Systems, devices and methods for dermal treatment

Abstract

Systems, devices, and methods for dermal treatment are provided. Various systems, devices, and methods provide treatment options involving intradermal or subcutaneous fluid delivery via a handheld device, needle, or microneedle. For fluid delivery, the system can include a syringe, a fluid-filled container, and a needle or hollow microneedle. The fluid-filled container can be compatible coupled to a treatment device for performing various dermal treatments, etc. Furthermore, the fluid delivery system can be utilized in several 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 / 248,396, filed September 24, 2021, and entitled "Systems, Devices and Methods for Dermal Treatments," the disclosure of which is incorporated by reference herein in its entirety.

[0002] The present application is generally directed to systems, devices, and methods for dermal treatment, including systems, devices, and methods that utilize machine vision for dermal injection. [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] Detailed Description Turning now to the drawings, systems, devices, and methods for dermal treatment are described in accordance with various embodiments of the present disclosure. Some embodiments are directed to precise intradermal or subcutaneous fluid delivery utilizing needles or microneedles. In some embodiments, the treatment device is handheld. In various embodiments, the handheld device utilizes a syringe or cartridge that is filled with fluid for intradermal or subcutaneous use. In various embodiments, the handheld device utilizes a needle or hollow microneedle to perform the fluid injection.

[0005] In certain embodiments, the intradermal or subcutaneous fluid system utilizes a treatment device and a replaceable fluid-filled container (e.g., a syringe or cartridge). The fluid-filled container may store a fluid (e.g., a medication or an adjuvant). In certain embodiments, the fluid-filled container is compatiblely coupled to the treatment device such that a syringe mechanism is capable of ejecting fluid out of the fluid-filled container through the needle or microneedle. In certain embodiments, the needle or microneedle is integrated with the fluid-filled container as a single component. In some embodiments, the needle or microneedle and the fluid-filled container are each individual components (e.g., luer lock connectors) that are capable of interlocking together.

[0006] In some embodiments, intradermal or subcutaneous delivery systems are utilized to deliver drugs and / or supplements, such as triamcinolone (triamcinolone acetonide or 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 stimulators into the skin, which can improve skin elasticity and appearance, among other benefits.

[0007] In some embodiments, the injection system incorporates an imaging system that captures image data utilized to assist and / or automatically perform the injection. In many embodiments, the imaging system includes an image acquisition system that includes camera optics. In some embodiments, the camera optics is capable of resolving an image of the skin. In some embodiments, the camera utilizes macro lenses, telecentric optics, and / or periscope optics. In various embodiments, the imaging system utilizes one or more imaging modalities, including (but not limited to) capturing color images (e.g., traditional Bayer filter or Bayer filter with two red pixels per blue and green pixel), multispectral images, near infrared images, extended color images (color + near infrared), monochrome images (black and white or red), and / or polarized light images. In some embodiments, the imaging system includes an illumination source, such as (but not limited to) a near infrared illumination source and / or a polarized light source. In some embodiments, the imaging system incorporates two or more cameras to perform depth sensing and / or an illumination system to assist in depth estimation. As can be readily appreciated, the use of a particular imaging system, camera type, number of cameras, imaging modality, and / or illumination source will typically depend on the requirements of a particular application, according to various embodiments of the present disclosure.

[0008] In some embodiments, the imaging system is part of a machine vision system that utilizes image processing to detect and / or track acne lesions in images captured by the imaging system. In some embodiments, the machine vision system also performs classification of the acne lesions and / or modifies the manner in which treatment is applied to the lesions based on the classification of the lesions. In some embodiments, all processing is performed within the handheld treatment device. In some embodiments, the handheld treatment device captures images, performs initial processing (e.g., image acquisition and image / video encoding), and transmits processed image data via a wired and / or wireless connection to another device for image processing. In some embodiments, the device that performs image processing is a dedicated device associated with the treatment device. In some embodiments, the device that performs image processing is a mobile computing device (e.g., phone, tablet) that is configured by a software application to process image data captured by the handheld injector device. As can be easily understood, the specific hardware configuration and / or image processing performed by the machine vision system utilized in combination with the handheld treatment system will depend on the requirements of a particular application, according to embodiments of the present disclosure. Additionally, any of the imaging systems and / or machine vision systems described herein may be utilized interchangeably in combination with any of the systems described herein, including (but not limited to) fluid injection systems, without departing from the scope of the present invention.

[0009] 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 particular aspect, feature, or combination thereof, or require that any one or more particular advantages exist or problems be solved.

[0010] Various embodiments of intradermal or subcutaneous therapeutic systems and examples of therapeutic 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 fluid-filled container, even if a particular 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, fluid-filled container, machine vision system, injection process, processing system, 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.

[0011] 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.

[0012] 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.

[0013] Systems and devices for dermal treatment Various embodiments are directed to systems and devices for intradermal and / or subcutaneous treatment. In certain embodiments, the intradermal and / or subcutaneous treatment system includes a treatment device, a fluid-filled container, and / or a needle / microneedle. Generally, according to various embodiments described herein, a syringe is compatible with the fluid-filled container such that the syringe is configured to receive and operatively couple with the fluid-filled container. In certain embodiments, when the syringe and the fluid-filled container are operatively coupled, the syringe provides a mechanism for providing treatment (e.g., ejecting fluid from the fluid-filled container through the needle / microneedle). In certain embodiments, the needle or microneedle is integrated with the fluid-filled container as a single component. In certain embodiments, the needle or microneedle and the fluid-filled container are each individual components (e.g., luer lock connectors) that can be coupled together.

[0014] Treatment Devices In an embodiment, the treatment device is configured to provide a mechanism for fluid ejection out of the fluid-filled container. The injector can operate via mechanical or electromechanical means. In an embodiment, the injector includes one or more buttons or triggers for initiating and / or driving the mechanical and / or electrical components of the device. In an embodiment, the button or trigger is mechanically or electrically operatively coupled to an internal piston that is operatively coupled to the cartridge for ejecting the component out of the fluid-filled container through the needle or microneedle. 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 fluid-filled container and / or return the internal 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.

[0015] In an embodiment, the electromechanical treatment 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 an embodiment, the treatment device includes a computing system, memory, and / or software for providing instructions for performing various tasks of the treatment 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.

[0016] 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.

[0017] In certain embodiments, the treatment 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 a 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 injection of fluid.

[0018] In many embodiments, the treatment device includes a stabilizing feature (e.g., an abutment or base) that can be utilized to position and / or stabilize the syringe and needle system at a desired location on the skin. In certain embodiments, the stabilizing feature extends from and connects to the syringe system via a connector, which can be any suitable connector, such as a rod and / or post. In certain embodiments, the stabilizing feature is a proximal surface of the syringe system housing. In certain embodiments, the stabilizing feature and the needle are cooperatively positioned such that the ejection tip of the needle is capable of extending 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 location. For example, facial skin is about 1.5 mm to 2 mm, with further variation on facial locations (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.

[0019] In many embodiments, the stabilization feature includes elements for cooling and / or heating, which may provide a means for reducing pain or providing comfort to the user during injection. Any suitable elements for providing cooling and / or heating may be utilized, such as (for example) coils, resistors, vents, vacuum, and / or fans. In some embodiments, a vibrator is incorporated into the stabilization feature or needle, which may also provide a means for reducing pain or providing comfort to the user during injection.

[0020] 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.

[0021] In many embodiments, the treatment device includes one or more imaging modalities (e.g., 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, polarized light, multispectral, and / or infrared cameras. In some embodiments, the imaging modality is an ultrasound system that helps visualize the injection site and internal tissue structures. In certain embodiments, the imaging modality is positioned proximal to the cartridge so that it can visualize the treatment site and / or procedure.

[0022] When mounted on the injection device, the camera may be in close proximity to the treatment site. To accommodate the relatively small focal distance, various optical systems can be utilized in various embodiments of the present disclosure. In some embodiments, a lens barrel incorporating a macro lens is utilized. In some embodiments, a folded optical system and / or a periscope optical system is utilized. In some embodiments, a telecentric lens system is utilized to provide a large depth of field. As can be readily understood, any optical system suitable for the requirements of a particular treatment can be utilized in accordance with the embodiments of the present disclosure. In some embodiments, a light is utilized to enhance the camera and / or user visualization. In many embodiments, a laser is utilized to help guide the user to the proper injection site. In some embodiments, the laser works in conjunction with the camera to provide precision treatment. In some embodiments, an illumination system is utilized (e.g., an infrared light source) that enhances characteristics (e.g., polarized light) and / or enables subcutaneous imaging. As can be readily understood, any illumination system suitable for the requirements of a particular application can be utilized in combination with an imaging system in accordance with the embodiments of the present disclosure.

[0023] In some embodiments, the treatment device includes a means for providing feedback to ensure proper treatment. 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 device. 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 treatment. In some embodiments, the syringe system includes a means for providing feedback as to when the syringe system has finished delivering treatment. 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, tactile feedback such as vibration, and audible sounds.

[0024] Fluid-filled container Some embodiments are directed to an exchangeable fluid-filled container to be utilized in conjunction with a treatment device. Any compatible cartridge, syringe, or other fluid-filled container can be utilized with the device. In various embodiments, the fluid-filled container is compatible with the treatment device. In certain embodiments, the fluid-filled container includes a reversible coupling and / or locking mechanism to facilitate receipt of the cartridge into a receptacle of the treatment device. In certain embodiments, the fluid-filled container includes a compatible component for coupling and / or locking with the treatment device. 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 cartridge can be displaced from the treatment device, and the displacement can occur prior to and / or after use of the cartridge components.

[0025] Many embodiments are directed to a fluid-filled container to be utilized in conjunction with a treatment device. In certain embodiments, the fluid-filled container 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 container contains between about 0.01 cc and 10 cc. In various embodiments, the fluid-filled container 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, 1.0 cc, 1.5 cc, 2.0 cc, 2.5 cc, 3.0 cc, 3.5 cc, 4.0 cc, 4.5 cc, 5.0 cc, 5.5 cc, 6.0 cc, 6.5 cc, 7.0 cc, 7.5 cc, 8.0 cc, 8.5 cc, 9.0 cc, 9.5 cc, or 10.0 cc.

[0026] In some embodiments, the fluid-filled container is for limited use, such as a single-use fluid-filled container or a multi-use fluid-filled container. In various embodiments, the fluid-filled container contains fluid for multiple injections. In some embodiments, the fluid-filled container is disposable after fluid ejection. In some embodiments, the fluid-filled container contains a plunger or is under pressure to facilitate ejection of the fluid out of the container through a needle, microneedle, or other tip.

[0027] In some embodiments, the plunger of the fluid-filled container can be operatively coupled to an internal drive of the treatment device (e.g., a syringe device). In some embodiments, the internal drive of the treatment device can contact a surface of the fluid-filled container (e.g., the surface opposite the needle) such that the drive can operatively push the plunger of the fluid-filled container, resulting in ejection of liquid out of the container. In some embodiments, the fluid-filled container can be operatively coupled to an internal drive mechanism of the treatment device such that the internal drive mechanism can move the injection system axially away from and / or toward a central portion of the treatment device. In some embodiments, movement of the fluid-filled container via the internal drive mechanism of the treatment device simultaneously moves the ejection tip of the needle or microneedle away from and / or toward a 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.

[0028] Some embodiments are directed to fluid-filled containers, particularly fluids for use in dermatological treatments and / or adjuncts. Fluids to be used within the fluid-filled containers include (but are not limited to) drugs, adjuncts, triamcinolone, hyaluronic acid, collagen, or other liquids.

[0029] Needles, Microneedles, and Injection Tips Some embodiments are directed to the use of needles, microneedles, and ejection tips to expel ingredients from ingredient-containing cartridges. The needle or microneedle can be used to inject the ingredients, while the ejection tip can provide localized treatment of the ingredients. In some embodiments, the needle, microneedle, or ejection tip is operatively coupled to a fluid-filled container such that fluid within the cartridge can be expelled from the container through the needle, microneedle, or tip. In some embodiments, the needle, microneedle, or ejection tip extends from a face of the container (e.g., the face opposite the face that interacts with the syringe's internal piston). In some embodiments, the needle, microneedle, or ejection tip is integrated with the cartridge such that the microneedle / tip and cartridge are a single component. In some embodiments, the microneedle / tip and cartridge are individual components that can mate together to ensure flow out of the cartridge and through the microneedle or tip, respectively. Any suitable means for mating the microneedle or tip with the cartridge can be utilized, such as (for example) a luer lock system or a gasket.

[0030] In various embodiments, one or more microneedles are operatively coupled to a fluid-filled container such that fluid can be ejected out of the container through the one or more microneedles. In some embodiments, a single microneedle is operatively coupled to the fluid-filled container. In some embodiments, multiple microneedles are operatively coupled to the fluid-filled container, which can be arranged in an array, a regular pattern (e.g., a circle), an irregular pattern, or any other configuration.

[0031] 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 the cooling, heating, or micro-vibration capability to the needle can be utilized.

[0032] 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 re-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.

[0033] Machine Vision Systems The handheld therapeutic device may incorporate and / or communicate with a machine vision system, including an imaging system and a processing system, such as (but not limited to) a machine vision processing system. As discussed above, any of a variety of imaging systems may be utilized as appropriate for the requirements of a particular application. In many embodiments, the imaging system is utilized to capture image data within the field of view of the imaging system. In some embodiments, the field of view of the imaging system images an area to which the device may administer a therapy (e.g., intradermal or subcutaneous injection of a fluid).

[0034] In some embodiments, a machine vision system controls obtaining image data, analyzes the image data, and detects a region of interest. In some embodiments, the region of interest is a region containing a detected dermal condition. In some embodiments, the region of interest may contain any dermal condition of interest in a particular application. The dermal condition may be a skin disease, a lesion (e.g., an acne lesion), a dermal injury, a keloid, a wrinkle, a dermal abnormality, a discoloration, or any other dermal condition that is detectable and treatable by a treatment system as described herein.

[0035] In many embodiments, detection is performed using one or more sets of rules that analyze pixels of the acquired image data to determine whether one or more dermal conditions (e.g., acne lesions) are present. Additional sets of rules can be utilized to classify the detected dermal conditions and / or machine learning models, including (but not limited to) support vector machines, cascades of classifiers, and / or neural networks (e.g., convolutional neural networks). In some embodiments, a classifier trained using a supervised learning process (e.g., a process in which a set of labeled images is utilized to train a classifier) ​​is utilized to detect whether a region of interest contains a dermal condition. In an embodiment, a process is utilized that both assesses in real time whether a region of interest contains a dermal condition, detects specific features of the dermal condition (e.g., pilosebaceous unit localization of acne lesions), and / or performs a classification of any detected dermal condition.

[0036] In some embodiments, the detection is performed using a neural network system that is trained to generate a set of features and includes layers that perform detection in different regions of interest. In this way, the neural network can efficiently generate a single set of features that is utilized to perform detection in parallel across regions of interest of several sizes and aspect ratios. In various embodiments, separate networks can be trained to perform detection of different classes of dermal conditions. In some embodiments, separate networks can be trained to perform detection of different classes of acne lesions (e.g., cystic acne, papulopustular acne, open comedones, and / or closed comedones). In this way, the networks can be evaluated in parallel to enable real-time detection and classification of dermal conditions. In some embodiments, a neural network such as the single shot multibox detector described in Liu, Wei, et al. "Ssd: Single shot multibox detector." European conference on computer vision. Springer, Cham, 2016 (the disclosure of which, including disclosures related to training and using SSD machine learning models in image processing applications, is incorporated herein by reference in its entirety) is utilized. Although a particular machine learning model is described above, it should be readily understood that any of a variety of machine learning models that may be utilized for image processing applications, including (but not limited to) convolutional neural networks (CNNs) such as Alexnet, ResNet, VGGNet, and / or Inception, may be utilized in accordance with embodiments of the present disclosure as appropriate for the requirements of a particular application.

[0037] In an embodiment, real-time processing of the acquired image data is accomplished by performing an initial detection of a dermal condition and then tracking the condition in subsequent images in a sequence of acquired images. In this manner, a less computationally intensive tracking process can be utilized to track the dermal condition. In some embodiments, processes including (but not limited to) optical flow and / or structure from motion techniques are utilized to track features of the detected dermal condition. In some embodiments, a feature detection process is performed to detect features, which can then be tracked. Features that may be detected include (but are not limited to) scale invariant feature transform (SIFT) features, log-polar SIFT features, SIFT-Histogram of Gradient (SIFT-HOG) features, and / or skin lesion specific bundles of features such as (but are not limited to) those described in Upadhyay, Pawan Kumar, and Satish Chandra. "An improved bag of dense features for skin lesion recognition." Journal of King Saud University-Computer and Information Sciences (2019) (the disclosure of which, including disclosure related to detection of skin specific features, is incorporated herein by reference in its entirety). As can be readily appreciated, any of a variety of processes appropriate to the requirements of a particular application can be utilized to perform feature tracking. In many embodiments, the ability to track features of a condition allows for detection of when a handheld treatment device is properly positioned to deliver treatment to a treatment site.

[0038] In some embodiments, the treatment site is determined based on the classification of the dermal condition and / or the particular treatment to be administered. In certain embodiments, the handheld treatment device provides audio, tactile, and / or visual feedback to assist the user in positioning the handheld treatment device in the proper orientation relative to the treatment site to which the treatment is to be delivered. In some embodiments, the handheld treatment device automatically initiates treatment once correctly oriented. In some embodiments, the handheld treatment device provides feedback to the user to manually initiate treatment once the handheld treatment device is correctly oriented. In certain embodiments, the treatment involves an injection, and the handheld treatment device includes a sensor that monitors the depth of penetration of the injection and / or the volume of fluid administered during the injection. [Brief description of the drawings]

[0039] 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.

[0040] [Figure 1A] 1A-1C provide illustrations of handheld therapeutic devices according to various embodiments of the present disclosure. [Figure 1B] 1A-1C provide illustrations of handheld therapeutic devices according to various embodiments of the present disclosure. [Figure 1C] 1A-1C provide illustrations of handheld therapeutic devices according to various embodiments of the present disclosure.

[0041] [Figure 1D] 1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure. [Figure 1E] 1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure. [Figure 1F]1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure. [Figure 1G] 1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure. [Figure 1H] 1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure. [Figure 1I] 1D-1I provide illustrations of a handheld therapeutic device incorporating a machine vision system according to various embodiments of the present disclosure.

[0042] [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.

[0043] [Figure 5A] 5A-5D provide illustrations of component syringe systems according to various embodiments of the present disclosure. [Figure 5B] 5A-5D provide illustrations of component syringe systems according to various embodiments of the present disclosure. [Figure 5C] 5A-5D provide illustrations of component syringe systems according to various embodiments of the present disclosure. [Figure 5D] 5A-5D provide illustrations of component syringe systems according to various embodiments of the present disclosure.

[0044] [Figure 5E] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure. [Figure 5F] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure. [Figure 5G] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure. [Figure 5H] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure. [Figure 5I] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure. [Figure 5J] 5E-5J provide illustrations of component syringe systems incorporating a variety of different machine vision systems, according to various embodiments of the present disclosure.

[0045] [Figure 6] 6A and 6B provide an illustration of a cartridge and microneedles as discrete components, according to various embodiments of the present disclosure.

[0046] [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.

[0047] [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.

[0048] [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.

[0049] [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.

[0050] [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.

[0051] [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.

[0052] [Figure 24] Figures 21-24 provide illustrations of optional features of an exemplary ejector system, according to various embodiments. Figures 24 and 25 provide illustrations of an exemplary electromechanical injector system, according to various embodiments. [Diagram 25] 24 and 25 provide illustrations of an exemplary electromechanical syringe system, according to various embodiments.

[0053] [Figure 26] 26A-26C provide illustrations of a camera system utilized within a handheld therapeutic device according to various embodiments of the present disclosure.

[0054] [Figure 27A] FIG. 27A illustrates a papular acne lesion.

[0055] [Figure 27B] 27B and 27C illustrate another papular acne lesion with infrared images of the lesion obtained using reflectance confocal microscopy. [Figure 27C] 27B and 27C illustrate another papular acne lesion with infrared images of the lesion obtained using reflectance confocal microscopy.

[0056] [Figure 28] FIG. 28 conceptually illustrates a desired injection trajectory for a cystic or papular acne lesion, according to an embodiment of the present disclosure.

[0057] [Figure 29] 29A and 29B conceptually illustrate the image processing process performed on images acquired by a machine vision system of a handheld therapeutic device, according to various embodiments of the present disclosure.

[0058] [Diagram 30] FIG. 30 is a flow chart illustrating a process for detecting, tracking, and administering medication via injection, according to various embodiments of the present disclosure.

[0059] [Diagram 31] FIG. 31 is a flow chart illustrating a process for detecting, tracking, and administering medication via injection using a single-shot detection (SSD) machine learning model to identify and classify acne lesions, according to various embodiments of the present disclosure.

[0060] [Diagram 32] FIG. 32 is a flow chart illustrating a process for obtaining an image according to an embodiment of the present disclosure.

[0061] [Diagram 33] FIG. 33 is a flow chart illustrating a process for determining an injection site for administering a medication to an acne lesion, according to an embodiment of the present disclosure.

[0062] [Diagram 34] FIG. 34 is a flow chart illustrating a process for performing an injection according to an embodiment of the present disclosure.

[0063] [Diagram 35] FIG. 35 conceptually illustrates a syringe processing system, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] Exemplary Systems and Devices 1A-1C, an example of a treatment device is provided in accordance with various embodiments of a handheld treatment device. As can be seen in FIG. 1A, a treatment device 101 with syringe capability can include a body 103 with an exterior covering 105 that covers an internal piston. The device 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 face 109 opposite a face 111 that mates with an ingredient-filled cartridge (not shown). The device 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 face 111 that can mate with a fluid-filled cartridge. The device 101 may also optionally include an optical feedback indicator 123 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.

[0065] 1B is a diagram of device 101 showing an ingredient-filled cartridge mating surface 111. Surface 111 includes a mating portion 117 for mating a syringe with the ingredient-filled cartridge. Surface 111 further shows an internal piston 119 that moves axially away from and toward a central portion 121 of the body.

[0066] FIG. 1C provides another example device 101 in which a button 107 extends from a curved surface of a cylindrical body 103 .

[0067] In some embodiments, the handheld therapeutic device incorporates an imaging system and / or an illumination system. In some embodiments, the imaging system includes one or more cameras or other imaging modalities (e.g., ultrasound). In some embodiments, the illumination system includes one or more illumination sources.

[0068] With particular reference to Figures 1D-1I, various embodiments of handheld treatment devices including a camera system and multiple illumination sources are illustrated. As discussed further below, the camera system utilized within the handheld treatment device can incorporate any of several different optical systems capable of capturing focused images of the skin during use of the handheld treatment device. With particular reference to Figures 1D and 1E, a handheld treatment device 140 is shown including a camera system having a telecentric optical system 142. When in use, the camera system has a view of the skin adjacent to the positioning support 146. With particular reference to Figures 1F and 1G, a handheld treatment device 150 is shown including a camera system having a periscope 152. When in use, the camera system has a view of the skin adjacent to the positioning support 156. With particular reference to Figures 1H and 1I, a handheld treatment device 160 is shown including a camera system having a macro optical system 162. When in use, the camera system has a view of the skin adjacent to the positioning support 166. As can be readily appreciated, any of a variety of camera systems can be utilized as appropriate for the requirements of a particular application to resolve images of areas of skin containing dermal disorders (e.g., acne lesions) in accordance with embodiments of the present disclosure.

[0069] The camera system and illumination source of the handheld therapy device illustrated in Figures 1D-1G are shown contained within a housing extending from the side of the handheld therapy device, which may be mounted thereon or integrated therein. However, any of a variety of housing form factors may be utilized as appropriate for the requirements of a particular application. A handheld therapy device including a cylindrical housing according to an embodiment of the present disclosure is illustrated in Figures 1H and 1I. Although the discussion of Figures 1D-1I above focuses on the imaging and illumination system that may be incorporated within the handheld therapy device, the handheld therapy device illustrated in Figures 1D-1I also includes components similar to those found in the handheld therapy device discussed above with reference to Figures 1A-1C. Furthermore, the handheld therapy device illustrated in Figures 1D-1I should be understood as being capable of implementing any of the components and / or features of any of the handheld therapy devices described herein.

[0070] 2A-4B provide various examples of an ingredient-filled cartridge 201 according to various embodiments. As can be seen in these figures, the cartridge can include a surface 203 capable of coupling with a syringe, including a central portion 205 that can interact with the internal piston of the syringe. Opposite the surface 203 capable of coupling with a syringe is a surface 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), a pattern (e.g., a circle), or an irregular pattern, each microneedle can have a microneedle ejection tip 210. 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. The plunger 213 can interact with a central portion 205 of the face 203, which can interact with the internal piston of the syringe such that the plunger can be moved axially away from the face 203 and towards one or more microneedles 209 / 211.

[0071] 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.

[0072] Provided in Figures 5A-5G is the exemplary therapeutic device 101 of Figure 1A operatively coupled with the exemplary ingredient-loaded cartridge 201 of Figures 2A-4B according to various embodiments. Figures 5E-5J illustrate a handheld therapeutic device similar to that shown in Figures 1D-1I, but configured to be operatively coupled with the exemplary ingredient-loaded cartridge 201 of Figures 2A-4B according to additional embodiments. As can be seen in Figure 5A, the cartridge 201 can be mounted in the device 101 such that the face 203 of the cartridge 201 contacts the face 111 of the device 101. A central portion 205 of the face 203 of the cartridge interacts with the internal piston 119 of the device 101. Additionally, the microneedle 209 extends away from the device 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 the face 207 of the cartridge 201 mounted within the device 101. The device 101 can also optionally include an optical feedback indicator 123 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 delivery of therapy, or any other suitable feedback. Additionally, the device 101 can incorporate one or more cameras 127 and visualization lights 129 that can be used to assist and / or record use of the device and cartridge.

[0073] As can be readily appreciated, cartridges similar to those discussed above with reference to Figures 5A-5D can also be utilized in a similar manner in the embodiments illustrated in Figures 5E-5J incorporating imaging and / or illumination systems.

[0074] 6A and 6B provide examples of a cartridge unit 601 and a microneedle unit 603 as individual units that may be assembled together, according to various embodiments. The cartridge 601 includes a surface 605 capable of mating with a syringe, including a central portion 607 that may interact with an internal piston of a syringe. Opposite the surface 605 capable of mating with a syringe is a surface 609 that may mating with a microneedle unit 603. Within the cartridge 601 is a plunger 611 and an ingredient fill portion 613 that stores fluid until it is ejected from the cartridge. The plunger 611 may interact with the central portion 607 of the surface 605, which may interact with the internal piston of a syringe such that the plunger may be moved axially away from the surface 605 and toward the microneedle assembly 603.

[0075] The microneedle unit 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 unit, 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 unit base 615. Although not shown, the microneedle unit can include multiple microneedles, which can be formed in an array or any other pattern. As shown in FIG. 6B, the microneedle unit 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.

[0076] Syringe System 7-9 are examples of microneedle injection systems with unassisted skin penetration, according to various embodiments. A cartridge 701 is loaded onto a treatment 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 treatment 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 treatment device 703 results in an injection system 711. The assembled injection system 711 includes a microneedle 713 that extends in a direction away from the treatment device 703. Assembly of the injection system 711 results in a microneedle injection tip 715 that is appropriately positioned in relation to an abutment 717 such that the injection 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 microneedle 713 may be concealed utilizing a covering 721 as shown in Figure 8. Although not shown, other cartridges (e.g., surface ablation tips, light emitting diodes) may be coupled into the syringe in a similar manner.

[0077] The assembled microneedle injector system 711 can be used for intradermal or subcutaneous injection of liquids or solvents. A user can pierce the skin with the microneedle ejection tip 715 at a 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 injector system 711 can inject the liquid into the skin. The sheath 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 sheath 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 a collapsed sheath 723. As described herein, the sheath can be retractable and / or removable instead of collapsible.

[0078] 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 treatment device 703 can be reused with a subsequent cartridge.

[0079] 10-12 are provided examples of microneedle injector systems with assisted skin penetration, according to various embodiments. A cartridge 1001 is loaded onto a treatment 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 treatment 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 treatment device 1003 results in an injector system 1011. The assembled injector system 1011 includes a microneedle 1013 extending in a direction away from the treatment 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 FIGS. 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, FIG. 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 FIG. 11. Although not shown, other cartridges (e.g., surface ablation tips, light emitting diodes) can be coupled into the syringe in a similar manner.

[0080] The assembled microneedle 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 suitable 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 posts 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 sheath 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 sheath 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 a collapsed sheath 1023. As described herein, instead of being collapsible, the sheath can be retractable and / or removable.

[0081] 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 treatment device 1003 can be reused with a subsequent cartridge.

[0082] Provided in FIG. 13A is an example of an electromechanical microneedle injector system with assisted skin penetration, according to various embodiments. A cartridge 1301 is loaded onto an electromechanical treatment 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 treatment 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 treatment device 1303 results in an injector system 1311. The assembled injector system 1311 includes a microneedle 1313 extending in a direction away from the treatment 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. 13A does not show an abutment, but one may be assumed to be present on the assembled system. The microneedle 1313 may be concealed utilizing a covering. Although not shown, other cartridges (e.g., surface ablation tips, light emitting diodes) may be coupled into the syringe in a similar manner.

[0083] The assembled microneedle syringe system 1311 can be used for intradermal or subcutaneous injection of liquids. Once the user has positioned 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 a button 1325 to actuate a rotatable threaded rod 1316 that is operatively coupled to an internal drive 1314, which can be powered by a battery 1320 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 an internal piston 1308. The rotatable threaded rod 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.

[0084] The syringe system 1311 utilizes a second rotatable rod 1319 that operates with an internal piston 1308 to facilitate liquid ejection. A button 1025 is utilized to initiate rotation of the rod 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 treatment device 1303 can be reused with a subsequent cartridge.

[0085] Provided in Figures 14-16B is an exemplary syringe system for performing intradermal or subcutaneous injections of liquid. 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. Also, Figures 16A and 16B show the fluid-filled syringe 1403 and needle assembly 1405 disposed within the housing compartment 1401. It should be understood that the exemplary system depicted in Figures 14-16B may utilize any of the camera systems described herein. In particular, exemplary systems can include camera systems with telecentric optics (see FIGS. 1D, 1E, 5E, and 5F), camera systems with periscopes (see FIGS. 1F, 1G, 5G, and 5H), or camera systems with macro optics (see FIGS. 1H, 1I, 5I, and 5J). Generally, these camera systems can be implemented by mounting the camera system housing and components on the intradermal or subcutaneous injection side of the housing, or integrated within the housing.

[0086] 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.

[0087] 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.

[0088] 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 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.

[0089] 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 can be performed.

[0090] 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. In particular, 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.

[0091] 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.

[0092] The button 1413 is in an initial outward state such that the inwardly projecting posts 1439 maintain in compression the spring 1437, which physically connects with the flange retainer 1423. The inwardly projecting posts 1439 each contain a protruding portion 1451 that contacts the flange retainer 1423, maintaining the flange retainer and plunger retainer 1425 in place and maintaining the spring 1437 in compression.

[0093] 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 .

[0094] 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 retainer 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 a 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.

[0095] 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.

[0096] 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).

[0097] 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 a 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 representative icons, color indicators, or scripts.

[0098] 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.

[0099] 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.

[0100] It should be understood that the exemplary system depicted in Figures 24 and 25 may utilize any of the camera systems described herein. In particular, the exemplary system may include a camera system with telecentric optics (see Figures 1D, 1E, 5E, 5F, and 26A), a camera system with periscope (see Figures 1F, 1G, 5G, 5H, and 26B), or a camera system with macro optics (see Figures 1H, 1I, 5I, 5J, and 26C). Generally, these camera systems can be implemented by mounting the camera system housing and components on the intradermal or subcutaneous injection side of the housing, or integrated into the housing. Furthermore, the processing system can instruct the electromechanical injector system to perform treatment according to a machine vision system as described herein. Thus, the camera system can image the dermal condition, and the machine vision system can identify the dermal disease and instruct the electromechanical device to perform the appropriate treatment.

[0101] Imaging System A variety of cameras and / or imaging devices can be utilized within the handheld therapeutic device according to various embodiments of the present invention. A challenge that can be encountered when incorporating a machine vision system within a handheld therapeutic device is the requirement to resolve an image of the skin at a potentially short focal length. As discussed further below, a variety of optical systems can be utilized to obtain an image of the skin proximate the end of the handheld therapeutic device according to various embodiments of the present invention.

[0102] In some embodiments, a camera system incorporating telecentric optics is utilized. A telecentric lens is typically considered to be a compound lens that can provide an orthogonal projection of an object. In other words, the use of a telecentric lens leaves the image size unchanged with object displacement, provided that the object remains within a certain range, often referred to as the depth of field (or telecentric range). The use of a telecentric lens can provide the benefit that the focus and ability of a machine vision system (see discussion below) to detect and classify acne lesions is independent of the distance of the handheld treatment device from the user's skin within the depth of field of the telecentric optics. An injector device incorporating an imaging system including a camera with telecentric optics according to an embodiment of the present invention is illustrated in FIG. 26A.

[0103] In many embodiments, periscope optics are utilized to redirect light into the imaging system to allow for increased separation between the camera aperture and the image sensor. In this manner, a longer distance can be established between the camera module and the scene being imaged (e.g., the user's skin). A syringe device incorporating an imaging system including a camera with periscope optics according to an embodiment of the present invention is illustrated in FIG. 26B.

[0104] In some embodiments, a macro lens is utilized to enable the camera system to capture images close to the camera aperture. The term macro lens is typically used to refer to an optical system (including a compound lens) designed to enable capture of extremely close-up images. In some embodiments, a camera module containing a macro lens can be positioned with a field of view of the area below the handheld treatment device. A syringe device incorporating an imaging system including a camera with a macro lens according to an embodiment of the present invention is illustrated in FIG. 26C. A challenge that may be encountered with macro lenses is that they often have a limited depth of field. Thus, handheld treatment devices according to many embodiments of the present disclosure will often utilize an imaging system incorporating a macro lens in combination with stabilization features (e.g., a stabilization support similar to the stabilization support of the handheld treatment device described above with reference to FIGS. 1A-1I) and / or an autofocus mechanism.

[0105] In some embodiments, the camera system captures color images (e.g., using an image sensor configured with a Bayer color filter pattern). In many embodiments, color images are captured using a color filter pattern (e.g., an RGRB Bayer-like filter pattern) that includes twice as many red pixels as blue or green pixels. In some embodiments, the image sensor is also configured to capture image data in the near-infrared spectrum (e.g., by not including an IR-cut filter in the optical system). In an embodiment, a monochrome image sensor is utilized to capture black and white images. In various embodiments, color filters are utilized to enable capture of monochrome images in specific spectral bands, including (but not limited to) red channels, near-infrared wavelengths, and / or extended color spectral bands, including visible and near-infrared wavelengths. Certain embodiments also utilize image sensors configured to perform multispectral imaging. In some embodiments, the camera's optical system can also include a polarizing filter to enable imaging of polarized light. As can be readily appreciated, the number of specific spectral bands and / or channels imaged by the imaging system will depend greatly on the requirements of a particular application, according to embodiments of the present disclosure. Furthermore, the particular image sensors and / or spectral filters described above can be utilized in any of the imaging systems described herein, including (but not limited to) the imaging systems described with reference to Figures 1D-1I and 26A-26C.

[0106] Machine Vision Systems A handheld therapeutic device according to many embodiments of the present disclosure utilizes a machine vision system to identify features of interest on the user's skin and / or control the application of a treatment. In some embodiments, the machine vision system obtains image data using an imaging system, such as, but not limited to, any of the imaging systems described above. The machine vision system can process the image data in real time to identify areas containing features of interest. In many embodiments, the features of interest are dermal conditions (e.g., acne lesions), and the machine vision system both detects and classifies the detected conditions. As discussed further below, the ability to classify dermal conditions can enable the application of different treatments. In some embodiments, the machine vision system utilizes information about the detected dermal conditions to guide the treatment. In certain embodiments, the machine vision system generates feedback via a user interface to guide the user in the manual initiation of the treatment. In some embodiments, the machine vision system utilizes information about the detected features to automatically initiate the application of the treatment once the handheld therapeutic device is properly positioned.

[0107] Image data obtained by an imaging system forming part of the machine vision system of the handheld treatment device is conceptually illustrated in FIG. 27A. In the illustrated embodiment, the image data is a color image that has been dewarped to remove distortions introduced by the optics of the camera used to capture the image data. As discussed further below, the machine vision system, according to many embodiments of the present disclosure, can detect the presence of a dermal condition in an image. Once detected, various processes can be performed by the machine vision system, including (but not limited to) classifying the dermal condition, tracking the detected dermal condition, and targeting the application of treatment. In FIG. 27A, throughout the various examples of the machine vision process (see FIGS. 27A-29B), the dermal condition detected is an acne lesion. It should be understood that an acne lesion is utilized as an example of a dermal condition, and that a variety of dermal conditions can be detected and treated in accordance with various embodiments of the present invention. Thus, the devices and methods described herein can be utilized to detect and treat any dermal condition that can be detected via machine vision learning and treated via intradermal or subcutaneous fluid injection. The dermal condition may be a skin disease, a lesion (e.g., an acne lesion), a dermal injury, a keloid, a wrinkle, a dermal abnormality, a discoloration, or any other dermal condition that is detectable and treatable by a treatment system as described herein.

[0108] While the image shown in FIG. 27A is a color image, machine vision systems according to many embodiments of the present invention can obtain image data in any of a variety of spectral bands, including (but not limited to) obtaining image data in multiple spectral bands. FIGS. 27B and 27C conceptually illustrate image data that may be obtained in the visible and near-infrared spectrum. FIGS. 27B and 27C are reprinted from Manfredini, M., et al., “In vivo monitoring of topical therapy for acne with reflectance confocal microscopy.” Skin Research and Technology 23.1 (2017): 36-40, the disclosure of which is incorporated herein by reference in its entirety. FIG. 27B illustrates an image of an acne lesion. FIG. 27C is an image generated using reflected near-infrared wavelengths of light. The fiducial markers in FIG. 27C indicate pores in the skin, and the image itself captures information about the underlying structure of the pilosebaceous unit. As discussed further below, infrared wavelengths can penetrate a subject's skin and enable an imaging system that captures image data in the infrared spectrum to capture information about the underlying structure of the pilosebaceous unit. The extent to which infrared light penetrates the skin depends on the interaction of the infrared light with molecules such as water and hemoglobin. In many embodiments, a polarized light illumination source can be utilized in combination with an imaging system having a linear polarizing filter to image features of acne lesions, including (but not limited to) features of the pilosebaceous unit.

[0109] Information about the underlying structure of the pilosebaceous unit can be utilized in targeting the administration of treatment using techniques including, but not limited to, injection. For example, the injection site and needle trajectory can depend on various details. In some cases, when the acne lesion is cystic or papular, the treatment can be administered via injection at the center of the acne lesion, with the injection trajectory following the angle and path of the hair follicle contained within the pilosebaceous unit. An injection trajectory at the center of the acne lesion following the angle and path of the hair follicle is conceptually illustrated in FIG. 28 and shown as a yellow arrow. By following the hair follicle, trauma to the surrounding skin and atrophy of the surrounding tissue can be reduced. In some cases where the injection administers an anti-inflammatory agent, the anti-inflammatory efficacy can be increased by delivery of the anti-inflammatory agent to the bulb of the hair follicle. The red arrow in FIG. 28 shows an injection into the bulb of the hair follicle, which is directly down through the user's skin and more likely to cause trauma to the surrounding tissue.

[0110] Although specific treatments for acne lesions that are cystic or papular are described above with respect to FIG. 28, the machine vision system according to many embodiments of the present disclosure possesses the ability to classify detected acne lesions. In some cases, when an acne lesion that is pustular is detected, the machine vision system can administer the injection at a location adjacent to the visible pores of the acne lesion, avoiding the pus filling the pilosebaceous unit from diluting the delivered medication. In some embodiments, the machine vision system directs the injection in a trajectory parallel to the pilosebaceous unit, which can improve efficacy and minimize skin trauma. It is understood that the described injection sites and trajectories are potential examples and should not be construed as limiting injection sites and trajectories for cystic, papular, or pustular acne lesions.

[0111] A process that may be utilized by a machine vision system according to embodiments of the present invention to detect skin conditions and administer treatment in accordance with various embodiments of the present disclosure is conceptually illustrated in Figures 29A and 29B. In this particular example, the process involves first detecting acne lesions, which are indicated in Figure 29A by blue bounding boxes.

[0112] In some embodiments, the skin condition is detected by identifying a region of interest in the image that is likely to contain the skin condition. In some embodiments, a classifier can be utilized to determine the type of skin condition contained within the region of interest. As described in the examples above, the classification of the acne lesion can determine the manner in which treatment is administered by the machine vision system using the handheld treatment device. In the illustrated example, the skin condition is an acne lesion visible in FIG. 29A and is determined to be a papular lesion. In some cases, the machine vision determines that the papular lesion should be treated via injection of a medication into the pores of the acne lesion. The machine vision system can track the acne lesion and compare the location of the acne lesion to the current target injection site of the handheld treatment device. In FIG. 29A, the region of interest containing the acne lesion is adjacent to the target injection site of the handheld treatment device, which is indicated by a red bounding box. FIG. 29B conceptually illustrates a user moving the handheld treatment device such that the acne lesion is located within the target injection site. In some embodiments, the machine vision system provides feedback via a user interface instructing the user to administer the injection. In some embodiments, the machine vision system automatically administers the injection.

[0113] A machine vision system according to an embodiment of the present invention can integrate signals for additional sensors in the handheld therapeutic device and / or other devices. In some embodiments, the machine vision system administers the therapy via injection, and one or more sets of injection needles utilized to administer the therapy are monitored using force or displacement sensors. If force or displacement sensor information is available, the machine vision system can utilize the sensor information to control the depth of the injection.

[0114] In an embodiment, the machine vision system is capable of classifying the location of the skin in determining the depth of the injection. The location of the skin on the user's body may affect the injection depth (e.g., the forehead is typically shallower than the skin on the user's back). The location of the skin may be determined based on one or more of user input, image data, and / or inertial measurements from an inertial measurement unit of the orientation of the handheld therapeutic device relative to gravity. The machine vision system may also utilize information including (but not limited to) a classification of the stage of the dermal condition to affect the depth of the injection. In some embodiments, the machine vision system may perform the classification based on one or more of the color, height relative to the plane of the surrounding skin, and / or diameter of the dermal condition. As may be readily appreciated, any of the various machine vision classifications, sensor inputs obtained prior to injection, and / or sensor inputs obtained during injection may be utilized to determine and / or control the depth of the injection as appropriate for the requirements of a particular application according to various embodiments of the present disclosure.

[0115] Although various machine vision systems and processes for administering treatments, including (but not limited to) injection treatments, are described above with respect to Figures 27A-29B, any of a variety of machine vision systems incorporating any of a number of different imaging systems can be utilized to obtain image data and perform processes for directing administration of treatments as appropriate to the requirements of a particular application (including applications involving any of a variety of dermatological conditions) according to various embodiments of the present disclosure. Machine vision processes and processing systems that may be utilized to implement machine vision processes according to various embodiments of the present invention are discussed further below.

[0116] Machine Vision Process A machine vision system according to various embodiments of the present disclosure is capable of detecting features such as dermal conditions (e.g., acne lesions) on a user's skin for the purpose of administering treatment (without being limited thereto). The process can be performed in real-time based on image data captured at short distances as the user manipulates a handheld treatment device incorporating an imaging system.

[0117] A process for administering treatment using a handheld treatment device based on image data is conceptually illustrated in FIG. 30. Process 3000 includes steps of acquiring image data and detecting a dermal condition (3002). In some embodiments, real-time processing is achieved by acquiring additional images and utilizing a tracking process to track the location of the dermal condition (3004). In this manner, the location of the lesion detected in the previous image can be utilized to predict the location of the lesion in the newly acquired image. By constraining the search for the condition, computational efficiencies can be achieved that allow the location of the acne lesion to be determined in real time.

[0118] As discussed above, a condition may be visible within the field of view of the machine vision system, but not located at a location where a treatment can be effectively administered. In addition, the treatment location itself may be determined based on the classification of the condition. Thus, a determination (3006) is made as to whether the location of the dermal condition and / or its orientation relative to the handheld treatment device is appropriate for administration of a treatment appropriate to the type of condition. Once the handheld treatment device is appropriately positioned relative to the condition, the treatment can be administered (3008). As described above, the machine vision system can provide an indication via a user interface on the handheld treatment device that prompts the user to manually initiate administration of the treatment. In some embodiments, the machine vision system can initiate automated administration of the treatment.

[0119] When the position of the handheld therapeutic device is not appropriate for administering a treatment, the handheld device can continue to track the location of the dermal condition (3004). In some embodiments, the machine vision system can provide feedback (e.g., visual and / or audio feedback) via the user interface to guide the user in manipulating the handheld therapeutic device relative to the detected dermal condition. In this manner, the handheld therapeutic device can prompt the user to position the handheld therapeutic device in an orientation where it is appropriate for administering a treatment.

[0120] Although a particular machine vision process is described above with respect to Figure 30, any of a variety of machine vision processes may be utilized, including processes that may be modified to accommodate different imaging systems, illumination sources, and / or treatment modalities as appropriate for the requirements of a particular application, in accordance with various embodiments of the present invention. Particular processes that may be utilized to perform detection, tracking, and / or classification in a machine vision process, such as (but not limited to) the machine vision process described above with respect to Figure 30, are discussed further below.

[0121] Machine vision process incorporating machine vision models A machine vision system incorporated into a handheld therapeutic device according to various embodiments of the present invention may utilize a machine vision model to perform detection, tracking, and / or classification of dermal conditions. In some embodiments, a neural network such as a single shot multibox detector described in Liu, Wei, et al. "Ssd: Single shot multibox detector." European conference on computer vision. Springer, Cham, 2016 (incorporated above by reference) is utilized. However, it should be readily understood that detection, tracking, and / or classification in a machine vision process according to various embodiments of the present disclosure may be performed using any of a variety of heuristic and / or machine learning models adapted for use in image processing applications, including (but not limited to) convolutional neural networks (CNNs) such as Alexnet, ResNet, VGGNet, and / or Inception. As can be readily understood, the particular machine learning model utilized will depend greatly on the requirements of the particular application.

[0122] A machine vision process incorporating the use of a single shot multibox detector (SSD) machine learning model to perform dermal condition detection and classification according to various embodiments of the present disclosure is conceptually illustrated in FIG. 31. The process 3100 includes obtaining an image (3102) and performing detection of a dermal condition using an SSD detector. The SSD detector utilizes a convolutional neural network that receives an image patch (e.g., a 200×200 pixel image patch) and is trained to extract features that can be utilized to both i) determine the likelihood that a region of interest of a particular size and aspect contains a dermal condition and ii) classify the detected dermal condition. In some embodiments involving classification of acne lesions, the classifier can determine the likelihood that the detected lesion is a cystic acne lesion, a papulopustular acne lesion, an open comedone, and / or a closed comedone.

[0123] Once a lesion has been detected and classified, a desired injection site and / or injection orientation can be determined. Based on this determination, the process 3100 can evaluate (3106) whether a region of interest (ROI) containing the detected dermal condition is within an injection zone where an injection may potentially be administered by a handheld treatment device. Although the discussion of FIG. 31 refers to treatment via injection, it should be readily understood that a similar process may be utilized in combination with alternative treatment modalities.

[0124] When the detected dermal condition is not located within an injection zone where an injection may potentially be administered by the handheld therapeutic device, the machine vision process may continue to acquire images (3108) and track the detected image (3110) until the detected lesion is located within the injection zone. In many embodiments, the machine vision process may provide feedback (e.g., auditory, kinesthetic, tactile, and / or visual feedback) (3112) via the handheld therapeutic device and / or another device, such as (but not limited to) a mobile computing device (e.g., a mobile phone, tablet computer, and / or laptop computer in communication with the handheld therapeutic device) to assist the user in positioning the handheld therapeutic device in the proper orientation. In some embodiments, a camera is utilized to capture live video of the user manipulating the handheld therapeutic device (e.g., via a front camera on a mobile phone), and a feedback user interface device is displayed on the live video to instruct the user. In many embodiments, the handheld therapeutic device includes an array of piezoelectric devices that may provide vibration kinesthetic feedback at different locations on the surface of the handheld therapeutic device, which may provide guidance regarding the manipulation of the handheld therapeutic device by the user. As can be readily appreciated, the particular manner in which a machine vision process provides feedback to a user will be determined in large part by the requirements of a particular application.

[0125] Once the machine vision process 3100 determines that the detected dermal condition is located within the injection zone of the portable therapeutic device (3106), a determination can be made as to whether the appropriate injection site is currently being targeted by the handheld therapeutic device. In some embodiments, the determination is based on the location where one or more needles would penetrate the user's skin given the current orientation of the handheld therapeutic device. In some embodiments, the determination is based on the trajectory where one or more needles would penetrate the user's skin given the current orientation of the handheld therapeutic device. The process continues to acquire and analyze imaged data until the target is acquired.

[0126] Once the target is obtained, the machine vision process can cause the injection to be performed (3116). In some embodiments, the machine vision process provides an indication (e.g., an audio, tactile, and / or visual indication) to the user to manually initiate the injection. In many embodiments, the machine vision process initiates the injection automatically.

[0127] Various machine vision processes utilizing machine learning models to administer a treatment are described above with respect to Figure 31, however, any of a variety of machine learning processes utilizing heuristics and / or different classes of machine models such as (but not limited to) neural networks, convolutional neural networks, recurrent neural networks, support vector machines, and / or cascades of classifiers may be utilized as appropriate for the requirements of a particular application according to various embodiments of the present disclosure. Various processes that may be utilized by a machine vision system to obtain image data, determine an injection target, and / or perform an injection according to different embodiments of the present disclosure are discussed further below.

[0128] Obtaining image data Image data acquisition processes that may be utilized according to various embodiments of the present disclosure typically depend on the particular image sensor and / or imaging modality utilized to acquire the image data. In many embodiments, image data is acquired using a camera having an optical system including a lens or compound lens and an image sensor (e.g., a CMOS image sensor). In some embodiments, the imaging system captures images that include geometric and / or photometric distortions that may be intentional (e.g., due to the optical power of the lens system) and / or unintentional (e.g., imperfections in the optical system and / or image sensor). Thus, image acquisition processes according to some embodiments utilize dewarping transformations and / or image normalization to convert the captured image data into an acquired image that can be provided to subsequent image processing operations within a machine vision process.

[0129] A process for acquiring image data according to an embodiment of the invention is conceptually illustrated in FIG. 32. Process 3200 can begin with illumination (3202) of a scene being imaged using an illumination source. As discussed above, an illumination source such as (but not limited to) an infrared and / or linear polarized light source can be utilized to image features that become prominent when so illuminated. Process 3200 includes capturing (3204) image data. The image data is dewarped (3206). In some embodiments, the dewarping is performed based on calibration data. The dewarped image can also be photometrically normalized (3208) utilizing photometric calibration data. The resulting acquired image can then undergo additional transformations (e.g., edge enhancement and / or high-pass filtering) prior to being provided as an input to a machine vision process such as (but not limited to) a feature detection process.

[0130] Although various image data acquisition processes are described above with respect to Figure 32, any of a variety of image data acquisition processes appropriate to the requirements of a particular imaging system and / or machine vision process may be utilized as appropriate for the requirements of a particular application according to various embodiments of the present disclosure. Processes that may be utilized within a machine vision process to identify an injection site target according to various embodiments of the present invention are discussed further below.

[0131] Injection site target identification The response of various types of dermal conditions may depend on the site where the treatment is administered. Thus, the machine vision process according to many embodiments of the present invention targets the treatment site in a manner that depends on the classification of the particular lesion and / or feature. The examples below focus on the classification of acne lesions, but it should be understood that any dermal condition that can be treated by alternative injection methods depending on the classification may utilize the injection process as described in FIG. 33.

[0132] A process that may be utilized by a machine vision system to determine an injection site target for an acne lesion according to various embodiments of the present disclosure is shown in FIG. 33. The process 3300 includes a step of determining whether a particular region of interest in which an acne lesion is detected contains a pustular lesion (3302). When the lesion is a pustular lesion, the process 3300 targets an injection site adjacent to a pilosebaceous unit (3304). When the lesion is not a pustular lesion, the process 3300 targets the pilosebaceous unit as the injection site (3306).

[0133] Both potential targets require knowledge of the location of the pilosebaceous unit. Thus, the pilosebaceous unit is identified regardless of the type of lesion (3308, 3310). When the lesion is a pustular lesion, the orientation of the handheld therapeutic device is monitored until a determination is made (312) that the orientation will result in an injection trajectory that is offset and parallel to the pilosebaceous unit. At that point, the process causes the injection to be performed (3316). As described above, the process can provide an indication to the user to begin the injection and / or to automatically begin the injection. When the lesion is not a pustular lesion, the orientation of the handheld therapeutic device is monitored until a determination is made (3314) that the orientation will result in an injection trajectory that enters the pilosebaceous unit through a pore and is parallel to the pilosebaceous unit. At that point, the process causes the injection to be performed (3316).

[0134] Although a particular process is described above with reference to FIG. 33 for selecting a treatment site target based on classification performed within a machine vision process, any of a variety of processes can be utilized that incorporate a variety of image data, utilize any of a variety of machine vision classification techniques, and / or obtain an injection site target in any of a variety of ways appropriate to the requirements of a particular application, according to various embodiments of the present disclosure.

[0135] Process for controlling injections Once a decision is made to begin an injection, a handheld therapeutic device according to various embodiments of the present disclosure is capable of administering the injection to a depth appropriate for the particular treatment being administered. As described above, the particular depth may depend on factors including (but not limited to) the location on the body and / or the particular treatment being administered. In some embodiments, the depth of the injection is determined based on sensor information received during the injection process.

[0136] A process for automatically performing an injection using a needle or microneedle according to an embodiment of the present invention is illustrated in FIG. 34. The process 3400 may include a step of determining an initial injection depth, beginning with the start of the injection (3402). During the injection, a force and / or displacement sensor is monitored (3404), and information derived from the sensor is utilized to determine if the appropriate depth has been reached and to stop further penetration of one or more needles or microneedles and / or to initiate delivery of a treatment (e.g., an injection). In the illustrated embodiment, the treatment includes injection of a fluid through the needle or microneedle. As can be readily appreciated, any of a variety of treatments can be administered using a process similar to the process described with reference to FIG. 34, including (but not limited to) any of the treatment modalities described above. Additionally, any of a variety of machine vision processes can be utilized alone or in combination within a machine vision system implemented according to an embodiment of the present disclosure. Various computational platforms that can be utilized to implement a machine vision system according to various embodiments of the present disclosure are discussed further below.

[0137] Machine Vision Processing System The machine vision system utilized in the handheld therapeutic device according to various embodiments of the present disclosure typically utilizes a processing system including one or more of a CPU, a GPU, and / or a neural processing engine. In some embodiments, image data is captured and processed using an image signal processor, and the acquired image data is then analyzed using one or more machine learning models implemented using a CPU, a GPU, and / or a neural processing engine. In some embodiments, the machine vision processing system is stored in the handheld therapeutic device. In some embodiments, the machine vision processing system is stored separately from and communicates with the handheld therapeutic device. In an embodiment, the machine vision processing system is connected to the handheld therapeutic device via a cable. In various embodiments, the machine vision processing system communicates with the handheld therapeutic device via a wireless connection. In some embodiments where the machine vision processing system is separate from the handheld therapeutic device, the handheld therapeutic device includes an imaging system and a processing system that handles the acquisition of image data. In many embodiments, the processing system also encodes the acquired image data and transmits the encoded image data to the machine vision processing system. In one embodiment, the machine vision processing system is implemented as a software application on a computing device such as (but not limited to) a mobile phone, a tablet computer, a wearable device (e.g., a watch and / or AR glasses), and / or a portable computer.

[0138] A machine vision processing system according to various embodiments of the present disclosure is illustrated in FIG. 35. The machine vision processing system 3500 includes a processor system 3502, an I / O interface 3504, a sensor system 3505, and a memory system 3506. As can be readily appreciated, the processor system 3502, the I / O interface 3504, the sensor system 3505, and the memory system 3506 can be implemented using any of a variety of components appropriate to the requirements of a particular application, including (but not limited to) a CPU, a GPU, an ISP, a DSP, a wireless modem (e.g., WiFi, Bluetooth modem), a serial interface, a depth sensor, an IMU, a pressure sensor, an ultrasonic sensor, a volatile memory (e.g., DRAM), and / or a non-volatile memory (e.g., SRAM and / or NAND flash). In the illustrated embodiment, the memory system is capable of storing a therapy application 3508. The therapy application can be downloaded and / or stored in the non-volatile memory. When executed, the therapy application can configure the processing system to implement machine vision processes, including (but not limited to) the machine vision processes described above and / or combinations and / or modified versions of the machine vision processes described above. In some embodiments, the therapy application 3508 utilizes calibration data 3510 stored in the memory system 3506 during image acquisition to perform processing, including (but not limited to) dewarping and photometric normalization of digitally captured images received via the I / O interface 3504 from one or more image acquisition systems (not shown), such as (but not limited to) a camera, a depth camera, a near-IR camera, and / or any other type of imaging system capable of capturing image data using an imaging sensor. In an embodiment, the therapy application 3508 utilizes model parameters 3512 stored in memory to process the acquired image data using machine learning models to perform processes, including (but not limited to) detection, tracking, classification, and / or therapeutic targeting.Model parameters 3512 for any of a variety of machine learning models can be utilized by the therapy application, including (but not limited to) the various machine learning models described above. In some embodiments, acquired image data 3514 is temporarily stored in a memory system during processing and / or saved for use in training / retraining model parameters.

[0139] In some embodiments, the machine vision processing system also includes a user interface. In some embodiments, the user interface can be any of a variety of input and / or output user interface modalities, including (but not limited to) buttons, audio devices, visual display devices (e.g., LEDs and / or displays). In some embodiments, the machine vision processing system communicates with an external device (e.g., a mobile phone) to display the user interface. As can be readily appreciated, the particular user interface and / or user interface input and output modalities will depend largely on the requirements of a particular application, according to various embodiments of the present disclosure.

[0140] Although a particular machine vision processing system is described above with reference to FIG. 35, it should be readily understood that the machine vision processes and / or other processes utilized in providing therapy via a handheld therapeutic device according to various embodiments of the present disclosure may be implemented on any of a variety of processing devices, including combinations of processing devices. Thus, handheld therapeutic devices according to embodiments of the present disclosure should be understood as not being limited to a particular imaging system, illumination system, machine vision processing system, therapy system, and / or injection system. The handheld therapeutic device can be implemented using any of the combinations of systems described herein and / or modified versions of the systems described herein to perform the processes, combinations of processes, and / or modified versions of the processes described herein.

[0141] Liquid Delivery Applications 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.

[0142] 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.

[0143] 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 0.5 mg / mL to 10 mg / mL. Thus, a solution containing triamcinolone can be contained in a fluid container (e.g., a syringe or cartridge) as described herein. The triamcinolone-containing container can be utilized in an injector system with microneedles. The 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.

[0144] 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.

[0145] 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.

[0146] 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

1. 1. A dermal condition treatment system comprising: a memory containing a therapy application; a set of one or more processors; 1. A handheld device, comprising:

1. An injection system comprising: a fluid-filled container, a needle in fluid communication with the fluid-filled container, and an internal drive system capable of ejecting fluid from the fluid-filled container and out of the needle; an image acquisition system having a camera optical system; An injection system comprising: a handheld device comprising: Equipped with the memory and the set of one or more processors are in communication with the handheld device; The set of one or more processors, via the therapy application: acquiring image data using the image acquisition system; detecting features in the obtained image data; using the acquired image data to identify a treatment site; initiating a treatment injection at the treatment site via the injection system; A dermal condition treatment system capable of performing steps including:

2. 10. The dermal condition treatment system of claim 1, wherein the injection system performs intradermal or subcutaneous fluid injections at the treatment site in response to performing the step of applying the treatment.

3. The camera optical system includes: Bayer camera, a monochrome camera capable of capturing red light; a monochrome camera capable of imaging an extended color spectral band including visible and near-infrared wavelengths; a camera capable of capturing near-infrared light; a camera capable of capturing infrared light; a camera including a polarizing filter; a camera capable of capturing multispectral images, or Depth Camera 10. The dermal condition treatment system of claim 1, comprising:

4. The camera optical system includes: Macro lens, Telecentric optics, or Periscope Optical System 10. The dermal condition treatment system of claim 1, comprising:

5. an illumination source activatable by said set of one or more processors; Furthermore, 10. The dermal condition treatment system of claim 1, wherein the set of one or more processors is also capable of performing the additional step of activating the illumination source via the treatment application.

6. The lighting system comprises: an infrared light source; a near-infrared light source; Linear polarized light source and 6. The dermal condition treatment system of claim 5, selected from the group consisting of:

7. a near-infrared light source that is activatable by the set of one or more processors via the therapy application; Furthermore, 10. The dermal condition treatment system of claim 1, wherein the image acquisition system comprises at least one camera capable of imaging near-infrared light.

8. a linearly polarized light source that is activatable by the set of one or more processors via the therapy application; Furthermore, 10. The dermal condition treatment system of claim 1, wherein the image acquisition system comprises at least one camera including a polarizing filter.

9. the obtained image data comprises a sequence of images; detecting the features in the acquired image data includes detecting a dermal condition in the sequence of images; Identifying the treatment site using the acquired image data includes: tracking the detected dermal condition using the sequence of images.

10. The dermal condition treatment system of claim 1, comprising:

10. 10. The dermal condition treatment system of claim 1, further comprising a sensor for monitoring injection depth, wherein the set of one or more processors is capable of directing the internal drive unit to control the injection depth via the treatment application and the sensor.

11. The dermal condition treatment system of claim 1 , wherein the set of one or more processors is stored within the handheld device.

12. The dermal condition treatment system of claim 1 , wherein the set of one or more processors is stored separately from the handheld device.

13. 10. The dermal condition treatment system of claim 1, wherein the fluid in the fluid-filled container comprises triamcinolone.

14. 1. A dermal condition treatment system comprising: a memory containing a therapy application; a set of one or more processors; 1. A handheld device, comprising: an injection system comprising at least one needle, said injection system being capable of ejecting a liquid through said at least one needle; at least one camera capable of communicating with the set of one or more processors; a handheld device comprising: Equipped with the memory and the set of one or more processors are in communication with the handheld device; The set of one or more processors, via the therapy application: obtaining image data using the at least one camera, the image data comprising a sequence of images; detecting a lesion in the sequence of images; tracking the detected lesion using the sequence of images; using the sequence of images to identify a treatment site; initiating injection of the liquid into the treatment area using the injection system; A dermal condition treatment system capable of performing steps including:

15. Obtaining image data using the at least one camera further comprises: capturing an image using the at least one camera; dewarping the captured image; normalizing the dewarped image; 15. The dermal condition treatment system of claim 14, comprising:

16. One of the at least one cameras includes at least one filter, the at least one filter comprising: A polarizing filter; a Bayer color filter that filters light onto the set of pixels such that two of four adjacent pixels image green light, one of the pixels image blue light, and one of the pixels image red light; a Bayer color filter that filters light onto the set of pixels such that two of four adjacent pixels image red light, one of the pixels image blue light, and one of the pixels image green light; a multispectral filter; A color filter that allows capture of a monochrome image in a specific spectral band, the specific spectral band comprising: The red channel, Near-infrared wavelengths, an extended color spectral band including visible and near-infrared wavelengths; a color filter selected from the group consisting of 15. The dermal condition treatment system of claim 14, selected from the group consisting of:

17. an illumination source activatable by said set of one or more processors; Furthermore, 15. The dermal condition treatment system of claim 14, wherein the set of one or more processors is also capable of performing the additional step of activating the illumination source via the treatment application.

18. The handheld device further comprises a lighting system, the lighting system comprising: Infrared light source, a near-infrared light source, or linear polarized light source 15. The dermal condition treatment system of claim 14, comprising:

19. a near-infrared light source that is activatable by the set of one or more processors via the therapy application; Furthermore, 15. The dermal condition treatment system of claim 14, wherein one of the at least one camera is capable of imaging near-infrared light.

20. a linearly polarized light source that is activatable by the set of one or more processors via the therapy application; Furthermore, 15. The dermal condition treatment system of claim 14, wherein one of the at least one camera includes a polarizing filter.

21. 15. The dermal condition treatment system of claim 14, wherein the injection system further comprises at least one force or displacement sensor and is controllable by the set of at least one processor via the treatment application.

22. Initiating injection of the liquid into the treatment site using the injection system includes: Determining the injection depth; monitoring sensor data generated by the at least one force or displacement sensor; determining whether the injection depth has been reached based on the sensor data; controlling the injection system to eject the liquid through the at least one needle when it is determined that the injection depth has been reached; 22. The dermal condition treatment system of claim 21, comprising:

23. 15. The dermal condition treatment system of claim 14, wherein initiating injection of the liquid into the treatment site using the injection system includes providing an indication via a user interface, the indication directing a user to manually initiate the injection.

24. 15. The dermal condition treatment system of claim 14, wherein the set of one or more processors is stored within the handheld device.

25. 15. The dermal condition treatment system of claim 14, wherein the set of one or more processors is stored separately from the handheld device.

26. 15. The dermal condition treatment system of claim 14, wherein the liquid is triamcinolone.

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