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WO2024196973A1 - Ballonnet thermique de forme plane pour réduction de graisse mésentérique - Google Patents

Ballonnet thermique de forme plane pour réduction de graisse mésentérique Download PDF

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Publication number
WO2024196973A1
WO2024196973A1 PCT/US2024/020622 US2024020622W WO2024196973A1 WO 2024196973 A1 WO2024196973 A1 WO 2024196973A1 US 2024020622 W US2024020622 W US 2024020622W WO 2024196973 A1 WO2024196973 A1 WO 2024196973A1
Authority
WO
WIPO (PCT)
Prior art keywords
recited
surgical device
inflatable member
tissue
cooling
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/020622
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English (en)
Inventor
Alexei V. Babkin
Rafi MAZOR
Pedram Nourian
Edmund J. Roschak
William Vincent
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B2m Medical Inc
Original Assignee
B2m Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B2m Medical Inc filed Critical B2m Medical Inc
Publication of WO2024196973A1 publication Critical patent/WO2024196973A1/fr
Priority to US19/066,601 priority Critical patent/US12433657B2/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00041—Heating, e.g. defrosting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A61B2018/00232—Balloons having an irregular shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • 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, may be found in the abdomen, under the abdominal muscles. Visceral fat is associated with high blood pressure, increased risk of heart disease, insulin resistance and diabetes, stroke, some cancers, and continued presence in the body may contribute to these conditions. Though diet and exercise can help eliminate visceral fat, diet and exercise are not well -tolerated by the typical overweight patient.
  • a surgical device for reducing visceral fat in the abdominal cavity comprises an elongate shaft and an inflatable member.
  • the inflatable member comprises a small-profile deflated configuration for being advanced into the abdominal cavity and a large-profile inflated configuration comprising a planar distal treatment surface for treating the visceral fat.
  • the thermal fluid preferably a gas, is circulated through the inflatable member at a temperature range sufficient to cause cryolipolysis to the fat cells but not damage non-target tissues.
  • the inflatable member can have several chambers, reinforcing members, and ports to provide controlled flow patterns that maintain the shape of the inflatable member when activated.
  • the inflatable member comprises a plurality of chambers.
  • the inflatable member has a treatment chamber separated from a supporting chamber by a divider and optionally, the supporting chamber and the front chamber have a substantially equal volume.
  • the divider includes at least one opening for fluidly connecting the treatment chamber to the supporting chamber.
  • the divider includes a plurality of openings, and preferably, the openings are arranged around the periphery of the divider.
  • the inflatable member further comprises a plurality of reinforcing members to maintain the treatment surface in a fixed relation to the rear surface when the inflatable member is inflated.
  • the reinforcing members can be closed cells extending from the rear surface to the treatment surface.
  • the reinforcing members can be cylindrically-shaped, and optionally, each reinforcing member forms a dimple at the treatment surface.
  • the inflatable member is adapted and operable to direct the thermal fluid evenly therethrough such that the planar distal treatment surface has a substantially uniform temperature and remains planar even when applied against the visceral fat.
  • the geometry of the flow channels and profile of the inflatable member cause the inflatable member to be somewhat stiff when activated, and thereby maintain the desired planar shape even when urged against tissues having a change in elevation.
  • the inflatable member has a square profile when inflated.
  • the inflatable member has a mattress-like shape when inflated.
  • the inflatable member has a flat planar distal treatment surface when inflated.
  • the thermal fluid is circulated through the inflatable member by the inlet line and outlet line at a temperature sufficient to cause cryolipolysis, thereby leaving the untargeted (non-fat cells) unablated.
  • the thermal fluid is circulated through the inflatable member at a temperature between -20 °C and -40 °C.
  • a system for cooling tissue comprises: a thermal fluid source; a surgical device having an inflatable member as recited herein and coupled to the thermal fluid source; a temperature sensor arranged to measure the thermal fluid entering (or within) the inflatable member (Ti); a pressure control device to control the pressure of the thermal fluid transported to the inflatable member (Pi); and a controller operable to maintain the temperature in the inflatable member between -35° C and -40° C, and optionally about -40° C, based on Ti and by adjusting the Pi using the pressure control device.
  • the pressure control device is a regulator or pump.
  • the controller is operable to compute total energy removed from the tissue, and optionally, halt the cooling once a threshold amount of energy has been delivered.
  • a method of using the system as described herein to cool tissue comprises cooling the tissue for a time duration based on the thickness of the tissue.
  • the time duration can vary and in embodiments, ranges from 10 to 120 sec. for thickness’ ranging from 1-5 mm, and in some embodiments, 20- 40 sec. for thinner tissue or when multiple cooling devices are applied simultaneously as described herein.
  • the tissue thickness is estimated by the physician, optionally, visually.
  • the method comprises providing two surgical devices, and sandwiching the tissue between opposing inflatable members, and cooling the tissue between the opposing inflatable members for a modified time duration based on the thickness of the tissue, and a predicted time temperature profile arising from both of the opposing inflatable members.
  • the modified time duration can vary, and is typically shorter than the unmodified time duration. In embodiments, the modified time duration ranges from 10 to 20 sec, optionally about 15-18 seconds.
  • the method comprises cooling the target tissue to below 10 C, to below 0° C, to below -10° C, and in some instances to between -20° C and -40° C.
  • the controller is operable to cool the target tissue to below 10° C, to below 0° C, to below -10° C, and in some instances to between -20° C and -40° C.
  • FIG. 1 illustrates a schematic drawing of a system for reducing mesenteric fat in accordance with an embodiment of the invention
  • FIGS. 2A-2D illustrate sequentially a laparoscopic method for reducing mesenteric fat in accordance with an embodiment of the invention
  • FIGS. 3-4 illustrate sequentially deploying the treatment device from a delivery configuration to a deployed configuration, respectively, in accordance with an embodiment of the invention
  • FIG. 5 is an enlarged view of the distal end of the treatment device shown in FIG. 4;
  • FIG. 6 is a front view of a distal end of a treatment device in an inflated configuration in accordance with an embodiment of the invention
  • FIG. 7 A is a cross sectional view of the treatment device shown in FIG. 6 taken along line 7A-7A;
  • FIGS. 7B-7C are front view flow illustrations of the front and rear chambers, respectively, of the inflatable member shown in FIG. 7A;
  • FIG. 8 is a schematic diagram of a treatment device in accordance with an embodiment of the invention.
  • FIG. 9 is a perspective view of a treatment device shown in another configuration in accordance with an embodiment of the invention.
  • FIGS. 10-11 are side and bottom views, respectively, of the distal treatment section of the device shown in FIG. 9;
  • FIG. 12 is an illustration of another laparoscopic method for reducing mesenteric fat in accordance with an embodiment of the invention.
  • FIG. 13 is a computer simulation of a temperature profile in tissue arising from application of opposing cooling devices in accordance with embodiments of the invention.
  • nonablative 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.
  • 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 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.
  • 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.
  • a coolant such as a gas or liquid is circulated between the treatment device 20 and the console 30 via umbilical cord 32.
  • the umbilical cord is flexible and detachably coupled to the console via a connector 34.
  • the length of the umbilical cord ranges from 3-8 feet.
  • Console 30 may include a number of additional components and features including, for example, computer and display 36 which are operable to connect with a laparoscope or other imaging equipment for displaying the operative field and/or target anatomy during the procedure.
  • Console may include a coolant source, heat exchanger, power supply, and controller for controlling and monitoring coolant flow, temperature, time elapsed, and other parameters as desired.
  • FIGS. 2A-2D describe a laparoscopic method for reducing mesenteric fat in accordance with an embodiment of the invention.
  • a first trocar 101 comprising a cannula 103 and an obturator 105 is shown inserted through an abdominal wall 107 of a patient 109 such that the cannula 103 gains access to the abdominal cavity 111 of the patient 109.
  • the obturator 105 is then removed with the cannula 103 automatically sealing at the seal 113.
  • a small intestine 115 of the patient 109 includes a portion of visceral fat 117 to be treated.
  • a second trocar 119 is shown inserted through the abdominal wall 107 to provide insufflation via an insufflation line 121.
  • the space in the abdominal cavity 111 is thus enlarged.
  • the insufflation may be applied through the first trocar 101.
  • the first trocar 101 may be more safely inserted further into the abdominal cavity 111, as shown in FIG. 2B.
  • a third trocar 123 is inserted through the abdominal wall 107 and is used to provide access to a laparoscope 125 for illuminating and viewing the procedure.
  • the size of trocars 101, 119, 123 may vary. Non-limiting exemplary sizes include: 5 mm trocars, 10 mm trocars, or 12 mm trocars depending upon the size requirements of the devices to be placed through the lumens.
  • the cooling probe 100 and introducer sheath 127 are then advanced together through the lumen of the cannula 103.
  • the introducer sheath 127 is retracted by the user.
  • the cooling probe 100 is now advanced by the user so that the mattress 108 exits the cannula 103 and is able to be inflated to its expanded configuration, described herein.
  • the mattress 108 is placed over a desired portion of visceral fat 117 to be treated, and activated.
  • the coolant inflates and circulates through the mattress 108, thus removing heat from the visceral fat 117 until the visceral fat is brought to a target temperature to cause cryolipolysis.
  • Exemplary target temperatures for the cooling apparatus range from -60° C to -35 ° C, more preferably between -35° C to -45° C, and most preferably about -40 ° C for the portion of the cooling device to make contact with the target tissue.
  • Exemplary target temperatures for the tissue range from -40°C to +10° C, -40°C to ⁇ -10°C, and in some embodiments between -10° C to + 10° C or between 0° C and +10° C.
  • the visceral fat by maintaining the visceral fat at a temperature between +10° C and -40 ° C, or between about -20° C and about -40° C for a duration of, for example, 10 to 30 seconds, up to 10 minutes, the visceral fat undergoes apoptosis while the normal intestinal tissues are protected from significant damage. This is because the visceral fat tends to be more sensitive to the lower temperatures than the surrounding normal tissue.
  • the cooling is terminated.
  • the cooling probe 100 is retracted into the lumen of the cannula 103, compressing the deflated balloon 108 of the cooling probe 100 toward its collapsed configuration.
  • a treated portion 141 of the visceral fat is shown in FIG. 2D.
  • FIGS. 2A-2D illustrate a method for reducing the visceral fat of a patient
  • the invention is not intended to be so limited and may include other steps except where excluded in any appended claims. Any of the steps or features described herein may be omitted or combined in any logical manner except where such steps or features conflict with one another.
  • FIGS. 3-4 illustrate a cooling probe 300 and introducer sheath 320 arranged in an extended configuration (for device insertion and withdrawal) and a retracted configuration (for tissue treatment), respectively.
  • introducer sheath 320 is shown extended distally. Consequently, the collapsed/folded balloon is hidden from view by the sheath.
  • introducer sheath 320 is shown retracted proximally along shaft 312.
  • flared proximal end 322 is pulled relative to handle 310, exposing the balloon 340.
  • the balloon 340 is then activated, as described herein, causing it to inflate into its predefined shape for treating the target tissue.
  • FIG. 5 is an enlarged view of the inflated treatment balloon 340 shown in FIG. 4.
  • the inflated balloon 340 is shown attached to the distal part of a shaft 312.
  • the shaft is thermally insulated such that no tissue damage is caused by shaft if tissue is inadvertently touched hy the shaft during a procedure.
  • the inflated treatment balloon 340 is shown having a thin, planar, and square shape. Structural dimples 360 are shown on the treatment surface. The structural dimples act as reinforcing members, connecting the treatment surface to the rear surface (not shown). The structural reinforcing members serve to maintain the balloon 340 in the mattress-like structure shown in FIG. 5 including the flat treatment surface, when inflated.
  • the balloon comprises 4 to 100 reinforcing members, and more preferably 9 to 50 reinforcing members.
  • the surface area of the treatment surface of the balloon when inflated may vary.
  • An exemplary range is between 2000 to 10,000 mm 2 and more preferably between 3000 and 6000 mm 2 .
  • An exemplary range for the thickness of the balloon when inflated is between 5 and 10 mm.
  • the shape of the balloon when inflated, may also vary. Although the balloon is shown having a square profile in FIGS. 5-6, in other embodiments of the invention, the shape of the balloon is different. Exemplary shapes include circle, rectangle, oval, semi-circle, arcuate or bending, and annular. In embodiments, a kit of devices is provided in which the devices include complementary balloon shapes to cover an entire tissue area. For example, the base of a semi-circular shape may be combined with a side of a square shape to contiguously extend the overall footprint of the tissue to be cooled.
  • Exemplary materials for making the balloon are thin-walled elastic materials such as, for example, 0.003 inches polyurethane.
  • an elastic material is used for making the balloon, it is desirable to incorporate the reinforcing structure (e.g., cells 460) described herein to compensate for the stretching of the balloon during inflation and to maintain its shape.
  • the material of the balloon, shape, thickness, and arrangement of the cells cooperate together to maintain the planar shape of the balloon when inflated and provide a stiffness such that the balloon may be urged against the visceral tissue and maintain its flat planar-like shape.
  • FIG. 6 shows an enlarged front view of a distal end 400 of a cooling device in accordance with another embodiment of the invention.
  • FIG. 7A shows an enlarged cross sectional view of the distal end 400 taken along line 7A-7A.
  • the treatment balloon includes two chambers: a frontal chamber 440 for treating the tissue, and a supporting or rear chamber 450 for the fluid return and to provide structural stability.
  • the volume of the rear chamber 450 is roughly equal to that of the front chamber 440 in the balloon shown in FIGS. 6-7A.
  • the volumes of the chambers may differ from one another.
  • a middle layer 442 is shown between the chambers 440, 450.
  • a plurality of openings 430(a)-430(l) are disposed through the middle layer to fluidly connect the frontal treatment chamber 440 to the rear chamber 450.
  • the openings are shown arranged evenly about the periphery of the inflated balloon to optimize flow distribution from the fluid inlet 420, through the treatment chamber 440, the rear chamber 450, and out the return line 426.
  • the flow is activated by opening valve 432, discussed herein.
  • the number of openings to fluidly connect the front and rear chambers may vary and in embodiments, ranges from 4 to 40, and more preferably 9 to 30.
  • Each of the reinforcing members 460 is shown extending from the front treatment surface, through the middle layer 442, and to the rear surface.
  • the shape of the reinforcing members may vary.
  • the reinforcing members take the form of a hollow cylindrical cell, forming a dimple on each of the distal and proximal surfaces of the inflated balloon.
  • the inventors have found that the arrangement of the openings and reinforcing members, and the size of the chambers creates an even flow distribution when the fluid (e.g., gas) is circulated through the balloon.
  • the balloon quickly forms (and is maintained) in its predefined shape while cooling the target tissues.
  • FIGS. 7B-7C are front view flow illustrations of the front and rear chambers, respectively, of the balloon 401 shown in FIG. 7 A.
  • front chamber flow pattern radiates from centrally located fluid inlet 420 to peripheral openings
  • FIG. 8 is a schematic diagram of a cooling device 500 in accordance with an embodiment of the invention.
  • the device 500 includes a handle 510 and a distal treatment balloon 520 connected to the handle by a rigid shaft 522.
  • a flexible hose or umbilical cord 530 extends rearwardly from the handle.
  • the handle 510, shaft 520 and hose 530 comprise thermal insulation to prevent cooling collateral (and untargeted) tissues.
  • FIG. 8 also shows the hose 530 terminating at a connector 540.
  • the connector is configured to detachably connect to a console such as console 30, described above with reference to FIG. 1.
  • Cold fluid inlet and cold fluid return lines 532, 534 are shown extending from the connector 540 through the hose 530, handle 510, shaft 522, and to the balloon 520.
  • the cooling fluid is circulated along the flow lines 532, 534 and through the balloon 520 to treat the tissue as described herein.
  • the thermal fluid is a low pressure gas such as low- pressure gaseous carbon dioxide.
  • carbon dioxide is a preferred fluid because, and without intending to be bound to theory, it is commonly used in laparoscopic surgery, readily available and well tolerated if leaked in small amounts.
  • the thermal fluid e.g., the CO2 gas
  • the thermal fluid is pre-chilled in the console (not shown) using a heat exchanger.
  • An exemplary pre-chill temperature of the fluid in the console ranges from -70 to -40 ° C, and in some embodiments is about -65° C.
  • An exemplary balloon temperature ranges from -20 and -40 ° C, and in some embodiments, is about -30°C.
  • the balloon temperature can be adjusted but, in accordance with embodiments of the invention, is preferably maintained within a target interval such that tissue ablation is avoided.
  • the target interval for the balloon temperature to avoid tissue ablation ranges from -20° C to -40°C .
  • lines 532, 534 are schematically shown as parallel, the lines could be arranged in other configurations such as a coaxial arrangement, preferably, with the incoming gas flowing along a central channel and the return gas flowing through the annulus of the coaxial arrangement.
  • the handle 510 can include a user interface.
  • the user interface in FIG. 8 includes a power or start switch 512 (e.g., button activated) and visual indicators 514 (e.g., LEDs).
  • the indicators can be operable to provide the status/state of the treatment.
  • the user interface may include a display such as, for example, a touch screen display.
  • the handle 510 is shown including sensors 536, 538 for evaluating temperature of the outlet line and balloon inlet, respectively. Exemplary sensors are thermocouples.
  • the temperature sensing locations within the cooling device are strategically positioned to ensure accurate monitoring of the cooling process.
  • Two temperature sensors can be incorporated into the design.
  • One temperature sensor e.g., sensor 5348 is situated within the inlet stream of the cooling gas as it enters the treatment balloon 520. This placement location allows for real-time monitoring of the gas temperature at the initial point of contact with the tissue.
  • the second temperature sensor e.g., sensor 536) is positioned within the return stream of the cooling gas as it exits the treatment balloon. This placement facilitates continuous monitoring of the gas temperature after it has interacted with the tissue.
  • Exemplary temperature sensors utilized in the device are type T thermocouples, selected for their precision and reliability.
  • thermocouples possess a wide sensing range spanning from -200°C to +200°C, ensuring compatibility with various cooling applications. Furthermore, the sensors exhibit a high degree of accuracy, with a tolerance of ⁇ 0.1 °C, thus providing precise temperature measurements.
  • the temperature readings obtained from the sensors represent the instantaneous temperature of the fluid (typically, gas) stream at their respective locations. These measurements serve as indicators of the cooling efficiency and effectiveness of the device.
  • the temperature measurements captured by the sensors reflect the conditions within the gas stream, providing valuable insights into the thermal dynamics of the treatment process and that the tissue temperature remains within the desired range throughout the duration of the procedure.
  • a computing device e.g., processor, computer or controller
  • a computing device is programmed and operable to calculate thermodynamic properties of the gas during the cooling process in real-time. This calculation is based on the continuous monitoring of temperature differentials using temperature sensors strategically placed at the inlet and outlet of the device, discussed herein.
  • the temperature differentials (AT) obtained from these sensors is used to calculate the change in enthalpy (energy) of the gas.
  • the change in enthalpy is derived from AT and is the basis for solving the energy equation.
  • the total energy is correlated to temperatures at specific tissue depths. By correlating the total energy removed from the tissue by monitoring temperature at specific tissue depths, a comprehensive understanding of the treatment's efficacy is achieved. This iterative process of data analysis ensures that the device operates optimally, delivering consistent and predictable outcomes.
  • a desired depth or tissue thickness can be observed/estimated, and the system can be operated to remove a total amount of energy sufficient to treat the tissue based on decreasing the temperature of the tissue at the desired depth to a desired temperature (e.g., between 0 and +10° C for a relatively deep penetration or thick tissue).
  • the controller and computer can be programmed and operable to allow the physician to tune the energy removed based on time duration, balloon temperature, flowrate or inlet pressure, and the number of devices (or shapes of devices) applied to the tissue.
  • the heat exchanges and energy calculations, described herein, can be used for monitoring the treatment progress.
  • three indicator lights e.g., green, yellow, red
  • green indicates that the balloon is in the correct temperature range and ready to be positioned on the tissue; yellow will indicate treatment in progress; a red light will indicate the application is over and the device needs to be detached from the tissue.
  • the red light will change to green once the ballon temperature reaches a treatment temperature.
  • the handle 510 is also shown including a pressure transducer 544 for evaluating pressure along the outlet fluid line 534.
  • flow rate is computed based on the pressure along the outlet fluid line versus the initial or inlet pressure somewhere along the inlet line (e.g., at the fluid source or regulator).
  • a regulator is arranged along the flowpath between the fluid source and the cooling device to control the pressure to the cooling device.
  • the regulator can be electronically controlled.
  • the temperature of the fluid being delivered to the balloon and returning from the balloon is monitored. Such information can be input to a control algorithm for controlling flowrate, temperature, duration, and optimizing treatment. Indeed, it is to be appreciated that the number, location and type of sensors may vary widely and the invention is intended to include all such variations unless excluded in any appended claims.
  • the device 500 may have additional functional lines 546.
  • warming gas lines can be incorporated into the device to warm the balloon 520 by actively circulating a warm gas through the system.
  • the warming cycle can be performed by shutting off the flow of the chilled gas; in which case the balloon warms by ambient temperature and radiation (namely, passive warming).
  • FIG. 8 additionally shows lines for electrical reading/controls 542. Signals and power may be transmitted between the console and the device via the electrical wires 542.
  • the electrical conductors may be housed in one or more dedicated service lumens.
  • valve control lines may be incorporated into the shaft to control the valve(s) 432, described above with reference to FIG. 7 A.
  • the valve control lines may be configured to pneumatically (or otherwise) open and close the valves 432.
  • the above described functional lines can be operably coupled to the console (not shown) via the hose 530 and connector 540.
  • the connector 540 is operable to connect to the console at least the chilled gas lines (inlet line 532 and outlet line 534) and electrical wires 542 (signals and controls in-and-out).
  • the connector is operable to connect additional lines from the device 500 to the console including, for example, warming lines 546, fiber optics, and irrigation or suction lines.
  • the shape or profile of the connector 540 may vary.
  • An example of a connector is a ‘push-to-connect’ type connector.
  • the connector is cylindrical and keyed for proper alignment with the console receptable.
  • the connector or the receptable features an outer freely rotating sleeve (comprising internal threads). After the connector is advanced into the receptable, the sleeve is screwed onto external threads present on the opposing component. As the sleeve is further rotated, the connector is further urged into the receptacle, and locked in place.
  • the umbilical cord and handle are configured to detach from one another.
  • the handle may include a port to receive a distal end connector of the umbilical cord.
  • FIG. 9 shows a front side perspective view of another medical cooling device 600 in accordance with an embodiment of the invention comprising a tilted balloon 640.
  • FIGS. 10-11 show side and bottom views, respectively, of the balloon shown in FIG. 9.
  • the interface between the balloon and the shaft is operable to hinge.
  • the hinge feature comprises a flexible flange, that allows the balloon to articulate when pressed to the mesentery.
  • the balloon 640 is operable to adjust to sloped target tissues 650, and/or to adjust to being delivered into the patient at an angle to the target tissues.
  • the balloon angle (T) relative to the shaft can accommodate non-perpendicular angles.
  • the device 600 is operable to title to an angle (T) less than 90 degrees, and more preferably less than 45 degrees.
  • FIG. 11 is a bottom view of the balloon 640 shown in FIG 9.
  • FIG. 11 is provided to illustrate the balloon may also tilt angle (R) when viewed from the bottom.
  • angle (R) can vary from 0 to 90 degrees, and more preferably less than 45 degrees.
  • FIG. 12 shows another method in accordance with embodiments of the invention to cool fat by applying cooling power to both sides of a mesentery tissue 702.
  • a portion of the mesentery 702 is shown attached to the large intestines 710 or small intestines 706, and two cooling probes 721 and 722 are shown engaged with the mesentery.
  • One cooling probe 721 has been inserted into the body from a first portal 723 and its cooling head 724 has been placed against one surface of the mesentery
  • a second cooling probe 722 has been inserted into the body from a second portal 725 and its cooling head 726 has been placed against a second, opposing surface of the mesentery.
  • Graspers 727 and 728 may be used to manipulate the intestines and/or mesentery sheet as necessary, and are shown inserted into the abdomen through portals 729 and 730. As shown in FIG. 12, a section of the intestine (710, 706) has been grasped with graspers 727, 728 and lifted and/or pulled anteriorly so that the attached section of the mesentery 702 hangs down from the intestine (extends posteriorly, depending on the configuration of the mesentery), exposing mesentery surfaces to the cooling heads of the cooling probes.
  • the cooling probes 721, 722 have been inserted into the abdomen, and the cooling balloons 724, 726 have been deployed on opposite sides of the mesentery section 702, with the cooling faces opposite each other and aligned with each other, namely, in a sandwich-like arrangement with the mesentery section.
  • the probes are inserted endoscopically, through a portal or cannula inserted into the abdomen of the patient as described above in connection with FIGS. 2A-2D.
  • a portal or cannula inserted into the abdomen of the patient as described above in connection with FIGS. 2A-2D.
  • the distal ends of probes which carry the cooling heads may be inserted through the portals and applied to the mesentery.
  • Graspers with grasping jaws, or other retracting tools can be inserted through the abdominal wall to hold the intestine and/or mesentery in a convenient configuration to facilitate application of the cooling heads.
  • the cooling heads may be disengaged from the surfaces of the mesentery sheet. If the cooling operation has resulted in adhesion of the mesentery to the cooling heads, disengagement may be facilitated with active warming by applying energy to the heating elements, supplying warm fluid through the cooling fluid lumens, or waiting for passive warming to release the tissue from the cooling heads.
  • a cooling device (e.g., cooling device 300 as shown in FIGS. 3, 4) will be inserted bilaterally through each of the 12mm trocars.
  • Graspers e.g., graspers 727 and 728 shown in FIG. 12
  • the surgeon will present the mesentery by lifting a loop of the intestine using the graspers.
  • the presented tissue thickness can be estimated by the physician in addition to having any measurements from preoperative scans if available.
  • a cooling balloon e.g. inflatable member 520 shown in FIG. 8 will contact the mesenteric fat from both sides, so that the two balloons, once deployed will be superimposed on either side of the mesentery as shown in FIG. 12.
  • the cooling device will be activated as described herein to cool the mesenteric fat to a desired target temperature.
  • Exemplary target temperature ranges (°C) for the mesenteric fat to be cooled are: 0 to +10, -10 to + 10, -20 to 0, -40 to 0, and -40 to -20.
  • Each cooling cycle can be ⁇ 30 sec. and, in some embodiments, between 10 and 15 sec.
  • the cooling device itself including, without limitation, the rear balloon chamber and the fluid inlet lines may have a slightly lower temperature than the above listed target tissue temperatures in order to obtain the desired target temperature.
  • the fluid inlet temperature at the balloon is maintained by circulating thermal fluid through the inflatable member at about -40°C such that the target tissue temperature (namely, the tissue mass in contact with the balloon) is cooled to about -40 °C immediately adjacent the balloon surface, and up to about -10 °C to +10 °C 3-5 mm from the surface of the balloon, depending on the time duration the cooling is activated.
  • Exemplary time durations range as described herein and can be under one minute and more preferably under 30 sec.
  • a warming cycle is applied to prevent sticking and serves to ensure safe detachment of the balloons from the mesentery.
  • the balloons are deflated and retracted from the abdominal cavity.
  • FIG. 13 is a three-dimensional computer simulation illustrating a temperature profile during the cooling cycle.
  • the following parameters were used in the computation shown in FIG. 13: the time duration is 18 sec., the tissue is fat, the tissue thickness is 5 mm, the opposing cooling devices are stainless-steel, rectangular in shape, and held at a constant temperature of -40 °C.
  • the software used to perform the computer simulation was COSMOL® developed by COSMOL, Inc. (Burlington, Massachusetts).
  • the chart shows that the full thickness of the tissue (5 mm) decreases to +10 °C (or less) after only 18 seconds.
  • the temperature of the tissue decreases the closer to the surface of the instrument, and ultimately approaches about -40 °C at the surface of the instruments.
  • This data shows the full transmural thickness of a 5 mm thick fat can be cooled to 10 °C or less after only 18 seconds when the cooling devices are applied to opposite sides of the tissue and held at the proper temperature.

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Abstract

La présente invention concerne un dispositif chirurgical conçu pour réduire la graisse viscérale dans la cavité abdominale et comprenant une tige allongée et un élément gonflable. L'élément gonflable comprend une configuration dégonflée à petit profil pour être avancé dans la cavité abdominale et une configuration gonflée à grand profil comprenant une surface de traitement distale plane pour traiter la graisse viscérale. Le fluide thermique, de préférence un gaz, est mis en circulation à travers l'élément gonflable à une plage de température suffisante pour provoquer la cryolipolyse sur les cellules adipeuses mais pas pour endommager les tissus non cibles. L'élément gonflable peut avoir plusieurs chambres, éléments de renforcement et orifices pour fournir des modèles d'écoulement commandés qui maintiennent la forme de l'élément gonflable lorsqu'il est gonflé.
PCT/US2024/020622 2022-01-04 2024-03-20 Ballonnet thermique de forme plane pour réduction de graisse mésentérique Pending WO2024196973A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12433657B2 (en) 2022-01-04 2025-10-07 B2M Medical, Inc. Planar-shaped thermal balloon for mesenteric fat reduction

Citations (5)

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Publication number Priority date Publication date Assignee Title
US20130317497A1 (en) * 1998-01-14 2013-11-28 Mederi Therapeutics Inc. Gerd treatment apparatus and method
US9861423B2 (en) * 2012-01-27 2018-01-09 Medtronic Cryocath Lp Balloon design to enhance cooling uniformity
US20210030457A1 (en) * 2010-02-15 2021-02-04 The General Hospital Corporation Methods and devices for selective disruption of visceral fat by controlled cooling
CN115137549A (zh) * 2022-01-29 2022-10-04 瓴科医疗科技(杭州)有限公司 一种亚低温治疗用双层热交换球囊
US20230000669A1 (en) * 2019-11-20 2023-01-05 B2M Medical, Inc. Systems and methods for treatment of visceral fat

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130317497A1 (en) * 1998-01-14 2013-11-28 Mederi Therapeutics Inc. Gerd treatment apparatus and method
US20210030457A1 (en) * 2010-02-15 2021-02-04 The General Hospital Corporation Methods and devices for selective disruption of visceral fat by controlled cooling
US9861423B2 (en) * 2012-01-27 2018-01-09 Medtronic Cryocath Lp Balloon design to enhance cooling uniformity
US20230000669A1 (en) * 2019-11-20 2023-01-05 B2M Medical, Inc. Systems and methods for treatment of visceral fat
CN115137549A (zh) * 2022-01-29 2022-10-04 瓴科医疗科技(杭州)有限公司 一种亚低温治疗用双层热交换球囊

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12433657B2 (en) 2022-01-04 2025-10-07 B2M Medical, Inc. Planar-shaped thermal balloon for mesenteric fat reduction

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