WO2024137986A1 - Bistouri électrique bipolaire - Google Patents

Bistouri électrique bipolaire Download PDF

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Publication number
WO2024137986A1
WO2024137986A1 PCT/US2023/085429 US2023085429W WO2024137986A1 WO 2024137986 A1 WO2024137986 A1 WO 2024137986A1 US 2023085429 W US2023085429 W US 2023085429W WO 2024137986 A1 WO2024137986 A1 WO 2024137986A1
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WO
WIPO (PCT)
Prior art keywords
electrode
inner electrode
surgical instrument
electrosurgical
intermediate insulation
Prior art date
Application number
PCT/US2023/085429
Other languages
English (en)
Inventor
Bryan Antonio CONTRERAS-MORA
Jacob TONKEL
Kevin Christopher FELT
Marko BINDREITER
Aaron Germain
Michael D. Walker
Guliano GRILLI
Jan Echeverry
Original Assignee
Biomet Manufacturing, Llc
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 Biomet Manufacturing, Llc filed Critical Biomet Manufacturing, Llc
Publication of WO2024137986A1 publication Critical patent/WO2024137986A1/fr

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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
    • A61B18/1477—Needle-like probes
    • 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
    • A61B18/1402—Probes for open surgery
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • 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
    • A61B2018/00589—Coagulation
    • 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
    • A61B2018/00595—Cauterization
    • 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
    • A61B2018/00601—Cutting
    • 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
    • A61B2018/00607—Coagulation and cutting with the same instrument
    • 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
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/00922—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device by switching or controlling the treatment energy directly within the hand-piece
    • 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
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/00958—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device for switching between different working modes of the main function
    • 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
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • 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

Definitions

  • the present disclosure is generally directed to, but not by way of limitation, systems, devices and methods relating to electrosurgery. More specifically, the present application is directed to electrosurgical device having two poles.
  • Electrosurgery is a surgical technique that uses high-frequency electrical current to cut, coagulate, desiccate, and fulgurate tissue. There is ongoing effort to improve electrosurgery techniques and electrosurgical devices.
  • Electrosurgery is a surgical technique that uses high-frequency electrical current to cut, coagulate, desiccate, and fulgurate tissue. Electrosurgery has several advantages over traditional surgery, including the ability to precisely control the amount of tissue destruction, the ability to coagulate blood vessels to minimize bleeding, and the ability to reduce the amount of thermal injury to surrounding tissue. However, electrosurgery also has some limitations, such as the potential for electrical burns or tissue charring, and the risk of electrical interference with pacemakers and other electronic devices. There are several different types of electrosurgery, such as monopolar electrosurgery and bipolar electrosurgery.
  • Monopolar electrosurgery may be used during open surgery to remove or seal off areas of tissue, such as during a biopsy or to control bleeding.
  • the electrical current can be delivered through a handheld device called an electrocautery pen, a monopolar forceps, or a monopolar pencil. The current can return to the electrosurgical generator via a grounding pad placed on the patient’s skin.
  • Monopolar electrosurgery has several benefits, including its ability to quickly and effectively cut or coagulate tissue with minimal blood loss. However, monopolar electrosurgery also may have some potential drawbacks, including the risk of electrical current passing through unintended areas of the body and the risk of thermal injury to surrounding tissue.
  • monopolar electrosurgery Another drawback of monopolar electrosurgery is lateral thermal spread.
  • the device can undesirably heat tissue surrounding the active electrode.
  • Monopolar devices can generate more heat during coagulation than comparable bipolar devices and ultrasonic devices. Thus, careful operation of the device is called for.
  • the active electrode can touch a structure with a narrow pedicle or a narrow band of adhesion.
  • the increased current density at that remote narrow area can cause an unintended burn.
  • the use of monopolar devices can be avoided in these areas, thereby limiting their use.
  • the present subject matter can provide solutions to these and other problems, such as by providing bipolar electrosurgical systems, devices and methods.
  • Bipolar electrosurgery is similar to monopolar electrosurgery in that there are two electrodes. However, both electrodes can be located on the instrument itself rather than having one electrode remote from the instrument, such as a pad grounded on the skin of the patient. In conventional bipolar surgery, the electrical current can be delivered through a pair of small, insulated jaws on a forceps. Bipolar electrosurgery can have several advantages compared to monopolar electrosurgery.
  • An advantage of bipolar surgery can be a reduced risk of electrical current passing through the body of the patient. For example, because the electrical current is contained within the bipolar forceps and may not pass through the body, there is a lower risk of electrical current passing through unintended areas of the body, which can minimize the risk of tissue damage or other complications.
  • Another advantage can be a reduced risk of thermal injury.
  • the electrical current used in bipolar electrosurgery may be less likely to cause thermal injury to the surrounding tissue, as it is more contained within the bipolar forceps. This makes it a safer option for use near sensitive structures such as nerves or blood vessels.
  • bipolar electrosurgery can be well-suited for use in laparoscopic surgery, as the electrical current is contained within the laparoscopic instruments and may not pass through the abdominal wall.
  • Another advantage can be better control over an area that is targeted, which can help prevent damage to other sensitive tissues.
  • Another advantage can be a reduced risk of patient burns.
  • Another advantage can be a suitability for use in patients having implanted devices.
  • the containment of the electrical current can help prevent a short- circuit or a misfire of the implanted device.
  • existing bipolar devices may provide coagulation abilities, but may not be able to provide the cutting of tissue.
  • the bipolar device of the present disclosure can provide cutting of tissue.
  • the bipolar devices of the present disclosure can provide better access to pathology than existing bipolar devices.
  • the bipolar devices of the present disclosure can provide significant ablation and cutting performance improvements over existing bipolar devices.
  • the electrosurgical bipolar pencils of the present disclosure can include a needlelike active inner electrode that is insulated by ceramic and a return electrode that surrounds the ceramic.
  • the active inner electrode and the return electrode can be connected inside a handle.
  • the handle can direct the active inner electrode and the return electrode to a radiofrequency (RF) generator.
  • RF radiofrequency
  • the ergonomic configuration, e.g., the appearance and shape, of the electrosurgical bipolar pencil can be similar to that of a pen, e.g., a conventional monopolar electrosurgical pen.
  • the return electrode can comprise a dome shape at the end of the electrosurgical bipolar pencil to facilitate contact with tissue surrounding the inner electrode.
  • the electrosurgical bipolar pencil can allow for the active inner electrode or the outer electrode to reciprocate in a manner that provides appropriate surface area contact for the active inner electrode and the return electrode.
  • the shapes and positions of the inner electrode and the outer electrode can facilitate plasma formation at the inner electrode using a low amount of electrical energy.
  • an electrosurgical bipolar surgical instrument can comprise an elongate shaft extending along a central axis between a proximal end portion and a distal end portion, an outer electrode extending from the distal end portion, an inner electrode extending from within the elongate shaft into the outer electrode, and an intermediate insulation member disposed between outer electrode and the inner electrode.
  • FIG. 1 is a perspective view of a electrosurgical bipolar pencil comprising an outer dome electrode, an intermediate insulation layer and an inner electrode pin, the single-use electrosurgical bipolar pencil configured for direct connection to a generator and footswitch or for standalone use.
  • FIG. 2A is a perspective view of an electrosurgical bipolar pencil comprising an outer dome electrode, an intermediate insulation layer and an inner electrode pin, the electrosurgical bipolar pencil configured to have a single-use disposable tip for use with a reusable handpiece and connection to a generator and a footswitch.
  • FIG. 2B is a close-up view of a tip assembly of the electrosurgical bipolar pencil of FIG. 2A showing the outer dome electrode, the intermediate insulation layer and the inner electrode pin.
  • FIG. 3A is a perspective front end view of an electrosurgical bipolar pencil comprising a shaft, an outer dome electrode, an intermediate insulation layer and a stationary inner electrode.
  • FIG. 3B is a side cross-sectional view of the electrosurgical bipolar pencil of FIG. 3A.
  • FIG. 4A is a side schematic view of the electrosurgical bipolar pencil of FIG. 3 A with the stationary inner electrode positioned to be spaced from tissue.
  • FIG. 4B is a side schematic view of the electrosurgical bipolar pencil of FIG. 3 A with the stationary inner electrode positioned to be inserted into tissue.
  • FIG. 5A is a perspective side view of an electrosurgical bipolar pencil comprising a shaft, an outer dome electrode, an intermediate insulation layer and a moveable inner electrode in an extended state.
  • FIG. 5B is a perspective side view of the electrosurgical bipolar pencil of FIG. 5 A with the moveable inner electrode in a retracted state.
  • FIG. 6A is a perspective cross-sectional view of an electrosurgical bipolar pencil comprising a shaft, an outer dome electrode, an intermediate insulation layer and a moveable inner electrode in an extended state.
  • FIG. 6B is a perspective cross-sectional view of the electrosurgical bipolar pencil of FIG. 6A with the moveable inner electrode in an retracted state.
  • FIG. 7A is a side cross-sectional view of the electrosurgical bipolar pencil of FIG. 5A - FIG. 6B in an extended state relative to tissue.
  • FIG. 7B is a side cross-sectional view of the electrosurgical bipolar pencil of FIG. 5A - FIG. 6B in a retracted state relative to tissue.
  • FIG. 8A a side perspective view of an electrosurgical bipolar pencil having a moveable outer dome electrode in an extended state.
  • FIG. 8B a side perspective view of an electrosurgical bipolar pencil having a moveable outer dome electrode in a retracted state.
  • FIG. 9 is a side cross-sectional view of the electrosurgical bipolar pencil of FIG. 8A and FIG. 8B showing a spring mechanism connecting the outer dome electrode to a shaft.
  • FIG. 10A is a side view of the electrosurgical bipolar pencil of FIG. 8A and FIG. 8B with the moveable outer dome electrode in an extended state relative to tissue.
  • FIG. 10B is a side view of the electrosurgical bipolar pencil of FIG. 8 A and FIG. 8B with the moveable outer dome electrode in a retracted state relative to tissue.
  • FIG. 11 A is a perspective side view of an electrosurgical bipolar pencil comprising a shaft, an outer dome electrode, an intermediate insulation layer and a reciprocating inner electrode in an extended state.
  • FIG. 1 IB is a perspective side view of the electrosurgical bipolar pencil of FIG.
  • FIG. 12A is a perspective cross-sectional view of an electrosurgical bipolar pencil comprising a shaft, an outer dome electrode, an intermediate insulation layer and a reciprocating inner electrode in an extended state.
  • FIG. 12B is a perspective cross-sectional view of the electrosurgical bipolar pencil of FIG. 12A with the reciprocating inner electrode in a retracted state.
  • FIG. 13A is a side cross-sectional view of a reciprocating mechanism for the electrosurgical bipolar pencil of FIG. 11A - FIG. 12B with a drive shaft in a retracted state.
  • FIG. 13B is a side cross-sectional view of the reciprocating mechanism of FIG.
  • FIG. 14 is a side cross-sectional view of a reciprocating mechanism suitable for use with the electrosurgical bipolar pencil of FIG. 11A - FIG. 12B.
  • FIG. 15 A is an end view of an electrosurgical bipolar pencil comprising an outer dome electrode, an intermediate insulation layer and a moveable inner electrode having a pin tip.
  • FIG. 15B is a side view of the electrosurgical bipolar pencil of FIG. 15 A showing the pin tip extended beyond the outer dome electrode.
  • FIG. 1 is a perspective view of electrosurgical pencil 100 in a standalone configuration.
  • Electrosurgical pencil 100 can comprise handpiece 102, shaft 104 and tip 106.
  • Handpiece 102 can include button 108A, button 108B and button 108C.
  • Tip 106 can comprise outer dome electrode 110, intermediate insulation layer 112 and inner electrode pin 114.
  • Electrosurgical pencil 100 can be configured as a disposable device using less expensive components compared to reusable devices. Disposable devices can have advantages over reusable devices due to, for example, the avoidance of having to clean, sanitize and sterilize the device, thereby eliminating the risk of contamination and infection associated with reused devices.
  • Electrosurgical pencil 100 can comprise a device configured to emit electrical energy to cut and resect tissue.
  • electrosurgical pencil 100 can comprise a self-contained device including battery 116 within handpiece 102 to deliver electrical energy to inner electrode pin 114 of tip 106.
  • handpiece 102 can include electric motor 118 to produce rotational shaft power suitable for use with reciprocating mechanism 560 of FIG. 13A and FIG. 13B and reciprocating mechanism 600 of FIG.14.
  • electrosurgical pencil 100 can be configured to be attached to generator 152 of FIG. 2 using appropriate wiring and cables, and can thus optionally not include an internal battery.
  • Button 108A can be used to activate the electrical energy at tip 106, such as by comprising an on/off switch.
  • Button 108A and button 108C can be used to control the function, e.g., waveform, and magnitude, e.g., voltage, of the electrical energy delivered to tip 106, respectively.
  • electrical energy can be delivered to inner electrode pin 114, passed through tissue when tip 106 is engaged with tissue, and return back to electrosurgical pencil 100 at outer dome electrode 110.
  • electrosurgical pencil 100 can comprise an electrosurgical bipolar pencil.
  • Intermediate insulation layer 112 can be used to electrically isolate inner electrode pin 114 from outer dome electrode 110.
  • the distal tip of inner electrode pin 114 can extend distally beyond intermediate insulation layer 112 in an axial direction to contact target tissue.
  • Outer dome electrode 110 can contact tissue surrounding the target tissue.
  • tip 106 can be configured as a removable tip such that tip 106 can be disposable and the remaining portions of electrosurgical pencil 100 can be reused.
  • tip 106 can be constructed according to any of the examples described herein.
  • tip 106 can be configured so that inner electrode pin 114 is fixed, inner electrode pin 114 is spring loaded, inner electrode pin 114 reciprocates, outer dome electrode 110 is fixed, outer dome electrode 110 is spring loaded, or outer dome electrode 110 reciprocates.
  • FIG. 2A is a perspective view of electrosurgical pencil 150 for use with a surgical system.
  • Electrosurgical pencil 150 can be used with generator 152 and footswitch system 154.
  • Generator 152 can include fluid inputs at manifold 156.
  • Electrosurgical pencil 150 can be configured as a disposable device using less expensive components compared to reusable devices.
  • Generator 152 and footswitch system 154 can be configured as reusable components.
  • Components of FIG. 2A are not necessarily drawn to scale relative to each other.
  • tip 176 can be configured as a removable tip such that tip 176 can be disposable and the remaining portions of electrosurgical pencil 150 can be reused.
  • Footswitch system 154 can be connected to generator 152 via cable 160 and generator 152 can be connected to electrosurgical pencil 150 via cable 162 and handpiece 163. Footswitch system 154 can be configured to control operations of manifold 156 and electrosurgical pencil 150. Fluid lines 164 for input and output of a fluid connect manifold 156 to a source of pressurized fluid (not illustrated). Suction lines 166 for input and output of suction connect manifold 156 to a vacuum source (not illustrated).
  • Footswitch system 154 can include pedal 168A for controlling a first function of electrosurgical pencil 150, such as a cutting function, pedal 168B for controlling a second function of electrosurgical pencil 150, such as coagulation, and pedal 168C for controlling a third function of manifold 156, such as flush. Footswitch system 154 can include switch 170A for controlling a fourth function of electrosurgical pencil 150, such as a cutting mode, switch 170B for controlling a fifth function of electrosurgical pencil 150, such as flow, and switch 170C for controlling a sixth function of manifold 156, such as mode.
  • Electrosurgical pencil 150 can include plug 172, shaft 174 and tip 176. Plug 172 of electrosurgical pencil 150 can be inserted into socket 178 of handpiece 163. Electrical contacts on plug 172 can be linked with mating electrical contacts within socket 178 to allow electrical power from generator 152 to travel to tip 176.
  • FIG. 2B is a close-up view of tip 176 of electrosurgical pencil 150 of FIG. 2A showing outer dome electrode 180, intermediate insulation layer 182 and inner electrode pin 184. Details of tip 176 are discussed below. Specifically, tip 176 can be constructed according to any of the examples described herein. For example, tip 176 can be configured so that inner electrode pin 184 is fixed, inner electrode pin 184 is spring loaded, inner electrode pin 184 reciprocates, outer dome electrode 180 is fixed, outer dome electrode 180 is spring loaded, or outer dome electrode 180 reciprocates. As described herein, electrical energy can be delivered to inner electrode pin 184, passed through tissue when tip 176 is engaged with tissue, and return back to electrosurgical pencil 150 at outer dome electrode 180.
  • electrosurgical pencil 150 can comprise an electrosurgical bipolar pencil.
  • FIG. 3A is a perspective front end view of electrosurgical pencil 200 comprising tip assembly 202 and shaft 204.
  • FIG. 3B is a side cross-sectional view of electrosurgical pencil 200 of FIG. 3 A.
  • FIG. 3 A and FIG. 3B are discussed concurrently.
  • tip assembly 202 can be used with shaft 104 and shaft 174 of FIG. 1 and FIG. 2A, respectively.
  • Tip assembly 202 can comprise outer dome electrode 206, intermediate insulation layer 210 and inner electrode 212.
  • inner electrode 212 can comprise a stationary electrode configured to extend from intermediate insulation layer 210 a fixed distance along axis AA.
  • Shaft 204 can comprise a tubular body 214 to which outer dome electrode 206 can be attached.
  • Tubular body 214 can be covered by sheath 216 on the exterior and can include passage 218 (FIG. 3B) on the interior.
  • Outer dome electrode 206 can comprise tubular body 220 having an internal passage 222 (FIG. 3B) coaxially aligned with passage 218 of shaft 204.
  • tubular body 220 can comprise a monolithic body.
  • the distal section of tubular body including outer surface 224 can be separated from a proximal section.
  • the distal portion can be attached to the proximal portion by any suitable connects, such as an interference fit type connection, the use of fasteners, such as set screws, or via the use of a detent mechanism.
  • a separable distal portion of insulation layer 210 can be attached to the removable portion of tubular body 220 so the two components can be attached and removed together.
  • Outer dome electrode 206 can include outer surface 224 and end face 226.
  • Internal passage 222 of outer dome electrode 206 can receive intermediate insulation layer 210.
  • Intermediate insulation layer 210 can comprise cylindrical body 228 having end face 230 and internal passage 232 (FIG. 3B).
  • Inner electrode 212 can be disposed within internal passage 232 and can comprise elongate shaft 234 and pointed tip 236. In the example of FIG.
  • inner electrode 212 can be fixed in place within internal passage 232 such that pointed tip 236 is fixed outside of intermediate insulation layer 210.
  • inner electrode 212 can be held in place via an interference fit with internal passage 232.
  • inner electrode 212 can be metallurgically bonded in place via welding or soldering.
  • inner electrode 212 can be held in place mechanically via fasteners, such as a set screw. As such, the set screw can be accessible from an exterior of electrosurgical pencil 200 so that the distance that pointed tip 236 extends beyond end face 226 can be adjusted by a user.
  • Shaft 204 can extend proximally to connect to a handpiece as described herein.
  • Shaft 204 can be hollow and can include conductors for delivering electrical current from an electrical generator (e.g., battery 116 of FIG. 1 or generator 152 of FIG. 2A) to inner electrode 212 and receiving current from outer dome electrode 206, or vice versa.
  • Tubular body 214 can have an outer cross-sectional shape to facilitate insertion into tissue, to provide internal space within for the components of electrosurgical pencil 200, and to provide strength to shaft 204.
  • tubular body 214 can have a cross-sectional profile that is circular, triangular, rectangular or square.
  • tubular body 214 have a rounded pyramidal shape with three planar surfaces joined by three rounded edge surfaces.
  • Tubular body 214 can provide a support for or can be integral or monolithic with outer dome electrode 206, as discussed below.
  • Tubular body 214 can be made of various materials to provide desirable structural support and electrical conducting properties.
  • tubular body 214 can be conductive.
  • tubular body 214 is separate from outer dome electrode 206, tubular body 214 can be insulative.
  • tubular body 214 can be fabricated from steel, stainless steel alloys, aluminum, aluminum alloys, other metals and metal alloys, ceramic, glass, fiberglass, plastics, polymers and other materials.
  • Tubular body 214 can be covered by sheath 216 to provide electrical isolation, e.g., to prevent current from leaving or entering tubular body 214.
  • sheath 216 can comprise a polymeric heat shrink wrap. Sheath 216 can be omitted in examples, such as when tubular body 214 is separate from outer dome electrode 206.
  • Inner electrode 212 can extend proximally from what is shown in FIG. 3B to connect to wiring or other appropriate connectors that can be put in communication with an electrical power source, such as battery 116 (FIG. 1) or generator 152 (FIG. 2A).
  • Inner electrode 212 can be covered with sheath 244 within tubular body 214 to provide electrical isolation.
  • sheath 244 can comprise a polymeric heat shrink wrap.
  • Inner electrode 212 can be exposed distal of tubular body 214, or at some other delineating mark, to allow electrical energy to exit or pass through inner electrode 212.
  • Portions of inner electrode 212 not covered by sheath 244, and proximal of end face 230, can be surrounded by intermediate insulation layer 210.
  • Pointed tip 236 can be exposed, e.g., not covered by sheath 244 and not surrounded by intermediate insulation layer 210 or outer dome electrode 206.
  • Inner electrode 212 can be fabricated of various conducting materials, such as steel, aluminum, copper, alloys thereof and the like.
  • Elongate shaft 234 can comprise a cylindrical body and pointed tip 236 can comprise a conical body.
  • elongate shaft 234 can comprise a monolithic body.
  • the distal section of elongate shaft 234 including pointed tip 236 can be separated from a proximal section.
  • elongate shaft 234 can comprise a step at the end of sheath 244. However, such a step can be omitted.
  • Elongate shaft 234 can extend through passage 218 of tubular body 214 and internal passage 222 of outer dome electrode 206.
  • elongate shaft 234 can extend through internal passage 232 intermediate insulation layer 210.
  • passage 218, internal passage 222, internal passage 232 and elongate shaft 234 can be coaxial along longitudinal axis AA. However, elongate shaft 234 can be offset from longitudinal axis AA.
  • the distal end of the cylindrical body comprising elongate shaft 234 can be located approximately at end face 230 such that the base of the cone that forms pointed tip 236 at the juncture of the cylindrical body can be approximately flush with end face 230.
  • end face 230 can be recessed into outer dome electrode 206 relative to end face 226.
  • all of the tapering of pointed tip 236 can be located outside of cylindrical body 228 of intermediate insulation layer 210.
  • the base of the cone that forms pointed tip 236 can be positioned within internal passage 232 or further out of internal passage 232. The shape of pointed tip 236 is discussed in greater detail below.
  • Intermediate insulation layer 210 can be positioned between inner electrode 212 and outer dome electrode 206 to prevent electrical conductivity therebetween.
  • intermediate insulation layer 210 can be fabricated of an insulating material, such as ceramic, glass, plastic, fiberglass, wood and the like, to prevent electrical contact between inner electrode 212 and outer dome electrode 206.
  • intermediate insulation layer 210 is fabricated from ceramic to provide sufficient insulating capabilities for the current and power typically associated with electrosurgical devices.
  • Cylindrical body 228 of intermediate insulation layer 210 can surround elongate shaft 234 within internal passage 222 of outer dome electrode 206 and partially within passage 218 of tubular body 214 of shaft 204. Cylindrical body 228 can stabilize elongate shaft 234 to prevent or inhibit radial movement relative to longitudinal axis AA.
  • Cylindrical body 228 can be connected to, or integral with, enlarged cylindrical portion 238.
  • Enlarged cylindrical portion 238 can be positioned within passage 218 of tubular body 214 of shaft 204.
  • Enlarged cylindrical portion 238 can be positioned against ledge 240 of tubular body 220 of outer dome electrode 206.
  • Intermediate insulation layer 210 can be held in place within passage 218 via flange 242 of shaft 204.
  • Enlarged cylindrical portion 238 can stabilize inner electrode 212 within passage 218 to prevent radial movement relative to longitudinal axis AA.
  • cylindrical body 228 be configured to separate from enlarged cylindrical portion 238.
  • cylindrical body 228 can simply abut enlarged cylindrical body 228 and can be held in place by engagement of tubular body 220 with tubular body 214, or can be inserted into a socket within enlarged cylindrical body.
  • Outer dome electrode 206 can extend from tubular body 214.
  • outer dome electrode 206 can be integral or monolithic with tubular body 214 to form an extension of tubular body 214.
  • outer dome electrode 206 can be attached to tubular body 214, such as via a threaded connection, a welded connection or fasteners.
  • Outer dome electrode 206 can be fabricated from a conducting material, such as stainless steel, aluminum, copper, alloys thereof or the like.
  • Outer dome electrode 206 can be connected to wiring or other appropriate connectors that can be put in communication with an electrical power source, such as battery 116 (FIG. 1) or generator 152 (FIG. 2A).
  • Outer dome electrode 206 can have a shape configured to facilitate generation of a large contact surface area with tissue when tip assembly 202 is pushed into engagement with tissue.
  • outer dome electrode 206 can have a conical shape that is truncated to form end face 226.
  • outer dome electrode 206 can have circular cross-sectional profiles of decreasing diameter between tubular body 214 and end face 226.
  • outer dome electrode 206 can have a pyramidal shape.
  • outer dome electrode 206 can have triangular cross-sectional profiles of decreasing diameter between tubular body 214 and end face 226.
  • outer dome electrode 206 can have a rounded pyramidal shape with three planar surfaces joined by three rounded edge surfaces.
  • the three-planar surfaces can have parabolic shapes, as shown in FIG. 3B.
  • tissue can engage the facets of outer dome electrode 206 to form good electrical contact, such as to allow current exiting inner electrode 212 to pass through the tissue and return to outer dome electrode 206.
  • the facets also provide large surface areas to contact the anatomy.
  • FIG. 4A is a side schematic view of electrosurgical pencil 200 of FIG. 3B with inner electrode 212 positioned spaced from tissue 250.
  • FIG. 4B is a side schematic view of electrosurgical pencil 200 of FIG. 4B with inner electrode 212 positioned inserted into tissue 250.
  • electrosurgical pencil 200 can be inserted into anatomy and guided toward target tissue to be treated with electrotherapy, e.g., cauterizing, cutting and the like. Electrosurgical pencil 200 can be configured to not provide electrical output to inner electrode 212 while being navigated to the target tissue, such as by not depressing button 108A (FIG. 1). The target tissue can typically be surrounded by other tissue that may or may not be treated. Outer dome electrode 206 can push the surrounding tissue away from pointed tip 236 until a surgeon or user is ready to engage pointed tip 236 with target tissue. Once at the site of the target tissue within the anatomy, pointed tip 236 can be pressed into the target tissue to perform the treatment.
  • electrotherapy e.g., cauterizing, cutting and the like.
  • Electrosurgical pencil 200 can be configured to not provide electrical output to inner electrode 212 while being navigated to the target tissue, such as by not depressing button 108A (FIG. 1).
  • the target tissue can typically be surrounded by other tissue that may or may not be treated.
  • pointed tip 236 Electrical activation of pointed tip 236 can be performed, such as by depressing button 108 A, before, during or after insertion of pointed tip 236 into the target tissue.
  • Current can flow out of pointed tip 236, into tissue 250 and then return to outer dome electrode 206.
  • the pointed shape of pointed tip 236 can focus the output of electric current emanating from pointed tip 236 to a focused area.
  • a greater amount of electrosurgical power e.g., cauterizing power, cutting power, ablating power, etc.
  • Surfaces of outer dome electrode 206 can be positioned in close proximity to pointed tip 236 to provide a short path for the return of electrical current to electrosurgical pencil 200.
  • end face 226 can separated from inner electrode 212 by the thickness of intermediate insulation layer 210.
  • other electricity proximate inner electrode 212 such as stray current from inner electrode 212, can be collected for return to electrosurgical pencil 200.
  • the ratio of the surface area of outer dome electrode 206 in contact with tissue to the surface area of inner electrode 212 in contact with tissue is high, thereby facilitating cutting at inner electrode 212 and dissipation at outer dome electrode 206. Further description of pointed tip 236, intermediate insulation layer 210 and outer dome electrode 206 is provided below with reference to FIG. 15A and FIG. 15B.
  • FIG. 5 A is a perspective side view of electrosurgical pencil 300 comprising shaft 302 and tip assembly 304 in an extended state.
  • FIG. 5B is a perspective side view of electrosurgical pencil 300 comprising a shaft 302 and tip assembly 304 in a retracted state.
  • Tip assembly 304 can comprise outer dome electrode 306, intermediate insulation layer 308 and moveable inner electrode 310.
  • FIG. 6A is a perspective cross-sectional view of electrosurgical pencil 300 of FIG. 5 A with moveable inner electrode 310 in an extended state.
  • FIG. 6B is a perspective cross-sectional view of electrosurgical pencil 300 of FIG. 6A with moveable inner electrode 310 in a retracted state.
  • FIG. 5 A - FIG. 6B are discussed concurrently.
  • moveable inner electrode 310 can comprise a moveable electrode configured to be extended from intermediate insulation layer 308 (FIG. 5A and FIG. 6A) and depressed to retreat into intermediate insulation layer 308 (FIG. 5B and FIG. 6B).
  • Retraction or depression of pointed tip 336 (FIG. 7A) into internal passage 332 can be advantageous in lessoning the chances of plasma forming on outer dome electrode 306 by ensuring that outer dome electrode is in contact with a large surface area of tissue when pointed tip 336 is electrically activated.
  • electrosurgical pencil 300 can include one or more locks to immobilize inner electrode 312 in the extended state (FIG. 7A) or the retracted state (FIG. 7B).
  • the locks can comprise set screws (not illustrated) extending into tubular body 314 to engage proximal section 350 of inner electrode 312.
  • the set screw can press against proximal section 350 to prevent axial displacement thereof.
  • electrosurgical pencil 300 can comprise a lever (not illustrated) extending out of tubular body 314 through a slot to allow a user to manually move inner electrode 312 in the axial direction.
  • Shaft 302 can comprise tubular body 314 to which outer dome electrode 306 can be attached.
  • Tubular body 314 can be covered by sheath 316 on the exterior and can include passage 318 on the interior.
  • Outer dome electrode 306 can comprise tubular body 320 having internal passage 322 coaxially aligned with passage 318 of shaft 302.
  • Outer dome electrode 306 can include outer surface 324 and end face 326.
  • Internal passage 322 of outer dome electrode 306 can receive intermediate insulation layer 308.
  • Intermediate insulation layer 308 can comprise cylindrical body 328 having end face 330 and internal passage 332.
  • Inner electrode 312 can be disposed within internal passage 332 and can comprise elongate shaft 334 and pointed tip 336.
  • Intermediate insulation layer 308 can further comprise proximal section 340 located proximally of cylindrical body 328.
  • Proximal section 340 can include internal chamber 342, which can be larger in diameter than internal passage 332.
  • Proximal section 340 can include port 344 to allow inner electrode 312 to pass into internal chamber 342.
  • Intermediate insulation layer 308 can be held in place within passage 318 via flange 346 of shaft 302.
  • Inner electrode 312 can further comprise proximal section 350 and flange 352.
  • Proximal section 350 can comprise sheath 354.
  • Biasing element 360 can be positioned around proximal section 350 proximal of flange 352.
  • Electrosurgical pencil 300 can be configured to operate similarly as electrosurgical pencil 200 of FIG. 3A and FIG. 3B.
  • inner electrode 312 can be electrified to deliver current to target tissue
  • outer dome electrode 306 can be provide a return path for the current
  • intermediate insulation layer 308 can electrically isolate inner electrode 312 from outer dome electrode 306.
  • moveable inner electrode 310 can be configured to slide within intermediate insulation layer 308.
  • moveable inner electrode 310 can include flange 352 configured to engage with internal chamber 342, as discussed in greater detail with reference to FIG. 7 A and FIG. 7B.
  • FIG. 7A is a side cross-sectional view of electrosurgical pencil 300 of FIG. 5A - FIG. 6B in an extended position relative to tissue 370.
  • FIG. 7B is a side cross-sectional view of electrosurgical pencil 300 of FIG. 5A - FIG. 6B in a retracted position relative to tissue 370.
  • electrosurgical pencil 300 can be guided to target tissue, such as tissue 370.
  • Electrosurgical pencil 300 can be guided with moveable inner electrode 310 in the extended state as shown in FIG. 7A.
  • moveable inner electrode 310 can be moved distally, to the right in FIG. 7A, so that flange 352 engages the distal end of internal chamber 342.
  • Moveable inner electrode 310 can be biased distally via biasing element 360.
  • Biasing element 360 can push against the proximal end of internal chamber 342.
  • biasing element 360 can comprise a spring, such as coil spring or a helix spring, disposed about the exterior of moveable inner electrode 310.
  • biasing element 360 can be disposed about the perimeter of moveable inner electrode 310.
  • biasing elements such as leaf springs, bellows springs, corrugated washers/washer springs and the like.
  • Biasing element 360 can push moveable inner electrode 310 with sufficient force to immobilize moveable inner electrode 310 during movement of electrosurgical pencil 200.
  • the force of biasing element 360 can be set to allow moveable inner electrode 310 to be pushed proximally, e.g., to the left in FIG. 7A, when pointed tip 336 is engaged with tissue by a user.
  • FIG. 7B engagement of pointed tip 336 with tissue 370 can cause moveable inner electrode 310 to be pushed proximally, toward the left in FIG. 7B.
  • the force of tissue 370 pushing against pointed tip 336 can cause biasing element 360 to compress via movement of flange 352.
  • Pointed tip 336 can be fully retracted into internal passage 332 such that pointed tip 336 is proximal of end face 326.
  • biasing element 360 can be fully compressed once pointed tip 336 is retracted into internal passage 332, thereby preventing further proximal movement of moveable inner electrode 310.
  • distal-most point of pointed tip 336 be in a plane with end face 326 so that the shortest distance between moveable inner electrode 310 and outer dome electrode 306 is at the distal-most point of pointed tip 336.
  • electrical current leaving pointed tip 336 can travel through only a small portion of tissue 370, such as in the area where electrotherapy is intended to be administered, before returning to outer dome electrode 306, thereby eliminating or reducing the possibility of stray electrical current travelling to undesirable areas of tissue.
  • retraction of pointed tip 336 into internal passage 332 can allow outer dome electrode 306 to be plunged deeper into tissue to allow more of outer dome electrode 306 to contact tissue before moveable inner electrode 310 is activated, thereby limiting the ability to form plasma on outer dome electrode 306. Furthermore, the less amount of moveable inner electrode 310 that is exposed to tissue, the greater the likelihood to form plasma at moveable inner electrode 310. As mentioned, it can be desirable for the ratio of the surface area of the return electrode, e.g., outer dome electrode 306, in contact with tissue and the surface area of the active electrode, e.g., moveable inner electrode 310, in contact with tissue to be high to facilitate the formation of plasma where intended. Thus, with pointed tip 336 retracted, the ratio goes up.
  • outer dome electrode 306 a large amount of tissue can be in contact with outer dome electrode 306 to decrease the current density and the ability to generate plasma, while a very small amount of tissue can be in contact with moveable inner electrode 310 to increase the current density and the ability to generate plasma.
  • the ratio of exposed surface area of pointed tip 336 to outer dome electrode 306 is higher in FIG. 7B than in FIG. 7A, thereby allowing the configuration of FIG. 7B to better form plasma and cut tissue.
  • FIG. 8A a side perspective view of electrosurgical pencil 400 having shaft 402 and moveable tip assembly 404 in an extended position.
  • FIG. 8B a side perspective view of electrosurgical pencil 400 having shaft 402 and moveable tip assembly 404 in a retracted position.
  • FIG. 8A and FIG. 8B are discussed concurrently.
  • Moveable tip assembly 404 can comprise outer dome electrode 406, intermediate insulation layer 408 and inner electrode 410.
  • moveable tip assembly 404 can comprise a moveable tip assembly configured to be extended from shaft 402 (FIG. 8A) and depressed to contact shaft 402 (FIG. 8B), thereby allowing pointed tip 436 (FIG. 9) to be selectively exposed when outer dome electrode 406 is pushed against tissue.
  • FIG. 9 is a side cross-sectional view of electrosurgical pencil 400 of FIG. 8A and FIG. 8B showing coupling mechanism 412 connecting outer dome electrode 406 to shaft 402.
  • Intermediate insulation layer 408 can be axially aligned with proximal body 440.
  • Moveable tip assembly 404 can comprise concentric portions of outer dome electrode 406, intermediate insulation layer 408 and inner electrode 410.
  • all of outer dome electrode 406 can be moveable and can be located distal of tubular body 414.
  • Cylindrical body 428 of intermediate insulation layer 408 can be retained within internal passage 422 of outer dome electrode 406, such as via interference fit or an adhesive, for example.
  • Elongate shaft 434 of inner electrode 410 can be configured to slide within internal passage 432 of cylindrical body 428.
  • shaft 302 can comprise a tubular body 414 to which outer dome electrode 406 can be attached moveable tip assembly 404.
  • Tubular body 414 can be covered by sheath 416 on the exterior and can include passage 418 on the interior.
  • Outer dome electrode 406 can comprise tubular body 420 having an internal passage 422 coaxially aligned with passage 418 of shaft 402.
  • Outer dome electrode 406 can include outer surface 424 and end face 426.
  • Internal passage 422 of outer dome electrode 406 can receive intermediate insulation layer 408.
  • Intermediate insulation layer 408 can comprise a distal portion having cylindrical body 428 having end face 430 and internal passage 432.
  • Inner electrode 410 can be disposed within internal passage 432 and can comprise elongate shaft 434 and pointed tip 436.
  • Intermediate insulation layer 408 can further comprise a proximal section comprising proximal body 440 located proximally of cylindrical body 428.
  • Proximal body 440 can include internal chamber 442, which can be larger in diameter than internal passage 432.
  • Inner electrode 410 can further comprise proximal section 450 having sheath 454.
  • Moveable tip assembly 404 can be connected to shaft 402 by coupling mechanism 412, which can comprise first spring 460A and second spring 460B.
  • Proximal body 440 can comprise first pocket 462A and second pocket 462B to receive first spring 460A and second spring 460B, respectively.
  • First pocket 462A can comprise first rear wall 464A and second pocket 462B can comprise second rear wall 464B.
  • First spring 460A and second spring 460B can connect moveable tip assembly 404 to shaft 402. First spring 460A and second spring 460B are shown exposed in FIG. 9 for illustrative purposes.
  • first spring 460A and second spring 460B can be covered, such as by a flexible tube or corrugated tube connected to moveable tip assembly 404 and shaft 402.
  • first spring 460A and second spring 460B can be electrically isolated from electricity flow or can form part of the current flow through outer dome electrode 406.
  • outer dome electrode 406 can be connected to wiring extending through the gap between outer dome electrode 406 and tubular body 414.
  • First spring 460A and second spring 460B can be attached to proximal face 470, or another portion of tubular body 420, of outer dome electrode 406 via any suitable means such as by welding or an interference fit.
  • distal ends of first spring 460A and second spring 460B can be located within sockets (not illustrated) located within tubular body 420.
  • Proximal ends of first spring 460A and second spring 460B can be attached to distal face 472, or another portion of tubular body 414, via any suitable means such as by welding or an interference fit.
  • proximal ends of first spring 460A and second spring 460B can be located within first pocket 462A and second pocket 462B, respectively, located within tubular body 414.
  • First rear wall 464A and second pocket 462B can provide surfaces against which first spring 460A and second spring 460B can press against, respectively.
  • first spring 460A and second spring 460B can be pushed into first pocket 462A and second pocket 462B, respectively.
  • proximal face 470 of tubular body 420 can engage with distal face 472 of tubular body 414 so that first spring 460A and second spring 460B can be fully pushed into first pocket 462A and second pocket 462B, respectively.
  • the distance between proximal face 470 and distal face 472 can be approximately equal to the longitudinal length of pointed tip 436.
  • First spring 460A and second spring 460B illustrate various examples of moveably connecting outer dome electrode 406 to shaft 402.
  • Electrosurgical pencil 400 can be configured to operate similarly as electrosurgical pencil 200 of FIG. 3A and FIG. 3B.
  • inner electrode 410 can be electrified to deliver current to target tissue
  • outer dome electrode 406 can be provide a return path for the current
  • intermediate insulation layer 408 can electrically isolate inner electrode 410 from outer dome electrode 406.
  • inner electrode 410 can being held in place, such as with mechanical or metallurgical means, similar to inner electrode 212.
  • outer dome electrode 406 can be configured to retract proximally along with a portion of intermediate insulation layer 408.
  • first spring 460A and second spring 460B can be positioned between outer dome electrode 406 and cylindrical body 428 of intermediate insulation layer 408 to allow pointed tip 436 to be exposed, as discussed in greater detail with reference to FIG. 10A and FIG. 10B.
  • FIG. 10A is a side view of electrosurgical pencil 400 of FIG. 8A and FIG. 8B with outer dome electrode 406 in an extended position relative to tissue 480.
  • FIG. 10B is a side view of electrosurgical pencil 400 of FIG. 8 A and FIG. 8B with outer dome electrode 406 in a retracted position relative to tissue 480.
  • FIG. 10A and FIG. 10B are discussed concurrently.
  • Pointed tip 436 can interact with tissue 480 in a similar manner as pointed tip 336 interacts with tissue 370 shown in FIG. 7A and FIG. 7B.
  • electrical current can exit pointed tip 336 from the distal-most point of pointed tip 336 and enter portions of tissue 480.
  • the electrical current leaving pointed tip 436 can travel through only a small portion of tissue 480, such as in the area where electrotherapy is intended to be administered, before returning to outer dome electrode 406, thereby eliminating or reducing the possibility of stray electrical current travelling to undesirable areas of tissue.
  • FIG. 10A and FIG. 10B can allow outer dome electrode 406 to contact tissue before inner electrode 410, which can be advantageous in ensuring that plasma forms on inner electrode 410 rather than outer dome electrode 406.
  • outer dome electrode 406 can contact tissue first and as electrosurgical pencil 400 is pushed deeper into tissue, e.g., pushed harder against tissue, inner electrode 410 can become exposed when ready to be electrically activated.
  • FIG. 11 A is a perspective side view of electrosurgical pencil 500 comprising shaft 502 and tip assembly 504 in an extended state.
  • FIG. 1 IB is a perspective side view of electrosurgical pencil 500 of FIG. 11 A in a retracted state.
  • Tip assembly 504 can comprise outer dome electrode 506, intermediate insulation layer 508 and reciprocating inner electrode 510.
  • FIG. 12A is a perspective cross-sectional view of electrosurgical pencil 500 with reciprocating inner electrode 510 in an extended state.
  • FIG. 12B is a perspective cross-sectional view of electrosurgical pencil 500 of FIG. 12A with reciprocating inner electrode 510 in a retracted state.
  • FIG. 11A - FIG. 12B are discussed concurrently.
  • Shaft 502 can comprise a tubular body 514 to which outer dome electrode 506 can be attached.
  • Tubular body 514 can be covered by sheath 516 on the exterior and can include passage 518 on the interior.
  • Outer dome electrode 506 can comprise tubular body 520 having internal passage 522 coaxially aligned with passage 518 of shaft 502.
  • Outer dome electrode 506 can include outer surface 524 and end face 526.
  • Internal passage 522 of outer dome electrode 506 can receive intermediate insulation layer 508.
  • Intermediate insulation layer 508 can comprise cylindrical body 528 having end face 530 and internal passage 532.
  • Reciprocating inner electrode 510 can be disposed within internal passage 532 and can comprise elongate shaft 534 and pointed tip 536.
  • Intermediate insulation layer 508 can further comprise proximal section 540 located proximally of cylindrical body 528.
  • Proximal section 540 can include internal chamber 542, which can be larger in diameter than internal passage 532.
  • Reciprocating inner electrode 510 can further comprise proximal section 550.
  • Proximal section 550 can comprise sheath 554.
  • Electrosurgical pencil 500 can be configured to operate similarly as electrosurgical pencil 200 of FIG. 3 A and FIG. 3B.
  • reciprocating inner electrode 510 can be electrified to deliver current to target tissue
  • outer dome electrode 506 can be provide a return path for the current
  • intermediate insulation layer 508 can electrically isolate reciprocating inner electrode 510 from outer dome electrode 506.
  • reciprocating inner electrode 510 can be configured to slide within intermediate insulation layer 508.
  • reciprocating inner electrode 1 510 can be connected to a reciprocation device, such as reciprocating mechanism 560 (FIG.13 A) to provide continuous back-and-forth motion to reciprocating inner electrode 510, as indicated by arrow 558, as discussed in greater detail with reference to FIG. 13A and FIG. 13B.
  • a reciprocation device such as reciprocating mechanism 560 (FIG.13 A) to provide continuous back-and-forth motion to reciprocating inner electrode 510, as indicated by arrow 558, as discussed in greater detail with reference to FIG. 13A and FIG. 13B.
  • FIG. 13A is a side cross-sectional view of reciprocating mechanism 560 for the electrosurgical pencil 500 of FIG. 11 A - FIG. 12B with drive shaft 562 in a retracted state.
  • FIG. 13B is a side cross-sectional view of reciprocating mechanism 560 of FIG. 13A with drive shaft 562 in an extended state.
  • FIG. 13A and FIG. 13B are discussed concurrently.
  • Reciprocating mechanism 560 can comprise cam 564 that can be connected to a rotating drive mechanism (not illustrated).
  • reciprocating mechanism 560 can be connected to electric motor 118 within handpiece 102 (FIG. 1).
  • Cam 564 can include socket 566 having base 568 and lobe 570.
  • a proximal portion of drive shaft 562 can be located in socket 566.
  • Drive shaft 562 can comprise socket 572 having lower base 574 and upper base 576.
  • Spring 578 can be positioned between cam 564 and drive shaft 562 to push drive shaft 562 proximally, to the left in FIG. 13 A, as shown by arrow 580.
  • Rotation of cam 564 in the direction of arrow 582, such as by electric motor 118 (FIG. 1), can cause drive shaft 562 to move distally, to the right in FIG. 13B, as shown by arrow 584.
  • the position of reciprocating inner electrode 510 can be controlled to be in a retracted state while electrosurgical pencil 500 is navigated to the target tissue to prevent plasma formation on outer dome electrode 506, similar to what is discussed with reference to FIG. 9 to FIG. 10B. That is, a user of electrosurgical pencil 100 (FIG. 1) can push a button on handpiece 102 to advance reciprocating inner electrode 510 to a desired position before activating electrical energy therein.
  • reciprocation of reciprocating inner electrode 510 can be used to remove debris from reciprocating inner electrode 510.
  • eschar, or burnt tissue can adhere to the inner electrodes of the electrosurgical pencils described herein.
  • the reciprocating motion of reciprocating inner electrode 510 can prevent the adhesion of eschar to reciprocating inner electrode 510 or, if eschar becomes attached, the reciprocating motion can scrape the eschar from reciprocating inner electrode 510.
  • the gap between the outer diameter of reciprocating inner electrode 510 and the inner diameter of internal passage 532 can be small to facilitate such scraping.
  • the build-up of eschar, which is non-conductive, is undesirable because it can affect the amount of the surface area of reciprocating inner electrode 510 that is exposed to tissue, which can affect plasma formation.
  • FIG. 14 is a side cross-sectional view of reciprocating mechanism 600 suitable for use with electrosurgical pencil 500 of FIG. 11A - FIG. 12B.
  • Reciprocating mechanism 600 can be configured similarly as reciprocating mechanism 560 of FIG. 13A and FIG.
  • Reciprocating mechanism 600 can include drive shaft 562 and cam 564 as with reciprocating mechanism 560.
  • reciprocating mechanism 600 can include the addition of contact 602, which can facilitate use with handpiece 163 and socket 178 of FIG. 2A.
  • contact 602 can allow conductor 604 within drive shaft 562 to reach mating conductors within handpiece 163 while components connected to contact 602 reciprocate.
  • Conductor 604 can additionally be used in reciprocating mechanism 560 of FIG. 13A and FIG. 13B.
  • Drive shaft 562 can connect to electric motor 118 in handpiece 163 and can rotate about axis AA (FIG. 3B, for example).
  • Cam 564 can reciprocate due to input from drive shaft 562 as indicated by arrow 606.
  • Plug 608 can connect to drive shaft 562 and can surround cam 564.
  • Plug 608 can comprise plug 172 of FIG. 2A.
  • Conductor 604 can be attached to cam 564 and can reciprocated with cam 564.
  • Conductor 604 can extend to tip 176 (FIG. 2A) to provide electrification to an inner electrode as described herein.
  • Hub 610 of contact 602 can be stationary, but can be configured to allow conductor 604 to rotate therein.
  • Contacts 613 can be electrical contact with conductor 604 and contacts 615 can be in electrical contact with socket 178. Contacts 613 and 615 can be in electrical communication via appropriate wiring and the like.
  • reciprocating mechanism 560 and reciprocating mechanism 600 can be configured according to the reciprocating mechanisms described in Pat. No. US 11,712,291 to Germain et al., titled “Arthroscopic Devices and Methods,” the contents of which are hereby incorporated in their entirety by this reference.
  • FIG. 15 A is an end view of electrosurgical pencil 100 comprising outer dome electrode 206, intermediate insulation layer 210 and inner electrode 212 having pointed tip 236.
  • FIG. 15B is a side view of electrosurgical pencil 100 of FIG. 15A showing pointed tip 236 extended beyond outer dome electrode 206.
  • the diameter of inner electrode 212 can have dimension 612.
  • dimension 612 can be approximately 0.013 inches.
  • dimension 612 can be in the range of approximately 0.010 inches to approximately 0.02 inches.
  • the outer diameter of inner electrode 212 can be spaced from the inner diameter of end face 230 by dimension 614.
  • dimension 614 can be approximately 0.016 inches (-0.4064 mm).
  • dimension 614 can be in the range of approximately 0.010 inches (-0.254 mm) to approximately 0.02 inches (-0.508 mm).
  • the outer diameter of end face 226 can be spaced from the outer diameter of end face 230 by dimension 616.
  • dimension 616 can be approximately 0.0076 inches (-0.19304 mm).
  • dimension 616 can be in the range of approximately 0.006 inches (-0.1524 mm) to approximately 0.009 inches (-0.2286 mm).
  • Pointed tip 236 can project beyond end face 226 dimension 618.
  • dimension 618 can be approximately 0.042 inches (-1.0668 mm).
  • dimension 618 can be in the range of approximately 0.03 inches (-0.762 mm) to approximately 0.06 inches (-1.524 mm).
  • pointed tip 236 can have a surface area of approximately 0.0008 square inches (-0.516 square mm).
  • outer dome electrode 206 can have an outer surface area of approximately 0.0895 square inches (-57.74 square mm).
  • end face 226 can have a surface area of approximately 0.0014 (-0.903 square mm).
  • the surface area ratio of outer dome electrode 206 to pointed tip 236 can be approximately 1.75: 1, and the surface area ratio of end face 226 to pointed tip 236 can be approximately 111.88:1.
  • the systems, devices and methods discussed in the present application can be useful in providing bipolar electrosurgical instruments and pencils that can generate adequate amounts of plasma to perform cutting, ablation, cauterizing and the like with low power consumption.
  • the bipolar electrosurgical pencils described herein can eliminate the need for a return electrode comprising a pad connected to the body of a patient, thereby reducing the return path for electricity travelling through the patient. This can reduce or eliminate the risk of unintentional delivering plasma to tissue where treatment is not desired.
  • the shapes of the inner electrodes and outer electrodes can be configured to provide a high surface area ratio between the two.
  • the inner electrode can have a sharp tip and the outer electrode can have a multi-faceted dome shape.
  • the sharp tip of the inner active electrode can focus electrical energy for the formation of plasma and can reduce the surface area of the inner electrode in contact with tissue.
  • the dome shape of the outer inactive electrode can increase the surface area of the outer inactive electrode that contacts tissue.
  • Example 1 is an electrosurgical bipolar surgical instrument comprising: an elongate shaft extending along a central axis between a proximal end portion and a distal end portion; an outer electrode extending from the distal end portion; an inner electrode extending from within the elongate shaft into the outer electrode; and an intermediate insulation member disposed between outer electrode and the inner electrode.
  • Example 2 the subject matter of Example 1 optionally includes wherein: the elongate shaft has a first outer surface; and the outer electrode has a second outer surface contiguous with the first outer surface.
  • Example 3 the subject matter of Example 2 optionally includes wherein the first outer surface of the elongate shaft is covered with an insulator.
  • Example 4 the subject matter of any one or more of Examples 1-3 optionally include wherein the outer electrode, the inner electrode and the intermediate insulation member are concentric.
  • Example 5 the subject matter of any one or more of Examples 1-4 optionally include wherein the elongate shaft, the outer electrode, the inner electrode and the intermediate insulation member are coaxial.
  • Example 6 the subject matter of any one or more of Examples 2-5 optionally include wherein the outer electrode comprises a dome that tapers downward from the elongate shaft toward the central axis of the elongate shaft.
  • Example 7 the subject matter of Example 6 optionally includes wherein the dome comprises a three-sided pyramid with rounded edges.
  • Example 8 the subject matter of any one or more of Examples 1-7 optionally include wherein the inner electrode comprises a pin having an elongate cylindrical body and conical tip.
  • Example 9 the subject matter of Example 8 optionally includes wherein the inner electrode is fixed relative to the intermediate insulation member in an extended position such that the conical tip is positioned distal of the intermediate insulation member.
  • Example 10 the subject matter of any one or more of Examples 1-9 optionally include wherein the outer electrode is moveable relative to the elongate shaft to allow a tip of the inner electrode to protrude from the intermediate insulation member.
  • Example 11 the subject matter of Example 10 optionally includes wherein a portion of the intermediate insulation member moved with the outer electrode.
  • Example 12 the subject matter of any one or more of Examples 9-11 optionally include wherein the outer electrode is biased distally via one or more biasing elements to cover the conical tip.
  • Example 13 the subject matter of any one or more of Examples 8-12 optionally include wherein the inner electrode is moveable relative to the elongate shaft to move the conical tip into and out of the intermediate insulation member.
  • Example 14 the subject matter of Example 13 optionally includes wherein the inner electrode is biased out of the intermediate insulation member.
  • Example 15 the subject matter of any one or more of Examples 13-14 optionally include a reciprocating device connected to the elongate shaft to reciprocate the inner electrode.
  • Example 16 the subject matter of any one or more of Examples 7-15 optionally include wherein: the outer electrode comprises a first distal end face; and the intermediate insulation member comprises a second distal end face; wherein the second distal end face is recessed into the outer electrode.
  • Example 17 the subject matter of any one or more of Examples 1-16 optionally include the inner electrode comprises a pointed tip that extends beyond the outer electrode approximately 0.04 inches.
  • Example 18 the subject matter of Example 17 optionally includes wherein: the intermediate insulation member positions the outer electrode away from the inner electrode approximately 0.016 inches; and the inner electrode has a diameter of approximately 0.013 inches.
  • Example 19 the subject matter of any one or more of Examples 1-18 optionally include wherein the outer electrode extends from a distal-most end of the elongate shaft.
  • Example 20 the subject matter of any one or more of Examples 1-19 optionally include wherein the inner electrode is surrounded by an insulating sleeve within the elongate shaft.
  • Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine- readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples.
  • An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times.
  • Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un instrument bipolaire d'électrochirurgie comprend une tige allongée s'étendant le long d'un axe central entre une partie d'extrémité proximale et une partie d'extrémité distale, une électrode externe s'étendant depuis la partie d'extrémité distale, une électrode interne s'étendant depuis l'intérieur de la tige allongée dans l'électrode externe, et un élément d'isolation intermédiaire disposé entre l'électrode externe et l'électrode interne.
PCT/US2023/085429 2022-12-22 2023-12-21 Bistouri électrique bipolaire WO2024137986A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263434595P 2022-12-22 2022-12-22
US63/434,595 2022-12-22

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WO2024137986A1 true WO2024137986A1 (fr) 2024-06-27

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4034762A (en) * 1975-08-04 1977-07-12 Electro Medical Systems, Inc. Vas cautery apparatus
JPH06142111A (ja) * 1992-04-14 1994-05-24 Olympus Optical Co Ltd トラカール
GB2308979A (en) * 1996-01-09 1997-07-16 Gyrus Medical Ltd An electrosurgical instrument and electrode assembly
US20020009687A1 (en) * 2000-07-24 2002-01-24 Livaditis Gus J. Electrosurgical tool for tissue coagulation in vital pulp therapy
US7749221B2 (en) * 2005-08-23 2010-07-06 Rontal Daniel A Retractable electrosurgical electrode
JP2012170777A (ja) * 2011-02-24 2012-09-10 Olympus Corp アブレーションデバイス
CN211911787U (zh) * 2019-12-05 2020-11-13 江西奇仁生物科技有限责任公司 双极电刀笔

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4034762A (en) * 1975-08-04 1977-07-12 Electro Medical Systems, Inc. Vas cautery apparatus
JPH06142111A (ja) * 1992-04-14 1994-05-24 Olympus Optical Co Ltd トラカール
GB2308979A (en) * 1996-01-09 1997-07-16 Gyrus Medical Ltd An electrosurgical instrument and electrode assembly
US20020009687A1 (en) * 2000-07-24 2002-01-24 Livaditis Gus J. Electrosurgical tool for tissue coagulation in vital pulp therapy
US7749221B2 (en) * 2005-08-23 2010-07-06 Rontal Daniel A Retractable electrosurgical electrode
JP2012170777A (ja) * 2011-02-24 2012-09-10 Olympus Corp アブレーションデバイス
CN211911787U (zh) * 2019-12-05 2020-11-13 江西奇仁生物科技有限责任公司 双极电刀笔

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