Patent Application
20240293652
The application is generally directed to systems, devices, and methods for intradermal or subdermal fluid delivery, and more specifically to systems, devices, and methods that utilize controlled injection amount and depth for delivery of medicinal or supplemental fluid into or just below the dermis.
Hollowed microneedles are small applicators to deliver fluids, especially vaccines or medications. Microneedles are typically used in transdermal, intraocular, or intracochlear fluidic delivery. Because of their small size, microneedles typically do not cause injury to the site of injection and are generally considered less hazardous than other injection methods, such as a conventional hypodermic needle.
The disclosure generally provides systems, devices, and methods for intradermal or subdermal fluid delivery. In various implementations, the various systems, the various devices, or the various methods control the amount of fluid to be delivered. In various implementations, the various systems, the various devices, or the various methods control the depth of needle insertion at site of injection, especially within the intradermal layer. In various implementations, the various systems, the various devices, or the various methods conceal and/or cover the needle from a user, which can prevent harm to the user and/or prevent damage to the needle.
In an aspect, a system for intradermal or subdermal fluid delivery into a site injection comprises a housing compartment. The housing compartment comprises a flange holder system, a plunger retainer system, and an actuator of an injection mechanism that expels a controlled dose fluid.
In some implementations, the flange holder system comprises a movable flange holder and a flange holder hard stop.
In some implementations, the plunger retainer system comprises a moveable plunger retainer and a plunger retainer hard stop.
In some implementations, the flange holder and the plunger retainer are each movable in an proximal direction along a central axis of the housing compartment.
In some implementations, actuation 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 hard stop halting the proximal movement of the flange holder.
In some implementations, the flange holder contacts the flange holder hard stop, the plunger retainer continues to move in the proximal direction until the plunger retainer contacts the plunger retainer hard stop halting the proximal movement of the plunger retainer.
In some implementations, the system for intradermal or subdermal fluid delivery into a site injection further comprises a fluid-filled syringe comprising a flange and a plunger.
In some implementations, the flange is situated within the flange holder and plunger is situated in the plunger retainer of the housing compartment.
In some implementations, the system for intradermal or subdermal fluid delivery into a site injection further comprises a needle assembly attached to the fluid-filled syringe. The needle assembly comprises a needle that is in operable connection with the fluid-filled syringe.
In some implementations, actuation of the injection mechanism via the actuator results in the flange holder and the plunger retainer moving in the proximal direction resulting in moving the fluid-filled syringe inclusive of the flange and the plunger, and the needle assembly in the proximal direction until the flange holder contacts the flange holder hard stop halting the proximal movement of the flange and the needle assembly. When the flange holder contacts the flange holder hard stop, the plunger retainer continues to move in the proximal direction resulting in the plunger to continue to move in the proximal direction until the plunger retainer contacts the plunger retainer hard stop halting the proximal movement of the plunger. The continued proximal movement of the plunger after the halting of the proximal movement of the flange and the needle assembly results in the expulsion of the controlled dose of fluid from the fluid-filled syringe via the needle of the needle assembly.
In some implementations, the flange holder comprises a groove, and the plunger retainer comprises a slider that cooperates within the groove. When the flange holder contacts the flange holder hard stop, the plunger retainer continues to move in the proximal direction via the slider within the groove.
In some implementations, a latch connects the flange holder and the plunger retainer. When the flange holder contacts the flange holder hard stop, the latch is released allowing the plunger retainer to continue to move in the proximal direction independent of the flange holder movement.
In some implementations, the system for intradermal or subdermal fluid delivery into a site injection further comprises a force for providing proximal movement. The plunger retainer is in connection with the force for providing proximal movement such that the plunger retainer moves in the proximal direction via the actuation of the injection mechanism. The flange holder moves in the proximal direction via the latch connecting the flange holder and the plunger retainer.
In some implementations, the force for providing proximal movement is a compressed spring.
In some implementations, the force for providing proximal movement is an electromechanical linear actuator.
In some implementations, the dose amount of the controlled dose of fluid is determined in part by the continued proximal movement of the plunger after the halting of the proximal movement of the flange and the needle assembly.
In some implementations, the movement of the flange holder in the proximal direction is configured to result in the needle inserting into a site of injection when a proximal face of the housing compartment is in contact with the site of injection.
In some implementations, the syringe flange holder contains an indentation that is contoured to the shape of the flange.
In some implementations, the plunger retainer holder contains at least one indentation that is contoured to the shape of a plunger grip at the distal end of the plunger.
In some implementations, the plunger retainer holder contains a plurality of indentations that allow for flexibility of the plunger grip location.
In some implementations, the actuator of the injection mechanism comprises a button.
In some implementations, one or more inward protruding struts is in connection with button and the flange holder. When the button is depressed, the one or more inward protruding struts prevents proximal movement of the flange holder. Compression of the button results in a disconnection between the one or more inward protruding struts and the flange holder, allowing proximal movement of the flange holder.
In some implementations, compression of the button results in linear force provided by an electromechanical linear actuator to provide proximal movement of the plunger retainer.
In some implementations, the needle has a length that such that the needle tip extends beyond the proximal face a length equal to an intradermal insertion depth when inserted into skin of an individual.
In some implementations, the needle assembly further comprises a needle cap. The needle has a length such that the needle tip extends beyond the needle cap a length equal to an intradermal insertion depth when inserted into skin of an individual.
In some implementations, the needle assembly further comprises a needle cover that surrounds the needle and a spring in connection with the needle cover. When the spring is decompressed, the needle cover prevents exposure of a tip of the needle. When the spring is compressed, the tip of the needle is exposed.
In some implementations, the needle assembly further comprises an outer cylinder encircling the needle cover. An inner face of the outer cylinder comprises one or more slotted tracks. The needle cover comprises a protruding slider that extends from an outer face of the needle cover and 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.
In some implementations, the limited exposure of the needle allows for positioning of the needle tip beyond the needle cover.
In some implementations, the positioning of the needle tip beyond the needle cover results in an intradermal insertion depth when inserted into skin of an individual.
In some implementations, the needle assembly further comprises an actuator with an arm that is capable of inserting within the one or more slotted tracks. The needle assembly actuator with the arm is capable of preventing exposure of the needle by preventing compression of the spring by preventing the protruding slider from moving within the one or more slotted tracks.
In some implementations, opening of the needle assembly actuator with the arm allows exposure of the needle. The opening of the needle assembly actuator opens up at least one slotted track of the one or more slotted tracks to allow movement of the protruding slider and compression of the spring.
In some implementations, the one or more slotted tracks contains a first angled wall such that an initial compression of the spring results in the protruding slider to move along the inner circumference of the outer cylinder via the first angled wall, resulting in the needle cover to rotate along a central axis. Decompression of the spring after the initial compression results the protruding slider to move further along the inner circumference of the outer cylinder via a second angled wall resulting in the protruding slider to move into a hard corner that prevents further compression of the spring.
In some implementations, the positioning of the needle tip beyond the needle cover is approximately between 0.5 mm to 2.0 mm.
In some implementations, a fluid-filled syringe is in operable connection with the needle. The operable connection is a Luer lock.
In some implementations, the fluid within the fluid-filled syringe is a medication or a supplement for the skin.
In some implementations, the fluid within the fluid-filled syringe is triamcinolone, hyaluronic acid, collagen, or a collagen stimulating agent.
In some implementations, a method is for injecting a particular dose of fluid at a particular depth. The method comprises providing an injector system comprising a housing compartment comprising a flange holder system, a plunger retainer system, a fluid-filled syringe comprising a flange and a plunger, a needle assembly attached to the fluid-filled syringe, and an actuator of an injection mechanism that expels a controlled dose fluid. The method further comprises placing the needle assembly proximal to a site of injection. The method further comprises actuating the actuator resulting in the needle of the needle assembly inserting into the site of injection at a particular depth and the expulsion of a controlled dose of fluid from the fluid-filled syringe via the needle of the needle assembly.
In some implementations, a needle cap is for controlling the depth of insertion of a needle. The needle cap comprises a cylindrical tube having a proximal orifice on a proximal face and distal orifice opposite of the proximal orifice. The distal orifice is capable of fitting onto a base of a needle such that a tip of the needle inserts through the proximal orifice and is a particular distance from the proximal face.
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.
Turning now to the drawings, systems, devices and methods for precise intradermal fluidic delivery utilizing needles or microneedles are described, in accordance with various embodiments of the disclosure. In certain embodiments, an intradermal or a subdermal fluidic system utilizes an injector device and a replaceable injection system. The injection system can comprise a cartridge with microneedle or a syringe with needle that can store a fluid (e.g., medication or supplement). In certain embodiments, a replaceable injection system is compatibly coupled with an injector device such that the mechanics of the injector is capable of ejecting the fluid out of the injection system through a microneedle or needle. In certain embodiments, a microneedle or needle is integrated with the cartridge or syringe as a single component. In certain embodiments, a microneedle or a needle and a cartridge or syringe are each an individual component capable of interlocking together (e.g., Luer lock connector).
In certain embodiments, an intradermal or subdermal delivery system is utilized for delivery of a medication and/or supplement, such as triamcinolone (Kenalog), hyaluronic acid, or collagen (or a collagen stimulating agent), which can be used in a variety of treatment applications for skin. For instance, in certain embodiments, an intradermal or subdermal delivery system delivers triamcinolone into an acne lesion as an acne treatment. In certain embodiments, an intradermal or subdermal delivery system delivers hyaluronic acid into the skin. And in certain embodiments, an intradermal or subdermal delivery system delivers collagen and/or a collagen producing agent into the skin, which can improve skin elasticity and appearance.
The described systems, devices, and methods should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The disclosed systems, devices, and methods are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, devices, and methods require that any one or more specific advantages be present or problems be solved.
Various embodiments of intradermal or subdermal fluidic delivery systems and examples of fluidic delivery devices and cartridges are disclosed herein, and any combination of these options can be made unless specifically excluded. For example, any of the fluidic delivery devices disclosed, can be used with any type of compatible replaceable injection system, even if a specific combination is not explicitly described. Likewise, the different constructions and features of fluidic delivery systems 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 mutually exclusive or physically impossible.
Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached 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.
The terms “proximal” and “distal” as used throughout the description relate to a site of injection. Accordingly, a proximal face or proximal portion of a device is the face or the portion that would be more proximal to a site of injection when an injection is performed. Conversely, a distal face or distal portion of a device is the face or the portion that would be more distal to a site of injection when an injection is performed. Likewise, a proximal movement would be movement of a component in a direction towards a site of injection and a distal movement would be movement of a component in an opposite direction. Although these terms are in relationship to a site of injection, it is to be understood that these terms are used for reference and the site of injection does not need to be present when interpreting the components or movements of the devices and systems described herein.
Various embodiments are directed towards systems and devices for intradermal and/or subdermal injection. In certain embodiments, an intradermal and/or subdermal injection system includes an injector device, a cartridge or syringe, and a microneedle or needle. Generally, and in accordance with various embodiments described herein, an injector system is compatible with a fluid-filled replaceable injection system such that the injector is configured to receive and operatively link with the replaceable injection system. In certain embodiments, when an injector and replaceable injection system are operatively linked, the injector provides mechanics to eject liquid from the replaceable injection system through the needle. In certain embodiments, a microneedle or needle is integrated with the cartridge or syringe as a single component. In certain embodiments, a microneedle or a needle and a cartridge or syringe are each an individual component capable of interlocking together (e.g., Luer lock connector).
In certain embodiments, an injector device is configured to provide mechanics for fluidic ejection out of a replaceable injection system. An injector can operate via mechanical or electromechanical means. In certain embodiments, an injector includes one or more actuators (e.g., buttons or triggers) to initiate and/or drive the mechanical and/or electrical components of the device. In certain embodiments, an actuator is mechanically or electrically operatively linked with an internal driver system that is operatively linked with a replaceable injection system to eject liquid out and through a needle. In certain embodiments, an internal driver system cooperatively interacts with a compression spring, which can help control the flow of fluidic ejection out of the cartridge and/or return the driver to an initial position. In certain embodiments, an actuator is operatively linked with an internal driver mechanism that is capable of driving the needle to pierce and situate within the skin for injection. In certain embodiments, an internal driver mechanism is a linear actuator utilizes one or more of: rotatable threaded rod, a worm gear, a rack and pinion, or a solenoid coil. In certain embodiments, a differential screw mechanism is utilized for fine micron (or less) movements.
In certain embodiments, an electromechanical injector device includes a power source or battery, such as (for example) a lithium ion battery, however any appropriate power source or batter can be utilized. In certain embodiments, an injector device includes a computation system and/or software to provide instructions on performing various tasks of the injector device. Various tasks to be performed include (but are not limited to) penetration of skin with a needle, ejection of components out of a replaceable injection system, retrieval of the needle out the skin, provide laser/light, calculation of dosage, calculation of volume to administer, calculation of needle depth for administration, camera image data (live or captured), storage of data, and connection with internet systems or other systems (e.g., Bluetooth, cloud systems, Wi-Fi enabled, cellular data enabled). Data that can be stored within a memory of the treatment device include (but are not limited to) procedure logs, cartridge logs (e.g., type, volume), location logs, dosage logs, and needle depth logs.
In certain embodiments, the needle remains unexposed to the user during the injection process. In certain embodiments, an injection device includes one or more sensors, which can be utilized to sense needle penetration, requisite needle depth, fluid ejection, local pressure, or any other appropriate sensation to be detected. In certain embodiments, an injection device in conjunction with a needle includes a sensor for measuring electrical impedance, which may be used to detect skin contact, needle penetration, and/or needle depth. In certain embodiments, a spacer on the needle system is provided to ensure proper needle penetration and depth.
In certain embodiments, an injector device includes housing for receiving a fluid-filled replaceable injection system (e.g., cartridge system or syringe system). In certain embodiments, a housing includes a reversible coupling and/or locking mechanism to facilitate the reception of the replaceable injection system. In certain embodiments, a replaceable injection system includes compatible components for coupling and/or locking with the injector. Any appropriate reversible coupling and/or locking mechanism can be utilized, such as (for example) a hook and with receiving groove, a flange, a threaded screw, a twist lock, a ball and lock pin, or any capable combination of coupling and/or locking mechanisms. In certain embodiments, a coupling and/or locking mechanism is reversible such that the replaceable injection system can be displaced from the replaceable injection system, in which displacement can occur prior to and/or after ejection of fluid.
In certain embodiments, an injector device includes a stabilizing feature (e.g., foot or base), which can be utilized to locate and/or stabilize the injector and needle system at a desired location on the skin. In certain embodiments, a stabilizing feature is extended from and connected to an injector system via a connector, which can be any appropriate connector such as a rod and/or strut. In certain embodiments, a stabilizing feature is the proximal face of an injector system housing. In certain embodiments, a stabilizing feature and a needle are cooperatively positioned such that the ejection tip of the needle is capable of extending beyond the stabilizing feature a requisite distance for intradermal or subdermal delivery. Human skin has a depth of approximately 0.5 mm to 5.0 mm, depending on the location. For instance, facial skin is approximately between 1.5 mm and 2 mm, and further varies on facial location (e.g., average thickness of forehead skin is approximately 1.7 mm and average thickness of cheek skin is approximately 1.85 mm). Accordingly, depending on location and use (e.g., intradermal or subdermal injection), in accordance with various embodiments, a needle tip is positioned between 0.5 mm to 5.0 mm beyond the stabilizing feature at time of injection. For uses on facial skin, in accordance with various embodiments, a needle or microneedle tip is positioned approximately between 0.5 mm to 2.0 mm beyond a stabilizing feature at time of injection. In various embodiments, a 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 at time of injection.
In certain embodiments, a housing of the injector system partially or entirely conceals the replaceable injection system. In certain embodiments, a housing further conceals a needle. In certain embodiments, a housing can include an orifice (e.g., pinhole) for the needle to be exposed during skin penetration. In certain embodiments, the proximal face of the housing surrounding the orifice can provide stabilizing and/or positioning effect at a desired location on the skin. In certain embodiments, the orifice and a needle are cooperatively positioned such that the ejection tip of the needle is capable of extending beyond the orifice a requisite distance for intradermal or subdermal delivery.
In certain embodiments, an injector system includes one or more cameras, which may be used to help visualize the treatment and/or record treatment sites images or data. Any appropriate camera can be utilized, including (but not limited to) visible light and infrared cameras. In certain embodiments, a camera is positioned proximal to a replaceable injection system such that it is capable of visualizing the treatment site and/or procedure. In certain embodiments, a light is utilized to enhance camera and/or user visualization. In certain embodiments, a laser is utilized to help guide a user to the proper injection site. In certain embodiments, a laser works in conjunction with a camera to provide precise treatment.
In certain embodiments, an injector system includes a means for providing feedback to ensure proper treatment. In certain embodiments, an injector system includes a means for providing feedback for when the replaceable injection system is securely within the device. In certain embodiments an injector system includes a means for providing feedback for when the replaceable injection system is not securely within the device. In certain embodiments, an injector system includes a means for providing feedback for when the injector system is ready for use. In certain embodiments, an injector system includes a means for providing feedback for when the injector system is actively providing treatment. In certain embodiments, an injector system includes a means for providing feedback for when the injector system has finished providing treatment. Any appropriate means for providing feedback can be utilized, including (but not limited to) a white light, a colored light, covering or uncovering of mechanical features on the device with and without use of color, and an audible sound.
Several embodiments are directed towards interchangeable fluid-filled injection systems to be utilized in conjunction with an injector device. Replaceable injection systems include (but are not limited to) syringe systems and cartridge systems. In certain embodiments, a cartridge is a sealed container with fluid therein, which can be hermetically sealed. Any appropriate volume of fluid can be utilized. In various embodiments, a fluid-filled injection system contains approximately 0.01 cc to 1 cc. In various embodiments, a fluid-filled injection system contains approximately 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.
In certain embodiments, a replaceable injection system is for limited-use, such as single-use injection systems or multi-use injection systems. In various embodiments, a replaceable injection system contains fluid for one to ten injections. In certain embodiments, a replaceable injection system is disposable after liquid ejection. In certain embodiments, a replaceable injection system contains a plunger to facilitate ejection of liquid out of the cartridge and through a needle or microneedle.
In certain embodiments, a plunger of a replaceable injection system is capable of operatively linking with an internal driver of an injector device. In certain embodiments, an internal piston of an injector is capable of contacting a face of a replaceable injection system (e.g., a face opposite of a needle) such that the piston can operatively push a plunger of the injection system, resulting in ejection of liquid out of the injection system. In certain embodiments, a replaceable injection system is capable of operatively linking with an internal drive mechanism of an injector device such that the internal drive mechanism can move an injection system in an axial direction away and/or toward from a center portion of the injector. In certain embodiments, movement of a replaceable injection system via an internal drive mechanism of an injector simultaneously moves the ejection tip of a needle or microneedle and/or toward from a center portion of the injector, such that the internal drive mechanism operatively drives the needle or microneedle to pierce and insert into skin. In certain embodiments, an internal drive mechanism of an injector moves the ejection tip of a needle or microneedle to the requisite position beyond a stabilizing feature.
In certain embodiments, a needle or a microneedle is operatively linked with replaceable injection system such that fluid within the injection system can be expelled via the needle or microneedle. In certain embodiments, a needle or microneedle extends from a proximal face of the injection system (e.g., a face proximal to a site of injection when in use). In certain embodiments, a needle or microneedle is integrated with the replaceable injection system such that the needle or microneedle and injection system are a single component. In certain embodiments, a needle or microneedle and replaceable injection system are each an individual component capable of fitting together to ensure fluidic flow out of the injection system and through the needle or microneedle. Any appropriate means for fitting a needle or microneedle with a replaceable injection system can be utilized, such as (for example) a Luer lock system or a gasket.
In various embodiments, one or more needles or microneedles is operatively linked with a fluid-filled injection system such that fluid can be ejected out of the injection system via the one or more needles or microneedles. In certain embodiments, a single needle or microneedle is operatively linked with a fluid-filled cartridge. In certain embodiments, a plurality of needles or microneedles is operatively linked with a fluid-filled injection system, which can be arranged in an array, a regular pattern (e.g. circle), an irregular pattern, or any other configuration.
In some embodiments, a needle or microneedle has ability to provide a cooling effect, a heating effect, or a microvibration effect. Accordingly, a means to provide cooling, heating, or microvibration is operatively linked with the needle to provide the function. Any appropriate means for providing needles or microneedles with cooling, heating, or microvibration capability can be utilized.
In certain embodiments, one or more needles or microneedles are veiled or concealed, which may be desirable to prevent harm to a user from the needle or microneedle or for preventing damage to the needle or microneedle. Any appropriate means of veiling or concealing one or more needle or microneedles can be utilized. In certain embodiments, a covering is situated surrounding a microneedle. In certain embodiments, a covering is rigid and/or firm material. In embodiments utilizing a rigid and/or firm covering, the covering can unveil or reveal the microneedle through an orifice or pinhole, which can happen as it is advanced or prior to advancement into the injection site. In certain embodiments, a covering is collapsible and/or puncturable material such that a needle or microneedle is unveiled or revealed by the covering collapsing and/or the needle or microneedle puncturing through the covering. Puncturable material include (but are not limited to) rubber, neoprene, PTFE, ePTFE and metallic foil. In certain embodiments, after ejection of fluid out of the cartridge via a needle or microneedle, the needle or microneedle is re-veiled or re-concealed. In certain embodiments, a rigid or firm covering ejects outwards from the housing and covers the needle or microneedle after injection.
Turning now to
Provided in
Provided in
Microneedle component 603 includes a base 615 with a face 617 capable of coupling with face 609 of cartridge 601. The coupling can be any appropriate coupling that allows for adequate fluid from the cartridge and into the microneedle assembly, such as (for example) a Luer lock or gasket. Opposite of face 617 is a face 619 with a microneedle 621 that extends away from the microneedle assembly base 615. Although not shown, a microneedle assembly can include a plurality of microneedles, which can be formed into an array or any other appropriate pattern. As shown in
Provided in
Assembled injector system 711 can be used for intradermal or subdermal injection of liquid. A user can penetrate skin with microneedle ejection tip 715 at a desired location, moving microneedle 713 perpendicular to the surface of the skin and penetrating into the skin until foot 717 rests upon the outer surface of the skin, resulting in the microneedle tip having the requisite depth for proper intradermal or subdermal injection. With proper depth, injector system 711 can inject liquid into the skin. Covering 721 can be pierceable or include a pinhole such that microneedle 713 can be exposed to penetrate the user's skin. As shown in
Injector system 711 utilizes a spring 719 that is operative with internal piston 708 to facilitate liquid ejection. A button 725 is utilized to move piston 708 in an axial direction towards cartridge 701. As piston 708 moves in the axial direction, the piston interacts with center portion 707 of face 705, pushing the center portion in the axial direction and towards microneedle 713. Center portion 707 interactions with a plunger 727 to displace liquid within a liquid containing portion 729 of cartridge 701, resulting in liquid passing through microneedle 713 and out of ejection tip 715. After injection of liquid into the skin, microneedle 713 can be removed the skin. Multi-use cartridges can be utilized for multiple injections and the steps to inject liquid into another desired location can be repeated. After cartridge 701 is spent, it can be removed and disposed and injector device 703 can be reused with a subsequent cartridge.
Provided in
Assembled injector system 1011 can be used for intradermal or subdermal injection of liquid. Once a user positions injector system 1011, the system can assist the user to penetrate their skin with microneedle ejection tip 1015 at a desired location. The user can push a button 1025 to initiate internal driver 1014, thus moving microneedle 1013 perpendicular to the surface of the skin and penetrating into the skin until ejection tip 1015 requisite depth for proper intradermal or subdermal injection. As shown in
Injector system 1011 utilizes a spring 1019 that is operative with internal piston 1008 to facilitate liquid ejection. Button 1025 is utilized to move piston 1008 in an axial direction towards cartridge 1001. Alternatively, a second button can be utilized to facilitate movement of the piston in the axial direction. As piston 1008 moves in the axial direction, the piston interacts with center portion 1007 of face 1005, pushing the center portion in the axial direction and towards microneedle 1013. Center portion 1007 interactions with a plunger 1027 to displace liquid within a liquid containing portion 1029 of cartridge 1001, resulting in liquid passing through microneedle 1013 and out of ejection tip 1015. After injection of liquid into the skin, microneedle 1013 can be removed the skin. Multi-use cartridges can be utilized for multiple injections and the steps to inject liquid into another desired location can be repeated. After cartridge 1001 is spent, it can be removed and disposed and injector device 1003 can be reused with a subsequent cartridge.
Provided in
Assembled injector system 1311 can be used for intradermal or subdermal injection of liquid. Once a user positions injector system 1311, the system can assist the user to penetrate their skin with microneedle ejection tip 1315 at a desired location. The user can push a button 1325 to initiate rotatable threaded rod or release a spring 1316 that is operatively linked with internal driver 1314. Electromechanical devices can be powered by a battery or other power source. Initiation of internal driver 1314 moves microneedle 1313 perpendicular to the surface of the skin and penetrating into the skin until ejection tip 1315 requisite depth for proper intradermal or subdermal injection. Internal driver 1314 is a one or more rigid outer members, such as one or more struts or sheath encircling inner piston 1308. Rotatable threaded rod or releasable spring 1316 can push internal driver 1314 in an axial direction towards cartridge 1301, resulting in the outer portion 1310 of face 1309 pushing the cartridge in the axial direction. As cartridge 1301 moves axially, microneedle 1313 penetrates the user skin until ejection tip 1315 reaches proper depth. With proper depth, injector system 1311 can inject liquid into the skin.
Injector system 1311 utilizes a second rotatable rod or releasable spring 1319 that is operative with internal piston 1308 to facilitate liquid ejection. Button 1025 is utilized to initiate rotation of rod or release of spring 1319 to move piston 1308 in an axial direction towards cartridge 1301. As piston 1308 moves in the axial direction, the piston interacts with center portion 1307 of face 1305, pushing the center portion in the axial direction and towards microneedle 1313. Center portion 1307 interactions with a plunger 1327 to displace liquid within a liquid containing portion 1329 of cartridge 1301, resulting in liquid passing through microneedle 1313 and out of ejection tip 1315. After injection of liquid into the skin, microneedle 1313 can be removed the skin. Multi-use cartridges can be utilized for multiple injections and the steps to inject liquid into another desired location can be repeated. After cartridge 1301 is spent, it can be removed and disposed and injector device 1303 can be reused with a subsequent cartridge.
Provided in
Housing compartment 1401 contains a proximal portion 1407 that is associated with needle assembly 1405 and provides a proximal face 1409 for contacting with skin when performing injection and an orifice 1411 to allow for injection. Housing compartment 1401 further contains a button 1413 for actuating an injection mechanism. A lid 1415 is provided with a latch 1417 that can open to allow for situating fluid-filled syringe 1403 and needle assembly within housing 1401. A window 1419 is provided for viewing the fluid-filled syringe 1403 and volume of fluid therein.
Needle assembly 1405 can connect with fluid-filled syringe 1403 by any appropriate means, such as a Luer lock. A connected fluid-filled syringe 1403 and needle assembly 1405 can be received by the housing 1401, which can contain a contoured indentation 1421 that conforms to the connected fluid-filled syringe 1403 and needle assembly 1405. Within housing 1401 are a syringe flange holder 1423 and plunger retainer 1425. Flange holder 1423 contains an indentation 1427 that is contoured to the shape of the syringe flange 1429 such that the syringe flange and snugly fit within the indentation. Likewise, plunger retainer 1425 contains a plurality of indentations 1431 each of which are contoured to the shape of plunger grip 1433 at the distal end of plunger 1432 such that the plunger grip and fit within one of the indentations. The plurality indentations allow for flexibility of plunger grip location which may vary depending on the volume of fluid within the syringe and the dose of fluid to be expelled.
Flange holder 1423 and plunger retainer 1425 each are movable in either a proximal direction or a distal direction along a central axis. Flange holder 1423 contains a groove 1434 that cooperates with slider 1436 of plunger retainer 1425. Groove 1434 and slider 1436 allow for plunger retainer 1425 capability to slide in either direction along the groove, independent of movement of flange holder 1423. Syringe flange holder 1423 and plunger retainer 1425 connect with each other via a latch 1438, and the plunger retainer contains a driver 1435 in operable connection with a compressed spring 1437 to provide the driving force for the injection mechanism. Spring 1437 is held in place by a distal base 1440 at the distal end of the system. Button 1413 contains two inward protruding struts 1439 that hold driver 1435 in place and spring 1437 in a compressed state. When button 1413 is pressed inward, inward protruding struts 1439 move along with the button in an inward direction, releasing the compression of spring 1437 to provide a force for driver 1435 to drive flange holder 1423 and plunger retainer 1425 in direction toward proximal portion 1407 along the central axis.
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. Protective cover 1443 can prevent exposure of needle 1441 before and after injection, preventing the ability of the needle to prick or cause injury when not performing injection. Outer cylinder 1445 can provide a means to grip needle assembly 1405 and can further help facilitate ensuring protective cover 1443 adequately covers needle 1441. Actuator ring 1447 can unlock a mechanism for re-covering of protective cover 1443 over needle 1441 after injection. It should be understood that the needle assembly can be a standard needle without a protective cover, an outer cylinder, and an actuator ring. In some implementations, when used in housing compartment 1401 the length of the needle is such that when performing fluid injection, the tip of the needle extends beyond proximal face 1409 to control needle depth at the site of injection. In some implementations, the needle has a length such that controlled intradermal injection can be performed. In some implementations, a needle cap is used with the needle to control the depth of penetration into the site of injection (see
Button 1413 is in an initial outward state such that inward protruding struts 1439 maintain spring 1437 in a compressed state, which is in physical connection with flange holder 1423. Inward protruding struts 1439 each contain a protruding portion 1451 that is in contact with flange holder 1423, maintaining the flange holder and plunger retainer 1425 in place and spring 1437 in the compressed state.
The inner face of 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 face of cover 2605. In combination with spring 2611, slotted track 2613 and protruding slider 2615 works with an actuator arm 2617 that extends inwardly from actuator ring 2609 to ensure that needle 2603 remains within cover 2605 prior to injection.
Slotted track 2613 can include an angled wall 2621 that causes protruding slider 2615 to move along the inner circumference of outer cylinder 2607 as the slider is pushed inwardly, resulting in needle cover 2605 to rotate about a central axis. Rotation of protruding slider 2615 allows it to enter within a slotted track 2623 that is opened up by the outward movement of actuator arm 2617. Protruding slider 2615 can move inwardly within slotted track 2623, reaching a hard stop when it comes into contact with actuator arm 2617. When protruding slider 2615 reaches actuator arm 2617, needle cover 2605 cannot move further inward and provides a limited exposure of needle 2603. Accordingly, the position of actuator arm 2617 when actuator ring 2609 is opened provides a limited depth that the needle can insert within skin surface 2619, controlling the depth point of fluid injection.
Provided in
Various methods can be performed for injecting fluid at a particular depth utilizing a needle and needle cap. One exemplary method can be as follows:
The various embodiments of intradermal or subdermal fluid delivery systems can be utilized in a number of applications that require liquid delivery into the skin. In certain embodiments, a fluid delivery system is used for delivery of medication or supplement into the skin. In certain embodiments, triamcinolone (Kenalog) is utilized within a fluid delivery system. In certain embodiments, hyaluronic acid is utilized within a fluid delivery system. In certain embodiments, collagen or a collagen stimulating agent is utilized within a fluid delivery system.
Triamcinolone is a glucocorticoid use to treat various skin ailments, including (but not limited to) acne, eczema, dermatitis, allergies, and rash. Triamcinolone can reduce swelling, itching, and redness.
Treatment of an acne lesion can reduce the swelling and redness within 12 hours with single dose at a volume of 0.01 mLs to 0.20 mLs and at a concentration between 1 mg/mL and 10 mg/mL. Accordingly, a solution containing triamcinolone can be contained within fluid-containing portion of a cartridge or syringe, as described herein. The triamcinolone-containing cartridge or syringe can be utilized within an injector system. A needle or microneedle can penetrate the skin the requisite amount for intralesion delivery (e.g., intradermal or subdermal delivery at the site of the lesion). The injector system can inject the triamcinolone into the lesion as a treatment. The treatment can be performed multiple times on a single lesion or can be performed on multiple lesions, as needed. In many instances, a single dose will result in substantial clearance of an acne lesion. Similar procedures can be performed on other skin ailments.
Hyaluronic acid is a glycogen that is naturally produced in the skin. Hyaluronic acid injections into the skin can boos the amount of localized skin hyaluronic acid. Benefits of hyaluronic acid include (but are not limited to) mitigating the appearance of aging of skin, reducing wrinkles, reducing inflammation in the skin, and assisting in would healing.
Collagen is protein that is naturally produced in the skin. Collagen injections (or injection of collagen stimulating agents) into the skin can boost the amount of localized skin collagen. Benefits of collagen (or collagen stimulating agent) include (but are not limited to) reducing appearance of scars (especially acne scars), flattening out wrinkles, and filling-in skin depression. Collagen stimulating agents include (but are not limited to) microneedling, vitamin C, proline, glycine, copper, aloe vera, ginseng, and algae.
Various medications and supplements can be combined within the same cartridge for use in intradermal or subdermal fluid delivery system. For instance, one exemplary combination is triamcinolone with collagen (or a collagen stimulating agent).
This application claims priority to U.S. Provisional Application Ser. No. 63/223,915, entitled “Systems, Devices and Methods for Intradermal or Subdermal Fluid Delivery,” filed Jul. 20, 2021, and U.S. Provisional Application Ser. No. 63/235,085, entitled “Systems, Devices and Methods for Dermal Treatments,” filed Aug. 19, 2021, the disclosures of which are each incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/073953 | 7/20/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63235085 | Aug 2021 | US | |
| 63223915 | Jul 2021 | US |
