Microvolume Syringe with Dose Guidance and Instructions for Use

Abstract

Injector devices and methods for using them to deliver a medication into a patient's body (e.g., subretinal within an eye) are provided. The injector includes a cartridge including a piston slidably disposed within the cartridge for delivering the medication into the cartridge via an outlet, a plunger coupled to the piston, a source of pressurized fluid, and a driver including an actuator member for at least partially opening a fluid path between the source and the plunger to advance the plunger and piston to deliver the medication from the cartridge. One or more sensors are operably coupled to the plunger to measure displacement of the plunger, a processor is coupled to the sensor to analyze the sensor signal to measure the amount of medication delivered from the cartridge, and an output device (e.g., one or more LEDs or a speaker) provides an output related to the amount of medication delivered.

Description

[Technical Field]

[0001] Related application data This application claims the benefit of co-pending provisional applications Docket Nos. 62 / 899,058, filed September 11, 2019, and 63 / 003,117, filed March 31, 2020, the entire disclosures of which are expressly incorporated herein by reference.

[0002] The present invention relates to devices and methods for delivering drugs into a patient's body, and more particularly to syringes for delivering precise doses of drugs, such as gene vectors and / or stem cells, subretinally into a patient's eye, as well as systems and methods for using such syringes. [Background technology]

[0003] In many applications, controlled delivery of medication is desired while maintaining precise positional control of the delivery needle to deliver a precise amount of fluid to a precise location. For example, the syringe may be used for subretinal injections in the treatment of several ocular conditions.

[0004] Such subretinal injections are associated with numerous complications. For example, it can be difficult to accurately position the tip of the syringe cannula within the eye, especially when it passes through the retinal layers. Furthermore, the formation of a bleb (a bolus of fluid delivered subretinally) carries the risk of retinal damage or tearing.

[0005] Furthermore, these current procedures typically require two surgeons: a primary surgeon who positions the cannula tip near the retina, and an assistant surgeon who pushes the syringe plunger rod as the primary surgeon advances the tip toward the retina. The assistant surgeon records the plunger position at bleb initiation and calculates the amount of fluid delivered in real time to verify that the target dose has been reached. Thus, the current procedure is complex, and it is difficult to know when the target dose has been delivered.

[0006] Therefore, devices and methods for facilitating the delivery of fluids into a patient's body would be useful. Summary of the Invention

[0007] The present invention relates to devices and methods for delivering drugs into a patient's body, and more particularly to syringes, systems, and methods of using such syringes for delivering precise doses of drugs (e.g., gene vectors and / or stem cells) subretinally within a patient's eye.

[0008] According to an exemplary embodiment, an apparatus for delivering a medicament into a patient's body is provided, comprising: a syringe cartridge including a housing having a proximal end and a distal end and defining an interior, the syringe cartridge further including a piston slidably disposed within the interior for delivering a medicament into the interior through an outlet at the distal end; a syringe driver including a plunger for advancing the piston within the housing, a source of pressurized fluid, and an actuator member for at least partially opening a flow path between the source and the plunger to advance the plunger and the piston to deliver a medicament from within the housing; one or more sensors operably coupled to the plunger for measuring displacement of the plunger, e.g., axially within the driver; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to determine an amount of medicament delivered through the outlet; and an output device coupled to the processor for providing one or more outputs related to the amount of medicament delivered through the outlet.

[0009] According to another embodiment, a syringe device for delivering a drug into a patient's body is provided, comprising: a syringe cartridge having a housing defining an interior, the syringe cartridge further including a piston slidably disposed within the interior for delivering a drug within the interior through an outlet at a distal end of the housing; a syringe driver including a plunger for advancing the piston within the housing, a source of pressurized fluid, and an actuator member for at least partially opening a flow path between the source and the plunger to advance the plunger and the piston to deliver a drug from within the housing; one or more sensors operably coupled to the plunger for measuring displacement of the plunger within the interior; and a signal coupled to the one or more sensors. a processor for analyzing the signal to measure the amount of drug delivered from the outlet, for example, to measure a volume based at least in part on the displacement of the plunger; an initiation actuator coupled to the processor; and one or more light sources coupled to the processor, the processor activating the one or more light sources to a) emit a first color when the actuator member is first actuated to begin delivering drug from the cartridge, b) emit a second color when the processor detects that the initiation actuator has been actuated to indicate that drug is being delivered to a target location, at which point the processor begins to measure the amount of drug delivered to the target location based at least in part on the signal, and c) emit a third color when the processor confirms that a predetermined dose of drug has been delivered to the target location.

[0010] According to yet another embodiment, a system for delivering a medication into a patient's body is provided, comprising: an injector device comprising: a syringe cartridge including a housing defining an interior and a piston slidably disposed within the interior for delivering the medication within the housing through a distal outlet; a syringe driver including: a plunger coupled to the piston, a driver module, and an actuator member for delivering pressurized fluid into the driver module to advance the plunger and piston to deliver the medication from within the housing; one or more sensors operably coupled to the plunger within the housing for measuring displacement of the plunger; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to determine an amount of medication delivered through the outlet, e.g., based at least in part on the displacement of the plunger; and one or more output devices and an injector communication interface coupled to the processor for providing one or more outputs related to the amount of medication delivered through the outlet. The system further includes an electronic device including: a device communication interface for sending and receiving signals to and from the syringe communication interface; a user interface for inputting a "start" signal to be sent to the processor, whereby the processor analyzes signals from the one or more sensors to determine the amount of medication delivered; and a display for presenting an indicator field containing information regarding the amount of medication delivered from the outlet as received in the signal from the processor.

[0011] In an exemplary embodiment, the one or more output devices include one or more light sources coupled to the processor, wherein the processor activates the one or more light sources to emit a first color when the actuator member is initially actuated to initiate delivery of medication from the cartridge, and to emit a second color to indicate that medication is being delivered to a target location when the processor detects that an initiation actuator has been actuated, at which point the processor begins to measure the amount of medication delivered to the target location based at least in part on the signal, and to emit a third color when the processor confirms that a predetermined dose of medication has been delivered to the target location.

[0012] According to another embodiment, a method for delivering a medication into a patient's body is provided, comprising the steps of providing or loading a quantity of medication into a syringe cartridge including a piston and a cannula slidably disposed therein; coupling the syringe cartridge to a driver, thereby coupling a plunger of the driver to the piston; inserting the cannula into the patient's body; and actuating an actuator of the driver to advance the plunger, thereby advancing the piston and delivering medication from the interior into the patient's body, wherein one or more sensors measure displacement of the plunger, signals from the one or more sensors are analyzed to determine an amount of medication delivered from the cannula based at least in part on the signals, and an output is provided related to the amount of medication delivered.

[0013] In one embodiment, the output includes a light source that emits a first color to provide a visual indication that medication is being delivered from the cartridge when the actuator member is first actuated. Optionally, the method also includes positioning the cannula at a target location; and actuating a start actuator of the driver to indicate that medication is being delivered to the target location, at which point signals from one or more sensors are analyzed to determine the amount of medication delivered to the target location, and the light source emits a second color to visually indicate that medication is being delivered to the target location. Optionally, the light source can emit a third color when a predetermined dose of medication has been delivered to the target location to visually indicate that the dose has been delivered.

[0014] According to yet another embodiment, a method for delivering a medication into a patient's body is provided, comprising: loading a quantity of medication into a syringe cartridge including a piston and a cannula slidably disposed therein; coupling the syringe cartridge to a driver, thereby coupling a plunger of the driver to the piston; inserting the cannula into a patient's body; and actuating an actuator of the driver to advance the plunger, thereby advancing the piston and delivering medication from the interior into the patient's body, wherein one or more sensors measure displacement of the plunger and receive a signal from the one or more sensors. The method includes analyzing the signal to determine the amount of medication delivered from the cannula based at least in part on the signal, and causing a light source to emit a first color when the actuator member is first actuated to visually indicate that medication is being delivered from the cartridge; positioning the cannula at a target location; and actuating a start actuator of the driver to indicate that medication is being delivered to the target location, at which point signals from the one or more sensors are analyzed to determine the amount of medication delivered to the target location, and causing the light source to emit a second color to visually indicate that medication is being delivered to the target location.

[0015] According to another embodiment, a method for delivering a medication into a patient's body is provided, comprising the steps of: loading a quantity of medication into a syringe cartridge, the syringe cartridge including a piston and a cannula slidably disposed therein; coupling the syringe cartridge to a driver, thereby coupling a plunger of the driver to the piston; inserting the cannula into the patient's body; and actuating an actuator of the driver to advance the plunger, thereby advancing the piston and delivering medication from the interior into the patient's body, wherein one or more sensors measure displacement of the plunger, signals from the one or more sensors are analyzed to monitor an amount of medication delivered from the cannula based at least in part on the signals, and an output is provided related to the amount of medication delivered.

[0016] According to yet another embodiment, there is provided a method for delivering a medication subretinally in a patient's eye, comprising: loading a quantity of medication into a syringe cartridge, the syringe cartridge including a piston and a cannula slidably disposed therein; coupling the syringe cartridge to a driver, thereby coupling a plunger of the driver to the piston; inserting the cannula into the patient's eye such that the cannula is positioned adjacent to the patient's retina; and actuating an actuator of the driver to advance the plunger, thereby advancing the piston and delivering medication from the interior to the patient's eye, wherein one or more sensors measure displacement of the plunger, a processor analyzes signals from the one or more sensors, medication delivered from the cannula is monitored based at least in part on the signals, and an output is provided related to the amount of medication delivered. The method also includes the steps of advancing the cannula through the retina while continuing to deliver the agent; and activating an actuation device upon puncturing the retina, wherein the actuation device transmits an initiation signal to the processor, and the processor continues to analyze signals from the one or more sensors to monitor the amount of agent delivered subretinal.

[0017] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0018] The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features and design elements in the drawings are not drawn to scale. On the contrary, the dimensions of the various features and design elements have been arbitrarily increased or reduced for clarity. The drawings include: [Figure 1] FIG. 1 is an enlarged cross-sectional view of a human eye illustrating the administration of a subretinal injection into the eye using a syringe device. [Figure 2A] FIG. 2A is a perspective view of an exemplary embodiment of a syringe including a driver and a syringe cartridge coupled to the driver for delivering a medication into a patient's body. [Figure 2B] FIG. 2B is a cross-sectional view of the syringe of FIG. 2A. [Figure 2C] FIG. 2C is a schematic diagram showing the electronic components of the syringe of FIGS. 2A and 2B. [Figure 3] FIG. 3 is a cross-sectional view of an exemplary driver of the syringe of FIGS. 2A-2C, including a plunger slidable within a driver housing for delivering medication from a syringe cartridge. [Figure 4] FIG. 4 illustrates an exemplary embodiment of electronic components that may be provided within the driver housing of FIG. 3, including, for example, one or more optical sensors and multicolor LEDs coupled to a processor. [Figure 5A] FIG. 5A illustrates a portable electronic device in communication with a syringe, such as the syringe of FIGS. 2A-2C. [Figure 5A] FIG. 5B illustrates an exemplary display that may be presented on an electronic device in communication with the syringe shown in FIG. 5A. [Figure 6]6A and 6B are perspective and cross-sectional views, respectively, of another exemplary embodiment of a syringe. [Figure 7] 7A-7C are side views illustrating an exemplary embodiment of a loading device for loading a medication into a syringe cartridge. [Figure 8] 8A and 8B are side views of an exemplary embodiment of a needle cannula that may be attached to a syringe cartridge to deliver medication from the cartridge. DETAILED DESCRIPTION OF THE INVENTION

[0019] Before describing exemplary embodiments, it should be understood that the present invention is not limited to the particular embodiments described, as such may, of course, vary. The following detailed description is merely exemplary in nature and is not intended to limit the subject embodiments or the application and uses of these embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any express or implied discussion presented in the preceding technical field, background, brief summary, or the following detailed description. It is to be understood that the scope of the present invention will be limited only by the appended claims, and that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0020] Where a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range is also specifically disclosed, unless the context clearly dictates otherwise. Each subrange between a stated value or intervening value within a stated range and any other stated or intervening value within that stated range is included in the invention. The upper and lower limits of these subranges may individually be included or excluded, and any ranges in which either or both limits are included in a subrange are also included in the invention, unless specifically excluded in the stated range. When a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential exemplary methods and materials are described herein.

[0022] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "compound" includes a plurality of such compounds, and a reference to a "polymer" includes a reference to one or more polymers and their equivalents known to those skilled in the art. Many applications exist in which controlled delivery of a medicament is desired while maintaining precise positional control of a delivery needle and / or monitoring delivery to ensure a desired amount of fluid has been delivered. The devices and methods described herein can facilitate precise delivery of medicaments, such as one or more viscous fluids or other flowable substances, into a patient's body for various therapeutic and / or diagnostic purposes. As used herein, "medicament" is intended to refer to any fluid, drug, or material, such as those described herein. For example, the following is a summary of exemplary applications in which the devices and methods described herein can be used to deliver fluids into a patient's body:

[0023] Ophthalmology: As shown in Figure 1, syringe device 8 may be used for subretinal injections in the treatment of several disease states of eye 90. Syringe device 8 may include a syringe cartridge and syringe driver (not shown), similar to any of the embodiments described herein.

[0024] Treatment of Retinal Vein Occlusion: Multiple indications can be treated by administering therapeutic agents into the subretinal space 92 of the eye 90, as shown in Figure 1. In the case of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), 50–150 μL of tissue plasminogen activator (TPA) can be administered with a relatively small hypodermic needle (e.g., 41 gauge or smaller) to dissolve blood clots formed by subretinal hemorrhage during retinal surgery. In such cases, the ophthalmologist positions the tip beneath the surface of the patient's retina and slowly injects TPA to create a drug bleb, which dissolves the clotted blood over the course of several days.

[0025] Gene Therapy for Macular Degeneration: Age-related macular degeneration (AMD) is a leading cause of vision loss and blindness in older adults. AMD is a progressive eye disease of the macula, a part of the retina that enables people to read, recognize faces, and drive. The disease initially causes distortion of central vision and ultimately leads to legal blindness. A layer of cells at the back of the eye, called the retinal pigment epithelium (RPE), supports, protects, and nourishes the retina's light-sensitive cells, namely, the rod and cone photoreceptors. Dysfunction and / or loss of these RPE cells plays a key role in photoreceptor loss and, ultimately, AMD-related blindness. Recent advances in research have demonstrated the potential for new therapies to treat AMD. Human embryonic stem cells, gene therapy, complement factors, and viral vectors have been developed and are undergoing early-stage animal studies and / or clinical trials. Some of these therapies require precise control of the location, rate, and / or total volume of cells administered to targeted areas of the eye, including the subretinal and suprachoroidal spaces.

[0026] Dermal Fillers and Botulinum Toxin for Use in Cosmetic Procedures: Dermal filler procedures involve injecting a highly viscous purified liquid or gel into various parts of the anatomy to replenish subcutaneous fat lost with age and enhance volume and fullness, particularly in the lips, chin, nasolabial folds, tear troughs, and cheeks. Botulinum toxin is also injected into the glabella, forehead, and orbicularis oculi areas to neutralize and relax the muscles and reduce wrinkles in these areas of the face. In all of these procedures, the ability to precisely control the flow rate and repeatedly inject highly viscous liquids into tissues with varying resistance improves consistency during injection, and tracking the injection volume allows for consistent results with repeated treatments.

[0027] 2A-2C, an exemplary syringe device 10 for delivering a medicament 6 into a patient's body includes a syringe cartridge 12 including a cartridge housing having proximal and distal ends 12a, 12b and defining an interior 14, a piston 16 slidably disposed within the interior 14 for delivering the medicament 6 into the interior 14 via an outlet or port 18 and / or needle cannula 19 in the distal end 12b of the cartridge 12, and a syringe driver 20 including a housing 22 including a plunger 30 and a drive module 40 for advancing the piston 16 within the interior 14 of the cartridge 12.

[0028] The proximal end 12a of the syringe cartridge 12 may be sized to be received within the distal region 23 of the driver housing 22 or otherwise removably coupled to the distal end 22b of the housing 22 such that the plunger 30 can be coupled to the piston 16 and advanced into the interior 14 of the cartridge 12 to deliver the medicament 6 via the port 18 and cannula 19. For example, the proximal end 12a of the cartridge 12 and the housing 22 may include one or more cooperating connectors (not shown) for securing the cartridge 12 to the housing 22 when inserted into the distal region 23, e.g., so that the port 18 (and needle or cannula 19 connected to the port 18) extends distally from the housing 22. When the cartridge 12 is fully seated, e.g., one or more cooperating connectors 17, 35 can be used to couple the piston 16 to the plunger 30 such that distal advancement of the plunger 30 advances the piston 16 within the interior 14.

[0029] In this manner, a desired amount of medication 6 can be loaded or provided in the interior 14 of cartridge 12, which can be coupled to driver 20 immediately prior to injection, e.g., as further described elsewhere herein. Needle or cannula 19 can be removably connected to port 18 or can be permanently integrated. Alternatively, the cartridge can be permanently integrated into the driver housing, e.g., to provide a non-separable, e.g., single-use, disposable device.

[0030] 2B and 3, the driver 20 includes an outer housing 22 containing a driver module 40 including, for example, a pressurized fluid and / or other energy source 44, hydraulic fluid, and a lever or other actuator member 42 for at least partially opening one or more fluid paths between the source 44 and the plunger 30 to advance the plunger 30 and deliver medicament from the cartridge 12. For example, as shown in FIG. 2B, a canister of pressurized gas or other high-power energy storage device 44 may be provided, for example, in the proximal end 22a of the housing 22, which may be opened by a pin 43 during initial actuation of the syringe 10 to deliver pressurized gas to a gas chamber 45, which applies a distal force to a fluid piston 46. An incompressible fluid, for example, a silicone fluid, may be provided beyond the fluid piston 46 in a fluid chamber 47 that communicates with the interior of a plunger chamber 48 such that, upon actuation of the lever 42, the fluid enters the plunger chamber 48 and distally advances the plunger 30. In an exemplary embodiment, a needle valve (not shown) is provided that includes a needle coupled to lever 42, e.g., by a carriage (not shown) within housing 122, which, when lever 42 is actuated, is displaced to open an orifice communicating between fluid chamber 47 and plunger housing 48, e.g., to allow fluid to flow at a substantially constant rate to displace plunger 130 at a desired rate, as further described elsewhere herein. Additional information regarding exemplary embodiments of driver modules that may be included in driver 20 is disclosed in U.S. Publication Nos. 2017 / 0258583, 2017 / 0312422, and 2019 / 0167906, the entire disclosures of which are expressly incorporated herein by reference.

[0031] 2C and 4 , the driver 20 also includes one or more electronic components, such as one or more sensors 50 operably coupled to the plunger 30 to measure the displacement of the plunger 30 within the housing 22, a processor 52 coupled to the sensor 50 to process and / or analyze signals from the sensor 50 to determine an amount of medication delivered from the port 18 based at least in part on the signals, one or more batteries or other power sources 54, and one or more output devices, such as one or more LEDs 56 a and / or speakers 56 b coupled to the processor 52 to provide one or more outputs, such as volume, flow rate, and / or other parameters related to medication delivered from the syringe cartridge 12 as described elsewhere herein. In the illustrated exemplary embodiment, the one or more optical sensors 50 may be mounted within the housing 22 near, e.g., concentrically with, the plunger 30, which may be coupled to the processor 52, including, e.g., a linear quadrature decoder and / or other hardware or software components, to correlate the linear displacement of the plunger 30 within the housing 22 with the amount of medication delivered from the syringe cartridge 12 to the patient.

[0032] The processor 52 may monitor one or more delivery parameters (e.g., the amount of fluid injected) during delivery of the medication based on signals from the sensor 50 and may, for example, activate an output device 56 to communicate information to the user and / or otherwise facilitate delivery. For example, one or more LEDs or other light sources 56a (e.g., multi-colored LEDs or multiple LEDs of different colors) may be provided that are activated to provide visual indications regarding the actuation and / or operation of the syringe 10, as described elsewhere herein. Additionally or alternatively, the output device may include a speaker or other sound generator 56b that may generate an audible signal in addition to, or instead of, the light sources 56a.

[0033] Optionally, processor 52 may include a clock (not shown), for example, to measure time events and / or add timestamps to data stored or communicated by processor 52. For example, injector 10 may include on-board memory (not shown) in communication with processor 52 for storing data from signals from sensor 50, volumes, or other information determined by processor 52 from the signals (e.g., total amount delivered, delivery rate, dosing profile information, delivery time, time between different events such as between cartridge loading and delivery, etc.). In another option, injector 10 includes a temperature sensor (not shown) in communication with processor 52 for monitoring the temperature of the medicament.

[0034] Additionally, the injector 10 may include a wireless interface including one or more antennas (not shown) configured to transmit and / or receive signals using the communications interface 58 (e.g., Bluetooth™ or other RF communications protocol). For example, an external switch or actuation device (not shown) may be provided and utilized to communicate with the injector 10 via its wireless communications interface to communicate commands or other information with the processor 52 and / or receive data or other information from the processor 52. In one embodiment, the actuation device may simply be a switch that can be manually actuated by an operator (e.g., a surgeon or assistant), which communicates a “start” signal to the processor 52 via the communications interface 58, which in turn monitors signals from the sensor 50 to measure the amount delivered from the cartridge 12 based on the displacement of the plunger 30, e.g., to measure the dose or “bleb” delivered to the target site, as described elsewhere herein.

[0035] Alternatively, as shown in Figures 5A and 5B, the actuation device may be a wireless electronic device 60 (e.g., a mobile phone, tablet, etc. (not shown)), which provides a user interface through which an operator can communicate a start signal, for example, by pressing a "start" icon 64b on the display 62 of the electronic device, as shown in Figure 5B.

[0036] In this alternative, the electronic device 60 may provide additional functionality to facilitate use of the injector 10. For example, a "ready" icon 64a may be provided on the display 62, which, when selected, causes the device 60 to send a signal (e.g., represented by signal 68) to activate the electronics of the injector 10 prior to use. For example, the processor 52 of the injector 10 may remain dormant until it detects a ready signal received by the interface 58, which may cause the processor 52 to activate the sensor 50 and / or other components of the injector 10 prior to injection. Additionally, the electronic device 60 may receive information from the injector 10 during delivery and present the information on the display 62 (e.g., in the indicator field 66). Alternatively, the injector 10 may include a switch or other actuator (not shown) that is used to turn on the electronics, i.e., connect the power source 54 to the processor 50 and / or other components of the injector 10. For example, a switch (not shown) may be provided in the distal region 23 or elsewhere in the housing 22 that is automatically activated when the cartridge 12 is inserted into the distal region 23 to wake up the electronics of the injector 10 prior to injection.

[0037] For example, as best seen in Figure 5B, a graphical representation or indicator field 66 may be presented on the display 62 indicating one or more of the position of the piston / plunger, the target amount of medication to be delivered, the actual amount of medication delivered, etc. In the illustrated embodiment, the black area 66a on the left side of the indicator 66 represents the initial position of the plunger 30 of the driver 20, which also corresponds to the initial position of the piston 16 in, for example, the syringe cartridge 12 that has been filled and coupled to the driver 20.

[0038] When the actuator 42 of the syringe 10 is actuated, the plunger 30 and piston 16 begin to displace to deliver the medication 6 from the syringe cartridge 12, which is represented, for example, by a different color region 66b on the indicator 66 (e.g., initially from a black region toward the opposite end of the indicator 66). For subretinal delivery, for example, an initial amount of medication may be delivered from the syringe cartridge 12 while the cannula is advanced toward and / or through the retina. For example, as further described elsewhere herein, the cannula 19 is initially positioned in a conventional manner toward the eye 90 (e.g., similar to the device shown in FIG. 1) and near the retina 94 (e.g., just in front of the retina).

[0039] When the surgeon is ready to deliver the agent subretinally, he or she can actuate the actuator 42, after which the cannula 19 can be advanced through the retina 94 while the agent is being delivered. The initial bolus of agent delivered before the retina 94 is penetrated is simply released into the interior of the eye 90 and is not considered part of the bleb volume intended for subretinal delivery. In this case, the surgeon may instruct his or her assistant to actuate the actuation device 60 immediately after penetrating the retina 94. For example, the assistant may select the “start” icon 64b shown in FIG. 5D , which may then cause the device 60 to communicate a “start” signal to the processor 52 of the injector 10 (via the interface 58) to begin measuring and / or monitoring the amount of agent delivered subretinal. Alternatively, a foot switch or other actuator (e.g., a button on the driver (not shown)) may be provided for the surgeon to trigger, which, for example, communicates a “start” signal when the surgeon steps on or otherwise activates a switch, as described elsewhere herein.

[0040] Optionally, processor 52 may activate output devices to communicate information to the surgeon during delivery. For example, when the actuator 42 of the syringe 10 is initially actuated, processor 52 may activate LED 56a to emit a yellow light (or other predetermined color) to provide visual confirmation that the medication is being delivered. When processor 52 receives a “start” signal, processor 52 activates LED 56a to emit a green light (or other predetermined color) to provide visual confirmation that the medication is being delivered subretinal (i.e., the amount of bleb being delivered is now being measured). Once the target amount has been delivered, processor 52 activates LED 56a to emit a red light (or again, another predetermined color) to provide visual confirmation that the target amount has been delivered. Alternatively, separate LEDs may be provided that can be sequentially activated to provide the desired visual status indication. Additionally or alternatively, speaker 56b may be activated at each of these stages to emit a sound (e.g., different sounds corresponding to initial delivery, subretinal delivery, and achievement of the target amount). If the actuation device is a wireless electronic device 60, the assistant may press a "start" icon (or otherwise interface with the electronic device) to cause the electronic device 60 to communicate a start signal to the processor 52. In this embodiment, the processor 52 may communicate information related to the delivery of the medication 6 to the electronic device 60 via the communication interface 58, e.g., for presentation on the display 62 and / or storage in the memory of the device 60. For example, as shown in FIG. 5B , when the actuator 42 is first actuated and medication begins to be delivered (e.g., before penetrating the retina), a yellow region 66b may be presented adjacent to a black (initial position) region 66a. Optionally, the leading edge of the yellow region may translate toward the opposite end of the indicator 66 in proportion to the amount delivered, e.g., until a start signal is received.

[0041] When a “start” signal is received by processor 52, yellow region 66b may stop and green region 66c may begin moving along indicator 66, visually indicating the amount of bleb delivered subretinal. Optionally, the processor of electronic device 60 may display the target volume on indicator 66 as a green outline 66d extending from the yellow region (or the black region when the syringe is first activated), e.g., to ensure that cartridge 12 has sufficient volume to deliver the target volume. Additionally or alternatively, the displayed indicator 66 may include a scale or other indicator identifying the volume so that an assistant can visually monitor the amount being delivered as the green region passes the corresponding indicator on the indicator. Once the target volume is achieved, green region 66c may stop and a red region (not shown) may begin moving along indicator 66, e.g., beyond target volume region 66d, to indicate an excess amount of agent being delivered. For example, in some applications, a surgeon may decide to deliver additional agent beyond the original target volume, and this volume may be indicated by a red region.

[0042] When the surgeon releases the actuator 42 of the syringe 10, delivery is halted and the cannula 19 can be removed from the patient, e.g., as in conventional methods. After delivery, the syringe processor 20 and / or electronic device 60 may store information related to the delivery for subsequent recording and / or analysis. For example, the amount of pre-bleb drug released into the eye (yellow area 66b), the amount of bleb (green area 66c and / or red area), and / or other parameters may be stored and used for subsequent analysis and / or treatment of the patient. Next, an exemplary method of using the syringe shown in FIGS. 2-4 to deliver a drug, such as a gene vector and / or stem cells, to the subretinal region 92 within a patient's eye 90, similar to the device 8 shown in FIG. 1, will be described. First, a quantity of drug 6 is loaded into the interior 14 of the syringe cartridge 12, which is sealed by a piston 16 slidably disposed within the interior 14. For example, as shown in FIGS. 7A-7C , the cartridge 12 is coupled to a filling device or adapter 80 including a housing 82 and a manual plunger 84 that can be used to load a medication (not shown) into the cartridge 12. As shown, the housing 82 includes a tubular body having an open end 82a sized to receive the proximal end 12a of the cartridge 12 therein. Optionally, the housing 82 may include one or more connectors (not shown) for removably securing the cartridge 12 during filling. The manual plunger 84 can be coupled to the piston 16 by threading a threaded nipple 84a on the plunger 84 (or another connector, not shown) into a similarly threaded recess on the piston (or other cooperating connector, not shown), for example, with the piston 16 in its distal-most position as shown in FIG. 7A . Once the cartridge 12 is coupled to the filling device 80, a needle cannula (not shown) can be connected to a port 18 on the cartridge 12 and inserted into a container of medication (not shown) with the piston 16 in its distal-most position (closer to the port 18). As shown in FIG. 7B, the manual plunger is pulled back so that the piston 16 moves proximally away from the port 17, thereby drawing the medicament 6 into the interior 14 as the piston 16 moves proximally.Once sufficiently filled, the cannula can be removed from the container and port 18 .

[0043] As shown in FIG. 7C, the plunger 84 can be unthreaded or otherwise removed from the piston 16, allowing the cartridge 12 to be removed from the filling device 80.

[0044] Once the syringe cartridge 12 is filled and / or filled to the desired volume, the cartridge 12 may be coupled to the driver 20. For example, the cartridge 12 may be inserted into the distal region 23 of the driver housing 22 until the driver plunger 30 couples to the piston 16. For example, as shown in FIG. 2B , the plunger 30 may include a tab or other connector 35 that may be received in or otherwise engage with the recess 17 or other connector on the piston 16. The syringe 10 is then ready to deliver the medication 6 to the patient. Alternatively, it will be appreciated that a separate syringe cartridge pre-filled with the desired amount of medication may be replaced with the integrated syringe region within the driver. Furthermore, if the port 18 of the syringe cartridge 12 is not initially provided with a needle cannula 19, the needle cannula 19 may be attached using conventional methods, such as a threaded connector, a luer fitting, or the like. The needle cannula may be connected to the port 18 of the cartridge 12 immediately prior to delivery. 8A and 8B, an exemplary embodiment of a cannula assembly 70 is shown that includes an inner injection cannula 72 and an outer protective cannula 76. The inner cannula 72 generally includes a proximal hub 74 that includes a hollow proximal end 74a sized to be received over or otherwise engage with the port 18 of a cartridge (e.g., cartridge 12 shown in FIGS. 7A-7C or that of any other embodiment herein), and an elongated tubular needle 75 that extends from a distal nipple 74b and terminates in a tip 75a, which may be sharp or blunt depending on the application.

[0045] The outer cannula 76 also includes a proximal hub 78 including a hollow proximal end 78a sized to be received over the nipple 74b of the inner cannula hub 74, and a needle 79 extending from the distal nipple 78b. The needles 75, 79 may be formed from stainless steel or other conventional material, and the hubs 74, 78 may be formed from plastic or other conventional material, e.g., such that the needles 75, 79 may be bonded or otherwise permanently attached to the hubs 74, 78, respectively. As shown, the inner needle 75 may be longer than the outer needle 79 so that, for example, the outer needle 79 may be used to protect the inner needle 75 during introduction and then retracted to expose the tip 75a of the inner needle 75.

[0046] For example, assembly 70 can be initially provided with outer cannula 76 in a distal position, with tip 75a of inner needle 75 covered by outer needle 79 and outer cannula hub 78 spaced distally from inner cannula hub 74, as shown, for example, in FIG. 8A . In this configuration, inner cannula hub 74 is received over port 18 of cartridge 12 for mounting assembly 70 to a syringe, such as any described herein. In use, outer needle 79 may remain over tip 75a of inner needle 75, for example, to protect tip 79a during introduction. For example, inner needle 75 may have a very small diameter and a relatively thin wall, making it fragile, while outer needle 79 may have a relatively thick wall and / or greater column strength to reduce the risk of bending or breaking outer needle 79. When assembly 70 is introduced into a patient's body, for example, through a trocar cannula having a septum or valve (not shown), outer needle 79 can open the septum or valve with minimal risk of injury to advance inner needle 75 through the trocar cannula.

[0047] Once the tip 79a of the outer needle 79 is positioned at a desired location (e.g., beyond the trocar cannula and within the patient's eye), the outer cannula 76 can be retracted to expose the tip 75a of the inner needle 75. For example, as shown in FIG. 8B, the outer cannula 76 is retracted until the outer cannula hub 78 is received over the nipple 74b and / or otherwise engages the inner cannula hub 74, thereby preventing further movement of the outer cannula 76, while the tip 75a of the inner needle 75 is then inserted into the target location for delivery of an agent, e.g., as further described elsewhere herein.

[0048] 2-4, once a needle or cannula (e.g., cannula 19 or cannula assembly 70) has been attached to cartridge 12, syringe 10 is ready for use. For example, actuator lever 42 may be actuated to first activate driver module 40, causing pin 43 to puncture gas canister 44, similar to the embodiments described in the applications incorporated by reference herein. Gas may then be released from canister 44 to power fluid plunger 46. Optionally, actuator 42 may be initially actuated to deliver a small bolus of medication from cartridge 12, for example, to fill cannula 19 and / or remove air or other potential contaminants. For example, when lever 42 is actuated (initially and during injection of medication 6), pin 49 opens a fluid passage from fluid chamber 47 to plunger housing 48, thereby allowing incompressible fluid to enter plunger housing 48 and advance plunger 30 at a substantially consistent and uniform translational velocity, for example, due to the pressure acting on fluid plunger 46 and the fluid entering plunger housing 48.

[0049] 5A and 5B, once this step is complete, a "Ready" icon 64a may be selected on the electronic device 60 to send a ready signal to the syringe processor 52, for example, to indicate the initial (zero) position of the plunger 30 and piston 16. This position may be presented as a black area 66a on the indicator 66 displayed on the electronic device 60 shown in FIG.

[0050] Similar to device 8 shown in FIG. 1 , cannula 19 may then be inserted into patient's eye 90, e.g., as in a conventional manner, such that cannula 19 is positioned near patient's retina 94. Actuator lever 42 may then be actuated to advance plunger 30, thereby advancing piston 16 to deliver medication 6 from interior 14 to patient's eye 90. Processor 52 may monitor the displacement of plunger 30 based on signals from sensor 50 and calculate in real time the amount of medication delivered to patient's eye 90.

[0051] The cannula 19 can then be advanced to penetrate the retina 94 while delivering the agent, at which point the surgeon may instruct an assistant to activate the activation device 60 (e.g., by pressing the "Start" icon 64b on the electronic device's display 62 or by activating a standalone switch). This action transmits a start signal to the processor 52, which continues to analyze signals from the sensor 50 to monitor further displacement of the plunger 30 and determine the amount of agent delivered subretinal. As previously described, the processor 52 can activate one or more output devices (e.g., LED 56a and / or speaker 56b) to confirm the status of agent delivery to the surgeon and / or communicate information to the electronic device 60 for the display 52 (e.g., indicator 66 shown in FIG. 5B). The surgeon can continue delivery (using the output device 56 and / or electronic device 60) until the target amount is delivered, confirm the amount, and deliver additional agent if necessary. Once the desired amount has been delivered, the surgeon can release lever 42 to stop delivery and then remove syringe 10, for example, using conventional methods.

[0052] 6A and 6B, another exemplary embodiment of a syringe 110 is shown, including a syringe cartridge 12 and a driver 120, which is generally similar to the previous embodiment. As with the previous embodiment, the cartridge 12 includes a piston 16 that is slidable within an interior 14 of the cartridge 12 and can be filled with a medication (e.g., pre-filled or filled immediately before use), and an outlet or port 18 to which a cannula (not shown) can be attached prior to use. When the cartridge 12 is inserted into a distal region 123 of the housing 122, one or more connectors on the cartridge 12 and / or housing 122 engage to secure the cartridge 12 and, substantially simultaneously, a tab 135 on the plunger 130 can secure a recess 17 on the piston 16 (or other connector). Additionally, a switch (not shown) can be provided that is activated when the cartridge 12 is inserted, which can activate the electronics of the syringe 110, as described elsewhere herein.

[0053] Also similar to the previous embodiment, the drive module 140 may include a canister of pressurized gas or other high-power energy storage device 144, for example in the proximal end 122a of the housing 122, which upon initial actuation of the syringe 110 is opened by a pin 143 to deliver pressurized gas around the canister 144 and apply a distal force to the fluid piston 146. Unlike the previous embodiment, in this version, the driver 120 includes an actuation cap 141 that is twisted or otherwise manually actuated (rather than utilizing the initial actuation of a lever 142, as described elsewhere herein) to open the canister 144 with the pin 143. Incompressible fluid is provided over the fluid piston 146 into a fluid chamber 147 that communicates with the interior of a plunger chamber 148, and upon actuation of the lever 142, the pin 149 is displaced to open a fluid path, allowing fluid to enter the plunger chamber 148 and advance the plunger 130 distally.

[0054] 6B , similar to the previous embodiment, the syringe 110 also includes one or more LEDs 156a mounted within the housing 122 adjacent an opening or window (not shown) for transmitting light outside the housing 122, and a speaker 156b for providing visual and / or audible signals during use of the syringe 110. For example, the LEDs 156a and speaker 156b may be coupled to a processor (not shown) within the housing 122 that is coupled to the battery 154, a communications interface 158 (including an antenna, not shown, for transmitting and receiving Bluetooth™ or other wireless signals), again similar to the previous embodiment. Additionally, the driver 120 may also include a button, switch, or other “wake-up” actuator (not shown), for example, within the distal region 123, that is actuated, for example, when a cartridge 12 is loaded into the driver 120, to “wake up” electrical components of the driver 120 and, for example, connect the battery 154 to the processor and / or other components (e.g., when the syringe 110 is used without an activation device).

[0055] Unlike the previous embodiment, the syringe 110 includes one or more sensors 150 that provide a magnetic tracking device for measuring the displacement of the plunger 130. For example, a stationary magnetic sensor 150a is mounted within the housing 122 adjacent to the plunger 130, e.g., immediately adjacent the distal end 134 of the plunger 130. A magnetic strip 150b is attached to the plunger and extends at least partially between the distal and proximal ends 134, 132 of the plunger 130. For example, the magnetic strip 150b may be an alternating polarity strip with a desired spacing (e.g., 1 mm pole spacing) between alternating poles along the length of the strip 150b. As the plunger 1130 moves axially, the strip moves axially past the magnetic sensor 150a, which may function like an encoder to track the axial displacement of the strip 150b. This causes the magnetic element 150b to pass alongside the magnetic sensor 150a as the plunger 130 advances distally, and the processor processes the generated signal to determine the displacement of the plunger 130 and, as in the previous embodiment, can measure the amount of medication delivered from the syringe 110, for example using a known value for the cross-sectional area of ​​the interior 14 of the cartridge 12.

[0056] Also, unlike the previous embodiment, the syringe 110 includes a "start" button or other actuator 151 on the driver 120, which can be used to communicate a "start" signal to the processor (instead of using a separate actuation device), which can be used to, for example, meter the dose of medication to be delivered, similar to other embodiments herein.

[0057] Generally, syringe 110 can be used similarly to the previous embodiments to deliver precise doses of medication into a patient's body, e.g., subretinal. For example, immediately prior to use, cartridge 12 can be filled and inserted into distal region 123, thereby coupling piston 16 to plunger 130 and activating the electronics of syringe 110. Cap 141 can then be twisted or otherwise actuated to open the gas cartridge, powering driver 120, which in turn can actuate lever 142, allowing pressurized fluid to advance plunger 130.

[0058] The syringe 110 is then ready to deliver a medication, for example, to a patient's eye (not shown). For example, a cannula (not shown) coupled to the port 18 is inserted into the patient's eye and positioned near the patient's retina. The actuator lever 142 is then actuated to advance the plunger 130, thereby advancing the piston 116 and beginning to deliver the medication from the interior 14 to the patient's eye. Optionally, a processor may monitor the displacement of the plunger 130 based on signals from the sensor 150 and calculate in real time the amount of medication delivered to the patient's eye.

[0059] The cannula is then advanced to penetrate the retina while continuing to deliver the agent, at which point the surgeon presses the "start" button 151 to transmit a start signal to the processor. The processor can continue to analyze the signal from the sensor 150 to monitor further displacement of the plunger 130 and determine the amount of agent delivered subretinal. As previously described, the processor activates one or more output devices (e.g., LED 156a and / or speaker 156b) to allow the surgeon to confirm the status of agent delivery. For example, the surgeon may use a change in output from the output device 156 to confirm the amount, continue delivery until the target amount is delivered, and optionally deliver additional agent as needed. Once the desired amount has been delivered, the surgeon can release the lever 142 to stop delivery and then remove the syringe 110, e.g., using conventional methods.

[0060] Thus, in this embodiment, the injector can be operated completely independently of the electronic tablet / smartphone. The processor can record data relating to, for example, the amount of medication delivered and / or other information in an on-board memory (not shown), which can be later retrieved, for example, by communicating with an external electronic device using the communications interface 158 to connect, for example, via Bluetooth™ or other protocol, and download the information.

[0061] The foregoing disclosure of exemplary embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many variations and modifications of the embodiments described herein will be apparent to those skilled in the art in light of the above disclosure.

[0062] It will also be understood that elements or components shown in any embodiment herein are illustrative of a particular embodiment and can be used on or in combination with other embodiments disclosed herein.

[0063] Furthermore, in describing representative embodiments, the present specification may present methods and / or processes as a particular sequence of steps. However, to the extent that these methods or processes do not depend on the particular order of steps described herein, the methods or processes should not be limited to the particular order of steps described. As one of ordinary skill in the art would understand, other orders of these steps are possible. Thus, the particular order of steps described in the specification should not be construed as a limitation on the scope of the claims.

[0064] While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein, it should be understood, however, that the invention should not be limited to the particular forms or methods disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Claims

1. 1. A syringe device for a surgeon to deliver precise doses of medication into a patient's body, comprising: a syringe cartridge including a cartridge housing having a proximal end and a distal end and defining an interior, the syringe cartridge further including a piston slidably disposed within the interior for delivering a medication into the interior through an outlet at the distal end; a syringe driver including: a driver housing including a plunger for advancing the piston within the cartridge housing; a source of pressurized fluid; and an actuator member configured to be actuated by a surgeon to at least partially open a flow path between the source and the plunger to advance the plunger and the piston for controlled delivery of a medicament from within the cartridge housing, the actuator member configured such that delivery of the medicament is discontinued when the surgeon releases the actuator member; one or more sensors operably coupled to the plunger for measuring displacement of the plunger; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to determine an amount of medication delivered through the outlet based at least in part on displacement of the plunger; an output device coupled to the processor for providing one or more outputs to a surgeon related to the amount of drug delivered from the outlet, for providing confirmation when a predetermined dose of drug has been delivered, and for enabling the surgeon to release the actuator member to stop delivery of the drug at the predetermined dose.

2. The device of claim 1 , wherein the output device comprises a light source coupled to the processor and configured to provide a visual indication related to the operation and behavior of the device.

3. 3. The device of claim 2, wherein the light source comprises a multi-color LED configured to emit a first color to indicate that the actuator has been initially actuated by a surgeon and that medication has been initially delivered from the cartridge, and a second color to indicate that medication has been delivered when the processor receives a start signal from the surgeon after the outlet is positioned at a target location.

4. 4. The device of claim 3, wherein the multi-color LED is configured to emit a third color when the processor confirms that a predetermined dose has been delivered to the target location.

5. The device of claim 1 , wherein the output device comprises a speaker coupled to the processor and configured to provide audible indications related to the operation and behavior of the device.

6. 10. The device of claim 1, further comprising a communications interface coupled to the processor for receiving wireless signals from an activation device, the processor configured to identify a "ready" signal from the wireless signals and activate the device from a dormant state.

7. 7. The device of claim 6, wherein the processor is further configured to identify a "start" signal from the wireless signal, and then the processor analyzes signals from one or more sensors to measure the amount of drug delivered from the outlet.

8. The device of claim 1 , wherein the one or more sensors include one or more optical sensors mounted within the driver housing near the plunger and generating a signal related to displacement of the plunger.

9. The device of claim 8 , wherein the one or more optical sensors are mounted concentrically around the plunger.

10. The device of claim 1 , wherein the one or more sensors include a magnetic sensor mounted within the driver housing near the plunger to generate a signal related to displacement of the plunger.

11. 11. The device of claim 10, further comprising a magnetic strip of alternating polarity on the plunger, each pole of the strip generating a signal as it passes the magnetic sensor to track displacement of the plunger.

12. The device of claim 1 , wherein the cartridge is removably coupled to the driver housing.

13. The device of claim 1 , wherein the cartridge is removably received within a distal region of the driver housing such that the outlet is directed distally relative to the driver.

14. The device of claim 13 , wherein the cartridge housing and the driver include one or more cooperating connectors that secure the cartridge within the distal region.

15. 15. The device of claim 13 or 14, wherein the piston and plunger include one or more connectors that couple the piston to the plunger when the cartridge is received within the distal region.

16. 15. The device of any one of claims 12 to 14, further comprising a switch that is actuated to provide power from a power source to the processor when the cartridge is coupled to the driver housing.

17. The device of claim 1 , wherein the cartridge housing is permanently coupled to the driver.

18. 10. The device of claim 1, further comprising a switch on the driver coupled to the processor that delivers a "start" signal when activated, whereby the processor analyzes signals from the one or more sensors to measure the amount of drug delivered from the outlet.

19. The device of claim 1 , further comprising a memory in communication with the processor for storing data including information related to a drug delivered from the outlet.

20. 20. The device of claim 19, wherein the processor is configured to determine, based at least in part on the signal, data for storage in the memory of one or more of: a total amount of drug delivered from the interior, a total amount delivered to a target location, a volume rate of drug delivered from the interior, and an administration profile of drug delivered from the interior.

21. 21. The device of claim 19 or 20, further comprising a clock in communication with the processor, the processor configured to add timestamps to data stored in the memory.

22. 22. The device of claim 21, wherein the processor is configured to determine from data from the clock one or more of the following: a time for delivery of the medication, a time between different events during delivery of the medication, and a time between loading of the cartridge and delivery of the medication.

23. The device of claim 1 , further comprising a temperature sensor in communication with the processor for monitoring the temperature of the medication within the cartridge.

24. 10. The device of claim 1, further comprising an actuation device and a syringe communication interface within the housing, the syringe communication interface receiving a "start" signal from the actuation device, whereby the processor analyzes signals from the one or more sensors to determine the amount of medication delivered.

25. 25. The device of claim 24, wherein the actuation device includes a switch operable to communicate the "start" signal to the processor.

26. 26. The device of claim 25, wherein the syringe communication interface includes wiring connecting the switch to the driver for communicating the "start" signal to the processor.

27. 25. The device of claim 24, wherein the syringe communication interface is configured to transmit and receive signals wirelessly.

28. 28. The device of claim 27, wherein the actuation device comprises an electronic device including a communication interface for communicating with the injector via the injector communication interface and a display for presenting information related to delivery of the medication.

29. 30. The device of claim 28, wherein the processor is configured to send a signal to the electronic device via the syringe communication interface that includes information regarding an amount of medication delivered from the outlet.

30. 30. The device of claim 29, wherein the electronic device is configured to present an indicator field on the display containing information regarding the amount of medication delivered from the outlet.

31. 1. A syringe device for a surgeon to deliver a precise dose of a drug into a patient's body, comprising: a syringe cartridge having a cartridge housing defining an interior, the syringe cartridge further including a piston slidably disposed within the interior for delivering a medication within the interior via an outlet at a distal end of the housing; a syringe driver including: a driver housing including a plunger for advancing the piston within the cartridge housing; a source of pressurized fluid; and an actuator member configured to be actuated by a surgeon to at least partially open a flow path between the source and the plunger to advance the plunger and the piston for controlled delivery of a medicament from within the cartridge housing, the actuator member configured such that delivery of the medicament is discontinued when the surgeon releases the actuator member; one or more sensors operably coupled to the plunger for measuring displacement of the plunger; a processor coupled to the one or more sensors and configured to analyze signals from the one or more sensors to determine an amount of medication delivered through the outlet based at least in part on displacement of the plunger; an initiation actuator coupled to the processor actuatable by a surgeon or an assistant; one or more light sources coupled to the processor; The processor activates the one or more light sources to a) emitting a first color when the actuator member is first actuated to begin delivering medicament from the cartridge; b) emitting a second color to indicate that medication is being delivered to the target location after the outlet is positioned at the target location when the processor detects that the initiation actuator has been actuated, at which point the processor begins to measure the amount of medication delivered to the target location based at least in part on the signal; c) emitting a third color when the processor confirms that the predetermined dose of the drug has been delivered to the target location, allowing a surgeon to release the actuator member to stop delivery of the drug at the predetermined dose.

32. 32. The device of claim 31, further comprising a speaker coupled to the processor, the processor configured to activate the speaker to emit different sounds when the one or more light sources emit first, second, and third colors, respectively.

33. A system for allowing a surgeon to deliver precise doses of medication into a patient's body, 1. A syringe device comprising: a) a syringe cartridge having a cartridge housing defining an interior and a piston slidably disposed within the interior for delivering a medication within the interior via a distal outlet of the housing; b) a syringe driver including a driver housing including a plunger coupled to the piston, a driver module, and an actuator member configured to be actuated by a surgeon to deliver pressurized fluid into the driver module to advance the plunger and piston to deliver medicament from within the cartridge housing; c) one or more sensors operably coupled to the plunger for measuring displacement of the plunger; d) a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to determine the amount of drug delivered through the outlet; e) one or more output devices coupled to the processor for providing one or more outputs to a surgeon related to the amount of agent delivered from the outlet; f) a syringe communication interface; and 1. An electronic device comprising: a) a device communication interface for transmitting and receiving signals to and from the syringe communication interface; b) a user interface for inputting a "start" signal to be sent to the processor, whereby the processor analyzes signals from the one or more sensors to determine the amount of drug delivered; and c) a display for presenting an indicator field containing information regarding the amount of drug delivered from the outlet received in the signal from the processor, the display providing confirmation when a predetermined dose of drug has been delivered and enabling a surgeon to release the actuator member to stop delivery of the drug at the predetermined dose.

34. The one or more output devices include one or more light sources coupled to the processor, the processor comprising: a) emitting a first color when the actuator member is first actuated to initiate delivery of medicament from the cartridge; b) emitting a second color different from the first color to indicate that medication is being delivered to the target location when the processor detects that a "start" signal on the user interface has been entered, at which point the processor begins to measure the amount of medication delivered to the target location based at least in part on the signal; c) activating the one or more light sources to emit a third color when the processor determines that a predetermined dose of medication has been delivered after the outlet is positioned at the target location.

35. 35. The system of claim 34, wherein the one or more output devices further comprise a speaker coupled to the processor, the processor configured to activate the speaker to emit different sounds when the one or more light sources emit the first, second, and third colors, respectively.

36. The electronic device further comprises a device processor for processing information received from the syringe device, the processor configured to present information in the indicator field, which comprises: a) presenting a first color area to identify that delivery of medicament from the cartridge has commenced when the actuator member is first actuated; b) presenting a second color region indicating that an amount of drug has been delivered to the target location when said "start" signal is transmitted; 34. The system of claim 33, further comprising: c) presenting a third color region when the predetermined dose of the drug is delivered to the target location.

37. 33. The device of any one of claims 1-14, 17-20, and 22-32, further comprising a valve member coupled to the actuator member, the valve member displaced upon actuation of the lever to open an orifice communicating between the fluid chamber of the source and the plunger, allowing fluid to flow through the orifice at a substantially constant rate to displace the plunger at a desired rate.

38. 38. The device of claim 37, wherein the actuator member includes a lever coupled to the valve member by a carriage that displaces the valve member when the lever is actuated.

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