Delivery device for precision injections

Abstract

A delivery device may be for a syringe having a syringe barrel and a plunger. The delivery device may include: a housing; a syringe holder configured to secure the syringe barrel; a motor received in the housing; a lead screw configured to be rotated by the motor; a threaded nut configured to be move longitudinally over the lead screw to advance the plunger through the syringe barrel; and a frame disposed in the housing along the lead screw. An actuator may be positioned along an outer surface of the syringe holder. A longitudinal axis of the syringe holder may be offset and parallel to a longitudinal axis of the housing.

Description

West ref. 202300044-WO DELIVERY DEVICE FOR PRECISION INJECTIONS Cross Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 609,470, filed December 13, 2023, the entirety of which is incorporated herein for any and all purposes. Technical Field

[0002] This disclosure relates generally to systems and methods for penetration devices with medical applications, and more particularly direct to systems and methods for precise injections. Background

[0003] Penetration devices such as needles are often used to inject medicament into cavities. Some injections involve delivery of high viscous drug products into small volumes, such as in retinal drug delivery. Summary

[0004] The present inventors realize that delivery or injection of high viscosity drug products through high gauge needles may require significant manual force sometimes higher than 20N that is unsafe for manual injections especially into tissues such as the eye. Sub-optimal dosing is another significant challenge in high viscous drug products due to poor user control in performing these injections.

[0005] The foregoing needs are met by the various embodiments as disclosed herein.

[0006] An aspect of the present disclosure is directed to a drug delivery having a delivery device for a syringe having a syringe barrel and a plunger. The delivery device may include: a housing; a syringe holder configured to secure the syringe barrel; a motor received in the housing; a lead screw configured to be rotated by the motor; a threaded nut configured to be move longitudinally over the lead screw to advance the plunger through the syringe barrel; and a frame disposed in the housing along the lead screw.

[0007] The delivery device may include one or more of the following features. The delivery device may include an actuator positioned along an outer surface of the syringe holder. A longitudinal axis of the syringe holder may extend along a longitudinal axis of the housing. The longitudinal axis of the syringe holder may be offset and parallel to the longitudinal axisWest ref. 202300044-WO of the housing. The syringe holder may include an alignment member fixed to the housing, a locking member movably attached to the alignment member, and a drive member attached to the thread nut and configured advance the plunger through the syringe barrel. The locking member may be pivotably attached to the alignment member. The locking member may have a first portion configured to receive the syringe barrel and a second portion disposed laterally of the first portion and configured to be supported by a hand of a user. The delivery device may include an actuator disposed on the alignment member. The delivery device may include one or more inputs positioned on a side surface of the housing. The delivery device may include a first printed circuit board (PCB) and a second PCB disposed in a parallel orientation. The frame may include a first frame member and a second frame member extending along the lead screw, wherein the first PCB and the second PCB are disposed in a parallel orientation with at least one of the first frame member and the second frame member. The first PCB and the second PCB may be separated by less than 5 millimeters. The delivery device may include a communication device disposed between the first PCB and the second PCB. The first PCB may be attached to at least one of a controller, a charger, a communication device, and / or a secondary power connection, and the second PCB may be attached to at least one of a boost converter, a motor driver, and / or an input driver. The delivery device may include a rigid-flex connector connecting the first PCB and the second PCB. The motor may be a stepper motor. The delivery device may include an optical encoder built into the motor.

[0008] Another aspect of the present disclosure is directed to a system including the delivery device and a syringe received in the syringe holder

[0009] Yet another aspect of the present disclosure is directed to a delivery device for a syringe having a syringe barrel and a plunger. The delivery device may include: a housing; a syringe holder configured to secure the syringe barrel, the syringe holder including an alignment member fixed to the housing, a locking member movably attached to the alignment member, and a drive member configured advance the plunger through the syringe barrel; a motor received in the housing and configured to advance the plunger through the syringe barrel; a lead screw configured to be rotated by the motor; a threaded nut attached to the drive member and configured to be move longitudinally over the lead screw; a frame disposed in the housing along the lead screw; and an actuator disposed on the alignment member.West ref. 202300044-WO

[0010] The delivery device may include one or more of the following features. A longitudinal axis of the syringe holder may be offset and parallel to the longitudinal axis of the housing. The locking member may form a vertical extension configured to extend past a flange of the syringe barrel and be configured to be supported by a thenar web space of a hand.

[0011] Even another aspect of the present disclosure is directed to a method of using the delivery device including receiving the syringe holder in a hand of a user; supporting the locking member by a thenar web space of the hand of the user; and pressing the actuator with a forefinger of the hand to draw a substance in the syringe and / or expel a substance from the syringe.

[0012] The present application is further understood when read in conjunction with the appended drawings. For the purpose of illustrating the subject matter, there are shown in the drawings exemplary embodiments of the subject matter; however, the presently disclosed subject matter is not limited to the specific methods, devices, and systems disclosed. In the drawings:

[0013] FIG. 1 illustrates an isometric view of a system including a syringe and delivery device, according to the present disclosure.

[0014] FIG. 2 illustrates the system of FIG. 1 drawing a medicament from a container.

[0015] FIG. 3 illustrates a side view of the syringe of FIGS. 1 and 2.

[0016] FIG. 4 illustrates an isometric view of the delivery device of FIGS. 1 and 2.

[0017] FIG. 5 illustrates an exploded view of the delivery device of FIGS. 1, 2 and 4.

[0018] FIG.6 illustrates an isometric view of internal components of the delivery device of FIGS. 1, 2, 4, and 5.

[0019] FIG. 7 illustrates an isometric view of an assembly of printed circuit boards of the delivery device of FIGS. 1, 2, and 4-6.

[0020] FIG.8 illustrates another isometric view of the delivery device of FIGS. 1, 2 and 4-7.

[0021] FIG. 9 illustrates a processing chart for the delivery device of FIGS. 1, 2 and 4-8.

[0022] FIG. 10 illustrates a partial internal view of the delivery of FIGS. 1, 2, and 4-6.

[0023] FIG. 11 illustrates an isometric view of a delivery device according to another aspect of this disclosure.

[0024] FIG. 12 illustrates another isometric view of the delivery device of FIG. 11.West ref. 202300044-WO

[0025] FIG. 13 illustrates an isometric view of a delivery device according to another aspect of this disclosure.

[0026] FIG. 14 illustrates another isometric view of the delivery device of FIG. 13.

[0027] Aspects of the disclosure will now be described in detail with reference to the drawings, wherein like reference numbers refer to like elements throughout, unless specified otherwise. Detailed of Illustrative Embodimentsand handheld automatic injector device for drug preparation and precise delivery of medicaments in various routes of administration. The injector device may be electromechanically-driven stepper-motor that solves challenges during manual injection of high viscous drug products.

[0029] The injector device may also provide a more accurate dosing, in reducing air bubbles during the manual fill process and preventing imprecise plunger alignment during manual priming, etc. Trapped air and imprecise volumes are especially challenging in small volume and / or highly viscous injections. The issue of air bubble formation during manual preparation of high viscous drugs with needles of 30 gauge and higher gauge is more severe than those seen in lower gauge needles due to the difficulty in getting rid of these bubbles through these narrow needle gauges. During preparation or priming air-bubbles tend to be trapped inside highly viscous drug products which are difficult to get rid of manually. The problem is particularly challenging in ophthalmology and retinal drug delivery that involves small volume and highly viscous injections, but the present disclosure is not limited to this route of administration. The present disclosure may additionally be applied to subcutaneous, intravenous, intramuscular, intrathecal, intraarticular, and / or intraparenchymal injections

[0030] The injector device may be for filling of products not limited to high viscous drug products, such as those of greater than 5 centipois (cP), and but mostly greater than 100cp, and / or low or ultra-low volume products (10ml) from a primary container. The primary container may be a vial, a syringe and / or a cartridge or any form of drug container. The automated precise injection via the appropriate route of administration into the tissue compartment or cavity of space.

[0031] In some applications, the suprachoroidal space (SCS) has been explored as a potential site for drug delivery to target the back of the eye, called the posterior segment. The posterior segment has several associated diseases that benefit from drug treatment, and drugWest ref. 202300044-WO delivery via the SCS has been shown to be more effective than direct intravitreal injections to the posterior segment. However, solid precise access to micrometer-scale tissue layers using needles is a challenging problem in the precision delivery of drugs. In sub-retinal injections it is critical to avoid injecting air into subretinal space. Injecting large air bubbles add extra volume into the subretinal space, and can displace high value gene therapy from the target tissues. This may cause a macular hole or damage the retina or retinal pigment epithelial cells. Air bubbles may be difficult to remove in such small volumes, and high precision is often required for priming. Injecting air bubbles during intravitreal injections can result in suboptimal intraocular pressure. Imprecise volumes from the air bubbles can also result in sub-optimal dosing of these drug products to patients. Since the injection volume in thevitreous humor is limited by an increase in intraocular pressure (IOP) and 50–typically used for most intravitreally (IVT) applied commercial products. The present disclosure is also configured for other routes of administration not limited to subcutaneous, intravenous, intramuscular, intrathecal, intraarticular, and intraparenchymal.

[0032] FIGS. 1-8 illustrates a system 10 including a syringe 100 and a delivery device 200. The syringe 100 may be attached to the delivery device 200, and the delivery device 200 and / or the syringe 100 may be handled and actuated by a user to deliver or inject a medicament from the syringe 100. In some embodiments, the syringe 100 may be a prefilled syringe. In some embodiments, the delivery device 200 may be configured to draw the medicament from a container 300 into the syringe 100 prior to delivery, as illustrated in FIG. 2. The system 10 may perform the drawing and / or the delivery automatically to provide improved reliability in the

[0033] As illustrated for example in FIG. 3, the syringe 100 may include a syringe body 102, a plunger rod 104, and a needle 106. The syringe 100 may be any type of injection device, including syringes and / or cartridges (one of ordinary skill understands that the terms “syringe” and “cartridge” can be used interchangeably, with the term “syringe” being used herein predominantly for sake of brevity) of various designs. As illustrated, the syringe body 102 may have a syringe barrel 108 extending from a proximal end to a distal end along a longitudinal direction. The syringe body 102 may further have a syringe tip 110 on a distal portion and a body flange 112 on a proximal portion. The syringe barrel 108 may be tubular or substantially cylindrical having an inner surface extending along the longitudinal direction to define a chamber 114. The chamber 114 may be configured to receive, store, and / or mix aWest ref. 202300044-WO medicament 115 for dispensing through a distal opening of the syringe tip 110. The plunger rod 104 may have an elongate body 116 and a plunger flange 118 at a proximal end of the elongated body 116 configured to be actuated. A stopper 120 may be disposed at a distal end of the plunger rod 104 for sealing the proximal end of the chamber 114 and be configured to push the medicament 115 from the chamber 114 through the needle 106. The needle 106 may be attached to a needle hub 122 that may be removably attached to the syringe tip 110. The syringe body 102 may be composed of a cyclic olefin polymer, such as Crystal Zenith® manufactured by Daikyo Seiko, Ltd. The needle 106 may have a small diameter, of 30 gauge orsome may be filled with the medicament 115 and packaged as a pre-filled syringe ready to be used after unpackaging. Thus, the system 10 may be used for delivery of the medicament 115 into the tissue compartment of choice without performing the filling step. However, the system 10 is not limited to when the medicament 115 is pre-filled. For example, the delivery device 200 may be configured for bidirectional flow to and / or from the container 300. The container 300 may be a vial, an ampoule, a cartridge, a tissue culture well plates, a Petri dishes, or other forms of containment for drugs products. For example, as illustrated in FIG. 2, the delivery device 200 may be configured to draw a dose of the medicament 115 by puncturing a seal of a vial 300 with the needle 106, and be configured to draw a dose of the medicament 115 with precise accuracy prior to injection of the dose.

[0035] The medicament 115 may include one or more of small molecules, biologics or biologicals not limited to peptide, protein or monoclonal antibodies, or antibody drug conjugates, gene therapies. The medicament 115 may be for viral vector-based gene therapies and not limited to adeno-viral, lentiviral or other carrier-based therapies such as Lipid Nanoparticle (LNP), microparticle, hydrogel, aqueous and non-aqueous vehicle-based therapies, and cell-based drug products. The medicament 115 may be distinct types of cells (e.g., CAR-T, neurons, retinal pigment epithelial cells, epidermal cells, fibroblasts, myoblasts, cardiomyoblasts, iPSCs, adipose derived stem cells, mesenchymal stem cells) or to their stage of differentiation or their source of production. Cell-based drug products may also include exosomes, or other cell-derived drug products, extracellular matrix (ECM) and ECM components (laminin, collagen, heparin sulfate proteoglycans, actin) or cellular assemblies or aggregates, scaffolds and tissue engineered medicinal product. TheWest ref. 202300044-WO medicament 115 may be Lucentis®, Eylea®, Eylea® HD, Syfovre®, Vabysmo®, RGX-314, Izervay®, Lytenava®, or Beovu® or ones in clinical pipeline such as Axitinib, RGX-314, ALK-001, AVD-104, ATSN-201, OPT-302. The system delivery device 200 is especially adept at injection a medicament 115 of high viscous. For example, in some embodiments, the medicament 115 may have a viscosity great than 5 cP. In some embodiments, the medicament 115 may have a viscosity great than 50 cP. In some embodiments, the medicament 115 may have a viscosity greater than 100 cP.

[0036] As illustrated in FIGS. 4-8, the delivery device 200 may include a housing 202, a syringe holder 220 attached to the housing 202, and a drive system disposed inside of the housing 202. The housing 202 may include a first housing member 203 and a second housing member 204 enclosing various components of the drive system including a motor 206 configured to actuate the drive system, a frame 208 supporting the drive system, and a circuit board assembly 210 configured to control operation of the drive system. The drive system may be configured to apply a longitudinal force to retract and / or push the plunger rod 104 relative to the syringe body 102 in order to fill the medicament 115 into the chamber 114 and / or expel the medicament 115 from the chamber 114 in order to deliver the medicament 115 to a body tissue.

[0037] The syringe holder 220 may have a longitudinal axis LSand hold the syringe 100 along the longitudinal axis LS. The longitudinal axis LSmay extend along a longitudinal axis LHof the housing 202. For example, the longitudinal axis LSof the syringe holder 220 may be offset and parallel to the longitudinal axis LHof the housing 202. The syringe holder 220 may be integral and / or an extension of the housing 202, or the syringe holder 220 may be separately formed and secured to the housing 202. The syringe holder 220 may include one or more components configured to receive and secure the syringe 100. The syringe holder 220 may include a first member or alignment member 222 that may be fixed relative to the housing 202 and / or the frame 208 and be configured to receive the syringe barrel 108. The alignment member 222 may have an elongated structure extending distally beyond the housing 202 along the longitudinal length of the syringe barrel 108. The alignment member 222 may have a width slightly larger than a circumference of the syringe body and be formed by a curved wall having a concave surface extending less than 360° (e.g., about 180°) around the circumference of the syringe body 102 to enable insertion of the syringe barrel 108 from a side. The curved wall may also have a convex outer surface 223. The alignment memberWest ref. 202300044-WO 222 may have a proximal portion 224 defining lateral slot 225 configured to receive the body flange 112 to longitudinally fix the syringe barrel 108 relative to the housing 202. The lateral slot 225 of the proximal portion 224 may have an open distal end through which the syringe body 102 extends and an open proximal end through which the plunger rod 104 extends. The alignment member 222 may have a distal portion 226 defining a flange 227 configured to reduce contact by the user with the distal end of the syringe 100 and / or tissue when the delivery device 200 is being handled in order to reduce inadvertent needle sticks and bacterial contamination. The alignment member 222 may extend into the housing 202 and / or be fixed to the frame 208.

[0038] The syringe holder 220 may include a second member or locking member 228 configured to move relative to the alignment member 222 to open the syringe holder 220 and receive the syringe 100. For example, the alignment member 222 and the locking member 228 may be pivotably attached to each other at a hinge 230, as illustrated assembled in FIG. 1. The hinge 230 may be formed by a pin 232 pivotably attaching the alignment member 222 and the locking member 228. As illustrated in FIG. 5, the alignment member 222 and / or the locking member 228 may have openings or sleeves that receive the pin 232 to form the hinge 230, allowing the locking member 228 to pivot relative to the alignment member 222 between an open configuration and a closed configuration. The syringe holder 220 may further include a latch 234 on a side of the syringe holder 220 opposite of the hinge 230 configured to enable opening of the locking member 228 relative to the alignment member 222. The latch 234 may be configured to releasably secure the locking member 228 to the alignment member 222 in the closed configuration. The latch 234 may include a locking member 236 configured to be releasably secured inside of an aperture of the locking member 228. For example, the locking member 236 may be a locking screw or nut that may be rotated to compress and lock the locking member 228 in the closed configuration.

[0039] The locking member 228 may have a variable lateral dimension configured to retain the syringe 100 during use and / or provide an ergonomic surface configured to stabilize the delivery device 200 in the hand of a user, as illustrated in FIG. 1. The locking member 228 may have a first portion 238 with a curvature having a concave inner surface configured to receive the syringe barrel 108 to prevent lateral movement of the syringe barrel 108 during use when retained in the syringe holder 220. The second body may have a second portion 240 extending proximally of the first portion 238 and be configured to receive the bodyWest ref. 202300044-WO flange 112. The second portion 240 may be disposed laterally of the first portion 238 (e.g., having a greater diameter and / or be further from the longitudinal axis LSof the syringe holder 220) to receive the diameter of the body flange 112. The locking member 228 may have a third portion 242 extending proximally of the second portion 240 and be configured to be supported by the hand of the user to provide stability during injection. The third portion 242 may have a lateral position equal to or greater than the second portion 240 (e.g., be aligned with the second portion 240 or be further from the longitudinal axis LSof the syringe holder 220). The third portion 242 may be configured to receive the plunger flange 118. Thus, the second portion 240 and / or the third portion 242 may embody a vertical extension extending over and past the body flange 112. The vertical extension may have a generally increasing or stepped width with respect to the longitudinal axis LSof the syringe holder 220. The vertical extension may provide a channel for the plunger flange 118 to pass into during the injection unimpededly. The vertical extension may provide an outer surface to be ergonomically supported by a thenar web space of the hand of the user, as illustrated in FIG. 1.

[0040] The delivery device 200 (loaded with the syringe 100) may be handheld and provide trilateral grasping between the thumb, the index finger and the middle finger. The shape, size, and weight distribution, texture of the delivery device 200 may be designed to enable trilateral grasping of delivery device 200 across wide range of hand sizes. Overall, the delivery device 200 may be lightweight, for example, weighing less than 200 grams (g). In some embodiments, the delivery device 200 may be less than 100 g, such as about 50 g. The delivery device 200 may have a length of about 4 inches (10mm), a width of about 1 inch (2.5mm), and a height about 2 inches (5mm). Thus, the delivery device 200 may be sized to ergonomically fit in the hand of a user. For example, as illustrated, the delivery device 200 may be sized for the locking member 228 to be supported by the skin of the thenar web space between the thumb and the forefinger. The syringe holder 220 may be sized to be wrapped around by a forefinger and the outer surface 223 of the alignment member 222 may provide a support for a tip of the forefinger. Thus, the delivery device 200 attached to the syringe 100 may be comfortably held between the forefinger, the thumb, and a middle finger of the hand of the user. An actuator 276 may be ergonomically placed along the outer surface 223 of the alignment member 222 to be readily actuated by the forefinger when held. The actuator 276 may be a button that can be intuitively pushed by the user to start and / or stop an injection. The center of gravity of the delivery device 200 may be exactly at the end of the device toWest ref. 202300044-WO further facilitate handling. As illustrated in FIG. 1, the center of gravity (CG) of the delivery device 200 (loaded with the syringe 100) may be positioned to favorably rest on and / or be supported by the dorsal hand muscles between the thumb and the adductor pollicis, flexor pollicis brevis, and / or abductor pollicis brevis providing stability to the injection procedure. For example, the center of gravity (CG) of the delivery device 200 (loaded with the syringe 100) may be aligned with the second portion 240 or the third portion 242 of the syringe holder 220 when held horizontally and / or handled to rest on the dorsal hand muscles. The delivery device 200 may be readily handled and actuated by a right hand or a left hand without modification. The delivery device 200 may be balanced and / or provide symmetrical placement of operating buttons that will allow a left- and right-handed user to operate it.

[0041] The syringe holder 220 may further include a third member or drive member 244 configured to advance and / or retract the plunger rod 104 relative to the syringe barrel 108. The drive member 244 may have a lateral slot 245 configured to receive the plunger flange 118 of the plunger rod 104. The lateral slot 245 of the drive member 244 may have a distal opening through which the plunger rod 104 extends and configured to pull the plunger rod 104. The drive member 244 may have a proximal wall configured to push a proximal end of the plunger flange 118. The proximal wall of the drive member 244 may be closed. The drive member 244 may be actuated by the drive system to advance and / or retract the plunger rod relative to the syringe body to pull the medicament 115 into the chamber 114 and / or expel the medicament 115 from the chamber 114.

[0042] The drive member 244 may be received in a longitudinal track of the housing 202. The drive member 244 may be attached to and / or integrated with a threaded nut 252 disposed around a lead screw 254. The lead screw 254 may be rotated by the motor 206 to longitudinally translate the threaded nut 252 and / or the drive member 244 through the longitudinal track of the housing 202. The distal end of the lead screw 254 may be attached to the motor 206 to impart rotation, and the proximal end of the lead screw 254 may be secured to a barrel mount 256 that is attached to the frame 208. The barrel mount 256 may have a non-threaded first opening through which the lead screw may be rotated during actuation and a second opening through which a linear rail 255 is fixed. The frame 208 may include first and second frame members 260 having a proximal end sandwiching the barrel mount 256. The first and second frame members 260 may extend parallel to each other. The lead screw 254 may extend between the first and second frame members 260, such that theWest ref. 202300044-WO first and second frame members 260 extend along the lead screw 254. A distal end of the first and second frame members 260 may be secured to the motor 206. The threaded nut 252 and / or the drive member 244 may move longitudinally between the first and second frame members 260, such that the frame 208 and / or longitudinal track of the housing 202 guides and / or prevents rotation of the threaded nut 252 and / or the drive member 244 as the lead screw 254 is rotated. The linear rail 255 may extend through the threaded nut 252 and / or the drive member 244 and further rotationally fix the drive member 244 as the drive member 244 is translated. One or more bearings 257 (see FIG 10) may be received within the drive member 244 and over the linear rail 255 to reduce friction between the components to facilitate the longitudinal translation while providing the rotational stability. The frame members 260 may be elongated and have flat panels made of a lightweight metal, such as aluminum to reduce the weight of the system 10 while providing sufficient rigidity for precise and reliable longitudinal movement of the plunger rod 104 for small volume deliveries. The frame 208 may reduce backlash that is vital for precision in small volume deliveries including priming, wherein volume is critical and / or the injection is into tissue with significant backpressure.

[0043] The motor 206 may be driven by an electrical current supplied by a battery 262. The motor may be a stepper motor that divides a rotation into a number of steps that may be translated into rotation of the lead screw 254. The motor 206 may have very small dimensions and allow precise volumes to be drawn in and could be controlled externally using an external user device. The motor 206 may rotate the lead screw 254 a given degree of rotation every electrical input pulse. In use, the motor 206 may have a coil winding (not shown), a permanent magnet rotor (not shown), and a steel stator (not shown) capable of carrying a magnetic flux. The battery 262 may energize the coil winding to create an electromagnetic field with a north and south pole. The stator may conduct the magnetic field and cause the permanent magnet rotor to align itself to the field. The stator magnetic field may be altered by sequentially energizing and de-energizing the stator coils that causes a stepping action and incrementally move the rotator resulting in angular motion of the lead screw 254. For example, the motor 206 may have a step angle of 18° per impulse imparting a linear travel of 0.015 mm for the nut 252. Thus, a full revolution (360°) of the motor 206 would be 20 steps. The motor 206 may reduce injection time. For example, the motor 206 may deliver a 0.05 ml dose injection in less than 2.5 seconds, and in some cases less than 1West ref. 202300044-WO second. The precision of the motor 206 may be especially advantageous in the removal of air bubbles in priming the medicament 215. The motor 206 may be without mediation, gears, and gear boxes that increases the precision. In some embodiments, the motor 206 may have an integrated stall detection module.

[0044] The speed and / or position of the motor 206 may be determined by an optical encoder 258. The optical encoder 258 may be built into the motor 206 to conserve space and reduce cost on expensive components. The optical encoder 258 may have a lensed LED light source and monolithic photodetector array with signal shaping electronics to produce a plurality of (e.g., two) channel bounceless outputs. An internal monolithic electronic module of the optical encoder 258 may convert the real-time shaft angle, speed, and direction into compatible outputs. Like the motor 206, the optical encoder 258 may have very small dimensions and allow precises volumes to be applied by the motor 206 and could be controlled externally using an external user device. Furthermore, the optical encoder 258 may be part of a feedback look that can stop an injection during a procedure, for example, in the case of the rise of intraocular pressure (IOP).

[0045] As further illustrated in FIG. 9, a controller 212 may control the motor 206 and various electronic components. The controller 212 may be in communication with an input driver 264, a communication device 266, a charger 268, an audible and / or tactile output device 270, and / or a visual output device 272. The controller 212 may be configured to prime the delivery device 200 and / or control the injection to deliver a specified dose of the medicament 115. The controller 212 may calculate a fill volume in the syringe 100 to prime and / or determine the dose to be injected. The controller 212 may also be configured to receive feedback from the various components. The controller 212 may be configured to sense the resistance in the syringe 100 during an injection, for example through feedback from the motor 206. The controller 212 may be configured to count a number of performed injections and / or monitor a voltage in the battery 262. The controller 212 may be configured to continuously and / or dynamically monitor the voltage in the battery 262 and calculate the battery capability or any component during the entire operation of the device. The controller 212 may be configured to calculate charge percentage of the battery 262 and / or any other power sources. The controller 212 may further enable checks to received feedback on the optimal type of the syringe 100, the optimal gauge of the needle 106, optimal temperature of the medicament 215. The controller 212 may provide safety controls preventing injectionWest ref. 202300044-WO and / or generating an indicator of such conditions, such as through the outputs 270, 272 and / or the user device. In some embodiments, additional components may be implemented including a flow sensor (not shown) that allows precise dose / flow rate / volume measurement and feedback loop to monitor / tune delivery of the medicament 215. However, in some embodiments, any additional sensors may be omitted to maintain a small footprint. The delivery device 200 may have a memory (not shown) in communication with the controller 212 that is configured to receive data (temporarily or permanently) associated with the controller 212. The delivery device 200 may be configured to transfer the data to the user device and / or a cloud storage through the communication device 266.

[0046] The controller 212 may include one or more devices selected from microprocessors, micro-controllers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines, logic circuits, analog circuits, digital circuits, or any other devices that manipulate signals (analog or digital).

[0047] The memory may be a single memory device or a plurality of memory devices including but not limited to read-only memory (ROM), random access memory (RAM), volatile memory, non-volatile memory, static random access memory (SRAM), dynamic random access memory (DRAM), flash memory (e.g. a NAND flash memory chip), cache memory, or any other device capable of storing digital information. The memory may also include a mass storage device such as a hard drive, optical drive, non-volatile solid state device or any other device capable of storing digital information. The processor 212 may operate under the control of an operating system that resides in the memory.

[0048] The battery 262 may be configured to supply electrical power to various components including the motor 206, either through the PCB or directly to the other components. The battery 262 may be a lithium-ion battery having a capacity and size determined by the application. The battery 262 may be rechargeable through a connection port 269.

[0049] As further illustrated in FIGS. 5 and 6, the various components may be mounted on the circuit board assembly 210. The circuit board assembly 210 may include one or more printed circuit boards (PCBs) assembled to support electronic components in a compact configuration. The circuit board assembly 210 may include a first PCB 280, a second PCB 282, and a third PCB 284. The electronic components may be attached to at least one of the first PCB 280, the second PCB 282, and / or the third PCB 284. The first PCB 280 may be a control PCB and have attached at least one of the controller 212, the charger 268, theWest ref. 202300044-WO communication device 266, and / or a secondary power connection. The second PCB 282 may be a power PCB and have attached at least one of a boost converter 286, a motor driver, and / or an input driver 264. The second power PCB 282 may be external of the first control PCB 280 with respect to the longitudinal axis LHof the housing 202. As illustrated in FIG. 6, the second PCB 282 may have a longitudinal length smaller than that of the first PCB 280 providing space for the battery 262. The battery 262 may be attached to an external surface of the first PCB 280 and be disposed distal of and / or colinear with the second PCB 282.

[0050] The first PCB 280 and the second PCB 282 may be connected to each other and arranged in a closely parallel orientation reducing the footprint compared to a single larger PCB. For example, the first PCB 280 and the second PCB 282 may be separated by a small space or gap of less than 5 millimeters, for example, about 2 millimeters (e.g., 2.1 mm). The communication device 266 may be received in the space. The first PCB 280 and the second PCB 282 may further extend parallel to the first and / or second frame members 260 to reduce the overall footprint of the housing 202. As illustrated in FIGS. 5-8, the first PCB 280, the second PCB 282, and / or one of the frame members 260 may be secured to each other in the parallel orientation by one or more fasteners 261 extending perpendicular to a plane of the first PCB 280, the second PCB 282, and / or one of the frame members 260. As further illustrated, one or more spacers 263 may receive and / or be integrated into the one or more fasteners 261 to maintain and support the first PCB 280, the second PCB 282, and / or one of the frame members 260 in the spaced apart orientation. The one or more spacers 263 may be in the form of a sleeve that receive the one or more fasteners 261 when assembled. The spacer 263 positioned between the first PCB 280 and the second PCB 282 may be unthreaded. The spacers 263 between the first PCB 280 and the frame member 260 may be integrated into the frame member 260 and be threaded to secure the first PCB 280 and the second PCB 282 to the frame member 260. Due to the parallel orientation, the first PCB 280 and the second PCB 282 may not have a direct board-to-board electrical connection and rather be connected by a separate electronic connector 283 (as illustrated in FIG. 7) allowing communication between the first PCB 280 and the second PCB 282. The connector 283 may have a first lateral end attached to the second PCB 282. One or both of the first and second PCBs 280, 282 may have a slot 285 on a side surface through which the connector 283 extends, conserving space and increasing surface area contact. The connector 283 may be rigid, flexible, rigid-flex and / or formed of a tape to facilitate assembly. For example, theWest ref. 202300044-WO connector 283 may be a rigid-flex PCB having a combination of flexible and rigid board components. The connector 283 may have multiple layers of flexible circuit board substrates attached to one or more rigid boards externally and / or internally. The flexible substrate may be in a constant state of flex and formed into the flexed curve during manufacturing and / or installation.

[0051] As illustrated in FIG. 8, the third PCB 284 may be received in an internal slot 229 of the alignment member 222 to connect to the actuator 276 extending through an opening of the alignment member 222. The internal slot 229 may be closed by a cover (not shown) on an insider of the alignment member 222 protecting the third PCB 284. As discussed herein, the actuator 276 may be positioned along the outer surface 223 of the alignment member 222 for the user to start and / or stop an injection while holding the delivery device 200. In a preferred embodiment, the actuator 276 may be a button that is pushed by the user. However, the actuator 276 may alternatively embody a toggle switch, a sliding switch, a touchpad, a rotatable dial, and / or another type of actuator. In some embodiments, the delivery device 200 may only initiate an injection when the actuator 276 is actuated and the injection may be stopped immediately after the actuator 276 is released. For example, the controller 212 may be configured to wait and continuously check the state of the actuator 276 and keep the motor 206 in a sleep mode unless the actuator 276 is actuated.

[0052] The delivery device 200 may include additional user inputs including one or more inputs 278, as illustrated in FIGS. 1 and 5. The one or more inputs 278 may be positioned on a side of the housing 202 to allow the user to actuate the inputs 278 while preventing inadvertent actuation when the system 10 is being held during the injection, as described herein. The input(s) 278 may include a plurality of inputs 278 positioned on a connection and / or pad recessed in the housing 202. In a preferred embodiment, the input(s) 278 may each be a button, but the input(s) 278 may alternatively embody a toggle switch, a sliding switch, a touchpad, a rotatable dial, and / or another type of input. The one or more inputs 278 may include menu and control keys. The input(s) 278 may include a power button configured to allow the user to turn the delivery device 200 on / off. The input(s) 278 may, additionally or alternatively, include a priming button configured to prime the syringe 100 and remove air bubbles from the medicament 115. The input(s) 278 may, additionally or alternatively, include a pairing button to allow the injector to wirelessly pair the communication device 266 to a user device for transfer of data, as discussed herein. AsWest ref. 202300044-WO illustrated in FIG. 6, the connector 279 may have a second lateral end attached to the pad of the input(s) 278 to connect the first and / or second PCBs 280, 282 to the input(s) 278. The inputs 278 may be disposed on a printed circuit board (PCB, not shown) and connected to the second PCB 282 through the connector 279. The connector 279 may be rigid, flexible, rigid- flex, and / or formed of a tape to facilitate assembly, similar to the connector 283. For example, the connector 279 may be a rigid-flex PCB having a combination of flexible and rigid board components. The connector 279 may have multiple layers of flexible circuit board substrates attached to one or more rigid boards externally and / or internally. The flexible substrate may be in a constant state of flex and formed into the flexed curve during manufacturing and / or installation. As further illustrated in FIG. 9, the actuator 276 and the input(s) 278 may be connected to the input driver 264 that may be embodied as a keyboard driver, which may be connected to the controller 212.

[0053] The communication device 266 may be received in a space between and / or sandwiched directly between the first PCB 280 and the second PCB 282. The communication device 266 may extend proximally out of the space between the first PCB 280 and the second PCB 282 in order to prevent blockage of an antenna of the communication device 266 to allow for wireless communication. The antenna of the communication device 266 may be configured for wireless (short-range and / or long-range) communication with a user device, a server, and / or a cloud platform. The user device may embody a smartphone, a tablet, a smart watch, smart glasses, a laptop, a desktop, a Global Positioning System (GPS) device, a gaming console, a smart TV, a smart appliance, and / or other connected devices. In some embodiments, the communication device 266 may be configured to implement a wireless communication protocol with the user device when positioned within a specific range, such as a short-range Bluetooth Low Energy (BLE) communication protocol. The communication device 266 may, additionally or alternatively, be configured for a wired connection. The delivery device 200 may be programmable for data collection, data transfer, and data analysis. The communication device 266 may receive and / or transmit data to provide flexibility in dose and / or regiment programming, making the delivery device 200 adaptable for a wide range of drug types and practices where more bespoke delivery is desired such as in advanced therapies. The communication device 266 may be configured to receive information not limited to the dose, drug property, drug fill volume, drug priming volume, drug flow rate, and patient information, for processing by theWest ref. 202300044-WO controller 212. The communication device 266 may be configured to transmit feedback data to an interested party on an injection being performed by the delivery device 200. The interested party may include a surgeon, a healthcare provider, and / or a caregiver that is located in proximity and / or remote from the delivery device 200 during the injection. In some embodiments, the delivery device 200 may be programmed, calibrated and / or controlled remotely by the user device via the communication device 266, such that part or the entirety of the injection procedure may be controlled remotely. Thus, the communication device 266 may allow for bidirectional or unidirectional communication.

[0054] The user device may be configured to run an app providing a digital platform allowing data from the injection / delivery procedure to be transferred via the communication device 266. The digital platform may receive data about tissue characteristics pertaining to a disease or therapeutic intervention and prognosis. The tissue characteristics such as volume of fluid may be used to determine the dose that can be automatically primed by the delivery device 200 for delivery. The characteristics may be received from imaging, not limited to ultrasound, OCT, Fundus imaging. The digital platform may be configured to schedule one or more injections, for example, to set reminders to the user.

[0055] The delivery device 200 may include the connection port 269 configured to supply power to the various components and / or transfer data to / from the controller 212. The connection port 269 may include a socket configured to receive an adaptor plug to provide an interface for the transfer of power and / or data. As illustrated in FIG. 9, the connection port 269 may be connected to the charger 268 for recharging the battery 262 that provides power to the components. However, it is also contemplated that the delivery device 200 is a wired device and the connection port 269 may provide power to the components directly, such that the battery 262 may be omitted. The charger 268 may, additionally or alternatively, be configured to power the battery 262 wireless, such that the connection port 269 may be omitted. For example, a wireless charger may be configured to generate a magnetic field that interacts with a copper coil in the charger 268 to produce an electric energy that provides power to the battery 262. The battery 262 and / or charger 268 may be connected to the boost converter 286 configured to step up the voltage to generate a power transmitted to the motor 206. The battery 262 and / or the charger 268 may, additionally or alternatively, be connected to a regulator 288 configured to regulate a power transmitted to the other components of the system. The regulator 288 may be a switching regulator and / or a low-dropout regulatorWest ref. 202300044-WO (LDO). The regulator 288 may be configured to output 3.3 volt power to the other components.

[0056] In some embodiments, the delivery device 200 may include a tactile and / or audible output 270 to provide feedback to the user. For example, the output 270 may be configured to generate tactile and / or audible feedback to the user to indicate one or more statuses of the delivery device 200 including a beginning of an injection, an end of an injection, a priming step is complete, the medicament 115 is filled in the syringe 100, a low level of the medicament 115 in the syringe 100, a power level in battery 262 is low, and / or a recharging process of the battery 262 is complete. The output 270 may be embodied by a buzzer, a speaker, and / or a vibrating motor.

[0057] In some embodiments, the delivery device 200 may include a visual output 272. Similar to the output 270, the visual output 272 may be configured to generate a visual feedback to the user to indicate one or more statuses of the delivery device including a beginning of an injection, an end of an injection, a priming step is complete, the medicament 115 is filled in the syringe 100, a low level of the medicament 115 in the syringe 100, a power level in battery 262 is low, and / or a recharging process of the battery 262 is complete. The output 272 may include one or more light emitting diodes (LEDs) and / or a screen. The visual output 272 may be physically on the delivery device 200 itself (e.g., on a side of the housing 202), connected to the delivery device 200 via a console or a display device, connected wirelessly via Bluetooth or other data transfer mechanism such as cloud into a storage or a user device. This user device could be a telephone or any other type of device, as discussed herein.

[0058] The system 10 and / or delivery device 200 may be used in a method, as disclosed herein. The method may include receiving the delivery device 200, and opening the syringe holder 220 by the user. For example, the syringe holder 220 may be opened by pivoting the locking member 228 relative to the alignment member 222. The method may include inserting the syringe 100 into the syringe holder 220, and securing the syringe body 102 to the alignment member 222 and the plunger rod 104 to the drive member 244. The user may manipulate the input(s) 278 to power on the injection device and activate the controller 212. The user may also manipulate the input(s) 278 to pair the delivery device 200 to the user device (not shown). The syringe holder 220 may be received in a hand of a user, as illustrated in FIG. 1. The syringe holder 220 may be received between the thumb and theWest ref. 202300044-WO forefinger of the hand, with the vertical extension of the locking member 228 supported by the thenar web space of the hand. The tip of the forefinger may be supported by the outer surface 223 of the alignment member 222, and the tip of the thumb may be supported by the syringe 100. As discussed herein, the longitudinal axis LSof the syringe holder 220 may be offset and parallel to the longitudinal axis LHof the housing 202 to facilitate handing. Furthermore, the center of gravity may be exactly at the end of the system 10 to further facilitate handling. In some embodiments, the method may include drawing the medicament into the chamber 114, for example, by inserting the needle 106 into a seal of the container 300, as illustrated in FIG. 2. The user may press the actuator 276 to actuate the motor 206 to retract the plunger rod 104 and generate a negative pressure in the chamber 114 to draw the medicament 115. In some embodiments, the method may be used with a pre-filled syringe 100, such that the user does not have to fill the medicament 115 into the chamber. The method may further include the user manipulating the injection device 200 to puncture tissue of a patient with the needle 106 and inject the medicament 115 into the tissue of the patient. The injection may be performed by the user pressing the actuator 276. The tissue may be an eye, and the medicament 115 may have a high viscosity, such as greater than 100 cP.

[0059] The delivery device 200 may be programmable or preprogrammed to work with a specific type of medicament 215 depending on its constitution and properties that affect delivery. The delivery device 200 may be programmable or preprogrammed to work with high viscosity medicaments 215 not limited to greater than 5 cP, and but mostly greater than 100 cP. The delivery device 200 may be programmable or preprogrammed to work with medicaments 215 that sediment in a Luer connector or other areas within the syringe device 100 upon storage or delivery. The delivery device 200 may be programmable for preparation, fill, and delivery of medicaments 215 of non-Newtonian fluids not limited to hydrogels or thixotropic fluids. The delivery device 200 may be programmable or preprogrammed based on the delivery properties of the medicament 215, not limited to viscosity, volume, delivery rate, tissue back pressure. The delivery device 200 may be programmable or pre-programmed based on the disease characteristics that affect dose, volume of the delivered medicament 215. For example, the disease characteristics may be the stiffness of the tissue such as the vitreous humor in intravitreal injections upon progression of the disease such as age-related macular degeneration. Additionally or alternatively, the disease characteristics may be the dermis in intradermal injections. TheWest ref. 202300044-WO delivery device 200 may be programmable or preprogrammed based on properties of the syringe device 100, such as break loose and glide force, dead volume, gauge of the needle 106, length of the needle 106, needle wall thickness etc. Thus, the delivery device 200 may be calibrated based on the tolerance of the system 10, properties of the medicament 15, the dose, and / or the features of the syringe device 100 not limited to diameter of the syringe barrel 108, gauge of the needle 106, inner diameter, and length. The delivery device 200 is not limited to these specific examples or applications. The delivery device 200 may be assembled without any welding, which allows for fast assembly.

[0060] The delivery device 200 may be programmable or preprogrammed for air-bubble free preparation of the syringe device 100 intended for injections into the eye not limited to intravitreal, suprachoroidal, sub-retinal or other routes in the eye. The container 300 prepared using this device or a prefilled primary container either by manufacturer, surgeon, healthcare professional or an authorized person, agency or institution may be used to delivery injections. The air-bubble free preparation of the syringe may be enabled by a controlled drug withdrawal process provided by the delivery system 200. The controlled withdrawal process is not limited to programmed drawing in of the fluid / drug product from a drug container into another drug container. The controlled withdrawal process may be enabled by a system which is not limited to electromechanically, pneumatic, or other delivery driver mechanisms. In another embodiment, the device is capable of purging the air bubbles generated during the fill-finish process inside the primary container, during storage due to off-gassing of drug product solutions or due to other unknown causes, or generated during withdrawing as in the case of not limited to withdrawing of the high viscous drug products from vial 300 into syringe system 100.

[0061] FIGS. 11-14 depict alternative embodiments of delivery systems as described throughout this application. Except where clearly contradictory, delivery system 400 in FIGS. 11 and 12 and delivery system 500 in FIGS. 13 and 14 can include any or all of the features, structures, and relationships described with respect to the delivery system 200 including, for example, the syringe, the syringe holder, the housing, the actuator, the drive mechanism and other components and / or features described with respect to the delivery system 200.

[0062] As shown in FIGS. 11 and 12, a delivery system 400 can include a housing 402 configured to receive a syringe 100. The housing 402 can be ergonomically shaped to allow the user to hold the delivery system 400 in one hand. For example, the housing 402 can beWest ref. 202300044-WO sized and shaped to comfortably fit in the user’s palm with the user’s fingers and thumb contacting and / or grasping portions of the housing 402. The syringe 100 used with the delivery system 400 can be, for example, the same or substantially the same as the syringe 100 described elsewhere in this application. The housing 402 can define a receptacle 404 configured to receive the syringe 100 therein. An actuator 476 can be disposed on or in the housing 402. The actuator 476 can be the same as, or substantially similar to, any embodiments of the actuator 276 described elsewhere in this application. It will be understood that the delivery system 400 includes additional components inside the housing that together can operate to dispense the medicament, such as a motor, a power source (e.g., a battery), a plunger and plunger rod, and other components described elsewhere with respect to other embodiments of the delivery system.

[0063] In some aspects, the delivery system 400 can include a level indicator 406 on or in the housing. The level indicator 406 can help the user maintain the delivery system 400 at the desired angle relative to a surface and / or notify the use if the delivery system 400 is held at a position outside of a desired acceptable range. The level indicator 406 can be a physical bubble indicator or can be a digital indicator, for example, one that utilizes a gyroscope or gyroscopic capability. In some aspects, the desired angle of the housing 402 will be measured relative to the earth. In specific exemplary embodiments, the desired angle can be approximately 90 degrees.

[0064] In some aspects, the delivery system 400 can include a syringe indicator 408 to help the user see whether the syringe 100 is properly seated within the receptacle 404. The syringe indicator 408 can include a first configuration corresponding to the syringe 100 not being fully seated within the receptacle 404 and a second configuration corresponding to the syringe 100 being fully seated within the receptacle 404. In some aspects, the syringe indicator 408 can be a mechanical protrusion that protrudes relative to the housing 402 at a first position when in the first configuration and a second, different position when in the second configuration. In other aspects, the syringe indicator 408 can be a visual indicator that can provide a first visual cue (e.g., a light, a lighting pattern, a specific color, etc.) in the first configuration and a second, different visual cue in the second configuration.

[0065] Referring to FIGS. 13 and 14, a delivery system 500 is depicted. The delivery system 500 can include a housing 502 configured to receive a syringe 100. The syringe 100 used with the delivery system 500 can be, for example, the same or substantially the same as theWest ref. 202300044-WO syringe 100 described elsewhere in this application. The housing 502 can be ergonomically shaped to allow the user to hold the delivery system 500 in one hand. For example, the housing 502 can be sized and shaped to comfortably fit in the user’s palm with the user’s fingers and thumb contacting and / or grasping portions of the housing 502. In some aspects, the housing 502 can define a designated finger receptacle 512. The user can insert one or more fingers into the finger receptacle 512 to help grasp and control the delivery system 500 during use.

[0066] The housing 502 can define a receptacle 504 configured to receive the syringe 100 therein. An actuator 576 can be disposed on the housing 502. The delivery system 500 can include a plurality of actuators 576. Each actuator 576 can be designed to operate a separate part of the delivery process, such as turning the device on / off, initiating / pausing / stopping injection, priming the device, etc. The actuator 576 can be the same as, or substantially similar to, any embodiments of the actuator 276 or actuator 476 described elsewhere in this application. It will be understood that the delivery system 500 includes additional components inside the housing that together can operate to dispense the medicament, such as a motor, a power source (e.g., a battery), a plunger and plunger rod, and other components described elsewhere with respect to other embodiments of the delivery system.

[0067] While devices, systems, and methods have been described in connection with the various embodiments of the various figures, it will be appreciated by those skilled in the art that changes could be made to the embodiments without departing from the broad inventive concept thereof. It is understood, therefore, that this disclosure is not limited to the particular embodiments disclosed, and it is intended to cover modifications within the spirit and scope of the present disclosure as defined by the claims.

Claims

West ref. 202300044-WO What is claimed is:

1. A delivery device for a syringe having a syringe barrel and a plunger, the delivery device comprising: a housing; a syringe holder configured to secure the syringe barrel; a motor received in the housing; a lead screw configured to be rotated by the motor; a threaded nut configured to be move longitudinally over the lead screw to advance the plunger through the syringe barrel; and a frame disposed in the housing along the lead screw.

2. The delivery device of claim 1, further comprising an actuator positioned along an outer surface of the syringe holder.

3. The delivery device of claim 1, wherein a longitudinal axis of the syringe holder extends along a longitudinal axis of the housing.

4. The delivery device of claim 3, wherein the longitudinal axis of the syringe holder is offset and parallel to the longitudinal axis of the housing.

5. The delivery device of claim 1, wherein the syringe holder includes an alignment member fixed to the housing, a locking member movably attached to the alignment member, and a drive member attached to the thread nut and configured advance the plunger through the syringe barrel.

6. The delivery device of claim 5, wherein the locking member is pivotably attached to the alignment member.

7. The delivery device of claim 5, wherein the locking member has a first portion configured to receive the syringe barrel and a second portion disposed laterally of the first portion and configured to be supported by a hand of a user.

8. The delivery device of claim 5, further comprising an actuator disposed on the alignment member.West ref. 202300044-WO 9. The delivery device of claim 1, further comprising one or more inputs positioned on a side surface of the housing.

10. The delivery device of claim 1, further comprising a first printed circuit board (PCB) and a second PCB disposed in a parallel orientation.

11. The delivery device of claim 10, wherein the frame includes a first frame member and a second frame member extending along the lead screw, wherein the first PCB and the second PCB are disposed in a parallel orientation with at least one of the first frame member and the second frame member.

12. The delivery device of claim 10, wherein the first PCB and the second PCB are separated by less than 5 millimeters.

13. The delivery device of claim 10, further comprising a communication device disposed between the first PCB and the second PCB.

14. The delivery device of claim 10, wherein the first PCB is attached to at least one of a controller, a charger, a communication device, and / or a secondary power connection, and the second PCB is attached to at least one of a boost converter, a motor driver, and / or an input driver.

15. The delivery device of claim 10, further comprising a rigid-flex connector connecting the first PCB and the second PCB.

16. The delivery device of claim 1, wherein the motor is a stepper motor.

17. The delivery device of claim 1, further comprising an optical encoder built into the motor.

18. A system comprising: the delivery device of claim 1; and a syringe received in the syringe holder.

19. A delivery device for a syringe having a syringe barrel and a plunger, the delivery device comprising:West ref. 202300044-WO a housing; a syringe holder configured to secure the syringe barrel, the syringe holder including an alignment member fixed to the housing, a locking member movably attached to the alignment member, and a drive member configured advance the plunger through the syringe barrel; a motor received in the housing and configured to advance the plunger through the syringe barrel; a lead screw configured to be rotated by the motor; a threaded nut attached to the drive member and configured to be move longitudinally over the lead screw; a frame disposed in the housing along the lead screw; and an actuator disposed on the alignment member.

20. The delivery device of claim 19, wherein a longitudinal axis of the syringe holder is offset and parallel to the longitudinal axis of the housing.

21. The delivery device of claim 19, wherein the locking member forms a vertical extension configured to extend past a flange of the syringe barrel and be configured to be supported by a thenar web space of a hand.

22. A method of using the delivery device of claim 19, receiving the syringe holder in a hand of a user; supporting the locking member by a thenar web space of the hand of the user; and pressing the actuator with a forefinger of the hand to draw a substance in the syringe and / or expel a substance from the syringe.

Images