Therapeutic agent delivery device with single motor drive - Patent application

Abstract

The therapeutic agent delivery device includes a syringe assembly having a plunger, a drive mechanism, and a shuttle system coupled to a syringe of the syringe assembly. The drive mechanism includes a motor and a lead screw for engaging the plunger, and a controller configured to facilitate distal movement of the shuttle system relative to the syringe assembly and distal movement of the syringe to extend a needle from the therapeutic agent delivery device. The lead screw can drive the plunger to deliver the drug. Rotating the lead screw after driving the plunger can facilitate retraction of the lead screw from the plunger and facilitate proximal movement of the shuttle system and the syringe relative to the syringe assembly. The drive mechanism and shuttle system can be an integral assembly.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 306,130, filed February 3, 2022, which is incorporated by reference in its entirety. [Background technology]

[0002] The present disclosure relates to therapeutic agent delivery devices, and in particular to portable therapeutic agent delivery devices such as syringe pens.

[0003] Patients suffering from several different diseases must frequently inject themselves with medication. To allow a person to conveniently and accurately self-administer medication, various devices, commonly known as syringe pens or injection pens, have been developed. Generally, these pens include a piston and a cartridge containing one or more doses of medication. Typically, the drive member, which extends from within the base of the syringe pen and is operatively connected to the pen's rear mechanism that controls the movement of the drive member, is movable forward to advance the piston within the cartridge in such a manner that a needle, typically at its opposite end, penetrates the plunger to dispense the contained medication from an outlet at the opposite cartridge end. In a disposable pen, when the pen is used to exhaust the supply of medication in the cartridge, the user may discard the entire pen and then begin using a replacement pen. In a reusable pen, when the pen is used to exhaust the supply of medication in the cartridge, the user may disassemble the pen, replace the used cartridge with a new cartridge, and reassemble the pen for subsequent use.

[0004] It would be desirable to provide a therapeutic agent delivery device with improved features for providing a reusable device while simplifying the manufacture of the therapeutic agent delivery device. Summary of the Invention

[0005] According to an embodiment of the present disclosure ("Example 1"), a therapeutic agent delivery device is described having a proximal end and a distal end. The device includes a syringe assembly including a syringe having a plunger, a shuttle system coupled to the syringe, and a drive mechanism including a lead screw. The lead screw has a distal end configured to engage the plunger. The controller is configured to actuate the drive mechanism to move the shuttle system distally relative to the syringe assembly and rotate the lead screw in a first direction to a position that facilitates moving the syringe distally relative to the syringe assembly from a first position to a second position to extend the needle from the distal end of the therapeutic agent delivery device; actuate the drive mechanism to rotate the lead screw in a second direction, where a distal end of the lead screw drives a plunger of the syringe to the second position to deliver the therapeutic agent; actuate the drive mechanism to rotate the lead screw in the first direction after rotating the lead screw in the second direction to retract the distal end of the lead screw from the plunger to facilitate moving the shuttle system and syringe proximally relative to the syringe assembly from the second position toward the first position; and terminate actuation of the drive mechanism to stop rotation of the lead screw after moving the shuttle system and syringe proximally.

[0006] According to an embodiment ("Example 2") of the present disclosure, a plunger drive and syringe movement system is described. The system includes a cam follower, a cam ramp, a one-way clutch coupled to the cam follower, and a carriage coupled to a syringe of a syringe assembly. The system includes a lead screw operably coupled to the cam follower, and a motor. The lead screw includes a distal end for engaging a plunger within the syringe. The motor is operably coupled to the lead screw to drive the lead screw in a first direction and a second direction. Driving the lead screw in the first direction facilitates rotation of the cam follower relative to the cam ramp to a position to allow for a change in displacement of the carriage relative to the cam ramp. Driving the lead screw in the second direction facilitates moving the plunger distally to expel a therapeutic agent contained within the syringe.

[0007] According to an embodiment ("Example 3") of the present disclosure, a method for delivering a therapeutic agent from a therapeutic agent delivery device is provided. The therapeutic agent delivery device has a reusable assembly and a syringe assembly. The method includes one or more of the following steps: Providing a therapeutic agent delivery device in a resting configuration defined by positioning a cam follower of the device at a first position on a plateau portion of a cam ramp; Rotating the cam follower to a second position relative to the cam ramp within a valley portion of the cam ramp, thus displacing a shuttle assembly of the device to drive a syringe of the syringe assembly distally relative to the therapeutic agent delivery device to a deployed configuration; Driving a lead screw distally along a longitudinal axis of the therapeutic agent delivery device such that the lead screw displaces a plunger of the syringe to the deployed configuration to dispense the therapeutic agent.

[0008] The above and other advantages and objects of the present invention, and the manner in which they are accomplished, will become more apparent, and the invention itself will be better understood, by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a top perspective view of a therapeutic agent delivery device according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a front perspective view of the therapeutic agent delivery device of FIG. 1. [Diagram 3] 2 is a top perspective view of a syringe assembly portion of the therapeutic agent delivery device of FIG. 1. [Figure 4] FIG. 2 is an exploded view of the therapeutic agent delivery device of FIG. 1. [Diagram 5] 2 is a top perspective view of various internal components of the therapeutic agent delivery device of FIG. 1. [Figure 6] FIG. 6 is a cross-sectional view of the internal components of the therapeutic agent delivery device of FIG. 5. [Figure 7] 2 is a schematic representation of the electronics assembly of the therapeutic agent delivery device of FIG. 1. [Figure 8]FIG. 2 is a cross-sectional view of the drive mechanism of the therapeutic agent delivery device of FIG. 1. [Figure 9A] 2 is a top perspective view of a portion of the drive mechanism of the therapeutic agent delivery device of FIG. 1. [Figure 9B] FIG. 9B is a cross-sectional view of a portion of the drive mechanism shown in FIG. 9A. [Figure 10A] 2 is a top perspective view of a portion of the drive mechanism of the therapeutic agent delivery device of FIG. 1. [Figure 10B] FIG. 10B is a cross-sectional view of a portion of the drive mechanism of FIG. 10A. [Figure 11A] 2 is a top perspective view of a portion of the therapy delivery device of FIG. 1. [Figure 11B] FIG. 11B is a cross-sectional view of a portion of the therapy delivery device shown in FIG. [Figure 12A] FIG. 13 is a cross-sectional view of a drive mechanism of a therapy delivery device in a first position. [Figure 12B] FIG. 13 is a cross-sectional view of a drive mechanism of a therapy delivery device in a second position. [Figure 13A] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance. [Figure 13B] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance. [Figure 13C] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance. [Figure 13D] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance. [Figure 13E] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance. [Figure 13F] 1 illustrates cross-sectional views of a therapeutic delivery device through various steps of delivering a therapeutic substance.

[0010] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale and certain features may be exaggerated or omitted in some of the drawings to better illustrate and explain the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The therapeutic agent delivery device according to the present disclosure carries and dispenses one or more therapeutic agents, which may also be referred to as drugs or medications, which may include, for example, epinephrine, anesthetics, analgesics, steroids, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, GIP / GLP-1 combined agonists such as tirzepatide, basal insulin, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, including but not limited to IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, therapeutic agents for pain-related treatments such as galcanezumab or lasmiditan, or lebrikizumab, and any therapeutic agent that may be delivered by the devices described herein. Therapeutic agent delivery devices according to the present disclosure are generally operated by a user (e.g., a health care professional, a caregiver, or another person) in the manner described herein to deliver one or more therapeutic agents to a patient (e.g., another person or user).

[0012] Any directional references used with respect to any of the drawings, such as right or left, up or down, or top or bottom, are intended for convenience of description and are not intended to limit the disclosure or any of its components to any particular location or spatial orientation. It should be noted that although rotation may be described herein with respect to a clockwise or counterclockwise direction, rotation should not be limited to the particular direction described, as mechanical components may be arranged to function when certain components are rotating in the opposite direction. To this end, rotation in a first direction or a second direction may be used to refer to either a clockwise or counterclockwise direction.

[0013] 1-2 illustrate a therapeutic agent delivery device 100 according to an exemplary embodiment of the present disclosure. Illustratively, the therapeutic agent delivery device 100 has a syringe pen-like shape, although other shapes may alternatively be used. The therapeutic agent delivery device 100 generally includes a reusable part 102, which may also be referred to as a drive part, and a disposable part 104, which may also be referred to as a drug-carrying part or cartridge. The reusable part 102 facilitates delivery of a therapeutic agent 106 (FIG. 6). In addition, the disposable part 104 removably couples to the reusable part 102 such that the disposable part 104 can be removed from the reusable part 102 and discarded after the therapeutic agent 106 has been delivered from the disposable part 104. Another disposable part (not shown, e.g., having the same or different features as the disposable part 104) is then attached to the reusable part 102, thereby preparing the therapeutic agent delivery device 100 for subsequent use. The parts of the disposable part 104 are further described with reference to FIG. 3. The therapeutic agent delivery device 100 includes a proximal end 108 and a distal end 110 opposite the proximal end 108. During use of the therapeutic agent delivery device 100, the proximal end 108 is further from the patient and configured to be actuated by a user, and the distal end 110 is closer to the patient and configured to deliver a therapeutic agent to the patient. The therapeutic agent delivery device 100 also includes a longitudinal axis L extending between the proximal end 108 and the distal end 110. FIGS. 1-2 additionally illustrate various internal components of the therapeutic agent delivery device 100 in phantom. For example, a reusable portion housing 112 in the portion 102 having components of a drive mechanism 116 and a portion of a syringe assembly 118 (FIG. 3) are shown in phantom within the therapeutic agent delivery device 100, as will be further described below with reference to FIGS. 4-5.

[0014] FIG. 3 illustrates a perspective view of an exemplary embodiment of a portion of the disposable portion 104 of the therapeutic agent delivery device 100. More specifically, FIG. 3 illustrates the syringe 119 of the syringe assembly 118 (FIG. 4). The syringe assembly 118 includes a rigid needle protection portion at the distal end 121 of the syringe 119 to shield the needle or other carrier for the therapeutic agent prior to deploying the syringe assembly 118. In this manner, during use of the therapeutic agent delivery device 100, the patient, physician, or user may deploy a needle or other carrier for the agent within the syringe assembly 118 to deliver the therapeutic agent, the disposable portion 104 may be disposed, and a new disposable portion 104 may be replaced within the reusable portion 102. However, various other embodiments of the disposable portion 104 may be incorporated using the reusable portion 102.

[0015] The above-described configuration of the therapeutic agent delivery device 100 provides the advantage that one portion, i.e., the reusable portion 102, may house circuits or other components that may be more expensive and may be maintained for use. For example, the therapeutic agent delivery device 100 may be a delivery device for injecting insulin or other diabetes treatments. The patient may inject the therapeutic agent from the disposable portion 104 of the device 100, which is disposed on and removed from the therapeutic agent delivery device 100, and the reusable portion 102 is maintained for further use. This may reduce costs for the manufacturer as well as the patient or user. However, in various other embodiments, the entire therapeutic agent delivery device 100 may be disposable, which may mean only one use. The therapeutic agent delivery device 100 and its internal components are further described herein.

[0016] With specific reference to the exploded view of FIG. 4, various components of the therapeutic agent delivery device 100 will be described. As illustrated, at the proximal end 108 of the device 100, the device 100 includes an outer frame 113. As previously described, the device 100, and thus the outer frame 113, may have a pen-like shape. The outer frame 113 includes a user ejector input 161 for ejecting the syringe assembly of the disposable part 104 as needed, such as after delivering the therapeutic agent. The user ejector input 161 is illustrated as being positioned on a side wall of the outer frame 113, but may have various other configurations, such as on a proximal-most surface of the outer frame 113 or on various sides of the outer frame 113. Additionally, the housing 112 of the reusable part 102 is an internal frame that may be received within the outer frame 113 of the device 100. More specifically, the outer frame 113 may be generally cylindrical in shape and may define an interior region for receiving the housing 112 and various internal components of the reusable part 102 .

[0017] 4 and 6, the syringe assembly 118 includes an assembly housing 141 that surrounds the syringe 119. The assembly housing 141 may include a proximal portion 143 and a distal portion 145 that mate with one another. The proximal portion 143 is a tubular body sized to fit over the flange 111 and the barrel 135 of the syringe 119. The distal portion 145 is a tubular body sized to fit over the barrel 135 of the syringe 119. The proximal portion 143 is shown having a distal end opening sized to receive the proximal end of the distal portion 145 to define a sealed housing for the syringe. A base cap 149 is removably coupled to the distal end of the distal portion 145. The base cap 149 is configured to be withdrawn by a user prior to use of the device. A base cap 149, which is secured to the rigid needle guard at the distal end 121 of the syringe 119, is configured to, when withdrawn, simultaneously detach the rigid needle guard from the needle 120, thereby exposing the needle for use. A retraction biasing member 117, shown in its expanded configuration in FIG. 6, is positioned between a proximally facing edge of the distal portion 145 and the flange 111 of the syringe 119, within the annular space defined between the inside of the proximal portion 143 and the outer surface of the syringe barrel 135.

[0018] The reusable part 102 includes a shuttle system 109 (see FIG. 8 ). In one embodiment, the shuttle system 109 is coupled to a syringe assembly 118 and configured to move the syringe 119 at least in a distal direction relative to the syringe assembly 118 and the housing 112, and may also be configured to move the syringe 119 in a proximal direction. The shuttle system 109 may include a carriage 146, a coupling tube 182, a clutch 158 that receives an insertion bias member 159, a cam follower 156 coupled to the clutch 158, and a guide housing, also referred to as a guide 160, positioned radially relative to the cam follower 156.

[0019] The reusable part 102 includes a drive mechanism 116, a portion of which is shown in Figures 10A-10B. In one embodiment, the drive mechanism includes a gear train 150 positioned within a carriage 146, a lead screw 180 and at least one actuator 148 extending from the carriage 146, and a nut 154. The actuator includes a drive shaft that is controllably rotated by input from a controller. As described below, the drive mechanism can be actuated to move the lead screw in a proximal or distal direction.

[0020] While the shuttle system 109 and the drive mechanism 116 may be different assemblies coupled to a housing, they may also be integrated into a single subassembly, for example as shown in FIG. 8. To this end, the description herein may refer to the components of the drive mechanism 116 and the shuttle system 109 as belonging to one or the other. For example, the carriage 146 may also be referred to herein as a motor shuttle, since the actuator is mounted to the carriage, the gear train 150 and the nut 154 may be positioned within the carriage 146, and the lead screw 180 extends through the carriage 146 and into the coupling tube 182. The user input 105 may be coupled to the outer frame 113 at a proximal end to enclose the components of the drive mechanism 116 with the outer frame 113 and thus the device 100. The input 105 may be a movable button or a touch / pressure surface for initiating actuation.

[0021] FIG. 4 shows another embodiment of the housing, referred to as housing 112'. The housing 112 or 112' additionally receives a power source 138, shown as at least one battery 139, which may be positioned adjacent to a syringe assembly carrier 129 coupled to the housing 112'. The syringe assembly carrier 129 and the syringe carrier housing 125 coupled to the housing 112' are configured together to house the syringe assembly 118. The syringe carrier housing 125 and the carrier 129 may be permanently attached to the housing 112. When inserted into the housing 112', the syringe assembly 118 remains axially and rotationally fixed during operation of the drive mechanism 116. After use, the user may remove and discard the syringe assembly 118 from the housing 112'. The syringe carrier housing 125 may be coupled to a proximal end of the syringe assembly carrier 129 to cover the syringe assembly 118, except for the base cap 149.

[0022] 4, the syringe assembly carrier 129 may include a printed circuit board 127 disposed about a shaft of the syringe assembly carrier 129, and in some embodiments, the syringe assembly carrier 129 may be coupled to components of an electronics assembly, such as, for example, an audio speaker and a charging port used to plug into an energy source to charge a battery 139. The board 127 houses one or more components of an electronics assembly 134, described below. Other portions of the device 100 may include additional circuit boards and electronics assembly components. Additionally, the device 100 includes a disposable portion 104, illustratively a disposable syringe assembly 118. The syringe assembly 118 may be received within the device frame 113, for example, via the syringe carrier 129 as further described herein, and the plunger of the syringe assembly 118 is positioned to be driven by a drive mechanism 116. The shuttle system 109 and drive mechanism 116 are configured to (1) drive the syringe 119 relative to the assembly housing 141 of the syringe assembly 118 and relative to the housing 112 or 112' and frame 113 of the device, and (2) move the plunger to expel the therapeutic agent 106 (FIG. 6). As explained, the syringe assembly 118 as the disposable portion 104 can then be removed and replaced with a separate and / or new disposable syringe assembly. In some embodiments, the entire device may be disposable, with the syringe assembly 118 permanently accompanying the device and not withdrawable.

[0023] 5 and 6, the internal components and other features of the reusable part 102 and the disposable part 104 are further illustrated and described. FIGS. 5-6 show another embodiment of a housing of the reusable part 102, referred to herein as the housing 112, which movably carries a user input 105 (FIGS. 1 and 4) through an outer frame 113 (FIG. 4) and a drive mechanism 116. The user input 105 may be received via mechanical and / or electrical means, e.g., a mechanical switch or an electrical switch. The user input 105 may be actuable (e.g., slidable or depressable) by a user to actuate the drive mechanism 116. The shuttle system 109 and the drive mechanism 116 thereby translate distally in unison relative to the housing 112 or 112′ to drive the syringe 119 relative to the syringe assembly housing of the disposable part 104. More specifically, the shuttle system 109 and the drive mechanism 116 translatably drive the syringe 119 relative to the syringe assembly 118 from a contained configuration to a deployed configuration. In the contained configuration, the needle 120 of the syringe 119 is disposed proximally relative to a distal end 122 of the device housing 112 or 112'. In other words, in the contained configuration, the needle 120 is stored within the therapeutic agent delivery device 100. In the deployed configuration, the needle 120 extends at least partially distally beyond the distal end 122 of the housing 112 or 112'. As a result, in the deployed configuration, the needle 120 is configured to pierce the patient's skin when the distal end of the device contacts the patient's skin to deliver the therapeutic agent subcutaneously. During the deployed configuration, the drive mechanism 116 is actuated to translate the plunger 126 of the syringe 119 distally relative to the syringe barrel 135 of the syringe 119. A plunger 126 carried within a therapeutic agent carrying passage 130 of the syringe 119 is driven distally to expel the therapeutic agent 106 through the needle 120. As illustrated in Figure 6, components of the syringe carrier housing 125 and syringe assembly carrier 129 are missing, leaving the syringe assembly 118 inside the syringe carrier housing 125 and carrier 129 of Figure 4.The retraction biasing member 117 is shown in its expanded configuration and can be loaded during movement of the syringe 119 relative to the syringe assembly 118. The retraction biasing member 117 can be a spring, although a variety of other biasing members can be incorporated. As the syringe 119 moves axially relative to the syringe assembly housing 141, a portion of the syringe 119, e.g., the flange 111, engages the retraction biasing member 117 and loads the retraction biasing member 117 into a compressed configuration for later deployment to assist in retraction of the syringe 119 relative to the assembly housing 141. Additional details of these components are provided below. Retraction of the syringe 119 and the lead screw 180 is described below.

[0024] 7, the device 100 may also include a securing mechanism 132 for selectively securing the disposable portion 104 to the reusable portion 102. The securing mechanism 132 also facilitates easy attachment and removal of the disposable portion 104 to and from the reusable portion 102. In addition to the above components, the therapeutic agent delivery device 100 also includes an electronics assembly 134 that facilitates operation of the device 100 in the manner described herein. The electronics assembly 134 includes an electronic controller 136 that is operably coupled to and receives power from a power source 138, such as a battery. The electronic controller 136 is also operably coupled to a user input 114 and one or more sensors 140. As described in more detail below, the sensors 140 may sense, for example, the actuation of components of the device 100, the position of the components of the device 100 relative to one another, and / or the position of the device 100 relative to the patient.

[0025] Components of the electronics assembly 134 may also be carried by either of the parts 102, 104. In some embodiments, some components of the electronics assembly 134 are carried by the reusable part 102 and some components are carried by the disposable part 104 (both shown in Figures 1 and 2), as described in more detail below. For example, the disposable part 104 may include an identifier 142 (e.g., an RFID transmitter or an EEPROM) to facilitate providing characteristics of the therapeutic agent 106 to the reusable part 102. Such characteristics may include, for example, the type and / or amount of the therapeutic agent 106 carried by the syringe assembly 118. The reusable part 102 may use the characteristics of the therapeutic agent 106 to determine, for example, whether a patient associated with the reusable part 102 is authorized or prescribed to use the therapeutic agent 106. As another example, the disposable part may include a locking device 144 operably coupled to the controller 136. The locking device 144 may initially prevent the syringe 119 from moving from the stored configuration to the deployed configuration, and the controller 136 may actuate the locking device 144 to allow the syringe 119 to move from the stored configuration to the deployed configuration. In other embodiments, each of the components of the electronics assembly 134 is carried by the reusable part 102. In some embodiments, the controller 136 is operably coupled to one or more of the other components of the electronics assembly 134 by a wired connection. In some embodiments, the controller 136 is operably coupled to one or more of the other components of the electronics assembly 134 by a wireless connection.

[0026] The electronics assembly 134 includes at least one processor that executes software and / or firmware stored in a memory (not shown) of the device 100. The software / firmware code includes instructions that, when executed by the processor, cause the system controller 136 to perform the functions described herein. The at least one processor includes control logic / applications operable to implement the operations described herein, including detection of device information, such as the dose delivered by the device based on detection of the displacement of the sensed element relative to the housing / sensing element or a change in its state. The processor may be operable to store data in the memory that represents the device information, such as the type, dose, time, and other data detected. The memory is any suitable computer-readable medium that is accessible by the processor. The memory may be a single storage device or multiple storage devices, may be located internal or external to the processor, and may include both volatile and non-volatile media. Exemplary memory includes random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, magnetic storage, optical disk storage, or any other suitable medium configured to store data and accessible by a processor. Electronics assembly 134 may include a display (not shown) by which at least a portion of the device information or other information may be visually and / or audibly indicated. The display may be an LED display, or an LCD, or other known form of device display.The electronics assembly 134 may include a communication module (not shown) that is further operable to transmit and / or receive signals representing device information to and from a wirelessly paired remote electronic device, such as a user's smartphone or a cloud or server, via Bluetooth low energy (BLE) or other suitable short-range or long-range wireless communication protocols, such as near-field communication (NFC), WIFI, or cellular networks. Similar to the device 100, the remote electronic device (not shown) may include a processor, memory, communication devices, and may further include a display for a user interface. The remote electronic device may include a mobile device, such as a smartphone. Alternatively, any suitable computing device may be used, including, but not limited to, a laptop, desktop, tablet, or server computer.

[0027] 8, a cross-section of various internal components of the drive mechanism 116 and shuttle system 109 is shown. Specifically, a carriage 146, also referred to as a motor shuttle, is translatably carried within the housing 112' (FIG. 4) or housing 112 (FIG. 5) of the reusable part 102. The carriage 146 carries an actuator 148 that is operably coupled to the electronic controller 136. The actuator 148 may be a rotary actuator, more specifically, an electric motor, that is drivingly coupled to a transmission or reducer.

[0028] 9A-10B, the actuator 148 is drivingly coupled to a gear train 150. The gear train 150 may comprise a single gear or, as shown, a first gear 152, which is drivingly coupled to a second gear 153 rotationally fixed to a nut 154, also referred to herein as a drive nut, such that movement of the first gear 152 and the second gear 153 rotates the nut 154 about a rotation axis R1 (FIG. 12A) that is substantially parallel (i.e., parallel ±10 degrees) to the longitudinal axis L of the device 100. The axis L may be coaxial with the axis R1. The nut 154 is operably coupled to a lead screw 180, also referred to as a drive screw, that extends along the longitudinal axis L (FIG. 1) within the device 100. The gear train 150 is positioned at least partially within a carriage 146, which includes an axial through opening 189, also referred to as a bore, aligned with a passageway 190 of the nut 154 for receiving the lead screw 180 and the coupling tube 182. As best illustrated in FIG. 10B, the passageway 190 of the nut 154 is threaded such that there is a threaded engagement between the nut 154 and the lead screw 180 when the therapeutic agent delivery device 100 is assembled. The threaded engagement between the nut 154 and the lead screw 180 is configured such that the nut 154 is axially coupled to the lead screw 180 in both axial directions (i.e., proximally and distally). In this manner, rotation of the nut 154 in either a clockwise or counterclockwise direction displaces the lead screw 180 proximally or distally relative to the nut 154 as the lead screw 180 moves proximally and / or distally within the passageway 190. In other words, because the nut 154, the coupling tube 182, and the clutch 158 are rotationally fixed relative to one another, rotation of the nut 154 axially translates the lead screw 180. More specifically, rotation of the nut 154 in a clockwise direction displaces the lead screw 180 in a first direction, such as a proximal direction, along the longitudinal axis L, while rotation of the nut 154 in a counterclockwise direction displaces the lead screw 180 in a second direction, such as a distal direction, along the longitudinal axis L opposite the first direction.

[0029] Distal displacement of the lead screw 180 allows the lead screw 180 to engage the plunger 126 (FIG. 6), such that the interaction of the gear train 150, the actuator 148, the nut 154, and the lead screw 180 may act as a plunger or stopper drive system. Additionally, as shown in FIG. 8, a coupling tube 182 surrounds at least a portion of the lead screw 180 and extends longitudinally from the carriage 146 proximally to the follower 156. More specifically, the coupling tube 182 couples to the follower 156 by receiving a post 181 that extends through the coupling tube 182 and past the follower 156. Thus, in some embodiments, rotation of the lead screw 180 and the coupling tube 182 rotates the follower 156 and the clutch 158. In other words, the nut 154, the coupling tube 182, the lead screw 180, the follower 156, the clutch 158, and the guide 160 are in a coaxial relationship, as described further herein.

[0030] As shown in FIGS. 9A-9B, the carriage 146 includes a body 200 with an actuator mounting portion 202 configured to receive mounting of the actuator 148. In one example, the mounting portion 202 is configured to allow the actuator 148 to be axially oriented along an axis that is offset and parallel to the longitudinal axis L. The carriage 146 may include a gear housing portion 204. The gear housing portion 204 may define a cavity in axially spaced relation between a carriage proximal face 206 and a plate 208 that attaches to the carriage proximal face 206 to form a body in which a gear and nut are disposed and capable of rotating. The carriage 146 may also include an at least partially cylindrical shroud 210 extending distally from a carriage body distal face 212 and defined about the longitudinal axis L. The carriage 146 may also include an at least partially cylindrical push member 214 extending distally from the body distal surface 212 and defined about a longitudinal axis L. The push member 214 is shown having a smaller diameter than the shroud 210, thereby disposing the push member within the shroud. The push member 214 may include an at least partially closed distal end 216 defining a push surface for engaging or being engaged with the proximal end of the syringe, specifically the flange 111 of the syringe 119. In one example, a spacer 217 may be disposed inside the proximal portion 143 of the assembly housing 141 along the proximal surface of the flange 111 such that the push surface of the push member 214 directly engages the spacer rather than the flange 111. The spacer may transmit force from the push member 214 to the syringe flange 111, but may protect the flange from a direct impact force of the push member 214 that may damage the syringe. The material of the spacer 217 may have force reducing properties, and some exemplary materials may have a durometer of 0 to 70 (Shore A). Other example materials for the spacer 217 include, but are not limited to, elastomers, polyvinyl chloride, urethane, polytetrafluoroethylene, or other plastics.The spacer 217 is shown having an annular shape with an inner cross-sectional area sized to block the passage of the pusher member 214 and an outer cross-sectional area sized equal to or less than the inner cross-sectional area of ​​the proximal portion 143 of the assembly housing 141. Engagement between the pusher member 214 and the spacer 217 is shown in FIG. 6 , located atop the syringe flange 111. The pusher member 214 may be configured to have a portion inserted distally into the interior of the syringe beyond the flange. A lead screw opening 218 may be defined in the center of the distal end 216 along the axis L, through which the lead screw 180 may move relative to the pusher member.

[0031] 11A-11B, the drive mechanism 116 includes a clutch 158 (FIG. 8) positioned within the follower 156. As previously described, the clutch 158 is fixed to the follower 156 such that rotation of the coupling tube 182 causes the actuator-driven rotation of the nut 154 to rotate the follower 156 in a first direction via the clutch 158. Additionally, the clutch 158 is fixed axially and rotationally with the follower 156 such that axial movement of the clutch 158 rotates the follower 156 and axial movement of the clutch 158 causes the follower 156 to move axially. More specifically, the clutch 158 may be a one-way clutch. In this manner, the clutch 158 only rotates in one rotational direction, e.g., counterclockwise, and only counterclockwise rotation of the coupling tube 182 driven by the actuator 148 rotates and displaces the follower 156 and the clutch 158. To this end, rotation of the coupling tube 182 in the opposite direction, i.e., clockwise, does not result in rotation of the clutch 158 and therefore the follower 156 does not rotate during this phase of operation. This provides an advantage of the actuator 148 being able to provide the actuation required to move the syringe 119 to the deployed configuration and expel the therapeutic agent from the needle 120, as will be further described below with reference to Figures 13A-13F. However, various other embodiments of the clutch may be used. For example, a two-way clutch may be used and various other mechanisms may be incorporated to limit the directionality of the rotation.

[0032] 11A-11B, the follower 156 is movably coupled to a guide 160, also referred to herein as a cam ramp, which is fixed relative to the housing 112 or 112' of the reusable part 102. An insertion biasing member 159 is shown positioned between the follower 156 and the housing 112 (see FIG. 6). Such member 159 in its extended configuration can be engaged between an end cap of the housing 112 and the follower 156, or not engaged with the housing as shown. Although illustrated as a spring, the insertion biasing member 159 can take a variety of other forms, for example, a pulley, a cord, or any other suitable biasing means. The insertion biasing member 159 coupled to the follower 156 (FIGS. 4 and 6) is configured to bias the follower 156 distally into engagement with the guide 160. In general, follower 156 and guide 160 include features that facilitate movement of follower 156 relative to guide 160 as follower 156 rotates about rotation axis R1. Follower 156 may include one or more radial protrusions that movably engage a track defined by a proximally facing surface of guide 160. In the embodiment shown, follower 156 includes at least two radially outwardly extending protrusions 164 that move along an angular track 166 or generally proximally facing wall defined by guide 160 as follower 156 is rotated by actuator 148. Protrusions 164 move simultaneously along two similar sections, or halves, of track 166. 11A , each half of track 166 includes a plateau portion 168 joined to a cliff portion 170 at an edge 172, a valley portion 174 joined to cliff portion 170 opposite plateau portion 168, and a slope portion 176 joined to valley portion 174 opposite cliff portion 170. Each slope portion 176 also joins to a plateau portion 168 on the other half of track 166.

[0033] 11A, the various portions of the track 166 are as follows: The cliff portion 170 is substantially parallel (i.e., parallel ±10 degrees) to the longitudinal axis L of the device 100. The plateau portion 168 and the valley portion 174 are substantially perpendicular (i.e., perpendicular ±10 degrees) to the longitudinal axis L of the device 100. The slope portion 176 extends helically relative to the longitudinal axis L of the device 100.

[0034] In other embodiments, the follower 156 and / or the guide 160 may have different configurations. For example, the track 166 may have a different shape. More specifically, the track 166 may include an additional sloped portion (not shown) instead of the cliff portion 170, and such sloped portion may extend spirally in the opposite direction to the sloped portion 176. As another example, the follower 156 may include a different number of protrusions 164 and / or the guide 160 may include a track 166 with a different number of similar sections. For example, the follower 156 may include at least one protrusion 164. As yet another example, the follower 156 may include a track 166 that movably receives one or more protrusions 164 formed on the guide 160.

[0035] 11A-11B, the follower 156 is displaced distally relative to the guide 160 in the second position when the protrusion 164 of the follower 156 rotates about axis R1 by actuating the actuator 148 as described herein such that the protrusion 164 is no longer positioned in the plateau portion 168 but is instead angularly positioned in the valley portion 174. More specifically, actuation of the actuator 148 rotates the clutch 158 in a clockwise or first direction, thereby rotating the coupling tube 182, which rotates the follower 156. The rotation of the follower 156 then rotationally moves the protrusion 164 (FIG. 11B) along the track 166 about axis R1 such that the protrusion 164 is positioned in the valley portion 174 using the insertion bias member 159 (FIG. 6) to define the second position of the follower 156. The second position of the follower defines a second position of the shuttle system 109 and drive mechanism 116. This actuation of the actuator 148 also slightly retracts the lead screw 180 via the nut 154, releasing the insertion biasing member 159 (FIG. 6), displacing the follower 156, coupling tube 182, carriage 146, and other components of the shuttle system 109 distally relative to the housing, biasing the guide and apparatus by the spring force. Thus, the distal displacement of the follower 156 and clutch 158 displaces the carriage and drive mechanism 116 distally, which includes at least the follower 156, clutch 158, actuator 148, gear train 150, lead screw 180, coupling tube 182, and carriage 146. Distal displacement of the shuttle system 109 and drive mechanism 116 contributes to translation of the syringe 119 relative to the syringe assembly housing 141 to move it distally to the deployed configuration.

[0036] For example, FIG. 12A illustrates the shuttle system 109 and drive mechanism 116 in a first position. More specifically, the first position is defined by the protrusion 164 (FIG. 11A) of the follower 156 positioned on a plateau portion such that the follower 156 is held in an upward or more proximal position relative to the proximal end 108 of the therapeutic agent delivery device 100. As described with reference to FIGS. 11A and 11B, the clutch 158 rotates, causing the follower 156 to rotate about axis R1. This resulting position is shown in FIG. 12B. Illustratively, the clutch 158 and follower 156 are positioned further distally along the longitudinal axis L relative to the positioning of FIG. 12A. In addition to the displacement of the clutch 158 and follower 156, the carriage 146 carrying the gear train 150 is also displaced distally.

[0037] The operation of the therapeutic agent delivery device 100 will now be described in further detail with reference to Figures 13A-13F. Figure 13A illustrates the therapeutic agent delivery device 100 in a starting position, with the shuttle system 109 and drive mechanism 116 in a first position prior to any displacement of the shuttle system and drive mechanism, more specifically, prior to displacement of the follower 156. The insertion biasing member 159 (Figure 6) is in a loaded configuration. The retraction biasing member 117 is in an unloaded configuration (Figure 13B). The actuator drive shaft of the actuator 148 can then be actuated in a clockwise direction, which rotates the first gear 152, the nut 154, and thus the coupling tube 182 in their respective rotational directions. In this manner, the rotation of the follower 156 about the axis R1 causes the projection 164 (Figure 11A) to descend to the valley portion 174 (Figure 11A) of the track 166, as discussed with reference to Figures 11A and 11B. 13B, the shuttle system 109 and corresponding components of the drive mechanism 116 are displaced distally relative to the proximal end 108 of the therapeutic agent delivery device 100. Additionally, this rotates the lead screw 180, releasing the insertion biasing member 159 (FIG. 6) to further assist in displacing the syringe 119 distally. During this movement, the force of the insertion biasing member 159 is greater than the force of the retraction biasing member 117, thereby loading the retraction biasing member 117 and preparing it for the subsequent retraction phase of operation. While the shuttle system 109 moves distally relative to the syringe assembly housing 141 of the syringe assembly 118, the shroud 210 of the carriage engages the proximal end of the syringe assembly 118. The distal end 216 of the pusher member extends into an opening 118a (FIG. 4) disposed at the proximal end of the proximal portion 143 of the syringe assembly 118 to engage a spacer 217 on top of the syringe flange 111 and drive the syringe 119 to move distally relative to the syringe assembly housing. This FIG. 13B positioning defines a second position of the shuttle system 109 and drive mechanism 116 and defines a deployed position of the syringe assembly 118 after the syringe 119 has been distally displaced. More specifically, after the syringe 119 has been distally displaced, the syringe 119 moves distally relative to the syringe assembly housing 141.

[0038] 13C, the actuator shaft of the actuator 148 may then be actuated in a counterclockwise or second direction to drivingly engage and rotate the components of the gear train 150. Due to the threaded engagement between the nut 154 and the lead screw 180, the clockwise rotation of the nut 154 rotates and axially displaces the lead screw 180 distally and along the longitudinal axis L as the lead screw 180 threads axially onto the nut 154. Because the clutch 158 is a one-way clutch, the counterclockwise movement of the actuator 148 does not result in any rotation or axial displacement of the clutch 158 and follower 156. In this manner, the actuator 148 displaces the lead screw 180 distally without displacing the carriage 146. As previously described, the distal displacement of the lead screw 180 while in its deployed position engages and drivingly displaces the lead screw 180 with the plunger 126 of the syringe assembly 118. This then expels the therapeutic agent 106 from the syringe assembly 118. The agent 106 can be expelled completely in a single actuation, or the agent 106 can be delivered multiple times in different acts.

[0039] 13D, once the therapeutic agent 106 has been fully expelled, the actuator shaft of the actuator 148 is again actuated in a clockwise direction. This retracts the lead screw 180 as the nut 154 threadably engages the nut 154 in both axial directions (i.e., proximally and distally). Additionally, the clutch 158 rotates due to the clockwise rotation of the coupling tube 182. Thus, the follower 156, due to its engagement with the clutch, rotates about the axis R1 and again climbs the track 166 of the guide 160, which defines the first position of the follower 156 and the first position of the drive mechanism 116, until the protrusion 164 is again rotationally positioned on the plateau portion 168. Additionally, during movement of clutch 158 and follower 156 and carriage 146 in the proximal direction along longitudinal axis L, syringe 119 is displaced proximally and needle 120 is retracted to a retracted position within syringe assembly 118 and therapeutic agent delivery device 100. Additionally, this releases retraction biasing member 117 (FIG. 13B) to further assist the proximal displacement of syringe 119 within syringe assembly 118 due to spring force.

[0040] 13E, various internal components of the therapeutic agent delivery device 100 are illustrated with the drive mechanism 116 positioned in a first position and the lead screw 180 still displaced distally. Stated another way, the needle 120 has been retracted, but the lead screw 180 has not been fully retracted. Additionally, in this configuration, a lockout feature (not shown) may be implemented to prevent the needle 120 from re-extending from the distal end 110 of the therapeutic agent delivery device 100.

[0041] The actuator shaft of the actuator 148 continues to actuate in a clockwise direction until the lead screw 180 is fully retracted back to its original position and the follower 156 is in the first position such that the syringe assembly 118 is no longer in the deployed configuration. Additionally, this loads the insertion biasing member 159 (FIG. 6) for the next use. This positioning is illustrated in FIG. 13F. Once in this position, actuation and rotation of the actuator 148 may be stopped. The syringe assembly 118 as the disposable part 104 may then be removed from the remainder of the device 100 as previously described, and a new disposable part may be loaded into the device 100. The device 100 may then be used repeatedly to dispense therapeutic agents according to the methods described above.

[0042] As explained above, the use of the one-way clutch 158 in combination with the remaining components of the drive mechanism 116 allows for the use of the therapeutic agent delivery device 100 with a single motor, as opposed to at least two motors that may be required in conventional designs of drug delivery devices. For example, rather than requiring a first motor to place the syringe assembly 118 in a deployed configuration and a second motor to effect displacement of the lead screw and displacement of the plunger to expel the therapeutic agent, the present disclosure allows for one motor to be used to accomplish both functions. This provides various advantages, such as at least the ability to reduce the space required within the therapeutic agent delivery device 100 for internal components. In this manner, the size of the therapeutic agent delivery device 100 may be optimized, enhancing the portability and convenience of the device. Additionally, by reducing the number of motors required, manufacturing costs may be reduced and ease of manufacture and / or assembly may be enhanced.

[0043] While the invention has been illustrated and described as having preferred embodiments, the invention can be modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains.

[0044] Various aspects are described in this disclosure, including but not limited to the following aspects. 1. A therapeutic agent delivery device having a proximal end and a distal end, the therapeutic agent delivery device comprising: a syringe assembly including a syringe having a plunger; a shuttle system coupled to the syringe; a drive mechanism including a lead screw, the lead screw having a distal end configured to engage the plunger; and a controller configured to actuate the drive mechanism to move the shuttle system distally relative to the syringe assembly and to rotate the lead screw in a first direction to a position that facilitates moving the syringe distally relative to the syringe assembly from a first position to a second position to extend a needle from the distal end of the therapeutic agent delivery device; and a controller configured to: rotate the lead screw in a second direction, where a distal end of the lead screw drives a plunger of a syringe to a second position to deliver the therapeutic agent; actuate a drive mechanism to rotate the lead screw in a first direction after rotating the lead screw in the second direction to retract the distal end of the lead screw from the plunger to facilitate proximal movement of a shuttle system and a syringe relative to a syringe assembly from the second position toward the first position; and terminate actuation of the drive mechanism to stop rotation of the lead screw after moving the shuttle system and the syringe proximally. 2. The therapeutic agent delivery device of aspect 1, wherein the shuttle system includes a spring, and wherein rotation of the lead screw in a first direction releases the spring to drive the syringe distally. 3. The therapeutic agent delivery device of aspect 1 or 2, wherein the shuttle system further comprises a clutch operably coupled to the lead screw, a cam follower coupled to the clutch, and a guide positioned radially relative to the cam follower. 4. The therapeutic agent delivery device of aspect 3, wherein the drive mechanism further includes an actuator and a drive nut operably coupled to the actuator, the shuttle system includes a coupling tube coupled between the drive nut and the clutch, and the drive nut, coupling tube, and clutch are rotationally fixed relative to one another. 5. A therapeutic agent delivery device as described in aspect 4, wherein the drive nut includes a threaded bore for engaging along the outside of the lead screw, the lead screw being axially movable in response to rotation of the drive nut. 6. The therapeutic agent delivery device of aspect 4, wherein the drive nut, coupling tube, lead screw, cam follower, and guide are in a coaxial relationship. 7. A therapeutic agent delivery device according to any one of aspects 4 to 6, wherein the clutch is rotationally and axially fixed to the cam follower, and rotation of the clutch in a first direction causes the cam follower to rotate in the first direction and rotation of the clutch in a second direction does not cause the cam follower to rotate in the second direction. 8. A therapeutic agent delivery device according to any one of aspects 4-7, wherein the guide includes a plateau portion and a valley portion disposed distal to the plateau portion, and the shuttle system includes a first position defined by a cam follower protrusion positioned on the plateau portion of the guide and a second position defined by a cam follower protrusion positioned on the valley portion of the guide. 9. A therapeutic agent delivery device according to any one of aspects 4 to 8, wherein the shuttle system includes a carriage translatable within a housing of the therapeutic agent delivery device, the drive mechanism includes a gear train, the carriage carries an actuator, the gear train is coupled between the actuator and a drive nut, and the drive nut is coupled to the clutch and cam follower via a coupling tube. 10. The therapeutic agent delivery device of aspect 9, wherein the carriage includes a push element engageable with the syringe. 11. The therapeutic agent delivery device of aspect 10, wherein the actuator is mounted to the carriage such that the actuator extends along the longitudinal axis of the lead screw. 12. The therapeutic agent delivery device of aspect 10, wherein the carriage includes a distally extending shroud, the shroud being disposed radially outward of the push element. 13. A plunger drive and syringe movement system including: a cam follower, a cam ramp, a one-way clutch coupled to the cam follower, a carriage coupled to a syringe of a syringe assembly, a lead screw operably coupled to the cam follower, the lead screw including a distal end for engaging a plunger within the syringe, and a motor operably coupled to the lead screw to drive the lead screw in a first direction and a second direction, where driving the lead screw in the first direction facilitates rotating the cam follower relative to the cam ramp to a position to enable a change in displacement of the carriage relative to the cam ramp, and driving the lead screw in the second direction facilitates moving the plunger distally to expel a therapeutic agent contained within the syringe. 14. The system of aspect 13, wherein driving the lead screw in a first direction displaces the lead screw proximally and driving the lead screw in a second direction displaces the lead screw distally. 15. The system of aspect 13 or 14, wherein the one-way clutch is configured such that rotating the one-way clutch in a first direction allows the cam follower to rotate in a first direction and rotating the one-way clutch in a second direction prevents the cam follower from rotating in the second direction. 16. The system of any one of aspects 13-15, further including a drive nut operably coupled to the motor and a coupling tube coupled between the one-way clutch and the drive nut, the coupling tube rotationally and axially fixed relative to the drive nut and the one-way clutch, and the drive nut drivingly engaged with the lead screw. 17. The system of aspect 16, wherein the drive nut and motor are coupled to the carriage, the coupling tube and lead screw extend axially from the carriage along the longitudinal axis, and the carriage further includes a push element extending distally along the longitudinal axis. 18. A method for delivering a therapeutic agent from a therapeutic agent delivery device having a reusable assembly and a syringe assembly, the method including: providing a therapeutic agent delivery device in a resting configuration defined by positioning a cam follower of the device at a first position on a plateau portion of a cam ramp; rotating the cam follower relative to the cam ramp to a second position within a valley portion of the cam ramp, thus displacing a shuttle assembly of the device to drive a syringe of the syringe assembly distally relative to the therapeutic agent delivery device to a deployed configuration; and driving a lead screw distally along a longitudinal axis of the therapeutic agent delivery device such that the lead screw displaces a plunger of the syringe to the deployed configuration to dispense the therapeutic agent. 19. The method of embodiment 18, wherein driving the syringe distally comprises positioning a needle of the syringe distally beyond a distal end of the therapeutic agent delivery device. 20. The method of aspect 19, wherein the method further includes the step of rotating the cam follower relative to the cam ramp from the second position to the first position, thus displacing the shuttle assembly to enable the syringe of the syringe assembly to move proximally relative to the therapeutic agent delivery device from the deployed configuration to the contained configuration. 21. The method of any one of aspects 18-20, wherein the reusable assembly includes a one-way clutch operably coupled to the cam follower such that distal driving of the lead screw does not rotate the cam follower. 22. The method of any one of aspects 18-21, wherein the method further comprises the step of removing the syringe assembly from the therapeutic agent delivery device to allow for replacement of the syringe assembly. 23. The device of any one of aspects 1-12, wherein the syringe assembly comprises a reservoir containing the therapeutic agent.

Claims

1. 1. A therapeutic agent delivery device having a proximal end and a distal end, a syringe assembly including a syringe having a plunger; a shuttle system coupled to the syringe, the syringe being movable distally in response to distal movement of the shuttle system; and a drive mechanism comprising a lead screw having a distal end configured to engage the plunger, the shuttle system being movably coupled to the lead screw, the shuttle system being movable distally in response to rotation of the lead screw in a first direction; Controller and Equipped with The controller: actuating the drive mechanism to rotate the lead screw in the first direction to move the shuttle system distally relative to the syringe assembly and move the syringe distally from a first position to a second position relative to the syringe assembly to extend a needle from the distal end of the therapeutic agent delivery device; actuating the drive mechanism to rotate the lead screw in a second direction opposite to the first direction, wherein the distal end of the lead screw drives the plunger of the syringe to the second position to deliver a therapeutic agent; after rotating the leadscrew in the second direction, actuating the drive mechanism to rotate the leadscrew in the first direction to retract the distal end of the leadscrew from the plunger and move the shuttle system and the syringe proximally relative to the syringe assembly from the second position toward the first position; terminating actuation of the drive mechanism to stop rotation of the lead screw after the shuttle system and the syringe have been moved proximally. The therapeutic agent delivery device is configured to:

2. The therapeutic agent delivery device of claim 1 , wherein the shuttle system includes a spring, and wherein rotation of the lead screw in the first direction releases the spring to drive the syringe distally.

3. 3. The therapeutic agent delivery device of claim 1 or 2, wherein the shuttle system further comprises a clutch operably coupled to the lead screw, a cam follower coupled to the clutch, and a guide positioned radially relative to the cam follower.

4. 4. The therapeutic agent delivery device of claim 3, wherein the drive mechanism further comprises an actuator and a drive nut operably coupled to the actuator, the shuttle system comprises a coupling tube coupled between the drive nut and the clutch, and the drive nut, the coupling tube, and the clutch are rotationally fixed relative to one another.

5. 5. The therapeutic agent delivery device of claim 4, wherein the drive nut includes a threaded bore for engaging along an exterior side of the lead screw, the lead screw being axially movable in response to rotation of the drive nut.

6. The therapeutic agent delivery device of claim 4 , wherein the drive nut, the coupling tube, the lead screw, the cam follower, and the guide are in a coaxial relationship.

7. 5. The therapeutic agent delivery device of claim 4, wherein the clutch is rotationally and axially fixed to the cam follower, and wherein rotation of the clutch in the first direction causes the cam follower to rotate in the first direction and rotation of the clutch in the second direction causes the cam follower not to rotate in the second direction.

8. 5. The therapeutic agent delivery device of claim 4, wherein the guide comprises a plateau portion and a valley portion disposed distal to the plateau portion, and the shuttle system includes a first position defined by a protrusion of the cam follower positioned at the plateau portion of the guide and a second position defined by the protrusion of the cam follower positioned at the valley portion of the guide.

9. 5. The therapeutic agent delivery device of claim 4, wherein the shuttle system comprises a carriage translatable within a housing of the therapeutic agent delivery device, the drive mechanism comprises a gear train, the carriage carries the actuator, the gear train is coupled between the actuator and the drive nut, and the drive nut is coupled to the clutch and the cam follower via the coupling tube.

10. The therapeutic agent delivery device of claim 9 , wherein the carriage includes a push element engageable with the syringe.

11. The therapeutic agent delivery device of claim 10 , wherein the actuator is mounted to the carriage such that the actuator extends along a longitudinal axis of the lead screw.

12. The therapeutic agent delivery device of claim 10 , wherein the carriage includes a distally extending shroud, the shroud disposed radially outward of the pusher element.

13. The device of claim 1 or 2, wherein the syringe assembly comprises a reservoir containing a therapeutic agent.

14. 1. A plunger actuation and syringe movement system comprising: a cam follower, a cam ramp, a one-way clutch coupled to the cam follower, a carriage configured to couple to a syringe of a syringe assembly, and a coupling tube coupling the cam follower to the carriage and distally movable in response to rotation of the cam follower. a lead screw operably coupled to the cam follower, the lead screw having a distal end for engaging a plunger within the syringe; and a motor operably coupled to the lead screw to drive the lead screw in a first direction and a second direction; driving the lead screw in the first direction to rotate the cam follower to a position relative to the cam ramp to allow a change in displacement of the carriage relative to the cam ramp and a distal movement of the syringe; A plunger actuation and syringe movement system, wherein said driving of said lead screw in said second direction causes said plunger to move distally and expel a therapeutic agent contained within said syringe.

15. 15. The system of claim 14, wherein said driving the lead screw in the first direction displaces the lead screw proximally and said driving the lead screw in the second direction displaces the lead screw distally.

16. 16. The system of claim 14 or 15, wherein the one-way clutch is configured such that rotating the one-way clutch in a first direction allows the cam follower to rotate in the first direction and rotating the one-way clutch in a second direction prevents the cam follower from rotating in the second direction.

17. 16. The system of claim 14 or 15, further comprising a drive nut operably coupled to the motor and a coupling tube coupled between the one-way clutch and the drive nut, the coupling tube being rotationally and axially fixed relative to the drive nut and the one-way clutch, and the drive nut drivingly engaged to the lead screw.

18. 18. The system of claim 17, wherein the drive nut and the motor are coupled to the carriage, the coupling tube and the lead screw extend axially from the carriage along a longitudinal axis, and the carriage further comprises a push element extending distally along the longitudinal axis.

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