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WO2022115868A1 - Dispositif électrochirurgical avec revêtement antiadhésif - Google Patents

Dispositif électrochirurgical avec revêtement antiadhésif Download PDF

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Publication number
WO2022115868A1
WO2022115868A1 PCT/US2021/072606 US2021072606W WO2022115868A1 WO 2022115868 A1 WO2022115868 A1 WO 2022115868A1 US 2021072606 W US2021072606 W US 2021072606W WO 2022115868 A1 WO2022115868 A1 WO 2022115868A1
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WO
WIPO (PCT)
Prior art keywords
stick coating
tissue
sealing plate
thickness
electrosurgical device
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.)
Ceased
Application number
PCT/US2021/072606
Other languages
English (en)
Inventor
Kester Julian Batchelor
Teo Heng Jimmy YANG
Bryan Tissington
Riyad Moe
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Individual
Original Assignee
Individual
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Filing date
Publication date
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Publication of WO2022115868A1 publication Critical patent/WO2022115868A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—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
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • 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
    • 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
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • 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
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/0013—Coatings on the energy applicator non-sticking
    • 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
    • A61B2018/0063—Sealing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/62—Plasma-deposition of organic layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D2518/00—Other type of polymers
    • B05D2518/10—Silicon-containing polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D5/00—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
    • B05D5/08—Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures to obtain an anti-friction or anti-adhesive surface

Definitions

  • This document pertains generally, but not by way of limitation, to electrosurgical devices that can be used for various surgical procedures. More specifically, but not by way of limitation, the present application relates to an electrosurgical device including opposing jaw members having sealing plates with improved non-stick coatings and methods for manufacturing the same.
  • Electrosurgical forceps utilize mechanical clamping action along with electrical energy to effect hemostasis on the clamped tissue.
  • the forceps (open, laparoscopic or endoscopic) include electrosurgical sealing plates which apply the electrosurgical energy to the clamped tissue.
  • electrosurgical sealing plates which apply the electrosurgical energy to the clamped tissue.
  • these materials may interfere with the efficacy and efficiency of hemostasis and have a tendency to release from the instrument's substrate due to formation of microporosity, delamination, and/or abrasive wear, thus exposing underlying portions of the instrument to direct tissue contact and related sticking issues.
  • these holes or voids in the coating lead to nonuniform variations in the capacitive transmission of the electrical energy to the tissue of the patient and may create localized excess heating, resulting in tissue damage, undesired irregular sticking of tissue to the electrodes.
  • the present inventors have recognized, among other things, that problems to be solved in using electrosurgical devices is to provide a non-stick coating at various thicknesses to minimize undesired irregular sticking or damage to tissue while providing benefits.
  • the present inventors have recognized that providing a non-stick coating at certain thickness ranges, e.g., but not limited to, about 10 nanometers (nm) to about 30 nm, discourages the reuse of the device beyond an intended number of uses. That is, the non-stick coating thickness can be determined based on the wearing rate of the non-stick coating such that a number of intended uses is predetermined.
  • the non-stick coating will begin to wear and after the number of intended uses the tissue adhesion resistance provided by the non-stick coating can decrease to an extent that would discourage reuse of the surgical device. Additionally, the inventors have recognized that providing the non-stick coating at other thicknesses, e.g., but not limited to, about 90 nm to about 250 nm, can provide better instrument response, such as delivering more heating, at lower power delivery values.
  • the electrosurgical instruments described herein include at least one tissue sealing plate including a non-stick coating configured to reduce the sticking of soft tissue to the sealing plate during application of energy while encouraging single patient use or providing better instrument response.
  • an electrosurgical instrument includes at least one jaw member having an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue and a non-stick coating having a thickness of from about 10 nm to about 30 nm disposed on at least a portion of the tissue sealing plate.
  • the non-stick coating is formed from one of polydimethylsiloxane (PDMSO), hexamethyldisiloxane (HMDSO), tetramethyldisiloxane (TMDSO or TMDS) and other polysiloxanes.
  • an electrosurgical instrument includes at least one jaw member having an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue and a non-stick coating having a thickness of from about 90 nm to about 250 nm disposed on at least a portion of the tissue sealing plate.
  • the non-stick coating is formed from one of PDMSO, HMDSO, and TMDSO.
  • the non-stick coating has a substantially uniform thickness. In another example, the non-stick coating has a non-uniform thickness. In another example, the non-stick coating is discontinuous. In another example, the non-stick coating is continuous.
  • the electrosurgical instrument also includes an insulative layer disposed on at least a portion of the tissue sealing plate.
  • the non-stick coating is disposed on at least a portion of each of the pair of opposing jaw members.
  • the tissue sealing plate is formed of stainless steel.
  • an electrosurgical instrument includes a pair of opposing jaw members.
  • Each of the opposing jaw members includes an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue, a support base configured to support the tissue sealing plate, and an insulative housing configured to secure the tissue sealing plate to the support base.
  • a non-stick coating having a thickness of from about 10 nm to 30 nm is disposed on at least a portion of at least one of the opposing jaw members. In one example, the non-stick coating is disposed on at least a portion of each of the tissue sealing plates, the support base, and the insulative housing.
  • the non-stick coating thickness has a substantially uniform thickness on the tissues sealing plates, the support base, and the insulative housing. In another example, the coating has a non-uniform thickness. In another example, the non-stick coating is discontinuous. In another example, the non-stick coating is continuous.
  • an electrosurgical instrument includes a pair of opposing jaw members.
  • Each of the opposing jaw members includes an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue, a support base configured to support the tissue sealing plate, and an insulative housing configured to secure the tissue sealing plate to the support base.
  • a non-stick coating having a thickness of from about 90 nm to 250 nm is disposed on at least a portion of at least one of the opposing jaw members. In one example, the non-stick coating is disposed on at least a portion of each of the tissue sealing plates, the support base, and the insulative housing.
  • the non-stick coating thickness has a substantially uniform thickness on the tissues sealing plates, the support base, and the insulative housing. In another example, the coating has a non-uniform thickness. In another example, the non-stick coating is discontinuous. In another example, the non-stick coating is continuous.
  • a method of inhibiting tissue from sticking to an electrically conductive component of an electrosurgical tissue sealing device during application of energy to tissue while minimizing single patient use includes applying a non-stick coating on at least a portion of an electrically conductive component of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique. The method also includes controlling a thickness of the non-stick coating applied to be from about 10 nm to about 30 nm.
  • a method of inhibiting tissue from sticking to an electrically conductive component of an electrosurgical tissue sealing device during application of energy to tissue while providing better instrument response, such as delivering more heating, at lower power delivery values includes applying a non-stick coating on at least a portion of an electrically conductive component of an electrosurgical tissue sealing device using a plasma enhanced chemical vapor deposition technique. The method also includes controlling a thickness of the non-stick coating applied to be from about 90 nm to about 250 nm.
  • FIG. 1 is a side view of an electrosurgical device having jaws in an open configuration, according to an example of the present application.
  • FIG. 2A is a side view of a portion of an electrosurgical device including the jaws, in accordance with at least one example.
  • FIG. 2B is a perspective view of the portion of the electrosurgical device in FIG. 2A.
  • FIG. 3 illustrates an expanded view of a jaw member, in accordance with at least one example.
  • FIG. 4 illustrates a graph of power versus load of an example generator system.
  • FIG. 5 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 6 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 7 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 8 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 9 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 10 illustrates a jaw member including a non-stick coating, in accordance with at least one example.
  • FIG. 11 illustrates the sticking results between Example 1 and Comparative Example A.
  • the present disclosure is directed to electrosurgical devices having a non-stick coating disposed on one or more components (e.g., tissue sealing plates, jaw members, electrical leads, insulators etc.).
  • the thickness of the non-stick coating is controlled, allowing for desired electrical performance, while providing tissue sticking reduction during tissue sealing.
  • the present inventors have determined that various thickness ranges for the non-stick coating can provide additional benefits beyond tissue adhesion resistance.
  • FIG. 1 illustrates a side view of a forceps 10 with jaws 12 in an open position.
  • Directional descriptors such as proximal and distal are used within their ordinary meaning in the art.
  • the proximal direction P and distal direction D, as well as top T and bottom B, are indicated on the axes provided in FIG. 1.
  • the forceps can include a handpiece 14, one or more actuators 20, an outer shaft 28 (or outer tube), an inner shaft 26 (or inner tube), a drive bar 27, and an end effector 16.
  • the forceps 10 can include the handpiece 14 at a proximal end and the end effector 16 at a distal end.
  • An intermediate portion 18 can extend between the handpiece 14 and the end effector 16 to operably couple the handpiece 14 to the end effector 16.
  • Various movements of the end effector 16 can be controlled by one or more actuation systems 20 of the handpiece 14.
  • the end effector 16 can include the jaws 12 that are capable of moving between an open position and a closed position.
  • the end effector 16 can be rotated along a longitudinal axis of the forceps 10.
  • the end effector 16 can include a cutting blade and an electrically conductive tissue sealing plate, e.g., an electrode, for applying electrosurgical energy.
  • the forceps 10 can include the jaws 12, a housing 22, a lever 24, the inner shaft 26, the drive bar 27, the outer shaft 28, a rotational actuator 30, a blade 32, a trigger 34 and/or an activation button 36.
  • the end effector 16, or a portion of the end effector 16 can be one or more of: opened, closed, rotated, extended, retracted, and electrosurgically energized.
  • the user can displace the lever 24 proximally to drive the jaws 12 from the open position (FIG. 1) to a closed position.
  • moving the jaws 12 from the open position to the closed position allows a user to clamp down on and compress a tissue.
  • the handpiece 14 can also allow a user to rotate the end effector 16.
  • rotating rotational actuator 30 causes the end effector 16 to rotate by rotating both the inner shaft 26, drive bar 27, and the outer shaft 28 together.
  • a user can depress the activation button 36 to cause an electrosurgical energy to be delivered to the end effector 16, such as to an electrode.
  • Application of electrosurgical energy can be used to treat the tissue such as seal or otherwise affect the tissue being clamped.
  • the electrosurgical energy can cause tissue to be sealed, ablated, and/or coagulated.
  • Electrosurgical energy can be applied to any suitable electrode.
  • the forceps 10 can be used to cut the treated tissue via a blade assembly 32 (also referred to as blade 32).
  • the handpiece 14 can enable a user to extend and retract the blade 32.
  • the blade 32 can be extended by displacing the trigger 34 proximally.
  • the blade 32 can be retracted by allowing the trigger 34 to return distally to a default position.
  • the default position of the trigger 34 is shown in FIG. 1.
  • the handpiece 14 can include features that inhibit the blade 32 from being extended until the jaws 12 are at least partially closed, or fully closed.
  • the forceps 10 can be used to perform a treatment on a patient, such as a surgical procedure.
  • a distal portion of the forceps 10, including the jaws 12 can be inserted into a body of a patient, such as through an incision or another anatomical feature of the patient’s body. While a proximal portion of the forceps 10, including the housing 22 remains outside the incision or another anatomical feature of the body.
  • Actuation of the lever 24 causes the jaws 12 to clamp onto a tissue.
  • the rotational actuator 30 can be rotated via a user input to rotate the jaws 12 for maneuvering the jaws 12 at any time during the procedure.
  • Activation button 36 can be actuated to provide electrical energy to jaws 12 to cauterize, desiccate, or seal the tissue within the closed jaws 12.
  • Trigger 34 can be moved to translate the blade 32 distally in order to cut the tissue within the jaws 12.
  • FIG. 2 A illustrates a side view of a portion of forceps 10, in accordance with at least one example of this disclosure.
  • FIG. 2B illustrates a perspective view of a portion of the forceps 10.
  • FIGS. 2A and 2B are discussed below concurrently.
  • the forceps 10 can include a top jaw 40 (including flanges 42), a bottom jaw 44 (including flanges 46), a drive pin 48, a pivot pin 50, an inner shaft 52, and an outer shaft 28.
  • the outer shaft 28 can include outer arms 58.
  • the forceps 10 can be used with various surgical procedures.
  • the end effector 16 includes pair of opposing jaw members 40, 44 that rotate about a pivot pin 50 and that are movable relative to one another to grasp tissue.
  • the jaw members 40, 44 include an electrically conductive sealing plate
  • a sensor can be disposed on or proximate to at least one of the jaw members 40, 44 of the forceps 10 for sensing tissue parameters (e.g., temperature, impedance, etc.) generated by the application of electrosurgical energy to tissue via the jaw members 40, 44.
  • the sensor may include a temperature sensor, tissue hydration sensor, impedance sensor, optical clarity sensor, or the like.
  • a cable, coupling the forceps 10 to an electrosurgical generator can transmit sensed tissue parameters as data to the electrosurgical generator having suitable data processing components (e.g., microcontroller, memory, sensor circuitry, etc.) for controlling delivery of electrosurgical energy to the forceps 10 based on data received from the sensor.
  • FIG. 3. illustrates an exploded view of the jaw member 44, as shown in FIGS. 2A and 2B.
  • Jaw member 44 can be identical to jaw member 40.
  • the jaw member 44 can include the electrically conductive sealing plate 60, e.g., an electrode, including a blade slot 64, a frame 66 (including flanges 46), an overmold 68 including a blade slot 70, and a support 72.
  • a wire 74 can electrically couple the electrically conductive sealing plate 60 to an energy source.
  • the overmold 68 can include the blade slot 70, which can be aligned with the blade slot 64 of the electrically conductive sealing plate 60 when the overmold 68 is secured to the electrically conductive sealing plate 60 (such as when the overmold 68 is overmolded to the frame 66 and the electrically conductive sealing plate 60.
  • the frame 66 can include a slot 76 that can receive the support 72 therein.
  • the support 72 can help to support the electrically conductive sealing plate 60 on the frame 66.
  • the electrically conductive sealing plate 60 includes an underside surface 82 that can include an electrically insulative layer 86 bonded thereto or otherwise disposed thereon.
  • the electrically insulative layer 86 can electrically insulate the electrically conductive sealing plate 60, from the support 72 and the frame 66.
  • the electrically insulative layer 86 is formed from polyimide.
  • any suitable electrically insulative material may be utilized, such as polycarbonate, polyethylene, etc.
  • the jaw member 44 include an external surface 84 that includes a non-stick coating 62 disposed thereon.
  • the non-stick coating 62 may be disposed on selective portions of either of the jaw members 40, 44, or may be disposed on the entire external surface 84.
  • the non-stick coating 62 is disposed on a tissue-engaging surface 90 of the electrically conductive sealing plate 60.
  • the non-stick coating 62 is configured to reduce the sticking of tissue to the electrical conducting sealing plates, the jaw members, the electrical leads, and/or the surrounding insulating material.
  • the support 72 is configured to support the electrically conductive sealing plate 60 thereon.
  • the electrically conductive sealing plate 60 may be affixed atop the support 72 that can be coupled to or integral with the frame 66.
  • the electrically conductive sealing plate 60 can be coupled to the support 72 and/or frame 66, by any suitable method including but not limited to snap-fitting, overmolding, stamping, ultrasonic welding, laser welding, etc.
  • the support 72, frame 66, and the electrically conductive sealing plate 60 is at least partially encapsulated by overmold 68, by way of an overmolding process to secure the electrically conductive sealing plates 60 to the support 72 and the frame 66.
  • the electrically conductive sealing plate 60 can include teeth 78 that can define recesses 80.
  • the recesses 80 can be located on a side edge of the electrically conductive sealing plate 60.
  • the recesses 80 can be configured to let material of the overmold 68 infiltrate (or fill in) the recesses (or spaces or gaps) 80 so that the electrically conductive sealing plate 60 is secured to the overmold 68.
  • the electrically conductive sealing plate 60 is an electrode (or can include an electrode) which can be electrically connected to the wire (or conduit) 74.
  • the electrically conductive sealing plate 60 is coupled to wire 74 (e.g., electrical lead/ conduit), via any suitable method (e.g., ultrasonic welding, crimping, soldering, etc.).
  • the wire 74 serves to deliver electrosurgical energy (e.g., from an electrosurgical energy generator) to the electrically conductive sealing plate 60.
  • Jaw member 44 may also include a series of stop members 92 disposed on the tissue-engaging surface of the electrically conductive sealing plate 60 to facilitate gripping and manipulation of tissue and to define a gap between the jaw members 40, 44 during sealing and cutting of tissue.
  • the series of stop members 92 may be disposed (e.g., formed, deposited, sprayed, affixed, coupled, etc.) onto the electrically conductive sealing plate 60 during manufacturing. Some or all of the stop members 92 may be coated with the non-stick coating 62 or, alternatively, may be disposed on top of the non-stick coating 62.
  • the non-stick coating is applied to portions of the electrosurgical device to provide tissue adherence resistant (anti-stick) properties. Any material capable of providing the desired functionality (namely, reduction of tissue sticking while simultaneously maintaining sufficient electrical transmission to permit tissue sealing) may be used as the non-stick coating, provided it has adequate biocompatibility. In some examples, the material may be porous to allow for electrical transmission.
  • materials such as silicone and silicone resins can be used for the non-stick coating.
  • the silicone and silicone resins can be applied using a plasma deposition process to precisely control thickness, and can withstand the heat generated during tissue sealing.
  • Silicone resins suitable for the non-stick coating include, but are not limited to, polydimethyl siloxanes, polyester-modified methylphenyl polysiloxanes, such as polymethylsilane and polymethylsiloxane, and hydroxyl functional silicone resins.
  • the non-stick coating is made from a composition including a siloxane, which may include hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or combinations thereof
  • the non-stick coating is a polydimethylsiloxane (“PMDSO” coating.
  • the non-stick coating is a hexamethyldisiloxane (“HMDSO”) coating.
  • the non-stick coating is a tetramethyldisiloxane (TMDSO or TMDS).
  • the application of the non-stick coating may be accomplished using any system and process capable of precisely controlling the thickness of the coating.
  • HMDSO is deposited on the electrically conductive sealing plates using plasma enhanced chemical vapor deposition (PECVD) or other suitable methods such as atmospheric pressure plasma enhanced chemical vapor deposition (AP -PECVD).
  • PECVD plasma enhanced chemical vapor deposition
  • AP -PECVD atmospheric pressure plasma enhanced chemical vapor deposition
  • the application of the polydimethylsiloxane coating may be accomplished using a system and process that includes a plasma device coupled to a power source, a source of liquid and/or gas ionizable media (e.g., oxygen), a pump, and a vacuum chamber.
  • the power source may include any suitable components for delivering power or matching impedance to the plasma device. More particularly, the power source may be any radio frequency generator or other suitable power source capable of producing electrical power to ignite and sustain the ionizable media to generate a plasma effluent.
  • the PMDSO coating in one example, can be formed by PECVD of hexamethyldisiloxane (“HMDSO”).
  • HMDSO hexamethyldisiloxane
  • the polydimethylsiloxane coating operates to reduce the sticking of tissue to the sealing plates and/or the entire jaw member. Additionally, the polydimethylsiloxane coating may operate to reduce the pitting of the sealing plates and may provide durability against electrical and/or mechanical degradation of the sealing plates and the jaw members, as a whole.
  • the HMDSO plasma coating may be applied using a system or process which includes a plasma device that is coupled to a power source, an ionizable media source and a precursor or pre-ionization source.
  • the power source may include any suitable components for delivering power or matching impedance to the plasma device. More particularly, the power source may be any radio frequency generator or other suitable power source capable of producing electrical power to ignite and sustain the ionizable media to generate a plasma effluent.
  • Plasmas are generated using electrical energy that is delivered as either direct current (DC) electricity or alternating current (AC) electricity, in either continuous or pulsed modes, at frequencies from about 0.1 hertz (Hz) to about 100 gigahertz (GHz), including radio frequency bands (“RF”, from about 0.1 MHz to about 100 MHz) and microwave bands (“MW”, from about 0.1 GHz to about 100 GHz), using appropriate generators, electrodes, and antennas.
  • AC electrical energy may be supplied at a frequency from about 0.1 MHz to about 2,450 MHz, in embodiments from about 1 MHz to about 160 MHz.
  • the plasma may also be ignited by using continuous or pulsed direct current (DC) electrical energy or continuous or pulsed RF electrical energy or combinations thereof.
  • DC direct current
  • AC alternating current
  • Choice of excitation frequency, the workpiece, as well as the electrical circuit that is used to deliver electrical energy to the circuit affects many properties and requirements of the plasma.
  • the performance of the plasma chemical generation, the gas or liquid feedstock delivery system and the design of the electrical excitation circuitry are interrelated, as the choices of operating voltage, frequency and current levels, as well as phase, effect the electron temperature and electron density.
  • choices of electrical excitation and plasma device hardware also determine how a given plasma system responds dynamically to the introduction of new ingredients to the host plasma gas or liquid media.
  • the corresponding dynamic adjustment of the electrical drive such as via dynamic match networks or adjustments to voltage, current, or excitation frequency may be used to maintain controlled power transfer from the electrical circuit to the plasma.
  • a thickness of the non-stick coating can be in the range of 10 nm to about 250 nm and provide non-stick benefits. However, while non-stick properties can be provided, various portions of this range can provide additional benefits, while still providing tissue adhesion resistance and sensing capability.
  • Examples of the present disclosure provide for disposing a non-stick coating on components of an electro surgical device (e.g., electrically conductive sealing plates, jaw members, wires, insulators, etc.) at a particular thickness or within a particular range of thicknesses such that the non-stick coating provides adequate tissue sticking reduction during tissue sealing without negatively impacting tissue sealing performance of the vessel sealing instrument.
  • an electro surgical device e.g., electrically conductive sealing plates, jaw members, wires, insulators, etc.
  • the non-stick coating can be a thin coating, e.g., having a thickness in the range of, but not limited to, about 10 nm to about 30 nm. In one possibly more preferred example, the non-stick coating has a thickness in the range of about 10 nm to about 20 nm. In one example, the non-stick coating has a predetermined number of activations and can promote single-use.
  • the electrosurgical device or a portion of the electrosurgical device has a non-stick coating thickness that allows a surgeon to perform a particular procedure on a patient, but the non-stick properties reduce after the predetermined number of activations to discourage a user from attempting to sterilize and reuse the electrosurgical device (or a portion of the electrosurgical device) on a subsequent patient. Promoting single-use lessens the risk of cross-contamination and hospital acquired diseases.
  • the preferred coating thickness may be more than 3 nm to provide some level of non-stick performance, but no more than 17 nm to encourage only a single use of a device and may be optimally targeted for application to a surface in a range of about 10 nm to 15 nm.
  • Benefits of such thin coatings described herein include that while the duration of use may be reduced because of the reduced durability of thin coatings, a surprising benefit is the ability to provide a coating thickness that is matched or corresponds to one expected use of a device (the life of one treatment or surgical procedure) and discourages re-use of products intended to be single use devices.
  • the thin coatings can also improve the measurement and monitoring of phase angle delivered by the generator compared to thicker coatings.
  • the non-stick coating thickness can be controlled to such that natural wearing of the non-stick coating that occurs within the number of predetermined activations and still provides non-stick properties. However, after the number of predetermined activations, the non-stick properties are reduced such that might be dissuaded from using the device for another full procedure. As discussed herein, the non-stick coating provides enhanced non stick properties compared to an uncoated device. Once the non-stick coating wears, it can generally have similar anti-stick properties of the uncoated device.
  • the number of predetermined activations can be from about
  • non-stick properties can be provided by the non-stick coating for the predetermined number of activations.
  • the non stick coating has a thickness of about 15 nm and can be used to provide approximately 30 activations of enhanced anti-stick properties as compared to an uncoated device during 30 activations.
  • the non-stick coating can have a thickness in a range of about 90 nm to about 250 nm, that can provide better instrument response, such as delivering more heating, at lower power delivery values.
  • the thickness of the non-stick coating is 200 nm to 250 nm. In one example, the thickness of the non-stick coating is greater than 200 such as, but not limited to 220 nm.
  • Generators used with electrosurgical devices have a limited output of maximum voltage, maximum power, and maximum current. These limits can be imposed by the hardware or by the software to control the system in particular use scenarios. The hardware limit can become an issue when a generator is being used with a RF device that it wasn’t originally intended to be used with.
  • the thickness of the non-stick coating can be at least 225 nm to provide increased resistance, but less than 250 nm to limit additional insulative properties of the coating, and preferably about 230 nm. Due to the greater resistance of the thick non-stick coating compared to traditional electrosurgical devices, the preferred thickness can provide unexpected results of more preferable instrument response, such as delivering more heating, at lower power delivery values.
  • FIG. 4 illustrates a graph of power versus load of an example generator system. As seen in FIG. 4, the current output is not sufficient to supply the maximum power in lower resistances. That is, the optimal output is not achieved at resistances below 7 Ohms. Additionally, the graph illustrates that the optimal output is not achieved at resistances above 75 Ohms. The values illustrated in FIG. 4 are just examples and the values at which the optimal output is not achieved for a particular system vary depending on the particular system being used. [0063] Tissue also sees a reduction in resistance as it heats (assuming the fluid content remains unaltered and does not change to the more resistive state of steam).
  • the resistance of the device can be increased by an amount such that the benefit of having the ability for a lower current system to boil the material between the jaws at lower material resistances.
  • settings of the generator will also have to be adjusted to accommodate this change for things such as short circuits and absolute detection points.
  • the artificial increase in the seen resistance requires the value of short circuits to be raised by approximately the same amount as the artificial offset.
  • the value also has to be offset to accommodate for this difference.
  • FIGS. 5 through 10 provide simplified examples of a jaw member 100 including a body portion 102 and an electrically conductive sealing plate 104 (hereinafter “sealing plate 104”) having a non-stick coating 106.
  • the examples shown can be applied to jaw members 40, 44 discussed herein. Further, any combination of FIGS. 5 through 10 can be used to apply the non-stick coating to jaw members.
  • FIG. 5 illustrates an example where the non-stick coating 106 is applied to cover the entire external surface 108 of the sealing plate 104 including the tissue engaging surface 110 and the side surface 112 of the sealing plate 104.
  • the coating thickness can be uniform or not uniform.
  • FIG. 6 illustrates an example where the non-stick coating 106 is applied to cover the entire external surface 108 of the sealing plate 104 including the tissue engaging surface 110 and the side surface 112 of the sealing plate 104.
  • the non-stick coating 106 extends past the sealing plate 104 and onto the body portion 102 of the jaw member 100.
  • the coating thickness can be uniform or not uniform along the tissue engaging surface 110 and the body portion 102.
  • FIG. 7 illustrates an example where the non-stick coating 106 is applied to cover the entire external surface 108 of the sealing plate 104 including the tissue engaging surface 110 and the side surface 112 of the sealing plate 104. However, the non-stick coating 106 extends past the sealing plate 104 and onto the entire body portion 102 of the jaw member 100. As illustrated in FIG. 7, a first portion of the non-stick coating can have thickness A, which can be within the range of 10 nm to about 30 nm and any one or more other portions of the non-stick coating may have a thickness than 30 nm.
  • the non-stick coating along a majority of the tissue engaging surface 110 of the electrically conductive sealing plates can have the non-stick coating thickness A, which is within a range of 10 nm to about 30 nm and portions of the non-stick coating not on the tissue engaging surface of the electrically conductive sealing plates can have thickness B, which is greater than 30 nm, such as for example, but not limited to about 50 nm to about 250 nm.
  • thickness A which is within a range of 10 nm to about 30 nm
  • portions of the non-stick coating not on the tissue engaging surface of the electrically conductive sealing plates can have thickness B, which is greater than 30 nm, such as for example, but not limited to about 50 nm to about 250 nm.
  • FIG. 7 illustrates the sealing plate 140 having thickness A and the jaw body 102 having thickness B.
  • FIG. 8 illustrates an example where the non-stick coating 106 is applied to cover a portion of the external surface 108 of the sealing plate 104 and a portion of the jaw body 102.
  • the non-stick coating along the sealing plate 104 can include portions that do not include any non-stick coating, i.e., discontinuous.
  • FIG. 9 illustrates an example similar to the example shown in FIG. 5 but an insulative layer 108 is disposed between the sealing plate 104 and the jaw body 102.
  • the insulative layer can be formed from polyimide. However, in other examples, any suitable electrically insulative material may be utilized, such as polycarbonate, polyethylene, etc.
  • FIG. 10 illustrates an example similar to the example shown in FIG. 5 but a first coating 110 is deposited between the sealing plate 104 and the non-stick coating 106.
  • the first coating 100 can be a material that can increase the hardness and/or durability of the device.
  • the first coating 110 can be formed from one of chromium nitride and titanium nitride.
  • the thickness of the TiN or the CrN coating can be around 150 microns. While, e.g., the TiN is a slight electrical insulator compared to the steel of the sealing plate, it is negligible and would have little effect on the overall resistance with the non-stick coating 106 formed from a siloxane coating.
  • This example compares non-coated jaw members with jaw members having a 15 nm non-stick coating of HMDSO.
  • Example 1 Two sets of electrosurgical jaw members were tested.
  • the device in Example 1 was coated with 15 nm of HMDSO.
  • the device in Comparative Example A was not coated with the HMDSO.
  • the jaw members were connected to a VALLEYLABTM FT 10 electrosurgical generator available from Medtronic of Minneapolis, Minn. The generator was used to energize the jaw members to seal tissue for testing.
  • Example 1 and Comparative Example A were tested in sequence and repeated in the same sequence for 59 activations.
  • Example 1 and Comparative Example A were cleaned after the 26 th and 51 st activation with water, a wipe, and plastic dental pick. The following scoring guide shown in Table 1 was used.
  • FIG. 11 illustrates the results for Example 1 (Ex 1) and the Comparative Example A (CE A) sticking results. After the 26 th activation a cleaning, as described herein was performed on both devices. The coated device in Example 1 exhibits less sticking up to approximately the 30 th activation compared to the non-coated device in Comparative Example A. Thus, the non-stick coating of 15 nm can provide non-stick benefits greater than a non-coated device for approximately 30 activations.
  • the benefits of the systems and methods of the present disclosure can include tissue adherence resistance with non-stick coatings with certain thicknesses providing additional benefits beyond non-stick properties such as 1) encouraging one-time use and 2) providing better instrument response, such as delivering more heating, at lower power delivery values.
  • Example 1 includes an electrosurgical device.
  • the electrosurgical device includes at least one jaw member having an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue, and a non-stick coating disposed on at least a portion of the electrically conductive tissue sealing plate.
  • Example 2 the subject matter of Example 1 includes, where the non-stick coating is selected from one of polydimethylsiloxane, hexamethyldisiloxane, and tetram ethyl di sil oxane .
  • Example 3 the subject matter of Examples 1-2 includes, wherein the non-stick coating has a thickness within a range of about 10 nm to about 30 nm.
  • Example 4 the subject matter of Examples 1-3 includes, wherein the non-stick coating has a thickness of about 15 nm.
  • Example 5 the subject matter of Examples 1-4 includes, wherein the thickness of the non-stick coating has a predetermined number of activations before a tissue adhesion resistance of the non-stick coating decreases to that of a non-coated electrosurgical device.
  • Example 6 the subject matter of Examples 1-5 includes, wherein the predetermined number of activations is from about 20 activations to about 50 activations, wherein each activation is an application of energy to a patient’s tissue via the conductive tissue sealing plate.
  • Example 7 the subject matter of Examples 1-6 includes, wherein the non-stick coating has a thickness within a range of about 90 nm to about 250 nm.
  • Example 8 the subject matter of Examples 1-7 includes, wherein the non-stick coating has a thickness within a range of about 200 nm to about 250 nm.
  • Example 9 the subject matter of Examples 1-8 includes, wherein the non-stick coating has a thickness of about 220 nm.
  • Example 10 the subject matter of Examples 1-9 includes, wherein the non-stick coating has a substantially uniform thickness.
  • Example 11 the subject matter of Examples 1-10 includes, wherein the non stick coating has a non-uniform thickness.
  • Example 12 the subject matter of Examples 1-11 includes, wherein the non stick coating is discontinuous.
  • Example 13 the subject matter of Examples 1-12 includes, wherein the non stick coating is continuous.
  • Example 14 the subject matter of Examples 1-13 includes, an insulative layer disposed on at least a portion of the tissue sealing plate.
  • Example 15 the subject matter of Examples 1-14 includes, wherein the non stick coating is disposed on at least a portion of the at least one jaw member.
  • Example 16 the subject matter of Examples 1-13 includes, wherein the tissue sealing plate is formed of stainless steel.
  • Example 17 includes an electrosurgical device.
  • the electrosurgical device includes a pair of opposing jaw members, each of the opposing jaw members including: an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue; a support base configured to support the tissue sealing plate; and an insulative housing configured to secure the tissue sealing plate to the support base; and a non-stick coating disposed on at least a portion of at least one of the opposing jaw members, the non-stick coating having a thickness of from about 10 nm to 30 nm.
  • Example 18 the subject matter of Examples 1-2 includes, wherein the non stick coating is selected from one of polydimethylsiloxane, hexamethyldisiloxane, and tetram ethyl di sil oxane .
  • Example 19 the subject matter of Examples 17-18 includes, wherein the non stick coating has a thickness within a range of about 10 nm to about 30 nm.
  • Example 20 the subject matter of Examples 17-19 includes, wherein the non stick coating has a thickness of about 15 nm.
  • Example 21 the subject matter of Examples 17-20 includes, wherein the thickness of the non-stick coating has a predetermined number of activations before a tissue adhesion resistance of the non-stick coating decreases to that of a non-coated electrosurgical device.
  • Example 22 the subject matter of Examples 17-21 includes, wherein wherein the predetermined number of activations is from about 20 activations to about 50 activations, wherein each use is an application of energy to a patient’s tissue via the conductive tissue sealing plate.
  • Example 23 the subject matter of Examples 17-22 includes, wherein the non stick coating has a thickness within a range of about 90 nm to about 250 nm.
  • Example 24 the subject matter of Examples 17-23 includes, wherein the non stick coating has a thickness within a range of about 200 nm to about 250 nm.
  • Example 25 the subject matter of Examples 17-24 includes, wherein the non stick coating has a thickness of about 220 nm.
  • Example 26 the subject matter of Examples 17-25 includes, wherein the non stick coating disposed on at least a portion of each of the tissue sealing plate, the support base, and the insulative housing.
  • Example 27 the subject matter of Examples 17-26 includes, wherein the non stick coating has a substantially uniform thickness.
  • Example 28 the subject matter of Examples 17-27 includes, wherein the non stick coating has a non-uniform thickness.
  • Example 29 the subject matter of Examples 17-28 includes, wherein the non stick coating is discontinuous.
  • Example 30 the subject matter of Examples 17-29 includes, wherein the non stick coating is continuous.
  • Example 31 includes an electrosurgical device.
  • the electrosurgical device includes a pair of opposing jaw members, each of the opposing jaw members including: an electrically conductive tissue sealing plate configured to operably couple to a source of electrosurgical energy for treating tissue; a support base configured to support the tissue sealing plate; and an insulative housing configured to secure the tissue sealing plate to the support base; a first coating disposed on at least a portion of the electrically conductive tissue sealing plate of at least one of the opposing jaw members, the first coating configured to increase the durability of the at least one of the opposing jaw members; and a non-stick coating disposed on at least a portion of at least one of the opposing jaw members including a portion of the first coating.
  • Example 32 the subject matter of Example 31 includes, wherein the non-stick coating is selected from one of polydimethylsiloxane, hexamethyldisiloxane, and tetram ethyl di sil oxane .
  • Example 33 the subject matter of Examples 31-32 includes, wherein the first coating is selected from chromium nitride and titanium nitride.
  • Example 34 the subject matter of Examples 31-33 includes, wherein a thickness of the non-stick coating is within a range of about 10 nm to about 30 nm.
  • Example 35 the subject matter of Examples 31-34 includes, wherein a thickness of the non-stick coating is within is about 15 nm.
  • Example 36 the subject matter of Examples 31-35 includes, wherein a thickness of the non-stick coating is within a range of about 90 nm to about 250 nm.
  • Example 37 the subject matter of Examples 31-36 includes, wherein the non stick coating has a thickness within a range of about 200 nm to about 250 nm.
  • Example 38 the subject matter of Examples 31-37 includes, wherein the non stick coating has a thickness of about 220 nm.
  • Example 39 includes a method manufacturing an electrosurgical device.
  • the method includes coupling an electrically conductive sealing plate to a support base to form a jaw member; and applying a non-stick coating over at least a portion of the electrically conductive sealing plate, wherein the non-stick coating reduces sticking of the tissue to the electrically conductive sealing plate as compared to a non-coated electrically conductive sealing plate during delivery of electrosurgical energy.
  • Example 40 the subject matter of Example 39 includes, wherein the non-stick coating is selected from one of polydimethylsiloxane, hexamethyldisiloxane, and tetram ethyl di sil oxane .
  • Example 41 the subject matter of Examples 39-40 includes, wherein the non stick coating has a thickness within a range of about 10 nm to about 30 nm.
  • Example 42 the subject matter of Examples 39-41 includes, wherein the non stick coating has a thickness of about 15 nm.
  • Example 43 the subject matter of Examples 39-42 includes, wherein a thickness of the non-stick coating is within a range of about 90 nm to about 250 nm.
  • Example 44 the subject matter of Examples 39-43 includes, where the non stick coating has a thickness within a range of about 200 nm to about 250 nm.
  • Example 45 the subject matter of Examples 39-44 includes, wherein the non stick coating has a thickness of about 220 nm.
  • Example 46 the subject matter of Examples 39-45 includes, overmolding an insulative material about the support base to secure the electrically conductive sealing plate thereto.
  • Example 47 the subject matter of Examples 39-46 includes, coupling an electrical lead to the electrically conductive sealing surface, the electrical lead configured to connect the electrically conductive sealing surface to an energy source.
  • Example 48 includes a method of manufacturing an electrosurgical device.
  • the method includes applying a first coating to at least a portion of an electrically conductive sealing plate to form a coated electrically conductive sealing plate; coupling the coated electrically conductive sealing plate to a support base to form a jaw member; and applying a non-stick coating over at least a portion of the coated electrically conductive sealing plate, wherein the non-stick coating reduces sticking of the tissue to the electrically conductive sealing plate as compared to a non-coated electrically conductive sealing plate during delivery of electrosurgical energy.
  • Example 49 the subject matter of Example 48 includes, wherein the non-stick coating is selected from one of polydimethylsiloxane, hexamethyldisiloxane, and tetram ethyl di sil oxane .
  • Example 50 the subject matter of Examples 48-49 includes, wherein the first coating is selected from chromium nitride and titanium nitride.
  • Example 51 the subject matter of Examples 48-50 includes, wherein the non stick coating has a thickness within a range of about 10 nm to about 30 nm.
  • Example 52 the subject matter of Examples 48-51 includes, wherein the non stick coating has a thickness of about 15 nm.
  • Example 53 the subject matter of Examples 48-52 includes, wherein a thickness of the non-stick coating is within a range of about 90 nm to about 250 nm.
  • Example 54 the subject matter of Examples 48-53 includes, wherein the non stick coating has a thickness within a range of about 200 nm to about 250 nm.
  • Example 55 the subject matter of Examples 48-54 includes, wherein the non stick coating has a thickness of about 220 nm.
  • Example 56 the subject matter of Examples 48-55 includes, overmolding an insulative material about the support base to secure the electrically conductive sealing plate thereto.
  • Example 57 the subject matter of Examples 48-56 includes coupling an electrical lead to the electrically conductive sealing surface, the electrical lead configured to connect the electrically conductive sealing surface to an energy source.

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Abstract

Un instrument électrochirurgical comprend un élément de mâchoire ayant une plaque d'étanchéité de tissu électriquement conductrice conçue pour être couplée de manière fonctionnelle à une source d'énergie électrochirurgicale pour traiter un tissu. Dans un exemple, un dispositif électrochirurgical peut comprendre au moins un élément de mâchoire ayant une plaque d'étanchéité de tissu électriquement conductrice conçue pour être couplée de manière fonctionnelle à une source d'énergie électrochirurgicale afin de traiter un tissu, et un revêtement antiadhésif disposé sur au moins une partie de la plaque d'étanchéité de tissu électriquement conductrice.
PCT/US2021/072606 2020-11-25 2021-11-24 Dispositif électrochirurgical avec revêtement antiadhésif Ceased WO2022115868A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3459482A1 (fr) * 2017-09-22 2019-03-27 Covidien LP Dispositif de scellement tissulaire électrochirurgicale à revêtement anti-adhésif
US20190090935A1 (en) * 2017-09-22 2019-03-28 Covidien Lp Electrosurgical tissue sealing device with non-stick coating
US20200305960A1 (en) 2019-03-29 2020-10-01 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Forceps motion transfer assembly

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3459482A1 (fr) * 2017-09-22 2019-03-27 Covidien LP Dispositif de scellement tissulaire électrochirurgicale à revêtement anti-adhésif
US20190090935A1 (en) * 2017-09-22 2019-03-28 Covidien Lp Electrosurgical tissue sealing device with non-stick coating
US20200305960A1 (en) 2019-03-29 2020-10-01 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Forceps motion transfer assembly

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