive mechanism may include a state reader configured to read or recognize one or more corresponding state triggers. The state triggers may be spaced incrementally over the belt, where, during operation of the drive mechanism, interaction between the state reader and the state triggers transmits a signal to a power and control system to provide information to a user. The state reader may be an optical state reader and the corresponding state triggers be optical state triggers, an electromechanical state reader and the corresponding state triggers be electromechanical state triggers, or a mechanical state reader and the corresponding state triggers be mechanical state triggers. In a further embodiment, the present invention provides a drug delivery pump with controlled drug delivery. The drug delivery pump has a housing and an assembly platform, on which an activation mechanism, an insertion mechanism, a fluid path connection, a power and control system, and a controlled delivery drive mechanism can be mounted, said drive mechanism having a drive housing, a piston, and a biasing member, the biasing member being initially retained in an activated state and configured to exert pressure on an interface surface of the piston. The piston is configured for substantially axial translation within a drug container with a piston seal and a cylinder.A strap is connected at one end to the piston and at the other end to a winch assembly of a delivery regulating mechanism, where the strap restricts free expansion of the biasing member from its initial activated state and free axial translation of the piston upon which the biasing member exerts pressure. The drug container may contain a drug fluid within a drug chamber for delivery to a target. Optionally, a cover sleeve may be used between the biasing member and the piston interface surface to conceal the internal components of the cylinder (i.e., the piston and biasing member) from view during operation of the drive mechanism.The belt is configured to be released from a capstan assembly of the supply regulation mechanism to calibrate the free expansion of the biasing member from its initial activated state and the free axial translation of the piston on which the biasing member exerts pressure. In another embodiment, the drug pump further includes a gear assembly. The gear assembly may include a capstan gear connected to a capstan assembly around which the belt may be removably wrapped, and whose rotation releases the belt from the capstan assembly to calibrate the free expansion of the biasing member from its initial activated state and the free axial translation of the piston against which the biasing member exerts pressure. Calibration of the belt controls the rate or profile of drug delivery to a target. The piston may consist of one or more parts and is connected to a distal end of the belt. The capstan assembly is coupled to a regulating mechanism that controls the rotation of the capstan assembly and, therefore, the calibration of the translation of the piston. In yet another embodiment, the drug pump may include a status reader configured to read or recognize one or more corresponding status triggers. The status triggers may be spaced incrementally over the belt, where, during operation of the drive mechanism, interaction between the status reader and the status triggers transmits a signal to a power and control system to provide information to a user. The status reader may be an optical status reader and the corresponding status triggers be optical status triggers, an electromechanical status reader and the corresponding status triggers be electromechanical status triggers, or a mechanical status reader and the corresponding status triggers be mechanical status triggers. In another embodiment, the drug pump's power and control system is configured to receive one or more inputs to calibrate the release of the belt by the winch assembly and thereby allow axial translation of the piston by the biasing member to translate a piston seal within a cylinder. The input(s) may be provided by actuating 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 belt and winch assembly on the free axial translation of the piston against which the biasing member exerts pressure to meet a desired drug delivery rate or profile, to change the dose volume for target delivery, and / or to start, stop, or otherwise interrupt operation of the drive mechanism. In at least one embodiment of the present invention, the drug delivery profile can be adjusted. For example, it may be desirable to deliver a bolus injection of drug before, during, or after certain activities such as eating, exercising, sleeping, etc. A "bolus injection" is any metered volume of drug delivered, often regardless of the timing or duration of delivery. In contrast, a "basal injection" often has a controlled delivery rate and / or a drug delivery profile with varying delivery rates at different time intervals. Similarly, the user may desire to increase or decrease the basal delivery rate of the drug at these or other times. In at least one embodiment, the delivery profile can be adjusted by the user to achieve this desired drug delivery.The user can adjust the delivery profile by interacting with the drug delivery device itself or, alternatively, by using an external device, such as a smartphone. For example, the user can adjust the delivery profile by moving the trigger mechanism or by using an external delivery control mechanism or one integrated into a separate device. In another embodiment of the present invention, the delivery profile may be automatically adjusted based on one or more inputs. For example, the delivery profile may be adjusted based on activity level, heart rate, blood sugar level, blood pressure, etc. As discussed above, these measurements may be used to determine the need for a bolus injection or to increase or decrease the basal injection delivery rate or adjust the basal injection delivery profile. In at least one embodiment, these measurements may be monitored by the device itself. Additionally or alternatively, they may be monitored by a secondary device such as a smartphone, a smartwatch, a heart rate monitor, a glucose monitor, a blood pressure monitor, or the like.In some embodiments, the delivery profile can be adjusted based on these measurements without requiring user intervention. In the case of monitoring and / or control by a secondary device, the secondary device and the drug delivery device can be in wireless or wired communication with each other. This communication can be via Bluetooth, near-field communication, Wi-Fi, or any other method known to one of skill in the relevant art of device interconnectivity. In a preferred embodiment, however, the monitoring / adjustment mechanism may alert and make recommendations to the user, and the user may have active control to initiate / authorize or dismiss the recommendation made by the monitoring / adjustment mechanism. For example, if one or more of the measurements is above or below a specified threshold value, the device may provide an audible, visual, or tactile alert to the user. In one example, the alert is provided by a vibration of the device, thereby providing a discreet alert to the user. Additionally or alternatively, the alert may be provided by the user's smartphone or other secondary device. The user may be able to view the current status of the measurements in a software program or web interface on the device itself, a computer, a smartphone, or other device.The software or web interface may provide a recommended setting for the delivery profile. Based on this information, the user can adjust the delivery rate of the drug delivery device. As previously stated, the user can adjust the delivery profile by shifting the trigger mechanism or by using an external delivery control mechanism or one integrated into a separate device. In one embodiment, in response to a signal to adjust the delivery profile, either based on user input or based on the measurements described above, the power and control system may cause a change in the speed of movement of the actuator. The change in the speed of movement of the actuator causes a change in the rotational speed of the throttle mechanism, which, in turn, controls the rate of delivery of the drug to the target. Alternatively, the delivery profile may be altered by a change in the characteristics of the flow path of the drug through the conduit connecting the drug container and the insertion mechanism. The change may be caused by the introduction, removal, or modification of a flow restrictor that restricts the flow of the drug from the drug container to the insertion mechanism.For example, a flow restrictor may have multiple flow paths that can be selectively placed in fluid communication with an inlet and an outlet of the flow restrictor. By providing flow paths with different lengths or cross-sections, the delivery rate can be controlled. In other embodiments, the delivery profile can be altered by introducing or removing a pinch from the conduit. A pinch in the flow path can interrupt or slow the flow of the drug through the conduit, thereby controlling the delivery rate to the target. Accordingly, one or more embodiments of the present invention can produce a change in the delivery rate of the drug from the drug container, thereby providing a dynamic control capability to the drive mechanism and / or the drug delivery device. The devices described herein may further include elements that prevent the delivery of an excessive volume of medication or delivery at too rapid a rate, e.g., to prevent a runaway condition from uncontrolled or unwanted delivery of the medication. By providing such automatic safety mechanisms, patient safety can be ensured. Some medications, such as insulin or other diabetic treatments, can be dangerous, and even potentially lethal, if not delivered according to prescribed parameters. Such safety mechanisms may include a brake mechanism, a piston seal piercing mechanism, and a piston seal displacement mechanism, such as those described in detail herein.The safety features described below can ensure that the drug supply is stopped if the supply deviates from the specified parameters. Novel embodiments of the present invention provide drive mechanisms that are capable of sizing, providing resistance to, or otherwise preventing free axial translation of the piston seal used to force a drug substance out of a drug container and thereby controlling the drug substance delivery rate. The novel delivery control drive mechanisms are further capable of providing a drug delivery progress status 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 and not exclusively, such that a stated integer or group of integers may include one or more non-stated integers or groups of integers.As will be further described below, embodiments of the present invention may include one or more additional components that may be considered standard components in the medical device industry. For example, embodiments may include one or more batteries used to power the motor, drive mechanisms, and drug pumps of the present invention. Components and embodiments containing those components are within the scope of the present invention and are to be understood as being within the scope and breadth of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS The following non-limiting embodiments of the invention are described herein with respect to the following drawings, where: FIG. 1A is an isometric view of a drug delivery pump with a drive mechanism, according to an embodiment of the present invention (shown without the adhesive patch); FIG. 1 B is an isometric view of the internal components of the drug delivery pump shown in FIG. 1A (shown without the adhesive patch); FIG. 1C is an isometric view of the drug delivery pump shown in FIG. 1A (shown without the adhesive patch) from another perspective; FIG. 2A is a top view, along an axis “A,” of the internal components of an exemplary drug delivery pump; FIG. 2B is an isometric view of a drive mechanism, in accordance with at least one embodiment of the present invention prior to activation; FIG. 20 is an isometric view of a drive mechanism, in accordance with at least one embodiment of the present invention during activation; FIG. 2D is an isometric view of an actuation mechanism, in accordance with at least one embodiment of the present invention, at a later stage during activation; FIG. 2E is an isometric view of a drive mechanism, in accordance with at least one embodiment of the present invention, at or near completion of drug delivery; FIGS. 3A-3D are top views corresponding to the operating stages shown in FIGS. 2A-2E, respectively; FIG. 4 is an isometric view of the drive mechanism, in accordance with at least one embodiment of the present invention, isolated from the drug delivery device; FIGS. 5A-5B are a top and bottom view, respectively, of the drive mechanism shown in FIG. 4; FIGS. 5C-5D are perspective views, one front and one rear, respectively, of the drive mechanism shown in FIG. 4; FIG. 6A is an isometric view of a drug delivery pump in which the insertion mechanism includes a rotatable biasing member; FIG. 6B is an enlarged view of the drive mechanism shown in FIG. 6A FIG. 7A is an isometric view of an insertion mechanism in an initial configuration; FIG. 7B is an enlarged and partial isometric view of the insertion mechanism of FIG. 7A; FIG. 8A is a side elevation view of the insertion mechanism of FIG. 7A in an initial configuration; FIG. 8B is an enlarged, partial side elevation view of the insertion mechanism of FIG. 8A; FIG. 9A is an isometric view of the insertion mechanism of FIG. 7A in an intermediate configuration; FIG. 9B is an enlarged and partial isometric view of the insertion mechanism of FIG. 9A; FIG. 10A is a side elevation view of the insertion mechanism of FIG. MA / a / zuzz / ui i ozy 9A in an intermediate configuration; FIG. 10B is an enlarged, partial side elevation view of the insertion mechanism of FIG. 10A; FIG. 11A is an isometric view of the insertion mechanism of FIG. 7A in a released configuration; FIG. 11B is an enlarged and partial isometric view of the insertion mechanism of FIG. 11A; FIG. 12A is a side elevation view of the insertion mechanism of FIG. 11A in a released configuration; FIG. 12B is an enlarged, partial side elevation view of the insertion mechanism of FIG. 12A; FIG. 13A is a side elevation view of an enabling mechanism in accordance with at least one embodiment of the present invention; FIG. 13B is an enlarged and partial side elevation view of the enabling mechanism of FIG. 13A; FIG. 14 is an isometric view of a regulating mechanism according to at least one embodiment of the present invention; FIGS. 15A-15B are isometric views of a wrench in accordance with at least one embodiment of the present invention; FIG. 15C is an isometric view of a wrench according to another embodiment of the present invention; FIG. 16 is a plan view of a main gear according to at least one embodiment of the present invention; FIG. 17A is an isometric view of a drive mechanism according to an embodiment of the invention in a first configuration; FIG. 17B is an enlarged and partial isometric view of the drive mechanism of FIG. 17A in the first configuration; FIG. 18A is an isometric view of the drive mechanism of FIG. 17A in a second configuration; FIG. 18B is an enlarged and partial isometric view of the drive mechanism of FIG. 18A in the second configuration; FIG. 19A is an isometric view of the drive mechanism of FIG. 17A in a third configuration; FIG. 19B is an enlarged and partial isometric view of the drive mechanism of FIG. 19A in the third configuration; FIG. 20A is an isometric view of the drive mechanism of FIG. 17A in a fourth configuration; FIG. 20B is an enlarged and partial isometric view of the drive mechanism of FIG. 20A in the fourth configuration; FIG. 21A is an isometric view of one embodiment of a winch drum and a winch gear in a first configuration; FIG. 21B is an isometric view of the winch drum and winch gear of FIG. 21A in a second configuration; FIG. 22 is an isometric view of a winch gear of the embodiment of FIGS. 21A-21B; FIG. 23 is an isometric view of a winch drum coupler of the embodiment of FIGS. 21A-21B; FIG. 24 is an isometric view of a winch of a movable head of a winch drum of the embodiment of FIGS. 21A-21B; FIG. 25A is a cross-sectional view of a safety mechanism according to an embodiment of the invention in an initial configuration; FIG. 25B is an enlarged, partial cross-sectional view of the safety mechanism of FIG. 25A in an initial configuration; FIG. 26A is a cross-sectional view of a safety mechanism of FIG. 25A in an actuated configuration; FIG. 26B is an enlarged, partial cross-sectional view of the safety mechanism of FIG. 26A in the actuated configuration; FIG. 27A is a cross-sectional view of a safety mechanism of FIG. 25A in a retracted configuration; FIG. 27B is an enlarged, partial cross-sectional view of the safety mechanism of FIG. 27A in the retracted configuration; FIGS. 28A-28B are cross-sectional views of a safety mechanism in accordance with another embodiment of the present invention; FIG. 29 is an isometric view according to one embodiment of a spring retainer for the safety mechanism of FIGS. 28A-28B; FIG. 30 is an isometric view according to another embodiment of a spring retainer for the safety mechanism of FIGS. 28A-28B; FIG. 31 is an isometric view of a sleeve for the safety mechanism of FIGS. 28A-28B; FIG. 32A is a partial cross-sectional view of a drug container and safety mechanism in an initial unrestrained configuration; and FIG. 32B is a partial cross-sectional view of the drug container and safety mechanism of FIG. 32A in an activated configuration. DETAILED DESCRIPTION The present invention provides drive mechanisms for delivering drug substances and drug delivery pumps incorporating such drive mechanisms. The drive mechanisms of the present invention may allow or enable one or more functions, including: (i) controlling the rate of drug delivery by sizing, providing resistance, or otherwise preventing free axial translation of the piston seal that is used to force a drug substance out of a drug container; (ii) actuating a needle insertion mechanism to provide a fluid path for delivery of the drug to a target; and (iii) connecting a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target.The drive mechanisms of the present invention control the drug delivery rate by sizing, resisting, or otherwise preventing free axial translation of the piston seal used to force a drug substance out of a drug container, and are thereby capable of delivering drug substances with variable delivery profiles and / or rates. Additionally, the drive mechanisms of the present invention provide integrated status indicating elements that provide feedback to the user before, during, and after drug delivery. For example, initial feedback may be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may provide one or more drug delivery status indications to the user.Upon completion of drug delivery, the drive mechanism and drug pump may provide a dose completion indication. The devices described herein can be configured for the delivery of controlled substances and can also include features that prevent so-called "runaway" delivery of the medication. When delivering controlled substances, this can be an important safety feature to protect the patient. For example, some medications, such as insulin, can be dangerous, and even potentially lethal, when administered in too large a quantity and / or at too rapid a rate. By providing such automatic safety shutoff mechanisms, patient safety can be ensured. As used herein to describe the drive mechanisms, drug delivery pumps, or any of the relative positions of the components of the present invention, the terms "axial" or "axially" generally refer to a longitudinal axis "A" about which the drug containers are preferably positioned, although not necessarily symmetrically thereabout. MA / a / zuzz / ui i ozu The term “radial” generally refers to a direction normal to the axis A. The terms “proximal,” “posterior,” “rear,” “behind,” or “backward” generally refer to an axial direction in the “P” direction. The terms “distal,” “frontal,” “anterior,” “oppressed,” or “forward” generally refer to an axial direction in the “D” direction. In the figures, reference characters “A” and “D” appear. 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 (COCs) and cyclic olefin polymers (COPs).The term "plastic" can include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be softened back to their original condition by heat; thermosetting polymers do not have this capability. As used herein, the term "plastic" primarily refers to moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, which also typically contain other ingredients such as curing agents, fillers, reinforcing agents, colorants, and / or plasticizers, etc., and which can be formed or molded by heat and pressure.As used herein, the term "plastic" is not intended to include glass, non-reactive polymers, or elastomers approved for use in applications where they are in direct contact with therapeutic fluids that may interact with plastic or that may be degraded by substituents that might otherwise enter the fluid from the plastic. The term "elastomer," "elastomeric," or "elastomeric material" primarily refers to rubbery, thermosetting, crosslinked polymers that are more easily deformed than plastics, but are approved for use with pharmaceutical-grade fluids and are not readily prone to gas infiltration or migration at ambient pressure and temperature.“Fluid” primarily refers to liquids, but may also include suspensions of solids dispersed in liquids, and gases dissolved in, or otherwise present within, liquids within fluid-containing portions of drug pumps. In accordance with various aspects and embodiments described herein, a “biasing member” is referred to, for example, in the context of one or more biasing members for exerting force on a piston seal. 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 coil spring, a compression or extension spring, a torsion or leaf spring, an elastic or highly compressible band, or any other member with similar functions.In at least one embodiment of the present invention, the biasing member is a spring, preferably a compression spring. MA / a / 4U44 / U11 04» The novel devices of the present invention provide drive mechanisms with integrated status indication and drug delivery pumps incorporating such drive mechanisms. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing. The devices described herein incorporate elements that simplify activation, operation, and locking of the device, even for untrained users. The novel devices of the present invention provide these convenient elements without any of the problems associated with known prior art devices. Certain non-limiting embodiments of the novel drug delivery pumps and drive mechanisms, and their respective components, are further described herein with reference to the accompanying figures. As used herein, the term “pump” is intended to include any number of drug delivery systems that are capable of dispensing a fluid to a target upon activation. Such drug delivery systems include, for example, injection systems, infusion pumps, bolus injectors, and the like. FIGS. 1A-2A show an exemplary drug delivery device in accordance with at least one embodiment of the present invention. FIGS. 1B and 2A show the drug delivery device with the top cover removed such that the internal components are visible. The drug delivery device may be used to deliver a drug treatment to a target. As shown in FIGS. 1A-1C, the drug pump 10 includes a pump cover 12.The pump cover 12 may include one or more cover subcomponents that are fixedly attachable to facilitate manufacturing, assembly, and operation of the drug pump. For example, the drug pump 10 includes a pump cover 12 that may include an upper cover 12A and a lower cover 12B. The pump cover 12 may include one or more tamper-indicating elements to identify whether the drug delivery device has been opened or tampered with. For example, the pump cover 12 may include one or more tamper-indicating labels or stickers, such as tags extending from the upper cover to the lower cover. Additionally or alternatively, the cover 12 may include one or more arms or pins connecting the upper cover and the lower cover.A broken or altered tamper-indicating element would indicate to the user, physician, supplier, manufacturer, or the like that the drug delivery device has possibly been tampered with, e.g., by accessing internal aspects of the device, so that the device can be evaluated and possibly discarded without use or risk to the user. The drug pump may further include an activation mechanism 14, a status indicator (not shown), and a window 18. The window 18 may be any translucent or transmissive surface through which the operation of the drug pump can be observed. As shown in FIGS. 1B and 2A, the drug pump 10 further includes the assembly platform 20, the drive mechanism 100 with the drug container 50, the insertion mechanism 200, the fluid path connection 300, and a power and control system 400.One or more of the components of such drug pumps may be modular in that, for example, they may be pre-assembled as separate components and configured into position on the assembly platform 20 of the drug pump 10 during manufacturing. The pump cover 12 contains all of the components of the device and provides a means for removably attaching the device 10 to the target. The pump cover 12 also provides protection for the internal components of the device 10 from environmental influences. The pump cover 12 is aesthetically and ergonomically designed in size, shape, and related elements to facilitate packaging, storage, handling, and use by users who may be untrained and / or have physical disabilities. Furthermore, the external surface of the pump cover 12 may be used to provide product labeling, safety instructions, and the like. Additionally, as described above, the cover 12 may include certain components, such as one or more windows or status indicators, that may provide the user with operational information. In at least one embodiment, the drug pump 10 provides an activation mechanism 14 that is moved by the user to activate the start command for the power and control system. In a preferred embodiment, the activation mechanism 14 is a start button that is located through the pump cover 12, for example, through an opening between the upper cover 12A and the lower cover 12B, and that comes into direct or indirect contact with the power and control system 400. In at least one embodiment, the start button may be a push button, and in other embodiments, it may be an on / off switch, a toggle switch, or any similar activation element known in the art. The pump cover 12 also provides one or more status windows and indicators.In other embodiments, the trigger mechanism 14, the status indicator and / or the window 18, and combinations thereof, may be provided on the top cover 12A or the bottom cover 12B, such as, for example, on a side visible to the user when the drug pump 10 is positioned on the target. The cover 12 will be described in greater detail below with respect to other components and embodiments of the present invention. The drug pump 10 is configured such that, upon activation by a user by depressing the activation mechanism, the activation mechanism is activated to perform one or more of the following functions: insert a fluid path into the target; ινΐΛ / a / zuzz / uii allow, connect, or open necessary connections between a drug container, a fluid path, and a sterile fluid conduit; and propel drug fluid stored in the drug container through the fluid path and fluid conduit for delivery to a target. In at least one embodiment, such delivery of drug fluid to a target is performed by the drive mechanism in a controlled manner. One or more optional safety mechanisms may be utilized, for example, to prevent premature activation of the drug pump. For example, an optional integrated sensor 24 may be provided in one embodiment as a safety feature to ensure that the power and control system, or the drive mechanism, cannot be engaged unless the drug pump 10 is in contact with the target.In one such embodiment, the integrated sensor is located at the bottom of the lower cover 12B, where it may contact the target. Upon displacement or activation of the integrated sensor 24, depression of the activation mechanism is permitted. Accordingly, in at least one embodiment, the integrated sensor is a mechanical safety mechanism, such as, for example, a mechanical latch, that prevents actuation of the drug pump 10 by the activation mechanism. In another embodiment, the integrated sensor may be an electromechanical sensor, such as a mechanical latch, that sends a signal to the power and control system to permit activation. In still other embodiments, the integrated sensor may be electrically based, such as, for example, an impedance-based, capacitive, or conductive sensor that must detect tissue before allowing activation of the power and control system.In at least one embodiment, the cover 12 is configured to at least partially prevent harmful matter from entering the drug pump. For example, the cover may be configured to restrict the passage of fluids into the drug pump. This may allow the device to be used in the shower, while swimming, or during other activities. The use of an integrated electrically-based sensor may eliminate potential entry points into the drug pump for these fluids. These concepts are not mutually exclusive, and one or more combinations may be used within the scope of the present invention to prevent, for example, premature activation of the drug pump. In a preferred embodiment, the drug pump 10 utilizes one or more integrated electrically-based sensors. Additional integrated safety mechanisms are described herein with respect to other components of the novel drug pumps. Power and control system: The power and control system may include a power source, which provides power for various electrical components within the drug pump, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive iviA / a / zuzz / uii discs, and one or more interconnects. Other components commonly used in such electrical systems may also be included, as will be appreciated by those skilled in the art. The feedback mechanism(s) may include, for example, audible alarms such as plezoalarms and / or light indicators such as light-emitting diodes (LEDs). The microcontroller may be, for example, a microprocessor. The power and control system controls various interactions of the device with the user and interfaces with the drive mechanism 100.In one embodiment, the power and control system is directly or indirectly interconnected with an integrated sensor 24 to identify whether the device is in contact with the target and / or the activation mechanism 14 to identify whether the device has been activated. The power and control system may also be interconnected with the status indicator of the pump cover 12, which may be a translucent or transmissive material that allows light transfer, to provide visual feedback to the user. The power and control system is interconnected with the drive mechanism 100 through one or more interconnects to relay a status indication, such as activation, drug delivery, and dose completion, to the user. This status indication may be presented to the user through auditory signals, for example, through audible alarms, and / or through visual indicators, for example, through LEDs.In a preferred embodiment, the control interfaces between the power and control system and the other components of the drug pump are not coupled or connected until activated by the user. This is a convenient safety feature that prevents accidental operation of the drug pump and can 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 user. For example, the power and control system may be configured such that, once the integrated sensor and / or trigger mechanism has been pressed, the power and control system provides a "ready to go" status signal via the status indicator if the device start-up checks provide no errors. After providing the "ready to go" status signal, and in one embodiment with the optional integrated sensor, if the integrated sensor remains in contact with the target, the power and control system will drive the drive mechanism 100 to begin delivering the drug treatment through the fluid path connection 300 and the sterile fluid conduit (not shown). Additionally, the power and control system can be configured to detect the removal of the drug pump from its container. The power and control system can be mechanically, electronically, or electromechanically connected to the container, such that removal of the drug pump from the container can activate or power the power and control system for use, or simply allow the power and control system to be actuated by the user. In such an embodiment, without the removal of the drug pump from the container, it cannot be activated. This provides an additional safety mechanism for the drug pump and the user.In at least one embodiment, the drug pump or power and control system may be electronically or electromechanically connected to the package, for example, by one or more of the following interaction sensors: Hall effect sensors; giant magnetoresistance (GMR) or magnetic field sensors; optical sensors; capacitive or capacitance change sensors; ultrasonic sensors; and linear displacement sensors, LVDTs, linear resistive sensors, or ratiometric linear resistive sensors; and combinations thereof, which are capable of coordinating to transmit a signal between the components to identify the location relative to them.Additionally or alternatively, the drug pump or power and control system may be mechanically connected to the container, for example, by a pin and slot relationship that activates the system when the pin is removed (i.e., once the drug pump is removed from the container). In a preferred embodiment of the present invention, once the power and control system is activated, the drive mechanism is initiated to perform one or more of the steps of driving the insertion mechanism 200 and connecting the fluid path 300, while simultaneously allowing drug fluid to be forced out of 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. Once the drug has been delivered to the target and after the completion of any additional wait time, to ensure that substantially the entire dose has been delivered to the target, the power and control system may provide a “removeable” status signal via the status indicator.This can be independently verified by the user by observing the drive mechanism and the delivery of drug doses through the window 18 of the pump cover 12. 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 indicating a fault or malfunction situations. The power and control system may be further configured to accept various user inputs to dynamically control the drive mechanisms 100 to meet a desired drug delivery rate or profile. For example, the power and control system may receive inputs, e.g., from activation, depressing, and / or partially or fully releasing the activation mechanism, to configure, start, stop, or otherwise adjust control of the drive mechanism 100 through the power and control system to meet the desired drug delivery rate or profile.Similarly, the power and control system may be configured to perform one or more of the following actions: receive those inputs to adjust the drug dose volume; prepare the drive mechanism, fluid path connection, and fluid conduit; and / or start, stop, or interrupt operation of the drive mechanism 100. Those inputs may be received by direct user action on the drug pump 10, such as through the use of the trigger mechanism 14 or a different control interface, or the power and control system may be configured to receive those inputs from a remote control device. Additionally or alternatively, those inputs may be preprogrammed. Other power and control system configurations may be utilized with the novel drug pumps of the present invention. 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 wait time that ensures that substantially the entire drug dose has been delivered before alerting the user of completion. Similarly, activation of the device may require a delayed depressing (i.e., pulsing) of the drug pump activation mechanism 10 prior to activation of the drug pump. Additionally, the system may include a feature that allows the user to respond to dose completion signals and deactivate or turn off the drug pump.Such an element may similarly require delayed depressing of the trigger mechanism to prevent accidental deactivation of the device. These elements provide drug pumps with convenient ease-of-use and safety integration parameters. An additional safety element may be integrated into the trigger mechanism to prevent partial depressing and, therefore, partial activation of the drug pumps. For example, the trigger mechanism and / or the power and control system may be configured such that the device is either completely off or completely on to prevent partial activation. These elements will be described in greater detail later with respect to other aspects of the novel drug pumps. Additionally, the power and control system may be configured to maintain regulation of the system's power source while simultaneously providing instantaneous power to an actuator. During operation of the drug pump, as will be described further herein, instantaneous power is required to move an actuator clockwise and counterclockwise between mechanical limits. This movement controls the movement of the drive system and, therefore, the drug delivery rate. Supplying power directly to the actuator may result in a large voltage drop, which may disrupt the power supply to other components of the drug pump. To prevent this, the power and control system may be configured to decouple the power source from the actuator when power is supplied to the actuator.To this end, the power and control system may include a switching device, such as a field-effect transistor; a charge-slowing device, such as a resistor; and a storage device, such as a capacitor. All three devices are connected in series between the power source and ground. The output is obtained from the capacitor and connected to the actuator through a control device, such as an H-bridge. During operation, the system operates as follows: First, the switching device is set to a fully closed configuration, connecting the power source to the storage device, and allowing the storage device to be charged by the power source for a defined period of time, e.g., by the RC time constant.Second, the switch is opened, disconnecting the power source from the storage device, where the storage device remains fully charged. Third, the charged storage device is applied to the control device. Fourth, the control device applies the stored energy to the actuator and controls the actuator's direction (clockwise or counterclockwise). In this way, the power source is not connected to the actuator when the actuator is operated, thereby ensuring that the power source does not experience a voltage drop. This process is repeated as needed to provide continuous clockwise and counterclockwise inputs from the actuator to the pump drive mechanism without causing the system's power source to collapse. Insertion mechanism: A number of insertion mechanisms can be used within the drug pumps of the present invention. The pump-type delivery devices of the present invention can be connected in fluid flow communication with a target, for example, through any suitable hollow tube. A hollow needle or a solid needle can be used to pierce the target and place a hollow cannula in the appropriate delivery position, where the needle is at least partially removed or withdrawn prior to delivery of the drug to the target. As indicated above, the fluid can be introduced into the body through any number of means, including but not limited to: an automatically inserted needle, a cannula, a microneedle array, or an infusion tube. A number of mechanisms can also be employed to trigger insertion of the needle into the target.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 target. The same spring, an additional spring, or other similar mechanism may be used to withdraw the needle from the target. In one embodiment, the insertion mechanism may be generally as described in International Patent Application No. PCT / US2012 / 53174 , which is for all purposes incorporated herein by reference in its entirety. Such a configuration may be used to insert the drug delivery line into or beneath the target in a manner that minimizes pain.Other known methods for inserting a fluid pathway may be utilized and are contemplated within the scope of the present invention, and include a rigid needle insertion mechanism and / or a rotating needle insertion mechanism developed by the assignee of the present invention. In at least one embodiment, the insertion mechanism 200 includes an insertion mechanism cover that may have a base for connection to the docking platform and / or the pump cover (as shown in FIG. 1B and FIG. 1C ). The connection of the base to the docking platform 20 may, for example, occur such that the bottom of the base is allowed to pass through a hole in the docking platform to allow direct contact of the base with the target. In such configurations, the bottom of the base may include a sealing membrane that may be removed prior to use of the drug pump 10. 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 can be connected to a sterile fluid line to allow fluid flow through the manifold, the cannula, and to the target 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 rigid hollow steel needles, and solid needles, more commonly known as “trocars.” In some embodiments, the needle is a 27 gauge solid trocar, and in other embodiments, the needle may be any size needle suitable for inserting the cannula for the type of drug and drug delivery (e.g., subcutaneous, intramuscular, intradermal, etc.) intended. In one or more embodiments, the insertion mechanism may be generally as described in International Patent Application No. sPCT / US2012 / 53174, published as WO 2013 / 033421 A2, International Patent Application No. sPCT / US2012 / 053241, published as WO 2013 / 033467 A2, or International Patent Application No. sPCT / US2015 / 052815, which for all purposes are incorporated herein by reference in their entirety. The base includes a base opening through which the needle and cannula can pass during operation of the insertion mechanism. The sterility of the cannula and needle is maintained by their initial positioning within the sterile parts of the insertion mechanism. The base opening may also be sealed from non-sterile environments, such as by a sealing membrane. In accordance with at least one embodiment of the present invention, the insertion mechanism is initially secured in a ready-for-use stage by one or more locking bolts that are initially positioned within locking windows of the insertion mechanism cover. In this initial configuration, the insertion biasing member and the retraction biasing member are each retained in their compressed and activated states. Displacement of the locking bolt(s), by one or more methods such as pulling, pushing, sliding, and / or rotating, allows the insertion biasing member to be decompressed relative to its initial compressed and activated state. This decompression of the insertion biasing member propels the needle and, optionally, the cannula toward the target.At the end of the insertion step or at the end of drug delivery (activated by the drive mechanism), the retraction biasing member is allowed to expand in the proximal direction relative to its initial activated state. This axial expansion in the proximal direction of the retraction biasing member retracts the needle. If a needle / trocar and cannula insertion configuration is used, retraction of the needle can occur while simultaneously maintaining the cannula in fluid communication with the target. Accordingly, the insertion mechanism can be used to insert a needle and cannula into the target and subsequently withdraw the needle while simultaneously retaining the cannula in position for drug delivery to the target. In one or more embodiments, the insertion mechanism may be generally as described in International Patent Application No. PCT / US2016 / 017534, filed February 10, 2016 , which for all purposes is incorporated herein by reference in its entirety. In at least one embodiment, as shown in FIG. 6A , the insertion mechanism includes a rotational biasing member 210 that is initially maintained in an activated state. In a preferred embodiment, the rotational biasing member is a torsion spring. The rotational biasing member may be prevented from being deactivated by interaction of engagement surface 208 with gear 112 as shown in FIG. 2A , or alternatively by contact of a component of the insertion mechanism with a rotation preventing element of the drug pump, as further described herein.Upon activation of the device, or other input, the rotational biasing member 210 is allowed to deactivate, at least partially. This causes one or more components of the insertion mechanism to rotate and, in turn, cause, or allow, insertion of the needle into the target. In addition, a cannula may be inserted into the target as described above. At a later time, for example, when the control arm or other component of the device recognizes that the tether is slack, the rotational biasing member may be allowed to deactivate further, which causes further rotation of one or more components of the insertion mechanism. This rotation may cause, or allow, the needle to be withdrawn from the target. The needle may be completely withdrawn in a single stage, or there may be multiple stages of retraction. In one embodiment, translation of the trigger mechanism may be part of or operational with a NIM trigger mechanism. The NIM trigger mechanism may include an enabling mechanism as shown in FIGS. 13A-13B . In this embodiment, translation of the trigger mechanism 14 may be coupled directly or indirectly to a slide gate 602. In a first configuration, the enabling mechanism is configured such that translation of the trigger mechanism and the slide gate does not cause activation of the needle insertion mechanism 200 or connection of the sterile fluid path 300. FIGS. 13A-13B illustrate the enabling mechanism configured such that translation of the activation mechanism 14 (see FIG. 1A) and the slide gate 602 causes activation of the needle insertion mechanism 200. The transformation of the enabling mechanism from the first configuration to the second configuration may be initiated, for example, by activation of an integrated sensor, or by the passage of a predetermined amount of time after actuation of the device. The transformation of the enabling mechanism from the first configuration to the second configuration may be effected by rotation of the actuator 101 which may cause a selector member 604 to align with an aspect of the slide gate 602.The selector member 604 may include a ramped surface 604A configured to contact a portion of the slide gate 602 upon translation of the actuation mechanism 14 and the slide gate 602. The selector member 604 may be or be mounted to an integral portion of the gear interface such as the key 1101. Contact of the slide gate 602 with the selector member 604 may cause the slide gate 602 to move such that a portion of the slide gate aligns with a portion of a firing arm or control arm 606, such as the boss 606A. In this configuration, translation of the actuation mechanism 14 causes translation of the firing arm 606. Translation of the firing arm 606 causes activation of the needle insertion mechanism 200 to insert the fluid path into the target.During manufacturing, shipping, and storage, the enabling mechanism is in the first configuration in which depressing the activation mechanism 14 does not activate the needle insertion mechanism 200. In this manner, the needle insertion mechanism is prevented from activating prematurely. Contact of the slide gate 602 with the selector member 604 may cause a substantially rigid body displacement of the slide gate, or alternatively, the contact may cause a deformation of the slide gate. For example, the slide gate may include a deformable (i.e., less rigid) portion that can be displaced by the contact. An example of a NIM activation mechanism is shown in FIGS. 7A-12B. For clarity, a number of components of the drug delivery device are hidden in these figures. The NIM activation mechanism includes: a sliding gate 602, a pull arm 606, a NIM latch 608, and a NIM retainer 610. Initially, as shown in FIGS. 7A-8B, the NIM retainer 610 is positioned such that the NIM retainer 610 contacts a protrusion 204 of the NIM 200 such that the protrusion 204 is prevented from rotating about the axis R (see FIG. 9B), thereby preventing activation of the NIM 200. In the embodiment shown, the NIM retainer 610 is configured for rotational movement about the axis B (see FIG. 11B). The NIM retainer 610 may, for example, be mounted to the cover 12 or to the top plate 1530 at the hole 610A.For example, a shaft or bolt may be provided in the bore 610A about which the NIM retainer 610 may rotate. The shaft or bolt may be an integral part of the shroud 12 or top plate 1530, or alternatively, may be a separate component. The NIM retainer 610 is prevented from rotating by contact between an arm 610B of the NIM retainer 610 and the NIM latch 608. The NIM latch 608 is disposed for translational movement (in the direction of the shaded arrow in FIG. 7B) and is initially held in position by a flexible arm 1530A that may engage a portion of the top plate 1530. The NIM latch 608 is initially in a first position where it is in contact with or adjacent to a bottom surface 606B of the pull arm 606. With the selector member 604 in the second configuration (shown in FIGS. 13A-13B), depressing the trigger mechanism 14 causes translation of the pull arm 606 as described above (in the direction of the solid arrow in FIG. 7A). The ramped surface 606C of the pull arm 606 contacts the NIM location 608 and causes the NIM latch 608 to translate in a direction substantially orthogonal to the direction of translation of the pull arm 606. FIGS. 9A-10B show the position of the pull arm 606 and the NIM latch 608 after translation of the pull arm. As shown, in this configuration, the NIM latch 608 is located adjacent to or in contact with an upper surface 606D of the pull arm 606. The window 608A of the NIM 608 interlock aligns with the arm 610B of the NIM 610 retainer.Thus, as shown in FIGS. 11A-12B, the NIM retainer 610 may rotate about axis B. The contact surfaces of the protrusion 204 and the retainer 610 may be configured such that the protrusion 204 applies a rotational force to the NIM retainer 610, whereby. MA / a / zuzz / ui i ozy the NIM retainer 610 is caused to rotate about axis B. Alternatively, or additionally, a biasing member may bias the NIM retainer 610 to rotate. The biasing member may be, for example, a torsion spring. Rotation of the NIM retainer 610 causes the NIM retainer 610 to disengage from the protrusion 204 of the NIM 200. The NIM 200 may thus be activated to insert a fluid path into a target. In other embodiments, the NIM location 608 may directly couple to a portion of the NIM 200, such as the protrusion 204, to initially prevent activation of the NIM 200. Translation of the NIM location 608 in a direction orthogonal to the translation of the pull arm 606 may cause the NIM location 608 to disengage from the NIM 200 and allow the NIM 200 to activate. Furthermore, while the slide gate 602 and pull arm 606 are shown here as separate components, it is contemplated that they may be combined into a single, unified component. In such an embodiment, the selector member may be initially configured to prevent translation of the slide gate and / or the pull arm. In another embodiment, the pull arm 606 is coupled to a portion of the NIM, whereby translation of the pull arm 606 enables activation of the NIM 200. In addition to the advantages described above, the insertion mechanisms described herein can also stop the flow of medication to the target tissue by disconnecting the fluid path. This can be an important safety feature for protecting the target. For example, some medications, such as insulin, can be dangerous, and even potentially lethal, when administered in too large a quantity and / or at too rapid a rate. By providing such automatic safety stop mechanisms, so-called "leakage" of medication delivery can be prevented, thereby ensuring patient safety.While the methods and associated structures for stopping the flow may be described with respect to one or more specific insertion mechanisms described herein, it will be appreciated that the method and associated structures may be used or adapted for any of the insertion mechanisms described herein or within the spirit and scope of the present disclosure. An interruption in the delivery of the drug to the target tissue may be triggered, for example, due to an error in drug delivery or user input. For example, the user may realize they have already received their drug dose and wish to interrupt or stop the drug delivery from the device. Following this user input to the device, the drug delivery may be stopped and / or the passage of fluid through the needle or cannula may be terminated by retracting the needle to its fully withdrawn position. Additionally or alternatively, the device may interrupt or stop drug delivery if it receives an error alert during operation. For example, if the drive mechanism malfunctions, the needle insertion mechanism may be triggered to fully withdraw and stop drug delivery to the target tissue to prevent excessive delivery of a medication to the target tissue. This capability of the needle insertion mechanism provides a valuable safety feature for drug delivery to a target. In some embodiments, retraction is triggered after the drug pump is removed from the target tissue. In other embodiments, retraction is triggered if it is determined that an error has occurred in the delivery of the drug to the target tissue. For example, an occlusion of the drug delivery path that prevents the flow of medication can be detected by a detection function of the drug delivery pump. After the occlusion is detected, a mechanical or electrical input can be used to initiate needle retraction. Fluid path connection: A number of fluid path connections may be utilized within embodiments of the present invention. Typically, a suitable fluid path connection includes a sterile fluid conduit, a piercing member, and a sterile sleeve attached to a drug container or a slidable pierceable member integrated within a drug container. The fluid path connection may further include one or more flow restrictors. Upon appropriate activation of the device 10, the fluid path connection 300 is enabled to connect the sterile fluid conduit 30 to the drug container of the drive mechanism 100. Such a connection may be facilitated by a piercing member, such as a needle, penetrating a pierceable seal of the drug container of the drive mechanism 100. Sterility of this connection may be maintained by making the connection within a flexible sterile sleeve.Upon substantially simultaneous activation of the insertion mechanism, the fluid path between the drug container and the insertion mechanism is complete to permit delivery of the drug to the target. In such an embodiment, the fluid path connection may be substantially similar to that described in International Patent Application No. PCT / US2012 / 054861, published as WO 2015027174 A4, or International Patent Application No. 2 PCT / US2012 / 020486, filed on March 2, 2016, both of which are for all purposes incorporated herein by reference in their entirety. In such an embodiment, a compressible sterile sleeve may be fixedly attached between the cap of the drug container and the connection point of the fluid path connection. The piercing member may be positioned within the sterile sleeve until a connection between the fluid path connection and the drug container is desired.The sterile sleeve can be sterilized to ensure sterility of the piercing member and fluid path prior to activation. Alternatively, the fluid path connection may be integrated into a drug container as described in international patent applications Nos. 2PCT / US2013 / 030478 or n.sPCT / US2014 / 052329, for example, which are for all purposes incorporated herein by reference in their entirety. According to one such embodiment, a drug container may have a drug chamber within a cylinder between a perforable seal and a piston seal. The drug chamber contains a drug fluid. Upon activation of the device by a user, an actuating mechanism exerts a force on a piston seal contained within the drug container.As the piston seal exerts force on the drug fluid and any air / gas bubbles or voids, a combination of pneumatic and hydraulic pressure builds up by compressing the air / gas and drug fluid and transmits the force to the sliding perforable seal. The perforable seal is caused to slide toward the cap, which causes it to be pierced by the piercing member retained within the integrated sterile fluid path connection. Consequently, the integrated sterile fluid path connection is connected (i.e., the fluid path is opened) by the combination of the pneumatic / hydraulic force of the air / gas and the drug fluid within the drug chamber created by activating an actuating mechanism.Once the integrated sterile fluid path connection is connected or opened, the drug fluid is allowed to flow from the drug container, through the integrated sterile fluid path connection, the sterile fluid conduit, and the insertion mechanism, and to the drug delivery target. In at least one embodiment, the fluid flows only through a manifold and a cannula and / or needle of the insertion mechanism, thereby maintaining the sterility of the fluid path before and during drug delivery. In a preferred embodiment, connection of the sterile fluid path is initiated by movement of the needle insertion mechanism, which is initiated by the drive mechanism. Additionally or alternatively, connection of the sterile fluid path is initiated by direct movement of the drive mechanism. For example, the drive mechanism may include a rotating gear, such as the star-shaped gear described in detail herein, that acts simultaneously or sequentially to control the drug delivery rate, to actuate the needle insertion mechanism, and / or initiate connection of the sterile fluid path. In a particular embodiment, shown in FIGS. 1A-1C , the drive mechanism performs all of these steps substantially simultaneously. The drive mechanism rotates a gear that acts on several other components.The gear acts on a gear assembly to control the drug delivery rate and simultaneously contacts a needle insertion mechanism to introduce a fluid pathway into the target. As the needle insertion mechanism is initiated, sterile fluid connection is made to allow flow of drug fluid from the drug container through the fluid pathway to the needle insertion mechanism for delivery to the target, as the gear and gear assembly of the drive mechanism control the drug delivery rate. Regardless of the fluid path connection used by the drug pump, the drug pump can deliver a variety of drugs with different viscosities and volumes. The drug pump can deliver a drug at a controlled flow rate and / or a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow restrictors within the fluid path connection and / or the sterile fluid conduit. In other embodiments, other flow rates can be provided by varying the geometric shape of the fluid flow path or delivery conduit, varying the speed with which a component of the drive mechanism advances within the drug container to dispense the drug therein, or combinations thereof.Additional details regarding the connection of the fluid path 300 and the sterile fluid conduit 30 are provided in later sections in reference to other embodiments. Drive mechanism: The drive mechanisms of the present invention may allow or enable various functions, including: (i) controlling the rate of drug delivery by sizing, providing resistance, or otherwise preventing free axial translation of the piston seal that is used to force a drug substance out of a drug container; (ii) actuating a needle insertion mechanism to provide a fluid path for delivery of the drug to a target; and (iii) connecting a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target. With respect to the embodiments shown in FIGS.2A-2E and 3A-3D , the drive mechanism 100 includes an actuator 101, a gear assembly 116 including a main gear 102, a drive housing 130, and a drug container 50 with a lid 52, a pierceable seal (not visible), a cylinder 58, and a piston seal 60. The main gear 102 may be, for example, a star-shaped gear arranged to contact multiple secondary gears or gear surfaces. A drug chamber 21, located within the cylinder 58 between the pierceable seal and the piston seal 60, may contain a drug fluid for delivery through the insertion mechanism and the drug pump to the target. The seals described herein may be comprised of a number of materials, but, in a preferred embodiment, are comprised of one or more elastomers or rubbers.The drive mechanism 100 may further comprise one or more drive biasing members, one or more release mechanisms, and one or more guides, as further described herein. The drive mechanism components function to force fluid out of the drug container through the pierceable seal, or preferably through the piercing member of the fluid path connection, for delivery via the fluid path connection, the sterile fluid conduit, and the insertion mechanism to the target. In a particular embodiment, the drive mechanism 100 employs one or more compression springs as the biasing member(s). Upon activation of the drug pump by the user, the power and control system may be actuated to directly or indirectly release the compression spring(s) from an activated state. Upon release, the compression spring(s) may exert pressure and act upon the piston seal to force fluid drug out of the drug container. The compression spring may exert pressure and act upon a piston, which in turn acts upon the piston seal to force fluid drug out of the drug container. Optionally, as will be further described below, the piston may include one or more safety mechanisms that may be configured to restrict translation of the piston to restrict the flow of the drug to the target.These safety mechanisms may include a brake mechanism, a piston seal piercing mechanism, and a piston seal displacement mechanism, such as those described in detail herein. The fluid path connection may be connected through the pierceable seal before, during, or after activation of the drive mechanism to allow fluid flow from the drug container, through the fluid path connection, the sterile fluid conduit, and the insertion mechanism, and to the drug delivery target. In at least one embodiment, fluid flows only through a manifold or needle and cannula of the insertion mechanism, thereby maintaining sterility of the fluid path before and during drug delivery. These components and their functions are described in greater detail herein. Turning now to the embodiment of the drive mechanism shown in FIGS. 2A-2E and 3A-3D , the drive mechanism 100 includes an actuator 101, a gear assembly 116 including a main gear 102, a drive housing 130, and a drug container 50 with a lid 52, a pierceable seal (not visible), a cylinder 58, and a piston seal 60. The main gear 102 may be, for example, a star-shaped gear arranged to contact multiple secondary gears or gear surfaces. A drug chamber 21, located within the cylinder 58 between the pierceable seal and the piston seal 60, may contain a drug fluid for delivery via the insertion mechanism and the drug pump INA / a / zuzz / uii to the target.Compressed within drive housing 130, between drug container 50 and the proximal end of cover 130 are one or more drive biasing members 122 and a piston 110, the drive biasing members 122 being configured to exert pressure on an interface surface 110C of piston 110, as will be further described herein. Optionally, a cover sleeve (not shown) may be used between the drive biasing members 122 and the interface surface 110C of piston 110 to, for example, promote more even distribution of force from the drive biasing member 122 to the piston 110, prevent deformation of the drive biasing members 122, and / or obscure the biasing members 122 from a user's view.The interface surface 110C of the piston 110 is caused to rest at a location substantially adjacent to or in contact with a proximal end of the seal 60. While the embodiments shown in FIGS. 2A-2E and 3A-3D illustrate a singular biasing member, it is also contemplated that one or more biasing members arranged to act in parallel or in series may be used. As best shown in FIG. 2E and FIG. 3D, the piston 110 may be comprised of one or more components and have an interface surface for contacting the piston seal. A strap, tape, string, or other retaining strip (referred to herein as the “strap” 525; see FIG. 3D) may be connected at one end to the piston 110. For example, the strap 525 may be connected to the piston 110 by being retained between the two components of the piston 110 in the assembled position, FIG. 3D shows the biasing member partially hidden to allow the connection of the strap to the piston to be seen. The strap 525 is connected at another end to a winch assembly 520 of a supply regulation or control mechanism 500. The winch assembly 520 includes the winch gear 520A and the winch drum 520B, the rotation of which is coupled, for example, by a keyed relationship.Through the use of the winch assembly 520 connected to one end of the belt 525, and the belt 525 connected to another end of the piston 110, the regulating mechanism 500 serves the function of controlling, calibrating, providing resistance to, or otherwise preventing free axial translation of the piston 110 and the piston seal 60 used to force a drug substance out of a drug container 50. Accordingly, the regulating mechanism 500 is a part of the gear assembly 116 aspect of the drive mechanism, which functions together to control the rate or profile of drug delivery to the target. As shown in FIGS. 2A-2E and 3A-3D, and in isolation in FIGS. 4 and 5A-5B, in some embodiments of the present invention, the regulating mechanism 500 includes a gear assembly controlled by an actuator 101 of the drive mechanism 100. The regulating mechanism retards or restricts the timing of the belt 525, and only allows it to advance at a regulated or desired speed or in accordance with selected intervals. This restricts the movement of the piston 110 within the cylinder 58, which is biased by one or more biasing members 122, thereby controlling the movement of the piston seal 60 and the delivery of the drug contained in the chamber 21. As the piston seal 60 advances in the drug container 50, the drug substance is dispensed through the sterile line connection 300, the conduit 30, the insertion mechanism 200, and to the drug delivery target.The actuator 101 may be any of a number of power / motion sources including, for example, a solenoid, a stepper motor, or a rotary drive motor. In one particular embodiment, the actuator 101 is a rotary stepper motor coupled to a gear interface such as a pin with a notch corresponding to the gear teeth of the main / star gear 102. In at least one embodiment, the notch in the gear interface forms a recess within which one or more teeth of the main gear may partially locate during operation of the system. This can be seen most clearly in FIGS. 5A-5B . When the gear interface 101A is in alignment with a tooth 102A of the main gear 102, the rotary motion of the motor 101 enables rotation of the main gear 102.When the notch is located between the gear teeth of the main gear, it can act as a resistance, for example, to rotation, reverse rotation, or unwinding of the gear assembly 116. In one particular embodiment, the motor 101 utilizes an alternating motor direction to rotate the motor 101 back and forth. This configuration assists in preventing a runaway condition, where the motor and gears are free to rotate, by utilizing the multi-direction of the motor to prevent continuous rotation in one direction (as would be required for a runaway condition). Furthermore, because the main gear 102 is only able to advance when a tooth 102A aligns with the notch in the gear interface 101A, the main gear 102 can only rotate incrementally.The bi-directional movement of the motor, coupled with the use of the gear interface coupled to the motor, provides suitable safety features to prevent a runaway condition that could potentially lead to over-delivery of the drug to the target. Additional details about the gear assembly 116, the regulating mechanism 500, and the drive mechanism 100 are provided herein. In a particular embodiment shown in FIGS. 5A-5B , the regulating element 500 further includes one or more gears 511, 512, 513, 514 of a gear assembly 516. One or more of the gears 511, 512, 513, 514 may be, for example, compound gears with a small diameter gear attached on a shared center shaft to a large diameter gear. Gear 513 may be rotatably coupled to winch assembly 520A, whereby rotation of gear assembly 516 is coupled to winch assembly 520.The compound gear 512 is coupled to the small diameter gear 513 such that rotary motion of the compound gear aspect 512B is transmitted by the meshing of the gears (e.g., by meshing of corresponding gear teeth) to the gear 513. The gear aspect 512A is coupled to the gear aspect 512B, whereby rotation of the compound gear 512 is coupled to the compound gear 511. The compound gear aspect 511A, whose rotation is coupled to the gear aspect 511B, is caused to rotate by the action of the compound gear aspect 102B of the main / star gear 102A. The compound gear aspect 102B, whose rotation is coupled to the main / star gear 102A, is caused to rotate by the interaction between the main / star gear 102A and the interface 101A of the actuator 101.Thus, rotation of the main / star gear 102A is transmitted to the capstan assembly 520. Accordingly, rotation of the gear assembly 516 initiated by the actuator 101 may be coupled to the capstan assembly 520 (i.e., via the gear assembly 516), thereby controlling timing of the belt 525 and the speed of movement of the piston seal 60 within the cylinder 58 to force a fluid out of the drug chamber 21. As described herein, other components of the regulating element 500 calibrate or restrict the rotary motion of the capstan assembly 520 and thus the axial translation of the piston 110 and the piston seal 60, or otherwise prevent free axial translation. As described above, the actuator 101 may be a number of known energy / motion sources including, for example, a motor (e.g.,, a DC motor, an AC motor, or a stepper motor) or a solenoid (e.g., a linear solenoid, a rotary solenoid). One of skill in the art will recognize that the regulating mechanism 500 may include any number of gears to achieve the desired gear ratio. The regulating mechanism may provide any convenient gear ratio between the main gear 102A and the capstan gear 520A. For example, the gear ratio may be selected based on the desired drug delivery profile. Additionally, the resolution of the gear assembly may be configured based on the number of teeth on the main gear 102. The more teeth the main gear 102 has, the better the resolution of the gear assembly.Conversely, if the main gear 102 has fewer teeth, the gear assembly will have lower resolution (i.e., more drug fluid will be delivered per rotation of the actuator). The embodiment described above and shown in FIGS. 1A-5D shows an actuator 101 that is in vertical alignment and in direct coupling with the MA / a / 4U44 / U11 04» 1102. A portion of the first flange 1101A of the key 1101 is disposed in a large passage 1102A of the main gear 1102. Tension applied to the belt by the drive biasing member applies a torque to the main gear (via the regulating mechanism 1500) that is in the direction of the solid arrow shown in FIG. 17B. Contact between the tooth 1102C of the main gear 1102 and the first flange 1101A of the key provides resistance to rotation in this direction. To allow the main gear 1102 to advance, the key 1101 may be rotated such that the first opening 1101F of the first flange 1101A aligns with the tooth 1102C of the main gear 1102. In the embodiment shown, the rotation is in the direction of the dashed arrow in FIG. 17B. The degree of rotation of the key 1101 will be limited by the contact of the rung 1101E of the second flange 1101B with the main gear 1102. In this position, the key 1101 does not impede rotation of the main gear 1102 since no teeth on the main gear are in contact with the key. If the regulating mechanism 1500 operates properly, the tension on the belt will cause the main gear 1102 to rotate (in the direction of the solid arrow in FIG. 17B) until a tooth 1102C of the main gear 1102 comes into contact with the second flange 1101B of the key 1101.Thus, the main gear 1102 advances at a controlled rate, allowing rotation of the key 1101 to control belt unwinding and piston translation. As shown in FIGS. 18A-18B, in this position, contact between the step 1101E of the second flange 1101B and the main gear 1102 restricts rotation of the key 1101 and thereby prevents the status reader interface 1101D from contacting the status reader 1550. From this position, the main gear 1102 may be allowed to advance another step by rotating the key 1101 in the opposite direction to the previous rotation. For example, if the key had rotated counterclockwise to move from the first position to the second position, the key will now rotate clockwise to move from the second position to the third position. After rotation of the second flange 1101B past the main gear 1102 such that the second opening 1101G aligns with the main gear 1102, the tooth 1102C of the main gear 1102 that was in contact with the second flange 1101B may advance until it comes into contact with the first flange 1101A. This third position is shown in FIGS. 19A-19B.In this position, the first flange 1101A is arranged in a small passage 1102B of the main gear 1102 and the second flange 1101B is aligned with a large passage 1102A of the main gear 1102, but is not arranged therein. Rotation of key 1101 will again allow main gear 1102 to advance. When moving from the third position to the fourth position, however, step 1101E of second flange 1101B will not come into contact with main gear 1102 since large passage 1102A of main gear 1102 is configured to allow passage of step 1101E (i.e., the large passage is large enough to allow the step to pass through). Thus, as shown in FIGS. 20A-20B, in the fourth position, status reader interface 1101D of key 1101 comes into contact with status reader 1550. This contact causes a signal to be sent to the power and control system. The status reader may be, for example, a detector switch that creates or modifies an electrical signal upon contact with, or movement of, the arm of the 1550A status reader.The status reader 1550 may be mounted to the cover 12 or the top plate 1530 and be in electrical communication with the power and control system. In this manner, the operation of the regulating mechanism can be monitored. In the embodiment described above, when the main gear 1102 is operating properly, the key 1101 will contact the status reader 1550 at a predefined rotation interval during operation, for example, once every four rotations of the key 1101. However, if the main gear 1102 is not rotating properly, the key 1101 will contact the status reader 1550 at some other interval or not at all. For example, if the main gear 1102 stops its rotation at a position, where the second flange 1101B aligns with a large passage 1102A of the main gear 1102, the key 1101 will come into contact with the status reader 1550 every two rotations of the key 1101 (i.e., every time the key rotates in the direction of the dashed arrow in FIG. 17B).Alternatively, if the main gear 1102 stops its rotation at a position where the second flange 1101B is aligned with a small passage 1102B of the main gear 1102, the key 1101 will be prevented from contacting the status reader 1550. Thus, the power and control system can compare the frequency of contact between the key and the status reader with an expected frequency and determine if the regulation mechanism is operating properly. This may provide safety advantages to the target. For example, if the key 1101 rotates four times and the power and control system does not receive a signal from the status reader 1550, the power and control system may stop delivery of the medication to the target. Similarly, if the power and control system receives a signal from the status reader 1550 after only two rotations, this would also indicate a failure in the throttle mechanism and result in termination of delivery. The power and control system may stop delivery by triggering one or more actions such as retracting the needle or cannula from the target. Although the embodiment described above is configured such that the key 1101 contacts the status reader 1550 once every four rotations, these components may be configured for any activation frequency, for example, by varying the timing of the large 1102A and small 1102B passages in the main gear 1102. In addition, the key 1101 may be configured to provide additional benefits in preventing drug delivery leaks. In the embodiment shown in FIGS. 15A-15B, the key 1101 is configured such that the main gear 1102 can only rotate one rotary advance at a time. At all times, because the first opening 1101F and the second opening 1101G are not aligned (i.e., they are offset about the circumference of the shaft), at least one of the first flange 1101A and the second flange 1101B is positioned to prevent rotation of the main gear 1102 by being in the travel path of the tooth 1102C of the main gear 1102. Furthermore, in the embodiment shown, the flanges 1101A, 1101B of the key 1101 are in an orientation substantially perpendicular to the travel path of the tooth 1102C of the main gear.Therefore, the force applied to the key by the main gear does not transmit a torque to the key and therefore the key 1101 cannot be back-driven by the main gear 1102. Therefore, the rotation of the main gear 1102 will be restricted by the key 1101 even when the actuator 101 is not actuated to prevent rotation of the key 1101. The drive mechanism may also be configured to allow unrestricted payout of the belt. FIG. 15C shows one embodiment of a key 2101 that would allow such a configuration of the drive mechanism. As shown, opening 2101F of first flange 2101A is circumferentially aligned with opening 2101G of second flange 2101B. Thus, upon rotation of key 1101, tooth 1102C of main gear 1102 aligns with both openings. This allows main gear 1102 to rotate freely, unrestricted by key 2101. Consequently, biasing member 122 is able to expand unrestricted by the belt. This results in substantially all of the contents of the drug container being delivered at once, at a rate controlled by the stiffness of the biasing member and the pneumatic / hydraulic resistance of the system.The versatility of being able to configure the drug delivery device to deliver a calibrated drug profile over an extended period of time, as described above, or alternatively, to deliver the drug in a single, relatively short dose, provides several advantages. Specifically, it allows the device to use similar components across a drug delivery device platform, thereby providing economies of scale in component and assembly prices. It should be noted that the regulating mechanisms 500, 1500 and actuators 101 of the present invention do not actuate the delivery of fluid substances from the drug chamber 21. The delivery of fluid substances from the drug chamber 21 is caused by the expansion of the biasing member 122 from its initial activated state and its action on the piston 110 and piston seal 60. Instead, the regulating mechanisms 500, 1500 perform the function of providing resistance to the free movement of the piston 110 and piston seal 60 as they are pressured by the expansion of the biasing member 122 from its initial activated state. The regulating mechanism 500, 1500 does not actuate the delivery, but merely controls the movement of the delivery. The belt limits or otherwise restricts the movement of the piston 110 and piston seal 60, but does not apply the force for the delivery.In accordance with a preferred embodiment, the drug pumps and controlled delivery drive mechanisms of the present invention include a regulating mechanism directly or indirectly connected to a belt that calibrates the axial translation of the piston 110 and piston seal 60, which are driven for axial translation by the biasing member 122. The drug delivery rate controlled by the regulating mechanism may be determined by: selecting the gear ratio of the gear assembly 516; selecting the main / star gear 102; selecting the diameter of the capstan drum 520B; using the electromechanical actuator 101 to control the rotational speed of the main / star gear 102, 1102; or any other method known to one of skill in the art.By using the electromechanical actuator 101 to control the rotational speed of the main / star gear 102, 1102 it may be possible to configure a drug pump to provide a variable dose rate (i.e., the rate of drug delivery is altered during a treatment). In another embodiment, the drug pump power and control system is configured to receive one or more inputs to calibrate the release of the belt 525 by the capstan assembly 520 and thereby allow axial translation of the piston 110 by the biasing member 122 to translate a piston seal 60 within a cylinder 58. The input(s) may be provided by actuating 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 belt 525 and the winch assembly 520 on the free axial translation of the piston 110 against which the biasing member 122 exerts pressure to meet a desired drug delivery rate or profile, to change the dose volume for target delivery, and / or to start, stop, or otherwise interrupt operation of the drive mechanism. For example, if the power and control system has determined that the pump is not operating properly, the power and control system may stop rotation of the actuator 101. iviA / a / zuzz / uii The components of the drive mechanism 100, upon activation, may be used to drive axial translation in the distal direction of the piston seal 60 of the drug container 50. Optionally, the drive mechanism 100 may include one or more compliance-related elements that allow for further axial translation of the piston seal 60 to, for example, ensure that substantially all of the drug dose has been delivered to the target. For example, the piston seal 60 itself may have some compressibility that allows for compliant pushing of the drug fluid from the drug container. The novel controlled delivery actuation mechanisms of the present invention may optionally integrate a status indication into the delivery of the drug dose. By using one or more status triggers and a corresponding status reader, the status of the actuation mechanism before, during, and after operation may be relayed to the power and control system to provide feedback to the user. This feedback may be tactile, visual, and / or audible, as described above, and may be redundant, such that more than one signal or type of feedback is provided to the user during use of the device. For example, initial feedback may be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may provide one or more drug delivery status indications to the user.Upon completion of drug delivery, the drive mechanism and drug pump can provide a dose completion indication. Since the dose completion indication is linked to the end of the piston's axial movement, the drive mechanism and drug pump provide the user with an accurate indication of dose completion. The belt 525 may have one or more state triggers, such as electrical contacts, optical marks, or electromechanical gaps or pins, that can contact or be recognized by a state reader. In at least one embodiment, a dose end state indication may be provided to the user once the state reader recognizes or contacts the end state trigger positioned on the belt 525 that would contact the state reader at the end of axial travel of the piston 110 and plunger 60 within the barrel 58 of the drug container 50.The status reader may be, for example, an electrical switch reader for contacting corresponding electrical contacts, an optical reader for recognizing corresponding optical markings, or a mechanical or electromechanical reader configured to contact corresponding pins, holes, or similar features on the belt. The status triggers may be positioned along the belt 525 to be read or recognized at positions corresponding to the beginning and end of drug delivery, as well as at desired intervals during drug delivery.As the drug pump is activated and drug delivery is initiated by the release of the biasing member 122 and the resulting force applied to the piston 110 and piston seal 60, the rate or profile of drug delivery to the target is controlled by the regulating mechanism 500, the gear assembly 516, and the capstan assembly 520 which releases the belt 525 and allows expansion of the biasing member 122 and axial translation of the piston 110 and piston seal 60. As this occurs, the state actuators of the belt 525 contact or are recognized by the state reader, and the state of the drive mechanism before, during, and after operation may be relayed to the power and control system to provide feedback to the user. By virtue of the number of state actuators located on the belt 525, the frequency of the advance state indication may be modified as desired.As described above, a variety of state readers can be used depending on the state triggers used by the system. In a preferred embodiment, the status reader may apply a tension force to the belt 525. When the system reaches the end of the dose, the belt 525 is slackened and the status reader 544 is allowed to rotate about a fulcrum. This rotation may operate an electrical or electromechanical switch, e.g., a circuit breaker, indicating that the belt 525 is slack to the power and control system. Additionally, a gear in the gear assembly may act as an encoder in conjunction with a sensor. The sensor / encoder combination is used to provide feedback on the rotation of the gear assembly, which in turn may be calibrated to the position of the piston 110 when the belt 525 is not slack. For example, the rotation of the main gear 102, 1102 may be configured to be monitored by an optical sensor.A reflective surface coating may be applied to at least a portion of the face of the main gear 102, 1102 to improve the accuracy of the optical sensor. Together, the status reader and sensor / encoder may provide position information, a dose completion signal, and an error indication, such as an occlusion, by observing that the belt 525 or other component of the drive mechanism is slack before reaching the expected number of motor rotations counted by the sensor / encoder. Referring again to FIGS. 2A-2E and 3A-3D, in addition to controlling the drug delivery rate by sizing, providing resistance to, or otherwise preventing free axial translation of the piston seal used to force a drug substance out of a drug container (whereby drug substances are delivered at variable delivery profiles and / or rates); the drive mechanisms of the present invention may simultaneously or sequentially perform the following steps: activating a needle insertion mechanism to provide a fluid path for delivery of the drug to a target; and connecting a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target. In at least one embodiment, as shown in FIGS.2A-2E and 3A-3D, initial movement by actuator 101 of drive mechanism 100 causes rotation of main / star gear 102. Main / star gear 102 is shown as a compound gear having aspects 102A and 102B (see FIG. 4). In one manner, main / star gear 102 transmits motion to regulating mechanism 500 via gear assembly 516. In the other manner, main / star gear 102 transmits motion to regulating mechanism 200 via gear 112. As main / star gear 102 causes gear 112 to rotate, gear 112 causes needle insertion mechanism 200 to initiate connection of the fluid path to the target, as described in detail above. In a particular embodiment, the needle insertion mechanism 200 is a rotary needle insertion mechanism.Accordingly, gear 112 is configured to engage a corresponding engagement surface 208 of needle insertion mechanism 200. Rotation of gear 112 causes rotation of needle insertion mechanism 200 through interaction between gears of gear 112 of drive mechanism 100 and the corresponding engagement surface 208 of needle insertion mechanism 200. Once appropriate rotation of needle insertion mechanism 200 occurs, e.g., rotation along the 'R' axis shown in FIG. 2D , the needle insertion mechanism may be initiated to create flow path engagement with the target, as described in detail above. In an alternative embodiment, as shown in FIGS. 6A-6B, the gear 112 may indirectly cause the needle insertion mechanism 200 to initiate connection of the fluid path to the target. For example, the gear 112 may be configured to engage a corresponding engagement surface of a control arm 202 (visible in FIGS. 6A and 6B) that contacts or blocks the needle insertion mechanism 200. Rotation of the gear 112 causes movement of the control arm 202, which may initiate or permit rotation of the needle insertion mechanism 200. One such needle insertion mechanism, as shown in FIGS. 6A-6B, includes a rotatable biasing member 210 that is initially maintained in an activated state.The rotatable biasing member may be prevented from being deactivated by contact of a component of the insertion mechanism with a rotation-preventing element, such as a locking aspect 206, of the drug pump. Rotation or translation of the aspect. 6 Blocking element 206 is initially prevented by contact with control arm 202. Translation of control arm 202, caused by rotation of gear 112, positions control arm 202 such that it no longer prevents rotation of blocking element 206. Upon activation of the device, or other input, rotatable biasing member 210 is allowed to at least partially deactivate. This causes one or more components of the insertion mechanism to rotate and in turn causes, or allows, insertion of the needle into the target. Additionally, a cannula may be inserted into the target as described above.At a later time, for example, when the control arm or other component of the device recognizes that the tether 525 is slack, the rotatable biasing member may be allowed to further deactivate, such as by further interaction with the control arm, which causes further rotation of one or more components of the insertion mechanism. This rotation may cause, or allow, the needle to be withdrawn from the target. The needle may be completely withdrawn in a single step, or there may be multiple steps of retraction. As shown in FIGS. 2A-2E and 3A-3D, rotation of the needle insertion mechanism 200 in this manner may also cause a connection of a sterile fluid path to a drug container to allow fluid flow from the drug container to the needle insertion mechanism for delivery to the target. The ramp aspect 222 of the needle insertion mechanism 200 is caused to bias a movable connection point 322 of the sterile fluid path connection 300. As the drive mechanism 100 causes the needle insertion mechanism 200 to rotate, a ramp aspect 222 of the needle insertion mechanism 200 biases the movable connection point 322 of the sterile fluid path connection 300 and translates it to facilitate a fluid connection therethrough.Such translation may occur, for example, in the direction of the unfilled arrow along the axis 'C' as shown in FIG. 2B. In at least one embodiment, the needle insertion mechanism 200 may be configured such that a particular degree of rotation about the axis of rotation 'R' (as shown in FIG. 2D) allows the needle / trocar to be withdrawn as detailed above. Additionally or alternatively, such retraction of the needle / trocar may be configured to occur upon user activity or upon movement or operation of another component of the drug pump. In at least one embodiment, the retraction of the needle / trocar may be configured to occur upon completion of drug delivery, triggered, for example, by the regulating mechanism 500 and / or one or more of the status readers as described above.During these operating stages, the delivery of fluid substances from the drug chamber 21 may be initiated, ongoing, and / or completed by the expansion of the biasing member 122 from its initial activated state and its action on the piston 110 and piston seal 60. As described above, the regulating mechanism 500 performs the function of providing resistance to the free movement of the piston 110 and piston seal 60 as they are pressured by the expansion of the biasing member 122 from its initial activated state. The regulating mechanism 500 does not actuate the delivery, but merely controls the movement of the delivery. The belt limits or otherwise restricts the movement of the piston 110 and piston seal 60, but does not apply the force for the delivery. This is visible through the advancement of the components shown in FIGS. 2A-2E and 3A-3D.The movement of the piston 110 and piston seal 60 as they are urged by the expansion of the biasing member 122 from its initial activated state is shown in the direction of the solid arrow (FIG. 2D) along the axis 'A' from the first or proximal position 'P' to the second or distal position 'D', as shown in the transition of FIGS. 2A-2E and 3A-3D. Additional aspects of the novel drive mechanism will be described with respect to FIG. 4 and FIGS. 5A-5B. FIG. 4 shows a perspective view of the drive mechanism, according to at least a first embodiment, during its initial locking stage. Initially, the strap 525 may retain the biasing member 122 in an initial activated position within the piston 110. Directly or indirectly upon activation of the device by the user, the drive mechanism 100 may be activated to allow the biasing member to transmit a force to the piston 110 and thus to the strap 525. This force on the strap 525 transmits a torque to the capstan drum 520B which causes the gear assembly 516 and the regulating mechanism 500 to begin moving. As shown in FIG.5A , the piston 110 and the biasing member 122 are both initially in an activated, compressed state behind the piston seal 60. The biasing member 122 may be maintained in this state following activation of the device between internal elements of the drive housing 130 and the interface surface 110C of the piston 110. As the drug pump 10 is activated and the drive mechanism 100 is driven into operation, the biasing member 122 is allowed to expand (i.e., decompress) axially in the distal direction (i.e., in the direction of the solid arrow shown in FIG. 2D). That expansion causes the biasing member 122 to act upon and translate distally the interface surface 110C and the piston 110, thereby distally translating the piston seal 60 to urge drug fluid out of the drug chamber 21 of the barrel 58.In at least one embodiment, a dose completion status indication may be provided to the user once the status reader contacts or recognizes that a status trigger positioned on the belt 525 substantially corresponds with the end of axial travel of the piston 110 and piston seal 60 within the barrel 58 of the drug container 50. The status triggers may be positioned along the belt 525 at various advances, such as advances corresponding to a certain volume measurement, to provide an advance status indication to the user. In at least one embodiment, the status reader is an optical status reader configured to recognize corresponding optical status triggers on the belt. As would be understood by one of skill in the art, those optical status triggers may be indicia that can be recognized 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 the like on the belt. Similarly, electrical contacts on the belt could be used as status indicators that contact or are otherwise recognized by the corresponding electrical status reader. The status triggers can be positioned along the belt 525 to be read or recognized at positions corresponding to the beginning and end of drug delivery, as well as at desired advances during drug delivery. As shown, the belt 525 passes substantially axially through the drive mechanism cover 130, the biasing member 122, and engages the piston 110 to restrict axial translation of the piston and the adjacent piston seal 60. Novel embodiments of the present invention may be used to calibrate, restrict, or otherwise impede free rotational motion of capstan drum 520B and thus axial translation of the components of controlled delivery drive mechanism 100. Accordingly, regulating mechanism 500 only controls movement of the drive mechanism, but does not apply force to deliver the drug. One or more additional biasing members 122, such as compression springs, may be used to drive or assist in driving piston 110. For example, a compression spring may be used within drive housing 130 for this purpose. Regulating mechanism 500 only controls, calibrates, or regulates that action.The controlled delivery drive mechanisms and / or drug pumps of the present invention may additionally allow for a compliance push to ensure that substantially all of the drug substance has been propelled out of the drug chamber 21. The piston seal 60 itself may have some compressibility to allow for a compliance push of the drug fluid from the drug container. For example, when an ejector piston seal is employed, i.e., a piston seal that can be deformed from an initial state, the piston seal can be caused to deform or "eject" to provide a compliance push of the drug fluid from the drug container.Additionally or alternatively, an electromechanical status switch and interconnection assembly may be used to contact, connect, or otherwise enable a transmission to the power and control system to indicate dose completion to the user. This configuration also allows for accurate indication of dose completion to the user. In at least one embodiment, the advance status indication may be provided to the user by reading or recognizing the rotary motion of one or more gears of the gear assembly 516. As the gear assembly 516 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 an advance status indication before, during, and after operation of the variable speed controlled delivery drive mechanism. A number of status readers may be used within embodiments of the present invention. For example, the drive mechanism may utilize a mechanical status reader that comes into physical contact with a gear tooth of one of the gears in the gear assembly.As the status reader comes into contact with the status actuator(s), which in this exemplary embodiment may be the gear tooth of one of the gears (or holes, pins, flanges, marks, electrical contacts, or the like on the gear), the status reader measures the rotational position of the gear and transmits a signal to the power and control system for indicating the status to the user. Additionally or alternatively, the drive mechanism may utilize an optical status reader. The optical status reader may be, for example, a light beam capable of recognizing motion and transmitting a signal to the power and control system.For example, the drive mechanism may utilize an optical status reader configured to recognize the movement of a gear tooth of one of the gears in the gear assembly (or holes, bolts, flanges, marks, electrical contacts, or the like on the gear). Similarly, the status reader may be an electrical switch configured to recognize electrical contacts on the gear. In either of these embodiments, the sensor may be used to then relay a signal to the power and control system to provide feedback to the user. As would be appreciated by one of ordinary skill in the art, optical status readers and corresponding actuators, electromechanical status readers and corresponding actuators, and / or mechanical status readers and corresponding actuators may all be utilized in embodiments of the present invention to provide an advance status indication to the user. While the drive mechanisms of the present invention are described with reference to the gear assembly and regulating mechanism shown in the figures, a variety of configurations may be acceptable and capable of being employed within embodiments of the present invention, as would be readily appreciated by one of ordinary skill in the art.Accordingly, embodiments of the present invention are not limited to the specific gear assembly and regulating mechanism described herein, which is provided as an example of one embodiment of those mechanisms for use within controlled delivery drive mechanisms and drug delivery pumps. In at least one embodiment of the present invention, the drug delivery profile can be adjusted. For example, it may be desirable to deliver a bolus injection of drug before, during, or after certain activities such as eating, exercising, sleeping, etc. A "bolus injection" is any metered volume of drug delivered, often regardless of the timing or duration of delivery. In contrast, a "basal injection" often has a controlled delivery rate and / or a drug delivery profile with varying delivery rates at different time intervals. Similarly, the user may desire to increase or decrease the basal delivery rate of the drug at these or other times. In at least one embodiment, the delivery profile can be adjusted by the user to achieve this desired drug delivery.The user can adjust the delivery profile by interacting with the drug delivery device itself or, alternatively, by using an external device, such as a smartphone. For example, the user can adjust the delivery profile by moving the trigger mechanism or by using an external delivery control mechanism or one integrated into a separate device. In another embodiment of the present invention, the delivery profile may be automatically adjusted based on one or more inputs. For example, the delivery profile may be adjusted based on activity level, heart rate, blood sugar level, blood pressure, etc. As discussed above, these measurements may be used to determine the need for a bolus injection or to increase or decrease the basal injection delivery rate or adjust the basal injection delivery profile. In at least one embodiment, these measurements may be monitored by the device itself. Additionally or alternatively, they may be monitored by a secondary device such as a smartphone, a smartwatch, a heart rate monitor, a glucose monitor, a blood pressure monitor, or the like.In some embodiments, the delivery profile can be adjusted based on these measurements without requiring user intervention. In the case of monitoring and / or control by a secondary device, the secondary device and the drug delivery device can be in wireless or wired communication with each other. This communication can be via Bluetooth, near-field communication, Wi-Fi, or any other method known to those skilled in the relevant art of device interconnectivity. In a preferred embodiment, however, the monitoring / adjustment mechanism may MA / a / zuzz / ui i ozy alert and make recommendations to the user, and the user may have active control to initiate / authorize or dismiss the recommendation made by the monitoring / adjustment mechanism. For example, if one or more of the measurements are above or below a specified threshold value, the device may provide an audible, visual, or tactile alert to the user. In one example, the alert is provided by a vibration of the device, thereby providing a discreet alert to the user. Additionally or alternatively, the alert may be provided by the user's smartphone or other secondary device. The user may be able to view the current status of the measurements in a software program or web interface on the device itself, a computer, a smartphone, or another device. The software program or web interface may provide a recommended adjustment to the provisioning profile.Based on this information, the user can adjust the delivery rate of the drug delivery device. As previously mentioned, the user can adjust the delivery profile by shifting the trigger mechanism or by using an external delivery control mechanism or one integrated into a separate device. In one embodiment, in response to a signal to adjust the delivery profile, either based on user input or based on the measurements described above, the power and control system may cause a change in the speed of movement of the actuator 101. The change in the speed of movement of the actuator 101 causes a change in the rotational speed of the regulating mechanism 500, 1500 which, in turn, controls the rate of drug delivery to the target. Alternatively, the delivery profile may be altered by a change in the characteristics of the flow path of the drug through the conduit connecting the drug container and the insertion mechanism. The change may be caused by the introduction, removal, or modification of a flow restrictor that restricts the flow of the drug from the drug container to the insertion mechanism.For example, a flow restrictor may have multiple flow paths that can be selectively placed in fluid communication with an inlet and an outlet of the flow restrictor. By providing flow paths with different lengths or cross-sections, the delivery rate can be controlled. In other embodiments, the delivery profile can be altered by introducing or removing a pinch from the conduit. A pinch in the flow path can interrupt or slow the flow of the drug through the conduit, thereby controlling the delivery rate to the target. Accordingly, one or more embodiments of the present invention can produce a change in the delivery rate of the drug from the drug container, thereby providing a dynamic control capability to the drive mechanism and / or the drug delivery device. In order to quickly prime the drug pump, while conserving energy, the drug pump may include a priming mechanism such as that shown in FIGS. 21A-24. The priming mechanism 700 may allow the belt to be unwound and the piston to be moved without rotation of the actuator 101. This movement of the piston 110 may provide at least two benefits. First, any gap between the piston 110 and the piston seal 60 will quickly close after assembly, bringing them into contact ready to begin drug delivery. Second, after the piston 110 contacts the piston seal 60, continued translation of the piston 110 will cause a commensurate displacement of the piston seal 60. This may allow the primed drug pump containing the priming mechanism to prime.Upon activation of the fluid path connection and opening of the fluid path from the drug container, translation of the piston seal 60 may cause any air or gas initially present in the fluid path connection 300, the fluid conduit 30, and the needle insertion mechanism 200 to be expelled. This air or gas may be replaced by the drug contained in the drug container to allow delivery of the drug to the target tissue to begin. In the embodiment shown in FIGS. 21A-24, the setup mechanism includes winch gear 1520 and winch drum 1522. Winch drum 1522 includes coupler 702, capstan 704, and furler 706. Winch gear 1520 is rotatably coupled to the gear interface via the gear assembly. Belt 1525 is wrapped around winch 704 and coupled to reel 706. Accordingly, tension applied to the belt by the piston causes torque to be applied to winch 704. Winch 704 is connected to coupler 702 such that rotation of winch 704 is transferred to coupler 702. In the illustrated embodiment, outer connecting aspect 704A of winch 704 is coupled to inner connecting aspect 702A of coupler 702 to transfer rotation from one component to another. In one embodiment, the connecting aspects are in the form of mating teeth.Thus, applying a force to the belt 1525 causes a rotational force to be applied to the coupler 702 in the direction of the arrow in FIG. 21 A. The winch gear 1520 includes a gear interface such as the spur gear interface 1520A shown in FIG. 22 that couples, via the gear assembly 116, to the actuator 101. The winch gear 1520 further includes the hollow 1520E within which the coupler 702 is at least partially disposed. The hollow 1520E is configured with elements for controlling rotation of the coupler 702, such as the ramp 1520D and the stop 1520C. The coupler 702, shown in FIG. 23, includes one or more extensions 702B that are configured to be relatively flexible. As shown in FIG. 21 A, the coupler 702 is initially positioned such that the inclined face 702C of the extension 702B is in a location adjacent to, or in contact with, the ramp 1520D of the capstan gear 1520.Contact between the inclined face 702C and the ramp 1520D prevents inadvertent rotation of the coupler 702 relative to the capstan gear 1520. One or more components of drug pump 10 form a release mechanism that initially engages release aspect 702D of coupler 702. This engagement initially prevents rotation of coupler 702. The release mechanism may be caused to release rotation of coupler 702 by a user action, such as depressing actuation mechanism 14. Alternatively, the rotation mechanism may be caused to permit rotation of coupler 702 by an action of power and control system 400. Upon disengagement of the release mechanism, and in response to torque applied by belt 525, coupler 702 rotates to the position shown in FIG. 21 B. In this position, extension 702B is in contact with stop 1520C. This contact prevents further relative rotation of coupler 702 with respect to capstan gear 1520 in the direction of the arrow in FIG. 21 A.Additionally, extension 702B may be coupled to rung 1520F of winch gear 1520 to thereby secure coupler 702 in position relative to winch gear 1520. With coupler 702 and winch gear 1520 in the configuration shown in FIG. 21B , any further rotation of coupler 702 must be accompanied by a commensurate rotation of capstan gear 1520. Since capstan gear 1520 is coupled to actuator 101 via gear assembly 116, rotation of coupler 702 is also controlled by actuator 101. In this manner, the translational speed of piston 110 and the delivery rate of the medicament may be controlled by actuator 101. Likewise, initial translation of piston 110 and rotation of coupler 702, from the position shown in FIG. 21A to that shown in FIG.21B, allow assembly tolerances to be assumed and the preparable drug delivery device to be prepared without rotating the actuator. This allows the preparable drug delivery device to save energy during this initial stage of operation. In at least one embodiment, the drug pump and / or drive mechanism includes one or more safety mechanisms to automatically slow or stop the flow of medication to the target in the event of a delivery failure. This can be a beneficial element in the delivery of controlled substances. Some substances, such as insulin, can be harmful or even lethal if delivered in too large an amount and / or at too rapid a delivery rate. The safety mechanisms described herein can be used to ensure that a so-called "runaway" delivery does not occur. For example, there may be means to stop or restrict the flow of medication in the event that the belt is loose or fails during operation. In one embodiment, the safety mechanism is a brake mechanism as shown in FIGS. 32A-32B. Disposed within cylinder 58 are brake 64, sleeve 62, plug 68, and optionally retainer 66. Bias member 122 biases sleeve 62. Strap 525 engages plug 68, allowing strap 525 to restrain movement of sleeve 62. This restraint controls the rate of expansion or deactivation of bias member 122. When strap 525 is under tension, plug 68 biases distal face 64A of brake 64, which causes proximal face 64B of brake 64 to bias sleeve 62. Because of this contact, and the profile of distal end 62A of sleeve 62, brake 64 is held in a substantially tapered configuration as shown in FIG. 32A.In this configuration, expansion or deactivation of the biasing member 122 is restricted by the belt. Also, in this conical configuration, the outer diameter of the brake 64 is smaller than the inner diameter of the cylinder 58, so translation of the brake is not restricted by contact with the inner wall of the drug container. This allows the brake to be in a position that is not sufficient for the brake to contact the inner wall of the cylinder. The brake contact is sufficient to restrict or prevent further deactivation of the biasing member and does not necessarily require complete contact of the brake with the inner wall of the cylinder. Similarly, the brake may be retained in an initial state that is not in brake contact with the inner wall of the cylinder, but does not necessarily require the absence of contact with the inner wall of the cylinder.In at least one embodiment, some contact between the brake and the inner wall of the cylinder may be desired prior to activation of the brake mechanism, for example, to center the brake within the cylinder, so long as the brake does not substantially restrict or prevent further deactivation of the biasing member prior to activation of the brake mechanism. Also, a portion of the brake 64 is in contact with the retainer 66. Because the brake 64 is held in this configuration by the plug 68 and the sleeve 62, translation of the sleeve 62, caused by decompression of the biasing member 122, is transferred to the retainer 66. Also, contact of the retainer 66 with the piston seal 60 causes translation of the piston seal 60. As shown in FIG. 32B, in the event that the belt 525 is slack or fails, the plug 68 is no longer held in position by the belt 525 and thus no longer restricts movement of the sleeve 62. As the biasing member 122 is decompressed or deactivated, the brake 64 transitions to a relatively less conical or flatter configuration. This may be caused by a natural tendency of the brake 64 to transition to this configuration, or alternatively, it may be caused by contact of the brake 64 with the retainer 66 and the sleeve 62. As the brake undergoes this transformation, it contacts the inner wall of the cylinder 58. In this manner, the brake acts as a wedge to restrict translation of the sleeve 62. This may prevent further translation or it may function to restrict the translational rate.Optionally, restoring tension to the belt may cause the plug to contact the brake and transform the brake back into its conical configuration, thereby restoring normal operation of the drug pump. FIGS. 32A-32B show the plug as having a spherical shape and the brake as having a conical shape. These shapes are used herein merely for illustrative purposes, and other shapes or configurations could readily be used to achieve the same or similar operation. For example, the plug itself may be conical in shape and, in one embodiment, be shaped to interface with the brake when the brake has a conical shape. In such a configuration, the conical shape of the plug assists in maintaining the conical shape of the brake by preventing contact between the outer diameter of the brake and the inner diameter of the cylinder in order to restrict axial translation of the sleeve 62 (i.e., applying a braking force).In another embodiment, the brake 64 could employ a star-shaped or other configuration when in a substantially flattened position so as to contact the inner diameter of the barrel 58 to prevent or restrict further axial translation of the sleeve 62. Without further translation of the sleeve 62, the biasing member 122 cannot expand or deactivate further, which, in turn, prevents or restricts further drug delivery to the target. This provides a necessary and useful safety measure for drug delivery to prevent excessive or accelerated delivery of the drug to the target. In another embodiment, shown in FIG. 25A-27B , the safety mechanism may be a piston seal piercing member 1000 and positioned at least partially within cylinder 58 or drive housing 1130. Piston seal piercing member 1000 may include one or more safety piercing members 1072, a center point 1074, a piston 1110, and a safety biasing member 1078. The piston may additionally have an opening 1110A through which strap 1525 may pass and an internal chamber 1110B wherein one or more components of piston seal piercing mechanism 1000 may be disposed. The piston may additionally be coupled to a safety base 1076. Base 1076 may include a central opening 1076A through which strap 1525 may pass and one or more peripheral openings 1076B into which the or the 1072 drilling members.The safety piercing member(s) 1072 may be, for example, a hollow needle, such as a stainless steel needle. Alternatively, the piercing members 1072 may be solid trocars. They may also be constructed of any other material such as a thermoplastic or thermosetting polymer. The piercing member(s) 1072 may have a beveled edge to increase the efficiency of piercing the piston seal 1060 and have a lumen 1072B through which the material may pass. The piercing member(s) 1072 may be connected to the center point 1074 by means known to those skilled in the art such as stacking, press fit, and adhesive. Alternatively, the piercing members may be integrally formed parts of the center point.A proximal plug 1070 and a distal plug 1068 may be fixedly coupled to the belt 1525 such that the plugs are locked in position along the belt 1525. The plugs 1068, 1070 may be, for example, spherical shaped cable covers. Alternatively, they may be an integral element of the belt 1525. The piston seal 1060 may include a cavity 1060A within which the distal end 1072A of the piercing member(s) 1072 are initially disposed. In an initial configuration, as shown in FIG. 25A-25B , the safety biasing member 1078 is held in a compressed or activated state between a portion of the center point 1074 such as the rim 1074A and an inner face 1110C of the piston 1110 by tension in the strap 1525. In the embodiment shown, the tension in the strap 1525 restricts movement of the center point 1074 through the proximal plug 1070 disposed in a cavity 1074B of the center point 1074. The stiffness of the safety biasing member 1078 is such that, during normal operation, the tension in the strap 1525 is sufficient to prevent decompression of the safety biasing member 1078. Thus, during normal operation, the center point 1074 and piercing member(s) 1072 do not translate relative to the piston 1110.In the absence of a drive mechanism tension failure, tension will be maintained on the belt 1525 and the safety biasing member 1078 will be prevented from decompressing through the drug delivery process. The distal plug 1068 may be located distal to at least a portion of the safety mechanism base 1076. Thus, tension of the belt 1525 is transmitted to the piston seal piercing mechanism 1000 via the distal plugs 1068 and proximal plugs 1070. The piston 1110 may include a flange 1110D disposed between the piston seal 1060 and the drive biasing member 122. Alternatively, the drive biasing member 122 may act on the safety mechanism base 1076. Movement of the drive biasing member 122 is transmitted via the flange 1110D of the piston 1110 and / or the safety mechanism base 1076 to the piston seal 1060.This also allows decompression of the drive biasing member 122 and translation of the piston seal 1060 to be restrained by the belt 1525. FIGS. 26A-26B show the member. MA / a / 2U22 / U11 02» drive deviation 122 in a partially decomposed state in which the piston seal 1060 has moved distally within the cylinder 58. In the event of a failure of the drive mechanism or regulating mechanism, and a resulting reduction in belt tension, the safety biasing member 1078 may be decompressed or disabled. As shown in FIGS. 27A-27B , this decompression of the safety biasing member 1078 causes the center point 1074 and the piercing member(s) 1072 to translate distally relative to the piston 1110. Accordingly, the distal end 1072A of the piercing member(s) 1072 pierces the piston seal 1060. Upon piercing the piston seal 1060, a fluid path is created from the drug chamber 21, through or around one or more piercing members 1072, and to the piston 1110, the proximal portion of the barrel 58, or another aspect of the drug pump 10.Since the fluid path through or around the piercing member(s) 1072 has a lower pressure (i.e., is a fluid path of least resistance) than the fluid path through the sterile fluid path connection 300, continued translation of the piston seal 1060 toward the distal end of the barrel 58 will cause fluid drug to travel through or around the piercing member(s) 1072. Therefore, the volume of drug delivered through the sterile fluid path connection 300 and to the target will be reduced or stopped. In this manner, the safety mechanism 1000 may reduce or eliminate the risk of a leak fluid delivery condition, thereby increasing the safety of the device. As noted above, the strap 1525 may directly or indirectly restrain translation of the piston 1110 at one or more locations. For example, in the embodiment shown in FIGS. 25A-27B , the strap 1525 may restrain translation of the piston 1110 at the distal plug 1068 and the proximal plug 1070, where the distal plugs 1068 and proximal plugs 1070 are separated by an intermediate portion 1525A of the strap 1525. This may provide additional redundant safety mechanisms. For example, if a failure occurs in either the distal plug 1068 or the intermediate portion 1525A of the strap 1525, the decompression rate of the drive biasing member 122 will continue to be restrained by the engagement of the strap 1525 with the piston 1110 in the proximal plug 1070.Failure of the drive mechanism or proximal strap 1525 relative to proximal plug 1070 will result in decompression of safety biasing member 1078, piercing of piston seal 1060 by piercing member(s) 1072, and restriction or reduction of flow of drug fluid to the target as described above. Intermediate portion 1525A may be an integral portion of strap 1525 or may be a separate component that couples directly or indirectly to strap 1525. During normal operation, the components of the drilling mechanism of the MA / a / 4U44 / U11 04» piston seal 1000 do not come into contact with the drug. Additionally, if the piercing mechanism of the piston seal 1000 is activated, fluid passing through or around the piercing member(s) 1072 will not be delivered to the target. Therefore, the components of the piercing mechanism of the piston seal 1000 do not require sterilization, although they may be configured to be sterilized if desired. A method of manufacturing a piston seal piercing mechanism includes one or more of the following steps: passing a strap 1525 through an opening 1110A of a piston 1110; attaching one or more piercing members 1072 to a center point 1074; positioning a safety biasing member 1078 against an inner proximal face 1110C of the piston 1110; passing the strap 1525 through an opening 1074B of the center point 1074; attaching a proximal plug 1070 to the strap 1525; passing the strap 1525 through a central opening 1076A of the safety base 1076; attaching a distal plug 1068 to the strap 1525. In another embodiment, shown in FIGS. 28A-28B, the safety mechanism is a piston seal displacement mechanism 2000. The displacement mechanism includes piston 2110, spring retainer 2074, sleeve 2084, safety biasing member 2078, plug 2068, and one or more transfer elements 2082. Plug 2068 may be fixedly coupled to belt 2525. Furthermore, plug 2068 may be located distal to at least a portion of sleeve 2084 such that plug 2068 restricts distal displacement of sleeve 2084. For example, plug 2068 may be disposed in recess 2084B of sleeve 2084 (shown in FIG. 31). The safety biasing member 2078 is positioned between the piston 2110 and the sleeve 2084, and is initially prevented from decompressing and / or deactivating due to the restriction of the travel of the sleeve 2084.In an initial position, the transfer elements 2082 are disposed within the openings 2110A of the piston and are retained in that position by contact with the sleeve 2084. The transfer elements 2082 are also in contact with a portion of the spring retainer 2074, such as the contact surface 2074A, and thereby prevent translation of the spring retainer 2074 relative to the piston 2110. Thus, the force transmitted to the spring retainer 2074 by the drive biasing member 122 is transferred through the transfer elements 2082 to the piston 2110 and from the piston 2110 to the piston seal 2060. The contact surface 2074A of the spring retainer 2074 may be inclined such that it applies a force to the transfer elements 2082 at least partially in a radially inward direction. Following a failure of the drive mechanism or the belt, decompression of the safety biasing member 2078 will no longer be restricted by the tension in the belt. Decompression of the safety biasing member 2078 causes the sleeve 2084 translates distally relative to piston 2110. As sleeve 2084 translates, receiving slot 2084A of sleeve 2084 aligns with transfer elements 2082. When so aligned, force applied to transfer elements 2082 by spring retainer 2074 causes transfer elements 2082 to descend into receiving slot 2084A. In this position, the transfer elements 2082 will no longer impede distal axial translation of the spring retainer 2074 relative to the piston 2110. Because of this, and in response to continued decompression of the drive biasing member 122, the spring retainer 2074 translates distally relative to the piston 2110, allowing the pins 2074B of the spring retainer 2074 to contact the piston seal 2060. The spring retainer 2074 may include any number of pins 2074B and preferably includes two or three pins. The pins 2074B may be equally spaced around the circumference of the spring retainer 2074, or alternatively, may be unequally spaced. As shown in FIGS. 29-30, the pins 2074B may include a ramped surface. Contact of the ramped surface with the piston seal 2060 may cause radial inward displacement of the piston seal 2060. This displacement of the piston seal 2060 may cause at least a partial loss of contact with the barrel 58, allowing the contents of the barrel to flow past the seal 2060 and into the proximal portion of the barrel 58.Continued distal translation of the piston seal 2060 will cause the cylinder contents to flow past the seal since this is a flow path of less resistance than the flow path through the sterile fluid path connection 300. The pins 2074B of the spring retainer 2074 may include biasing elements 2074C such as slots or indentations that facilitate fluid flow past the piston seal 2060. In another embodiment, the spring retainer 2074 is configured to cause the piston seal 2060 to skew within the cylinder upon contact (i.e., cause the central axis of the piston seal to not be parallel to the central axis of the cylinder). This allows the contents of the cylinder 58 to flow past the piston seal 2060 and restrict or eliminate further delivery to the target. To cause biasing of the piston seal 2060, the spring retainer 2074 may be configured to apply pressure to the piston seal 2060 in a non-uniform manner, for example, by having a single pin 2074B. Other forms of safety mechanisms can be used to ensure that the contents of the drug container are not delivered at too rapid a rate. For example, the fluid path connection may include a "relief" or pressure-release valve that opens in response to increased pressure within the fluid path. This pressure increase can be caused by the piston seal moving distally at too rapid a rate. With the valve in the open position, delivery of the drug fluid to the target may be stopped or reduced. The assembly and / or manufacturing of the controlled delivery drive mechanism 100, the drug delivery pump 10, or any of the individual components may utilize a number of materials and methodologies known 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 devices. Similarly, a number of known adhesives or glues may be employed in the manufacturing process. Additionally, lubricating and / or siliconizing processes and fluids may be employed during the manufacturing of the novel components and devices. In addition, known sterilization processes may be employed at one or more manufacturing or assembly steps to ensure sterility of the final product. The drive mechanism may be assembled using a number of methodologies. In one assembly method, the drug container 50 may first be assembled and filled with a fluid for delivery to the target. The drug container 50 includes a cap 52, a perforable seal 56, a barrel 58, and a piston seal 60. The perforable seal 56 may be fixedly coupled 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 piston seal 60 from the proximal end of the barrel 58. An optional connector mount 54 may be mounted to a distal end of the perforable seal 56. The connector mount 54 may guide insertion of the piercing member of the fluid path connection into the barrel 58 of the drug container 50.The drug container 50 may then be mounted to a distal end of the drive housing 130. One or more drive biasing members 122 may be inserted into a distal end of the drive housing 130. Optionally, a cover sleeve may be inserted into a distal end of the drive housing 130 to substantially cover the biasing member 122. A piston may be inserted into the distal end of the drive housing 130 such that it is at least partially located within an axial passageway of the biasing member 122 and the biasing member 122 is allowed to contact a piston interface surface 110C of the piston 110 at the distal end of the biasing member 122. An optional cover sleeve may be used to surround the biasing member 122 and contact the piston interface surface 110C of the piston 110. The piston 110 and the drive biasing member 122, and the optional cover sleeve, may be compressed within the drive housing. 130.That assembly positions the drive biasing member 122 in an initial, activated, compressed state and preferably places an interface surface of the piston 110C in contact with the proximal surface of the piston seal 60 within the proximal end of the cylinder 58. The piston, piston biasing member, contact sleeve, and optional components may be compressed and secured in the “ready to be driven” state within the drive housing 130 prior to attachment or assembly of the drug container 50. The tether 525 is pre-attached to the piston 110 and passed through the axial opening of the biasing member 122 and the drive mechanism cover 130, and then wound through the interior of the drug pump with the other end of the tether 525 wrapped around the capstan drum 520B of the regulating mechanism 500. A fluid path connection, and specifically a sterile sleeve of the fluid path 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 path connection which is itself connected to the insertion mechanism such that the fluid path, when opened, connected, or otherwise enabled, travels directly from the drug container, the fluid path connection, the fluid conduit, the insertion mechanism, and through the drug delivery cannula to the target. The components comprising the fluid flow path are then assembled. These components may be sterilized by a number of known methods and then fixedly or removably mounted on an assembly platform 20 or a cover 12 of the drug pump, as shown in FIG. 1 B. Certain optional standard components or variations of the drive mechanism 100 or the drug pump 10 are contemplated so long as they remain within the scope and scope of the present invention. For example, embodiments may include one or more batteries used to power a motor or solenoid, the drive mechanisms, and the drug pumps of the present invention. For this purpose, a variety of batteries known in the art may be used. Additionally, the top or bottom covers may optionally contain one or more transparent or translucent windows 18 to allow the user to observe the operation of the drug pump 10 or verify that the drug dose has been completed. Similarly, the drug pump 10 may contain an adhesive patch and a liner patch on the bottom surface of the cover 12.The adhesive patch may be used to adhere the drug pump 10 to the target for delivery of the drug dose. As would be readily understood by one of skill in the art, the adhesive patch may have an adhesive surface for adhesion of the drug pump to the target. The adhesive surface of the adhesive patch may be initially covered by a non-adhesive liner patch, which is removed from the adhesive patch prior to placing the drug pump 10 in contact with the target. Removal of the liner patch may further remove the sealing membrane 254 from the insertion mechanism 200, which opens the insertion mechanism to the target for drug delivery. Similarly, one or more of the components of the controlled delivery drive mechanism 100 and the drug pump 10 may be modified while remaining functionally within the scope and scope of the present invention. For example, as described above, while the drug pump cover 10 is shown as two separate components, the upper cover 12A and the lower cover 12B, these components may be a single, unified component. As described above, a glue, adhesive, or other known materials or methods may be used to join one or more components of the controlled delivery drive mechanism and / or the drug pump together. Alternatively, one or more components of the controlled delivery drive mechanism and / or the drug pump may be a unified component.For example, the top cover and bottom cover may be separate components joined together by glue or adhesive, a screw-fit connection, an interference fit, a fusion bond, a weld, an ultrasonic weld, and the like; or the top cover and bottom cover may be a single, unified component. These standard components and functional variations will be understood by those skilled in the art and are therefore within the scope and reach of the present invention. From the foregoing description, it will be understood that the controlled delivery drive mechanisms and drug pumps described herein provide an efficient and user-friendly system for the automated delivery of drugs from a drug container. The novel embodiments described herein provide drive mechanisms for the controlled delivery of drug substances and drug delivery pumps incorporating such controlled delivery drive mechanisms. The drive mechanisms of the present invention control the drug delivery rate by gauging, resisting, or otherwise preventing free axial translation of the piston seal used to force a drug substance out of a drug container and are thereby capable of delivering drug substances with variable delivery profiles and / or rates.Additionally, the drive mechanisms of the present invention may provide integrated status indication elements that provide information to the user before, during, and after drug delivery. For example, initial information may be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may provide one or more drug delivery status indications to the user. Upon completion of drug delivery, the drive mechanism and drug pump may provide a dose completion indication. The novel controlled delivery drive mechanisms of the present invention may be activated directly or indirectly by the user.Furthermore, the novel configurations of the controlled delivery drive mechanism and drug pumps of the present invention maintain the sterility of the fluid path during storage, shipping, and operation of the device. Because the path through which the drug fluid is transported within the device is maintained under completely sterile conditions, these components require sterilization only during the manufacturing process. These components include the drug container of the drive mechanism, the fluid path connection, the sterile fluid conduit, and 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 cover, and other components of the drug pump need not 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 final sterilization after assembly is complete. Furthermore, embodiments of the present invention allow for device architecture and / or component integration in ways that are not suitable for devices requiring final sterilization. For example, when sterilization of the entire device is necessary, the device architecture often requires adequate separation of components to allow the sterilizing gas or material to efficiently reach the desired surfaces.Eliminating the need for final sterilization allows for the reduction or elimination of these spaces and enables device architectures to offer smaller overall dimensions, human factors benefits, and / or industrial design options not available for devices requiring final sterilization. Manufacturing a drug pump includes the step of attaching the controlled delivery drive mechanism and the drug container, separately or as a combined component, to a drug pump assembly platform or cover. The manufacturing method further includes attaching the fluid path connection, the drug container, and the insertion mechanism to the assembly platform or cover. Additional components of the drug pump, as described above, including the power and control system, the actuation mechanism, and the control arm, may be bonded, pre-formed, or pre-assembled to the assembly platform or cover. An adhesive patch and a coating patch may be bonded to the surface of the drug pump cover that comes into contact with the user during operation of the device.The drug pump assembly method may further include positioning a safety mechanism such as a piston seal piercing mechanism at least partially within the cylinder and at a location adjacent to or in contact with the piston seal. A method of operating the drug pump includes the following steps: actuating, by a user, the trigger mechanism; moving a control arm to actuate an insertion mechanism; and actuating a power and control system to activate a controlled delivery drive mechanism to drive the flow of fluid drug through the drug pump according to a controlled drug delivery rate or profile. The method may further include the following step: coupling an optional integrated sensor prior to actuating the trigger mechanism. The method may similarly include the following step: establishing a connection between a fluid path connection and a drug container. Furthermore, the method of operation may include translating a piston seal within the controlled delivery drive mechanism by expansion of the biasing member acting on a piston within a drug container to drive fluid drug flow through the drug container, connecting the fluid path, a sterile fluid conduit, and the insertion mechanism for delivering the fluid drug to the target, wherein a regulating mechanism acting to restrict distribution of a belt is utilized to calibrate free axial translation of the piston. The method of operation of the drive mechanism and drug pump can be best appreciated with respect to FIGS. 2A-2E and FIGS. 3A-3D , as described above. Throughout the specification, the objective has been to describe preferred embodiments of the invention without limiting the latter to any specific embodiment or group of elements. Various changes and modifications may be made to the described and illustrated embodiments without departing from the present invention. The description of each patent and scientific document, computer program, and algorithm referenced herein is incorporated in its entirety by reference.

Claims

NOVELTY OF THE INVENTION Having described the present invention as above, the following claims are considered novel and therefore claimed as property. CLAIMS 1. A portable drug delivery device characterized in that it comprises: an outer cover attachable to a patient; a drug storage container positioned at least partially within the outer cover; an actuation mechanism positioned at least partially within the outer cover and configured to move a drug out of the drug storage container;an insertion mechanism positioned at least partially within the outer cover and comprising: an insertion mechanism cover, a rotary deflector member configured to rotate the insertion mechanism cover, and a delivery member connected or configured to be connected in fluid communication with the drug storage container and configured for insertion into the patient; and wherein the drive mechanism is operatively coupled with the insertion mechanism, such that operation of the drive mechanism releases the rotary deflector member to allow the rotary deflector member to rotate the insertion mechanism cover.

2. The portable drug delivery device according to claim 1, characterized in that the delivery member is operatively coupled with the insertion mechanism cover, such that the initial rotation of the insertion mechanism cover causes the delivery member to be inserted into the patient.

3. The portable drug delivery device according to claim 1, characterized in that it comprises a retainer selectively movable with respect to the insertion mechanism cover, the retainer having a first position in which the retainer is operatively coupled with the insertion mechanism cover to prevent rotation of the insertion mechanism cover and a second position in which the retainer is at least temporarily uncoupled from the insertion mechanism cover to allow rotation of the insertion mechanism cover.

4. The portable drug delivery device according to claim 3, characterized in that the insertion mechanism cover comprises a protrusion, the protrusion coming into contact with the retainer when the retainer is in the first position and not coming into contact with the retainer when the retainer is in the second position.

5. The portable drug delivery device according to claim 4, characterized in that the protrusion extends outwards from a cylindrical portion of the insertion mechanism cover.

6. The portable drug delivery device according to claim 3, characterized in that at least a portion of the retainer moves linearly when moving from the first position to the second position.

7. The portable drug delivery device according to claim 6, characterized in that said at least a part of the retainer moves in a direction perpendicular to a rotation axis of the insertion mechanism cover.

8. The portable drug delivery device according to claim 1, characterized in that at least a portion of the rotating deflection member surrounds at least a portion of the insertion mechanism cover.

9. The portable drug delivery device according to claim 3, characterized in that the drive mechanism is configured to move at least a portion of the retainer with respect to the cover of the insertion mechanism.

10. The portable drug delivery device according to claim 1, characterized in that the rotating deflection member comprises a torsion spring.

11. The portable drug delivery device according to claim 1, characterized in that the delivery member comprises a needle.

12. The portable drug delivery device according to claim 10, characterized in that the needle is hollow.

13. The portable drug delivery device according to claim 1, characterized in that it comprises an adhesive patch disposed on a lower surface of the outer cover for attaching the outer cover to the patient.

14. The portable drug delivery device according to claim 1, characterized in that the outer cover is removably attachable to the patient.

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