Systems, devices and methods for intradermal or subcutaneous fluid delivery - Patents.com

Abstract

Systems, devices, and methods are provided for intradermal or subcutaneous fluid delivery via microneedles. The delivery system can include an injector, a fluid-filled cartridge or syringe, and a needle. The cartridge or syringe can be compatible coupled to the injector device such that the injector device is capable of ejecting fluid out of the cartridge and through the needle. The fluid delivery system can be utilized in a number of applications, including medications and supplements for the skin.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 223,915, filed July 20, 2021, and entitled "Systems, Devices and Methods for Intradermal or Subdermal Fluid Delivery," and U.S. Provisional Application No. 63 / 235,085, filed August 19, 2021, and entitled "Systems, Devices and Methods for Dermal Treatments," the disclosures of which are each incorporated herein by reference in their entireties.

[0002] The present application is directed generally to systems, devices, and methods for intradermal or subcutaneous fluid delivery, and more specifically to systems, devices, and methods that utilize controlled injection volume and depth for delivery of medicinal or supplemental fluids into or just below the dermis. [Background technology]

[0003] Hollow microneedles are small applicators for delivering fluids, especially vaccines or medicines. Microneedles are typically used in transdermal, intraocular, or intracochlear fluid delivery. Due to their small size, microneedles typically do not cause injury to the site of injection and are generally considered to be less dangerous than other injection methods, such as conventional hypodermic needles. Summary of the Invention [Means for solving the problem]

[0004] The present disclosure generally provides systems, devices, and methods for intradermal or subcutaneous fluid delivery. In various implementations, the systems, devices, or methods control the amount of fluid to be delivered. In various implementations, the systems, devices, or methods control the depth of needle insertion at the site of injection, particularly within the intradermal layer. In various implementations, the systems, devices, or methods hide and / or cover the needle from the user, which can prevent harm to the user and / or prevent damage to the needle.

[0005] In one aspect, a system for intradermal or subcutaneous fluid delivery into a site of injection includes a housing compartment that includes a flange retainer system, a plunger retainer system, and an actuator of an injection mechanism that expels a controlled dose of fluid.

[0006] In some implementations, the flange retainer system includes a moveable flange retainer and a flange retainer positive stop.

[0007] In some implementations, the plunger retainer system comprises a movable plunger retainer and a plunger retainer positive stop.

[0008] In some implementations, the flange retainer and the plunger retainer are each movable proximally along a central axis of the housing compartment.

[0009] In some implementations, actuation of the injection mechanism via the actuator results in the flange retainer and plunger retainer moving proximally until the flange retainer contacts the flange retainer positive stop, stopping the proximal movement of the flange retainer.

[0010] In some implementations, the flange retainer contacts the flange retainer positive stop and the plunger retainer continues to move in the proximal direction until the plunger retainer contacts the plunger retainer positive stop, stopping the proximal movement of the plunger retainer.

[0011] In some implementations, the system for intradermal or subcutaneous fluid delivery into a site of injection further comprises a fluid-filled syringe comprising a flange and a plunger.

[0012] In some implementations, the flange is mounted within a flange retainer and the plunger is mounted within a plunger retainer in the housing compartment.

[0013] In some implementations, the system for intradermal or subcutaneous fluid delivery into a site of injection further comprises a needle assembly attached to the fluid-filled syringe. The needle assembly comprises a needle in operative connection with the fluid-filled syringe.

[0014] In some implementations, actuation of the injection mechanism via the actuator results in the flange retainer and plunger retainer moving in a proximal direction, causing the fluid-filled syringe including the flange and plunger and the needle assembly to move in a proximal direction until the flange retainer contacts the flange retainer positive stop, causing the proximal movement of the flange and needle assembly to stop. When the flange retainer contacts the flange retainer positive stop, the plunger retainer continues to move in a proximal direction, causing the plunger to continue to move in a proximal direction until the plunger retainer contacts the plunger retainer positive stop, causing the proximal movement of the plunger to stop. Continued proximal movement of the plunger after the proximal movement of the flange and needle assembly has stopped results in the ejection of a controlled dose of fluid from the fluid-filled syringe through the needle of the needle assembly.

[0015] In some implementations, the flange retainer includes a groove and the plunger retainer includes a slider that cooperates within the groove. When the flange retainer contacts the flange retainer positive stop, the plunger retainer continues to move proximally via the slider in the groove.

[0016] In some implementations, a latch connects the flange retainer and the plunger retainer. When the flange retainer contacts the flange retainer positive stop, the latch is released, allowing the plunger retainer to continue moving in the proximal direction independent of movement of the flange retainer.

[0017] In some implementations, the system for intradermal or subcutaneous fluid delivery into a site of injection further comprises a force for providing proximal movement. The plunger retainer connects with the force for providing proximal movement such that the plunger retainer moves in a proximal direction via actuation of the injection mechanism. The flange retainer moves in a proximal direction via a latch connecting the flange retainer and the plunger retainer.

[0018] In some implementations, the force for providing the proximal movement is a compressed spring.

[0019] In some implementations, the force for providing the proximal movement is an electromechanical linear actuator.

[0020] In some implementations, the amount of the controlled dose of fluid administered is determined in part by continued proximal movement of the plunger after proximal movement of the flange and needle assembly has halted.

[0021] In some implementations, movement of the flange retainer in the proximal direction is configured to result in the needle being inserted into the site of injection when the proximal face of the housing compartment contacts the site of injection.

[0022] In some implementations, the syringe flange retainer contains a recess that is contoured to the shape of the flange.

[0023] In some implementations, the plunger retainer holder contains at least one depression contoured to the shape of the plunger grip at the distal end of the plunger.

[0024] In some implementations, the plunger retainer holder contains a number of recesses that allow for flexibility in plunger grip location.

[0025] In some implementations, the actuator of the injection mechanism comprises a button.

[0026] In some implementations, one or more inwardly projecting posts connect with the button and the flange retainer. When the button is pressed, the one or more inwardly projecting posts prevent proximal movement of the flange retainer. Compression of the button results in a disconnect between the one or more inwardly projecting posts and the flange retainer, allowing proximal movement of the flange retainer.

[0027] In some implementations, compression of the button results in a linear force provided by an electromechanical linear actuator to provide proximal movement of the plunger retainer.

[0028] In some implementations, the needle has a length such that the needle tip, when inserted into an individual's skin, extends beyond the proximal face a length equal to the intradermal insertion depth.

[0029] In some implementations, the needle assembly further comprises a needle cap, the needle having a length such that the needle tip, when inserted into the skin of an individual, extends beyond the needle cap a length equal to the intradermal insertion depth.

[0030] In some implementations, the needle assembly further comprises a needle cover surrounding the needle and a spring connected to the needle cover. When the spring is decompressed, the needle cover prevents exposure of the tip of the needle. When the spring is compressed, the tip of the needle is exposed.

[0031] In some implementations, the needle assembly further comprises an outer cylinder surrounding the needle cover. The inner surface of the outer cylinder comprises one or more slotted tracks. The needle cover comprises a protruding slider extending from an outer surface of the needle cover into the one or more slotted tracks. The interaction between the protruding slider and the one or more slotted tracks allows for limited exposure of the needle when the spring is compressed.

[0032] In some implementations, the limited exposure of the needle allows for positioning of the needle tip beyond the needle cover.

[0033] In some implementations, the positioning of the needle tip beyond the needle cover results in a certain intradermal insertion depth when inserted into an individual's skin.

[0034] In some implementations, the needle assembly further comprises an actuator with an arm capable of being inserted into the one or more slotted tracks. The actuator of the needle assembly with an arm can prevent the protruding slider from moving in the one or more slotted tracks, thereby preventing compression of the spring and thus exposing the needle.

[0035] In some implementations, opening of the actuator of the needle assembly with the arm allows the needle to be exposed. Opening of the actuator of the needle assembly opens at least one slotted track of the one or more slotted tracks, allowing movement of the protruding slider and compression of the spring.

[0036] In some implementations, the one or more slotted tracks contain a first angled wall such that initial compression of the spring results in the protruding slider moving along the inner circumference of the outer cylinder through the first angled wall, causing the needle cover to rotate along the central axis. Decompression of the spring after initial compression results in the protruding slider moving further along the inner circumference of the outer cylinder through the second angled wall, causing the protruding slider to move into a hard corner that prevents further compression of the spring.

[0037] In some implementations, the positioning of the needle tip beyond the needle cover is about 0.5 mm to 2.0 mm.

[0038] In some implementations, the fluid-filled syringe is in operative connection with the needle. The operative connection is a Luer lock.

[0039] In some implementations, the fluid in the fluid-filled syringe is a medication or adjunct for the skin.

[0040] In some implementations, the fluid in the fluid-filled syringe is triamcinolone, hyaluronic acid, collagen, or a collagen stimulator.

[0041] In some implementations, a method is for injecting a specific dose of fluid to a specific depth. The method includes providing a syringe system including a fluid-filled syringe including a housing compartment, a flange, and a plunger including a flange retainer system and a plunger retainer system, a needle assembly attached to the fluid-filled syringe, and an actuator of an injection mechanism that ejects a controlled dose of fluid. The method further includes positioning the needle assembly proximate a site of injection. The method further includes actuating the actuator, resulting in a needle of the needle assembly being inserted into the site of injection at a specific depth, resulting in ejection of the controlled dose of fluid from the fluid-filled syringe through the needle of the needle assembly.

[0042] In some implementations, the needle cap is for controlling the depth of needle insertion. The needle cap comprises a cylindrical tube having a proximal orifice on a proximal face and a distal orifice opposite the proximal orifice. The distal orifice is capable of fitting onto the base of the needle such that the tip of the needle is inserted through the proximal orifice and is a particular distance from the proximal face. [Brief description of the drawings]

[0043] The description and claims will be more fully understood with reference to the following figures, which are presented as exemplary embodiments of the disclosure and should not be construed as a complete recitation of the scope of the disclosure.

[0044] [Figure 1] 1A-1C provide illustrations of syringe devices according to various embodiments of the present disclosure.

[0045] [Diagram 2] 2A-4B provide illustrations of fluid-filled cartridges according to various embodiments of the present disclosure. [Diagram 3] 2A-4B provide illustrations of fluid-filled cartridges according to various embodiments of the present disclosure. [Figure 4] 2A-4B provide illustrations of fluid-filled cartridges according to various embodiments of the present disclosure.

[0046] [Diagram 5] 5A-5D provide illustrations of syringe systems according to various embodiments of the present disclosure.

[0047] [Figure 6] 6A and 6B provide an illustration of a cartridge and microneedles as discrete components, according to various embodiments of the present disclosure.

[0048] [Figure 7] 7-9 provide illustrations of the mechanics of a syringe system with unassisted penetration, according to various embodiments of the present disclosure. [Figure 8] 7-9 provide illustrations of the mechanics of a syringe system with unassisted penetration, according to various embodiments of the present disclosure. [Figure 9] 7-9 provide illustrations of the mechanics of a syringe system with unassisted penetration, according to various embodiments of the present disclosure.

[0049] [Figure 10] 10-12 provide illustrations of mechanisms of a syringe system with assisted penetration, according to various embodiments of the present disclosure. [Figure 11] 10-12 provide illustrations of mechanisms of a syringe system with assisted penetration, according to various embodiments of the present disclosure. [Figure 12] 10-12 provide illustrations of mechanisms of a syringe system with assisted penetration, according to various embodiments of the present disclosure.

[0050] [Figure 13] FIG. 13 provides an illustration of the mechanism of an electromechanical syringe system with assisted penetration, according to various embodiments of the present disclosure.

[0051] [Figure 14] 14-16B provide illustrations of exemplary syringe systems, according to various embodiments. [Figure 15] 14-16B provide illustrations of exemplary syringe systems, according to various embodiments. [Figure 16A] 14-16B provide illustrations of exemplary syringe systems, according to various embodiments. [Figure 16B] 14-16B provide illustrations of exemplary syringe systems, according to various embodiments.

[0052] [Figure 17A] 17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments. [Figure 17B]17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments. [Figure 18A] 17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments. [Figure 18B] 17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments. [Figure 19] 17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments. [Figure 20] 17A-20 provide illustrations of the mechanics of an example ejector system, according to various embodiments.

[0053] [Figure 21] 21-24 provide illustrations of optional features of example ejector systems, according to various embodiments. [Figure 22] 21-24 provide illustrations of optional features of example ejector systems, according to various embodiments. [Figure 23] 21-24 provide illustrations of optional features of example ejector systems, according to various embodiments.

[0054] [Figure 24] 24 and 25 provide illustrations of an exemplary electromechanical syringe system, according to various embodiments. [Diagram 25] 24 and 25 provide illustrations of an exemplary electromechanical syringe system, according to various embodiments.

[0055] [Figure 26A] 26-29 provide illustrations of needle assemblies, according to various embodiments. [Figure 26B] 26-29 provide illustrations of needle assemblies, according to various embodiments. [Figure 27] 26-29 provide illustrations of needle assemblies, according to various embodiments. [Figure 28]26-29 provide illustrations of needle assemblies, according to various embodiments. [Figure 29] 26-29 provide illustrations of needle assemblies, according to various embodiments.

[0056] [Diagram 30] 30A and 30B provide illustrations of needle caps, according to various embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] Detailed Description Turning now to the drawings, systems, devices, and methods for precision intradermal fluid delivery utilizing needles or microneedles are described according to various embodiments of the present disclosure. In an embodiment, the intradermal or subcutaneous fluid system utilizes an injector device and an interchangeable injection system. The injection system can include a cartridge with microneedles or a syringe with needles that can store fluid (e.g., medication or auxiliary). In an embodiment, the interchangeable injection system is compatible coupled to the injector device such that a mechanism of the injector can eject fluid out of the injection system through the microneedle or needle. In an embodiment, the microneedle or needle is integrated with the cartridge or syringe as a single component. In an embodiment, the microneedle or needle and the cartridge or syringe are each individual components that can interlock together (e.g., luer lock connector).

[0058] In some embodiments, intradermal or subcutaneous delivery systems are utilized to deliver drugs and / or supplements, such as triamcinolone (Kenalog), hyaluronic acid, or collagen (or collagen stimulators), which can be used in various skin therapeutic applications. For example, in some embodiments, intradermal or subcutaneous delivery systems deliver triamcinolone into acne lesions as acne treatment. In some embodiments, intradermal or subcutaneous delivery systems deliver hyaluronic acid into the skin. Also, in some embodiments, intradermal or subcutaneous delivery systems deliver collagen and / or collagen production agents into the skin, which can improve skin elasticity and appearance.

[0059] The described systems, devices, and methods should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. The disclosed systems, devices, and methods are not limited to any specific aspect, feature, or combination thereof, or require that any one or more specific advantages exist or problems be solved.

[0060] Various embodiments of intradermal or subcutaneous fluid delivery systems and examples of fluid delivery devices and cartridges are disclosed herein, and any combination of these options can be made unless specifically excluded. For example, any of the disclosed fluid delivery devices can be used with any type of compatible interchangeable injection system, even if a specific combination is not explicitly described. Similarly, different structures and features of the fluid delivery system can be mixed and matched, such as by combining any delivery system type / feature, delivery device type / feature, cartridge, etc., even if not explicitly disclosed. In short, individual components of the disclosed systems can be combined unless they are mutually exclusive or physically impossible.

[0061] Although some operations of the disclosed methods are described in a particular sequential order for convenience of presentation, it should be understood that this mode of description encompasses rearrangements unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be rearranged or performed in parallel. Also, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatus.

[0062] The terms "proximal" and "distal" as used throughout the description relate to the site of injection. Thus, a proximal face or portion of a device is a face or portion that would be closer to the site of injection when an injection is performed. Conversely, a distal face or portion of a device is a face or portion that would be more distal to the site of injection when an injection is performed. Similarly, proximal movement would be movement of a component in a direction toward the site of injection, and distal movement would be movement of a component in the opposite direction. Although these terms relate to the site of injection, it should be understood that these terms are used for reference and that a site of injection need not be present when interpreting the components or movements of the devices and systems described herein. Systems and devices for intradermal and subcutaneous microinjection - Patents.com

[0063] Various embodiments are directed to systems and devices for intradermal and / or subcutaneous injection. In an embodiment, the intradermal and / or subcutaneous injection system includes an injector device, a cartridge or syringe, and a microneedle or needle. Generally, according to various embodiments described herein, the injector system is compatible with a fluid-filled replaceable injection system such that the injector is configured to receive and operatively couple with the replaceable injection system. In an embodiment, when the injector and the replaceable injection system are operatively coupled, the injector provides a mechanism for ejecting liquid from the replaceable injection system through the needle. In an embodiment, the microneedle or needle is integrated with the cartridge or syringe as a single component. In an embodiment, the microneedle or needle and the cartridge or syringe are each individual components (e.g., luer lock connectors) that can interlock together. Syringe System

[0064] In an embodiment, the injector device is configured to provide a mechanism for fluid ejection out of the replaceable injection system. The injector can operate via mechanical or electromechanical means. In an embodiment, the injector includes one or more actuators (e.g., buttons or triggers) for actuating and / or driving the mechanical and / or electrical components of the device. In an embodiment, the actuator is mechanically or electrically operatively coupled to an internal drive system that is operatively coupled to the replaceable injection system to eject liquid out of the needle and therethrough. In an embodiment, the internal drive system cooperatively interacts with a compression spring that can help control the flow of fluid ejection out of the cartridge and / or return the drive to an initial position. In an embodiment, the actuator is operatively coupled to an internal drive mechanism that can drive the needle to pierce and seat in the skin for injection. In an embodiment, the internal drive mechanism is a linear actuator that utilizes one or more of a rotatable threaded rod, a worm gear, a rack and pinion, or a solenoid coil. In some embodiments, a different screw mechanism is utilized for fine micron (or sub-micron) movements.

[0065] In some embodiments, the electromechanical injector device includes a power source or battery, such as (for example) a lithium ion battery, however, any suitable power source or battery can be utilized. In some embodiments, the injector device includes a computing system and / or software for providing instructions for performing various tasks of the injector device. Various tasks to be performed include (but are not limited to) piercing the skin with a needle, ejecting components out of the replaceable injection system, withdrawing the needle out of the skin, providing a laser / light, calculating dosage, calculating the volume to be administered, calculating needle depth for administration, camera image data (live or captured), storing data, and connecting to an internet system or other system (e.g., Bluetooth, cloud system, Wi-Fi enabled, cellular data enabled). Data that can be stored in the memory of the treatment device includes (but is not limited to) a procedure log, a cartridge log (e.g., type, volume), a location log, a dosage log, and a needle depth log.

[0066] In some embodiments, the needle remains unexposed to the user during the injection process. In some embodiments, the injection device includes one or more sensors that can be utilized to sense needle penetration, required needle depth, fluid ejection, local pressure, or any other suitable sensation to be detected. In some embodiments, the injection device in conjunction with the needle includes a sensor for measuring electrical impedance that can be used to detect skin contact, needle penetration, and / or needle depth. In some embodiments, a spacer on the needle system is provided to ensure proper needle penetration and depth.

[0067] In certain embodiments, the syringe device includes a housing for receiving a fluid-filled replaceable injection system (e.g., a cartridge system or a syringe system). In certain embodiments, the housing includes a reversible coupling and / or locking mechanism to facilitate receiving the replaceable injection system. In certain embodiments, the replaceable injection system includes a compatible component for coupling and / or locking with the syringe. Any suitable reversible coupling and / or locking mechanism can be utilized, such as (for example) a hook and receiving groove, a flange, a threaded screw, a twist lock, a ball and locking pin, or any possible combination of coupling and / or locking mechanisms. In certain embodiments, the coupling and / or locking mechanism is reversible such that the replaceable injection system can be displaced from the replaceable injection system, and the displacement can occur prior to and / or after the ejection of fluid.

[0068] In an embodiment, the injector device includes a stabilizing feature (e.g., an abutment or base) that can be utilized to position and / or stabilize the injector and needle system at a desired location on the skin. In an embodiment, the stabilizing feature extends from and connects to the injector system via a connector, which can be any suitable connector, such as a rod and / or post. In an embodiment, the stabilizing feature is a proximal surface of the injector system housing. In an embodiment, the stabilizing feature and the needle are cooperatively positioned such that the ejection tip of the needle can extend beyond the stabilizing feature the required distance for intradermal or subcutaneous delivery. Human skin has a depth of about 0.5 mm to 5.0 mm, depending on the location. For example, facial skin is about 1.5 mm to 2 mm, with further variation on the location of the face (e.g., the average thickness of skin on the forehead is about 1.7 mm, and the average thickness of skin on the cheek is about 1.85 mm). Thus, depending on the location and use (e.g., intradermal or subcutaneous injection), according to various embodiments, the needle tip is positioned 0.5 mm to 5.0 mm beyond the stabilizing feature during injection. For use on facial skin, according to various embodiments, the needle or microneedle tip is positioned approximately 0.5 mm to 2.0 mm beyond the stabilizing feature during injection. In various embodiments, the microneedle or needle tip is positioned approximately 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, or 5.0 mm beyond the stabilizing feature during injection.

[0069] In some embodiments, the housing of the syringe system partially or completely conceals the replaceable injection system. In some embodiments, the housing further conceals the needle. In some embodiments, the housing can include an orifice (e.g., a pinhole) through which the needle is exposed during skin penetration. In some embodiments, the proximal surface of the housing surrounding the orifice can provide a stabilizing and / or positioning effect at a desired location on the skin. In some embodiments, the orifice and the needle are cooperatively positioned such that the ejection tip of the needle can extend beyond the orifice a distance required for intradermal or subcutaneous delivery.

[0070] In some embodiments, the injector system includes one or more cameras that can be used to help visualize the treatment and / or record images or data of the treatment site. Any suitable camera can be utilized, including (but not limited to) visible light and infrared cameras. In some embodiments, the camera is positioned proximal to the interchangeable injection system so that it can visualize the treatment site and / or procedure. In some embodiments, light is utilized to enhance the camera and / or user visualization. In some embodiments, a laser is utilized to help guide the user to the appropriate injection site. In some embodiments, the laser works in conjunction with the camera to provide precision treatment.

[0071] In some embodiments, the syringe system includes a means for providing feedback to ensure proper therapy. In some embodiments, the syringe system includes a means for providing feedback as to when the replaceable injection system is securely in the device. In some embodiments, the syringe system includes a means for providing feedback as to when the replaceable injection system is not securely in the system. In some embodiments, the syringe system includes a means for providing feedback as to when the syringe system is ready for use. In some embodiments, the syringe system includes a means for providing feedback as to when the syringe system is actively delivering therapy. In some embodiments, the syringe system includes a means for providing feedback as to when the syringe system has finished delivering therapy. Any suitable means for providing feedback can be utilized, including (but not limited to) white lights, colored lights, covering or uncovering mechanical features on the device with or without the use of color, and audible sounds. Interchangeable Injection System

[0072] Some embodiments are directed to an interchangeable fluid-filled injection system to be utilized in conjunction with a syringe device. The interchangeable injection system includes (but is not limited to) a syringe system and a cartridge system. In certain embodiments, the cartridge is a sealed container with fluid therein that can be hermetically sealed. Any suitable volume of fluid can be utilized. In various embodiments, the fluid-filled injection system contains about 0.01 cc to 1 cc. In various embodiments, the fluid-filled injection system contains about 0.01 cc, 0.05 cc, 0.1 cc, 0.15 cc, 0.2 cc, 0.25 cc, 0.3 cc, 0.35 cc, 0.4 cc, 0.45 cc, 0.5 cc, 0.55 cc, 0.6 cc, 0.65 cc, 0.7 cc, 0.75 cc, 0.8 cc, 0.85 cc, 0.9 cc, 0.95 cc, or 1.0 cc.

[0073] In some embodiments, the replaceable injection system is for limited use, such as a single use injection system or a multi-use injection system. In various embodiments, the replaceable injection system contains fluid for 1-10 injections. In some embodiments, the replaceable injection system is disposable after fluid ejection. In some embodiments, the replaceable injection system contains a plunger to facilitate ejection of fluid through the needle or microneedle and out of the cartridge.

[0074] In some embodiments, the plunger of the replaceable injection system can be operatively coupled to the internal drive of the syringe device. In some embodiments, the internal piston of the syringe can contact a surface of the replaceable injection system (e.g., the surface opposite the needle) such that the piston can operatively push the plunger of the injection system, resulting in ejection of liquid out of the injection system. In some embodiments, the replaceable injection system can be operatively coupled to the internal drive mechanism of the syringe device such that the internal drive mechanism can move the injection system axially away from and / or towards the central portion of the syringe. In some embodiments, the movement of the replaceable injection system through the internal drive mechanism of the syringe simultaneously moves the ejection tip of the needle or microneedle away from and / or towards the central portion of the syringe such that the internal drive mechanism operatively drives the needle or microneedle to pierce and be inserted into the skin. In some embodiments, the internal drive mechanism of the syringe moves the ejection tip of the needle or microneedle past the stabilizing feature to the required position. Needles and Microneedles

[0075] In some embodiments, the needle or microneedle is operatively coupled to the interchangeable injection system such that fluid within the injection system can be ejected through the needle or microneedle. In some embodiments, the needle or microneedle extends from a proximal face of the injection system (e.g., a face proximal to the site of injection in use). In some embodiments, the needle or microneedle is integrated with the interchangeable injection system such that the needle or microneedle and the injection system are a single component. In some embodiments, the needle or microneedle and the interchangeable injection system are each individual components that can mate together to ensure fluid flow through the needle or microneedle and out of the injection system. Any suitable means for mating the needle or microneedle with the interchangeable injection system can be utilized, such as (for example) a luer lock system or a gasket.

[0076] In various embodiments, one or more needles or microneedles are operatively coupled to a fluid-filled injection system such that fluid can be ejected out of the injection system through one or more needles or microneedles. In some embodiments, a single needle or microneedle is operatively coupled to a fluid-filled cartridge. In some embodiments, multiple needles or microneedles are operatively coupled to a fluid-filled injection system, which can be arranged in an array, a regular pattern (e.g., a circle), an irregular pattern, or any other configuration.

[0077] In some embodiments, the needle or microneedle has the ability to provide a cooling effect, a heating effect, or a micro-vibration effect. Thus, a means for providing cooling, heating, or micro-vibration is operatively coupled to the needle to provide the function. Any suitable means for providing a cooling, heating, or micro-vibration capability to the needle or microneedle can be utilized.

[0078] In some embodiments, one or more needles or microneedles are covered or concealed, which may be desirable to prevent harm to the user from the needle or microneedle or to prevent damage to the needle or microneedle. Any suitable means of covering or concealing one or more needles or microneedles can be utilized. In some embodiments, a covering is installed around the microneedle. In some embodiments, the covering is a rigid and / or stiff material. In some embodiments utilizing a rigid and / or stiff covering, the covering can expose or reveal the microneedle through an orifice or pinhole, which can be done as it is advanced or prior to advancement into the injection site. In some embodiments, the covering is a crushable and / or pierceable material, such that the needle or microneedle is exposed or revealed by the covering collapsing and / or the needle or microneedle penetrating through the covering. Penetrable materials include (but are not limited to) rubber, neoprene, PTFE, ePTFE, and metal foil. In some embodiments, after ejection of fluid out of the cartridge through the needle or microneedle, the needle or microneedle is again concealed or re-hidden, hi some embodiments, a rigid or hard covering is ejected outwardly from the housing to cover the needle or microneedle after injection. Exemplary Systems and Devices

[0079] 1A-1C, an example of a syringe system is provided in accordance with various embodiments. As can be seen in FIG. 1A, the syringe 101 can include a body 103 with an exterior covering 105 that covers an internal piston. The syringe 101 can include a button 107 that can actuate and / or drive a mechanism of the internal piston and internal drive. As shown, the button 107 is on a surface 109 opposite a surface 111 that mates with a fluid-filled cartridge (not shown). The syringe 101 can further include a stabilizing and / or positioning abutment 113 that extends away from the body 103 via a post connector 115. As shown, the stabilizing and / or positioning abutment 113 extends away from a surface 111 that can mate with a fluid-filled cartridge. The syringe 101 may also optionally include an optical feedback indicator or window 123 with colored components and an audio feedback indicator 125 to provide feedback of one or more of the following: cartridge attachment, ready for use, active engagement of therapy, end of therapy delivery, or any other suitable feedback.

[0080] 1B is a view of syringe 101 showing face 111 that mates with a fluid-filled cartridge. Face 111 includes a mating portion 117 for mating the syringe with a fluid-filled cartridge. Face 111 further shows an internal piston 119 that moves axially away from and toward a central portion 121 of the body.

[0081] FIG. 1C provides another embodiment of a syringe 101 in which a button 107 extends from a curved surface of the cylindrical body 103.

[0082] 2A-4B provide various examples of a fluid-filled cartridge 201 according to various embodiments. As can be seen in these figures, the cartridge can include a face 203 capable of mating with a syringe, including a central portion 205 that can interact with the internal piston of the syringe. Opposite the face 203 capable of mating with a syringe is a face 207 with one or more microneedles. As seen in FIGS. 2A and 2B, a single microneedle 209 can be utilized. Alternatively, as seen in FIGS. 3A and 3B, multiple microneedles 211 can be utilized, which can be in the form of an array (e.g., 2×2), pattern (e.g., circle), or irregular pattern, each microneedle can have a microneedle ejection tip. Within the cartridge 201 is a plunger 213 and a fluid-filled portion 212 that stores the fluid until it is ejected from the cartridge. A plunger 213 can interact with a central portion 205 of face 203, which can interact with an internal piston of the syringe such that the plunger can be moved axially away from face 203 and toward one or more microneedles 209 / 211. Cartridge 201 includes a fluid-filled portion 212 that stores fluid until it is ejected from the cartridge.

[0083] 4A and 4B provide an example of a covering 215 that conceals and / or conceals one or more needles (only a single needle 209 is depicted as a dashed line), according to various embodiments. The covering 215 can surround the one or more needles to provide concealment. The covering can include one or more pin holes (not shown) that can allow exposure of the one or more concealed needles as they advance through the pin holes. Alternatively, the covering can be made of a pierceable material such that the one or more needles can be exposed by piercing through the material as they are advanced.

[0084] Provided in Figures 5A-5D is an exemplary syringe device 101 of Figure 1A operatively coupled with an exemplary fluid-filled cartridge 201 of Figures 2A-4B according to various embodiments. As can be seen in Figure 5A, the fluid cartridge 201 can be mounted within the syringe 101 such that a face 203 of the cartridge 201 contacts a face 111 of the syringe 101. A central portion 205 of the face 203 of the cartridge interacts with an internal piston 119 of the syringe 101. Additionally, the microneedle 209 extends away from the syringe 101 and is positioned such that the microneedle ejection tip 210 is advanced beyond the abutment 113. As discussed above, the precise location of the microneedle tip relative to the abutment depends on the desired type of delivery (e.g., intradermal or subcutaneous) and the thickness of the skin at the injection site. Figures 5B-5D show views of a face 207 of the cartridge 201 mounted within the syringe 101. The syringe 101 may also optionally include a light feedback indicator or window 123 with colored components and an audio feedback indicator 125 to provide feedback of one or more of the following: cartridge sticking, ready for use, active engagement of therapy, end of therapy delivery, or any other suitable feedback. Additionally, the device 101 may incorporate one or more cameras 127 and visualization lights 129 that may be used to assist and / or record use of the device and cartridge.

[0085] 6A and 6B provide examples of a cartridge component 601 and a microneedle component 603 as individual components that may be assembled together, according to various embodiments. Cartridge 601 includes a face 605 capable of mating with a syringe, including a central portion 607 that may interact with an internal piston of the syringe. Opposite face 605 capable of mating with a syringe is a face 609 capable of mating with a microneedle assembly 603. Within cartridge 601 is a plunger 611 and a fluid-filled portion 613 that stores fluid until it is ejected from the cartridge. Plunger 611 may interact with central portion 607 of face 605, which may interact with an internal piston of the syringe such that the plunger may be moved axially away from face 605 and toward microneedle assembly 603.

[0086] The microneedle component 603 includes a base 615 with a surface 617 that can mate with a surface 609 of the cartridge 601. The mate can be any suitable mate that allows proper fluid flow from the cartridge into the microneedle assembly, such as (for example) a luer lock or a gasket. Opposite the surface 617 is a surface 619 with microneedles 621 extending away from the microneedle assembly base 615. Although not shown, the microneedle assembly can include multiple microneedles, which can be formed in an array or any other suitable pattern. As shown in FIG. 6B, the microneedle assembly 603 can include a covering 623 that conceals and / or hides one or more needles (only a single needle 621 is depicted as a dashed line). The covering 623 can surround the one or more needles to provide concealment. The covering can include one or more pin holes (not shown) that can allow exposure of one or more hidden needles as they advance through the pin holes. Alternatively, the cover may be made of a pierceable material such that one or more needles may be exposed by piercing through the material as they are advanced.

[0087] 7-9 are examples of syringe systems with unassisted skin penetration, according to various embodiments. A cartridge 701 is loaded onto an injector device 703. The cartridge 701 includes a face 705 with a central portion 707 that cooperatively mates with a face 709 and an internal piston 708 of the injector device 703. An outer portion 710 of the face 709 includes a reversible mating and / or locking mechanism to facilitate reception of the face 705 of the cartridge 701. Coupling of the cartridge 701 and the injector device 703 results in an injector system 711. The assembled injector system 711 includes a microneedle 713 that extends in a direction away from the injector device 703. Assembly of the injector system 711 results in a microneedle ejection tip 715 that is appropriately positioned in relation to an abutment 717 such that the ejection tip extends beyond the abutment a distance required for intradermal or subcutaneous injection. Note that for simplicity and illustration, Figure 9 does not show the abutment, but one may be assumed to be present on the assembled system. The microneedles 713 may be concealed utilizing a covering 721 as shown in Figure 8.

[0088] The assembled syringe system 711 can be used for intradermal or subcutaneous injection of liquid. The user can pierce the skin with the microneedle ejection tip 715 at the desired location and move the microneedle 713 perpendicular to the surface of the skin until the abutment 717 rests on the outer surface of the skin resulting in the microneedle tip having the required depth for a proper intradermal or subcutaneous injection. At the appropriate depth, the syringe system 711 can inject the liquid into the skin. The covering 721 can be pierceable or include a pinhole so that the microneedle 713 can be exposed to pierce the user's skin. As shown in FIG. 8, the covering 721 is collapsible so that as the needle pierces the user's skin, it collapses until the needle reaches the required depth for a proper intradermal or subcutaneous injection, resulting in the collapsing of the covering 721. As described herein, instead of being collapsible, the covering can be retractable and / or removable.

[0089] The syringe system 711 utilizes a spring 719 that works with an internal piston 708 to facilitate liquid ejection. A button 725 is utilized to move the piston 708 axially toward the cartridge 701. As the piston 708 moves axially, it interacts with a central portion 707 of the face 705, pushing the central portion axially and toward the microneedle 713. The central portion 707 interacts with a plunger 727, displacing liquid within a liquid-containing portion 729 of the cartridge 701, resulting in the liquid passing through the microneedle 713 and out of the ejection tip 715. After injection of the liquid into the skin, the microneedle 713 can be removed from the skin. A multi-use cartridge can be utilized for multiple injections, and the steps to inject the liquid into another desired location can be repeated. After the cartridge 701 is consumed, it can be removed and disposed of, and the syringe device 703 can be reused with a subsequent cartridge.

[0090] 10-12 are provided examples of an injector system with assisted skin penetration, according to various embodiments. A cartridge 1001 is loaded onto an injector device 1003. The cartridge 1001 includes a face 1005, a central portion 1007 of which cooperatively mates with a face 1009 and an internal piston 1008 of the injector device 1003. An outer portion 1010 of the face 1009 includes a reversible coupling and / or locking mechanism to facilitate reception of the face 1005 of the cartridge 1001. The outer portion 1010 further includes an operative connection with an internal drive 1014, which facilitates assisted skin penetration. Coupling of the cartridge 1001 and the injector device 1003 results in an injector system 1011. The assembled injector system 1011 includes a microneedle 1013 extending in a direction away from the injector device 1003. Assembly of the syringe system 1011 results in a microneedle ejection tip 1015 that is slightly recessed from the distance required for intradermal or subcutaneous injection. As shown in Figures 10 and 11, the ejection tip 1015 is slightly recessed relative to the abutment 1017, which can allow a user to position the syringe system 1011 using the abutment 1017 prior to penetrating the skin with the microneedle 1013. Note that for simplicity and illustration, Figure 12 does not show the abutment, but one can be assumed to be present on the assembled system. The microneedle 1013 can be concealed using a covering 1021 as shown in Figure 11.

[0091] The assembled syringe system 1011 can be used for intradermal or subcutaneous injection of liquid. Once the user positions the syringe system 1011, the system can assist the user to pierce their skin with the microneedle ejection tip 1015 at the desired location. The user can press the button 1025 to start the internal drive 1014, thus moving the microneedle 1013 perpendicular to the surface of the skin and penetrating into the skin until the ejection tip 1015 is at the required depth for a proper intradermal or subcutaneous injection. As shown in FIG. 12, the internal drive 1014 is one or more rigid outer members, such as one or more struts or sheaths, that surround the inner piston 1008. The button 1025 can push the internal drive 1014 axially towards the cartridge 1001, resulting in the outer portion 1010 of the face 1009 pushing the cartridge axially. As the cartridge 1001 moves axially, the microneedles 1013 penetrate the user's skin until the ejection tip 1015 reaches the appropriate depth. At the appropriate depth, the syringe system 1011 can inject the liquid into the skin. The covering 1021 can be pierceable or include a pinhole so that the microneedles 1013 can be exposed to penetrate the user's skin. As shown in FIG. 11, the covering 1021 is collapsible so that as the needle penetrates the user's skin, it collapses until the needle reaches the required depth for appropriate intradermal or subcutaneous injection, resulting in the collapsing of the covering 1021. As described herein, instead of being collapsible, the covering can be retractable and / or removable.

[0092] The syringe system 1011 utilizes a spring 1019 that works with an internal piston 1008 to facilitate liquid ejection. A button 1025 is utilized to move the piston 1008 axially toward the cartridge 1001. Alternatively, a second button can be utilized to facilitate movement of the piston in the axial direction. As the piston 1008 moves axially, it interacts with a central portion 1007 of the face 1005, pushing the central portion axially and toward the microneedle 1013. The central portion 1007 interacts with a plunger 1027, displacing liquid within a liquid-containing portion 1029 of the cartridge 1001, resulting in liquid passing through the microneedle 1013 and out of the ejection tip 1015. After injection of the liquid into the skin, the microneedle 1013 can be removed from the skin. A multiple-use cartridge can be utilized for multiple injections, and the steps for injecting liquid into another desired location can be repeated. After the cartridge 1001 is consumed, it can be removed and disposed of, and the syringe device 1003 can be reused with a subsequent cartridge.

[0093] Provided in FIG. 13 is an example of an electromechanical or dual spring injector system with assisted skin penetration, according to various embodiments. A cartridge 1301 is loaded onto an injector device 1303. The cartridge 1301 includes a face 1305 with a central portion 1307 cooperatively mating with a face 1309 and an internal piston 1308 of the injector device 1303. An outer portion 1310 of the face 1309 includes a reversible mating and / or locking mechanism to facilitate reception of the face 1305 of the cartridge 1301. The outer portion 1310 further includes an operative connection with an internal drive 1314 that facilitates assisted skin penetration. Coupling of the cartridge 1301 and the injector device 1303 results in an injector system 1311. The assembled injector system 1311 includes a microneedle 1313 extending in a direction away from the injector device 1303. Assembly of the syringe system 1311 results in a microneedle ejection tip 1315 that is slightly recessed from the distance required for intradermal or subcutaneous injection. Note that for simplicity and illustration, FIG. 13 does not show an abutment, but one may be assumed to be present on the assembled system. The microneedle 1313 may be concealed using a covering.

[0094] The assembled syringe system 1311 can be used for intradermal or subcutaneous injection of liquid. Once the user positions the syringe system 1311, the system can assist the user in penetrating their skin with the microneedle ejection tip 1315 at the desired location. The user can press the button 1325 to actuate a rotatable threaded rod or release the spring 1316 that is operatively coupled to the internal drive 1314. The electromechanical device can be powered by a battery or other power source. Actuation of the internal drive 1314 can move the microneedle 1313 perpendicular to the surface of the skin and penetrate into the skin until the ejection tip 1315 is at the required depth for a suitable intradermal or subcutaneous injection. The internal drive 1314 is one or more rigid outer members, such as one or more struts or sheaths, that surround the inner piston 1308. A rotatable threaded rod or releasable spring 1316 can urge the internal drive 1314 axially towards the cartridge 1301, causing the outer portion 1310 of the face 1309 to axially urge the cartridge. As the cartridge 1301 moves axially, the microneedles 1313 penetrate the user's skin until the ejection tip 1315 reaches the appropriate depth. At the appropriate depth, the syringe system 1311 can inject the liquid into the skin.

[0095] The syringe system 1311 utilizes a second rotatable rod or releasable spring 1319 that operates with an internal piston 1308 to facilitate liquid ejection. A button 1025 is utilized to initiate rotation of the rod or release of the spring 1319 to move the piston 1308 axially toward the cartridge 1301. As the piston 1308 moves axially, it interacts with a central portion 1307 of the face 1305, pushing the central portion axially and toward the microneedle 1313. The central portion 1307 interacts with a plunger 1327, displacing liquid within a liquid-containing portion 1329 of the cartridge 1301, resulting in liquid passing through the microneedle 1313 and out of the ejection tip 1315. After injection of the liquid into the skin, the microneedle 1313 can be removed from the skin. A multiple-use cartridge can be utilized for multiple injections, and the steps to inject liquid into another desired location can be repeated. After the cartridge 1301 is consumed, it can be removed and disposed of, and the syringe device 1303 can be reused with a subsequent cartridge.

[0096] Provided in Figures 14-16B is an exemplary system for performing intradermal or subcutaneous injections of liquids. The system as shown comprises a housing compartment 1401, a fluid-filled syringe 1403, and a needle assembly 1405. Figure 14 shows the housing compartment 1401 in its closed state. Figure 15 shows the housing 1401 with the lid 1415 in an open position. Figures 16A and 16B also show the fluid-filled syringe 1403 and needle assembly 1405 disposed within the housing compartment 1401.

[0097] The housing compartment 1401 contains a proximal portion 1407 which is associated with the needle assembly 1405 and provides a proximal face 1409 for contacting the skin when performing an injection and an orifice 1411 for allowing the injection. The housing compartment 1401 further contains a button 1413 for activating the injection mechanism. A lid 1415 includes a latch 1417 which can be opened to allow installation of the fluid-filled syringe 1403 and needle assembly within the housing 1401. A window 1419 is provided for viewing the fluid-filled syringe 1403 and the volume of fluid therein.

[0098] The needle assembly 1405 can be connected to the fluid-filled syringe 1403 by any suitable means, such as a luer lock. The connected fluid-filled syringe 1403 and needle assembly 1405 can be received by a housing 1401, which can contain a contoured recess 1421 that conforms to the connected fluid-filled syringe 1403 and needle assembly 1405. Within the housing 1401 is a syringe flange retainer 1423 and a plunger retainer 1425. The flange retainer 1423 contains a recess 1427 that is contoured to the shape of a syringe flange 1429 such that the syringe flange fits closely within the recess. Similarly, the plunger retainer 1425 contains a number of recesses 1431, each of which is contoured to the shape of a plunger grip 1433 at a distal end of a plunger 1432 such that the plunger grip fits within one of the recesses. The multiple recesses allow for flexibility in plunger grip location, which can vary depending on the volume of fluid in the syringe and the dose of fluid to be expelled.

[0099] The flange retainer 1423 and the plunger retainer 1425 are each movable in either a proximal or distal direction along a central axis. The flange retainer 1423 contains a groove 1434 that cooperates with a slider 1436 of the plunger retainer 1425. The groove 1434 and slider 1436 allow the ability of the plunger retainer 1425 to slide in either direction along the groove independent of the movement of the flange retainer 1423. The syringe flange retainer 1423 and the plunger retainer 1425 connect to each other via a latch 1438, and the plunger retainer contains a driver 1435 that operably connects with a compressed spring 1437 to provide the driving force for the injection mechanism. The spring 1437 is held in place by a distal base 1440 at the distal end of the system. The button 1413 contains two inwardly projecting posts 1439 that hold the driver 1435 in place and keep the spring 1437 in compression. When the button 1413 is pressed inwardly, the inwardly projecting posts 1439 move inward with the button, relieving the compression of the spring 1437 and providing a force for the driver 1435 to drive the flange retainer 1423 and plunger retainer 1425 along the central axis toward the proximal portion 1407.

[0100] The needle assembly 1405 comprises a needle 1441. In some implementations, the needle assembly further comprises a protective cover 1443, an outer cylinder 1445, and an actuator ring 1447. The protective cover 1443 can prevent exposure of the needle 1441 before and after an injection and can prevent the ability of the needle to pierce or cause injury when an injection is not being performed. The outer cylinder 1445 can provide a means for gripping the needle assembly 1405 and can also help to ensure that the protective cover 1443 properly covers the needle 1441. The actuator ring 1447 can unlock a mechanism for re-covering the protective cover 1443 over the needle 1441 after an injection. It should be understood that the needle assembly can be a standard needle without the protective cover, outer cylinder, and actuator ring. In some implementations, when used within the housing compartment 1401, the length of the needle is such that the tip of the needle extends beyond the proximal face 1409 when performing a fluid injection to control the needle depth at the site of the injection. In some implementations, the needle has a length such that a controlled intradermal injection may be performed. In some implementations, a needle cap is used with the needle to control the depth of penetration into the site of the injection (see FIGS. 30A and 30B for exemplary needle caps).

[0101] 17A-20 provide examples of various configurations of a system for performing intradermal or subcutaneous fluid delivery. As described with reference to FIGS. 14-16B, the system includes a housing compartment 1401, a fluid-filled syringe 1403, and a needle assembly 1405. The needle assembly 1405 is attached to the fluid-filled syringe 1403 and fits within the housing compartment 1401. Specifically, the syringe flange 1429 is seated within the flange retainer 1423, and the plunger grip 1433 is seated within the plunger retainer 1425, securing the fluid-filled syringe 1403 within the housing.

[0102] 17A and 17B show the system in an initial state, where the system is loaded with a fluid-filled syringe 1403 and needle assembly 1405 and is ready to perform the injection mechanism. In this state, the fluid-filled syringe 1403, needle assembly 1405, flange retainer 1423, and plunger retainer 1425 are in a distal position along the central axis. The fluid-filled syringe 1403 contains a volume of fluid that exceeds the amount to be injected. The relative position of the plunger retainer 1425 along the central axis in the initial state determines the injection dose, and therefore the position can be adjusted in this initial state to control the injection dose. The needle 1441 is within the cover 1443, and the actuator ring 1447 is in an initial closed state. The proximal face 1409 contacts the skin surface 1449 at the site to receive the injection.

[0103] The button 1413 is in an initial outward state such that the inwardly projecting posts 1439 maintain in compression the springs 1437 which physically connect with the flange retainers 1423. The inwardly projecting posts 1439 each contain a protruding portion 1451 which contacts the flange retainers 1423, maintaining the flange retainers and plunger retainer 1425 in place and maintaining the springs 1437 in compression.

[0104] 18A and 18B show the actuation of the injection mechanism, which results in the needle 1441 penetrating into the skin surface 1449. The button 1413 is the actuator of the injection mechanism, which when compressed inward (1453) causes the protruding portions 1451 of the inwardly projecting posts 1439 to move further inward, so that they are no longer in contact with the flange retainer 1423. The compressed spring 1437 is decompressed, causing the driver 1435 to move proximally along the central axis. Using the spring force, the driver 1435 drives the flange retainer 1423 and plunger retainer 1425 proximally along the central axis. This results in the fluid-filled syringe 1403 and needle assembly 1405 sliding proximally towards the skin surface 1449. When the needle assembly 1405 contacts the skin surface 1449, the cover 1443 contacts the skin and ceases its movement, allowing the needle 1441 to move proximally past the cover as it penetrates into the skin surface. The flange holder 1423 continues to move proximally until it reaches the flange holder positive stop 1455, stopping the flange holder's proximal movement. The flange holder positive stop also controls the placement of the needle assembly 1405 relative to the skin surface 1449, allowing for precise subcutaneous or intradermal positioning of the needle tip. Additionally, as the needle assembly 1405 moves proximally, the actuator ring 1447 impacts the actuator ring positive stop 1457, releasing the actuator ring (i.e., the ring is now held in a more distal position relative to the outer cylinder 1445). By releasing the actuator ring, the cover 1443 will be enabled to re-cover the needle 1441 when the needle is removed from the skin surface 1449 .

[0105] 19 illustrates the delivery of a dose of fluid from a fluid-filled syringe 1403, through the needle 1441, and into the skin surface 1449. With the flange 1423 at the flange retainer positive stop 1455, the flange retainer can no longer move proximally, disengaging the latch 1438. At this point, the driver 1435 continues to drive the plunger retainer 1425 proximally via the groove 1434 in the flange retainer 1423 and the plunger retainer's slider 1436. As the plunger retainer 1425 moves proximally and the fluid-filled syringe 1403 remains in place, the plunger 1432 is pushed proximally, displacing the dose of fluid to be administered, which passes through the needle 1441 and into the skin surface 1449. The plunger retainer 1425 moves proximally until it contacts the plunger retainer positive stop 1459, which is rigidly connected to the flange retainer 1423. Thus, the distance between the position of the plunger retainer 1425 and the position of the plunger retainer positive stop 1459 controls the fluid dose. When the plunger retainer 1425 reaches the plunger retainer positive stop 1459, delivery of fluid into the skin 1449 is completed.

[0106] 20 illustrates removal of the syringe system from the skin surface 1449, resulting in the cover 1443 covering the needle 1441. The fluid-filled syringe 1403, needle assembly 1405, flange retainer 1423, and plunger retainer 1425 are in a proximal position. At this point, the lid 1415 can be opened for removal of the fluid-filled syringe 1403 and needle assembly 1405. To reset the syringe system, the plunger retainer 1425 and flange retainer 1423 can be slid distally to their initial distal positions. The button 1413 can be reset to its outward initial position such that the protruding portion 1451 of the inwardly facing post 1439 holds the driver 1435 and compressed spring 1437 in its initial position.

[0107] FIG. 21 shows the distal end of the injector system with an optional light indicator 1461, which may be battery powered (not shown). The light indicator 1461 may provide a variety of different status indications to help assist the user. The status indications may provide user notification of operability, ready for use, warnings, errors, injection status, and battery power status. Various optional status indications that may be utilized include (but are not limited to) on, not loaded, properly loaded, improperly loaded, ready to inject, injection in progress, injection completed, failure to complete injection, and low battery power. The various status indications may be signaled by different light colors and / or light patterns (e.g., blinking, flashing, wavy).

[0108] 22 shows the distal end of the injector system with an optional LED screen 1463, which may be powered by a battery 1465. The LED screen 1463 may provide a variety of different status indications to help assist the user. The status indications may provide user notification of operability, ready for use, warnings, errors, injection status, and battery power status. Various optional status indications that may be utilized include (but are not limited to) on, not loaded, properly loaded, improperly loaded, ready to inject, injection in progress, injection complete, failure to complete injection, and low battery power. The various status indications may be signaled by representative icons, color indicators, or scripts.

[0109] 23 shows the proximal end of the injector system with an optional camera 1467 and an optional laser light 1469, each of which may be powered by a battery 1465. The camera 1467 can take images of the lesion to be treated. The laser light 1469 can help assist the user in properly positioning the injector system over the lesion to be treated.

[0110] 24 and 25 show an electromechanical injector system having an electromechanical linear actuator 1471, a motor 1473, and a battery 1465 for powering the motor and the linear actuator. Any linear actuator can be utilized, such as (for example) a threaded screw, a worm gear, a rack and pinion, or a solenoid coil. The electromechanical injector shown here can have all the same components and features and have the same mechanical function as the spring powered injector system of FIGS. 14-20, with the following modifications. Instead of a compressed spring, the electromechanical injector system utilizes a linear actuator 1471 (for example, a rack and pinion, as shown), which can be driven by a motor 1473. The linear actuator 1471 includes a head 1475 that interfaces with a driver. Notably, the driver is slightly modified to be compatible with the head 1475 instead of a compressed spring. The button 1413 does not hold the spring in compression, but instead starts the motor to pivot the pinion, moving the head 1475 and the driver in a proximal direction. Movement of the driver in the proximal direction can proceed to drive the injection mechanism as shown in Figures 18A-20 and described in the accompanying text. The linear actuator 1471 can also effect the resetting of the injector system (i.e., pulling the driver in a distal direction) instead of manually resetting the injector system.

[0111] 26-29 depict exemplary needle assemblies and mechanisms for ensuring that the needle remains covered before and after fluid injection. The needle assemblies depicted here can be utilized with any syringe, with or without an injector system. In some implementations, the needle assemblies depicted here are utilized with the injector system shown in FIGS. 14-20.

[0112] FIG. 26 provides the needle assembly 2601 in an initial state. The needle assembly 2601 comprises a needle 2603, a needle cover 2605, an outer cylinder 2607, an actuator ring 2609, and a spring 2611. It is noted that the outer cylinder is depicted as transparent to aid in understanding the mechanism of the needle assembly. In the initial state, the spring 2611 is decompressed and connects with the needle cover 2605 such that pushing the cover inwardly compresses the spring 2611. In the decompressed state, the spring 2611 ensures that the needle cover 2605 extends beyond the tip of the needle 2603 such that the tip is not exposed and prevents any harm to the user. The actuator ring 2609 is initially provided in a closed state, with the ring in a proximal position relative to the outer cylinder 2607.

[0113] The inner surface of the outer cylinder 2607 has a topography that includes a slotted track 2613 that cooperatively interacts with a protruding slider 2615 that extends from the outer surface of the cover 2605. In combination with the spring 2611, the slotted track 2613 and the protruding slider 2615 cooperate with an actuator arm 2617 that extends inwardly from the actuator ring 2609 to ensure that the needle 2603 remains within the cover 2605 prior to an injection.

[0114] 27 shows the needle assembly 2601 being pushed against the skin surface 2619. The needle cover 2605 is pushed inward but maintains the covering of the needle 2603 while the actuator ring 2609 remains closed. The actuator arm 2617 extends into the slotted track 2613 and prevents the protruding slider 2615 from sliding further inward, providing a positive stop for further inward movement of the needle cover 2605 so that the needle tip remains unexposed.

[0115] 28 shows the actuator ring 2609 being released by pulling the ring distally away from the outer cylinder 2607, resulting in removal of the actuator arms 2617 from the slotted track 2613. With the actuator arms 2617 removed, the protruding slider 2615 can move inward along the slotted track 2613, allowing the needle cover 2605 to move further inward, exposing the tip of the needle 2603. The needle 2603 can be inserted into the skin surface 2619 so that fluid can be injected intradermally or subcutaneously via a syringe operatively connected to the needle assembly 2601.

[0116] The slotted track 2613 may include an angled wall 2621 that causes the protruding slider 2615 to move along the inner circumference of the outer cylinder 2607 as the slider is pushed inward, resulting in the needle cover 2605 rotating about a central axis. The rotation of the protruding slider 2615 allows it to enter into the slotted track 2623 that is opened by the outward movement of the actuator arm 2617. The protruding slider 2615 can move inward within the slotted track 2623 and reach a positive stop when it contacts the actuator arm 2617. Once the protruding slider 2615 reaches the actuator arm 2617, the needle cover 2605 cannot move further inward, providing limited exposure of the needle 2603. Thus, the position of the actuator arm 2617 when the actuator ring 2609 is released provides a limited depth to which the needle can be inserted into the skin surface 2619, controlling the depth point of the fluid injection.

[0117] 29 illustrates the removal of the needle assembly 2601 from the skin surface 2619. In particular, as the needle cover 2605 is pushed inward, the spring 2611 is compressed. And therefore, removal of the needle assembly 2601 from the skin surface 2619 results in the spring 2611 pushing the needle cover 2605 outward and extending beyond the tip of the needle 2603. As the needle cover 2605 is pushed outward, the protruding slider 2615 slides outward through the slotted track 2623 until it contacts the angled wall 2625. The force provided by the compression of the spring 2611 in conjunction with the angled wall 2625 causes the protruding slider 2615 to rotate along the inner circumference of the outer cylinder 2607 as the slider is pushed outward, resulting in the needle cover 2605 rotating about its central axis. Rotation of the protruding slider 2615 allows it to contact the hard corner 2627, resulting in the slider becoming seated between the hard corner and the angled wall 2625. To lock the protruding slider 2615 within the hard corner 2627, the actuator ring 2609 can be re-closed, causing the actuator arm 2617 to refill the slotted track 2623, preventing the slider from rotating back along the inner circumference of the outer cylinder 2607. Re-closure of the actuator ring 2609 can optionally be secured via a latch or other securing mechanism such that the actuator ring cannot be reopened and prevents re-exposure of the needle 2603.

[0118] Provided in Figures 30A and 30B is an exemplary needle cap for controlling the depth of needle penetration within the site of injection. The needle cap 3001 contains a proximal orifice 3003 and a distal orifice 3005. The needle cap 3001 can fit over the needle 3007 with the distal orifice 3005 seated and fitted over the needle base 3009. Thus, the distal orifice 3005 can have a circumference that fits closely around the needle base 3009 such that it can securely hug the base. The needle 3007 can extend through the proximal orifice 3003 such that the tip of the needle is a specific distance from the orifice and the proximal face 3011. This specific distance can be used to define a specific depth for the fluid injection. Thus, various implementations of needle caps have a length 3013 from the needle cap base 3015 to the proximal face 3011 that corresponds to the needle length and injection depth such that the portion of the needle exposed beyond the proximal face 3017 is the injection depth.

[0119] Various methods can be implemented to inject fluids to a specific depth utilizing a needle and needle cap. One exemplary method can be as follows. providing a fluid-filled syringe in operative connection with a needle; placing a needle cap over the needle such that the cap base fits over the needle base and the needle tip extends beyond the proximal orifice a specific distance, the specific distance defining an injection depth; inserting the needle into the injection site such that the proximal surface of the cap contacts the surface of the injection site and brings the needle tip to an injection depth within the injection site; Injecting fluid from the fluid-filled syringe at an injection depth through the fluid-filled syringe and needle. Fluid Delivery Applications

[0120] Various embodiments of the intradermal or subcutaneous fluid delivery system can be utilized in a number of applications requiring liquid delivery into the skin. In some embodiments, the fluid delivery system is used for delivery of a drug or adjunct into the skin. In some embodiments, triamcinolone (Kenalog) is utilized in the fluid delivery system. In some embodiments, hyaluronic acid is utilized in the fluid delivery system. In some embodiments, collagen or collagen stimulators are utilized in the fluid delivery system.

[0121] Triamcinolone is a glucocorticoid used to treat a variety of skin disorders, including (but not limited to) acne, eczema, dermatitis, allergies, and rashes. Triamcinolone can reduce swelling, itching, and redness.

[0122] Treatment of acne lesions can reduce swelling and redness within 12 hours with a single dose in a volume of 0.01 mL to 0.20 mL and a concentration of 1 mg / mL to 10 mg / mL. Thus, a solution containing triamcinolone can be contained within the fluid-containing portion of a cartridge or syringe as described herein. A triamcinolone-containing cartridge or syringe can be utilized within an injector system. A needle or microneedle can penetrate the skin as much as necessary for intralesional delivery (e.g., intradermal or subcutaneous delivery at the site of the lesion). The injector system can inject triamcinolone into the lesion as a treatment. Treatment can be performed multiple times on a single lesion or on multiple lesions as needed. In many cases, a single dose will result in substantial clearing of the acne lesion. Similar procedures can be performed for other skin diseases.

[0123] Hyaluronic acid is a glycogen that is naturally produced in the skin.Injecting hyaluronic acid into the skin can increase the amount of hyaluronic acid in the skin locally.The benefits of hyaluronic acid include (but are not limited to) reducing the appearance of aging of the skin, reducing wrinkles, reducing inflammation in the skin, and aiding in wound healing.

[0124] Collagen is a protein that is naturally produced in the skin. Collagen injections (or collagen stimulating agent injections) into the skin can increase the amount of collagen in the local skin. Benefits of collagen (or collagen stimulating agents) include (but are not limited to) reducing the appearance of scars (especially acne scars), smoothing wrinkles, and filling in skin depressions. Collagen stimulating agents include (but are not limited to) microneedling, vitamin C, proline, glycine, copper, aloe vera, ginseng, and algae.

[0125] Various drugs and adjuvants can be combined in the same cartridge for use in intradermal or subcutaneous fluid delivery systems. For example, one exemplary combination is triamcinolone with collagen (or a collagen stimulator).

Claims

Claim 1 A system for intradermal or subcutaneous fluid delivery into an injection site, comprising a housing compartment, the housing compartment comprising a flange retainer system, a plunger retainer system, and an actuator of an injection mechanism for discharging a controlled dose of fluid, the flange retainer system comprising a movable flange retainer and a flange retainer detent, the plunger retainer system comprising a movable plunger retainer and a plunger retainer detent, the flange retainer and the plunger retainer each being movable proximally along a central axis of the housing compartment, the housing compartment; a fluid-filled syringe, the fluid-filled syringe comprising a flange and a plunger, the flange being seated within the flange retainer and the plunger being seated within the plunger retainer, the fluid-filled syringe; a needle assembly attached to the fluid-filled syringe, the needle assembly comprising a needle operably connected to the fluid-filled syringe, the needle assembly comprising actuation of the injection mechanism via the actuator results in movement of the flange retainer and the plunger retainer in the proximal direction, causing the fluid-filled syringe and the needle assembly, including the flange and the plunger, to move in the proximal direction until the flange retainer contacts the flange retainer detent and arrests proximal movement of the flange and the needle assembly; when the flange retainer contacts the flange retainer detent, the plunger retainer continues to move in the proximal direction, causing the plunger to continue to move in the proximal direction until the plunger retainer contacts the plunger retainer detent and arrests proximal movement of the plunger; the continued proximal movement of the plunger after arrest of proximal movement of the flange and the needle assembly results in discharge of the controlled dose of fluid from the fluid-filled syringe through the needle of the needle assembly. A system Claim 2 The flange holder comprises a groove, the plunger retainer comprises a slider that cooperates within the groove, and when the flange holder contacts the flange holder positive stop, the plunger retainer continues to move in the proximal direction via the slider within the groove, the system of claim 1.

3. The latch connects the flange holder and the plunger retainer, and when the flange holder contacts the flange holder positive stop, the latch is released, enabling the plunger retainer to continue to move in the proximal direction independently of the movement of the flange holder, the system of claim 1.

4. Further comprising a force for providing proximal movement, the plunger retainer is connected to the force for providing proximal movement such that the plunger retainer moves in the proximal direction via the actuation of the injection mechanism, and the flange holder moves in the proximal direction via the latch connecting the flange holder and the plunger retainer, the system of claim 3.

5. The force for providing proximal movement is a compressed spring, the system of claim 4.

6. The force for providing proximal movement is an electromechanical linear actuator, the system of claim 4.

7. The administered amount of the controlled dose of fluid is determined in part by the continued proximal movement of the plunger after the proximal movement of the flange and the needle assembly has stopped, the system of claim 1.

8. The movement of the flange holder in the proximal direction is configured to result in the needle being inserted into the injection site when the proximal surface of the housing compartment contacts the injection site, the system of claim 1.

9. The flange holder contains a recess that is contoured to the shape of the flange, the system of claim 1.

10. The plunger retainer contains at least one recess that is contoured to the shape of a plunger grip at the distal end of the plunger, the system of any one of claims 1 to 9.

11. The plunger retainer contains a plurality of recesses that allow for flexibility at the location of the plunger grip, the system of claim 10. **Claim 12**: The actuator of the injection mechanism comprises a button, and one or more inwardly projecting struts are connected to the button and the flange retainer. When the button is pressed, the one or more inwardly projecting struts prevent proximal movement of the flange retainer, and compression of the button results in disconnection between the one or more inwardly projecting struts and the flange retainer, enabling proximal movement of the flange retainer. The system according to claim 1. **Claim 13** Compression of the button results in a linear force provided by an electromechanical linear actuator, providing proximal movement of the plunger retainer. The system according to claim 1. **Claim 14** The needle has a length such that when the needle tip is inserted into an individual's skin, it extends beyond the proximal face by a length equal to the intradermal insertion depth. The system according to claim 1. **Claim 15** The needle assembly further comprises a needle cap, and the needle has a length such that when the needle tip is inserted into an individual's skin, it extends beyond the needle cap by a length equal to the intradermal insertion depth. The system according to claim 1. **Claim 16** The needle assembly further comprises a needle cover surrounding the needle and a spring connected to the needle cover. When the spring is decompressed, the needle cover prevents exposure of the tip of the needle, and when the spring is compressed, the tip of the needle is exposed. The system according to claim 1. **Claim 17** A housing compartment for receiving a fluid-filled syringe and a needle assembly to form a system for intradermal or subcutaneous fluid delivery into a site of injection. The housing compartment comprises a flange retainer system, a plunger retainer system, and an actuator of an injection mechanism for discharging a controlled dose of fluid. The flange retainer system comprises a movable flange retainer and a flange retainer detent. The plunger retainer system comprises a movable plunger retainer and a plunger retainer detent. The flange retainer and the plunger retainer are each movable in a proximal direction along the central axis of the housing compartment. The operation of the injection mechanism via the actuator results in the flange holder and the plunger retainer moving in the proximal direction until the flange holder contacts the flange holder positive stop and the proximal movement of the flange holder is stopped. When the flange holder contacts the flange holder positive stop, the plunger retainer continues to move in the proximal direction until the plunger retainer contacts the plunger retainer positive stop and the proximal movement of the plunger retainer is stopped, within the housing compartment.

18. The flange holder comprises a groove, the plunger retainer comprises a slider that cooperates within the groove, and when the flange holder contacts the flange holder positive stop, the plunger retainer continues to move in the proximal direction via the slider within the groove, for the housing compartment according to claim 17.

19. A latch connects the flange holder and the plunger retainer, and when the flange holder contacts the flange holder positive stop, the latch is released to enable the plunger retainer to continue to move in the proximal direction independently of the movement of the flange holder, for the housing compartment according to claim 17 or 18.

20. Further comprising a force for providing proximal movement, the plunger retainer is connected to the force for providing proximal movement such that the plunger retainer moves in the proximal direction via the operation of the injection mechanism, and the flange holder moves in the proximal direction via the latch that connects the flange holder and the plunger retainer, for the housing compartment according to claim 19.

21. The force for providing proximal movement is a compressed spring, for the housing compartment according to claim 20.

22. The force for providing proximal movement is an electromechanical linear actuator, for the housing compartment according to claim 20.

23. The syringe flange holder contains a recess that is contoured to the shape of the flange of the syringe, for the housing compartment according to claim 17.

24. The plunger retainer holder is the housing compartment according to claim 17, containing at least one recess contoured to the shape of the plunger grip at the distal end of the syringe plunger.

25. The plunger retainer holder is the housing compartment according to claim 24, containing a plurality of recesses enabling flexibility at the location of the plunger grip.

26. The actuator of the injection mechanism comprises a button, one or more inwardly projecting struts are connected to the button and the flange holder, and when the button is depressed, the one or more inwardly projecting struts prevent proximal movement of the flange holder, compression of the button results in disconnection between the one or more inwardly projecting struts and the flange holder, enabling proximal movement of the flange holder, the housing compartment according to claim 17.

27. The actuator of the injection mechanism comprises a button, compression of the button results in a linear force provided by an electromechanical linear actuator, providing proximal movement of the plunger retainer, the housing compartment according to claim 17.

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