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WO2025075690A1 - Appareil électrochirurgical à orifice de rinçage - Google Patents

Appareil électrochirurgical à orifice de rinçage Download PDF

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Publication number
WO2025075690A1
WO2025075690A1 PCT/US2024/036993 US2024036993W WO2025075690A1 WO 2025075690 A1 WO2025075690 A1 WO 2025075690A1 US 2024036993 W US2024036993 W US 2024036993W WO 2025075690 A1 WO2025075690 A1 WO 2025075690A1
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WO
WIPO (PCT)
Prior art keywords
distal end
fluid
handpiece
port
coupled
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/US2024/036993
Other languages
English (en)
Inventor
James Joseph Mitchell
Steven Michael FLANDERS
Bradley A. Rentschler
MD Drew SCHNITT
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.)
Apyx Medical Corp
Original Assignee
Apyx Medical Corp
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 Apyx Medical Corp filed Critical Apyx Medical Corp
Publication of WO2025075690A1 publication Critical patent/WO2025075690A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/042—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating using additional gas becoming plasma
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A61B2018/00583—Coblation, i.e. ablation using a cold plasma
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/1253—Generators therefor characterised by the output polarity monopolar
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007—Aspiration

Definitions

  • Gas plasma is an ionized gas capable of conducting electrical energy. Plasmas are used in surgical devices to conduct electrosurgical energy to a patient. The plasma conducts the energy by providing a pathway of relatively low electrical resistance. The electrosurgical energy will follow through the plasma to cut, coagulate, desiccate, or fulgurate blood or tissue of the patient. There is no physical contact required between an electrode and the tissue treated.
  • the electrosurgical apparatus further includes a ceramic tip coupled to the distal end of the electrically conductive tube, a distal end of the electrode being disposed in the ceramic tip.
  • each slot of the ceramic tip includes a stop such that when the electrode is coupled to the distal end of the electrically conducting tube, the electrode retains the ceramic tip to the distal end of the electrically conductive tube.
  • the at least one fluid is tumescent anesthesia.
  • the at least one fluid is fat.
  • FIG. 6 illustrates a perspective view of internal components of an electrosurgical apparatus in accordance with an embodiment of the present disclosure
  • FIG. 7 a side view of a distal portion of an electrosurgical apparatus in accordance with an embodiment of the present disclosure
  • FIG. 10 is an exploded perspective view of the distal portion of the electrosurgical apparatus of FIG. 9 in accordance with an embodiment of the present disclosure
  • FIG. 13 is perspective view of a distal tip of the electrosurgical apparatus shown in FIG.12 in accordance with another embodiment of the present disclosure
  • FIG. 14 is a top view of the distal tip shown in FIG. 13;
  • FIG. 16 is a cross-sectional view of the side view of the distal tip shown in FIG. 15;
  • FIG. 17 is a block diagram of an electrosurgical system in accordance with an embodiment of the present disclosure.
  • FIG. 18 is a flowchart illustrating a method in accordance with an embodiment of the present disclosure.
  • proximal will refer to the end of the device, e.g., instrument, apparatus, applicator, handpiece, forceps, etc., which is closer to the user, while the term “distal” will refer to the end which is further from the user.
  • distal will refer to the end which is further from the user.
  • the phrase “coupled” is defined to mean directly connected to or indirectly connected with through one or more intermediate components. Such intermediate components may include both hardware and software based components.
  • the present disclosure is directed to an electrosurgical apparatus.
  • the electrosurgical apparatus of the present disclosure includes a connector, a housing, a shaft, and a distal tip.
  • the connector is configured to be coupled to an electrosurgical generator and gas supply.
  • the electrosurgical apparatus is configured to provide electrosurgical energy and inert gas to an electrode within the distal tip of the electrosurgical apparatus to generate a plasma beam to coagulate/contract tissue as needed.
  • the housing of the electrosurgical apparatus includes a flush port to receive a sterile fluid, e.g., saline, to flush and/or remove debris in or about the distal tip.
  • the shaft is flexible and formable to enable a user to contour the shaft around tight anatomical locations.
  • FIG. 1 shows an exemplary monopolar electrosurgical system generally indicated as 10 comprising an electrosurgical generator (ESU) generally indicated as 12 to generate power for the electrosurgical apparatus 10 and a plasma generator generally indicated as 14 to generate and apply a plasma stream 16 to a surgical site or target area 18 on a patient 20 resting on a conductive plate or support surface 22.
  • the electrosurgical generator 12 includes a transformer generally indicated as 24 including a primary 31 and secondary 33 coupled to an electrical source (not shown) to provide high frequency electrical energy to the plasma generator 14.
  • the electrosurgical generator 12 comprises an isolated floating potential not referenced to any potential. Thus, current flows between the active and return electrodes. If the output is not isolated, but referenced to "earth", current can flow to areas with ground potential. If the contact surface of these areas and the patient is relatively small, an undesirable burning can occur.
  • the plasma generator 14 comprises a handpiece or holder 26 having an electrode 28 at least partially disposed within a fluid flow housing 29 and coupled to the transformer 24 to receive the high frequency electrical energy therefrom to at least partially ionize noble gas fed to the fluid flow housing 29 of the handpiece or holder 26 to generate or create the plasma stream 16.
  • the high frequency electrical energy is fed from the secondary 33 of the transformer 24 through an active conductor 30 to the electrode 28 (collectively active electrode) in the handpiece 26 to create the plasma stream 16 for application to the surgical site 18 on the patient 20.
  • a current limiting capacitor 25 is provided in series with the electrode 28 to limit the amount of current being delivered to the patient 20.
  • the return path to the electrosurgical generator 12 is through the tissue and body fluid of the patient 20, the conductor plate or support member 22 and a return conductor 32 (collectively return electrode) to the secondary 33 of the transformer 24 to complete the isolated, floating potential circuit.
  • the electrosurgical generator 12 comprises an isolated non-floating potential not referenced to any potential.
  • the plasma current flow back to the electrosurgical generator 12 is through the tissue and body fluid and the patient 20. From there, the return current circuit is completed through the combined external capacitance to the plasma generator handpiece 26, surgeon and through displacement current.
  • the capacitance is determined, among other things, by the physical size of the patient 20.
  • Such an electrosurgical apparatus and generator are described in commonly owned U.S. Patent No. 7,316,682 to Konesky, the contents of which are hereby incorporated by reference in its entirety.
  • transformer 24 may be disposed in the plasma generator handpiece 26.
  • other transformers may be provided in the generator 12 for providing a proper voltage and current to the transformer in the handpiece 26, e.g., a step-down transformer, a step-up transformer or any combination thereof.
  • a plasma generator handpiece or electrosurgical apparatus including a flush or cleaning port for removing debris from a distal end of the electrosurgical apparatus.
  • the housing 106 includes a proximal end 112 and distal end 1 14.
  • Shaft 108 includes the distal tip or end 110 and a proximal end 1 16 that is coupled to the distal end 1 14 of the housing 106.
  • the proximal end 112 of housing 106 includes first and second ports 118, 120.
  • First port 1 18 is configured to receive a first end 122 of cable 104.
  • a second end 124 of cable 104 is coupled to connector 102.
  • Connector 102 is configured to couple apparatus 100 to an electrosurgical generator, such as ESU 12 for receiving electrosurgical energy and fluid (e.g., an inert gas, such as helium or argon) for use in procedures performed using apparatus 100, as will be described in greater detail below.
  • ESU 12 an electrosurgical generator
  • fluid e.g., an inert gas, such as helium or argon
  • Connector 102 includes shells 126A, 126B, which, when coupled together, form a housing for connector 102.
  • Connector 102 includes conductors or pins 128A-128E that project from the housing 102 and port 130 for receiving a gas, e.g., helium, for use in certain electrosurgical procedures.
  • Certain pins 128A-128E are coupled to conductors that extend from the connector 102 through cable 104 to housing 106, where at least one conductor is coupled to the electrode disposed in the distal tip 1 10. At least one tube is disposed in the cable 104 and extends from port 130 to port 118 on the proximal end 1 12 of housing 106.
  • certain conductors 128A-128E are coupled to a processor and/or memory (not shown) disposed is connector 102 to form a circuit via which an electrosurgical generator (e.g., ESU 12) can communicate with when connector 102 is coupled to a corresponding receptacle of the electrosurgical generator.
  • processor and/or memory is an electrically erasable programmable readonly memory (EEPROM) that stores information (e.g., settings, parameters, etc., associated with apparatus 100) that may be read by the electrosurgical generator to use apparatus 100.
  • EEPROM electrically erasable programmable readonly memory
  • memory may store information related to recommended flow rates of inert gas provided to apparatus 100, properties of electrosurgical energy to be provided to apparatus 100, time information used by ESU 12 to disable ESU 12 after a predetermined amount of time apparatus 100 has been used for (e.g., 12 hours), etc. It is to be appreciated that additional information and/or only a subset of the above described information may be stored in the memory.
  • FIGS. 5 and 6 internal components of the apparatus 100 are illustrated, where FIG. 5 illustrates a top view of internal components and FIG. 6 illustrates a perspective of internal components without the housing 102.
  • a y-adapter 140 is provided that includes a first input port 142, a second input port 144 and an output port 146.
  • First input port 142 is coupled to tube 148 that is disposed in cable 104.
  • Tube 148 includes a first end 150 that is coupled to the first input port 142 via check valve 152.
  • a second end (not shown) of tube 148 is coupled to port 130 in connector 102.
  • a flush tube 154 is provided including a first end 156 coupled to the second input port 144 of y-adapter 140 and a second end 158 coupled to a second check valve 160.
  • the output port 146 of y-adapter 140 is coupled to conductive shaft 161 (shown in FIGS. 8-10) via tube 162. It is to be appreciated that a check valve allows flow of a fluid in one direction, e.g., from an input of the check valve to an output of the check valve, but not in the reverse direction.
  • a gas flow path extends from the connector 102 to the distal end 110 of shaft 108.
  • y-adapter 140 is shown disposed in the housing 106, it is to be appreciated that y-adapter 140 may be positioned anywhere along the gas flow path, for example, in, connector 102, in cable 104, in shaft 108 and/or at distal tip 1 10.
  • the y-adapter may be disposed in an electrosurgical generator (ESU) supplying and/or controlling the gas to the connector 102.
  • ESU electrosurgical generator
  • FIGS. 7 and 8 a distal portion of apparatus 100 is shown in accordance with an embodiment of the present disclosure, where, in FIG. 7, a side view of the distal portion is shown and, in FIG. 8, the side view of the distal end 110 is shown with an outer sheath removed.
  • the distal tip 1 10 includes a ceramic tip 170 coupled to a distal end 172 of conductive tube 161 with electrode 180 disposed with the ceramic tip 170 and conductive tube 161.
  • An outer insulating sheath 174 is disposed over the conductive tube 161 from a proximal end of the conductive tube 161 to a distal end of the ceramic tip 170.
  • the outer sheath 174 includes heat shrink material.
  • the conductive tube 161 , ceramic tip 170 and outer sheath 174 form the shaft 108.
  • the device shaft 108 is flexible and formable.
  • the conductive tube 161 is made of 304 Stainless Steel with a hardness that provides enough stiffness to allow the shaft 108 to retain its shape during use but will also deform when stressed beyond what would normally be encountered during use. This allows the user to “shape” the shaft 108 when a bend or curved shaft would be more beneficial. This provides the user the option to contour the shaft 108 around tight anatomical locations not normally treated with larger, stiffer devices. These areas include vaginal labia, hands, knees, as well as regions on the face (forehead, areas around the orbit when accessed from the zygomatic or temporal bone, nasolabial folds, etc.).
  • exemplary materials for the conductive tube 161 may include, but are not limited to, stainless steel, titanium, tungsten carbide, nitinol, kovar (Iron-Nickel-Cobalt alloy), MP25N (Nickel-cobalt alloy) and Inconel.
  • electrode 180 includes a distal end 182 and proximal end 184.
  • the distal end 182 of electrode 180 tapers to a point 186; however, it is to be appreciated that distal end 182 may be of other shapes and still be within the scope of the present disclosure.
  • the distal end 182 of electrode 180 may be rounded, flat with an edge perpendicular to the longitudinal axis of the shaft, squared, etc.
  • the distal end 182 of electrode 180 further includes tabs 188 which are used to guide the distal end 182 of electrode 180 in the ceramic tip 170, the details of which are described below.
  • the proximal end 184 of electrode 180 includes two flexible legs 190, each leg including foot 191 extending from the leg in a perpendicular manner in relation to a longitudinal axis of the electrode 108.
  • each leg 190 moves back to their normal position and a free end of each leg, i.e., foot 191 , enters a respective aperture 192 to retain the electrode 180 to the conductive tube 161 and to electrically couple the conductive tube 161 to the electrode 180, as shown in FIG. 8.
  • the free end or foot 191 of each leg 190 may be welded to the respective aperture 192.
  • FIGS. 1 1A-1 1 C the ceramic tip 170 of apparatus 100 is shown in accordance with an embodiment of the present disclosure, where, in FIG. 11 A is a side view of the ceramic tip 170, FIG. 1 1 B is a front view of the ceramic tip 170 and FIG. 1 1 C is a side cross-section view along lines C-C as indicated in FIG. 1 1 B.
  • the ceramic tip 170 includes a proximal end 202 and a distal end 204 with a channel 206 extending the entire length of the tip 170.
  • the proximal end 202 includes a first joint portion 208 that includes at least two recesses 210 and two projections 212.
  • the two projections 212 are located on an edge of the proximal end 202 of the tip 170 and the two recesses 210 are adjacent the projections 212 towards the distal end 204 of tip 170.
  • a second complementary joint portion 214 is formed on the distal end 172 of conductive tube 161 , where complementary joint point 214 includes two recesses 216 and two projections 218. When the first joint portion 208 comes into contact with the second joint portion 214, the projections 212 are disposed in recesses 216 and projections 218 are disposed in recesses 210, as shown in FIGS. 7 and 8.
  • the legs 190 of electrode 180 are disposed in channel 206 of the ceramic tip 170 via the distal end 204.
  • Tabs 188 of electrode 180 are aligned in the slots 220 of ceramic tip 170 and the electrode is slid toward the proximal end 202 of the ceramic tip 170 until the tabs make contact with stops 222 of slots 220.
  • the proximal end 184 of the electrode 180 is then disposed into the distal end 172 of conductive tube 161. Free ends of the flexible legs 190 are brought together and slide into the distal end 172 of conductive tube 161 until the feet 191 reach apertures 192 formed on the conductive tube 161.
  • each leg 190 When the feet 191 of legs 190 reach the apertures 192, the legs 190 move back to their normal position and a foot 191 of each leg enters a respective aperture 192 to retain the electrode 180 to the conductive tube 161 and to electrically couple the conductive tube 161 to the electrode 180, as shown in FIG. 8. At this point, the first joint portion 208 mates with the second joint portion 214.
  • the free end of each leg 190 may be welded to the respective aperture 192 to lock in place the ceramic tip 170.
  • connector 102 of apparatus 100 may be coupled to an ESU, such as, ESU 12 to receive electrosurgical energy and/or gas therefrom.
  • button 103 disposed on or accessible from housing 106, may activate the ESU to provide the electrosurgical energy and/or gas.
  • the connector 102 may receive electrical energy via pins 128A-E and provide the electrosurgical energy to conductive tube 161 via conductors disposed in cable 104.
  • the connector 102 may receive a gas (from ESU 12 or a separate gas source) and provide the gas to conductive tube 161 via tube 148 disposed in cable 104.
  • the gas provided via tube 148 will pass through check valve 152 and enter first input port 142 of y-adapter 140.
  • the proximal end of conductive tube 161 is coupled to output port 146 of y-adapter 140 via tubing 162.
  • check valve 152 prevents any fluid (e.g., the sterile saline) from entering tube 148 and flowing to the ESU and/or any other gas source.
  • the apparatus includes an extendable/retractable blade electrode.
  • the distal end 182 of electrode 180 is configured as a blade electrode which can extend pass a distal end of ceramic tip 170 for mechanical cutting (when no electrosurgical energy/gas is applied to tube 161 ) or electrical cutting (when electrical energy is applied to the tube 161 ).
  • a proximal end of the outer sheath 174 is rigidly coupled to the distal end 114 of housing 106 while conductive tube 161 is allowed to slide within the outer sheath 174.
  • the ceramic tip 170 may be rigidly coupled to the distal end of the outer sheath 170 such that movement of the conductive tube 161 may slide the distal end 182 of the electrode 180 passed the distal end of the ceramic tip 170.
  • the proximal end of the ceramic tip 170 may be configured to enable partial movement of the distal end of the conductive tube 161 into the ceramic tip 170 thus extending the electrode 180.
  • button 103 may be coupled to the proximal end of conductive tube 161 and configured to be slidable along the longitudinal axis of the housing 106 to move the conductive tube 161 to extend and retract the electrode 180.
  • Tubing 162 may stretchable (or include a predetermined length of slack) to allow movement of the conductive tube 161 .
  • a plasma generator handpiece or electrosurgical apparatus has a 360-degree tissue treatment area about the longitudinal axis of the distal tip.
  • Apparatus 300 includes a connector or plug 302, a housing 306, a shaft 308 including a distal tip 310, and an electrode disposed within the distal tip 310.
  • the housing 306 includes a proximal end 312 and distal end 314.
  • Shaft 308 includes the distal tip or end 310 and a proximal end 316 that is coupled to the distal end 314 of the housing 306.
  • the proximal end 312 of housing 306 includes first and second ports 318, 320.
  • First port 318 is configured to receive a first end 322 of cable 304.
  • a second end 324 of cable 304 is coupled to connector 302.
  • housing 306 includes a y-adapter 140 that includes a first input port 142, a second input port 144 and an output port 146.
  • First input port 142 is coupled to tube 148 that is disposed in cable 304.
  • Tube 148 includes a first end 150 that is coupled to the first input port 142 via check valve 150.
  • a second end (not shown) of tube 148 is coupled to port 130 in connector 302.
  • a flush tube 354 is provided including a first end 156 coupled to the second input port 144 of y-adapter 140 and a second end 158 coupled to a second check valve 360.
  • the output port 146 of y-adapter 140 is coupled to non-conductive shaft 308 of the presently-described embodiment.
  • the non-conductive shaft 308 terminates in distal end 310 which enables a 360 degree treatment area.
  • a gas flow path extends from the connector 302 to the distal end 310 of shaft 308.
  • y-adapter 140 is described as disposed in the housing 306, it is to be appreciated that y-adapter 140 may be positioned anywhere along the gas flow path, for example, in, connector 302, in cable 304, in shaft 308 and/or at distal tip 310. In one embodiment, the y-adapter may be disposed in an electrosurgical generator (ESU) supplying and/or controlling the gas to the connector 302.
  • ESU electrosurgical generator
  • FIGS. 13-16 a distal portion 310 of apparatus 300 is shown in accordance with an embodiment of the present disclosure, where FIG. 13 is a perspective view of the distal portion 310, FIG. 14 is a top view of distal tip 310, FIG. 15 is a side view of distal tip 310 and FIG. 16 is a cross-sectional view of the side view of distal tip 310 shown in FIG. 15.
  • Apparatus 300 includes an electrically conducting member or electrode 318 (shown in FIG. 16), e.g., a conductive rod, wire, or other suitable electrode, disposed through shaft 308.
  • a distal end of the electrically conducting member or electrode 318 is disposed in the distal tip 310 while a proximal end is disposed in the housing 306 and coupled to at least one conductor disposed in tube 304.
  • electrode 318 is made of tungsten, however, other suitable materials are contemplated to be within the scope of the present disclosure.
  • Shaft 308 is made of a non-conducting material and is configured to provide inert gas to tip 310.
  • Electrode 318 is configured to provide electrosurgical energy to tip 310.
  • shaft 308 is configured to enable a degree of flexibility (e.g., bending of shaft 308) to facilitate the insertion of tip 310 and shaft 308 through subdermal tissue during electrosurgical procedures performed with apparatus 300.
  • the shaft 308 may be configured from insulating or non- conductive materials.
  • Exemplary materials for the outer sheath may include, but are not limited to, polytetrafluoroethylene (PTFE), polyimide (PI), polyvinyl chloride (PVC), polyurethane, polyethylene, polyolefin, silicone, Ethylene tetrafluoroethylene (ETFE), Fluorinated ethylene propylene (FEP), polypropylene, high density polypropylene and PEEK (polyetheretherketone).
  • PTFE polytetrafluoroethylene
  • PI polyimide
  • PVC polyvinyl chloride
  • ETP Ethylene tetrafluoroethylene
  • FEP Fluorinated ethylene propylene
  • polypropylene high density polypropylene and PEEK (polyetheretherketone).
  • the shaft 308 is flexible and formable. This allows the user to “shape” the shaft 308 when a bend or curved shaft would be more
  • Tip 310 includes a distal end 330 and a proximal end 332.
  • Tip 310 includes at least one port 334A,334B disposed through a side wall of tip 310 and oriented in a radial direction traverse to axis 336.
  • Tip 310 further includes interior 338, which includes an inner wall 352A, 352B having a slot or channel 340.
  • Inner wall 352A, 352B is angled or slanted such that wall 352A, 352B transverses the longitudinal axis 336 at a predetermined angle.
  • tip 310 is disposed adjacent to shaft 308 and a tube 342 is disposed through the distal end of shaft 308 into the interior of shaft 308 and through the proximal end 332 of tip 310 into the interior 338 of tip 310.
  • An adhesive is used to bond the tube 342 to the interior of shaft 308 and the interior 338 of tip 310, thereby coupling tip 310 to shaft 308.
  • Tube 342 provides support to the connection or junction points between shaft 308 and tip 310 to prevent bending at the connection or junction point. It is to be appreciated that tube 342 may be made of conductive or non-conductive materials in various embodiments of the present disclosure.
  • electrode 318 extends from the interior of shaft 308 through tube 342 and interior 338.
  • a distal end 344 of electrode 318 is securely received by the slot 340 of interior 338 such that a distal portion electrode 318 is disposed adjacent to at least one port 334A, 334B.
  • Port 334A, 334B is disposed through a side wall of tip 310 such that port 334A, 334B is oriented in a radial direction with respect to axis 336.
  • Port 334A, 334B includes a curved surface 338 having a concavely rounded edge perimeter 346 disposed adjacent to the exterior walls of tip 310.
  • Distal end 330 of tip 310 includes an exterior surface or wall 348 shaped as an elliptic paraboloid or an elliptical cone with a blunted or rounded tip 350 converging toward distal end 330.
  • tip 310, wall 338, and edge 346 are shaped such that when tip 310 is moved through subcutaneous tissue, the curved surfaces 350, 338, 346 of tip 310 enable tip 310 to glide through the subcutaneous tissue with minimal resistance.
  • inert gas such as Helium
  • electrode 318 When inert gas, such as Helium, is provided through shaft 308 and into interior 338 and electrode 318 is energized, at least some of the inert gas is ionized and plasma is generated within interior 338 of tip 310.
  • Port 334A, 334B arcs about axis 336 at a predetermined arc length.
  • each port 334A, 334B arcs about axis 336 such that the arc length of each port 334A, 334B is slightly less than half the circumference of tip 310. It is to be appreciated that the arc length of each port 334A, 334B shown is merely exemplary and that other arc lengths are contemplated to be within the scope of the present disclosure.
  • Ports 334A, 334B are diametrically opposed with respect to axis 336, such that ports 334A, 334B are oriented in opposite directions.
  • the interior of tip 310 includes a wall having a first portion 352A and a second portion 352B.
  • the first portion 352A is angled to direct inert gas and plasma generated to exit via port 334A and the second portion 352B is angled to direct inert gas and plasma generated to exit via port 334B.
  • tip 310 may be configured such that gas and plasma exit both ports 334A, 334B simultaneously and tissue disposed various positions 360° about axis 336 exterior to tip 310 may be treated using apparatus 300.
  • the distal tip 310 may be flushed with, for example, sterile saline.
  • a source of sterile saline e.g. a syringe
  • check valve 360 is a one-way valve such that any fluid push into the valve toward the device 300 may not go in the reverse direction back to the source.
  • check valve 152 prevents any fluid (e.g., the sterile saline) from entering tube 148 and flowing to the ESU and/or any other gas source.
  • apparatuses 100,300 including button 103, 303 for controlling the electrosurgical energy and/or gas
  • one or more foot switches may be provided and coupled to the ESU for controlling the different modes of operation of apparatus 100,300, including the characteristics of a plasma beam emitted from tip 110,310.
  • communication signals are sent via a foot switch interface to ESU 12 to control the electrosurgical energy provided via ESU 12 to apparatus 100,300.
  • the foot switch interface is configured to control the mode of operation (e.g., cold plasma, coagulation, ablation, etc.) that apparatus 100,300 is in during a procedure.
  • additional foot switches may be included in foot switch interface for controlling the power provided by ESU 12 to apparatus 100, 300 and/or the gas provided by a gas supply (e.g., including in ESU 12) to apparatus 100,300.
  • the addition of the flush port to the apparatus of the present disclosure allows the apparatus or handpiece to be used for infiltration and/or fat transfer.
  • the apparatus may utilize the flush port to deliver tumescent anesthesia or fat to a patient through the apparatus or handpiece. In this way, the apparatus or handpiece of the present disclosure can serve two purposes: (i) plasma energy device and (ii) cannula for infiltration and fat transfer in body contouring procedures.
  • the system 400 includes apparatus 100, 300 coupled to an electrosurgical generator 412.
  • the electrosurgical generator 412 is also coupled to a gas source 414.
  • electrosurgical energy and a gas e.g., helium, is provided to apparatus 100, 300 via cable 404, as described above.
  • a gas flow path extends from the connector 402 to the distal end 1 10, 310 of shaft.
  • y-adapter is described above as being disposed in the housing, it is to be appreciated that y-adapter may be positioned anywhere along the gas flow path, for example, in, connector 402, in cable 404, in shaft 108, 308 and/or at distal tip 110, 310.
  • the y-adapter may be disposed in an electrosurgical generator (ESU) 412 supplying and/or controlling the gas to the connector 402.
  • ESU electrosurgical generator
  • the system 400 further includes a fat storage source 464 (e.g., a syringe, fat transfer canister, etc.), anesthesia source 466 and a saline source 468.
  • a fat storage source 464 e.g., a syringe, fat transfer canister, etc.
  • anesthesia source 466 and a saline source 468 may be coupled separately (and at different times) to apparatus 100, 300 via check valve 460 and flush line 454.
  • a fluid controller 462 is provided.
  • each of the fat storage source 464, anesthesia source 466 and a saline source 468 may be coupled as inputs to the fluid controller 462.
  • An output of the fluid controller 462 is then coupled to the apparatus 100, 330 via check valve 460 and flush line 454.
  • the fluid controller 462 may include at least one pump for facilitating the flow of a fluid from a respective source 464, 466, 468 to the apparatus 100, 300.
  • the at least one pump may be adjustable to a predetermined flow rate.
  • the fluid controller 462 is coupled to the electrosurgical generator 412 via two-way communication connection 472.
  • the fluid controller 462 and the at least one pump may be controlled via signals transmitted from the electrosurgical generator 412. For example, based on a procedure selected by a user via a user interface disposed on the electrosurgical generator 412, the electrosurgical generator 412 may generate an appropriate signal to select a source, e.g., source 464, 466, 468, to be fed to apparatus 100, 300. It is to be appreciated that in one embodiment, the electrosurgical generator 412 and fluid controller 462 may be disposed in a single housing.
  • the system 400 includes an ultrasonic handpiece 470 and fat aspiration system 469 that emulsifies and/or removes fat from a subdermal tissue plane of a patient 476.
  • the fat aspiration system 469 is coupled to the fat storage source 464, where fat aspirated by the fat aspiration system 469 is transferred from the patient 476 to the fat storage source 464.
  • a method 500 for body contouring in accordance with an embodiment of present disclosure is illustrated. Initially, apparatus 100, 300 is coupled to electrosurgical generator 412 via cable 404 and connector 402. Then, the apparatus 100, 300 is coupled to the anesthesia source 466 via flush line 454 and check valve 460.
  • the apparatus 100, 300 is coupled to the anesthesia source 466 via the fluid controller 462; and in a different embodiment, the apparatus 100, 300 is coupled to the anesthesia source 466 without the fluid controller 462.
  • the distal tip 1 10, 310 is disposed in a subdermal tissue plane of a patient 476 and is injected with tumescent anesthesia as provided from source 466 to control bleeding and reduce pain. This step is also referred to as infiltration.
  • an ultrasonic handpiece 470 is disposed in the subdermal tissue plane to emulsify fat in the subdermal tissue plane, e.g., via ultrasonic assisted liposuction.
  • the emulsified fat is then aspirated or removed from the subdermal tissue plane, in step 506.
  • the emulsified fat is removed via a separate suction device 471 coupled to the fat aspiration system 469.
  • the aspirated fat may then be transferred using the fat aspiration system 469 to the fat storage source 464.
  • step 508 electrosurgical energy and gas is provided to the apparatus 100, 300 via cable 404 and plasma is generated at the distal tip 1 10, 310 and applied in the subdermal tissue plane.
  • the aspirated fat is processed for reinjection into the patient, in step 510.
  • step 512 the processed fat is transferred into the patient 476 in areas where the patient desires to have more volume.
  • the apparatus 100, 300 is coupled to the fat storage source 464 via flush line 454 and check valve 460.
  • the apparatus 100, 300 is coupled to the fat storage source 464 via the fluid controller 462; and in a different embodiment, the apparatus 100, 300 is coupled to the fat storage source 464 without the fluid controller 462.
  • the defined steps may be carried out in any order, in less than the defined steps or simultaneously (except where the context excludes that possibility), and the method can include one or more other steps which are carried out before any of the defined steps, between two of the defined steps, or after all the defined steps (except where the context excludes that possibility).
  • the method may include the infiltration step 502, the aspirating step 506, the application of plasma step 508 and the transferring of fat step 512.
  • the emulsifying fat step 504 and processing fat step 410 may either be: 1 .) not performed at all, 2.) performed at different times in relation to steps 502, 506, 508, 512 as shown in FIG. 18 or 3.) performed after steps 502, 506, 508 512 are completed.
  • ESU 12 may include controls for controlling the electrosurgical energy and/or gas provided to apparatus 100, 300 and foot switch interface may be removed.
  • ESU 12 may include an input/output interface disposed on a housing of the ESU 12 for inputting information into the ESU and displaying information to a user.
  • the input/output interface may include, for example, buttons, pushbuttons, dials, etc. for entering parameters into the ESU 12.
  • the ESU 12 may include a touchscreen which enables both entering and displaying of information.
  • block diagrams and flowchart illustrations depict methods, apparatuses (i.e., systems), and computer program products.
  • Any and all such functions (“depicted functions”) can be implemented by computer program instructions; by special-purpose, hardware- based computer systems; by combinations of special purpose hardware and computer instructions; by combinations of general- purpose hardware and computer instructions; and so on - any and all of which may be generally referred to herein as a “circuit,” “module,” “controller” or “system.”

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Abstract

La divulgation porte sur un appareil électrochirurgical. L'appareil électrochirurgical de la présente divulgation comprend un connecteur, un boîtier, une tige et une pointe distale. Le connecteur est conçu pour être accouplé à un générateur électrochirurgical et à une alimentation en gaz. L'appareil électrochirurgical est conçu pour fournir de l'énergie électrochirurgicale et du gaz inerte à une électrode à l'intérieur de la pointe distale de l'appareil électrochirurgical, afin de générer un faisceau de plasma pour coaguler/contracter un tissu selon les besoins. Le boîtier de l'appareil électrochirurgical comprend un orifice de rinçage destiné à recevoir un fluide, par exemple une solution saline, servant à rincer et/ou éliminer des débris dans ou autour de la pointe distale, et/ou recevoir un fluide différent, par exemple, une anesthésie tumescente, à fournir à un site chirurgical par l'intermédiaire de la pointe distale. Dans certains modes de réalisation, la tige est souple et malléable pour permettre à un utilisateur de modeler la tige autour d'emplacements anatomiques étroits.
PCT/US2024/036993 2023-10-02 2024-07-08 Appareil électrochirurgical à orifice de rinçage Pending WO2025075690A1 (fr)

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US7011644B1 (en) * 1995-02-06 2006-03-14 Andrew Mark S Tissue liquefaction and aspiration for dental treatment
US20090088775A1 (en) * 2007-09-30 2009-04-02 Nitish Swarup Methods of user interface with alternate tool mode for robotic surgical tools
US7717129B2 (en) * 2006-09-18 2010-05-18 Alcon, Inc. Automatic stop cock valve
US20100228182A1 (en) * 2005-09-07 2010-09-09 Cabochon Aesthetics, Inc. Dissection handpiece and method for reducing the appearance of cellulite
US20110112520A1 (en) * 2009-11-11 2011-05-12 Invasix Corporation Method and device for fat treatment
KR20150011346A (ko) * 2012-04-06 2015-01-30 안타레스 팔마, 인코퍼레이티드 테스토스테론 조성물의 바늘-보조식 젯 주입 투여 장치 및 방법
US10010693B2 (en) * 2011-06-28 2018-07-03 Fisher & Paykel Healthcare Limited Medical tubing
US20190380766A1 (en) * 2018-06-14 2019-12-19 Apyx Medical Corporation Devices, systems and methods for subdermal coagulation
CN214049987U (zh) * 2020-11-23 2021-08-27 中国人民解放军联勤保障部队第九0四医院 一种电动术中用盐水吸引冲洗器
US20230093858A1 (en) * 2020-02-26 2023-03-30 Apyx Medical Corporation Electrosurgical apparatus with flexible shaft

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7011644B1 (en) * 1995-02-06 2006-03-14 Andrew Mark S Tissue liquefaction and aspiration for dental treatment
US20100228182A1 (en) * 2005-09-07 2010-09-09 Cabochon Aesthetics, Inc. Dissection handpiece and method for reducing the appearance of cellulite
US7717129B2 (en) * 2006-09-18 2010-05-18 Alcon, Inc. Automatic stop cock valve
US20090088775A1 (en) * 2007-09-30 2009-04-02 Nitish Swarup Methods of user interface with alternate tool mode for robotic surgical tools
US20110112520A1 (en) * 2009-11-11 2011-05-12 Invasix Corporation Method and device for fat treatment
US10010693B2 (en) * 2011-06-28 2018-07-03 Fisher & Paykel Healthcare Limited Medical tubing
KR20150011346A (ko) * 2012-04-06 2015-01-30 안타레스 팔마, 인코퍼레이티드 테스토스테론 조성물의 바늘-보조식 젯 주입 투여 장치 및 방법
US20190380766A1 (en) * 2018-06-14 2019-12-19 Apyx Medical Corporation Devices, systems and methods for subdermal coagulation
US20230093858A1 (en) * 2020-02-26 2023-03-30 Apyx Medical Corporation Electrosurgical apparatus with flexible shaft
CN214049987U (zh) * 2020-11-23 2021-08-27 中国人民解放军联勤保障部队第九0四医院 一种电动术中用盐水吸引冲洗器

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