All-in-one body contouring system and methods thereof

Abstract

An all-in-one body contouring system is provided for performing infiltration, ultrasound-assisted liposuction, aspiration, powered liposuction, skin tightening, fat transfer, and electrosurgery within a single integrated platform. The system includes modular subsystems coordinated by at least one central controller and user interface. An aspiration subsystem employs dual pumps operable in independent or series modes to optimize vacuum performance for single or multi-user operation. A powered liposuction subsystem includes a multi-button handpiece allowing independent activation of infiltration, aspiration, or reciprocation for improved procedural flexibility. Multi-user synchronization software enables two surgeons to operate separate subsystems simultaneously with real-time coordination of shared resources. Graphical user interfaces display live system parameters, procedural sequencing, and safety alerts. The system's control architecture dynamically manages mode switching, power regulation, and vacuum distribution to enhance procedural efficiency, safety, and ergonomics in aesthetic and reconstructive body contouring procedures.

Description

[0001] Docket No.: Apyx-094PCT

[0002] ALL-IN-ONE BODY CONTOURING SYSTEM AND METHODS THEREOF

[0003] PRIORITY

[0004] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 717,585, filed November 7, 2024, entitled “ALL-IN-ONE BODY CONTOURING SYSTEM AND METHODS THEREOF”, the contents of which are hereby incorporated by reference in its entirety.

[0005] BACKGROUND

[0006] Field. The present disclosure relates generally to surgery and electrosurgery systems and apparatuses, and more particularly, to an all-in-one body contouring system including hardware, software, graphical user interfaces, and accessories for performing infiltration of tumescent anesthesia, fat emulsification using ultrasound to facilitate fat removal, liposuction, powered aspiration for more efficient fat removal, skin tightening, fat processing and fat transfer to body areas requiring enhanced fat volume.

[0007] Description of the Related Art.

[0008] In the field of cosmetic plastic surgery, body contouring refers to a variety of procedures designed to reshape and improve the appearance of the body by removing excess fat and skin and tightening the underlying tissue. These procedures are often sought by individuals who have experienced significant weight loss, aging, or pregnancy, which can result in accumulations of fat, undesired loss of fat in certain body areas, and sagging or loose skin. Common body contouring procedures include fat removal through liposuction, excisional procedures to remove excess skin and / or fat, and skin tightening. These procedures can be performed individually or in combination, depending on the patient's goals and needs. The main objective of body contouring is to create a more toned and defined appearance. Docket No.: Apyx-094PCT

[0009] SUMMARY

[0010] An all-in-one body contouring system is provided including hardware, software, graphical user interfaces, and accessories for performing infiltration of tumescent anesthesia, fat emulsification using ultrasound to facilitate fat removal, liposuction, powered aspiration for more efficient fat removal, skin tightening, and fat transfer to body areas requiring enhanced fat volume.

[0011] In certain embodiments, the all-in-one body contouring system includes an infiltration subsystem, an ultrasound-assisted liposuction (UAL) subsystem, an aspiration subsystem, a powered aspiration / infiltration subsystem, a skin-tightening subsystem, a fat-transfer subsystem, and an electrosurgery subsystem, all coordinated through at least one controller and graphical user interface (GUI). The controller is configured to enable coordinated and simultaneous operation of multiple subsystems, including dynamic mode switching and real-time display of subsystem parameters.

[0012] According to one aspect of the present disclosure, an all-in-one body contouring system includes an infiltration subsystem including a peristaltic pump, tubing, and a scale module configured to quantify a volume of tumescent anesthesia delivered to a patient based on weight loss from a fluid container; an ultrasound-assisted liposuction (UAL) subsystem including an amplifier, a handpiece, and a probe configured to deliver ultrasound energy for emulsifying adipose tissue; an aspiration subsystem including at least two vacuum pumps selectively operable in independent, series, or parallel configurations to generate variable vacuum pressure for aspirating emulsified fat; a powered aspiration and infiltration subsystem including a reciprocating handpiece configured to oscillate a cannula for fat removal or infiltration; a skin tightening subsystem including a plasma generator and a handpiece for subdermal tissue treatment; and at least one controller operatively coupled to the subsystems and configured to coordinate operation thereof through a user interface that displays subsystem parameters and accepts user input.

[0013] In one aspect, the scale module converts measured weight loss of the fluid container to volume using a selectable density corresponding to tumescent anesthesia or fat. Docket No.: Apyx-094PCT

[0014] In another aspect, the peristaltic pump is reversible to deliver or remove fluids through the same tubing for infiltration, aspiration, or fat transfer.

[0015] In another aspect, the peristaltic pump is configured in a forward direction to deliver tumescent fluid from a fluid bag to a patient and in a reverse direction to pump harvested fat from the patient into a fluid bag or a replacement container for collection or processing.

[0016] In a further aspect, operation of the peristaltic pump in the reverse direction provides a controlled, low-shear aspiration profile configured to gently harvest viable adipose tissue suitable for subsequent fat transfer or reinjection.

[0017] In one aspect, the peristaltic pump is operated at a controlled low rotational speed in the forward direction, configured to provide a gentle, low-shear flow that preserves adipocyte viability during reinjection of adipose tissue, wherein the flow is in the range of 10-60 ml / min.

[0018] In another aspect, the controller is configured to automatically reverse operation of the peristaltic pump in response to a user-selected procedural mode or command entered through the user interface to switch between infiltration and fat transfer functions.

[0019] In yet another aspect, the aspiration subsystem includes pressure sensors and control logic configured to automatically switch the vacuum pumps between independent and series modes based on a measured deviation from a target vacuum level or barometric pressure.

[0020] In a further aspect, the UAL subsystem includes a frequency tracking algorithm configured to maintain operation of the probe at a resonance frequency by monitoring electrical impedance or phase and adjusting frequency accordingly.

[0021] In one aspect, the user interface comprises multiple regions corresponding to separate subsystems.

[0022] In another aspect, the powered aspiration and infiltration subsystem includes at least one handpiece having a plurality of user-actuatable buttons independently controlling the infiltration pump, aspiration pump, and reciprocation of the handpiece.

[0023] In a further aspect, the plasma generator handpiece includes a flexible shaft and an electrode disposed therein configured to ionize an inert gas for subdermal skin tightening. Docket No.: Apyx-094PCT

[0024] In still another aspect, the controller is configured to coordinate operation of at least two handpieces simultaneously, each assigned to a separate user, while maintaining independent vacuum and power control.

[0025] In one aspect, the system further includes wireless footswitches communicatively coupled to the controller for activation of the infiltration pump and / or the handpiece of the UAL subsystem.

[0026] In another aspect, the system further includes a fat processing subsystem configured to process harvested fat prior to reinjection.

[0027] In a further aspect, the controller is configured to monitor or control one or more functions of the fat processing subsystem.

[0028] In one aspect, the fat processing subsystem is fluidly coupled to the aspiration subsystem or to the peristaltic pump of the infiltration subsystem to enable closed-loop fat transfer.

[0029] In another aspect, the controller is configured to operate the peristaltic pump in a forward direction to transfer processed fat from a collection container to an injection cannula.

[0030] In a further aspect, the system further includes an electrosurgical subsystem including at least one of a monopolar and / or bipolar handpiece for applying electrosurgical energy to patient tissue.

[0031] In one aspect, the system further includes a remote services module coupled to the controller for enabling remote diagnostics of at least one subsystem and providing updated functionality to the controller.

[0032] According to another aspect of the present disclosure, a method for performing body contouring using an integrated system includes the steps of: infiltrating tumescent anesthesia into subcutaneous tissue using a peristaltic pump and scale-based volume monitoring; emulsifying fat tissue by applying ultrasound energy through a probe operated at a resonance frequency tracked by a frequency tracking algorithm; aspirating emulsified fat using dual vacuum pumps operating in independent, series or parallel configuration; tightening skin tissue using a plasma handpiece emitting plasma through one or more ports; and transferring harvested fat using the peristaltic pump. Docket No.: Apyx-094PCT

[0033] In one aspect, the method further includes dynamically switching the aspiration subsystem from series to independent operation when a second user activates the second pump.

[0034] In another aspect, the method further includes automatically limiting ultrasound power when impedance changes indicative of high-density tissue, highly fibrotic tissue, or probe end-hits are detected.

[0035] In a further aspect, infiltration flow is stopped when the controller detects that a preset volume threshold has been delivered, and an alert is displayed on the user interface.

[0036] In one aspect, the method further includes performing powered aspiration by actuating a reciprocating handpiece while maintaining vacuum pressure at a user- selected setpoint.

[0037] In another aspect, the plasma handpiece generates simultaneous 360-degree plasma discharge through opposed ports to treat tissue surrounding a distal tip.

[0038] In a further aspect, the method further includes delivering tumescent fluid from a fluid bag to a patient by operating a peristaltic pump in a forward direction and reversing the pump to draw harvested fat from the patient into a fluid bag or a collection container.

[0039] In yet another aspect, the reversing operation of the peristaltic pump provides a controlled, low-shear aspiration profile that gently collects viable adipose tissue suitable for subsequent fat transfer or reinjection.

[0040] In one aspect, the method further includes automatically reversing the direction of the peristaltic pump in response to a user-selected procedural mode or command entered through the user interface to switch between infiltration and fat-transfer functions.

[0041] In another aspect, the method further includes processing harvested fat by a fat processing subsystem prior to reinjection.

[0042] In one aspect, the fat processing subsystem comprises a closed, sterile cartridge or chamber coupled to the peristaltic pump to permit processing and transfer of harvested fat without manual handling.

[0043] In a further aspect, the method further includes reversing operation of the peristaltic pump to deliver processed fat from the cartridge to an injection cannula at a user-selected flow rate. Docket No.: Apyx-094PCT

[0044] In another aspect, the method further includes monitoring weight or pressure data from a scale module to determine a volume of fat collected, processed, and transferred.

[0045] In one aspect, the method further includes maintaining a closed-loop circuit among the aspiration, processing, and infiltration subsystems to minimize contamination and preserve adipocyte viability during transfer.

[0046] In another aspect, each of the dual vacuum pumps are controlled based on measured pressure.

[0047] According to a further aspect of the present disclosure, an all-in-one bodycontouring system includes a plurality of surgical subsystems including an infiltration subsystem, an ultrasound-assisted liposuction (UAL) subsystem, an aspiration subsystem, a powered liposuction subsystem, a skin-tightening subsystem, a fat-transfer subsystem, and an electrosurgery subsystem; a shared housing supporting at least two of the subsystems; a user interface configured to display operating parameters and controls for at least a subset of the subsystems; and at least one controller operatively coupled to the subsystems and to the user interface, the at least one controller being configured to coordinate operation of the subsystems so that a user can perform infiltration, emulsification, aspiration, fat transfer, and skin-tightening procedures through a single integrated platform.

[0048] In one aspect, the housing comprises first and second enclosures, each containing at least one of the subsystems and each having a respective user interface.

[0049] In another aspect, the at least one controller enables shared fluid, pneumatic, and electrical routing among the subsystems to permit continuous procedural transition without manual reconnection.

[0050] In a further aspect, the at least one controller is configured to activate or deactivate individual subsystems according to a procedural sequence stored in memory.

[0051] In one aspect, the subsystems communicate via a common digital bus.

[0052] In another aspect, the common digital bus operates under at least one of RS-422, RS-232, CAN, Ethernet, USB, Serial Peripheral Interface (SPI), l2C (inter-integrated circuit), UART or wireless link. Docket No.: Apyx-094PCT

[0053] In a further aspect, the system further includes sensors associated with the subsystems, the controller being configured to aggregate sensor data to maintain coordinated pressure, flow, and power parameters across the system.

[0054] In one aspect, the user interface is a graphic user interface (GUI) comprising a multi-region display, each region corresponding to a specific subsystem and presenting real-time indicators of a respective subsystem.

[0055] In another aspect, the user interface permits simultaneous control of at least two subsystems.

[0056] In one aspect, the user interface issues audible or visual alerts when an operational threshold for volume, pressure, or temperature is reached.

[0057] In a further aspect, the user interface is touch-sensitive and permits mode switching between infiltration, UAL, aspiration, powered liposuction, fat-transfer, and skintightening interfaces without interrupting subsystem operation.

[0058] In another aspect, the at least one controller comprises a primary processor configured to execute software modules corresponding to each subsystem.

[0059] In yet another aspect, the at least one controller includes at least one secondary processor communicatively coupled to the primary processor and dedicated to local control of one or more subsystems.

[0060] In one aspect, the primary and secondary processors exchange command and status data via a synchronized communication link to coordinate multi-subsystem operation.

[0061] In a further aspect, the at least one controller communicates wirelessly with at least one remote interface or footswitch to permit redundant activation of the infiltration or UAL subsystem.

[0062] In another aspect, the at least one controller is configured to coordinate safety interlocks among the subsystems to prevent concurrent activation of incompatible energy modes.

[0063] In one aspect, the at least one controller communicates wirelessly with at least one remote interface configured to display operating parameters and controls for at least a subset of the subsystems. Docket No.: Apyx-094PCT

[0064] In another aspect, the remote interface includes at least one of a mobile device, tablet and / or a laptop.

[0065] According to yet another aspect of the present disclosure, an aspiration subsystem for a body contouring system includes a first aspiration pump and a second aspiration pump each having a suction port and an exhaust port; a valve assembly coupled between the suction and exhaust ports of the pumps and a fat-collection circuit; at least one controller configured to operate the pumps selectively in: (i) an independent mode, wherein each pump generates vacuum pressure for a separate aspiration circuit; (ii) a series mode, wherein the exhaust port of the first pump is pneumatically coupled to the suction port of the second pump to achieve an increased pressure ratio; and (iii) a parallel mode, wherein the suction ports of both pumps are coupled to a common aspiration circuit to increase volumetric flow rate; and a pressure sensor operatively connected to the controller, the controller being configured to switch between the independent, series, and parallel modes based on a measured vacuum level or procedural condition.

[0066] In one aspect, the at least one controller automatically transitions from the series or parallel mode to the independent mode when two user handpieces are simultaneously activated.

[0067] In another aspect, the at least one controller automatically transitions from the independent mode to the series mode when a deviation between a measured and a target vacuum level exceeds a threshold or when ambient barometric pressure decreases below a predetermined value.

[0068] In a further aspect, the pressure sensor is disposed between the valve assembly and the fat-collection canister to monitor real-time vacuum stability during aspiration.

[0069] In another aspect, the subsystem further includes a user interface configured to display real-time vacuum pressure of each pump.

[0070] In one aspect, the valve assembly comprises a plurality of electronically actuated valves configured to route pneumatic flow paths corresponding to the independent, series, and parallel configurations.

[0071] According to another aspect of the present disclosure, a power liposuction subsystem includes a powered handpiece including a motor configured to reciprocate a cannula at a selectable speed and stroke length; an infiltration pump and an aspiration Docket No.: Apyx-094PCT pump fluidly connectable to the cannula through tubing; a plurality of user-actuatable buttons disposed on the handpiece and electrically coupled to a controller; and the controller being configured such that each of the plurality of buttons independently activates a respective function selected from infiltration, aspiration, and reciprocation of the handpiece, whereby a user may perform infiltration, aspiration, powered infiltration or powered aspiration without interruption of other subsystem operations.

[0072] In one aspect, the handpiece includes a first button assigned to control the infiltration pump, a second button assigned to control the aspiration pump, and a third button assigned to control the reciprocation motor.

[0073] In another aspect, at least one of the buttons is re-mappable by user input through a user interface to toggle between infiltration and aspiration control.

[0074] In a further aspect, the buttons are configured to operate in a momentary mode requiring continuous depression for activation, or a toggle mode enabling latched operation following a single press.

[0075] In one aspect, the controller allows simultaneous activation of two or more buttons to execute combined modes including: (a) powered infiltration using infiltration plus reciprocation; (b) powered aspiration using aspiration plus reciprocation; (c) powered fat transfer; or (d) mechanical equalization using reciprocation alone without fluid flow.

[0076] In another aspect, each button includes tactile or visual feedback, such as backlighting or haptic response, confirming function activation or deactivation.

[0077] In one aspect, at least one of the buttons is configured to toggle between infiltration and aspiration control.

[0078] In a further aspect, at least one of the buttons is configured to toggle the infiltration pump between infiltrating fluid to a patient, aspirating fat from the patient and / or transferring fat to the patient.

[0079] BRIEF DESCRIPTION OF THE DRAWINGS

[0080] The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which: Docket No.: Apyx-094PCT

[0081] FIG. 1 is a front view of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0082] FIG. 2 is a side view of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0083] FIG. 3A is a block diagram of various subsystems of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0084] FIG. 3B is a schematic diagram illustrating various flows and connections of an all- in-one body contouring system in accordance with an embodiment of the present disclosure;

[0085] FIG. 4 illustrates a screen shot of a graphic user interface (GUI) of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0086] FIG. 5 illustrates an infiltration subsystem of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0087] FIG. 6 illustrates an ultrasound-assisted liposuction (UAL) subsystem of an all-in- one body contouring system in accordance with an embodiment of the present disclosure;

[0088] FIG. 7A illustrates an aspiration subsystem of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0089] FIG. 7B illustrates another aspiration subsystem of an all-in-one body contouring system in accordance with another embodiment of the present disclosure;

[0090] FIG. 8 illustrates a power liposuction subsystem of an all-in-one body contouring system in accordance with an embodiment of the present disclosure;

[0091] FIG. 9 is a perspective view of an electrosurgical apparatus in accordance with another embodiment of the present disclosure;

[0092] FIG. 10 is perspective view of a distal tip of the electrosurgical apparatus shown in FIG.9 in accordance with another embodiment of the present disclosure;

[0093] FIG. 11 is a top view of the distal tip shown in FIG. 10;

[0094] FIG. 12 is a side view the distal tip shown in FIG. 10;

[0095] FIG. 13 is a cross-sectional view of the side view of the distal tip shown in FIG. 12.

[0096] FIG. 14 illustrates a fat transfer subsystem of an all-in-one body contouring system in accordance with an embodiment of the present disclosure; Docket No.: Apyx-094PCT

[0097] FIG. 15 illustrates monopolar and bipolar electrosurgery subsystem of an all-in- one body contouring system in accordance with an embodiment of the present disclosure; and

[0098] FIG. 16 is a flowchart illustrating a method of an all-in-one body contouring system in accordance with an embodiment of the present disclosure.

[0099] It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not necessarily the only possible configuration for illustrating the disclosure. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiment.

[0100] DETAILED DESCRIPTION

[0101] Preferred embodiments of the present disclosure will be described hereinbelow with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. In the drawings and in the description which follow, the term “proximal”, as is traditional, will refer to the end of the device, e.g., instrument, apparatus, applicator, handpiece, forceps, etc., which is closer to the user, while the term “distal” will refer to the end which is further from the user. Herein, the phrase “coupled” is defined to mean directly connected to or indirectly connected with through one or more intermediate components. Such intermediate components may include both hardware and software-based components.

[0102] The present disclosure is directed to an all-in-one body contouring system. The present disclosure provides for a system that combines all components needed to perform a body contouring procedure from start to finish. The all-in-one body contouring system of the present disclosure includes hardware, software, graphical user interfaces, and accessories for performing infiltration of tumescent anesthesia, fat emulsification using ultrasound to facilitate fat removal, liposuction, powered aspiration for more efficient fat removal, skin tightening, fat processing and fat transfer to body areas requiring Docket No.: Apyx-094PCT enhanced fat volume. The body contouring system includes at least the following subsystems to implement the above functionality: an infiltration subsystem; a fat emulsification using ultrasound subsystem, i.e., an Ultrasound-Assisted Liposuction (UAL) subsystem; an aspiration subsystem; a powered aspiration / infiltration / fat transfer subsystem, i.e., a Power Liposuction subsystem; a skin tightening subsystem; a fat transfer subsystem and a monopolar and bipolar electrosurgery subsystem. Further description of each of these subsystems is included below.

[0103] Referring to FIGS. 1 and 2, a body contouring system 100 is illustrated in accordance with an embodiment of the present disclosure. The system 100 includes a first housing or enclosure 102 for housing at least one subsystem and a second housing or enclosure 104 for housing at least another subsystem. Each of the housings 102, 104 includes a graphic user interface (GUI) 106, 108 respectively, e.g., a touch screen display, for displaying or outputting information to a user and for receiving input from a user. The housings 102, 104 may be disposed on a cart 110 enabling the system 100 to be easily moved into a proper or convenient location during a procedure. The cart 110 includes a lower enclosure portion 111 for housing various components of the system 100 and at least one support member 103

[0104] Referring to FIG. 3A, a functional block diagram of an all-in-one body contouring system 100 is illustrated in accordance with an embodiment of the present disclosure. The system 100 includes an infiltration subsystem 200, a fat emulsification using ultrasound subsystem, i.e. an Ultrasound-Assisted Liposuction (UAL) subsystem 300, an aspiration subsystem 400, a powered aspiration / infiltration / fat transfer subsystem, i.e., a Power Liposuction subsystem 500, a skin tightening subsystem 600, a fat transfer subsystem 700 and a monopolar and bipolar electrosurgery subsystem 800. In certain embodiments, portions of certain subsystems may be disposed in one of the housings 102, 104. For example, in one embodiment, portions of the infiltration subsystem 200, the fat Emulsification Using Ultrasound - Ultrasound-Assisted Liposuction (UAL) subsystem 300, the aspiration subsystem 400, the Powered Aspiration / Infiltration / Fat Transfer - Power Liposuction subsystem 500 and the fat transfer subsystem 700 are disposed in housing 104, while portions of the skin tightening subsystem 600 and a monopolar and bipolar electrosurgery subsystem 800 are disposed in housing 102. Other portions of the Docket No.: Apyx-094PCT subsystems may be disposed on or in enclosure 111 or coupled to the at least one support member 103. In one embodiment, GUI 106 is disposed on a surface of housing 102 and GUI 108 is disposed on a surface of housing 104. In other embodiments, portions of the subsystems 200, 300, 400, 500, 600, 700, 800 may be disposed in a single housing. In the single housing embodiment, a single GUI may be provided to control and interact with the various subsystems. In other embodiments of the single housing, two separate GUIs 106, 108 may be provided on a surface of the single housing, while in other embodiments, a separate GUI may be provided for each subsystem 200, 300, 400, 500, 600, 700, 800.

[0105] It is to be appreciated that if a single GUI is provided the GUI may be divided or arranged into separate sections, where a particular section is associated to a particular subsystem. Referring to FIG. 4, a screen shot of a graphic user interface (GUI) 108 is provided. The GUI 108 is divided into at least four sections, where section 122 is associated to the infiltration subsystem 200, section 124 is associated to the fat Emulsification Using Ultrasound - Ultrasound-Assisted Liposuction (UAL) subsystem 300, section 126 is associated to the aspiration subsystem 400 and section 128 is associated to the Powered Aspiration / Infiltration / Fat Transfer - Power Liposuction subsystem 500. It is to be appreciated that the GUI 108 shown in FIG. 4 is merely exemplary and other configurations (for example, more or less than four sections, different sizes for each section, different colors for each section, etc.) are contemplated to be within the scope of the present disclosure.

[0106] At least one controller 120 is provided for enabling the functionality of the overall system 100 and / or each subsystem 200, 300, 400, 500, 600, 700, 800. In one embodiment, a single controller 120 is provided and coupled to each subsystem 200, 300, 400, 500, 600, 700, 800 and GUIs 106, 108. In this embodiment, the single controller 120 receives inputs from at least one GUI 106, 108 and routes the input to an appropriate subsystem 200, 300, 400, 500, 600, 700, 800. Similarly, the single controller receives data from each of the subsystems 200, 300, 400, 500, 600, 700, 800 and routes the data to an appropriate other subsystem 200, 300, 400, 500, 600, 700, 800 and / or GUI 106, 108. The single controller 120 includes software, functions and / or algorithms to implement the functionality of each subsystem 200, 300, 400, 500, 600, 700, 800, as will be described in more detail below. Docket No.: Apyx-094PCT

[0107] In another embodiment, a controller 120 may be provided for a subset of the subsystems 200, 300, 400, 500, 600, 700, 800. For example, in one embodiment as shown in FIG. 3B, a controller 120-1 may be provided in housing 102, where the controller 120 is coupled to the skin tightening subsystem 600, monopolar and bipolar electrosurgery subsystem 800 and GUI 106. A second controller 120-2 is then provided and coupled to the infiltration subsystem 200, the fat Emulsification Using Ultrasound - Ultrasound-Assisted Liposuction (UAL) subsystem 300, the aspiration subsystem 400, the Powered Aspiration / I nfiltration / Fat Transfer - Power Liposuction subsystem 500, the fat transfer subsystem 700 and GUI 108. In this embodiment, the first and second controllers may be communicatively coupled to each other via hardwired or wireless connectivity 105.

[0108] In a further embodiment, each subsystem 200, 300, 400, 500, 600, 700, 800 may include a separate, independent controller 120 for enabling the functionality of a respective subsystem. In this embodiment, an additional controller may be provided to coordinate operations and functionality between the independent controllers.

[0109] In certain embodiments, the controller 120 executes coordinated control logic that synchronizes operation of the infiltration, UAL, aspiration, powered liposuction, and skintightening subsystems. Communication among the subsystems may occur via a digital bus 105 (e.g., the digital bus may operate under the following, but not limited to, RS-422, RS-232, CAN, Ethernet, USB, Serial Peripheral Interface (SPI), l2C (inter-integrated circuit), UART or wireless link, among others). The controller 120 may automatically activate or deactivate subsystems according to a procedural sequence or user-selected workflow stored in memory. The GUI 106, 108 may present distinct, color-coded regions corresponding to individual subsystems, allowing simultaneous monitoring and control of each.

[0110] It is to be appreciated that the functions of the subsystems 200, 300, 400, 500, 600, 700, 800 shown in FIG. 3A may be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. In one embodiment, some or all of the functions of controller(s) 120 may be performed by at least one processor, such as a computer or an electronic data processor, digital signal processor or embedded micro-controller, field programmable gate array Docket No.: Apyx-094PCT

[0111] (FPGA), in accordance with code, such as computer program code, software, firmware, register transfer logic and / or integrated circuits that are coded to perform such functions, unless indicated otherwise. When provided by a processor, the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and may implicitly include, without limitation, digital signal processor (DSP) hardware, read only memory (ROM) for storing software and / or firmware, random access memory (RAM), and nonvolatile storage.

[0112] In some embodiments, at least one remote interface 180 may be provided, wherein the at least one controller 120 communicates wirelessly with at least one remote interface 180 and the remote interface 180 is configured to display operating parameters and controls for at least a subset of the subsystems. In one embodiment, the remote interface 180 generates the same or similar graphic user interface as GUI 106, 108. In various embodiments, the remote interface 180 may include a touchscreen for displaying information and receiving inputs. Exemplary remote interfaces may include at least one of a mobile device (e.g., a mobile phone), tablet and / or a laptop. The remote interface 180 may operate under various known wireless protocols, e.g., WiFi, Bluetooth®, etc., and may communicate to the system 100 via wireless transceiver 115 (as shown in FIG. 3B) and / or communication module 866 (as shown in FIG. 15). In some embodiments, the remote interface 180 may be protected by a sterile wrap.

[0113] FIG. 3B is a schematic diagram illustrating various flows, portions of various subsystems and connections of an all-in-one body contouring system in accordance with an embodiment of the present disclosure.

[0114] Each of the subsystems 200, 300, 400, 500, 600, 700, 800 will now be described in more detail.

[0115] I. Infiltration Subsystem 200

[0116] The infiltration step in body contouring is a crucial part of a liposuction procedure where a specially formulated solution, often referred to as tumescent anesthesia or Klein solution, is injected into the targeted area where fat is to be removed. This solution Docket No.: Apyx-094PCT typically contains a mixture of saline (sterile salt water), a local anesthetic (like lidocaine), and a vasoconstrictor (usually epinephrine).

[0117] The main purposes of the infiltration step include:

[0118] • Anesthesia: The local anesthetic (lidocaine) numbs the area, reducing or eliminating pain during the procedure.

[0119] • Vasoconstriction: Epinephrine causes blood vessels to constrict, reducing blood loss and minimizing bruising and swelling.

[0120] • Fat Emulsification: The tumescent fluid helps to loosen and emulsify the fat, making it easier to remove through the cannula. In ultrasound-assisted systems, the infiltrated fluid also enhances acoustic coupling and supports cavitation and microstreaming effects.

[0121] • Hydration: The saline in the solution helps to hydrate the tissues, reducing trauma during the suctioning process used during fat removal.

[0122] Tumescent anesthesia is the most commonly used form of anesthesia in liposuction for the following reasons:

[0123] • Safety: Tumescent anesthesia is considered very safe, reducing the need for general anesthesia, which carries more risks and complications.

[0124] • Reduced Bleeding: The vasoconstrictor (epinephrine) in the tumescent solution significantly reduces bleeding during the procedure by constricting blood vessels in the treated area.

[0125] • Effective Pain Management: The high concentration of lidocaine provides effective and prolonged local anesthesia, keeping the patient comfortable both during and after the procedure.

[0126] • Less Postoperative Discomfort: The residual effect of the lidocaine can last for several hours post-surgery, minimizing the need for additional pain medication.

[0127] • Precision: The tumescent technique allows for more precise fat removal, as the fluid not only numbs the area but also provides a clearer working environment by separating the fat from surrounding tissues.

[0128] Overall, tumescent anesthesia has become the standard in liposuction due to its combination of safety, effectiveness, and patient comfort.

[0129] Referring to FIG. 5, an infiltration subsystem 200 is illustrated in accordance with an embodiment of the present disclosure. The infiltration subsystem 200 of the all-in-one body contouring system 100 includes at least the following components: a weighing scale module 202, infiltration tubing 204, a pump system 206, footswitches 208, 210, and at least one handpiece 212. The pump system 206 includes a pump head 207 and pump motor 209. Docket No.: Apyx-094PCT

[0130] A weighing scale module 202 is provided with a means for hanging a standard bag 203 typically used in medical settings for delivering intravenous (IV) fluids. In one embodiment, the weighing scale module 202 is coupled to the support member 103 and in communication with controller 120. The tumescent anesthesia used during infiltration is most commonly prepared in an IV bag. The IV bag 203 containing tumescent anesthesia is hung from the scale module 202. The scale module 202 is used to accurately quantify the amount of tumescent anesthesia removed from the IV bag 203 and delivered to the patient. It is to be appreciated that the weighing scale module 202 is the most accurate way to quantify volume of tumescent delivered to the patient when using an infiltration handle 212 with flow controls 216 on the handle 212. With flow controls on the handle 212, the infiltration pump 206 will continue to run / rotate when the valve in the infiltration handle 212 is closed and not allowing the flow of fluid. In this scenario, using the number of rotations of the pump to calculate volume of fluid results in inaccuracies. The controller 120 converts weight removed from the bag 203 to volume of fluid removed utilizing the known density of tumescent anesthesia. The system allows for use of the scale module 202 to quantify the volume of fluids other than tumescent anesthesia by allowing input of different fluid densities, e.g., via GUI 108. For example, the scale 202 can accurately quantify the volume of fat injected into the patient during fat transfer by allowing the user to change between the density of tumescent to the density of fat in the system.

[0131] In one embodiment, controller 120 may monitor the volume of fluid delivered and alert a user via GUI 108 that a predetermined threshold or limit has been reached or exceeded. In other embodiments, controller 120 may monitor the volume of fluid delivered and send a signal to the pump system 206 that a predetermined threshold or limit has been reached or exceeded to trigger the pump system 206 to stop providing fluid to the patient. In either embodiment, the predetermined threshold or limit may be adjustable by a user via GUI 108. The predetermined threshold or limit may also be set based on a type of procedure input via GUI 108 or based on the type of fluid to be pumped, where the type of fluid is input via GUI 108.

[0132] Infiltration tubing 204 facilitates the transfer of tumescent from the IV bag 203 to the instrument 212 used to deliver the fluid to the patient. The infiltration tubing 204 is Docket No.: Apyx-094PCT routed from the IV bag 203 through an infiltration pump 206 to the instrument 212 used to deliver the fluid to the patient. The infiltration tubing 204 in the all-in-one body contouring system is sized to allow it to be used for two purposes in the body contouring procedure: infiltration and fat transfer. The infiltration tubing 204 is made with a larger internal diameter to facilitate these dual uses. The larger internal diameter is important for the fat transfer portion of the procedure, as will be described below.

[0133] A pump system 206, e.g., a peristaltic pump system including a pump head 207 and pump motor 209, is included in the system 200 to pump the tumescent from the IV bag 203 to the patient. The infiltration tubing 204 is positioned in the peristaltic pump head 207 such that the roller heads of the peristaltic pump head 207 produce the pressure differential needed to draw the fluid from the IV bag 203 and push it to the patient. The pump 206 may be controlled to enable flow rates of about 100 ml / min to about 1 ,000 ml / min for tumescent infiltration. As shown in FIG. 3B, the pump motor 209 is disposed in enclosure 111 , while the pump head 207 is disposed outside of the enclosure 111 , e.g., on an outer surface of the enclosure 111. The peristaltic pump 206 can also be used to pump fat to the patient during the fat transfer portion of the procedure, as will be described in more detail below.

[0134] The peristaltic pump head 207 is reversible to allow pumping of fluids through the infiltration tubing 204 in both directions. The peristaltic pump system 206 can also be used to remove fat from the patient when more gentle removal of the fat is desired for fat transfer later in the procedure. The motor controller 209 for the pump system 206 is selected to allow for pumping flow rates ranging from about 1 to about 1000 cc / min. Flow rates as low as 1 cc / min are important for fat transfer to delicate areas or areas requiring less volume such as the face. Flow rates as high as 1000 cc / min are desirable for some surgeons performing large volume liposuction.

[0135] The peristaltic pump 206 can also be used to pump fat to the patient during the fat transfer portion of the procedure. The peristaltic pump may be operated at a controlled low rotational speed in the forward direction, configured to provide a gentle, low-shear flow that preserves adipocyte viability during reinjection of adipose tissue. In one embodiment, the pump 206 may be controlled to provide flow to reinject fat in the range Docket No.: Apyx-094PCT of about 20 to 30 ml / min. In other embodiments, the range of flow may be about 10 ml / min to about 60 ml / min.

[0136] Footswitches 208, 210 are provided to control pump 206, via controller 102. The two footswitches 208, 210 are included in the system to turn on / off the infiltration pump 206. Two footswitches are included in the system because multiple physicians are often operating at the same time on the same patient during body contouring procedures. In this scenario, it is useful to have one footswitch on either side of the OR (operating room) table to allow the pump to be controlled by two different physicians on different sides of the table. The footswitches 208, 210 may be wireless to reduce the number of cables present in the OR, where signals from the wireless footswitches 208, 210 are received by wireless transceiver module 115 and forwarded to controller 120.

[0137] The footswitches 208, 210 can be configured to operate in two different modes: “press and hold” mode and “toggle on / off” mode. “Press and hold” mode requires the physician to keep the footswitch depressed for the entire time in which they desire to have fluid flowing. The physician must stop pressing the footswitch to stop the flow of fluid. “Toggle on / off” mode requires the physician to press the footswitch one time to start the flow of fluid and press the footswitch a second time to stop the flow of fluid. This mode is desirable by some physicians as it obviates the need to keep the footswitch depressed.

[0138] In some embodiments, each footswitch 208, 210 includes two individual pedals: one for infiltration and one for ultrasound-assisted liposuction (UAL). The functionality of the pedal for ultrasound-assisted liposuction (UAL) will be described below in relation to FIG. 6.

[0139] The infiltration handle 212 may be provided with flow controls or no flow controls on the handle. The infiltration handle 212 is used as an ergonomic instrument for injecting the tumescent anesthesia into the patient. The infiltration tubing 204 is connected to the proximal end 213 of the handle 212. An infiltration cannula 214 is typically connected to the distal end 215 of the handle 212. The handle 212 is designed with a straight through hole, or lumen, to allow direct flow of the tumescent from the proximal to distal end 215 of the handle 212. The connection ends of the infiltration handle 212 allow for connection of the infiltration tubing 204 and cannulas 214 to the handle. These connections may consist of any of the typical types of connections used on tubing and cannulas such as Docket No.: Apyx-094PCT luer-lock, Toomey, VentX, tapered connection for tubing typically referred to as a Christmas tree connection, etc.

[0140] In some embodiments, an infiltration handle 212 with flow controls 216 on the handle 212 may be provided. An infiltration handle 212 with flow controls on the handle serves the same purpose as the handle with no flow controls. Some physicians prefer being able to start and stop the flow of tumescent using a control 216 on the infiltration handle 212 as opposed to using the footswitch to turn on / off the infiltration pump. This design is especially useful when using the “toggle on / off” mode of the footswitch. In this situation, the surgeon does not have to push the footswitch again to stop the flow of fluid. This can be controlled by the handle. Starting and stopping the flow of tumescent can be achieved through various valve designs that can be opened and closed using a button, lever, or other means on the handle 212. The infiltration handle 212 with flow controls can be designed with the valve in a normally open position so that the tumescent flows freely if the physician is not closing the valve. The physician can then activate the controls 216, e.g., button, lever, etc., only when they desire to stop the flow of tumescent.

[0141] Infiltration cannulas 214 are used to inject the tumescent anesthesia into the patient. The cannulas 214 are either connected to the distal end 215 of the infiltration handles 212 or directly to the distal end of the infiltration tubing 204. The cannulas are offered in various diameters, with various hole configurations, and with various connection configurations for attaching to the infiltration handles or tubing.

[0142] Agraphical user interface for controlling the infiltration subsystem 200, e.g., section 122 of GUI 108, is provided. The system 100 contains a graphical user interface (GUI) for controlling the various components of the infiltration subsystem. The GUI 122 includes an indicator 131 for displaying the flow rate and controls 132 for setting the desired fluid flow rate for the pump. The GUI 122 contains a “button” 134 that allows for fast priming of the infiltration tubing. Pressing the button 134 instantly increases the fluid flow rate setting to the maximum flow rate to facilitate fast priming of the infiltration tubing. Priming consists of the initial filling of the infiltration tubing 204 with fluid from the IV bag 203 to the distal end of the infiltration cannula 214. After priming, the button 134 is pressed again to return to the current fluid flow rate setpoint. Forward button 133 configures the pump head 207 to pump fluid from the bag 203 through the tubing 204 through the cannula 214 to the Docket No.: Apyx-094PCT patient. Reverse button 135 configures the pump head 207 to pump fluid from the cannula 214 to the bag 203.

[0143] The GU1 122 displays the total accumulated volume 136 of tumescent delivered to the patient. The GUI 122 contains a reset button 137 to allow the total accumulated volume to be reset to “zero” when desired. The GUI 122 displays the volume 138 of tumescent delivered to a local treatment area. The GUI 122 contains a reset button 139 to allow the local volume 138 to be reset to “zero” when desired. As an example, the local volume 138 allows the physician to know how much tumescent was delivered to only the abdomen of the patient while the total accumulated volume 136 allows the surgeon to track how much total volume of tumescent has been delivered to all body areas of the patient. It is to be appreciated that the total volume 136 and local volume 138 are determined based on signals received at the controller 102 from the scale module 202. To prevent accidental reset of the total accumulated volume, while intending to reset the local volume, the total accumulated volume reset “button” could be configured to only work with a touch and hold activation (i.e., long press). Alternatively, the GUI 122 can be configured so that the total accumulated volume reset “button” will only work if the local area volume has been reset to “zero”.

[0144] II. Fat Emulsification Using Ultrasound - UAL Subsystem 300

[0145] Emulsifying fat using ultrasound during a liposuction procedure is commonly referred to as Ultrasound-Assisted Liposuction (UAL). UAL is a specialized form of liposuction that uses ultrasound energy to emulsify or disrupt adipose tissue, thereby facilitating its aspiration from the body. This technique enhances the effectiveness of traditional suction-only liposuction, particularly in areas where fat is more fibrous or difficult to remove. In UAL, a small, specialized probe is inserted beneath the skin through small incisions. This probe emits ultrasound waves that emulsify the fat, making it easier to suction out through a standard liposuction cannula.

[0146] UAL is a preferred method by many physicians for the following reasons:

[0147] • Improved Fat Removal in Fibrous Areas: UAL is particularly effective in areas with dense or fibrous fat deposits, such as the back, male chest (gynecomastia), or flanks, where traditional liposuction might struggle to remove fat efficiently. Docket No.: Apyx-094PCT

[0148] • Enhanced Precision and Contouring: UAL allows for more precise contouring, making it a popular choice for patients seeking detailed body sculpting, particularly in challenging areas.

[0149] • Less Physical Strain on Surgeons: Because the ultrasound waves break down the fat before suctioning, the procedure can be less physically demanding for the surgeon, allowing for more controlled and effective fat removal.

[0150] • Reduced Bruising and Swelling: The ultrasound energy helps to cauterize small blood vessels during the procedure, potentially reducing bruising, swelling, and postoperative recovery time compared to traditional liposuction.

[0151] • Lower Risk of Complications: When performed correctly, UAL can reduce the risk of irregularities and uneven fat removal, which can sometimes occur with traditional liposuction.

[0152] Referring to FIG. 6, the ultrasound subsystem 300 of the all-in-one body contouring system includes an ultrasound amplifier 302, at least one handpiece 304 and at least one probe 306. The ultrasound amplifier 302 provides electrical energy to the piezoelectric transducer contained inside the ultrasound handpieces 304. The ultrasound amplifier 302 is controlled via controller 120 and / or GUI 124. In some embodiments, the controller 120 includes a frequency tracking algorithm (FTA) or function. The frequency tracking algorithm is used to increase the efficiency and safety of an ultrasound-assisted liposuction (UAL) system. When performing UAL, a probe 306 is placed in a handpiece (HP) 304 and ultrasound energy is delivered to the HP / probe assembly 304 / 306 from an ultrasound amplifier 302. The probe 306 is placed under the skin, in the subdermal tissue plane, and used to deliver ultrasound energy to the subcutaneous fat. The ultrasound energy causes the fat to be emulsified which makes it much easier to extract with suction. The ultrasound energy delivered to the probe 306 causes the probe 306 to vibrate at ultrasound frequencies. To maximize the effectiveness of the probe in emulsifying the fat, the goal is to keep the probe vibrating at, or near, its maximum amount of displacement (i.e., keep the tip moving back and forth as much as possible). The ultrasound frequency that vibrates the probe at its maximum displacement is called its resonance frequency. It’s difficult to maintain the probe 306 at its resonance frequency because the conditions Docket No.: Apyx-094PCT are constantly changing. Changes in conditions such as temperature of the handpiece 304 or how much of the probe 306 is in / out of the tissue causes the resonance frequency of the probe to change. The frequency tracking algorithm maximizes the efficiency of the ultrasound probe by monitoring the frequency at which the probe is vibrating and then changes the frequency in an attempt to keep it in resonance as much as possible. By maximizing the amount of time the probe vibrates at its resonance frequency, the efficiency of the system is maximized in emulsifying the fat. This makes the UAL procedure much more efficient. The frequency tracking algorithm can also be used to make the device safer. There are certain conditions that put the patient at a higher risk of thermal injury from the ultrasound energy. The FTA can detect these potentially unsafe conditions by monitoring the frequency of vibration and adjusting the power delivered to the probe. For example, end hits or instances where the probe is deeply embedded within dense or fibrous tissue can result in inefficient energy transfer, such that a smaller portion of the applied ultrasound energy is converted into mechanical motion and a larger portion is dissipated as heat. The FTA detects these conditions indirectly by analyzing the electrical response of the transducer. In particular, the FTA measures the voltage and current supplied to the transducer and determines derived electrical parameters, such as impedance and phase relationship, that vary with the mechanical loading of the probe. When such conditions are detected, the FTA may limit or reduce the delivered power, or terminate output, to maintain stable operation and prevent excessive heating of the probe or surrounding tissue, thereby reducing the risk of thermal injury to the patient. The ultrasound amplifier may power two different ultrasound HPs simultaneously to allow two users to work at the same time.

[0153] The ultrasound handpieces (HPs) 304 receive the electrical energy from the ultrasound amplifier 302, convert the electrical energy to ultrasound energy using a piezoelectric transducer, and transfer the ultrasound energy to ultrasound probes 306 that are connected to the distal end of the HPs 304. In one embodiment, the piezoelectric transducer may be a Langevin transducer but could be of other designs. A Langevin transducer consists of at least the following components: 1 . Piezoelectric Elements: The core of the Langevin transducer consists of one or more piezoelectric crystals or ceramic discs. These materials are sandwiched between two or more metal electrodes or plates; Docket No.: Apyx-094PCT

[0154] 2. Back Mass: The piezoelectric elements are typically attached to a back mass. The back mass provides mechanical support and helps dampen the backward transmission of energy; and 3. Front Mass: The front mass (also called the radiating plate) directs the ultrasound energy forward.

[0155] The electrical energy from the amplifier 302 causes the piezoelectric elements to undergo rapid expansion and contraction due to the piezoelectric effect. This effect is the ability of certain materials to change shape when an electric field is applied, and conversely, to generate an electric field when they are mechanically deformed. The rapid expansion and contraction of the piezoelectric elements create mechanical vibrations. These vibrations are transmitted through the front mass of the transducer and delivered to the ultrasound probes that are connected through a threaded connection to the distal end of the front mass. The mechanical vibrations of the ultrasound probes produce ultrasound waves that propagate through the surrounding medium (such as tumescent and subcutaneous fat).

[0156] The ultrasound probes 306 are connected through a threaded connection to the distal end of the front mass. Other means of connections are possible, but a threaded connection is preferred to ensure efficient transfer of the mechanical vibrations from the front mass to the probes. The primary mechanism of action for the ultrasound probes causing emulsification of the fat is cavitation. The vibration of the ultrasound probes causes cavitation of microbubbles in the tumescent fluid. The ultrasound energy produces cyclic compression and rarefaction of these bubbles. Once the bubbles reach a certain size (resonant size = 180 microns), they undergo rapid collapse, releasing localized mechanical energy that breaks apart the fat. Fat cells are bound together relatively loosely compared to muscle, fascia, nerves, and blood vessels. Because of this, the regions around the fat cells are easily infiltrated with tumescent solution. Conversely, because the muscle, fascia, nerves and blood vessel cells are more tightly bound to each other the tumescent solution cannot infiltrate around the cells (or blood vessels would leak, as an example). Therefore, the bubble expansion and collapse occur outside of the muscle, fascia, nerves and blood vessel cells reducing the impact of cavitation on these tissues.

[0157] In this way, UAL targets the fat and spares the other tissues in the area, increasing the safety of the procedure. The probes 306 may be configured in multiple diameters and Docket No.: Apyx-094PCT lengths depending on body area being treated. The probes 306 may also be configured with multiple groove configurations at the distal tip. Different quantities of grooves and different groove designs impact the amount and direction of the energy delivered to the tissue. Probes 306 with fewer grooves concentrate energy axially, directing it forward for deeper penetration, whereas probes with a greater number of grooves distribute energy more radially, producing broader, more diffuse emulsification. Preferred material for the probes is titanium alloy (Ti-6AI-4V).

[0158] FTA is optimized to maintain resonance (either at series resonance, or at an intermediate point between series and parallel resonance). Maintaining resonance creates more cavitation. More cavitation causes more microbubbles to reach their resonant size and burst (collapse). More microbubbles bursting causes faster / more thorough emulsification of the fat but the tissue selectivity of the mechanism of action still protects the other tissues.

[0159] It is to be appreciated that the subsystem 300 may include a probe wrench for tighten the threaded connection between the ultrasound HPs and probes. The probe wrench may include a torque limiting feature to prevent over- and / or under-tightening of the probes. Improper tightening can cause damage to the HPs, probes, or both.

[0160] The subsystem 300 may further include skin ports. Skin ports are used to protect the skin around the incision site through which the ultrasound probes are inserted. Since the probes are vibrating at ultrasound frequencies, the skin around the incision sites is susceptible to burns. The skin ports are protective sleeves that are inserted into the incision sites. The ultrasound probes are inserted into the subcutaneous tissue plane through these protective sleeves. The ports are sized to minimize the size of the incision needed for the different ultrasound probe sizes. The ports are made of autoclavable materials to allow them to be cleaned, resterilized, and reused by the user. The preferred material is autoclavable plastic such as Radel or Ultem. Alternatively, the ports can be made single-use disposable and delivered sterile to the user. The preferred materials are non-autoclavable plastics (to prevent re-use) such as ABS. One skin port is designed with threads for use around the umbilicus. The ports include introducers to help with placement through the incisions. The ports are designed to have a snap-fit with the introducers. The snap-fit is designed with a balance between being tight enough to prevent the ports from Docket No.: Apyx-094PCT accidentally falling off the introducers and being loose enough to allow the port to be removed from the introducer with one hand (i.e. with the thumb). The ports have features to allow sutures to be placed to hold them securely in position. The ports are sized to allow subsequent steps in the body contouring procedure (i.e. aspiration and skin tightening) to be performed through the skin ports. This protects the skin in these subsequent steps and obviates the need for removal of the skin ports after UAL.

[0161] A skin port incision opener tool may be provided and serves two purposes: (i) to undermine the skin around the incisions to allow for placement of the skin ports and (ii) to serve as the introducer for the threaded skin port for use around the umbilicus. The tool is made of autoclavable material to allow it to be cleaned, resterilized, and reused by the user. The preferred material is anodized aluminum. The tool is designed to have a snap-fit with the umbilicus skin port. The snap-fit is designed with a balance between being tight enough to prevent the skin port from accidentally falling off and being loose enough to allow the port to be removed from the introducer with one hand (i.e. with the thumb). The tool is designed to allow for placement of the umbilicus skin port through twisting or screwing into place.

[0162] A graphical user interface for controlling the UAL subsystem 300, e.g., section 124 of GUI 108 is provided. The GUI 124 allows for setting the UAL power level 140 to high, medium, or low. The GUI 124 allows for choosing between Standard and Continuous mode 142. Standard mode delivers pulsed or modulated ultrasound energy. Continuous mode delivers continuous ultrasound energy. The GUI 124 displays the amount of time 144 the ultrasound HP has been activated. The timer counter 144 may have an adjustable limit that informs the user that the desired UAL application has been reached. The GUI 124 has a reset button 146 for resetting the activation time when the user moves to a new treatment area.

[0163] As described in relation to FIG. 5, footswitches 208, 210 may include two individual pedals: one for infiltration and one for ultrasound-assisted liposuction (UAL). Since footswitches 208, 210 also work in conjunction with the UAL subsystems, the footswitches 208, 210 are shown again in FIG. 6. The appropriate pedal of footswitches 208, 210 are provided to control the UAL subsystem 300, via controller 102. The appropriate pedal of the two footswitches 208, 210 are included in the system to activate the ultrasound Docket No.: Apyx-094PCT handpiece 304. Two footswitches 208, 210 are included in the system because multiple physicians are often operating at the same time on the same patient during body contouring procedures. In this scenario, it is useful to have one footswitch on either side of the OR (operating room) table to allow the ultrasound handpiece to be controlled by two different physicians on different sides of the table. The footswitches 208, 210 may be wireless to reduce the number of cables present in the OR, where signals from the wireless footswitches 208, 210 are received by wireless transceiver module 115 and forwarded to controller 120.

[0164] III. Aspiration Subsystem 400

[0165] The aspiration or fat removal portion of a body contouring procedure involves physically suctioning out the excess fat that has accumulated in undesired locations on the body. After infiltration, aspiration can be performed without a prior step to loosen or emulsify the fat. This is often referred to as traditional liposuction or suction-assisted liposuction (SAL). As discussed above, newer methods of liposuction have been developed that utilize energy such as ultrasound or laser energy to loosen or emulsify the fat prior to performing aspiration. The loosening or emulsification of the fat makes the fat easier to remove from the body during the aspiration step.

[0166] Generally, the aspiration process proceeds as follows:

[0167] • Insertion of the Cannula: After the fat has been prepared through infiltration or other methods (e.g., UAL), the surgeon makes small incisions in the skin, or use existing incisions from previous steps, and inserts the cannula.

[0168] • Aspiration of fat: The surgeon moves the cannula back and forth beneath the skin in a controlled manner, dislodging the adipose tissue from surrounding connective structures. The vacuum pressure imparted on the cannula aspirates (sucks out) the fat through the tube. The goal is to remove excess fat evenly, preventing any irregularities in contouring.

[0169] • Monitoring and Adjustment: Throughout the aspiration process, the surgeon carefully monitors the amount of fat being removed and the overall shape of the treated area. This step is done slowly and precisely to ensure smooth and naturallooking results. Docket No.: Apyx-094PCT

[0170] Completion: Once the desired amount of fat is removed and the area has been sculpted to the patient’s aesthetic goals, the cannula is withdrawn, and the incisions are either left open for drainage or closed with sutures.

[0171] The duration of the aspiration step can vary depending on several factors:

[0172] • Size and Number of Treated Areas: Larger areas (e.g., abdomen, thighs, back) or multiple areas being treated in one session will require more time for fat removal.

[0173] • Fat Volume to Be Removed: The more fat that needs to be aspirated, the longer the procedure will take. Smaller, localized treatments may only take 20-30 minutes, while large-volume liposuction can take significantly longer.

[0174] • Precision Required: High-definition body contouring procedures that require detailed sculpting for muscle definition (such as abdominal etching) may prolong the aspiration step as the surgeon must remove fat with extreme precision.

[0175] The aspiration step may take anywhere from 30 minutes to several hours, depending on the extent of the treatment. In most cases, it is the longest step in the liposuction procedure. Therefore, increasing the efficiency of the aspiration step can have a significant impact on reducing the overall procedure time.

[0176] Referring to FIGS. 7A-7B, the aspiration subsystem 400 of the all-in-one body contouring system 100 includes at least the following components: aspiration cannulas 402, aspiration handles 404, suction tubing 406, fat collection canisters 408, filters 410 and suction pumps 412. As shown in FIG. 3B, pumps 412 are disposed in enclosure 111 , while canisters 408 are coupled to support member 103, as shown in FIG. 1 .

[0177] Aspiration cannulas 402 are thin, hollow tubes with different configurations of holes at the distal end. The proximal ends of the cannulas 402 are connected either to a handle 404 or directly to suction tubing 406. The aspiration cannulas 402 are configured in multiple diameters and lengths depending on body area being treated. The preferred material for the cannulas is stainless steel. The cannulas may be offered in reusable or single-use disposable configurations. The reusable cannulas are designed to be repeatably cleaned and steam sterilized by the user at their facility. The single-use disposable cannulas are provided sterile to the user and are disposed of after use. The aspiration cannulas 402 may be configured with a venting feature that allows for a small, Docket No.: Apyx-094PCT controlled amount of air from outside the suction system to be pulled into the aspiration handle / suction tubing. This venting allows for more efficient removal and transport of the fat through the aspiration system.

[0178] Aspiration handles or handpieces 404 make the aspiration cannulas 402 easier to hold and manipulate. The distal end 403 of the handle 404 connects to the cannula 402, and the proximal end 405 of the handle 404 connects to suction tubing 406. The handle 404 is cannulated so that the distal end 403 (including the cannula 402) is in direct fluid communication with the proximal end 405 (including the suction tubing 406). This allows vacuum pressure to be pulled through the handle 404 and the cannula 402 via the suction tubing 406. The aspiration handle 404 is designed to connect to aspiration cannulas 402 that are widely available on the market. This allows the body contouring system 100 to be offered with a small selection of aspiration cannulas. If a user prefers a cannula not offered as part of the body contouring system, they can source cannulas of different sizes or hole configurations from other sources that will still connect to the aspiration handles of the body contouring system 100. This has the advantage of minimizing inventory costs for the manufacturer of the body contouring system.

[0179] The aspiration handles 404 may be designed with a venting feature that allows for a small, controlled amount of air from outside the suction system to be pulled into the aspiration handle / suction tubing 404 / 406. This venting allows for more efficient removal and transport of the fat through the aspiration system.

[0180] The suction tubing 406 is used to connect the vacuum source, e.g., pumps 412-1 , 412-2, to the handle / aspiration cannula 404 / 402. The distal end 407 of the tubing 406 connects to the handle / aspiration cannula 404 / 402 and the proximal end 409 connects to fat collection canisters 408.

[0181] The fat collection canisters 408 are reservoirs within the suction or aspiration system 400 that are used to remove and collect the fat from the suction tubing 406. The fat collection canisters 408 have multiple inlet / outlet ports on the lids of the canisters 408. An inlet port 420 is connected to the suction tubing 406, and an outlet port 422 is connected to another section of tubing 424. Vacuum pressure is pulled from the inlet port 420 of the canister 408 to the outlet port 422. Docket No.: Apyx-094PCT

[0182] The tubing 424 connected to the outlet port 422 of the fat collection canister 408 may be connected to a filter 410. The purpose of the filter 410 is to remove any residual moisture or fat residue from the air leaving the fat collection canister 408 prior to the air entering the suction pump 412. The tubing 424 leaving the fat collection canister 408 is connected to the inlet of the filter 410. The outlet of the filter 410 is connected to another section of tubing 426 that connects directly to the suction pump 412.

[0183] The suction pumps 412 are used to impart the vacuum (negative) pressure on the entire aspiration system 400 that is used to pull fat from the body, through the cannula 402, through the handle 404, through the suction tubing 406, and deposit it into the fat collection canister 408. In some embodiments, the aspiration subsystem 400 contains two suction pumps 412-1 , 412-2 which allows for two users to perform the aspiration step at the same time. This dual-user capability greatly improves the efficiency of the aspiration step and reduces the overall procedure time. Since the aspiration subsystem 400 contains two suction pumps 412, the system is configured to allow for two complete aspiration systems to function at the same time independently. Accommodations contained within the system to facilitate two complete aspiration systems include: canister holders to accommodate up to four fat collection canisters; filter holders to accommodate up to two filters and tubing management for two systems.

[0184] In conventional systems, a single aspiration pump is limited both in the maximum vacuum level it can achieve (which is constrained by local atmospheric pressure) and in the pumping rate at which it reaches a desired vacuum setpoint. These limitations become more pronounced at higher altitudes but also restrict performance at sea level. To address these constraints, the system 400 allows the two pumps 412-1 , 412-2 to operate either in series or in parallel, under software or user control. In a single-user configuration (i.e., enhanced vacuum mode): When one user is active, the two pumps 412 operate in series. This configuration produces a higher overall pressure ratio, enabling deeper achievable vacuum, faster pull-down to the setpoint, and greater efficiency during aspiration. In addition, the use of two smaller pumps operating cooperatively achieves these performance gains with lower acoustic output and reduced vibration compared with a single large-capacity pump. In a dual-user configuration: when two users aspirate Docket No.: Apyx-094PCT simultaneously, the system automatically switches the pumps 412-1 , 412-2 to independent operation, providing balanced vacuum and flow to both aspiration circuits.

[0185] In various embodiments, the aspiration system 400 can operate in multiple pneumatic configurations. In an independent mode, each pump 412-1 , 412-2 functions as a separate vacuum source dedicated to its respective user circuit, allowing two users to operate simultaneously with isolated vacuum control. In a series mode, both pumps 412-1 , 412-2 operate cooperatively in a staged configuration to increase the overall pressure ratio, enabling deeper vacuum and reduced pump-down time to vacuum setpoint for a single user. In a parallel mode, both pumps 412-1 , 412-2 contribute to a common vacuum source, combining their flow capacity to provide reduced pump-down time to vacuum setpoint for a single user.

[0186] In some embodiments, the pneumatic assembly is configured to support independent and series operation (as illustrated in FIG. 7A), providing reduced component complexity while achieving performance benefits comparable to parallel operation. In other embodiments, the system may support independent, series, and parallel operation (as shown in FIG. 7B), allowing additional flexibility in matching vacuum performance to procedural requirements.

[0187] Referring to FIG. 7A, in independent mode, valve 1 (430) is configured to establish communication between aspiration pump 1 exhaust port 413 and atmosphere 415, and to block communication between aspiration pump 1 exhaust port 413 and aspiration pump 2 suction port 417. Valve 2 (432) is configured to establish communication between aspiration pump 2 suction port 417 and the filter / canister / handpiece circuit 410 / 408 / 404.

[0188] In series mode, valve 1 (430) is configured to establish communication between aspiration pump 1 exhaust port 413 and aspiration pump 2 suction port 417, and to block communication between aspiration pump 1 exhaust port 413 and atmosphere 415. Valve 2 (432) is configured to block communication between aspiration pump 2 suction port 417 and the filter / canister / handpiece circuit 410 / 408 / 404.

[0189] Referring to FIG. 7B, in independent mode, valve 1 (430) is configured to block communication between aspiration pump 1 suction port 419 and valve 2 (432) or valve 3 (434). Valve 2 (432) is configured to establish communication between aspiration pump 2 suction port 417 and the filter / canister / handpiece circuit 410 / 408 / 404, and to block Docket No.: Apyx-094PCT communication between aspiration pump 2 suction port 417 and valve 1 (430). Valve 3 (434) is configured to establish communication between aspiration pump 1 exhaust port 413 and atmosphere 415, and to block communication between aspiration pump 1 exhaust port 413 and valve 1 (430).

[0190] In series mode, valve 1 (430) is configured to establish communication between valve 2 (432) and valve 3 (434), and to block communication between aspiration pump 1 suction port 419 and valve 2 (432) or valve 3 (434). Valve 2 (432) is configured to establish communication between aspiration pump 2 suction port 417 and valve 1 (430), and to block communication between aspiration pump 2 suction port 417 and the filter / canister / handpiece circuit 410 / 408 / 404. Valve 3 (434) is configured to establish communication between aspiration pump 1 exhaust port 413 and valve 1 (430), and to block communication between aspiration pump 1 exhaust port 413 and atmosphere 415.

[0191] In parallel mode, valve 1 (430) is configured to establish communication between aspiration pump 1 suction port 419 and valve 2 (432), and to block communication between valve 2 (432) and valve 3 (434). Valve 2 (432) is configured to establish communication between aspiration pump 2 suction port 417 and valve 1 (430), and to block communication between aspiration pump 2 suction port 417 and the filter / canister / handpiece circuit 410 / 408 / 404. Valve 3 (434) is configured to establish communication between aspiration pump 1 exhaust port 413 and atmosphere 415, and to block communication between aspiration pump 1 exhaust port 413 and valve 1 (430).

[0192] The controller 102 may dynamically transition between independent, series and parallel modes based on the number of active users, measured barometric pressure, or deviation between the measured and target vacuum levels as measured by pressure sensors 428, ensuring optimal performance across a wide range of clinical environments. For example, when only one user is using the system, the system may default into series mode. If two users are using the system, the system will switch to independent mode. In another example, measured barometric pressure may switch from a single pump being used to series mode when a predetermined barometric pressure setpoint or threshold is exceeded. In one embodiment, a barometric pressure sensor is provided in either housing 102, 104 and coupled to controller 102. In another embodiment, the barometric pressure may be obtained by determining a location of the system 100 via the remote services Docket No.: Apyx-094PCT module 170 and then employing a look-up table to determine, for example, the typical barometric pressure for the determined location. Through this dual-pump architecture, the system 400 maintains target vacuum levels more rapidly, quietly, and efficiently, regardless of altitude, without the size, weight, or noise penalty associated with a single oversized pump.

[0193] A graphical user interface is provided for controlling the aspiration subsystem 400, e.g., section 126 of GUI 108. The GUI 126 allows the user to set the level of vacuum pressure 152, 154 for each of the two aspiration systems 400. The GUI 126 allows the user to switch from operating the two aspiration pumps (ASP1 , ASP2) 412 of system 400 in series or in parallel, via inputs 156. In some embodiments, for example, if pump ASP1 412-1 is enabled, both pumps 412-1 , 412-2 are running in series mode. If both pumps ASP 1 421 -1 and ASP 2 412-2 are enabled, both pumps 412-1 , 412-2 operate in independent mode. If only pump ASP 2 412-2 is enabled, only one pump is running in independent mode, i.e., pump 412-2.

[0194] The GUI 126 displays the actual vacuum pressure being generated by each aspiration system to allow comparison to the set point, e.g., indicator 158 for pump 1 ASP1 and indicator 160 for pump 2 ASP2.

[0195] In certain embodiments, the infiltration pump system 206 comprises a peristaltic or other positive-displacement pump, as described above, configured for dual functionality, operating not only to deliver infiltration or tumescent fluid but also to generate controlled negative pressure for fat aspiration. When operated in this alternative aspiration mode, the infiltration pump system 206 functions as an independent aspiration source capable of generating sufficient vacuum for fat extraction, with a gentler and smoother pressure profile compared to conventional aspiration pumps.

[0196] The infiltration pump-based aspiration configuration may be connected to a sterile receptacle such as an empty saline bag or directly to a fat-processing cartridge or subsystem, allowing harvested fat to be collected in a closed, sterile environment. This configuration is well suited for targeted or precision fat-harvesting applications, or for use in conjunction with the primary aspiration system when a gentler or more controlled aspiration profile is desired. Docket No.: Apyx-094PCT

[0197] It is understood that the aspiration performance of the infiltration pump 206 can be varied by adjusting design or control parameters such as the pump-head diameter, hose inner diameter, or operating speed. By selecting appropriate combinations of these parameters, the infiltration pump 206 can achieve suction levels and flow rates comparable to those of conventional vacuum aspiration pumps. This scalability allows the infiltration-based aspiration mode to be optimized for different procedural volumes, tissue types, or clinical preferences.

[0198] Because a peristaltic pump can provide controlled flow through a closed tubing set, this infiltration pump-based aspiration mode can reduce mechanical handling and exposure to air of the aspirated tissue and may help limit shear exposure compared to conventional vacuum-driven aspiration systems conditions that are generally associated in the literature with improved adipocyte viability during fat harvesting. The aspirated material may subsequently be processed using the fat processing subsystem 700 for purification or sizing prior to reinjection. The infiltration pump-based aspiration mode may also be used together with the power liposuction subsystem 500 to pre-harvest or refine adipose tissue, or as an alternative to the main aspiration system in low- to moderateflow procedures. As an example, the pump head 207 may be configured in a forward mode via button 133 to pump fluid from bag 203 through the tubing 204 through the cannula 214 to the patient until the bag 203 is empty. After an ultrasound procedure to loosen or emulsify fat, the reverse button 135 configures the pump head 207 to pump fluid or fat from the cannula 214 to the same bag 203 or other sterile container, e.g., a canister, cartridge, filter-bag or other types of fat processing systems.

[0199] IV. Powered Aspi ration / l nf iltration / Fat Transfer - Power Liposuction Subsystem 500

[0200] Power-assisted liposuction is a form of liposuction that uses a specialized cannula that reciprocates or oscillates rapidly to help dislodge and remove adipose tissue more efficiently than traditional suction-assisted liposuction (SAL). The powered cannula is attached to a mechanized handpiece that delivers the rapid back-and-forth movement, which enhances the surgeon’s ability to dislodge fat with less manual effort. Generally, Power-Assisted Liposuction works as follows: Docket No.: Apyx-094PCT

[0201] • Cannula Insertion: As with traditional liposuction, the surgeon makes small incisions, or use existing incisions from previous steps, and inserts the cannula into the target area after the infiltration of tumescent fluid.

[0202] • Mechanized Vibration: The cannula used is connected to a motorized device that makes the tip of the cannula reciprocate or oscillate at a high speed (several thousand cycles per minute). This rapid motion helps to break up fat cells more easily compared to manual movements alone.

[0203] • Fat Aspiration: As the vibrating cannula moves through the fat tissue, it loosens and dislodges the adipose tissue, which is then suctioned out through the same cannula using the aspiration subsystem described above.

[0204] Power-assisted liposuction offers several advantages, such as increased precision, faster fat removal, and reduced trauma to surrounding tissues. It is particularly useful in treating larger areas of the body, dense fat deposits, and patients who desire shorter recovery times. Power-assisted liposuction combines the simplicity of traditional liposuction with the enhanced efficiency and comfort of mechanized assistance.

[0205] In addition to powered aspiration, there is clinical benefit to performing the infiltration and fat transfer portions of a body contouring procedure using reciprocating, powered cannulas.

[0206] The powered aspiration / infiltration / fat transfer subsystem 500 of the all-in-one body contouring system 100 includes at least two mechanized HPs 502 and a power liposuction control module 503. The mechanized HPs 502 cause the reciprocation of the cannulas 504. The HPs 502 may be designed to cause reciprocation of 1 -6000 cycles per minute. The HPs 502 may be designed to cause a reciprocation length of up to 6mm. The body contouring system 100 may be offered with multiple different HPs with different reciprocation lengths. The system 100 contains the ability to operate two mechanized HPs 502 to allow two users to perform procedures at the same time. This increases the efficiency of the procedure.

[0207] In some embodiments, the HPs 502 contain at least two buttons 506, 508 for operating the infiltration pump 206, the aspiration pumps 412, and the mechanized HP 502. The buttons 506, 508, 510 are configured to allow a user to operate the infiltration Docket No.: Apyx-094PCT pump 207, the aspiration pumps 412, and the mechanized HP 502 independently of one another. For example, using the buttons, the user can turn on the infiltration pump 207 by itself to be able to infiltrate without power. The user can then use the second button to turn on the reciprocation of the HP 502 so that powered infiltration can be performed. In a similar fashion, the user can turn on the aspiration pump 412 to perform traditional SAL with one button and then use the second button to turn on the reciprocation of the HP 502 to perform powered aspiration. For fat re-injection to the patient, the user can turn on the infiltration pump 207 by itself to be able to transfer fat without power. The user can then use the second button to turn on the reciprocation of the HP 502 so that powered fat transfer can be performed. The buttons can be configured to latch “on” with a single press and release of the button to remove the need for the user to keep the button depressed. This reduces user fatigue.

[0208] In a two-button configuration, one button may be used to control both infiltration and aspiration pumps. The second button may be used to control the reciprocation of the HP.

[0209] The GUI 128 may be configured to allow the user to select 160 the function (infiltration or aspiration pump) of the one button that controls both. Alternatively, the user may be able to toggle between these functions by performing a double-click, or a click- and-hold (long click) of the button.

[0210] In some embodiments, the HP 502 may also be configured to contain three buttons: one button 506 for the infiltration pump 206, one button 508 for the aspiration pump 412, and one button 510 for the reciprocation of the HP 502. The at least three buttons 506, 508, 510 enable a user to control or implement various modes of operation, For example, in one embodiment, the handpiece 502 can be operated with the motor precipitation deactivated and only the infiltration function active, allowing delivery of tumescent solution in the same manner as a conventional, non-powered cannula. In another embodiment, the handpiece 502 can be operated with both infiltration and motorized reciprocation active, which assists advancement through fibrous or dense tissue and promotes uniform distribution of the infiltration fluid. In another embodiment, the handpiece 502 can be operated with the motor reciprocation deactivated and only aspiration active, providing gentle suction suitable for small areas or precise contouring. In a further embodiment, the Docket No.: Apyx-094PCT handpiece 502 can be operated with both aspiration and motorized reciprocation active, providing efficient removal of adipose tissue and reduced operator effort during the primary suction phase. In yet another embodiment, the handpiece 502 can be operated with motorized reciprocation active and aspiration deactivated, allowing redistribution or mechanical disruption of residual adipose tissue without suction, for example during fat equalization or contour refinement. In a further embodiment, for fat re-injection to the patient, the user can turn on the infiltration pump 207 by itself to be able to transfer fat without power. The user can then use the second button to turn on the reciprocation of the handpiece 502 so that powered fat transfer can be performed.

[0211] Each button 506, 508, 510 may independently control infiltration, aspiration, or reciprocation functions, and may be re-mapped via the GUI 128 to toggle between infiltration and aspiration. Buttons 506, 508, 510 may operate in either a momentary (“press and hold”) or toggle (“latch on / off”) mode and may include visual or tactile feedback such as illumination or haptics. The controller 120 may restrict reciprocation when aspiration vacuum exceeds a preset threshold to reduce tissue trauma.

[0212] Adapters for connecting multiple different cannula designs are provided. The cannulas used for either infiltration 214, aspiration 402, or fat transfer must be able to be connected to the reciprocating portion of the HP 502. This most often requires the use of cannulas with special, custom connections that mate with the HP. The body contouring system may include adapters that allow for standard infiltration, aspiration, and fat transfer cannulas to mate with the HP 502. The distal end of the adapters may be designed to work with standard luer-lock, Toomey, VentX, tapered connection cannulas while the proximal end mates with the HP. This removes the need for custom cannulas.

[0213] Additionally, tubing adapters for connecting standard aspiration and infiltration tubing to the cannulas may be provided. When performing infiltration, aspiration, or fat transfer with powered cannulas, the infiltration, aspiration, or fat transfer tubing must be connected to the cannulas. Many power-assisted liposuction systems require the use of custom tubing to facilitate the connection to the cannula. The body contouring system may include tubing adapters that connect to the cannula adapters and allow for connection to standard infiltration, aspiration, and fat transfer tubing. This removes the need for custom tubing. Docket No.: Apyx-094PCT

[0214] A graphical user interface is provided for controlling the powered aspiration subsystem 500, e.g., section 128 of GUI 108. The GUI 128 allows the user to set the reciprocation speed 162 of the HP 502. The GUI 128 allows the user to switch 160 the function of one of the HP buttons between controlling the infiltration pump or the aspiration pump.

[0215] In certain embodiments, the power-assisted liposuction subsystem 500 may also be used in combination with the infiltration pump-based aspiration mode, in which the peristaltic infiltration pump 206 operates as an independent aspiration source.

[0216] V. Skin Tightening Subsystem 600

[0217] The skin tightening subsystem 600 of the all-in-one body contouring system 100 includes a helium plasma generator and handpieces (HPs). Plasma provided by the skin tightening subsystem 600 may be provided at portions of a patient where fat has been removed.

[0218] In a further embodiment of the present disclosure, a plasma generator handpiece or apparatus is provided that has a 360-degree tissue treatment area about the longitudinal axis of the distal tip for skin tightening. In some embodiments, the plasma generator handpiece may provide a 180-degree tissue treatment area about the longitudinal axis of the distal tip for skin tightening.

[0219] Referring to FIGS. 9-13, a plasma generator handpiece or apparatus 601 that provides a 360-degree tissue treatment area is shown in accordance with an embodiment of the present disclosure. Apparatus 601 includes a connector or plug 602, a housing 606, a shaft 608 including a distal tip 610, and an electrode disposed within the distal tip 610. In some embodiments, the handpiece 601 may include a flush port 660 and associated tubing 654 to facilitate removal of debris at the distal tip 610.

[0220] The housing 606 includes a proximal end 612 and distal end 614. Shaft 608 includes the distal tip or end 610 and a proximal end 616 that is coupled to the distal end 614 of the housing 606. The proximal end 612 of housing 606 includes first and second ports 618, 620. First port 618 is configured to receive a first end 622 of cable 604. A second end 624 of cable 604 is coupled to connector 602. Docket No.: Apyx-094PCT

[0221] Referring to FIGS. 10-13, a distal portion 610 of apparatus 601 is shown in accordance with an embodiment of the present disclosure, where FIG. 10 is a perspective view of the distal portion 610, FIG. 1 1 is a top view of distal tip 610, FIG. 12 is a side view of distal tip 610 and FIG. 13 is a cross-sectional view of the side view of distal tip 610 shown in FIG. 15. It is to be appreciated that the distal portion 610 may be provided in different configurations depending on an intended use.

[0222] Apparatus 601 includes an electrically conducting member or electrode 618 (shown in FIG. 9), e.g., a conductive rod, wire, or other suitable electrode, disposed through shaft 608. A distal end of the electrically conducting member or electrode 618 is disposed in the distal tip 610 while a proximal end is disposed in the housing 606 and coupled to at least one conductor disposed in tube 604. In one embodiment, electrode 618 is made of tungsten, however, other suitable materials are contemplated to be within the scope of the present disclosure. Shaft 608 is made of a non-conducting material and is configured to provide inert gas to tip 610. Electrode 618 is configured to provide electrosurgical energy to tip 610. In some embodiments, shaft 608 is configured to enable a degree of flexibility (e.g., bending of shaft 608) to facilitate the insertion of tip 610 and shaft 608 through subdermal tissue during electrosurgical procedures performed with apparatus 600.

[0223] Tip 610 includes a distal end 630 and a proximal end 632. Tip 610 includes at least one port 634A,634B disposed through a side wall of tip 610 and oriented in a radial direction traverse to axis 636. Tip 610 further includes interior 638, which includes an inner wall 652A, 652B having a slot or channel 640. Inner wall 652A, 652B is angled or slanted such that wall 652A, 652B transverses the longitudinal axis 636 at a predetermined angle.

[0224] Referring to FIG. 13, tip 610 is disposed adjacent to shaft 608 and a tube 642 is disposed through the distal end of shaft 608 into the interior of shaft 608 and through the proximal end 632 of tip 610 into the interior 638 of tip 610. An adhesive is used to bond the tube 642 to the interior of shaft 608 and the interior 638 of tip 610, thereby coupling tip 610 to shaft 608. Tube 642 provides support to the connection or junction points between shaft 608 and tip 610 to prevent bending at the connection or junction point. It Docket No.: Apyx-094PCT is to be appreciated that tube 642 may be made of conductive or non-conductive materials in various embodiments of the present disclosure.

[0225] When tip 610 is coupled to shaft 608, electrode 618 extends from the interior of shaft 608 through tube 642 and interior 638. A distal end 644 of electrode 618 is securely received by the slot 640 of interior 638 such that a distal portion electrode 618 is disposed adjacent to at least one port 634A, 634B. Port 634A, 634B is disposed through a side wall of tip 610 such that port 634A, 634B is oriented in a radial direction with respect to axis 636. Port 634A, 634B includes a curved surface 638 having a concavely rounded edge perimeter 646 disposed adjacent to the exterior walls of tip 610. Distal end 630 of tip 610 includes an exterior surface or wall 648 shaped as an elliptic paraboloid or an elliptical cone with a blunted or rounded tip 650 converging toward distal end 630.

[0226] It is to be appreciated that tip 610, wall 638, and edge 646 are shaped such that when tip 610 is moved through subcutaneous tissue, the curved surfaces 650, 638, 646 of tip 610 enable tip 610 to glide through the subcutaneous tissue with minimal resistance.

[0227] When inert gas, such as Helium, is provided through shaft 608 and into interior 638 and electrode 618 is energized, at least some of the inert gas is ionized and plasma is generated within interior 638 of tip 610. Port 634A, 634B arcs about axis 636 at a predetermined arc length. In one embodiment, each port 634A, 634B arcs about axis 636 such that the arc length of each port 634A, 634B is slightly less than half the circumference of tip 610. It is to be appreciated that the arc length of each port 634A, 634B shown is merely exemplary and that other arc lengths are contemplated to be within the scope of the present disclosure. Ports 634A, 634B are diametrically opposed with respect to axis 636, such that ports 634A, 634B are oriented in opposite directions. As best seen in FIG. 9, in this embodiment, the interior of tip 610 includes a wall having a first portion 652A and a second portion 652B. The first portion 652A is angled to direct inert gas and plasma generated to exit via port 634A and the second portion 652B is angled to direct inert gas and plasma generated to exit via port 634B. In this way, tip 610 may be configured such that gas and plasma exit both ports 634A, 634B simultaneously and tissue disposed various positions 360° about axis 636 exterior to tip 610 may be treated using apparatus 601 . Docket No.: Apyx-094PCT

[0228] It is to be appreciated that in other embodiments, only one port 634A, 634B may be used to provide an 180° tissue treatment area about the longitudinal axis 636.

[0229] In use, connector 602 of apparatus 601 may be coupled to subsystem 600, e.g., disposed in housing 102, to receive electrosurgical energy and / or gas therefrom. In one embodiment, button 603, disposed on or accessible from housing 606, may activate the subsystem 600 to provide the electrosurgical energy and / or gas. The connector 602 may receive electrical energy and provide the electrosurgical energy to electrode 618 via conductors disposed in cable 604. Furthermore, the connector 602 may receive a gas (from subsystem 600 or a separate gas source) and provide the gas to shaft 608 via cable 604. When electrosurgical energy and a gas is simultaneously provided to apparatus 601 , plasma is generated and emitted from the distal tip 610.

[0230] In use, the user moves the distal tip of the plasma device 601 through the tissue plane at a predetermined speed. In one embodiment, the predetermined speed is 1 centimeter per second. It is to be appreciated that the predetermined power curve of the waveform, the predetermined flow rate of the inert gas, and the predetermined speed of the tip through the tissue plane are selected such that, the temperature of the tissue being heated by the plasma emitted from the plasma device reaches at least 85° C and the tissue is not heated in bulk (e.g., in areas surrounding or further away from the target tissue), but instead is heated instantaneously and cools quickly after treatment.

[0231] Unlike with bulk tissue heating, the rapid heating of tissue performed by the subsystem 600 of the present disclosure allows the tissue surrounding the treatment site to remain at much cooler temperatures resulting in rapid cooling after the application of the energy through conductive heat transfer. Additionally, the energy provided to the tissue using the electrosurgical apparatuses of the present disclosure is focused on heating the fibroseptal network (FSN) instead of the dermis. The majority of soft tissue contraction induced by subcutaneous energy delivery devices is due to its effect on the fibroseptal network. Because of these unique heating and cooling properties of the electrosurgical apparatuses of the present disclosure, immediate soft tissue contraction can be achieved without unnecessarily heating the full thickness of the dermis.

[0232] VI. Fat Transfer Subsystem 700 Docket No.: Apyx-094PCT

[0233] The fat transfer portion of a body contouring procedure, also known as fat grafting or lipofilling, involves harvesting fat from one area of the body (through liposuction), processing the fat if needed, and re-injecting it into another area to enhance its shape, volume, or contour. This technique is commonly used to add fullness to areas like the buttocks, hips, breasts, or face.

[0234] Referring to FIG. 14, the fat transfer subsystem 700 of the all-in-one body contouring system 100 includes a fat collection canister 702 and at least one fat transfer cannula. A fat collection canister 702 designed specifically for the purpose of being able to extract the fat from the canister 702 during the fat transfer portion of the procedure. Design features of the fat collection canister include the following: sealing to prevent exposing the aspirated fat to air which can reduce the viability of the fat; and a port 704 at the bottom of the canister 702 that allows for tumescent or blood or other liquids to be removed from the bottom of the canister 702. Tumescent or blood or other liquids separate from the fat due to gravity and differences in density. The fat floats to the top which allows the other liquids to be removed from the bottom of the canister and leaves only fat remaining in the canister that can be reinjected into the patient.

[0235] Fat transfer cannulas allow the fat to be reinjected into the patient. The fat transfer cannulas are configured in multiple diameters and lengths depending on body area being treated. The preferred material for the cannulas is stainless steel. The cannulas may be offered in reusable or single-use disposable configurations. The reusable cannulas are designed to be repeatably cleaned and steam sterilized by the user at their facility. The single-use disposable cannulas are provided sterile to the user and are disposed of after use. The fat transfer cannulas may be designed with a single exit hole at the distal end of the cannula to allow for precision placement of the fat in the new area.

[0236] In certain embodiments, the fat transfer subsystem 700 may further include an integrated or stand-alone fat processing subsystem 706 configured to purify, concentrate, or size the harvested adipose tissue prior to reinjection. The goal of fat processing is, for example, to remove non-adipose components such as tumescent fluid, blood, oil, and cellular debris, while preserving viable adipocytes and stromal vascular fraction cells for reinjection. Docket No.: Apyx-094PCT

[0237] Several processing architectures may be implemented individually or in combination. In one embodiment, the fat processing subsystem may utilize a closed-loop filtration or membrane-based purification process of the type commonly used for fat washing and purification, wherein unwanted fluids and cellular debris are separated through differential flow or pore size within a sterile filtration chamber. The aspirated fat is circulated through a sterile filtration chamber where unwanted fluids and cellular debris are separated by differential flow or pore size, yielding purified, concentrated lipoaspirate suitable for grafting. This configuration minimizes handling, maintains sterility, and reduces exposure of the fat to air.

[0238] In another embodiment, the fat processing subsystem 706 may include a gravity- or centrifuge-assisted separation stage, as part of a decantation system. The harvested material is subjected to centrifugal or gravitational forces that stratify its components by density, typically resulting in an upper oil layer, a middle layer of viable fat, and a lower layer of aqueous or blood-containing fluid. Automated or semi-automated decanting mechanisms can then remove the undesired fractions, leaving purified adipose tissue ready for reinjection.

[0239] In some embodiments, the fat processing subsystem 706 may incorporate a fatsizing module in which the harvested fat is gently passed through a matrix of screens, blades, or orifices that divide larger lobules into smaller, more uniform parcels. The resulting micro-fat or nano-fat exhibits improved injectability through small-gauge cannulas and can be used for precision grafting in facial or contour-refinement procedures.

[0240] Alternatively, the fat processing subsystem 706 may employ a continuous or batch washing process in which the harvested lipoaspirate is repeatedly perfused with sterile saline or buffer solution while gentle agitation removes contaminants. In certain embodiments, the washing fluid may further include a biocompatible surfactant or membrane-stabilizing agent, such as Poloxamer 188 (P188) or an equivalent copolymer. Such additives may assist in removing free oil and cellular debris while stabilizing adipocyte membranes and thereby reducing cell damage during processing. The wash fluid is then evacuated under vacuum or gravity, leaving clean adipose tissue with reduced free lipids, inflammatory mediators, and other non-adipose components. Docket No.: Apyx-094PCT

[0241] In certain configurations, the fat processing subsystem 706 may combine two or more of the above techniques, e.g., centrifugation followed by filtration or sizing, to achieve the desired purity, concentration, and consistency to create a hybrid or modular system. The modules may be integrated within the main body-contouring system chassis or implemented as detachable, disposable processing cartridges 708.

[0242] Advantageously, the inclusion of a fat processing subsystem 706 allows the bodycontouring platform to function as a complete, closed, and sterile fat-harvesting and grafting solution. By automating purification and sizing within the same platform, the system reduces procedural steps, minimizes handling, and preserves adipocyte viability, ultimately improving graft retention and procedural efficiency.

[0243] The infiltration-based aspiration mode of the system may also be utilized to harvest adipose tissue intended for processing / g rafting. When used in this configuration, the peristaltic infiltration pump system 206 aspirates fat directly into a sterile collection bag or fat-processing cartridge, offering a closed and controlled harvesting method that can be used before or during the processing / grafting phase.

[0244] A graphical user interface for controlling the fat grafting and fat processing subsystem 700 may be provided as part of GUI 108. The system may include a graphical user interface (GUI) configured to monitor and control the components of the fat grafting and processing subsystem. The GUI may display the status and progress of fat collection, purification, and transfer, including indicators for volume processed, fluid separation, and readiness for grafting. The GUI may allow the user to select the desired processing mode, such as filtration, centrifugation, decantation, washing, treating or sizing, depending on which modules are connected or active. The GUI may include setpoint and timing controls for pump speed, wash cycles, centrifugation duration, or filtration flow rate. The GUI may display real-time parameters such as pressure, flow, and volume for any connected processing modules, and may automatically adjust or stop operation if out-of-range conditions are detected. The GUI may further include user prompts or guided steps for transferring purified fat to the grafting cannula or syringe assembly, ensuring a closed, sterile workflow.

[0245] VII. Monopolar and Bipolar Electrosurgery Subsystem 800 Docket No.: Apyx-094PCT

[0246] The all-in-one body contouring system 100 includes a monopolar and bipolar electrosurgical generator 800. Body contouring procedures may also require the need to remove excess skin and fat by excising it from the patient in procedures such as abdominoplasties and brachioplasties. In such procedures, standard electrosurgical operating modes such as cutting, coagulation, and ablation of tissue are necessary. The all-in-one body contouring system includes an electrosurgical generator to facilitate these types of procedures. This electrosurgical generator may also contain a helium plasma portion of the generator to facilitate the skin tightening portion of the procedure.

[0247] Referring to FIG. 15, a monopolar and bipolar electrosurgery subsystem 800 is shown in accordance with the present disclosure. Subsystem 800 includes an applicator or handpiece 810 and an electrosurgical generator unit (ESU) 850. In some embodiments, subsystem 800 further includes a gas supply 870.

[0248] Applicator 810 is configured to receive electrosurgical energy from ESU 850 via a cable 820. In some embodiments, applicator 810 is further configured to receive an inert gas from a gas source 870. In some embodiments, the inert gas is received from a gas supply 870 and provided from ESU 850 to applicator 810 via cable 8820. It is to be appreciated that gas supply 870 may be internal to ESU 850 or external to ESU 850. In other embodiments, applicator 810 receives the inert gas, e.g., helium, directly from gas supply 870. Applicator 810 includes a handle housing having a button and a shaft having a distal tip. When button is pressed, electrosurgical energy is delivered to applicator by ESU 850 and inert gas is delivered to applicator 810 by the gas source 870. The electrosurgical energy is used to energize an electrode disposed in the shaft. When the inert gas is passed over the energized electrode, a plasma is generated and emitted from tip to patient tissue, which allows for conduction of the radio frequency (RF) energy from the electrode to the patient in the form of a precise plasma beam. Exemplary applicators are shown and described in commonly-owned U.S. Patent No. 9,060,765, the contents of which are incorporated by reference.

[0249] It is to be appreciated that, in some embodiments, applicator 810 may be configured to apply or deliver energy to patient tissue in ways or forms other than plasma. For example, applicator 810 may deliver RF energy to patient tissue via direct contact of the electrode to patient tissue, e.g., in a monopolar or bipolar mode. In some Docket No.: Apyx-094PCT embodiments, the electrode may be retractable within shaft to enable the electrode to be extended and used to directly contact patient tissue to deliver RF energy or retract to deliver RF energy via plasma. In other embodiments, the electrode may be configured as a probe or heating element (e.g., heated by applying current received from ESU 50 to the heating element) and heat energy may be applied directly to patient tissue by the heat element.

[0250] ESU 850 includes controller or processor 851 , power supply 852, radio frequency (RF) output stage 854, I / O interface 856, alarm 858, memory 860, flow controller 862, sensor 864, and a communication module 866. Controller 851 is configured to control power supply 852 to supply electrosurgical energy being output from RF output stage 854 via at least one conductor extending through cable 820 to the applicator 810. I / O interface 856 is configured to receive user input (e.g., via GUI 106) to be provided to the controller 851 and output information (e.g., data to GUI 106) received from controller 851. Audible alarm 858 is controllable via controller 851 to alert an operator to various conditions or events.

[0251] Flow controller 862 is configured to control the flow of gas received from supply 870 to the applicator 810. The flow controller 862 is coupled to the controller 851 and receives control signals from the controller 851 based on user input via I / O interface 856 or based on an algorithm or software function stored in memory 860.

[0252] Communication module 866 of ESU 850 is configured to communicate with other devices (e.g., client devices, servers, etc.) via a communication link (e.g., wired or wireless) to send and receive data and communications. Controller 851 may use communication module 866 to send notifications to at least one other device via the communication link (e.g., wired or wireless), where the communications are associated with the various conditions or events. The communication module 866 may be a modem, network interface card (NIC), wireless transceiver, etc. The communication module 866 will perform its functionality by hardwired and / or wireless connectivity. The hardwire connection may include but is not limited to hard wire cabling e.g., parallel or serial cables, RS232, RS485, USB cable, Firewire (1394 connectivity) cables, Ethernet, and the appropriate communication port configuration disposed on a surface of housing 102. The wireless connection may operate under any of the various wireless protocols including Docket No.: Apyx-094PCT but not limited to Bluetooth™ interconnectivity, infrared connectivity, radio transmission connectivity including computer digital signal broadcasting and reception commonly referred to as Wi-Fi or 802.11.X (where x denotes the type of transmission), satellite transmission or any other type of communication protocols, communication architecture or systems currently existing or to be developed for wirelessly transmitting data including spread spectrum 900 MHz, or other frequencies, Zigbee, and / or any mesh enabled wireless communication.

[0253] In one embodiment, sensor 864 of ESU 850 is coupled to the output of RF output stage 854. Sensor 864 is configured to sample the voltage and / or current (or any other electrical properties) of the output of stage 854 and provide the sample voltage and / or current to controller 851 . Controller 851 may use the information to determine one or more properties associated with the power provided by ESU 850 to applicator 810. In one embodiment, sensor 864 may include at least one voltage sensor for sensing output voltage and at least one current sensor for sensing output current. Optionally, sensor 864 may include at least one analog-to-digital converter for converting the sensed signal to a digital signal to be input to controller 851 ; or alternatively, at least one analog-to-digital converter may be provided on controller 851 .

[0254] Referring to FIG. 16, a physician or user may perform a complete body-contouring procedure 900 utilizing the integrated system as follows: infiltrate tumescent anesthesia using the peristaltic pump and scale-based monitoring, step 902; emulsify adipose tissue by activating the UAL subsystem under frequency-tracking control, step 904; aspirate emulsified fat using the dual-pump aspiration subsystem operating independently, in series, or parallel as required, step 906; tighten subdermal tissue using the plasma handpiece emitting plasma through the distal tip, step 908; and transfer harvested fat applying a density calibration corresponding to fat, step 910. The controller 120 and GUI 106, 108 coordinate these steps, and may automatically adjust subsystem operation in response to user input or sensor feedback.

[0255] It is to be appreciated that these steps may be performed sequentially, simultaneously or in any combination. In some embodiments, only a subset of steps may be performed. For example, in one embodiment, a method or procedure may include infiltrating tumescent anesthesia using pump 206 and handpiece / cannula 212 / 214; Docket No.: Apyx-094PCT aspirating fat with the same pump 206 and handpiece / cannula 212 / 214 and transferring fat to areas of the patient with the same pump 206 and handpiece / cannula 212 / 214. In another example, a method or procedure may include infiltrating tumescent anesthesia using pump 206 and powered handpiece / cannula 502 / 504; aspirating fat with the same pump 206 and powered handpiece / cannula 502 / 504 and transferring fat to areas of the patient with the same pump 206 and powered handpiece / cannula 502 / 504. It is to be appreciated that the infiltration, aspiration and fat transfer steps described throughout this specification may also be employed using the cannulas with the powered handpiece. It is further to be appreciated that any of the steps described throughout this specification may be employed in various combinations to achieve the outcomes described herein and to create alternative methods and / or procedures

[0256] In certain embodiments, the system 100 further comprises a remote services module 170 (as shown in FIG. 3B) configured to enable bidirectional digital communication between one or more subsystems of the all-in-one body contouring platform and a remote data network, e.g., cellular, the Internet, LAN, WAN, etc. The remote services module 170 may be mounted externally on a subsystem housing, such as the housing 102 of the plasma generator, and include a communication interface configured to establish a secure connection with a cloud-based server. In one embodiment, communication module 856 of the electrosurgical subsystem 800 may act as the remote services module including all the functionality described herein. Through this link, subsystem and system-level information may be transmitted to a remote data repository, and service-related data or software updates may be received by the system.

[0257] The remote services module 170 is operatively coupled to at least one subsystem of the system 100 and is in communication with other subsystems through internal digital communication channels, e.g., communication channel 105. Accordingly, the remote services module 170 may access and transmit data originating from the plasma generator subsystem 800, infiltration subsystem 200, aspiration subsystem 400, ultrasound- assisted liposuction subsystem 300, power-assisted liposuction subsystem 500, or other connected components. The communication interface is configured to support secure transmission of performance, diagnostic, and usage data, as well as receipt of update or configuration information as required. The communication capability may be automatically Docket No.: Apyx-094PCT disabled when any connected subsystem is active in a treatment mode, thereby ensuring operational safety and data integrity during use.

[0258] The remote services module 170 may further include a secondary power source 172, such as a rechargeable battery, configured to maintain connectivity when the system 100 is disconnected from mains power. The battery may be automatically recharged when the system is powered on.

[0259] Information transmitted from the system 100 may include, but is not limited to, treatment logs, non-identifiable patient or procedural data, and system configuration parameters such as power level, operational mode, gas flow rate, pulse timing, and energy counters, as well as infiltration volume and rate, aspiration vacuum level, ultrasound frequency and amplitude, motor speed, and temperature or fault sensor readings from any subsystem of the all-in-one body contouring system 100. Additional transmitted data may include fault and error logs, subsystem identification data, calibration records, and hardware or software version identifiers. The remote services module 170 may also receive and store update files or configuration data for later local installation by an operator, as well as language or regional configuration files.

[0260] The remote services module 170 enables authorized service personnel to perform remote diagnostics, troubleshooting, or software provisioning across the integrated platform 100 without requiring physical access to the equipment. The system architecture thereby facilitates remote maintenance, firmware distribution, and performance monitoring for all subsystems of the platform 100, while preserving patient safety and regulatory compliance by disabling external communication during clinical use.

[0261] Throughout this disclosure and elsewhere, block diagrams and flowchart illustrations depict methods, apparatuses (i.e., systems), and computer program products. Each element of the block diagrams and flowchart illustrations, as well as each respective combination of elements in the block diagrams and flowchart illustrations, illustrates a function of the methods, apparatuses, and computer program products. Any and all such functions (“depicted functions”) can be implemented by computer program instructions; by special-purpose, hardware- based computer systems; by combinations of special purpose hardware and computer instructions; by combinations of general- Docket No.: Apyx-094PCT purpose hardware and computer instructions; and so on - any and all of which may be generally referred to herein as a “circuit,” “module,” “controller” or “system.”

[0262] Integration of all subsystems under a common controller offers significant engineering and operational benefits. A shared control board and power architecture reduce component count, wiring complexity, and overall system footprint, while improving reliability and serviceability. Unified electronics enables cross-communication among the subsystems, permitting procedural sequencing and interlocks that prevent incompatible operations from occurring simultaneously.

[0263] The unified GUI(s) presents the parameters of more than one subsystem on a single display, allowing the operator to monitor and adjust infiltration volume, ultrasonic power, aspiration pressure, plasma settings and electrosurgical power without switching between devices. This reduces cognitive load, setup time, and the risk of user error.

[0264] The integrated configuration further simplifies clinical and service logistics. Because all procedural modalities are contained within a single system and controlled through common electronics, the user needs only contact a single manufacturer or service provider in the event of malfunction or service needs. This eliminates the uncertainty associated with troubleshooting separate stand-alone devices, each supplied by different vendors. A unified service pathway reduces downtime, simplifies warranty administration, and ensures that updates or software revisions remain compatible across all subsystems.

[0265] The shared architecture also reduces operator confusion regarding peripheral connections. All cables, tubing sets, and footswitches are standardized and connected to common ports identified within the single console. Accordingly, the operator does not need to determine which accessory corresponds to which device, nor reconfigure connections when transitioning between procedural stages. This uniform interface decreases setup time, minimizes the risk of misconnection, and enhances procedural safety and reliability.

[0266] From a manufacturing and regulatory standpoint, the shared control electronics and software architecture simplify testing, validation, and documentation. Electrical-safety and electromagnetic-compatibility evaluations (e.g., IEC 60601 -1 , 60601 -1 -2) can be performed for the complete system rather than individually for each subsystem. Similarly, Docket No.: Apyx-094PCT a single software-validation file under IEC 62304 can cover all functions, and risk management can be consolidated into one FMEA and usability-engineering record. The result is reduced cost of compliance, streamlined maintenance, and improved traceability.

[0267] Clinically, the integrated system enables the entire body-contouring workflow, from infiltration through fat removal and skin tightening, to be completed using one console without exchanging devices or tubing sets. This continuity minimizes procedure time and contamination risk, while ensuring consistent performance parameters throughout the treatment. The unified architecture also facilitates data logging and post-procedure analysis by maintaining all operational parameters within a single record.

[0268] Overall, the integration of multiple subsystems within a single control framework provides a compact, reliable, and scalable platform that supports future modality additions through common hardware and firmware. These advantages distinguish the disclosed system from prior art devices that rely on separate, independently controlled instruments for each procedural phase.

[0269] It is to be appreciated that the various features shown and described are interchangeable, that is a feature shown in one embodiment may be incorporated into another embodiment.

[0270] The section headings used herein are provided for convenience of reference only and shall not be construed as having any substantive significance or limiting the scope of the disclosure in any way. The subject matter described under any particular heading may be combined with subject matter described under other headings as appropriate. The headings are not intended to define, limit, or characterize the invention(s) disclosed herein or the scope of the claims.

[0271] While the disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims.

[0272] Furthermore, although the foregoing text sets forth a detailed description of numerous embodiments, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible Docket No.: Apyx-094PCT embodiment, as describing every possible embodiment would be impractical, if not impossible. One could implement numerous alternate embodiments, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims. It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘ ’ is hereby defined to mean...” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.

Claims

Docket No.: Apyx-094PCTWHAT IS CLAIMED IS:1 . An all-in-one body contouring system comprising: an infiltration subsystem including a peristaltic pump, tubing, and a scale module configured to quantify a volume of tumescent anesthesia delivered to a patient based on weight loss from a fluid container; an ultrasound-assisted liposuction (UAL) subsystem including an amplifier, a handpiece, and a probe configured to deliver ultrasound energy for emulsifying adipose tissue; an aspiration subsystem including at least two vacuum pumps selectively operable in independent or series configurations to generate variable vacuum pressure for aspirating emulsified fat; a powered aspiration and infiltration subsystem including a reciprocating handpiece configured to oscillate a cannula for fat removal or infiltration; a skin tightening subsystem including a plasma generator and a handpiece for subdermal tissue treatment; and at least one controller operatively coupled to the subsystems and configured to coordinate operation thereof through a user interface that displays subsystem parameters and accepts user input.

2. The system of claim 1 , wherein the scale module converts measured weight loss of the fluid container to volume using a selectable density corresponding to tumescent anesthesia or fat.

3. The system of claim 1 , wherein the peristaltic pump is reversible to deliver or remove fluids through the same tubing for infiltration, aspiration, or fat transfer.

4. The system of claim 3, wherein the peristaltic pump is configured in a forward direction to deliver tumescent fluid from a fluid bag to a patient and in a reverse direction to pump harvested fat from the patient into a fluid bag or a replacement container for collection or processing.

5. The system of claim 4, wherein operation of the peristaltic pump in the reverse direction provides a controlled, low-shear aspiration profile configured to gently harvest viable adipose tissue suitable for subsequent fat transfer or reinjection.Docket No.: Apyx-094PCT6. The system of claim 5, wherein the peristaltic pump is operated at a controlled low rotational speed in the forward direction, configured to provide a gentle, low-shear flow that preserves adipocyte viability during reinjection of adipose tissue, wherein the flow is in the range of 10-60 ml / min.

7. The system of claim 5, wherein the controller is configured to automatically reverse operation of the peristaltic pump in response to a user-selected procedural mode or command entered through the user interface to switch between infiltration and fat transfer functions.

8. The system of claim 1 , wherein the aspiration subsystem includes pressure sensors and control logic configured to automatically switch the vacuum pumps between independent and series modes based on a measured deviation from a target vacuum level or barometric pressure.

9. The system of claim 1 , wherein the UAL subsystem includes a frequency tracking algorithm configured to maintain operation of the probe at a resonance frequency by monitoring electrical impedance or phase and adjusting frequency accordingly.

10. The system of claim 1 , wherein the user interface comprises multiple regions corresponding to separate subsystems.11 . The system of claim 1 , wherein the powered aspiration and infiltration subsystem includes at least one handpiece having a plurality of user-actuatable buttons independently controlling the infiltration pump, aspiration pump, and reciprocation of the handpiece.

12. The system of claim 1 , wherein the plasma generator handpiece includes a flexible shaft and an electrode disposed therein configured to ionize an inert gas for subdermal skin tightening.

13. The system of claim 1 , wherein the controller is configured to coordinate operation of at least two handpieces simultaneously, each assigned to a separate user, while maintaining independent vacuum and power control.

14. The system of claim 1 , further comprising wireless footswitches communicatively coupled to the controller for activation of the infiltration pump and / or the handpiece of the UAL subsystem.Docket No.: Apyx-094PCT15. The system of claim 1 , further comprising a fat processing subsystem configured to process harvested fat prior to reinjection.

16. The system of claim 15, wherein the controller is configured to monitor or control one or more functions of the fat processing subsystem.

17. The system of claim 15, wherein the fat processing subsystem is fluidly coupled to the aspiration subsystem or to the peristaltic pump of the infiltration subsystem to enable closed-loop fat transfer.

18. The system of claim 15, wherein the controller is configured to operate the peristaltic pump in a forward direction to transfer processed fat from a collection container to an injection cannula.

19. The system of claim 1 , further comprising an electrosurgical subsystem including at least one of a monopolar and / or bipolar handpiece for applying electrosurgical energy to patient tissue.

20. The system of claim 1 , further comprising a remote services module coupled to the controller for enabling remote diagnostics of at least one subsystem and providing updated functionality to the controller.

21. A method for performing body contouring using an integrated system comprising the steps of: infiltrating tumescent anesthesia into subcutaneous tissue using a peristaltic pump and scale-based volume monitoring; emulsifying fat tissue by applying ultrasound energy through a probe operated at a resonance frequency tracked by a frequency tracking algorithm; aspirating emulsified fat using dual vacuum pumps operating in independent or series configuration; tightening skin tissue using a plasma handpiece emitting plasma through one or more ports; and transferring harvested fat using the peristaltic pump.

22. The method of claim 21 , further comprising dynamically switching the aspiration subsystem from series to independent operation when a second user activates the second pump.Docket No.: Apyx-094PCT23. The method of claim 21 , further comprising automatically limiting ultrasound power when impedance changes indicative of high-density tissue, highly fibrotic tissue, or probe end-hits are detected.

24. The method of claim 21 , wherein infiltration flow is stopped when the controller detects that a preset volume threshold has been delivered, and an alert is displayed on the user interface.

25. The method of claim 21 , further comprising performing powered aspiration by actuating a reciprocating handpiece while maintaining vacuum pressure at a user- selected setpoint.

26. The method of claim 21 , wherein the plasma handpiece generates simultaneous 360-degree plasma discharge through opposed ports to treat tissue surrounding a distal tip.

27. The method of claim 21 , further comprising delivering tumescent fluid from a fluid bag to a patient by operating a peristaltic pump in a forward direction and reversing the pump to draw harvested fat from the patient into a fluid bag or a collection container.

28. The method of claim 27, wherein reversing operation of the peristaltic pump provides a controlled, low-shear aspiration profile that gently collects viable adipose tissue suitable for subsequent fat transfer or reinjection.

29. The method of claim 27, further comprising automatically reversing the direction of the peristaltic pump in response to a user-selected procedural mode or command entered through the user interface to switch between infiltration and fat-transfer functions.

30. The method of claim 21 , further comprising processing harvested fat by a fat processing subsystem prior to reinjection.

31. The method of claim 30, wherein the fat processing subsystem comprises a closed, sterile cartridge or chamber coupled to the peristaltic pump to permit processing and transfer of harvested fat without manual handling.

32. The method of claim 30, further comprising reversing operation of the peristaltic pump to deliver processed fat from the cartridge to an injection cannula at a user-selected flow rate.

33. The method of claim 30, further comprising monitoring weight or pressure data from a scale module to determine a volume of fat collected, processed, and transferred.Docket No.: Apyx-094PCT34. The method of claim 30, further comprising maintaining a closed-loop circuit among the aspiration, processing, and infiltration subsystems to minimize contamination and preserve adipocyte viability during transfer.

35. The method of claims 21 , wherein each of the dual vacuum pumps are controlled based on measured pressure.

36. An all-in-one body-contouring system comprising: a plurality of surgical subsystems including an infiltration subsystem, an ultrasound-assisted liposuction (UAL) subsystem, an aspiration subsystem, a powered liposuction subsystem, a skin-tightening subsystem, a fat-transfer subsystem, and an electrosurgery subsystem; a shared housing supporting at least two of the subsystems; a user interface configured to display operating parameters and controls for at least a subset of the subsystems; and at least one controller operatively coupled to the subsystems and to the user interface, the at least one controller being configured to coordinate operation of the subsystems so that a user can perform infiltration, emulsification, aspiration, fat transfer, and skin-tightening procedures through a single integrated platform.

37. The system of claim 36, wherein the housing comprises first and second enclosures, each containing at least one of the subsystems and each having a respective user interface.

38. The system of claim 36, wherein the at least one controller enables shared fluid, pneumatic, and electrical routing among the subsystems to permit continuous procedural transition without manual reconnection.

39. The system of claim 36, wherein the at least one controller is configured to activate or deactivate individual subsystems according to a procedural sequence stored in memory.

40. The system of claim 36, wherein the subsystems communicate via a common digital bus.

41. The system of claim 40, wherein the common digital bus operates under at least one of RS-422, RS-232, CAN, Ethernet, USB, Serial Peripheral Interface (SPI), l2C (interintegrated circuit), UART or wireless link.Docket No.: Apyx-094PCT42. The system of claim 36, further comprising sensors associated with the subsystems, the controller being configured to aggregate sensor data to maintain coordinated pressure, flow, and power parameters across the system.

43. The system of claim 36, wherein the user interface is a graphic user interface (GUI) comprising a multi-region display, each region corresponding to a specific subsystem and presenting real-time indicators of a respective subsystem.

44. The system of claim 36, wherein the user interface permits simultaneous control of at least two subsystems.

45. The system of claim 44, wherein the user interface issues audible or visual alerts when an operational threshold for volume, pressure, or temperature is reached.

46. The system of claim 44, wherein the user interface is touch-sensitive and permits mode switching between infiltration, UAL, aspiration, powered liposuction, fat-transfer, and skin-tightening interfaces without interrupting subsystem operation.

47. The system of claim 36, wherein the at least one controller comprises a primary processor configured to execute software modules corresponding to each subsystem.

48. The system of claim 47, wherein the at least one controller includes at least one secondary processor communicatively coupled to the primary processor and dedicated to local control of one or more subsystems.

49. The system of claim 48, wherein the primary and secondary processors exchange command and status data via a synchronized communication link to coordinate multisubsystem operation.

50. The system of claim 36, wherein the at least one controller communicates wirelessly with at least one remote interface or footswitch to permit redundant activation of the infiltration or UAL subsystem.

51. The system of claim 36, wherein the at least one controller is configured to coordinate safety interlocks among the subsystems to prevent concurrent activation of incompatible energy modes.

52. The system of claim 36, wherein the at least one controller communicates wirelessly with at least one remote interface configured to display operating parameters and controls for at least a subset of the subsystems.Docket No.: Apyx-094PCT53. The system of claim 52, wherein the remote interface includes at least one of a mobile device, tablet and / or a laptop.

54. An aspiration subsystem for a body contouring system, comprising: a first aspiration pump and a second aspiration pump each having a suction port and an exhaust port; a valve assembly coupled between the suction and exhaust ports of the pumps and a fat-collection circuit; at least one controller configured to operate the pumps selectively in:(i) an independent mode, wherein each pump generates vacuum pressure for a separate aspiration circuit; and(ii) a series mode, wherein the exhaust port of the first pump is pneumatically coupled to the suction port of the second pump to achieve an increased pressure ratio; and a pressure sensor operatively connected to the controller, the controller being configured to switch between the independent and series modes based on a measured vacuum level or procedural condition.

55. The subsystem of claim 54, wherein the at least one controller automatically transitions from the series mode to the independent mode when two user handpieces are simultaneously activated.

56. The subsystem of claim 54, wherein the at least one controller automatically transitions from the independent mode to the series mode when a deviation between a measured and a target vacuum level exceeds a threshold or when ambient barometric pressure decreases below a predetermined value.

57. The subsystem of claim 54, wherein the pressure sensor is disposed between the valve assembly and the fat-collection canister to monitor real-time vacuum stability during aspiration.

58. The subsystem of claim 54, further comprising a user interface configured to display real-time vacuum pressure of each pump.

59. The subsystem of claim 54, wherein the valve assembly comprises a plurality of electronically actuated valves configured to route pneumatic flow paths corresponding to the independent and series configurations.Docket No.: Apyx-094PCT60. A power liposuction subsystem comprising: a powered handpiece including a motor configured to reciprocate a cannula at a selectable speed and stroke length; an infiltration pump and an aspiration pump fluidly connectable to the cannula through tubing; a plurality of user-actuatable buttons disposed on the handpiece and electrically coupled to a controller; and the controller being configured such that each of the plurality of buttons independently activates a respective function selected from infiltration, aspiration, and reciprocation of the handpiece, whereby a user may perform infiltration, aspiration, powered infiltration or powered aspiration without interruption of other subsystem operations.61 . The subsystem of claim 60, wherein the handpiece includes a first button assigned to control the infiltration pump, a second button assigned to control the aspiration pump, and a third button assigned to control the reciprocation motor.

62. The subsystem of claim 60, wherein at least one of the buttons is re-mappable by user input through a user interface to toggle between infiltration and aspiration control.

63. The subsystem of claim 60, wherein the buttons are configured to operate in a momentary mode requiring continuous depression for activation, or a toggle mode enabling latched operation following a single press.

64. The subsystem of claim 60, wherein the controller allows simultaneous activation of two or more buttons to execute combined modes including:(a) powered infiltration using infiltration plus reciprocation;(b) powered aspiration using aspiration plus reciprocation;(c) powered fat transfer; or(d) mechanical equalization using reciprocation alone without fluid flow.

65. The subsystem of claim 60, wherein each button includes tactile or visual feedback, such as backlighting or haptic response, confirming function activation or deactivation.

66. The subsystem of claim 60, wherein at least one of the buttons is configured to toggle between infiltration and aspiration control.Docket No.: Apyx-094PCT67. The subsystem of claim 60, wherein at least one of the buttons is configured to toggle the infiltration pump between infiltrating fluid to a patient, aspirating fat from the patient and / or transferring fat to the patient.

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