Multimodule console for controlling thermal-based non-ablative surgical device for mesenteric fat reduction

Abstract

A surgical system for reducing visceral fat in the abdominal cavity comprises a novel console and a thermal treatment device. The console houses a computer and electronics for circulating a thermal fluid along a closed loop flowpath through the treatment device. The console is programmed and operable to, amongst other things, control temperature, adjust flow rate, compute cooling duration and power delivered, and detect for leaks along the flowpath. A GUI in the form of a tablet can be arranged with the console to display procedure information and to accept input from the physician.

Description

MULTIMODULE CONSOLE FOR CONTROLLING THERMAL-BASED NONABLATIVE SURGICAL DEVICE FOR MESENTERIC FAT REDUCTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This claims priority to provisional patent application number 63 / 520,929, filed August 21, 2023, entitled “Multimodule Console for Controlling Thermal -based Non-ablative Surgical Device for Mesenteric Fat Reduction’’.BACKGROUND OF THE INVENTION

[0002] Visceral fat is found inside the abdominal cavity and wraps around internal organs, as opposed to subcutaneous fat which is stored just below the skin. Visceral fat, and in particular mesenteric fat, is found within the mesentery, a tissue that attaches the intestine to the abdominal wall. Increase in the volume of visceral fat is associated with high blood pressure, increased risk of heart disease, insulin resistance and diabetes, stroke, some cancers, and if not reduced may contribute to these pathologies. Although diet and exercise can help reduce the volume of visceral fat, it’s not well-tolerated by the typical overweight patient.

[0003] Surgical excision or ablation are not good options for mesenteric fat reduction, because of the risk of damaging the vasculature, nerves, and lymph nodes associated with the mesenteric fat.

[0004] Accordingly, methods and apparatuses for effectively reducing visceral fat are still desired.SUMMARY OF THE INVENTION

[0005] A surgical system for reducing visceral fat in the abdominal cavity comprises a console, graphical user interface, and a handheld thermal treatment device.

[0006] In an embodiment of the invention, the console houses a plurality of functional modules, computer, and electronics for circulating a thermal fluid along a closed loop flowpath through the treatment device. The console is programmed and operable to control temperature, adjust flow rate and optionally detect for leaks.

[0007] In an embodiment of the invention, a temperature control module includes a first heat exchanger and a second heat exchanger to chill the thermal fluid along the flowpath.

[0008] In embodiments, the system further includes a first temperature sensor and a second temperature sensor to detect temperature at the fluid entrance and exit to the console.The computer adjusts the temperature of the first and / or second heat exchanger to adjust the temperature of the thermal fluid flowing along the flowpath.

[0009] In an embodiment of the invention, a fluid circulation module includes a first pressure transducer, a compressor, and a second pressure transducer. The first and second pressure sensors are operable with the computer to detect pressure along the flowpath across the treatment probe. The computer adjusts the compressor based on the pressure data to adjust the flowrate of the thermal fluid flowing along the flowpath.

[0010] In an embodiment of the invention, a tissue thickness module is programmed and operable to compute thickness of the mesentery section being interrogated based on position data received from a first position sensor / transmitter arranged on a first treatment probe and a second position sensor / transmitter arranged on a second treatment probe.

[0011] In an embodiment of the invention, an exposure predictor module is programmed and operable to compute a desired total cooling energy and duration for applying to the interrogated mesentery section for optimized efficacy based on the computed thickness.

[0012] In an embodiment of the invention, the exposure predictor module is implemented in the form of a machine learning model trained through multiple phases, preferably using different types of data including, without limitation, computer simulation data, empirical bench top data from animal tissue, pre-clinical and clinical data from animal and humans, respectively.

[0013] In an embodiment of the invention, the system is operable with a disposable treatment device, and in preferred embodiments, operable with a disposable treatment device comprising a balloon that is expanded by the thermal fluid.

[0014] In an embodiment of the invention, the thermal fluid is a gas, and in preferred embodiments, the thermal fluid is CO2 gas.

[0015] In an embodiment of the invention, the system conditions or prepares the thermal fluid to a desired temperature and circulates the thermal fluid through the treatment device at a predefined flow rate.

[0016] In an embodiment of the invention, the temperature sent to the treatment balloon from the console (console exit temperature) ranges from -10 to -75 °C with a preferred temperature range of —20 to -70° C.

[0017] In an embodiment of the invention, the flowrate of the thermal fluid ranges from 10 to 200 STP 1 / min, and more preferably from 30 to 100 STP 1 / min.

[0018] In an embodiment of the invention, the system includes at least one safety feature, and in a preferred embodiment, the at least one safety feature comprises a leak detection module.

[0019] In an embodiment of the invention, the system has a graphical user interface (GUI). The GUI is programmed and operable to control various functions including (a) (start / stop treatment), (b) display of information, and (c) safety warnings (e.g., temperature alert or leak detected). In an embodiment of the invention, the GUI is in the form of a tablet or touch screen display and communicates with the computer and electronics housed within the console.

[0020] In an embodiment of the invention, a system comprises a pair of cooling probes (optionally flat faced) configured for insertion into the abdomen and placement on opposite sides of a section of mesentery for application of cooling power to the mesentery. The cooling probes have tissue-contacting surfaces supplied with cooling power, such as flow of a cooling fluid proximate the surfaces.

[0021] In an embodiment of invention, a cooling surface of each probe is provided with positioning transmitters / sensors, operable to transmit and / or receive signal from corresponding transmitters / sensors on the other probe, to aid in determining the degree of alignment of the probes on opposite surfaces of the mesentery as well as determine the distance from one another, and optionally, in some embodiments, sensors are operable to provide 3D spatial coordinate information.

[0022] In an embodiment of invention, the total cooling power to be applied, and the length of time it is to be applied, may be determined based on the thickness of the mesentery as determined by positioning sensors arranged or otherwise embedded in the treatment devices and / or medical imaging such as optical (endoscopic or direct vision), magnetic, x-ray, Dexa, fluoroscopy or ultrasonic imaging.

[0023] In an embodiment of the invention, the energy to be applied to the tissue is computed, on a processor, in order to cool the tissue to a predetermined temperature at a given depth.

[0024] In an embodiment of the invention, the energy may be controlled in response to temperature measurements while applying cooling power. For example, in some embodiments of the invention, the energy may be determined, on a processor, based on the difference between two temperature sensors: one sensor reading temperature in the treatment portion (e.g., balloon) and a second sensor reading the temperature of the gas leaving the treatment portion (e.g., balloon) after cooling the tissue.BRIEF DESCRIPTION OF DRAWINGS

[0025] FIG. 1 is a schematic diagram of a system for circulating a coolant through a cooling probe for reducing mesenteric fat in accordance with an embodiment of the invention;

[0026] FIG. 2 is a block diagram of the system shown in FIG. 1 in accordance with an embodiment of the invention;

[0027] FIG. 3 is a schematic diagram of the control modules of the console shown in FIG. 2 in accordance with an embodiment of the invention;

[0028] FIG. 4 is an illustration of the system shown in FIG. 1 arranged in another configuration in accordance with an embodiment of the invention;

[0029] FIG. 5 is a flow chart of a method for performing a cooling treatment on a section of mesentery in accordance with an embodiment of the invention; and

[0030] FIG. 6 is a flow chart of a method for training a mesentery exposure predictor model through multiple phases in accordance with an embodiment of the invention.

[0031] The description, objects and advantages of embodiments of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.DETAILED DESCRIPTION OF THE INVENTION

[0032] Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges can independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to thosedescribed herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described. It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which can be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order that is logically possible.

[0033] All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail).

[0034] Methods and systems for cooling visceral fat while leaving surrounding tissue unharmed are disclosed in our prior International Patent Publication WO 2020 / 061202 (published March 26, 2020); International Patent Publication WO 2021102301 (published May 27, 2021); International Patent Publication WO 2023 / 133081 (published Jul7 13, 2023), entitled METHOD AND SYSTEM FOR MINIMALLY INVASIVE REMOVAL OF MESENTERIC FAT; and co-assigned Provisional Patent Application No. 63 / 453,748, filed March 21, 2023, entitled Planar- shaped Thermal Balloon for Mesenteric Fat Reduction [Attorney Ref. No. B2M005PRV], each of which is incorporated herein by reference in its entirety for all purposes. The inventors have found that visceral fat is more susceptible to destruction by cooling to cold temperatures which do not harm surrounding or nearby tissue such as blood vessels, nerves and lymph nodes. Visceral fat can be broken down by cooling to temperatures which traditionally have been considered non-ablative temperatures. These so-called non-ablative temperatures typically range from +10°C to -40°C, and more preferably -20°C to -40°C. Cryolipolysis is limited to the visceral fat and the surrounding or nearby tissue is not damaged. Cryogenically deadened visceral fat will be removed by the body over the course of a few weeks.

[0035] Turning now to FIG. 1, a treatment system 10 for reducing mesenteric fat in accordance with an embodiment of the invention is shown. The system 10 includes a handheld treatment device 20 connected to a console 30 via an umbilical cord 32. The treatment device 20 includes a distal treatment section 22 extending from a handle 24. In the system shown in FIG. 1, the cooling element 26 is shown in a deployed and inflated configuration, with sheath 28 retracted. The cooling element 26 is shown in the form of an inflated mattress or pillow with a planar distal treatment surface. The planar treatment surface delivers cooling energy to the target tissue, namely, the visceral and mesenteric fat. Examples of treatment devices and methods for reducing mesenteric fat are described in co-assigned Provisional Patent Application No. 63 / 453,748, filed March 21, 2023, entitled “Planar-shaped Thermal Balloon for Mesenteric Fat Reduction” [Attorney Ref. No. B2M005PRV], the entirety of which is incorporated herein by reference for all purposes. Although system 10 is shown operating with the planar shaped balloon treatment device 20, it is to be understood that the system may be operable with other types of treatment devices having a wide range of shapes and configurations except where excluded in any appended claims.

[0036] As described further herein, a coolant such as a gas is circulated between the treatment device 20 and the console 30 via umbilical cord 32. In embodiments, the umbilical cord is flexible and detachably coupled to the console via a connector 34. In embodiments the length of the umbilical cord ranges from 3-8 feet.

[0037] Console 30 may include several additional components and features including, for example, a processor, storage device, RAM, GPU, power supply, ports, and controller for controlling and monitoring coolant flow, temperature, time elapsed, and other parameters as desired.

[0038] The system 10 additionally shows a tablet 36 including a GUI which is programmed and operable to control operating parameters of the system, discussed further herein. The tablet is shown supported on a cart including castors.

[0039] An optional second console 40 is shown on an opposite side of the operating table 38. In embodiments, each is operable to control a dedicated a treatment device. In a preferred application, two treatment devices are arranged in the patient to apply cooling energy to opposite sides of (or “sandwich”) a section of the mesenteric fat.

[0040] Although not shown, in embodiments, the console(s) or display(s) include a connector operable to connect with a laparoscope or other imaging equipment for displaying the operative field and / or target anatomy during the procedure. The system 10 can be operated in a typical laparoscopic operating suite.

[0041] FIG. 2 is a block diagram of a cooling system 100 in accordance with an embodiment of the invention. The system is shown having a console 110, treatment probe 150, display 160, and GUI device 170 for interfacing with the physician.

[0042] The console 1 10 is shown having electronic components typically associated with a controller or computer including a processor 112, storage 114, RAM 116, graphics processing unit 118, power 120, ports 122 (e.g., one or more ports for connecting to the local network, printers, USB, etc.), and a communication interface 124 (e.g., communication card operable to wirelessly send and receive information via wifi, Bluetooth, or other).

[0043] The console 110 is also shown having a plurality of functional modules 130 operable to carry out various functions. The modules 130 shown in FIG. 2 include fat volume compute module 124 for determining the volume of fat to be treated, exposure predictor module 126 for estimating the duration of cooling for a treatment, temperature management module 132 for controlling the temperature of the coolant during the procedure, coolant circulation module 134 for driving the coolant through the system during operation, leak detection module 136 for detecting coolant leaks during operation, GUI control module 138 for controlling the user interface, and system state module 140 for monitoring the state of the system, each of which is described further herein.

[0044] FIG. 2 also shows treatment probe 150. Treatment probe 150 can be a cooling probe as described herein for applying thermal energy to the target tissue. Preferably, probe 150 is a single-use disposable device that is detachably connectable to the console 110. In the embodiment shown in FIG. 2, the probe 150 includes a power switch 152, sensors 154 (e.g., temperature sensor, pressure sensor, position sensors / transmitters, etc.), and LEDs 156 for indicating various information to the physician such as ready, on / off, error, etc. The locations of the components of the probe 150 (e.g., the sensors) may vary. For example, in a preferred embodiment of the invention, at least one of a position and temperature sensor is located at or in the close vicinity of the surface to contact the tissue, namely, the tissue treatment surface.

[0045] FIG. 2 shows fat volume compute module 124 for determining the volume of the mesentery. In embodiments, at least one position sensor / transmitter is arranged on the distal treatment surface of the probe. A second sensor / transmitter is arranged on a second probe. In embodiments, the sensors are used to align the two probes in the x-y planes to “sandwich” a section of mesentery fat to be treated, where the distance between the two probes (typically in the z-plane) is the thickness of the mesenteric fat. The fat volume compute module then computes the volume of tissue between the opposing probes.

[0046] Non-limiting examples of position sensors / transmitters for use with embodiments of the invention include electromagnetic sensors, ultrasonic sensors, and laser sensors such as, without limitation, a Hall Effect Current Sensor, TMCS 1107 (Texas Instruments); Miniature Ultrasonic Transducer, Piezoceramic transducers, (Precision Acoustics); Ultrasonic distance measuring sensors, UR12.D50-IAMC.7BCU (Baumer Ltd.); Laser distance measuring sensors, 0300.DI-GM1J.72CU (Baumer Ltd.); Inductive sensors, eddyNCDT (MicroEpsilon); and Capacitive sensors, capaNCDT (Micro-Epsilon).

[0047] For embodiments, the sensors detect and respond to electromagnetic fields or other energy generated by the opposing sensors (or another external source such as a field generator placed near' the operating area). The sensors transmit the distance between the probes, namely, the tissue thickness, or in some embodiments, the sensors are operable to transmit the precise location in three-dimensional space of each probe to the computer and the computer calculates the distance between the probes, namely the tissue thickness.

[0048] FIG. 2 also shows exposure predictor module 126 for determining a planned duration and total energy applied by the cooling treatment. As described further herein with reference to FIGS. 5-6, in embodiments, the exposure predictor module 126 applies a trained machine learning model or predictive algorithm to compute the planned duration and total energy applied by the cooling treatment.

[0049] FIG. 2 also shows display 160 connected to the console, and more typically, the display is connected to the GPU 118. In embodiments, the system includes a display or monitor to show various information associated with the procedure. Non-limiting exemplary information includes patient information, device temperature, pressure, flowrate, tissue thickness and / or volume, time elapsed, total energy applied, desired duration, and desired total energy applied. The display can also be operable to show various safety features including, for example, leak detection, discussed further herein.

[0050] FIG. 2 also shows a user interface (UI) device 170. Examples of UI devices include, without limitation, programmed portable computing devices such as tablets and smartphones for carrying out the functionalities discussed herein, as well as mouse, keyboard, microphone, and cameras.

[0051] In a preferred embodiment of the invention, the user interface includes a tablet that is programmed and operable with software (e.g., an “App”) to wirelessly (or through a wired connection) communicate with the processor, accept input from the user, and to send or display various information as described further herein. Nonlimiting examples of types ofinformation that can be displayed include status, temperature, pressure, flowrate, and time elapsed.

[0052] As described further herein, in an embodiment of the invention, a tablet or another type of computing device is programmed and operable to operate with multiple consoles such as consoles 34, 40 shown in FIG. 1, each of which can control and monitor a cooling treatment device.

[0053] FIG. 3 is a schematic diagram of various modules of a console 110 in accordance with an embodiment of the invention. The modules shown in FIG. 3 include temperature management module 200, gas circulation module 300, leak detection module 400, and computer and software 500.

[0054] Temperature Management Module

[0055] The temperature management module 200 serves to continuously cool the thermal fluid flowing along the closed loop flowpath. In the embodiment shown in FIG. 3, cooling is achieved by a cryocooler 210. Examples of cryocoolers include, without limitation, Sterling cooler, Gifford-McMahon cooler, pulse tube, evaporative cooler (refrigerator), liquid nitrogen-based cooler, Joule-Thomson cooler, etc. In a preferred embodiment, the cryocooler 210 is a Free Piston Sterling cooler.

[0056] A first heat exchanger 220 is thermally attached to the cryocooler 210. The thermal fluid flows through the heat exchanger. The thermal fluid is chilled by means of a heat exchange with the rejected heat transferred to the cryocooler. The thermal fluid is chilled to -10 to -75° C with a preferred temperature range of -40 to -70 °C.

[0057] The cryocooler also has a first temperature sensor (e.g., RTD) 212 and an electrical heater(s) 214 attached to its cooling head which can be used for precise temperature stabilization using a controlling algorithm (e.g., proportional or PID control algorithm, discussed herein).

[0058] The heater may have a hardwired electrical temperature switch 216 that will disable the heater(s) once its temperature exceeds a pre-determined value (e.g., 20°C). This is desired for the device protection in case software regulation mechanism fails or becomes inoperable.

[0059] The cryocooler also has a control unit 230 and a power supply 240.

[0060] After the thermal fluid is chilled, it flows into the treatment device via a probe connector 250 and is returned at a somewhat higher temperature to the temperature management module via the same (or different) probe connector. Its temperature is monitored by a second temperature sensor (RTD2) 260.

[0061] Optionally, the temperature management module 200 may have a second counterflow heat exchanger 222 that serves to pre-chill the incoming flow of the thermal fluid by heat exchange with the return flow of the fluid. The second heat exchanger increases the efficiency of the temperature management module 200 and ensures the return flow enters the flow circulation module 300, discussed herein, at a temperature close to that of ambient temperature.

[0062] The entire temperature management module is preferably placed inside a hermetic enclosure 270 to prevent moisture condensation. The enclosure, preferably the entire enclosure, is filled with thermally insulating material. Examples of insulating materials include without limitation foam, fibers, or aerogel.

[0063] Gas Circulation Module

[0064] FIG. 3 also shows gas or coolant circulation module 300 for circulating a thermal fluid (e.g., CO2 gas) in a closed loop arrangement.

[0065] The thermal fluid enters the module 300 at the return 302 of the temperature management module 200 at a pressure PIN and is brought to an elevated pressure POUT by a compressor 320. In embodiments, the compressor is operable to increase the pressure to 5-35 psi with a preferred range of 10-25 psi. The compressor 320 is shown being driven by a control unit 322 and a power supply 324.

[0066] The heat of compression (isotropic compression of gas) is removed from the thermal flow by a heat exchanger 330 that brings the temperature of the compressed gas to that of ambient temperature.

[0067] Both PIN and POUT are monitored by pressure transducers PT2 342 and PT1 344, respectively, and the flowrate of the thermal fluid is adjusted based on the measured difference in pressures (POUT - PIN). As described herein, the flowrate can be adjusted by controlling the speed of the compressor. In embodiments, the flowrate is controlled to range from 10 to 200 STP 1 / min, and more preferably from 30 to 100 STP 1 / min. The flow rate is shown being monitored by a mass flowmeter (FM2) 350.

[0068] The return pressure PIN may also need to be adjusted to be above that of ambient pressure to prevent air and moisture from entering the closed loop flowpath through, e.g., micro leaks, etc. In embodiments, the pressure transducer 342 is operable with a snubber 360 or other hardware device to reduce pressure peaks and noise.

[0069] The pressure PIN is also the back pressure of the probe. When the probe includes a treatment balloon it is desirable to adjust the back pressure such that the balloon will have the required structural stability (e.g., back chamber of the balloon has to be maintained at aslightly elevated pressure). In embodiments, the desired pressure PIN is 1-10 psi above ambient with a preferred range of 2-5 psi.

[0070] The pressure transducer PT2 342 can be used in an algorithm to maintain the return pressure at some pre-set value. This algorithm compares the pre-set value to an actual pressure PIN in real time and uses the difference (error) to control the pumping speed of the compressor 320. One example of an algorithm to control the pressure is a PID control algorithm in which the setpoint is the desired PIN and the output of the PID control algorithm is the measured PIN, where the flowrate is adjusted.

[0071] This gas circulation module 300 also has a number of solenoid valves that can be activated / deactivated by the computer and electronics 500, described herein. In embodiments, a set of valves are provided that provide the following functions:

[0072] 1. Connect / disconnect the treatment balloon from the gas circulation module (SV1 372 and SV5 374). This function is used to switch between treatment and warming modes of operation. In embodiments of the invention, a warming mode temporarily halts the flow of chilled gas to the balloon while keeping it inflated, enabling rapid natural warming through contact with the abdominal cavity. Alternatively, a brief deflation of the balloon can expedite the warming process. This function is also applied when connecting / disconnecting the balloon.

[0073] 2. Bypass, that is, to provide an alternative (bypass) circulation of gas that goes through the valve SV2 376 and a needle valve NV that is set to provide a pressure drop close to that of the treatment balloon. This function is used in a standby / ready mode between treatments; and

[0074] 3. Flush, two valves SV6 380 and SV3 382 are used to remove any pressure from the balloon before its folding and retraction and to flush the system after a new probe has been connected in order to remove any air and moisture from the closed loop of circulation (namely, a vent / flush mode).

[0075] The gas circulation module 300 also has a plurality of check valves. A first check valve with a low cracking pressure (CV1) 384 is used to initially fill the system with the thermal fluid from any external fluid (gas) supply. It is also used to maintain the amount of a thermal fluid in case of flowrate changes or any microleaks in the system. A second check valve (CV2) 386 is set to open at a maximum acceptable pressure of e.g., 30 psi in order to protect the compressor from over pressurization.

[0076] Leak Detection Module

[0077] FIG. 3 also shows leak detection module 400.

[0078] In the embodiment shown in FIG. 3, the leak detection module 400 has several purposes including: 1) fill - to initially fill the system with thermal fluid and then maintain a sufficient amount of fluid in the system based on the pressure and flowrate data; and 2) safety - to detect any leaks in the treatment probe (e.g., the disposable inflatable balloon).

[0079] Leak detection module 400 is shown comprising a flow meter 410, shut-off solenoid valve 420, pressure transducer 430, and a pressure regulator 440.

[0080] The pressure regulator 440 sets the working pressure of the system that will define the flowrate of the circulation module, described above. The pressure regulator 440 can be an electrically driven unit that is controlled by the computer 500, described herein.

[0081] The thermal fluid is contained in an external source or storage 450, and preferably independent of the system. Examples of thermal fluid sources include, without limitation, a tank or (more preferably) a hospital general supply line. A preferred supply is a hospital general carbon dioxide supply line.

[0082] The pressure regulator 440 conditions the thermal fluid to a desirable pressure (e.g., to < 30 psi). The target pressure is generally equal to the POUT pressure of the gas circulation module. Therefore, as described above, the pressure regulator serves to limit the flowrate of the thermal fluid in the system.

[0083] Valve (SV4) 420 connects the pressure regulator 440 to the rest of the system. Initially, the system can be flushed to remove any remaining air and moisture. Additionally, in embodiments, the pressure setting is adjustable during the treatment. The pressure regulator may be controlled by the physician as desired and based on procedure goals.

[0084] The mass flow meter FM1 410 registers any flow from the external supply into the system. Thus, if the system and the connected treatment device are fluid tight (leak free), the registered flowrate (after initial system fdl) shall be reduced to zero. The system will circulate the thermal fluid in a complete closed loop cycle without a need for external gas. If the system develops a leak, pressure behind the check valve CV 1 384 will drop, the check valve will open, and the flow meter 440 will register a flow of gas from the external source.

[0085] Flow can be classified as a leak if the detected flow exceeds a predetermined value. If a leak is determined during treatment, the system can be programmed to automatically shut down and vented in order to prevent excessive flow of the thermal fluid into the abdominal cavity.

[0086] Computer & Electronics

[0087] FIG. 3 also shows computer, electronics, and software 500. The computer, electronics and software are operable with the modules described above to provide severalfunctions including, without limitation: 1) measure, process and display data from the sensors, described herein; 2) control precure modes / functions including both manual and automatic modes (e.g., without limitation, powering system on / off, fluid fill, venting fluid, temperature control, flowrate control, emergency stop, etc.); 3) manage data and all calculations associated with control and diagnostic algorithms including, without limitation, mesentery fat thickness, cooling power, treatment duration, temperature, flowrate, and leak detection; and 4) interface with the user interface, namely, the user interface (UI), described herein.

[0088] For example, in embodiments, the electronics and computer are programmed and operable to record the status of the system, and to display the status on the GUI and, if equipped, LEDS on the probe handle. Exemplary status conditions include on, off, ready, leak detected and error.

[0089] In embodiments, each of the modules described above are incorporated into a single console (e.g., console 30 shown in FIG. 2). However, in some embodiments, the UI or GUI can be used with multiple consoles simultaneously (e.g., console 30 and console 40 shown in FIG. 1). The computer and electronics and if applicable (the App) can be programmed to operate in a synchronized (and optionally matched) manner.

[0090] FIG. 4 illustrates system 10 of FIG. 1 arranged in an alternative configuration.The configuration 10’ shown in FIG. 4 is similar to that shown in FIG. 1 except the consoles 30, 40 are arranged side by side instead of on opposite sides of the operating table 38. A treatment probe can be connected to each console and the procedure performed as described above. GUI 36 is arranged to control and display the information from both consoles. The consoles share one GUI 36.

[0091] In embodiments, data from both consoles including, without limitation, positioning / alignment data, temperature data, tissue thickness and pressure data is aggregated, processed, and stored in at least one of the consoles 30, 40, and the GUI is operable to control and display the information. For example, sensor position data from both consoles can be processed to compute mesentery thickness and volume, and exposure duration.

[0092] FIG. 5 is a flow chart of a method 600 for performing a cooling treatment on a section of mesentery in accordance with an embodiment of the invention.

[0093] Step 610 states to arrange cooling probes around the mesentery fat to be treated. This step can be performed by the physician applying cooling probes such as the probes 30, 40 described above to the mesentery.

[0094] Step 620 states to receive position signal data and tissue thickness from cooling probes. As described above, position sensors arranged in the probe send data to the consolesfor processing

[0095] Step 630 states to measure mesentery fat thickness based on the position signal data. In embodiments, the volume compute module (e.g., module 124 described above) is operable to receive the position / thickness data and compute the volume of the section of mesentery to be treated.

[0096] Step 640 states to compute planned total energy and duration of exposure based on thickness from step 630. In embodiments, a predictor module (e.g., module 126 described above) is operable to receive the thickness or volume information from step 630, and compute the planned total energy and duration of exposure. As described further herein, the predictor module 126 can have a wide range of computer-based implementations including without limitation: (a) an automatic lookup table to associate treatment time duration with different fat thicknesses based on historic empirical data, (b) an algebraic equation such as Fourier's law of thermal conduction as well as non-Fourier heat conduction models, and (c) machine learning algorithms (MLAs).

[0097] Step 650 states to apply cooling energy to mesentery fat by the cooling probes. This step is desirably performed without moving the probes from the initial positions during the position detection step 620.

[0098] Step 660 states to continuously compute real-time total energy delivered based on temperature readings received from the cooling probes. This step can be performed as described above with reference to the computer electronic and control software 500 in combination with the temperature management and gas circulation modules. An equation for thermal conduction of heat can be applied to compute total energy based on the energy transferred into the coolant as measured by coolant flowrate, and the coolant temperature (inflow sensor 212) and temperature (outflow temperature sensor 260).

[0099] Step 670 states to end exposure when real-time total energy or duration exceeds planned total energy or duration. In embodiments, the console(s) are programmed and operable to terminate the cooling when and if the real-time total energy (e.g., as determined by step 660) or duration (e.g., as measured by computer timer) exceeds planned total energy (e.g., as determined by step 640) or duration (e.g., as determined by step 640). In the embodiment described in FIG. 5, cooling power can be continuously evaluated against the planned cooling power and procedure time and optionally, adjusted to match the planned cooling power if. e.g., by decreasing the temperature of the fluid or increasing or decreasing the flowrate. Alternatively, the time or duration may be adjusted to adjust the total energy delivered. Indeed, the console and modules therein provide for a wide range of treatment andmonitoring options for the physician to plan and monitor and effectively control a cooling procedure. This is important in the present application so that the tissue is cooled to a target tissue temperature thereby achieving cryolipolysis while avoiding irreversible damage to surrounding tissue. In embodiments, a preferred target tissue temperature range is +10 to -40 degree C, and preferably about +5 to -30 degrees C.

[0100] The above described method 600 can be repeated during a single procedure across multiple segments of the mesentery. In embodiments, where the mesentery may range in length from 4 to 6 m, the above described method and cooling exposures are performed 30-50 times in a single procedure.

[0101] Exposure Predictor Model

[0102] As described above, an exposure predictor model (e.g., module 126 shown in FIG. 2) is programmed and operable to compute a planned total cooling energy and duration for exposing the tissue to the cooling therapy. The exposure predictor module can be implemented in various ways. In embodiments, the exposure predictor module is implemented as (a) an automatic lookup table to associate treatment time duration with different fat thicknesses based on historic empirical data, (b) an algebraic equation such as Fourier's law of thermal conduction as well as non-Fourier heat conduction models, and (c) machine learning algorithms (MLAs).

[0103] In preferred embodiments, the exposure predictor module is implemented using an MLA such as a Neural Network type model. These algorithms learn from data, discover patterns, and predict output values based on input variables. MLAs can be trained on labeled data (namely, supervised learning), work with unlabeled data (namely, unsupervised learning), or work with interaction in an environment.

[0104] Supervised learning involves training the model on labeled datasets with both input and output parameters. The training process continues until the MLA achieves a desired level of accuracy on the validation data. Examples of supervised learning-based MLAs include: Regression, Linear Regression, Polynomial Regression, Ridge Regression, Lasso Regression, Decision Tree, Random Forest, Logistic Regression, etc.

[0105] Unsupervised learning involves training the model on unlabeled datasets with both input and output parameters. The training process continues until the MLA achieves a desired level of accuracy on the validation data. Examples of unsupervised learning-based MLAs include: K-Means, Clustering, Hierarchical Clustering, Principal Component Analysis (PCA), and t-SNE.

[0106] Reinforcement learning involves training models to make sequences of decisions by interacting with an environment. During training, the MLA is exposed to a training environment where it trains itself continually using trial and error. The MLA learns from past experience and attempts to capture the best possible knowledge to make accurate decisions. An example of reinforcement learning MLA is Q-learning and the Markov Decision Process.

[0107] FIG. 6 is a flow chart of a method 700 for training a mesentery exposure predictor model through multiple phases in accordance with an embodiment of the invention.

[0108] Step 710 states to generate, during a phase I, mesentery temperature data based on a computer simulation model. An exemplary heat transfer computer simulation software is COMSOL which can be used to predict temperature gradients of the tissue and the total energy applied. Inputs to the model include, without limitation: the geometry of the probe, geometry of the tissue (e.g., tissue thickness), coolant type, tissue type, probe temperature, environment / body temperature, and other parameters requested in the heat transfer equation model.

[0109] Step 720 states to train the mesentery exposure predictor model based on the computer simulated data. In embodiments, this phase (I) is a supervised learning-based training. The labelled data is broken into a several training sets and a validation set. Training is performed until the model is able to predict an outcome with sufficient accuracy.

[0110] Step 730 states to generate, during a phase II, mesentery temperature data based on applying probe cooling surfaces to various thicknesses of sample tissue (e.g., pre-clinical, animal, cadaver, or benchtop). For each test, sensors are embedded within the center of the tissue sample and temperature as a function of time is recorded. Tissue temperature profiles can be recorded for tissue type, tissue thickness, probe temperatures, and time.

[0111] Step 740 states to train mesentery exposure predictor model based on the empirical data arising from sample tissue. This step can be performed similar to the training step 720 described above except with using the updated empirical based data.

[0112] During training, the algorithm itself and optionally the user can adjust internal parameters, or adjust the weights to certain parameters to minimize the prediction error. Additionally, types of data resulting in greater error can be used to seek out more such data. For example, if a 2 mm thickness of tissue results in greater error than the 5 mm thickness, more data for 2 mm can be generated and used to retrain the model. Such focus serves to build the model faster and more accurately than a pure even-handed duplication of testing.

[0113] Additionally, in embodiments, the weights can be adjusted for the various phases of training. For example, a preclinical pig tissue may be weighted higher than computer simulation testing data.

[0114] Step 750 states to perform treatment(s) on humans by application of the trained mesentery exposure predictor model. This step can be performed as described above in connection with FIG. 5.

[0115] Step 760 states to generate phase III mesentery temperature data based on treating human(s) (namely, clinical data) arising from step 750. In embodiments, the patient data is anonymized and stored for each procedure performed. In embodiments, for each procedure, the following is recorded: thickness of the fat tissue, duration of exposure and thus total energy applied, tissue temperature, and the number of applications and procedure success. Following a procedure (weeks-years), patient response in terms of clinical outcomes e.g. reduction in metabolic indices, whether as a grade / level or annotation by the physician or patient, and quantitative measure of mass or weight change of the fat tissue at a point in time following the procedure is also collected.

[0116] Multiple exposures

[0117] In cases where treating the fat tissue is challenging and treatment parameters chosen pose a risk to the tissue adjacent to the probe (e.g., very thick tissue that requires a relatively long (>1 min) cooling with low temperature (e.g. -40C)), multiple exposures of the tissue to a higher temperature will be conducted. Cooling fat tissue with a thawing cycle between each freeze can increase the effectiveness of the treatment while ensuring that the tissue in contact with the probe is safe.

[0118] Prophetic Example:

[0119] For a given 15mm mesenteric fat thickness, a single treatment would require 2 probes to treat with a desired temperature of -40C for over 1 minute in order to cool the tissue to + 10C at the center. To avoid possible damage to the mesenteric surface in contact with the probe, an alternative treatment could be cooling with -30C for 30 seconds, thawing, and then repeating the treatment. Since the tissue is “primed” for cooling after the first application, temperature penetration into the tissue is easier with greater effectiveness and reduced risk. The cooling / thawing cycles will be recorded and adjusted per tissue thickness.

[0120] It is also to be understood that the GUI may take a wide range of configurations. For example, GUI may include a monitor or TV, and a keyboard, mouse or another user input device. The GUI, monitor, keyboard etc. may be an on-board component of the console or set separately from the console (with a wired or wireless connection) as shown in FIG. 4.

[0121] Additionally, although the preferred thermal fluid is low pressure gaseous carbon dioxide, other substances can be used (e.g., nitrogen).

[0122] Additionally, the above invention has been described for thermally treating mesenteric fat hut the system is not intended to he so limited except where recited in any appended claims. The system may be used for controlling flowrate and temperature of the fluid through various probes for treating other types of tissues, fats, growths, nodules, and bodies of the patient.

[0123] Additionally, although the invention has been described for use with a handheld treatment probe, the invention is not intended to be so limited except as where recited in any appended claims. The invention may be used with, e.g., elongate flexible treatment catheters, as well as other types of instruments whether including an inflatable balloon or not.

[0124] Throughout the foregoing description, and for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the described techniques. It will be apparent, however, to one skilled in the art that these techniques can be practiced without some of these specific details. Although various embodiments that incorporate these teachings have been shown and described in detail, those skilled in the art could readily devise many other varied embodiments or mechanisms to incorporate these techniques. Also, embodiments can include various operations as set forth above, fewer operations, or more operations; or operations in another order than that specifically described above. Additionally, any of the components and steps described herein may be combined with one another in any logical manner except where such components or steps would be exclusive to one another. Accordingly, the scope and spirit of the invention should be judged in terms of the claims, which follow as well as the legal equivalents thereof.

Claims

CLAIMS1. A console for controlling circulation of a thermal fluid along a closed flowpath through a surgical treatment device for reducing visceral fat in a patient, the console comprising: an enclosure or housing; a connector for detachably connecting the console to the surgical treatment device; and a plurality of functional modules housed within the enclosure, wherein the plurality of functional modules comprise a temperature management module; and a fluid circulation module; and a computer and electronics programmed and operable to automatically control the temperature management module for controlling the temperature of the thermal fluid along the flowpath and the fluid circulation module for controlling the flowrate of the thermal fluid along the flowpath based on user input.

2. The system of claim 1, further comprising a leak detection module for detecting a leak of the thermal fluid along the flowpath.

3. The system of claim 2, wherein the leak detecting module comprises a flow meter.

4. The system of claim 1, further comprising a GUI for displaying status, temperature, and flowrate information associated with the console and the surgical treatment device.

5. The system of claim 1, wherein the fluid circulation module comprises, in sequence along the flowpath, a first pressure sensor, a compressor, and a second pressure sensor.

6. The system of claim 1, wherein the temperature management module further comprises a first heat exchanger along the flowpath to cool the thermal fluid prior to the thermal fluid entering the surgical treatment device.

7. The system of claim 6, wherein the temperature management module further comprises a second heat exchanger along the flowpath to cool the thermal fluid as it exits the fluid circulation module, and optionally, wherein the second heat exchanger is a passive heat exchanger.

8. The system of claim 7, wherein the temperature management module further comprises a first temperature sensor and a second temperature sensor located along the flowpath across the surgical treatment device, and wherein the computer is programmed and operable to adjust cooling power of the first heat exchanger based on the temperature data arising from the first and second temperature sensors.

9. The system of claim 8, wherein the computer is programmed and operable to maintain the temperature of the thermal fluid entering the surgical treatment device in the range from -10 to -75°C, and optionally from -30 to -50° C.

10. The system of claim 7, wherein the gas circulation module further comprises a third heat exchanger along the flowpath subsequent to the compressor, and operable to remove heat arising from compression of the thermal fluid.

11. The system of claim 1, wherein the thermal fluid is a gas, and optionally, wherein the gas is carbon dioxide.

12. The system of claim 11, further comprising a tank of carbon dioxide to supply the thermal fluid.

13. The system of claim 5, wherein the computer is programmed and operable to adjust compressor speed based on pressure data obtained from the first and second pressure sensors.

14. The system of claim 13, wherein the computer is programmed and operable to adjust the speed of the compressor to maintain a flowrate of thermal fluid along the flowpath between 10 to 200 STP 1 / min, and optionally, from 30 to 100 STP 1 / min.

15. The system of claim 14, wherein the computer is programmed and operable to adjust the speed of the compressor to maintain a back pressure of the fluid entering the temperature management module sufficient to maintain structural stability of an inflatable treatment balloon of the surgical treatment device and optionally, wherein the back pressure ranges from 2 to 5 psi.

16. A console for circulating a gas through a thermal treatment probe, the console comprising a plurality of electronically-controlled valves, and a computer to control the valves as described herein.

17. The console of claim 16, wherein the computer is operable to control one or more of the valves according to functional modes comprising: (a) connect / disconnect device mode, (b) standby / ready mode, and (c) system vent / flush mode.

18. A console comprising any one or more of the components and features described herein.

19. A system comprising a console and surgical treatment device as described herein, and optionally, a GUI.

20. The system of claim 6, wherein the temperature management module further comprises a heater to increase the temperature of the thermal fluid.

21. The system of claim 1, further comprising a mesentery fat volume compute module for determining the volume of fat to be treated.

22. The system of claim 21, wherein the volume of mesentery fat to treated is based on real time data.

23. The system of claim 22, wherein the volume of mesentery fat to be treated is based on data arising from position sensors arranged on the distal treatment surfaces of multiple surgical treatment devices.

24. The system of claim 23, further comprising an exposure predictor module programmed and operable to determine the planned length of time a cooling power is to be applied, based on the volume of the mesentery fat, and optionally, the planned total cooling energy.

25. The system of claim 24, wherein the exposure predictor module is a machine learning model.

26. The system of claim 25, wherein the model is trained through at least two different types of learning.

27. The system of claim 24, further comprising comparing the planned time and total cooling energy to a measured real-time duration and total energy, and to end the procedure if the planned duration or total cooling energy exceeds the real-time duration and total cooling energy, respectively.

28. A method for performing a cooling treatment on a section of mesentery comprising applying non-ablative cooling to the mesentery fat.

29. The method of claim 28, further comprising calculating, on a processor, the volume of fat to be treated, wherein the volume of mesentery fat to treated is calculated based on real time data.

30. The method of claim 29, wherein calculating the volume of mesentery fat to be treated is based on data arising from position sensors arranged on the distal treatment surfaces of multiple surgical treatment devices.

31. The method of claim 30, further comprising determining, on a processor, the planned length of time a cooling power is to be applied, based on the volume of the mesentery fat, and optionally, the planned total cooling energy.

32. The method of claim 31, wherein the determining the planned length of time and cooling power to be applied is performed using a machine learning model.

33. The method of claim 32, further comprising training the model through at least two different types of learning.

34. The method of claim 33, further comprising comparing the planned time and total cooling energy to a measured real-time duration and total energy, and to end the procedure if the planned duration or total cooling energy exceeds the real-time duration and total cooling energy, respectively.

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