Microvolume syringe with dosage instructions and method of use

Abstract

The present application provides a syringe device and a method for using the syringe device to deliver a drug to a patient's body, such as to a subretinal portion of an eye. The syringe includes a cartridge and a driver, the cartridge including a piston slidably disposed within an interior for delivering the drug within the interior through an outlet, the driver including a plunger coupled to the piston, a pressurized fluid source, 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 the drug from the interior. One or more sensors are operably coupled to the plunger to measure the displacement of the plunger, a processor is coupled to (one or more) sensors for analyzing sensor signals to measure the volume of the drug delivered from the interior, and an output device, such as one or more LEDs or speakers, provides an output related to the volume of the drug delivered.

Description

[0001] Related application data

[0002] This application claims the benefit of co-pending provisional applications Serial No. 62 / 899,058, filed September 11, 2019, and Serial No. 63 / 003,117, filed March 31, 2020, the entire disclosures of which are expressly incorporated herein by reference. Technical Field

[0003] The present invention relates to devices and methods for delivering agents into a patient's body, and more particularly, to syringes for delivering precise doses of agents (e.g., gene vectors and / or stem cells) subretinal within a patient's eye, and systems and methods for using such syringes. Background Art

[0004] There are many applications where controlled delivery of a drug is desired while maintaining precise position control of the delivery needle to deliver a precise volume of fluid at a precise location. For example, a syringe device can be used for subretinal injections to treat several disease conditions of the eye.

[0005] Such subretinal injections involve many complications. For example, it can be difficult to precisely position the tip of the syringe cannula within the eye, particularly when identifying when the tip passes through the retinal layer. In addition, the formation of blebs (i.e., lumps of fluid delivered subretinally) poses a risk of rupture or tearing of the retina.

[0006] Furthermore, this current procedure typically requires two surgeons, a primary surgeon who positions the cannula tip close to 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 attempts to record the plunger position at the onset of vacuoles and calculates the volume of fluid delivered in real time to determine when the target dose has been reached.

[0007] Therefore, current procedures are complicated and it is difficult to know when the target dose has been delivered.

[0008] Therefore, devices and methods that facilitate the delivery of fluids into a patient's body would be useful. Summary of the invention

[0009] The present invention relates to devices and methods for delivering agents into a patient's body, and more particularly, to syringes for delivering precise doses of agents (e.g., gene vectors and / or stem cells) subretinal within a patient's eye, and systems and methods for using such syringes.

[0010] According to an exemplary embodiment, a device for delivering a drug into a patient's body is provided, the device comprising: a syringe cartridge comprising a housing including a proximal end, a distal end and defining an interior, the cartridge further comprising a piston slidably disposed within the interior for delivering the drug within the interior through an outlet in the distal end; a syringe driver comprising a plunger for advancing the piston within the interior of 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 the drug from the interior of the housing; one or more sensors operably coupled to the plunger to measure displacement of the plunger, for example, axial displacement within the driver; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to determine a volume of the drug delivered from the outlet; and an output device coupled to the processor for providing one or more outputs related to the volume of the drug delivered from the outlet.

[0011] According to another embodiment, a syringe device for delivering a drug into a patient's body is provided, the syringe device comprising: a syringe cartridge comprising a housing defining an interior, the cartridge further comprising a piston slidably disposed within the interior for delivering the drug within the interior through an outlet of the housing; a syringe driver comprising a plunger for advancing the piston within the interior of 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 the drug from the interior of the housing; one or more sensors operably coupled to the plunger to measure displacement of the plunger within the interior; a processor coupled to the one or more sensors for analyzing the pressure applied to the plunger by the processor. signals from one or more sensors to measure the drug delivered from the outlet, for example, to measure the volume based at least in part on the displacement of the plunger; a starting actuator coupled to a processor; and one or more light sources coupled to the processor, the processor being configured to activate the one or more light sources to: a) emit a first color when the actuator member is initially actuated to begin delivering the drug from the drug cartridge, b) emit a second color to indicate when the drug has been delivered to a target location when the processor detects that the starting actuator has been actuated, at which point the processor begins measuring the volume of the 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 the drug has been delivered to the target location.

[0012] According to yet another embodiment, a system for delivering a drug into a patient's body is provided, the system comprising a syringe device comprising: a) a syringe cartridge comprising a housing defining an interior and a piston slidably disposed within the interior for delivering the drug within the interior through a distal outlet of the housing; a syringe driver comprising a plunger coupled to the piston, a driver module, and an actuator assembly for delivering pressurized fluid within the driver module to advance the plunger and the piston to deliver the drug from the interior of the housing; one or more sensors operably coupled to the plunger to measure displacement of the plunger within the interior; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to measure a volume of the drug delivered from the outlet, for example, based at least in part on displacement of the plunger; one or more output devices coupled to the processor for providing one or more outputs related to the volume of the drug delivered from the outlet; and a syringe communication interface. In addition, the system includes an electronic device, which includes: a device communication interface, which is used to transmit signals to and receive signals from the injector communication interface; a user interface, which is used to input a "start" signal for transmission to a processor, which then analyzes the signals from one or more sensors to measure the volume of the drug delivered; and a display, which is used to present an indicator field, which includes information about the volume of the drug delivered from the outlet received in the signal from the processor.

[0013] In an exemplary embodiment, one or more output devices include one or more light sources coupled to a processor, the processor being configured to activate the one or more light sources to: emit a first color when an actuator member is initially actuated to begin delivering medication from a medication cartridge; emit a second color when the processor detects that a start actuator has been actuated to indicate when the medication has been delivered to a target location, at which point the processor begins measuring a volume of medication delivered to the target location based at least in part on the signal; and emit a third color when the processor confirms that a predetermined dose of medication has been delivered to the target location.

[0014] According to another embodiment, a method for delivering a drug into a patient's body is provided, the method providing or loading a volume of the drug into the interior of a syringe cartridge, the syringe cartridge comprising a piston slidably disposed within the interior and a cannula; coupling the syringe cartridge to a drive, thereby coupling a plunger of the drive to the piston; inserting the cannula into the patient's body; activating an actuator of the drive to advance the plunger, thereby advancing the piston to deliver the drug from the interior into the patient's body, whereupon one or more sensors measure the displacement of the plunger, signals from the one or more sensors are analyzed to measure the volume of the drug delivered from the cannula based at least in part on the signals, and providing an output related to the volume of the drug delivered.

[0015] In one embodiment, the output includes the light source emitting a first color when the actuator member is initially actuated to provide a visual indication that the drug is being delivered from the drug box. Optionally, the method may also include positioning the cannula at the target location; and actuating a start actuator on the driver to indicate that the drug is being delivered to the target location, at which time the signal from the one or more sensors is analyzed to measure the volume of the drug delivered to the target location, and the light source emits a second color to provide a visual indication that the drug is being delivered to the target location. Optionally, when a predetermined dose of the drug has been delivered to the target location, the light source may emit a third color to provide a visual indication that the dose has been delivered.

[0016] According to another embodiment, a method for delivering a drug into a patient's body is provided, the method comprising: loading a volume of the drug into the interior of a syringe cartridge, the syringe cartridge comprising a piston slidably disposed within the interior and a cannula; coupling the syringe cartridge to a driver, thereby coupling the plunger of the driver to the piston; inserting the cannula into the patient's body; activating an actuator of the driver to advance the plunger, thereby advancing the piston to deliver the drug from the interior into the patient's body, whereupon one or more sensors measure the displacement of the plunger, signals from the one or more sensors are analyzed to measure the volume of the drug delivered from the cannula based at least in part on the signals, and when the actuator member is initially actuated, a light source emits a first color to provide a visual indication that the drug is being delivered from the cartridge; positioning the cannula at a target location; and actuating a start actuator on the driver to indicate that the drug is being delivered to the target location, at which time signals from the one or more sensors are analyzed to measure the volume of the drug delivered to the target location, and the light source emits a second color to provide a visual indication that the drug is being delivered to the target location.

[0017] According to another embodiment, a method for delivering a drug into a patient's body is provided, the method comprising: loading a volume of the drug into the interior of a syringe cartridge, the syringe cartridge comprising a piston slidably disposed within the interior and a cannula; coupling the syringe cartridge to a driver, thereby coupling the plunger of the driver to the piston; inserting the cannula into the patient's body; activating the actuator of the driver to advance the plunger, thereby advancing the piston to deliver the drug from the interior into the patient's body, whereupon one or more sensors measure the displacement of the plunger, and signals from the one or more sensors are analyzed to monitor the volume of the drug delivered from the cannula based at least in part on the signals, and providing an output related to the volume of the drug delivered.

[0018] According to yet another embodiment, a method for delivering a drug subretinaly in an eye of a patient is provided, the method comprising: loading a volume of the drug into the interior of a syringe cartridge, the syringe cartridge comprising a piston slidably disposed within the interior and a cannula; coupling the syringe cartridge to a driver, thereby coupling a plunger of the driver to the piston; inserting the cannula into the eye of the patient so that the cannula is disposed adjacent to the retina of the patient; activating an actuator of the driver to advance the plunger, thereby advancing the piston to deliver the drug from the interior to the eye of the patient, then one or more sensors measure the displacement of the plunger, a processor analyzes signals from the one or more sensors to monitor the volume of the drug delivered from the cannula based at least in part on the signals, and providing an output related to the volume of the drug delivered. The method may also include: advancing the cannula through the retina while continuing to deliver the drug; and activating an activation device when the retina is pierced, then the activation device transmits a start signal to the processor, and the processor continues to analyze signals from the one or more sensors to monitor the volume of the drug delivered subretinaly.

[0019] Other aspects and features of the present invention will become apparent from the following description considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention can be best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, as is customary, the various features and design elements of the drawings are not drawn to scale. Instead, the sizes of the various features and design elements are arbitrarily expanded or reduced for clarity. The following figures are included in the accompanying drawings:

[0021] Figure 1 is an enlarged cross-sectional view of a human eye showing the use of a syringe device to administer a subretinal injection to the eye.

[0022] Figure 2A is a perspective view of an exemplary embodiment of an injector including a driver and a syringe cartridge coupled to the driver for delivering a drug from the syringe cartridge into a patient's body.

[0023] Figure 2B yes Figure 2A Cross-sectional view of a syringe.

[0024] Figure 2C It shows Figure 2A and Figure 2B Schematic diagram of the electronic components of the injector.

[0025] Figure 3 yes Figure 2A-2C A cross-sectional view of an exemplary driver for a syringe of FIG. 1 , the exemplary driver including a plunger slidable within a driver housing for delivering a drug from a syringe cartridge.

[0026] Figure 4 shows that can be provided in Figure 3 Exemplary embodiments of electronic components within a driver housing, for example, include one or more optical sensors coupled to a processor and a multi-color LED.

[0027] Figure 5A A syringe such as Figure 2A-2C A portable electronic device that communicates with a syringe).

[0028] Figure 5B shows that can be presented with Figure 5A An exemplary display on an electronic device with which the injector communicates is shown.

[0029] Fig. 6A and Figure 6B 2 are a perspective view and a cross-sectional view, respectively, of another exemplary embodiment of a syringe.

[0030] Figure 7A-7C is a side view showing an exemplary embodiment of a loading device for loading a medicament into a syringe cartridge.

[0031] Fig. 8A and Figure 8B is a side view of an exemplary embodiment of a needle cannula that may be attached to a syringe cartridge to deliver medication from the cartridge. DETAILED DESCRIPTION

[0032] Before describing exemplary embodiments, it should be understood that the invention is not limited to the specific embodiments described, as such may, of course, vary. The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Any embodiment described herein as exemplary is not necessarily to be construed as being superior or more advantageous than other embodiments.

[0033] Furthermore, it is not intended to be bound by any express or implied theory presented in the foregoing technical field, background technology, summary of the invention or the following detailed description. It should also be understood that the terminology used herein is only for the purpose of describing specific embodiments and is not intended to be limiting, as the scope of the present invention will be limited only by the appended claims.

[0034] In the case of providing a numerical range, it should be understood that unless the context clearly stipulates otherwise, each intermediate value to one-tenth of the lower limit unit between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any specified value or intermediate value in the specified range and any other specified or intermediate value in the specified range is included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the range, and each range in which any limit is included, both limits are not included, or both limits are included in the smaller range is also included in the present invention, but is subject to any explicitly excluded restrictions in the specified range. In the case where the specified range includes one or two limits, the scope excluding one or both of those included limits is also included in the present invention.

[0035] 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 the 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 and exemplary methods and materials are now described.

[0036] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a compound" includes a plurality of such compounds and reference to "the polymer" includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[0037] There are many applications of controlled delivery of desired drugs, while maintaining precise position control of the delivery needle and / or monitoring delivery to confirm that the desired volume of fluid has been delivered. The apparatus and methods described herein can facilitate accurate delivery of drugs to the patient's body, such as one or more viscous fluids or other flowable materials for various treatments and / or diagnostic purposes. As used herein, "drug" is intended to refer to any such fluid, medicament or material, such as those described herein. For example, the following is a summary of exemplary applications, in which the apparatus and methods described herein can be used to deliver fluids to the patient's body.

[0038] ophthalmology :like Figure 1 As shown, syringe device 8 may be used for subretinal injections to treat several disease conditions of eye 90. Syringe device 8 may include a syringe cartridge and a syringe driver (not shown), similar to any of the embodiments described herein.

[0039] Treatment of retinal vein occlusion : A variety of indications can be treated by administering a therapeutic agent into the subretinal space 92 in the eye 90, e.g. Figure 1In cases of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO), 50 to 150 μL of tissue plasminogen activator (TPA) can be administered through a relatively small hypodermic needle (e.g., no larger than 41 gauge) to dissolve blood clots formed by subretinal hemorrhage during retinal surgical procedures. In these cases, the ophthalmologist can place the tip just below the surface of the patient's retina and slowly inject TPA to create a vacuole of the drug that dissolves the clotted blood over the course of several days.

[0040] Gene therapy for macular degeneration Age-related macular degeneration (AMD) is the main cause of vision loss and blindness in the elderly. AMD is a progressive eye disease of the retinal part (called macula), which enables people to read, visualize faces and drive. This disease initially causes central vision distortion, and eventually leads to legal blindness. A layer of cells at the back of the eye (called retinal pigment epithelium (RPE)) provides support, protection and nutrition for the photoreceptors of the retina (i.e., the photoreceptors composed of rods and cones). The dysfunction and / or loss of these RPE cells play a key role in the loss of photoreceptors, thereby playing a key role in AMD blindness. The latest progress of research shows the prospect of a new therapy for the treatment of AMD. Human embryonic stem cells, gene therapy, complement factors and viral vectors are being developed by early animal studies and / or clinical trials. Some of these treatments need to be applied to the target location (including subretinal space or suprachoroidal space) of the eye under the situation that position, volume delivery rate and / or total volume are accurately controlled.

[0041] Dermal fillers and botulinum toxin for cosmetic procedures : In dermal filler procedures, a high viscosity purified fluid or gel is injected into various parts of the anatomy to replace subcutaneous fat lost due to aging and to enhance the volume and fullness of features, particularly in the lips, chin, nasolabial folds, tear troughs, and cheeks. In other procedures, botulinum toxin is injected into the glabella, forehead, and orbicularis oculi areas to neutralize the muscles to provide relaxation and reduce wrinkles in those areas of the face. In all of these procedures, the ability to precisely control the flow rate, to repeat injections of high viscosity fluids in tissues with varying resistances will improve consistency between injections, and tracking the volume injected will allow for consistent results with repeated treatments.

[0042] Steering Figure 2A-2C, an exemplary syringe device 10 is shown for delivering a drug 6 into a patient's body, the syringe device 10 comprising: a syringe cartridge 12, the syringe cartridge 12 comprising a cartridge housing and a piston 16, the cartridge housing comprising a proximal end 12a and a distal end 12b and defining an interior 14, the piston 16 being slidably disposed in the interior 14 for delivering the drug 6 within the interior 14 through an outlet or port 18 and / or a needle cannula 19 on the distal end 12b of the cartridge 12; and a syringe driver 20 comprising a housing 22 accommodating a plunger 30 for advancing the piston 16 within the interior 14 of the cartridge 12, and a drive module 40.

[0043] The proximal end 12a of the syringe cartridge 12 can 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 drug 6 through the port 18 and the cannula 19. For example, the proximal end 12a of the cartridge 12 and the housing 22 can include one or more mating connectors (not shown) to secure the cartridge 12 to the housing 22 (once inserted into the distal region 23), e.g., such that the port 18 (and the needle or cannula 19 connected to the port 18) extends distally from the housing 22. When the cartridge 12 is fully in place, the piston 16 can be coupled to the plunger 30 (e.g., using one or more mating connectors 17, 35) such that distal advancement of the plunger 30 advances the piston 16 within the interior 14.

[0044] Thus, a desired volume of drug 6 can be loaded or otherwise provided in the interior 14 of the cartridge 12, which can then be coupled to the driver 20 immediately prior to injection, e.g., as further described elsewhere herein. The needle or cannula 19 can be removably connected to the port 18 or permanently integrated into the port 18. Alternatively, the cartridge can be permanently integrated into the driver housing, e.g., to provide an inseparable (e.g., disposable) device.

[0045] like Figure 2B and Figure 3 As best shown, the driver 20 includes an outer housing 22 that houses a driver module 40, for example, including a source of 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 flow paths between the source 44 and the plunger 30 to advance the plunger 30 to deliver the drug from the cartridge 12. For example, Figure 2BAs shown, a pressurized gas tank or other high-delivery force energy storage device 44 can be provided, for example, within the proximal end 22a of the housing 22, which can be opened by a pin 43 during initial activation of the syringe 10 to deliver pressurized gas into a gas chamber 45, which can apply a distal force to the fluid piston 46. An incompressible fluid (e.g., silicone oil) can be provided in a fluid chamber 47 distal to the fluid piston 46, which is in communication with the interior of a plunger chamber 48, so that upon actuation of the lever 42, the fluid can enter the plunger chamber 48 and distally advance the plunger 30. In an exemplary embodiment, a needle valve (not shown) can be provided, which includes a needle coupled to the lever 42, for example, by a bracket (not shown) within the housing 122, and the bracket can be displaced when the lever 42 is actuated to open an orifice in communication between the fluid chamber 47 and the plunger housing 48 (e.g., to allow fluid to flow at a substantially consistent rate, thereby displacing the plunger 130 at a desired speed), 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 / 0167,906, the entire disclosures of which are expressly incorporated herein by reference.

[0046] Additional references Figure 2C and Figure 4 The driver 20 also includes one or more electronic components, such as: one or more sensors 50, which are operably coupled to the plunger 30 to measure the displacement of the plunger 30 within the housing 22; a processor 52, which is coupled to the (one or more) sensors 50 for processing and / or analyzing signals from the (one or more) sensors 50 to determine the volume of the drug 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 (e.g., one or more LEDs 56a and / or speakers 56b), for example, coupled to the processor 52 for providing one or more outputs related to the drug delivered from the syringe cartridge 12, such as volume, flow rate and / or other parameters, as described elsewhere herein. In the exemplary embodiment shown, one or more optical sensors 50 can be mounted within the housing 22, adjacent to (e.g., concentrically surrounding) the plunger 30, which can be coupled to the processor 52 (e.g., including 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 volume of the drug delivered from the syringe cartridge 12 into the patient's body.

[0047] The processor 52 can monitor one or more delivery parameters (e.g., the volume of fluid injected) during the delivery of the drug based on signals from the (one or more) sensors 50, and activate (one or more) output devices 56, for example, to convey information to the user and / or otherwise facilitate delivery. For example, one or more LEDs or other light sources 56a (e.g., a multi-color LED or multiple LEDs of different colors) can be provided, which are activated to provide a visible indication related to the activation and / or operation of the injector 10, for example, as described elsewhere herein. Additionally or alternatively, the output device can include a speaker or other sound generator 56b, which can generate an audible signal in addition to or instead of the light source 56a.

[0048] Optionally, the processor 52 may include a clock (not shown), for example, to measure time events and / or add time stamps to data stored or transmitted by the processor 52. For example, the injector 10 may include an onboard memory (not shown) in communication with the processor 52 for storing data derived from signals from the sensor(s) 50, volumes determined by the processor 52 from the signals, or other information, such as total volume delivered, delivery rate, dose profile information, delivery time, times between different events (such as the time between loading and delivery of a cartridge), etc. In another option, the injector 10 includes a temperature sensor (not shown) in communication with the processor 52 for monitoring the temperature of the drug.

[0049] In addition, the syringe 10 may include a communication interface 58, such as a wireless interface, which includes one or more antennas (not shown) configured to transmit and / or receive signals using Bluetooth or other RF communication protocols. For example, an external switch or activation device (not shown) may be provided that can communicate with the syringe 10 (e.g., via its own wireless communication interface) and can be used to transmit instructions or other information to the processor 52 and / or receive data or other information from the processor 52. In one embodiment, the activation device can simply be a switch that can be manually activated by an operator (e.g., a surgeon or assistant), after which the activation device can transmit a "start" signal to the processor 52 via the communication interface 58, so that the processor 52 monitors the signal from the (one or more) sensor 50 to measure the volume delivered from the drug cartridge 12 based on the displacement of the plunger 30, for example, to measure the dose or "bubble" delivered to the target area, as described elsewhere herein.

[0050] Alternatively, if Figure 5A and Figure 5BAs shown, the activation device may be a wireless electronic device 60 (e.g., a mobile phone, a tablet computer, etc. (not shown)), which may provide a user interface to enable an operator to transmit a start signal, for example, by pressing a "start" icon 64b on a display 62 of the electronic device, for example. Figure 5B shown.

[0051] In this alternative, the electronic device 60 can provide additional functionality to facilitate use of the syringe 10. For example, a "ready" icon 64a can be provided on the display 62, which can be selected, and the device 60 can then transmit a signal (e.g., represented by signal 68) to initially activate the electronics of the syringe 10 before use. For example, the processor 52 of the syringe 10 can remain in a dormant state until it detects a ready signal received by the interface 58, and the processor 52 can then activate the sensor(s) 50 and / or other components of the syringe 10 before injection. In addition, the electronic device 60 can receive information from the syringe 10 during delivery and present the information on the display 62, such as in an indicator field 66. Alternatively, the syringe 10 can include a switch or other actuator (not shown) that can be used to turn on the electronics (e.g., connect the power supply 54 to the processor 50 and / or other components of the syringe 10). For example, a switch (not shown) may be provided within the distal region 23 or elsewhere within the housing 22 that may be automatically activated when the cartridge 12 is inserted into the distal region 23 to wake up the electronics of the injector 10 prior to use.

[0052] For example, Figure 5B As best shown in FIG. 1 , 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 volume of medication to be delivered, the actual volume of medication delivered, etc. In the illustrated embodiment, the black area 66 a to the left of the indicator 66 may represent the initial position of the plunger 30 of the driver 20, e.g., and also correspond to the initial position of the piston 16 within the syringe cartridge 12 (once the syringe cartridge 12 is filled and coupled to the driver 20).

[0053] When the actuator 42 of the syringe 10 is activated, the plunger 30 and piston 16 begin to shift to deliver the drug 6 from the syringe cartridge 12, which can be represented by the different colored areas 66b shown on the indicator 66, for example, initially from the black area toward the opposite end of the indicator 66. In the case of subretinal delivery, an initial volume of the drug can be delivered from the syringe cartridge 12, for example, as the cannula is advanced toward and / or through the retina. For example, as further described elsewhere herein, the cannula 19 can initially be introduced into the eye 90 using conventional methods (e.g., similar to Figure 1) and is positioned adjacent to the retina 94, for example, just in front of the retina.

[0054] Once the surgeon is ready to deliver the drug subretinaly, the actuator 42 can be activated, and the cannula 19 can then be advanced through the retina 94 as the drug is being delivered. The initial drug bolus delivered before the retina 94 is pierced is simply released into the interior of the eye 90 and is not considered part of the vacuolar volume intended for subretinal delivery. In this case, the surgeon can instruct the assistant to activate the activation device 60 immediately after piercing the retina 94. For example, the assistant can select the "start" icon 64b shown in Figure 5D, and the device 60 can then transmit a "start" signal to the processor 52 of the injector 10 (via the interface 58), which can begin measuring and / or monitoring the volume of the drug delivered subretinaly. Alternatively, a foot switch or other actuator (e.g., a button on the drive (not shown)) that the surgeon can trigger on his own can be provided, which can transmit a "start" signal, for example, when the surgeon steps on or otherwise activates the switch, as described elsewhere herein.

[0055] Optionally, the processor 52 can activate (one or more) output devices to transmit information to the surgeon during delivery. For example, when the actuator 42 of the syringe 10 is first activated, the processor 52 can activate the LED 56a to emit yellow light (or other predetermined colors) to provide visual confirmation that the drug is being delivered. Once the processor 52 receives the "start" signal, the processor 52 can activate the LED 56a to emit green light (or other predetermined colors) to provide visual confirmation that the drug is being delivered subretinal, that is, to confirm that the volume of the vesicle being delivered is now being measured. When the target volume has been delivered, the processor 52 can activate the LED 56a to emit red light (or, again, another predetermined color) to provide visual confirmation that the target volume has been delivered. Alternatively, separate LEDs can be provided, which can be sequentially activated to provide a desired visual status indication. Additionally or alternatively, the speaker 56b can be activated during each of these stages to emit a sound, for example, a different sound corresponding to initial delivery, subretinal delivery, and reaching the target volume.

[0056] If the activation device is a wireless electronic device 60, the assistant can press a "start" icon (or otherwise interact with the electronic device) to cause the electronic device 60 to transmit a start signal to the processor 52. In this embodiment, the processor 52 can transmit information related to the delivery of the drug 6 back to the electronic device 60 via the communication interface 58, for example, for presentation on the display 62 and / or storage in the memory of the device 60. For example, Figure 5BAs shown, when the actuator 42 is first activated and drug delivery begins (e.g., before piercing the retina), a yellow region 66b may appear adjacent to the 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 volume delivered, for example, until a start signal is received.

[0057] Once the processor 52 receives the "start" signal, the yellow area 66b can stop, and the green area 66c can begin to translate along the indicator 66 to visually indicate the volume of the vesicle delivered under the retina. Optionally, the processor of the electronic device 60 can display the target volume on the indicator 66, for example, as a green outline 66d extending from the yellow area (or the black area when the syringe is initially activated), for example, to ensure that the medicine box 12 has enough volume to deliver the target volume. Additionally or alternatively, the displayed indicator 66 may include other marks of scale or identification volume so that the assistant can visually monitor the volume being delivered when the green area passes the corresponding mark on the indicator. When the target volume is reached, the green area 66c can stop, and the red area (not shown) can begin to translate along the indicator 66, for example, beyond the target volume area 66d, to indicate the volume of the excessive drug being delivered. For example, in some applications, the surgeon may decide to deliver additional drugs beyond the original target volume, and the volume may be indicated by the red area.

[0058] Once the surgeon releases the actuator 42 of the injector 10, the delivery can be interrupted and the cannula 19 can be removed from the patient, for example, similar to conventional methods. After delivery, the injector processor 20 and / or the electronic device 60 can save information related to the delivery for subsequent recording and / or analysis. For example, the volume of the pre-vacuolar drug released into the eye (yellow area 66b), the volume of the vacuole (green area 66c and / or red area), and / or other parameters can be saved and used for subsequent analysis and / or treatment of the patient.

[0059] Now, a method for using FIG. 2- Figure 4 An exemplary method of using a syringe as shown in FIG. 1 , for example, for delivering a drug (such as a gene vector and / or stem cells) subretinal to a patient's eye 90 92 , for example, similar to Figure 1 8. Initially, a volume of drug 6 can be loaded into the interior 14 of the syringe cartridge 12, which is sealed by a piston 16 slidably disposed in the interior 14. For example, Figure 7A-7CAs shown, the medicine cartridge 12 can be coupled to a loading device or adapter 80, which includes a housing 82 and a manual plunger 84 that can be used to load a drug (not shown) into the medicine cartridge 12. As shown, the housing 82 includes a tubular body having an open end 82a, the size of the open end 82a being designed to receive the proximal end 12a of the medicine cartridge 12 therein. Optionally, the housing 82 may include one or more connectors (not shown) for removably securing the medicine cartridge 12 during loading. The manual plunger 84 can be coupled to the piston 16, for example, by screwing a threaded connector 84a on the plunger 84 into (or engaging another connector, not shown) a similar threaded groove (or other mating connector, not shown) on the piston 16, with the piston 16 being in its distal-most position, as shown. Fig. 7A Once the cartridge 12 is coupled to the loading device 80, a needle cannula (not shown) may be connected to the port 18 of the cartridge 12 and inserted into a container of medication (not shown) with the piston 16 in its most distal position (adjacent the port 18). Figure 7B As shown, the manual plunger can be withdrawn to direct the piston 16 proximally away from the port 17, thereby drawing the drug 6 into the interior 14 as the piston 16 moves proximally. Once fully filled, the cannula can be removed from the container and from the port 18. The plunger 84 can be unthreaded or otherwise disengaged from the piston 16, and the drug cartridge 12 can be removed from the loading device 80, as shown. Figure 7C shown.

[0060] Once the syringe cartridge 12 is filled and / or the desired volume is loaded, the cartridge 12 can be coupled to the driver 20. For example, the cartridge 12 is inserted into the distal region 23 of the driver housing 22 until the driver plunger 30 is coupled to the piston 16. For example, Figure 2B As shown, plunger 30 may include a lug or other connector 35, which may be received in or otherwise engage a groove 17 or other connector on piston 16. Then syringe 10 is ready to deliver drug 6 to the patient. Alternatively, it should be understood that the separate syringe cartridge may be replaced with an integrated syringe area within the driver, which may be prefilled with a desired volume of drug. In addition, if needle cannula 19 is not initially provided on port 18 of syringe cartridge 12, needle cannula 19 may be attached, for example, using conventional methods, such as threaded connectors, Luer interface devices, etc.

[0061] Immediately prior to delivery, a needle cannula may be connected to port 18 on cartridge 12. Fig. 8A and Figure 8B, shows an exemplary embodiment of a cannula assembly 70 including an inner injection cannula 72 and an outer protective cannula 76. The inner cannula 72 generally includes a proximal hub 74 and an elongated tubular needle 75, the proximal hub 74 including a hollow proximal end 74a, the size of the hollow proximal end 74a is designed to be received in a drug cartridge (e.g., such as Figure 7A-7C An elongated tubular needle 75 extends from a distal connector 74b and terminates in a tip 75a, which may be sharpened or blunted depending on the application.

[0062] The outer cannula 76 also includes a proximal hub 78 including a hollow proximal end 78a sized to be received over the connector 74b of the inner cannula hub 74, and a needle 79 extending from the distal connector 78b. The needles 75, 79 may be formed of stainless steel or other conventional materials, and the hubs 74, 78 may be formed of plastic or other conventional materials, for example, so that the needles 75, 79 may be glued or otherwise permanently attached to the respective hubs 74, 78. As shown, the inner needle 75 may be longer than the outer needle 79, for example, so that 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.

[0063] For example, assembly 70 may be initially provided with external cannula 76 in a distal position, e.g. Fig. 8A As shown, that is, the tip 75a of the inner needle 75 is covered by the outer needle 79 and the outer cannula needle seat 78 is spaced apart from the inner cannula needle seat 74 to the distal side. In this configuration, the inner cannula needle seat 74 can be received on the port 18 of the medicine box 12 to attach the assembly 70 to a syringe, such as any syringe described herein. During use, the outer needle 79 can be kept on the tip 75a of the inner needle 75 during introduction, for example to protect the tip 79a. For example, the inner needle 75 can have a very small diameter and a relatively thin wall, and therefore may be fragile, while the outer needle 79 can have a relatively thick wall and / or a larger column strength, which can reduce the risk of bending or breaking the outer needle 79. If the assembly 70 is introduced into the patient's body (e.g., into the eye) through a trocar cannula including a septum or valve (not shown), the outer needle 79 can be able to open the septum or valve at a minimum risk of damage to advance the inner needle 75 through the trocar cannula.

[0064] Once the tip 79a of the outer needle 79 is positioned in the desired position (e.g., beyond the trocar cannula in the patient's eye), the outer cannula 76 can be retracted to expose the tip 75a of the inner needle 75. Figure 8BAs shown, the outer cannula 76 has been retracted until the outer cannula needle hub 78 is received over the connector 74b and / or otherwise engaged with the inner cannula needle hub 74, thereby preventing subsequent movement of the outer cannula 76, and the tip 75a of the inner needle 75 can then be inserted into the target location to deliver the drug, for example, as further described elsewhere herein.

[0065] Back to Figure 2- Figure 4 , after the needle or cannula (e.g., cannula 19 or cannula assembly 70) is attached to the medicine box 12, the syringe 10 can be ready for use. For example, the actuator lever 42 can be activated to initially activate the driver module 40, such as piercing the gas tank 44 with a pin 43, similar to the embodiments described in the application incorporated herein by reference. Therefore, the gas can be released from the tank 44 to provide power for the fluid plunger 46. Optionally, the actuator 42 can be initially activated to deliver a small bolus of medicine from the medicine box 12, for example, to fill the cannula 19 and / or otherwise remove air or other potential contaminants. For example, when the lever 42 is actuated (initial and during the injection of the medicine 6), the pin 49 can open the fluid passage from the fluid chamber 47 to the plunger housing 48, which can cause the incompressible fluid to enter the plunger housing 48 and advance the plunger 30, for example, due to the pressure acting on the fluid plunger 46 and the fluid entering the plunger housing 48 with a substantially consistent and uniform translation rate.

[0066] If the syringe 10 is connected to an electronic device such as Figure 5A and Figure 5B Once this step is completed, the "ready" icon 64a can be selected on the electronic device 60, for example, to send a ready signal to the syringe processor 52 to indicate the initial (zero) position of the plunger 30 and piston 16. This position can be presented on an indicator 66 displayed on the electronic device 60, such as Figure 5B The black area 66a is shown in FIG.

[0067] Similar to Figure 1 The device 8 shown, cannula 19 can then be inserted into the patient's eye 90 so that cannula 19 is disposed adjacent to the patient's retina 94, for example, similar to conventional methods. Actuator lever 42 can then be activated to advance plunger 30, thereby advancing piston 16 to deliver drug 6 from interior 14 into the patient's eye 90. Processor 52 can monitor the displacement of plunger 30 based on signals from sensor(s) 50 and calculate in real time the volume of drug delivered into the patient's eye 90.

[0068] The cannula 19 can then be advanced to puncture the retina 94 while continuing to deliver the drug, and when this occurs, the surgeon can instruct the assistant to activate the activation device 60 (e.g., by pressing a "start" icon 64b on the display 62 of the electronic device or activating a separate switch). This action transmits a start signal to the processor 52, and the processor 52 continues to analyze the signals from the (one or more) sensors 50 to monitor further displacement of the plunger 30 and determine the volume of drug 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 drug delivery to the surgeon and / or transmit information to the electronic device 60 for display 52, for example, in Figure 5B The surgeon can continue to deliver until the target volume is delivered (using the output device 56 and / or the electronic device 60) to confirm the volume and optionally deliver additional medication (if desired). Once the desired volume is delivered, the surgeon can release the lever 42 to interrupt delivery and then remove the syringe 10, for example, using conventional methods.

[0069] Steering Fig. 6A and Figure 6B , another exemplary embodiment of an injector 110 including a syringe cartridge 12 and a driver 120 is shown, generally similar to the previous embodiments. Similar to the previous embodiments, the cartridge 12 includes a piston 16 slidable within an interior 14 of the cartridge 12, which can be filled with a drug (e.g., preloaded or loaded immediately before use) and an outlet or port 18, to which a cannula (not shown) can be attached before use. When the cartridge 12 is inserted into the distal region 123 of the housing 122, one or more connectors on the cartridge 12 and / or the housing 122 can engage to secure the cartridge 12, and the tab 135 (or other connector) on the plunger 130 can engage the groove 17 (or other connector) on the piston 16 substantially simultaneously. In addition, a switch (not shown) can be provided that is actuated when the cartridge 12 is inserted, which can activate the electronics of the injector 110, as described elsewhere herein.

[0070] Still similar to the previous embodiments, the drive module 140 includes a pressurized gas tank or other high-delivery force energy storage device 144 (e.g., within the proximal end 122a of the housing 122) that can be opened by a pin 143 during initial activation of the syringe 110 to deliver pressurized gas around the tank 144 to apply a distal force to the fluid piston 146. Unlike the previous embodiments, in this version, the driver 120 includes an activation cap 141 that can be twisted or otherwise manually actuated to cause the pin 143 to open the tank 144 (rather than using initial actuation of the lever 142, as described elsewhere herein). An incompressible fluid can be provided in a fluid chamber 147 distal to the fluid piston 146, which is in communication with the interior of the plunger chamber 148, so that upon actuation of the lever 142, the pin 149 is displaced to open a fluid path so that the fluid can enter the plunger chamber 148 and advance the plunger 130 distally.

[0071] like Figure 6B As shown, similar to the previous embodiments, the injector 110 also includes one or more LEDs 156a (e.g., mounted within the housing 122 adjacent to an opening or window (not shown) to transmit light out of the housing 122) and a speaker 156b for providing visual and / or audible signals during use of the injector 110. For example, also similar to the previous embodiments, the (one or more) LEDs 156a and the speaker 156b can be coupled to a processor (not shown) within the housing 122, which is coupled to the battery 154, a communication interface 158 (e.g., including an antenna (not shown) for transmitting and / or receiving Bluetooth or other wireless signals). In addition, the driver 120 can also include a button, switch or other "wake-up" actuator (not shown) (e.g., within the distal region 123), which can be activated to "wake up" the electronic components of the driver 120 when the drug cartridge 12 is loaded into the driver 120, for example, to connect the battery 154 to the processor and / or other components (e.g., in the case where the injector 110 is used without activating the device).

[0072] Unlike the previous embodiments, 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 can be mounted within the housing 122 adjacent to the plunger 130, for example, proximate to the distal end 134 of the plunger 130. A magnetic strip 150b can be mounted to the plunger, extending at least partially between the distal end 134 and the proximal end 132 of the plunger 130. For example, the magnetic strip 150b can be an alternating polarity strip having a desired spacing between alternating poles along the length of the strip 150b, for example, having a pole spacing of 1 mm. As the plunger 1130 moves axially, causing the strip to move axially past the magnetic sensor 150a, the magnetic sensor 150a can act like an encoder that tracks the axial displacement of the strip 150b. Thus, as the plunger 130 is advanced distally, the magnetic element 150b can pass along the magnetic sensor 150a and the processor can process the generated signal to determine the displacement of the plunger 130, for example, using a known value for the cross-sectional area of ​​the interior 14 of the cartridge 12 to measure the volume of medication delivered from the syringe 110, similar to the previous embodiments.

[0073] Also unlike previous embodiments, the syringe 110 includes a "start" button or other actuator 151 on the driver 120, which can be used to transmit a "start" signal to the processor (rather than using a separate activation device), for example, to measure the dose of drug delivered, similar to other embodiments herein.

[0074] In general, the syringe 110 can be used similar to the previous embodiments, for example, to deliver a precise dose of medication subretinal or otherwise to deliver a precise dose of medication to a patient's body. For example, the drug cartridge 12 can be filled and inserted into the distal region 123 immediately prior to use, thereby coupling the piston 16 to the plunger 130 and activating the electronics of the syringe 110. The cap 141 can then be twisted or otherwise actuated to open the gas tank and provide power to the driver 120, so that subsequent actuation of the lever 142 causes the pressurized fluid to advance the plunger 130, similar to the previous embodiments.

[0075] The syringe 110 is then ready to deliver the drug, for example, to the patient's eye (not shown). For example, a cannula (not shown) coupled to the port 18 may be inserted into the patient's eye so that the cannula is disposed adjacent to the patient's retina. The actuator lever 142 may then be activated to advance the plunger 130, thereby advancing the piston 116 to begin delivering the drug from the interior 14 to the patient's eye. Optionally, the processor may monitor the displacement of the plunger 130 based on a signal from the sensor 150 and calculate in real time the volume of the drug delivered to the patient's eye.

[0076] The cannula can then be advanced to pierce the retina while continuing to deliver the drug, and when this occurs, the surgeon can press the "start" button 151, which transmits a start signal to the processor. The processor can continue to analyze the signal from the sensor 150 to monitor the further displacement of the plunger 130 and determine the volume of the drug delivered subretina. As previously described, the processor can activate one or more output devices (e.g., LED 156a and / or speaker 156b) to confirm the state of drug delivery to the surgeon. For example, the surgeon can continue to deliver until the target volume is delivered, using the change in the output from the output device 156 to confirm the volume and optionally deliver additional drugs (if desired). Once the desired volume has been delivered, the surgeon can release the lever 142 to interrupt delivery, and then remove the syringe 110, for example, using conventional methods.

[0077] Thus, in this embodiment, the injector can be operated completely independently of the electronic tablet / smartphone. The processor can record data (e.g., data related to the volume of drug delivered and / or other information) in an onboard memory (not shown), which can later be retrieved, for example, by communicating with an external electronic device using the communication interface 158, for example, to connect via Bluetooth or other protocols to download information.

[0078] The foregoing disclosure of exemplary embodiments has been presented for the purpose of illustration and description. This is not intended to be exhaustive or to limit the invention to the precise form disclosed. In view of the above disclosure, many variations and modifications of the embodiments described herein will be apparent to those of ordinary skill in the art.

[0079] It should also be understood that elements or components shown with any embodiment herein are exemplary for that particular embodiment and may be used with or in combination with other embodiments disclosed herein.

[0080] In addition, when describing representative embodiments, the specification may have presented the method and / or process as a specific sequence of steps. However, to the extent that the method or process does not rely on the specific sequence of steps set forth herein, the method or process should not be limited to the specific sequence of steps described. As will be appreciated by those of ordinary skill in the art, other sequences of steps may be possible. Therefore, the specific sequence of steps set forth in the specification should not be interpreted as a limitation to the claims.

[0081] Although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but on the contrary, the invention will cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims

1. A syringe device for delivering a precise dose of a drug into a patient's body by a surgeon, comprising: A syringe cartridge comprising a cartridge housing including a proximal end, a distal end and defining an interior, the cartridge further comprising a piston slidably disposed within the interior for delivering a medicament within the interior through an outlet in the distal end; a syringe driver comprising a driver housing including a plunger for advancing the piston within the interior of the housing, a source of pressurized fluid, and an actuator member configured to be actuated by the surgeon for at least partially opening a flow path between the source of pressurized fluid and the plunger to advance the plunger and the piston to provide controlled delivery of the drug from the interior of the housing, wherein the actuator member is configured such that delivery of the drug is interrupted upon release of the actuator member by the surgeon; one or more sensors operably coupled to the plunger to measure displacement of the plunger; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to measure a volume of drug delivered from the outlet based at least in part on the displacement of the plunger; as well as an output device coupled to the processor for providing the surgeon with one or more outputs related to the volume of the drug delivered from the outlet to provide confirmation when a predetermined dose of the drug has been delivered, enabling the surgeon to release the actuator member to interrupt delivery of the drug at that time. 2 . The device of claim 1 , wherein the output device comprises a light source coupled to the processor and configured to provide visible indications related to activation and operation of the device.

3. The device of claim 2, wherein the light source comprises a multicolor LED configured to emit a first color to indicate when medication is initially delivered from the medication box, and to emit a second color to indicate when medication is being delivered after the outlet is positioned at a target location when the processor receives a start signal. 4 . The device of claim 3 , wherein the multi-color LED is configured to emit a third color when the processor confirms that the 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 activation and operation of the device.

6. The device of claim 1, further comprising a communication interface coupled to the processor for receiving a wireless signal from an activation device, the processor being configured to identify a ready signal from the wireless signal to activate the device from a sleep state.

7. The device of claim 6, wherein the processor is further configured to identify an activation signal from the wireless signal, whereupon the processor analyzes the signals from the one or more sensors to measure the volume of the drug delivered from the outlet.

8. The apparatus of claim 1, wherein the one or more sensors include one or more optical sensors mounted within the drive housing adjacent to the plunger to generate a signal related to the displacement of the plunger.

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

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

11. The apparatus of claim 10, further comprising an alternating polarity magnetic strip on the plunger, the alternating polarity magnetic strip configured to generate the signal to track the displacement of the plunger when each pole of the alternating polarity magnetic strip passes by the magnetic sensor.

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

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

14. The device of claim 13, wherein the cartridge housing includes one or more mating connectors that secure the cartridge within the distal region.

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

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

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

18. The device of claim 1 further comprising a switch on the driver, the switch coupled to the processor to deliver an activation signal when actuated, whereupon the processor analyzes signals from the one or more sensors to measure the volume of the drug delivered from the outlet.

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

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

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

22. The apparatus of claim 21, wherein the processor is configured to determine from data from the clock one or more of: a time of delivery of the medication, a time between different events during delivery of the medication, and a time between loading of the medication 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. The apparatus of claim 1, further comprising: Activate the device; as well as A syringe communication interface within the housing is configured to receive an activation signal from the activation device, whereupon the processor analyzes the signals from the one or more sensors to measure the volume of the drug delivered.

25. The apparatus of claim 24, wherein the activation device comprises a switch actuatable to transmit the activation signal to the processor.

26. The apparatus of claim 25, wherein the injector communication interface comprises a line connecting the switch to the driver for transmitting the activation signal to the processor.

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

28. The device of claim 27, wherein the activation 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 the delivery of the drug.

29. The device of claim 28, wherein the processor is configured to transmit a signal to the electronic device via the injector communication interface, the signal comprising information regarding the volume of the drug delivered from the outlet.

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

31. A syringe device for delivering a precise dose of medication into a patient's body by a surgeon, comprising: a syringe cartridge comprising a cartridge housing defining an interior, the cartridge further comprising a piston slidably disposed within the interior for delivering a medicament within the interior through an outlet in a distal end of the housing; a syringe driver comprising a driver housing including a plunger for advancing the piston within the interior of the cartridge housing, a source of pressurized fluid, and an actuator member configured to be actuated by the surgeon for at least partially opening a flow path between the source of pressurized fluid and the plunger to advance the plunger and the piston to provide controlled delivery of the medicament from the interior of the cartridge housing, wherein the actuator member is configured such that delivery of the medicament is interrupted upon release of the actuator member by the surgeon; one or more sensors operably coupled to the plunger to measure displacement of the plunger; a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to measure a volume of drug delivered from the outlet based at least in part on the displacement of the plunger; an activation actuator coupled to the processor; as well as one or more light sources coupled to the processor, the processor configured to activate the one or more light sources to: a) emitting a first color when the actuator member is initially actuated to initiate delivery of drug from the cartridge, b) emitting a second color to indicate when medication is being delivered after the outlet is positioned at a target location when the processor detects that the launch actuator has been actuated, at which time the processor begins measuring the volume of the medication delivered to the target location based at least in part on the signal, and c) emitting a third color when the processor confirms that a predetermined dose of the drug has been delivered to the target location, enabling the surgeon to release the actuator member at this time to interrupt the delivery of the drug.

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

33. A system for delivering a precise dose of a drug into a patient's body by a surgeon, comprising: A syringe device comprising: a) a syringe cartridge comprising a cartridge housing defining an interior and a piston slidably disposed within the interior for delivering a medicament within the interior through a distal outlet in the housing; b) a syringe driver comprising a driver housing including a plunger coupled to the piston, a driver module, and an actuator member for delivering pressurized fluid within the driver module to advance the plunger and the piston to provide controlled delivery of the drug from the interior of the cartridge housing, wherein the actuator member is configured such that delivery of the drug is interrupted upon release of the actuator member by a surgeon; c) one or more sensors operably coupled to the plunger to measure displacement of the plunger; d) a processor coupled to the one or more sensors for analyzing signals from the one or more sensors to measure a volume of drug delivered from the outlet; e) one or more output devices coupled to the processor for providing one or more outputs to the surgeon related to the volume of the drug delivered from the outlet, and f) an injector communication interface; and Electronic equipment, comprising: a) a device communication interface for transmitting signals to and receiving signals from the injector communication interface; b) a user interface for inputting an activation signal for transmission to the processor which then analyses the signals from the one or more sensors to measure the volume of the drug delivered; and c) a display for presenting an indicator field including information regarding the volume of the drug delivered from the outlet received in a signal from the processor to provide confirmation when a predetermined dose of the drug has been delivered, enabling the surgeon to release the actuator member at that time to interrupt the delivery of the drug.

34. The system of claim 33, wherein the one or more output devices include one or more light sources coupled to the processor, the processor being configured to activate the one or more light sources to: a) emitting a first color when the actuator member is initially actuated to initiate delivery of drug from the cartridge, b) emitting a second color to indicate when medication is being delivered after the outlet is positioned at a target location when the processor detects that the start actuator has been actuated, at which time the processor begins measuring the volume of the medication delivered to the target location based at least in part on the signal, and c) emitting a third color when the processor confirms that the predetermined dose of the drug has been delivered to the target location.

35. A system according to claim 34, wherein the one or more output devices further include a speaker coupled to the processor, the processor being configured to activate the speaker to emit different sounds when the one or more light sources emit each of the first color, the second color, and the third color.

36. The system of claim 33, wherein the electronic device further comprises a device processor for processing information received from the injector, the processor being configured to present information on the indicator field including: a) presenting a first colour region to identify when the actuator member is initially actuated to commence delivery of drug from the cartridge, b) presenting a second color area to identify when an activation signal has been transmitted to indicate the volume of drug delivered to the target location, and c) presenting a third color area when the predetermined dose of the drug has been delivered to the target location.

37. The apparatus 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 being displaced when a lever of the actuator member is actuated to open an orifice communicating between a fluid chamber of the pressurized fluid source and the plunger, such that fluid flows through the orifice at a substantially consistent rate to displace the plunger at a desired speed.

38. The apparatus of claim 37, wherein the actuator member comprises a lever coupled to the valve member by a bracket, the bracket displacing the valve member when the lever is actuated.

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