FAT USING DISSOLUTION AGENT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/726,426, entitled“Novel Method of Deep Peeling to Remove Under Skin Layer of Fat via Dissolution Using a Dissolution Agent Delivered via Micro Needles Array,” filed September 4, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also claims priority to and the benefit of U.S. Provisional Patent Application No. 62/801,309, entitled“Apparatus and Methods for Removal of Subcutaneous Fat Using Dissolution Agent,” filed February 5, 2019, the disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

[0003] Embodiments are described herein that relate to devices and methods for use in procedures involving the removal of subcutaneous fat of a subject/patient using a dissolution agent delivered via a needle array. The dissolution agent can dissolve the subcutaneous fat and the patient’s body can digest the results of the fat dissolution reaction.

[0004] One known procedure for subcutaneous fat reduction is liposuction, which can be a dangerous procedure that can pose health risks to the patient due in part to the sharp reduction in subcutaneous fat. In addition, such procedures typically have a low level of success.

[0005] Bariatric surgery is another surgical procedure to help patients lose weight (e.g., fat) but is highly invasive, expensive, and not all patients benefit from the procedure. Insurance plans do not normally cover the procedure with very rare exceptions in highly obese patients with life-threatening conditions. Conventional approaches to non-surgical guaranteed weight loss can involve either highly traumatic intense dieting followed by punishing invasive liposuction, that can leave a patient incapacitated or in severe discomfort for an extended period of time. [0006] Thus, a need exists for improved devices and procedures for reducing and/or removing subcutaneous fat layers in a subject’s body that is more economical and minimizes negative effects to the subject than other known fat reducing procedures.

SUMMARY

[0007] Devices and methods are described herein for use in transdermal lipolysis procedures to remove a subcutaneous layer of fat of a subject/patient using a dissolution agent delivered via a needle array. In some embodiments, a method includes coupling a needle cartridge to a treatment head of a robotic lipolysis treatment device. The cartridge includes a needle array having multiple needles. The treatment head can be positioned at a designated treatment area on a patient with a bottom end in contact with the skin of the patient. The treatment head can be actuated to insert at least a portion of the multiple needles through the skin of the patient and into the underlying subcutaneous fat layer of the patient. A dissolution agent can be injected through the multiple needles and into the subcutaneous fat layer. In some embodiments, the cartridge can include a top portion and a bottom portion removably coupleable to the top portion and the multiple needles are disposed on the top portion. In some embodiments, the dissolution agent is disposed in a chamber in the bottom portion and the multiple needles are actuated to draw the dissolution agent from the chamber and into the multiple needles. In some embodiments, the multiple needles are prefilled with a dose of dissolution agent.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a schematic illustration of robotic treatment device, according to an embodiment disposed adjacent a surgical table with a patient disposed thereon.

[0009] FIG. 2 is a schematic illustration of the robotic treatment device of FIG. 1.

[0010] FIG. 3A is a schematic illustration of a treatment head and cartridge of the robotic treatment device of FIG. 1.

[0011] FIG. 3B is a schematic illustration of an alternative embodiment of a treatment head and cartridge of the robotic treatment device of FIG. 1. [0012] FIG. 3C is a schematic illustration of an alternative embodiment of a treatment head and cartridges of the robotic treatment device of FIG. 1.

[0013] FIGS. 4A and 4B are a schematic illustrations showing an embodiment of a needle array disposed above a top surface of a subject’s skin and injecting a dissolution substance into the subject’s body, respectively.

[0014] FIG. 4C is a schematic illustration showing a needle array injecting dissolution substance into a subject’s body and illustrating layers of the subject’s skin and subcutaneous fat layer.

[0015] FIG. 5A is a side perspective view of a robotic treatment device, according to another embodiment.

[0016] FIG. 5B is an enlarged cross-sectional perspective view of a treatment head of the robotic treatment device of FIG. 5 A.

[0017] FIG. 6 is a perspective view of the treatment head of FIG. 5B with a portion of the outer housing removed for illustration purposes.

[0018] FIG. 7 is a bottom perspective view of the treatment head of FIG. 6 illustrating a needle array cartridge attached to the treatment head with the needles extended outward from the treatment head and a cartridge cap unattached.

[0019] FIG. 8 is a perspective view of the needle array cartridge of FIG. 7, with the top portion of the cartridge and needle array disposed above the bottom portion of the cartridge.

[0020] FIG. 9 is an enlarged perspective view of a lower portion of the treatment head of FIG. 6, with portion of outer housing removed, and the upper portion of the needle array cartridge attached thereto, with the needle array extended outward and the bottom portion of needle array cartridge unattached.

[0021] FIG. 10 is a cross-sectional perspective view of the portion of the treatment head and needle array cartridge of FIG. 9.

[0022] FIG. 11 is a cross-sectional view of the treatment head and needle array cartridge of FIG. 5B. [0023] FIG. 12 is a perspective view of a schematic illustration of a robotic treatment device, according to another embodiment, shown disposed adjacent a patient on a surgical table.

[0024] FIG. 13 is a perspective view of a treatment head of the robotic treatment device of FIG. 12.

[0025] FIG. 14 is a bottom perspective view of the treatment head of FIG. 13.

[0026] FIG. 15 A is a front perspective view of the treatment head of FIG. 13 with a portion of the outer housing removed for illustration purposes, and two enlarged views of portions of the treatment head.

[0027] FIG. 15B is a schematic illustration of a piezo motor that can be included in the treatment head of FIG. 13.

[0028] FIGS. 16A and 16B are schematic illustrations illustrating a change in electric potential as a function of needle insertion depth.

[0029] FIG. 17 illustrates a needle retraction mechanism included in a portion of the treatment head of FIG. 13.

[0030] FIG. 18A is a bottom perspective view of a portion of the treatment head of FIG. 13 and the robotic arm unit of FIG. 12 shown disposed near a patient.

[0031] FIG. 18B is a side perspective view of a portion of the treatment head of FIG. 18A shown disposed above the skin of a patient.

[0032] FIG. 19A is a side perspective view of the treatment head of FIG. 18A disposed in contact with the skin of a patient.

[0033] FIG. 19B is an enlarged side view of a portion of the treatment head of FIG. 18A disposed just above the skin of a patient with a portion of the outer housing removed for illustration purposes.

[0034] FIG. 20A is a side perspective view of the treatment head of FIG. 18A disposed in contact with the skin of a patient with the needles in an up position within the treatment head. [0035] FIG. 20B is side perspective view of the treatment head of FIG. 18A disposed in contact with the skin of a patient with a syringe portion of the needles in a down position and in contact with the skin of the patient.

[0036] FIG. 21 A is a perspective view of the treatment head of FIG. 18A disposed in contact with the skin of a patient with the sharp distal end of the needles in a down position and in contact with the skin of the patient.

[0037] FIG. 21B is a perspective view of the treatment head of FIG. 18A disposed in contact with the skin of a patient with the sharp distal end of the needles in a down position and inserted through the skin and subcutaneous fat layer of the patient.

[0038] FIG. 22 is a side view of the treatment head of FIG. 18A disposed in contact with the skin of a patient with the sharp distal end of the needles retracted back into an up position within the treatment head.

[0039] FIGS. 23A and 23B are a flowchart illustrating a method of treating a patient using a robotic treatment device to remove and/or reduce subcutaneous fat in a patient.

DETAILED DESCRIPTION

[0040] Devices and methods are described herein for use in transdermal lipolysis procedures to remove a subcutaneous layer of fat of a subject/patient using a dissolution agent delivered via a needle array (e.g., a microneedle array). The methods described herein are minimally invasive and utilize a removable and disposable needle array cartridge that can provide economic and/or hygienic benefits. The dissolution agents (e.g., lipolytic agents and substances) can dissolve subcutaneous fat, and the patient’s body can digest the results of the fat dissolution reaction. The needle array can be provided in a disposable cartridge that can be removably coupled to a robotic treatment device as described herein. In some embodiments, the needle array can include various sensors such as sensors used to accurately position the needle array at a desired treatment location on a patient’s body and ensure that all needles touch the patient’s skin uniformly.

[0041] The robotic treatment device can include, for example, a robotic arm coupled to a treatment head carrying the needle array cartridge. The robotic arm can provide multiple degrees of freedom of movement of the treatment head, and via controllers and micro engines within the treatment head, can control the movement and operation of the needle array. Because the treatment site on a patient’s body may not necessarily be a flat surface, the sensors and controllers can be used to uniformly position the needle array at a desired treatment site on the surface of the skin of the patient, prior to actuation of the needles into the skin. In some instances, prior to treatment the needle positions can be calibrated on a flat surface. In addition, the needle array can be primed (e.g., by removing any air in the needles) prior to insertion of the needle array.

[0042] In some embodiments, the density or spacing of the needles within the needle array can be about 3-5 millimeters (mm) between needles such that the dissolution agent injected from each needle into the patient will have some overlap and a uniform distribution of the dissolution agent. The gauge of needle can be, for example, a 34-guage (G) needle or less (e.g., 35G, 36G or 37G) with a length of, for example, 5mm or greater. With such a needle arrangement, and for example, 34G needles having an outer diameter of 0.00725 niches (0.1842 mm) and an inner diameter (which can vary depending on wall thickness of the needle) of about 0.00325 inches (in) (or about 0.0826 mm), a uniform injection of the lipolytic agent into the patient’s body can be achieved, with for example, a volume of lipolytic dissolving agent of about 0.05 cc to about 0.25 cc ((3-5 mm) x (3-5 mm) x (0.5-1 mm)) passing through each needle to eliminate, for example, 0.5-1 mm of subcutaneous fat at each injection site. In some embodiments, the pressure in each needle can be controlled individually or as a group or subgroup (e.g., 9, 16, 25 needles) of all the needles in an array.

[0043] In some embodiments, a procedure using the devices and methods described herein includes a multi-stage procedure of continuous deep peeling to reduce subcutaneous fat (e.g., fat tissue layer 0.5 inch under the skin), in a layer-by-layer manner. With deep peeling based on the use of a needle array as described herein, the patient will have time for rest after each procedure, allowing for the skin to have small incremental adjustments, as opposed to sudden changes that may have a negative impact on the patient’s body. The devices and methods described herein are designed to reduce or eliminate factors of significant risk and consequence of surgical fat removal by using this step-by-step procedure with a minimal invasion level. An example treatment plan may include monthly lipolysis procedures with the treatment device and needle array described herein until a level of acceptable fat elimination has been achieved for a particular patient. Such step-by-step reduction can reduce or prevent scars and minimize treatment related visible traces. [0044] In some embodiments, an apparatus includes a robotic arm having multiple linkages and a treatment head coupleable to an end of the robotic arm. At least one cartridge is removably coupleable to the treatment head. The removable cartridge can include a top portion and a removable bottom portion. The top portion includes a needle array having a set of needles, and the bottom portion includes a chamber containing a preset dose of a dissolution agent. Each of the needles is configured to receive a portion of the preset dose of dissolution agent from the chamber. The treatment head is configured to contact a patient’s skin and inject the preset dose of dissolution agent through the patient’s skin and into an underlying subcutaneous fat layer. The dissolution agent is configured to dissolve fat within the subcutaneous fat layer.

[0045] In some embodiments, a method includes coupling a needle cartridge to a treatment head of a robotic lipolysis treatment device. The cartridge includes a needle array having multiple needles. The treatment head can be positioned at a designated treatment area on a patient with a bottom end in contact with the skin of the patient. The treatment head can be actuated to insert at least a portion of the multiple needles through the skin of the patient and into a subcutaneous fat layer of the patient. A preset dose of a dissolution agent can be injected through the multiple needles and into the subcutaneous fat layer. In some embodiments, the cartridge can include a top portion and a bottom portion removably coupleable to the top portion and the multiple needles are disposed on the top portion. In some embodiments, the dissolution agent is disposed in a chamber in the bottom portion and the multiple needles are actuated to draw the dissolution agent from the chamber and into the multiple needles. In some embodiments, the multiple needles are prefilled with a dose of dissolution agent.

[0046] In some embodiments, a system for providing a patient with a lipolysis treatment using a dissolution agent can include a treatment head coupled to an end portion of a robotic arm and a computing device in communication with the treatment head and the robotic arm. The computing device includes at least a memory and a processor. The processor is configured to execute a set of instructions stored in the memory to (1) define a lipolysis treatment plan for a target area of the patient, (2) couple the treatment head to a cartridge having a needle array, (3) place the treatment head in contact with the skin of the patient within the target area, and (4) actuate the cartridge within the treatment head. Each needle included in the needle array contains a volume of the dissolution agent. The actuation of the cartridge within the treatment head be operable to (1) insert into a subcutaneous fat layer contained in the target area of the patient at least a portion of the needles included in the needle array according to the treatment plan and (2) inject into the subcutaneous fat layer the volume of the dissolution agent contained in each needle inserted into the subcutaneous fat layer.

[0047] FIGS. 1-3B are schematic illustrations of a robotic lipolysis treatment device 100 (also referred to herein as“treatment device”), a surgical table T and a patient P disposed thereon, according to an embodiment. The treatment device 100 can be used to reduce subcutaneous fat of the subject/patient P using a dissolution agent (e.g., lipolytic agent). As shown in FIG. 1, the treatment device 100 can include a computing device 124, a robotic arm unit 126 in communication with and controlled by the computing device 124 by a wired or wireless connection, and a treatment head 120, or manually controlled by the user. The robotic arm unit 126 can include a base structure (not shown in FIGS. 1-3B), and a robotic arm 128. The base structure can be for example, a floor support device, optionally with wheels to allow the robotic arm unit 126 to be moved to an in use position proximate the surgical table T or a stowed position disposed away from the surgical table T. The robotic arm 128 can be coupled to the treatment head 120 and include one or more linkages 129 (two shown in FIGS. 1 and 2) to provide, for example, the treatment head 120 with multiple degrees of freedom of movement (e.g., 6-axis movement). For example, the linkages 129 of the robotic arm 128 can be coupled together and/or to the treatment head 120 with various coupling joints, such as, for example, a pivot joint, a sliding or telescoping coupling, etc., such that the treatment head 120 can be moved in multiple linear and rotational directions and orientations, such as left-right, forward-backward, up-down, and/or rotational.

[0048] The computing device 124 can include one or more processors (e.g., one or more central processing units (CPU) or the like), one or more memory components, and one or more controllers, and can be in communication with the various components of the treatment device 100 through a wireless or wired connection (e.g., a network connection). The computing device 124 can also include, for example, (a) a monitor/display unit to visualize skin surface, skin depth map and injection process, (b) emergency shut-off unit for emergency interruption of treatment, and (c) an interface for the physician to manage the treatment process, including, for example, defining robotic arm path, exclusion of areas of risk from injection, etc. The computing device 124 can be configured to execute a set of instructions and/or code associated with controlling, for example, the robotic arm 128, the treatment head 120, and/or any other suitable portion of the treatment device 100.

[0049] The treatment head 120 can receive a removable and disposable needle array cartridge 130 (also referred to herein as“cartridge” or“needle cartridge”) that can be used to inject the dissolution agent into the patient P. The cartridge 130 can be stored in a cartridge storage unit or dispenser 123 as shown in FIG. 2. The dispenser 123 can store multiple new and/or used cartridges. The robotic arm unit 126 can be maneuvered or actuated to retrieve a cartridge 130 from the dispenser 123 prior to a treatment procedure, and the cartridge 130 can be coupled to a bottom portion of the treatment head 120 either automatically using the robotic arm unit 126, or manually by the medical provider using the device.

[0050] The treatment head 120 includes a pump mechanism 140, a needle management and control mechanism (based on micro motors) 127 (shown in FIGS. 3A and 3B as“Needle Control”), a sensor system that includes one or more sensors and/or scanners 125, and a mechanism to manipulate the cartridge 130 (not shown), each of which can be in communication with and controlled at least in part by the computing device 124. The pump or pump mechanism 140 can be used to draw the lipolytic agent into the needles of a needle array 136 of the cartridge 130, and to inject the lipolytic agent into a patient, as described in more detail below. The needle management and control mechanism 127 can control and manage each needle within the needle array 136 separately and/or collectively in a group or any number of subgroups. For example, each needle can be moved independently up and down to a defined distance. In addition, the needle management and control mechanism 127 can control the amount of the dissolution substance to inject and speed of injection within each needle separately.

[0051] The needle management and control mechanism 127 can include any suitable drive mechanism, motor, actuator, activator, and/or the like. For example, the motor can be a microelectromechanical systems (MEMS) device or the like, a piezo motor, and/or any other suitable drive mechanism. In some embodiments, the needle management and control mechanism 127 can include a MEMS device configured to provide a rotational output or the like that can be converted via any suitable gearing or kinematic linkage to linear movement configured to move the needle array 136 and/or plungers within the needles. In some embodiments, the needle management and control mechanism 127 can include one or more piezo motors that include a piezo material configured to transition between operating states in response to a flow of electric power or current. For example, the piezo material can expand and/or elongate in response to a flow of electric power or current, which in turn, can be used to move the needle array 136 and/or plungers within the needles. As such, the movement of the piezo material (e.g., either expanding or contracting) can be in a substantially linear motion, which in turn, can result in a substantially linear motion of the needle array 136 and/or plungers within the needles.

[0052] The cartridge 130 can include, for example, a set of electromagnetic locks which are in an on or off position depending on the magnetic or electric fields applied to them, from for example, an electromagnetic attachment mechanism for attaching the cartridge 130 to the treatment head 120. For example, one set of locks can control the attachment and detachment of a cartridge 130 to the treatment head 120. Another set of locks can control the attachment and detachment of a bottom part of the cartridge 130 to a top portion of the cartridge 130 (details of the cartridge 130 are described in more detail below). In one example, the cartridge 130 can include a magnetic attachment mechanism as described in more detail below.

[0053] The sensor system can include multiple different types of sensors 125 disposed at various locations within the treatment head 120 depending on the purpose and function of the sensor. The types of sensors 125 can include, for example, light and ultrasound sensors that can be used, for example, to analyze skin thickness or depth (e.g., ultra sound 20-25 MHz); and/or visual sensors or scanners, such as an optical scanner to scan the skin surface and identify any anomalies and dangerous areas at the treatment area, such as a mole, wart, etc.; and/or sensor(s) to analyze and sense the contact between the treatment device and the skin of the patient; and/or electric sensors to check each needle contact with the skin (e.g., sensors disposed in contact with needles); and/or sensor(s) to check cartridge attachment/detachment to treatment head 120. In some embodiments, a treatment head 120 can include sensors disposed along a bottom circumferential edge of the treatment device 120.

[0054] As shown in FIG. 3A, the cartridge 130 can include a top portion 132 that holds a needle array 136 and a bottom portion or cap 134 that contains a pre-filled amount of the lipolytic or dissolution agent (labeled LA). The needle array 136 can include multiple needles (e.g., nano, micro, other suitable types and/or sizes) that can be, for example, 34G or smaller (e.g., 35G, 36G, 37G) and 5 mm in length or greater. The bottom portion or cap 134 can maintain the lipolytic substance covered hermetically by a layer of medical resin (not shown in FIGS. 1-3B). The cartridge 130 can be provided in various sizes, such as, for example, 20cm x 20cm, lOcm x lOcm, 5cm x 5cm, and/or any size or fraction of a size therebetween. The top portion 132 can have a needle array 136 with a corresponding number of needles. In one example, the needles of the needle array 136 can be disposed, for example, with a distance of 5mm between each needle. The needles of the needle array 136 can be, for example, 34G steel injection needles. In one example embodiment, the cartridges 130 can be 5in x 5in with a 20 x 20 array of 34G injection needles (i.e., 400 needles). In some embodiments, each needle of the needle array 136 can have its own dose control element attached to it and a fixed volume of fat lipolytic agent. The dose control elements can be synchronized with needle control mechanism 127.

[0055] The disclosed devices and methods of treatment can be used with a wide range of dissolution agents. Non-limiting examples of dissolution agents include the following. A dissolution agent can be a lipolytic agent such as an aqueous phospholipid system that includes at least one phospholipid, at least one bile acid (naturally derived, or synthetic), and water. The term“phospholipid” means compounds such as 3-sn-phosphatidylcholine, soya (Phospholipon 90), 3-sn-phosphatidylcholine, reduced soya (Phospholipon 90H), 3-(3sn)- phosphohatidyl)glycerol soya (Phospholipon G), dimyristoylphosphatidylglycerol, lyso- phosphatidylcholine or dipalmitoyl-phosphatidylglycerol and the physiologically tolerated salts thereof. The term“bile acid” means compounds such as deoxycholic acid (“DA”), cholic acid, lithocholic acid, chenodeocycholic acid, hyodeoxycholic acid, trihydroxycoprostanic acid, ursodeoxycholic acid, taurocholic acid or glycocholic acid, and the physiologically tolerated salts thereof. Such dissolution agents can include other components, such as: a) other components assisting degradation of fat (including vitamins such as riboflavin (also referred to as vitamin B2 or lactoflavin) or carnitine (b-hydroxy-g-N- trimethylaminobutyrate - the L stereoisomers is suitable, but the D form can be harmful)); b) an anti-inflammatory compound (compounds such as tocopherol or a non-steroidal anti inflammatory drug such as diclofenac or a corticosteroid such as triamcinolone); c) antioxidants (such as ascorbic acid, sodium bisulfite or sodium pyrosulfite); d) preservatives (such as benzyl alcohol); e) buffers (an aqueous solution comprising a mixture of a weak acid and its conjugate base or a weak base and its conjugate acid to control pH, which in a phospholipid system can prevent the precipitation of DA). These systems can include, for example, any of those disclosed in U.S. Patent Publication Nos. 2009/0275545, 2010/0004216, and/or US Patent No. 10,071,105, the disclosure of each of which is incorporated herein by reference in its entirety. Two examples of such aqueous phospholipid systems are: a) the lipolytic agent sold under the trademark Kybella®, which is a substance approved by the U.S. FDA and is based on the chemical substances: Phosphatidylcholin (PC) and DA; and b) a generic compound approved in the European Union called Lipostabil, which is: 5% PC and 2.5% DA. Other dissolution agents that are later approved can also be used.

[0056] When the cartridge 130 is retrieved from the dispenser 123 and coupled to the treatment head 120, the cap 134 is coupled to the top portion 132. The cartridge 130 can be releasably coupled to the treatment head 120 with various different coupling methods. For example, in some embodiments, the cartridge 130 can be attached to the treatment head 120 using an electromagnetic lock (not shown). The electromagnetic lock can have an on/off mode, which depends on the electromagnetic field applied to or for it. The electromagnetic lock can be similar to a magnet detacher for closing a security tag on a product. For example, the magnetic lock or block can include two parts, combined or connected by a clip, which may change position under electromagnetic field impact. The clip keeps the two parts together in an initial position, and if and/or when the electromagnetic field is applied, the clip position will change to release the two parts. An example of such a mechanism is disclosed in U.S. Patent No. 9,779,599, the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, a latch system (not shown) can be used.

[0057] In general, an electromagnetic lock, magnetic lock, or maglock is a locking device that can include an electromagnet and an armature plate. There are two main types of electric locking devices. Locking devices can be either "fail safe" or "fail secure". A fail-secure locking device remains locked when power is lost. A fail-safe locking device is unlocked when de-energized. Direct pull electromagnetic locks are inherently fail-safe. In one example, the electromagnet portion of the lock is attached to, for example, a door frame and a mating armature plate is attached to the door. The two components are in contact when the door is closed. When the electromagnet is energized, a current passing through the electromagnet creates a magnetic flux that causes the armature plate to attract to the electromagnet, creating a locking action. Because the mating area of the electromagnet and armature is relatively large, the force created by the magnetic flux is strong enough to keep the door locked even under stress. [0058] The treatment head 120 detects the attachment of the cartridge 130 and causes the needle array 136 to be operatively coupled to the internal pump mechanism 140. In some embodiments, the treatment head 120 and/or the cartridge 130 can include an electric, electronic, and/or magnetic chip that can control the attachment of the cartridge 130 to the treatment head 120 and/or access to the cartridge 130 once the cartridge 130 is attached to the treatment head 120. For example, in addition to attaching to the treatment head 120 via the electromagnetic lock, the cartridge 130 can include a lock or seal mechanism configured to keep the cartridge 130 in a locked, sealed, and/or pre-use state prior to being coupled to the treatment head 120. The locked, sealed, and/or pre-use state can be such that access to the needle array 136 is limited and/or substantially prevented. In some embodiments, the locked, sealed, and/or pre-use state can be one in which actuation of the needle array 136 is prevented or limited. In other embodiments, the locked, sealed, and/or pre-use state can limit and/or substantially prevent the cap 134 from being removed from the top portion 132 of the cartridge 130, thereby blocking or preventing access to the needle array 136.

[0059] In some embodiments, the cartridge 130 can include a chip or one or more components of the electromagnetic lock that can be configured to control at least a portion of the cartridge 130 to maintain the cartridge 130 in the locked, sealed, and/or pre-use state until the cartridge 130 is attached to the treatment head 120. In some such embodiments, the cartridge 130 can only be unlocked by attaching the cartridge 130 to the treatment head 120. For example, a chip can be programmed with a hash code or the like and embedded into a portion of the cartridge 130. The cartridge 130 can be configured to remain in a locked state until the hash code is verified by attaching the cartridge 130 to the treatment head 120 (e.g., via the electromagnetic lock). This arrangement can ensure, for example, the sterility and/or security of the needle array 136 and/or the lipolytic substance or agent contained in the needles.

[0060] In some embodiments, the cartridge 130 can include one or more sensors that can detect a status of the needle array 136 and/or the lipolytic substance or agent contained therein. For example, the one or more sensors can sense a temperature and/or humidity, and if it is determined that the temperature and/or humidity is outside of an acceptable or desired range, the cartridge 130 can be maintained in the locked, sealed, and/or pre-use state whether or not the cartridge 130 is attached to the treatment head 120. Similarly, the one or more sensors can be configured to sense, detect, and/or otherwise determine an amount of vibration, an acceleration, a position or location, an orientation, and/or any other suitable characteristic. More generally, the cartridge 130 can include any suitable sensor or set of sensors configured to sense, detect, assess, and/or determine any number of characteristics, attributes, statuses, etc. associated with the cartridge 130 and, if any characteristic or the like is outside of an acceptable or desired range or beyond a predetermined tolerance, the cartridge 130 can be maintained in the locked, sealed, and/or pre-use state. In some instances, bringing the characteristic of the cartridge 130 within the predetermined tolerance can allow the cartridge 130 to be unlocked when attached to the treatment head 120. In other instances, exceeding the predetermined tolerance for a given characteristic may place the cartridge 130 in a permanently locked state (e.g., exceeding a temperature, humidity, of age threshold may place the cartridge 130 in a permanently locked state). This arrangement can, in some instances, ensure patient safety.

[0061] After the cartridge attachment has been confirmed, the needle management mechanism can actuate the needles of the needle array 136 to cause the needles be lowered through the medical resin and into the lipolytic agent LA within the bottom portion (or cap) 134. The pump 140 can then be actuated to draw or suction the lipolytic agent into the needles of the needle array 136. The bottom portion 134 can then be removed and placed back in the dispenser 123 or otherwise be set aside during the treatment procedure. After the procedure, the bottom portion 134 is again attached to the top portion 132 while still coupled to the treatment head 120, and the cartridge 130 as a whole (top portion 132 and bottom portion 134) is removed from the treatment head 120. This follows proper hygienic procedures for handling of the used cartridge 130 (e.g., needles). The used cartridge 130 can be placed back in the dispenser 123 or disposed of.

[0062] While the specific components have just been described as performing one or more actions, it should be understood that such actions can be initiated by and/or in response to one or more signals received from the computing device 124 and/or a portion thereof. For example, the computing device 124 can determine when the cartridge 130 is attached to the treatment head 120 based on signals, data, and/or information received from one or more sensors; the computing device 124 can execute a set of instructions or code to cause the robotic arm 128 to move the treatment head 120 in a desired manner, the computing device 124 can send a signal and/or a flow of electric power to actuate the needle array 136 and/or pump 140; and/or the computing device 124 can execute a set of instructions or code to cause the bottom portion 134 to be removed from and/or reattached to the top portion 132.

[0063] FIG. 3B illustrates an alternative embodiment of a treatment head 120’ with a cartridge 130’. In this embodiment, the cartridge 130’ includes a top portion 132’ and a bottom portion 134’, but the top portion 132’ contains the lipolytic substance and the bottom portion 134 functions as a cap. In this embodiment, the cartridge 130’ can be retrieved from the dispenser 123 and attached to the treatment head 120’ as described above and actuated to draw the lipolytic substance from the top portion 132’ into the needles 136’. The bottom portion or cap 134’ can then be removed. After a procedure is performed with the treatment device, the cap 134’ is placed back on the top portion 132’ and the cartridge 130’ removed as described above.

[0064] FIG. 3C illustrates yet another alternative embodiment of a treatment head 120”, a first cartridge 130” and multiple second cartridges 131”. In this embodiment, the first cartridge 130” (or also referred to as top cartridge) includes a portion 132” that defines a chamber that contains an amount of lipolytic substance to perform multiple treatments or an entire treatment plan. For example, the top cartridge 130” can include an amount of lipolytic agent to perform multiple injections for an entire treatment plan, such as a treatment plan including 10 separate injections at different treatment sites (e.g., for an abdominal area). The multiple second cartridges 131” (or bottom cartridges) include a needle array 136” and the needles are provided empty (no lipolytic agent). Although two bottom cartridges 131” are shown, it should be understood that there can be more than two bottom cartridges 131”. In use, in this embodiment, the first cartridge 130” can be retrieved from the dispenser 123 and attached to the treatment head 120” as described above. A bottom cartridge 13 l”-l is then operatively coupled to the treatment head 120” and top cartridge 130”. The device can be actuated to pull lipolytic agent from the top cartridge 130” and into the needles of the needle array 136” of the bottom cartridge 13 l”-l . The device can be used to perform a first injection at a treatment site and then the bottom cartridge 13 l”-l can be removed and a second cartridge 131”-2 can be retrieved from the dispenser 123 and operatively coupled to the treatment head 120” and top cartridge 130”. This can be repeated for the desired number of treatments.

[0065] In use, the treatment area of the patient can be marked by the physician and the treatment device 100 can scan the marked area and define the trajectory of movement (e.g., step-by-step horizontal movement, step-by-step vertical movement, etc.). When the physician approves the planned trajectory, the treatment head 120 can be actuated to retrieve a first cartridge 130 from the dispenser 123. The cartridge 130 is attached to the bottom portion of the treatment head 120 as described above. The attachment of the cartridge 130 to the treatment head 120 causes the needle array 136 to be operatively coupled to the internal pump mechanism 140.

[0066] FIGS. 4A-4C are schematic illustrations depicting the injection of a lipolytic agent into the skin and fat layer of a subject. FIG. 4A illustrates a portion of a cartridge 130” with needle array 136” disposed above the skin of a patient P. FIG. 4B illustrates the cartridge 130” actuated toward the patent P and the needles of the needle array 136” inserted into the skin of the patient P. FIG. 4C illustrates the cartridge 130” and needle array 136” inserted into the subcutaneous fat layer F under the skin layers SL of the patient P.

[0067] FIGS. 5A-11 illustrate a robotic lipolysis treatment device 200 (also referred to herein as“treatment device” or“robotic treatment device”), according to an embodiment. The robotic treatment device 200 can be used to reduce a subcutaneous layer of fat of the subject/patient using a dissolution agent (e.g., lipolytic agent) and can include features and components as described above for the previous embodiment. As shown in FIG. 5A, the treatment device 200 can include a computing device (not shown in FIGS. 5A-11), a robotic arm unit 226 in communication with and controlled by the computing device by a wired or wireless connection, and a treatment head 220, or manually controlled by the user. The robotic arm unit 226 can include a base structure 221, and a robotic arm 228. The base structure 221 (also referred to herein as“base”) can optionally include wheels to allow the robotic arm unit 226 to be moved to an in use position proximate a surgical table and patient or a stowed position disposed away for the surgical table. The robotic arm 228 can be coupled to the treatment head 220 and include one or more linkages 229 (two shown in FIGS. 1 and 2) to provide, for example, the treatment head 220 with multiple degrees of freedom of movement (e.g., 6-axis movement). For example, the linkages 229 of the robotic arm 228 can be coupled together and/or to the treatment head 220 with various coupling joints, such as, for example, a pivot joint, a sliding or telescoping coupling, etc., such that the treatment head 220 can be moved in multiple linear and rotational directions and orientations, such as left-right, forward-backward, up-down, and/or rotational. [0068] The computing device 224 can include one or more processors (e.g., one or more CPUs or the like), one or more memory components, one or more controllers, and can be in communication with the various components of the treatment device 200 through a wireless or wired connection (e.g., a network connection).

[0069] As with the previous embodiment, the treatment head 220 can receive a removable and disposable needle array cartridge 230 (also referred to herein as“cartridge” or “microneedle cartridge”) that can be used to inject the dissolution agent into a patient. The cartridge 230 can be stored in a cartridge storage unit or dispenser (not shown in FIGS. 5A- 11), such as dispenser 123, described above. The dispenser can store multiple new and used cartridges. The robotic arm unit 226 can be maneuvered or actuated to retrieve a cartridge 230 from the dispenser prior to a treatment procedure, and the cartridge 230 can be coupled to a bottom portion of the treatment head 220 either automatically using the robotic arm unit 226, or manually by the medical provider using the device.

[0070] As shown, for example, in FIG. 5B, the treatment head 220 includes a housing 238 that includes an upper housing portion 246 and a lower housing portion 242. The upper housing portion 246 and the lower housing portion 242 can be separate components coupled together or a single integrally formed component. Within an interior of the housing 238 is a pump mechanism 240, a needle management and control mechanism (based on micro motors) (not shown) and a cartridge mechanism (not shown) configured to manipulate a cartridge 230 coupled thereto, each of which can be in communication with and controlled by the CPU of the computing device. The lower housing portion 242 of the housing 238 includes a shaft 239 through which the cartridge mechanism is movably disposed. The treatment head 220 can also include an electrode component or device 237, and a pitch propeller 241, and a sensor element 225 that can include one or more sensors and/or scanners. The electrode 237 can control, detect, and/or sense patient skin touching. The pump 240 can be used to draw the lipolytic agent into needles 248 of a needle array 236 of the cartridge 230, and to inject the lipolytic agent into a patient, as described in more detail below. The pitch propeller 241 maintains the main pressure for injections of the lipolytic agent.

[0071] The sensor element 225 (also referred to herein as“sensor”) can be disposed at a bottom portion of the treatment head 220 as shown in FIGS. 5B-11 and can include one or more sensors and/or scanners. The sensor 225 can be included within a component separate from the lower housing portion 242 as shown, or can be incorporated within the bottom of the lower housing portion 242. The treatment head 220 can also include additional sensors and/or scanners at other locations disposed on or within the housing 238 of the treatment head 220. The sensor 225 can include, for example, light and/or ultrasound sensors that can be used, for example, to analyze skin thickness or depth (e.g., ultra sound 20-25MHz); and/or visual sensors or scanners, such as an optical scanner to scan the skin surface and identify any anomalies and dangerous areas at the treatment area, such as a mole, wart, etc.; and/or sensor(s) to analyze and sense the contact between the treatment device and the skin of the patient. The treatment head 220 can also include sensors, such as, for example, electric sensors to check each needle contact with the skin (e.g., sensors disposed in contact with needles) and/or sensor(s) to check cartridge attachment/detachment to treatment head (each not shown in FIGS. 5B-11).

[0072] In this embodiment, the cartridge(s) 230 include a top portion 232 that holds a needle array 236 with multiple needles 248 (also referred to herein as“needles”), and a bottom portion or cap 234 that contains a pre-filled amount of a lipolytic or dissolution agent (not shown). The cartridge 230 can be provided in various sizes, such as, for example, 20cm x 20cm, lOcm x lOcm, 5 cm x 5 cm, and/or any size or fraction of a size therebetween. The top portion 232 can have a needle array 236 with a corresponding number of needles 248. In one example, the needles 248 can be disposed, for example, with a distance of 5mm between each needle 248. The needles 248 can be, for example, 34G steel injection needles. In one example embodiment, the cartridges can be 5 inches by 5 inches with a 20 x 20 array of 34G injection needles 248 (i.e., 400 needles). In another embodiment, the cartridges can include a 10 x 10 array of 34G injection needles 248 (i.e., 100 needles).

[0073] The bottom portion or cap 234 of the cartridge 230 maintains the lipolytic substance covered hermetically by a layer of medical resin 244. The lipolytic substance can be any suitable agent described herein. The bottom portion 234 can also include a receiving mechanism 235 that can include and/or define a set of wells, reservoirs, chambers, grooves, troughs, containers, volumes, etc. configured to at least temporarily contain the lipolytic substance or agent. The bottom portion or cap 234 provides for insertion of each needle 248 into the bottom portion 234, through the medical resin 244, and into the receiving mechanism 235 to retrieve a desired amount or dose of the lipolytic agent disposed therein.

[0074] As described above for the previous embodiment, when a cartridge 230 is retrieved from the dispenser and coupled to the treatment head 220, the bottom portion or cap 234 is coupled to the top portion 232. As shown, for example, in FIGS. 5B, 7, 10 and 11, the cartridge 230 is coupled to the treatment head 220 such that the top portion 232 (with needle array 236) is disposed within an interior region of the lower housing portion 242 of the housing 238. FIGS. 5B, 7, 10, and 11 illustrate the needles extended downward outside of the lower housing portion 242 and the cap 234 removed for illustration purposes. When the cartridge 230 is attached to the treatment head 220, during a procedure, the needles 248 will be disposed in an upward position within the top portion 232 of the cartridge 230, and the cap 234 will be attached thereto. As described above, the cartridges 230 can be removably attached to the treatment head 220 using various coupling methods, such as, for example, an electromagnetic lock (not shown) or a latching system.

[0075] The cartridge mechanism within the treatment head 220 can include sensors used to detect when the cartridge 230 is attached and detached and can be controlled by the processor(s). As described above, the cartridge mechanism and/or the treatment head 220 can include an electric, electronic, and/or magnetic chip that can control the attachment of the cartridge 230 to the treatment head 220 and/or access to the cartridge 230 once the cartridge 230 is attached to the treatment head 220. For example, in addition to attaching to the treatment head 220 via the electromagnetic lock, the cartridge 230 can include a lock or seal mechanism configured to keep the cartridge 230 in a locked, sealed, and/or pre-use state prior to being coupled to the treatment head 220, as described above with reference to the cartridge 130. In addition, the cartridge 230 can include one or more sensors that can detect a characteristic, attribute, and/or status of the needle array 236 and/or the lipolytic substance or agent contained therein, and can prevent the cartridge 230 from being unlocked or actuated if one or more characteristics is outside of a desired range or beyond a predetermined tolerance, as described above with reference to the cartridge 230.

[0076] The attachment of the cartridge 230 to the treatment head 220 causes the needle array 236 to be operatively coupled to the internal pump mechanism 240 and the needle control mechanism (not shown). After the cartridge attachment has been confirmed, the pump 240 can be actuated to draw the dissolution agent from the cap 234 and into the needles 248. For example, the needle management mechanism can actuate the needles 248 to be lowered through the medical resin 244 and into the receiving mechanism 235 (e.g., wells or volumes) containing the lipolytic agent within the cap 234. The pump 240 can then suction the lipolytic substance into the needles 248 of the needle array 236. The bottom portion or cap 234 can then be removed and placed back in the dispenser or otherwise be set aside during the treatment procedure. After the procedure, the cap 234 is again attached to the top portion 232 while the top portion 232 is still coupled to the treatment head 220, and the cartridge 230 as a whole (top portion 232 and bottom portion or cap 234) is removed from the treatment head 220. As described above, this follows proper hygienic procedures for handling of the used cartridge 230 (e.g., needles). The used cartridge 230 can be placed back in the dispenser or disposed of.

[0077] During use of the robotic treatment device 200 to perform a lipolysis treatment on a patient, to begin the procedure, the physician can mark the treatment area perimeter on the patient, and the robotic treatment device 200 (e.g., using the treatment head 220) can scan the marked area and define the trajectory of movement of the treatment head 220 (e.g., step-by- step horizontal movement, step-by-step vertical movement, etc.). The skin can also be scanned to identify any risk areas such as moles, warts, etc. When the physician approves the planned trajectory, the robotic arm unit 226 can be actuated to retrieve a first cartridge 230 from the cartridge storage/dispenser and couple the cartridge 230 to the treatment head 220. As described above, the top portion 232 of the cartridge 230 and the needles 248 of the needle array 236 are disposed within an interior of the lower housing portion 242. In this position, the needles 248 have not been actuated to extend outward. The treatment head 220 is actuated to draw the lipolytic agent out of the bottom portion 234 of the cartridge 230. The bottom portion 234 can then be removed from the top portion 232 of the cartridge 230 and set aside.

[0078] The robotic arm 228 is actuated to be positioned at the treatment area according to the defined trajectory and the treatment head 220 is moved into contact with the patient’s skin. The sensor 225 can check to confirm that all four edges of the treatment head 220 have full contact with patient’s skin. The needles 248 can then be actuated to move downward until all the needles 248 of the array 236 touch the patient’s skin. Skin sensor(s) can signal when the contact has been achieved. The sensors of sensor element 225 (e.g., light and ultrasound sensors) can scan and analyze the skin thickness and define a depth of injection (this operation can be done also during initial scanning of treatment area). Based on manual commands by the physician or automatically, the treatment head 220 will be actuated to push the needles 248 down into the patient’s skin and into an underlying subcutaneous fat layer to make an injection to the defined depth. Where an area of risk, such as a wart or mole, has been identified, the needles 248 will not be actuated to move. The pump 240 and pumping mechanism 254 will pump a dose of lipolytic substance over each needle 248 in the needle array 236. After the lipolytic agent has been injected, the treatment head 220 will move the needle 248 upward higher than the outer edges of the treatment head 220. The robotic arm 228 can then be moved back to the cartridge storage/dispenser and reattach the bottom portion or cap 234 of the cartridge 230 to the treatment head 220. The empty or used cartridge 230 can then be removed from the treatment head 220 and placed back in the cartridge storage/dispenser or otherwise disposed of. The same cycle can be repeated with a second cartridge 230, and so on, until the entire treatment area has been treated.

[0079] FIGS. 12-22 illustrate a robotic lipolysis treatment device 300 (also referred to herein as “treatment device” or “robotic treatment device”), according to another embodiment. The robotic treatment device 300 can be used to reduce a subcutaneous layer of fat of the subject/patient using a dissolution agent (e.g., lipolytic agent) and can include features and components as described above for previous embodiments. As shown in FIG. 12, the robotic treatment device 300 can include a robotic arm unit 326 and a treatment head 320 coupled to the robotic arm unit 326. The robotic arm unit 326 is shown disposed adjacent a surgical table T with a portion of patient P shown disposed thereon. The robotic arm unit 326 and the treatment head 320 can both be in communication with and controlled by a computing device (not shown in FIGS. 12-22), by a wired or wireless connection as described above for previous embodiments. The robotic arm unit 326 can include a base structure 321, and a robotic arm 328. The base structure 321 (also referred to herein as “base”) can optionally include wheels to allow the robotic arm unit 326 to be moved to an in- use position proximate a surgical table T and patient P or a stowed position disposed away from the surgical table T. The robotic arm 328 can be coupled to the treatment head 320 and include one or more linkages 329 to provide, for example, the treatment head 320 with multiple degrees of freedom of movement (e.g., 6-axis movement). For example, the linkages 329 of the robotic arm 328 can be coupled together and/or to the treatment head 320 with various coupling joints, such as, for example, a pivot joint, a sliding or telescoping coupling, etc., such that the treatment head 320 can be moved in multiple linear and rotational directions and orientations, such as left-right, forward-backward, up-down, and/or rotational.

[0080] The computing device (not shown) can include one or more processors (e.g., one or more CPUs or the like), one or more memory components, one or more controllers, and be in communication with the various components of the robotic treatment device 300 through a wireless or wired connection.

[0081] As with the previous embodiment, the treatment head 320 can receive a removable and disposable needle array cartridge 330 (also referred to herein as“cartridge” or “needle cartridge”) that can be used to inject the dissolution agent into a patient. The cartridge 330 can be stored in a cartridge storage unit or dispenser (not shown in FIGS. 12- 22), such as dispenser 123, described above. The dispenser can store multiple cartridges 330 (e.g., new cartridges 330 and/or used cartridges 330. The robotic arm unit 326 can be maneuvered or actuated to retrieve a cartridge 330 from the dispenser prior to a treatment procedure, and the cartridge 330 can be coupled to the treatment head 320 either automatically using the robotic arm unit 326, or manually by the medical provider (e.g., physician). In alternative embodiments, the treatment head 320 and the cartridge 330 can be a combined or integrated device, mechanism, assembly, etc. In such embodiments, the robotic arm unit 326 can be maneuvered or actuated to couple to the treatment head 320, which can include the cartridge 330 disposed, pre-loaded, and/or integrated within the treatment head 320.

[0082] As shown, for example, in FIGS. 12-14, the treatment head 320 includes a housing 338 that includes an upper housing portion 346 and a lower housing portion 342. The upper housing portion 346 and the lower housing portion 342 can be separate components coupled together, or a single integrally formed component. The treatment head 320 is configured to receive at least a portion of the cartridge 330 within the housing 338. Although not shown, a cartridge mechanism configured to manipulate a cartridge 330 coupled thereto, can also be included. The various components of the treatment head 320 and/or cartridge 330 can be in communication with and controlled by the processor(s) of the computing device. The treatment head 320 and/or cartridge 330 can also include an electrode component or device (not shown), a pitch propeller (not shown) as described above for previous embodiments, and a sensor element 325 that can include one or more sensors and/or scanners.

[0083] The sensor element 325 (also referred to herein as“sensor”) can be disposed at a bottom portion of the treatment head 320 as shown in FIGS. 12-22, and can include one or more sensors and/or scanners as described above for previous embodiments. The sensor 325 can be included within a component separate from the lower housing portion 342 as shown, or can be incorporated within, at, or near the bottom of the lower housing portion 342. The sensor 325 can include, for example, light and/or ultrasound sensors that can be used, for example, to analyze skin thickness or depth (e.g., ultra sound 20-25MHz); and/or visual sensors or scanners, such as an optical scanner to scan the skin surface and identify any anomalies and dangerous areas at the treatment area, such as a mole, wart, etc.; and/or sensor(s) to analyze and sense the contact between the treatment device and the skin of the patient. The treatment head 320 can also include additional sensors and/or scanners at other locations disposed on or within the housing 338 of the treatment head 320. For example, the treatment head 320 can include one or more sensors used to check attachment/detachment of the cartridge 330 to the treatment head 320.

[0084] As described above for previous embodiments, during a treatment procedure, a cartridge 330 can be retrieved from a dispenser and removably attached to the treatment head 320 using various coupling methods, such as, for example, an electromagnetic lock (not shown) or a latching system (not shown). More specifically, the cartridge 330 and/or the treatment head 320 can include an electric, electronic, and/or magnetic chip that can control the attachment of the cartridge 330 to the treatment head 320 and/or access to the cartridge 330 once the cartridge 330 is attached to the treatment head 320. In some embodiments, attaching the cartridge 330 to the treatment head 320 via the electromagnetic lock can physically attach, and electrically or electronically connect, the cartridge 330 to the treatment head 320. The electrical or electronic connection can, for example, connect the cartridge 330 and/or any suitable component thereof to the computing device (described above).

[0085] In addition to attaching to the treatment head 320 via the electromagnetic lock, the cartridge 330 can include a lock or seal mechanism configured to keep the cartridge 330 in a locked, sealed, and/or pre-use state prior to being coupled to the treatment head 320, as described above with reference to the cartridge 130. In some embodiments, a bottom portion or cap of the cartridge 330 and/or of each needle 348 can form the lock or seal mechanism and can be configured to remain coupled to the cartridge 330 until the cartridge 330 is transitioned to an unlocked state (e.g., by attaching the cartridge 330 to the treatment head 320). In addition, the cartridge 330 can include one or more sensors that can detect a characteristic, attribute, and/or status of the needle array 336 and/or the lipolytic substance or agent contained therein, and can prevent the cartridge 330 from being unlocked or actuated if one or more characteristics is outside of a desired range or beyond a predetermined tolerance, as described above with reference to previous embodiments. For example, if one or more characteristics are outside of a desired range or beyond a predetermined tolerance, the cartridge 330 can remain in the locked state such that the bottom portion or cap of the cartridge 300 and/or of each needle 348 remains coupled to the cartridge 330, thereby blocking or preventing access to the needles 348.

[0086] In this embodiment, the cartridge(s) 330 includes or holds the needle array 336 with needles 348. The cartridge 330 can be provided in various sizes, such as, for example, 20cm x 20cm, lOcm x lOcm, 5cm x 5cm, and/or any size or fraction of a size therebetween. The needle array 336 can include a corresponding number of needles 348 based at least in part on the size of the cartridge 330. In one example, the needles 348 can be disposed, for example, with a distance of 5mm between each needle 348. The needles 348 can be, for example, 34G steel injection needles. In one example embodiment, the cartridge can be 5in x 5in with a 20 x 20 array of 34G injection needles 348 (i.e., 400 needles). In another embodiment, the needle array 336 can include a 10 x 10 array of 34G injection needles 348 (i.e., 100 needles).

[0087] In this embodiment, the needles 348 are prefilled with a preset dose of a lipolytic or dissolution agent (not shown). The lipolytic substance contained in the needles 348 can be any suitable agent described herein. Although not shown, in some embodiments the cartridge(s) 330 and/or each needle 348 included therein can have a bohom portion or cap that functions merely as a cap, for example, to protect an end portion of the needles 348 and/or to maintain the safety, security, and/or sterility of the end portion of the needles 348. The bohom portion or cap of the cartridge 330 and/or of each needle 348 included therein can include a layer of medical resin (not shown) to hermetically cover the ends of the needles 348 when the bohom portion or cap(s) are coupled thereto.

[0088] In an alternative embodiment, the cartridge 330 can include a chamber that contains the lipolytic substance, rather than the needles 348 being preloaded. In such an embodiment, when the cartridge 330 is attached to the treatment head 320, the pump mechanism 354 and pump 340 can push the lipolytic agent into the needles 348 from the chamber included in the cartridge 330. If the cartridge 330 includes a chamber containing the lipolysis agent, after the cartridge attachment has been confirmed, the treatment head 320 and/or the cartridge 330 can be actuated to move the dissolution agent from the chamber into the needles 348. In another alternative the bohom portion or cap of the cartridge 330 or of each needle 348 can include the lipolytic agent. For example, the cartridge 330 can include a bottom portion or cap similar to the bottom portion or cap described above with reference to the cartridge 230. If the lipolytic agent is within the bottom portion or cap of the cartridge 330 or of each needle 348, the treatment head 320 and/or cartridge 330 can be actuated to move the needles 348 downward through the medical resin and into the lipolytic agent within the bottom portion or cap as described above for previous embodiments. The lipolytic substance can then be drawn or suctioned into the needles 348 of the needle array 336. The bottom portion or cap can then be removed and placed back in the dispenser or otherwise be set aside during the treatment procedure.

[0089] In this embodiment, as shown in FIGS. 15A and 15B, the cartridge 330 can include a printed circuit board (PCB) 352 and piezo motors 347 disposed within a top portion of the cartridge 330. The piezo motors 347 are used to move one or more needles 348 included in a needle array 336 and/or used to actuate the pumping and injection within the needles 348. As shown in FIG. 15B, in some embodiments, a piezo motor 347 can include a baseplate 355, an actuator plate 356, a connection member 357, and a piezo material 358. The connection member 357 (e.g., a mechanical fastener or the like) can be configured to movably connect the actuator plate 356 to the baseplate 355. The piezo material 358 can be disposed between the actuator plate 356 and the baseplate 355. The piezo material 358 is configured to transition between a first state and a second state in response to a flow of electric power or current. More particularly, the first state can be, for example, a rest, relaxed, or unactuated state and the second state can be, for example, an expanded, elongated, actuated state. In some implementations, the piezo material can be configured to move or elongate a desired amount, which in turn, can move the actuator plate 356 a desired distance relative to the baseplate 355 (shown in FIG. 15B as Ad). Thus, the relative movement can be used to move the needle array 336, move any subset of the needles 348 included in the needle array 336, and/or actuate the pumping and/or injection within the needles. More particularly, the movement of the piezo material 358 (e.g., either expanding or contracting) can be in a substantially linear motion, which in turn, can result in a substantially linear motion of the actuator plate 356 relative to the baseplate 355 (e.g., the actuator plate 356 is moved closer to or away from the baseplate 355).

[0090] In some embodiments, the arrangement of the piezo motor 347 can be substantially similar to the arrangement shown in FIG. 15B and adapted for use in the cartridge 330. For example, the piezo motor 347 can include a piezo material disposed between a stationary plate, surface, structure, etc. and a movable plate, surface, structure, etc. Thus, the piezo material can be energized to move the movable plate relative to the stationary plate. Moreover, while the cartridge 330 can include a piezo motor having any suitable form and/or structure, such a piezo motor is generally configured to function in a manner similar to that of the piezo motor 347 (e.g., to function as a linear actuator or the like) to move the needles 348, needle array 336, plungers within the needles 348, and/or the like.

[0091] The cartridge 330 also includes a pump 340 with pump mechanism 354, an injector mechanism 350, an injector body 349, a fluid sensor 351, and an insertion or depth detector (not shown). The pump 340, pumping mechanism 354, and injector mechanism 350 of the cartridge 330 can be used to pump and inject a lipolytic agent into a patient using the needles 348 included in the needle array 336 of the cartridge 330 attached to the treatment head 320, as described in more detail below. More specifically, the pump mechanism 354 can control and maintain the pumping process with the pump 340, such, as for example, controlling pressure, speed of injection, etc. The injector mechanism 350 and injector body 349 are part of the needle control and management mechanism and can control the needle injections and movement of the needles 348 relative to the cartridge 330 and/or in and out of the body of the patient. When the needles 348 are coupled to the pumping mechanism 354, the injector body 349 can maintain and control the pumping of the dissolution agent through the needles 348 using the pump 340.

[0092] The fluid sensors 351 can be used to detect the level of lipolytic agent within the needles 348. In addition, the fluid sensors 351 can be used to detect one or attributes and/or characteristics associated with the lipolytic agent. For example, the fluid sensors 351 can be used to sense or detect a temperature or humidity of the lipolytic agent and/or a temperature or humidity within a portion of the cartridge 330. The fluid sensors 351 can also be used to check any other attribute or characteristic such as, for example, an agitation level of the lipolytic agent, an amount or size of bubbles contained in the lipolytic agent, a viscosity of the lipolytic agent, a color of the lipolytic agent, and/or the like. In some instances, the cartridge 330 can be discarded if the fluid sensors 351 detect an attribute or characteristic that is outside of a desired range or predetermined tolerance, thereby ensuring patient safety and/or efficacy. [0093] The insertion or depth detector can be and/or can include, for example, a ring electrode 345 and a metal pin 343 coupled to and/or included in the needles 348. The insertion or depth detector can be configured to detect contact with the skin of the patient, insertion of the needles 348 into the patient, a depth of insertion of the needles 348, and/or a tissue type within which the needles 348 are inserted. For example, the ring electrodes 345 can be placed in contact with the skin of the patient and the insertion or depth detector can be configured to detect and/or determine whether the needles 348 have been inserted and/or at what depth the needles 348 have been inserted based on, for example, a difference in electric potential between the metal pin 343 of the needles 348 and the ring electrode 345. More particularly, for a given charge, a difference in electric potential between the ring electrode 345 and the metal pin 343 of the needles 348 is a function of a relative distance therebetween. Thus, the insertion or depth detector can detect and/or sense the insertion or depth of the needles into tissue.

[0094] The insertion or depth detector can also detect a rate of change in the electric potential difference, which in turn, can be used to determine whether the needle 348 is being inserted through the same tissue or different tissue. For example, with the electric potential difference being a function of insertion depth, a rate of change in the electric potential is substantially constant when a needle 348 is inserted through the same tissue Ti, as illustrated in FIG. 16A. Conversely, in some instances, inserting a needle 348 through a first tissue Ti and then reaching and inserting the needle 348 through a second tissue T ₂ (e.g., at a greater insertion depth), will result in a change in the difference in potential energy between the metal pin 343 and the ring electrode 345, as illustrated in FIG. 16B. In some instances, the change in the tissue from Ti to T2 can produce a relatively sharp change in the electric potential. In some instances, the insertion or depth detector can be used, for example, to ensure patient safety based on detecting and/or controlling an insertion depth of the needle and/or based on detecting a change in tissue.

[0095] Although not shown in FIGS. 12-15B, in some embodiments, the cartridge 330 can include one or more needle retraction mechanisms configured to retract the needles 348 of the needle array 336 after injection and/or in response to issues during a procedure such as, for example, an interruption of electric power or current. For example, FIG. 17 illustrates a needle 348 in a pre-use or pre-actuated state, an inserted or injection state, and a retracted state. As shown, the cartridge 330 can include a retraction structure 348a and an energy storage member 348b. The retraction structure 348a can be a relatively fixed structure within the cartridge 330 and can allow the needle 348 to pass through a hollow portion thereof. In other words, each needle 348 can be configured to move relative to the corresponding retraction structure 348a when actuated (e.g., by the corresponding piezo motor 347). As shown in FIG. 17, the energy storage member 348b can be disposed between a portion or surface of the retraction structure 348a and a portion or surface of the needle 348. As such, the movement of the needle 348 relative to the retraction structure 348a can transition the energy storage member 348b from a first state having a relatively low potential energy to a second state having a relatively high potential energy. For example, in this embodiment, the energy storage member 348b can be a spring that is compressed as the corresponding needle 348 is inserted into the patient. In some instances, after injecting the dose of the lipolytic agent into the subcutaneous fat layer of the patient, a force otherwise used to insert and/or move the needle 348 can be reduced or removed, thereby allowing the spring to expand and/or transition to an uncompressed state. In turn, the spring can retract the needle 348 into and/or otherwise relative to the retraction structure 348a.

[0096] Although described as a spring, in other embodiments, the energy storage member 348b can be any suitable member configured to transition from a relatively low potential energy state to a relatively high potential energy state, which can then be converted to kinetic energy used to retract the corresponding needle 348. While described above as retracting the needles 348 in response to the lipolytic agent being injected, in other instances, the retraction mechanism can be used to retract the needles 348 in response to a loss of electric power and/or any other emergency during a procedure.

[0097] FIGS. 18A-22 illustrate various stages of the robotic treatment device 300 during a lipolysis treatment on a patient. In use, to begin the procedure, the physician can mark the treatment area perimeter on the patient, and the robotic treatment device 300 (e.g., using the treatment head 320) can scan the marked area and define the trajectory of movement of the treatment head 320 (e.g., step-by-step horizontal movement, step-by-step vertical movement, etc.). The skin can also be scanned to identify any risk areas such as moles, warts, etc. When the physician approves the planned trajectory, the robotic arm unit 326 can be actuated to retrieve a first cartridge 330 from the cartridge storage/dispenser and couple the cartridge 330 to the treatment head 320. [0098] When atached to the treatment head 320, the botom portion or cap of the cartridge 330 or of each needle 348 can be atached, for example, to protect the end portion of the needles 348. As mentioned above, the cartridge 330 and/or the treatment head 320 can include sensors to detect when the cartridge 330 is atached and detached and can be controlled by the computing device. In some embodiments, the attachment of the cartridge 330 to the treatment head 320 can also cause the needle array 336 to be operatively coupled to one or more internal components of the treatment head 320 and/or electrically or electronically connected to the computing device. Once the atachment of the cartridge 330 to the treatment head 320 is detected, the bottom portion or cap of the cartridge 330 and/or of each needle 348 can be removed (e.g., automatically by the robotic treatment system 300 or manually by a user such as a doctor or technician).

[0099] FIG. 18A illustrates the cartridge 330 coupled to the treatment head 320 and the lower portion or cap removed for illustration purposes. As shown in FIG. 18 A, the cartridge 330 and the needles 348 of the needle array 336 are disposed within an interior of the lower housing portion 342. In this position, the needles 348 have not been actuated to extend outward or downward. Optionally, prior to performing the treatment procedure and after the botom portion or cap has been removed, the needles 348 can be additionally processed by dipping them into a pain-reducing substance or sterilization substance.

[0100] The robotic arm 328 is positioned at the treatment area according to the defined trajectory as shown in FIG. 18B and the treatment head 320 can be moved into contact with the patient’s skin as shown in FIG. 20 A. FIGS. 19A and 19B illustrate the treatment head 320 positioned above or in slight contact with the skin of a patient P. FIG. 19B is a side view of a portion of the treatment head 320 with a portion of the housing removed to illustrate the needles 348 disposed in an up position (e.g., not extended outward of the housing 338 and sensor 325 or into the skin of the patient). With the treatment head 320 in contact with the skin of the patient P, the sensor 325 can check and confirm that all four edges of the treatment head 320 have full contact with patient’s skin.

[0101] The needles 348 can then be actuated to move downward until all the needles 348 of the array 336 touch the patient’s skin as shown in FIGS. 20B and 21A. For example, a syringe portion of the needles 348 can contact the skin, while a needle portion of the needles 348 (within the syringe) has not been actuated. The insertion and/or depth detector (shown in FIG. 15 A) can determine when the skin contact has been achieved or a desired insertion depth has been reached based on the ring electrodes 345 contacting the skin and/or an electric potential between the ring electrodes 345 and the metal pins 343 of the needles 348. The sensors of sensor element 325 (e.g., light and ultrasound sensors) can scan and analyze the skin thickness and define a desired depth of injection (this operation can be done also during initial scanning of treatment area).

[0102] Based on manual commands by the physician or automatically, the treatment head 320 and/or cartridge 330 can be actuated to push the needles 348 of the needle array 336 down into the patient’s skin and into an underlying subcutaneous fat layer to make an injection to the defined depth, as shown in FIG. 21B. In some instances, the insertion and/or depth detector can be used to detect the electric potential and/or a rate of change in the electric potential between the metal pin 343 of the needles 348 and the corresponding ring electrodes 345, which in turn, can be used to determine a depth of injection for each needle 348 and/or to determine whether a given needle 348 is inserted into the subcutaneous fat layer. Where an area of risk, such as a wart or mole, has been identified, the needles 348 will not be actuated to move. The pump 340 and pumping mechanism 354 will pump a dose of lipolytic substance out of each needle 348 in the needle array 336. After the lipolytic agent has been injected, the treatment head 320 and/or the cartridge 330 will move the needles 348 upward higher than the outer edges of the treatment head 320 (e.g., as shown in FIG. 22). For example, in some embodiments, the cartridge 330 can include a retraction mechanism as described above with reference to FIG. 17. The robotic arm 328 can then be moved back to the cartridge storage/dispenser and the bottom portion or cap of the cartridge 330 can be reattached to the treatment head 320. The empty or used cartridge 330 can then be removed from the treatment head 320 and placed back in the cartridge storage/dispenser or otherwise disposed of. The same cycle can be repeated with a second cartridge, and so on, until the entire treatment area has been treated.

[0103] FIGS. 23A-23B illustrate a method of performing a lipolysis treatment procedure, according to an embodiment. At 460, the physician can mark the treatment area (e.g., mark a perimeter of the area) on the patient, and at 461, the robotic treatment device can scan the marked area and define the trajectory of movement of the treatment head (e.g., step-by-step horizontal movement, step-by-step vertical movement, etc.). The skin can also be scanned to identify any risk areas such as moles, warts, etc. when the physician approves the planned trajectory. At 462, the robotic arm is positioned at the cartridge storage dispenser to retrieve a cartridge and attach the cartridge to the treatment head as described herein. If the lipolytic agent is contained within the bottom portion of the cartridge as indicated at 463, the treatment device is actuated to move the needle array into the bottom portion of the cartridge to draw the lipolytic substance into the needles at 464 and the lower portion or cap is removed at 465. If the lipolytic substance is disposed within the upper portion of the cartridge or pre-dosed within the needles, the cap can be removed at 465.

[0104] At 466, the needle array can optionally be dipped in a pain reducing or sterilization substance. At 467, the robotic arm is positioned adjacent the treatment area based on the defined trajectory and the treatment head (and cartridge) are moved down to touch the patient’s skin. At 468, the needle array is moved down until contact with the patient’s skin. At 469, a depth of injection is determined based on an analysis of the skin with sensors. At 470, the needles of the needle array are moved down through the skin and into an underlying subcutaneous fat layer of the patient to the defined depth. At 471, the treatment head is actuated to inject the lipolytic substance into the patient. At 472, the needle array is retracted back into the treatment head and the bottom portion of the cartridge is reattached to the top portion of the cartridge. At 473, the cartridge can be removed from the treatment head and disposed of or placed back into the storage/dispenser. The above procedural steps can be repeated as needed to treat other identified treatment areas.

[0105] The foregoing description has been presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. The descriptions were selected to explain the principles of the invention and their practical application to enable others skilled in the art to utilize the invention in various embodiments and various modifications as are suited to the particular use contemplated.

[0106] For example, the robotic treatment devices 100, 200, and/or 300 have been described herein as including a computing device and/or controller(s) configured to control one or more portions of the device. While generally described above, it should be understood that the computing devices and/or controllers described herein with reference to specific embodiments can be any suitable devices and are not intended to be limited to, for example, the components and/or functions specifically identified. By way of example, a computing device can be any suitable hardware-based computing device configured to send and/or receive data (e.g., via a connection, bus, network, etc.) and configured to receive, process, define, and/or store data such as, for example, treatment plans, patient profiles, treatment head atributes and/or characteristics, needle cartridge atributes and/or characteristics, dissolution agent atributes and/or characteristics, etc. In some embodiments, the computing device can be, for example, a personal computer (PC), a workstation, a server device or a distributed network of server devices, a virtual server or machine, and/or the like. In some embodiments, the computing device can be a smartphone, a tablet, a laptop, and/or the like.

[0107] The components of the computing device can be contained within a single housing or machine or can be distributed within and/or between multiple machines. For example, the computing device can include and/or can be collectively formed by any suitable number of server devices or the like. In some embodiments, the computing device can include and/or can be collectively formed by a client or mobile device (e.g., a smartphone, a tablet, and/or the like) and a server, which can be in communication via a network. In some embodiments, the computing device can be a virtual machine, virtual private server, and/or the like that is executed and/or run as an instance or guest on a physical server or group of servers. In some such embodiments, the computing device can be stored, run, executed, and/or otherwise implemented in a cloud-computing environment. Such a virtual machine, virtual private server, and/or cloud-based implementation can be similar in at least form and/or function to a physical machine. Thus, the computing device can be implemented as one or more physical machine(s) or as a virtual machine run on a physical machine. In some implementations, the robotic treatment devices described herein can include a computing device or controller disposed within a housing or structure of the treatment device and configured to receive instructions from, for example, one or more remote physical or virtual machines. For example, in some implementations, a computing device such as a remote laptop, tablet, smartphone, controller, etc. can be manipulated by a user to send data or instructions to and/or receive data or instructions from a computing device or controller disposed within a housing or structure of the treatment device.

[0108] In some implementations, a computing device configured to perform at least a portion of the lipolysis treatment methods described herein can include at least a memory, a processor, and a communication interface. The memory, the processor, and the communication interface can be connected and/or electrically coupled (e.g., via a system bus or the like) such that electric and/or electronic signals may be sent between the memory, the processor, and the communication interface. The computing device can also include and/or can otherwise be operably coupled to a database configured, for example, to store data associated the robotic treatment devices.

[0109] The memory of a computing device can be, for example, for example, a random access memory (RAM), a memory buffer, a hard drive, a read-only memory (ROM), an erasable programmable read-only memory (EPROM), and/or the like. The memory can be configured to store, for example, one or more software modules and/or code that can include instructions that can cause the processor to perform one or more processes, functions, and/or the like (e.g., processes, functions, etc. associated with performing the lipolysis treatment methods described herein). In some implementations, the memory can be physically housed and/or contained in or by the computing device. In other implementations, the memory and/or at least a portion thereof can be operatively coupled to the computing device and/or at least the processor. In such implementations, the memory can be, for example, included in and/or distributed across one or more devices such as, for example, server devices, cloud- based computing devices, network computing devices, and/or the like.

[0110] The processor can be a hardware-based integrated circuit (IC) and/or any other suitable processing device configured to run or execute a set of instructions and/or code stored, for example, in the memory. For example, the processor can be a general purpose processor, a central processing unit (CPU), an accelerated processing unit (APU), an application specific integrated circuit (ASIC), a network processor, a front end processor, a field programmable gate array (FPGA), a programmable logic array (PLA), and/or the like. The processor can be in communication with the memory via any suitable interconnection, system bus, circuit, and/or the like. The processor can include any number of engines, processing units, cores, etc. configured to execute code, instructions, modules, processes, and/or functions associated with performing the lipolysis treatment methods described herein.

[0111] The communication interface can be any suitable hardware-based device in communication with the processor and the memory and/or any suitable software stored in the memory and executed by the processor. In some implementations, the communication interface can include any suitable port such as a Universal Serial Bus (USB) port and/or the like. In some implementations, the communication interface can be a network interface card (NIC) or the like configured to communicate with a network (or any suitable device in communication with the network). In some implementations, the NIC can include, for example, one or more Ethernet interfaces, optical carrier (OC) interfaces, asynchronous transfer mode (ATM) interfaces, one or more wireless radios (e.g., a WiFi® radio, a Bluetooth® radio, etc.), and/or the like. In some implementations, the NIC can be configured to communicate with or via a network such as, for example, a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a worldwide interoperability for microwave access network (WiMAX), a telephone network (such as the Public Switched Telephone Network (PSTN) and/or a Public Land Mobile Network (PLMN)), an intranet, the Internet, an optical fiber (or fiber optic)-based network, a virtual network, a cellular network, and/or any other suitable network. In some embodiments, the network can include one or more networks of any type such as, for example, a LAN and the Internet. Moreover, the network can be implemented as a wired and/or wireless network.

[0112] The memory and/or at least a portion thereof can include and/or can be in communication with one or more data storage structures such as, for example, one or more databases (e.g., the database) and/or the like. The database can be any suitable data storage structure(s) such as, for example, a table, a repository, a relational database, an object- oriented database, an object-relational database, a structured query language (SQL) database, an extensible markup language (XML) database, and/or the like. In some embodiments, the database can be disposed in a housing, rack, and/or other physical structure including at least the memory, the processor, and/or the communication interface. In other embodiments, the computing device can include and/or can be operably coupled to any number of databases. In some implementations, the database can be configured to store data associated with the lipolysis treatment methods described herein.

[0113] The computing devices can also include and/or can be in communication with any suitable user interface. For example, in some embodiments, a user interface of the computing devices can be a display such as, for example, a cathode ray tube (CRT) monitor, a liquid crystal display (LCD) monitor, a light emitting diode (LED) monitor, and/or the like. In some instances, the display can be a touch sensitive display or the like (e.g., the touch sensitive display of a smartphone, tablet, wearable device, and/or the like). In some instances, the display can provide the user interface for a software application (e.g., a computer application, a mobile application, an internet web browser, and/or the like) that can allow the user to manipulate the computing device. In other implementations, the user interface can be any other suitable user interface such as a mouse, keyboard, display, and/or the like. [0114] Some embodiments described herein relate to a computer storage product with a non-transitory computer-readable medium (also can be referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor- readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) may be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as ASICs, Programmable Logic Devices (PLDs), ROM and RAM devices, etc. Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and/or computer code discussed herein.

[0115] Some embodiments and/or methods described herein can be performed by software (executed on hardware), hardware, or a combination thereof. Hardware modules may include, for example, a general-purpose processor, an FPGA, an ASIC, and/or the like. Software modules (executed on hardware) can be expressed in a variety of software languages (e.g., computer code), including C, C++, Java™, Ruby, Visual Basic™, Python™, and/or other object-oriented, procedural, or other programming language and development tools. Examples of computer code include, but are not limited to, micro-code or micro instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments may be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and/or development tools, and/or combinations thereof (e.g., Python™). Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code. [0116] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.

[0117] The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired or intended usage. Thus, it should be understood that the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use unless the context explicitly states otherwise. For example, the size of needles configured for use on a target area located on or near the abdomen of a patient may be larger than the size of needles configured for use on a target area located on or near the neck of a patient.

[0118] Where methods and/or events described above indicate certain events and/or procedures occurring in certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain events and/or procedures may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.