Patent Description:
Electrosurgical forceps utilize mechanical clamping action along with electrical energy to effect hemostasis on the clamped tissue. The forceps (open, laparoscopic or endoscopic) include sealing plates which apply energy to the clamped tissue. By controlling the intensity, frequency and duration of the energy applied through the sealing plates to the tissue, the surgeon can cut, coagulate, cauterize, and/or seal tissue.

In the past, efforts have been made to reduce the sticking of soft tissue to the sealing plate during application of energy. In general, such efforts have envisioned non-stick surface coatings, such as polytetrafluoroethylene (PTFE, commonly sold under the trademark TEFLON®) for increasing the lubricity of the tool surface. However, these materials may interfere with the efficacy and efficiency of hemostasis. Accordingly, there is a need for electrosurgical generators configured to operate with electrosurgical instruments having a non-stick coating disposed on one or more electrodes.

<CIT> discloses an electrosurgical instrument and system to remove part of a polymeric coating on its electrode.

<CIT> discloses an electrosurgical instrument with a non-stick polymeric coating.

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. According to the invention there is provided an electrosurgical system as recited in claim <NUM> with preferred features as set forth in the dependent claims.

According to one embodiment of the present disclosure, an electrosurgical system is provided. The electrosurgical system includes an electrosurgical instrument having an electrode with a polymeric dielectric coating; and an electrosurgical generator, which includes a power converter configured to generate RF energy; a sensor coupled to the power converter and configured to sense a parameter of the RF energy; and a controller coupled to the sensor and the power converter. The controller is configured to control the power converter to output an RF waveform to achieve conductor breakthrough through the polymeric dielectric coating. The controller is further configured to determine whether the conductor breakthrough occurred based on the parameter; and execute a treatment algorithm based on a determination of the conductor breakthrough.

According to one aspect of the above embodiment, the controller is further configured to compare the parameter to a set threshold indicative of the conductor breakthrough. The controller is further configured to control the power converter to output the RF waveform for a set period of time and to execute the treatment algorithm based on the determination of the conductor breakthrough occurring within the set period of time.

According to another aspect of the above embodiment, the parameter that is measured is impedance and the controller is further configured to compare the measured impedance to a set impedance threshold. The controller is further configured to execute the treatment algorithm in response to the measured impedance being below the set impedance threshold and to adjust a power setting of the treatment algorithm prior to the execution of the treatment algorithm in response to the measured impedance being above the set impedance threshold. The controller is further configured to adjust a power setting of the RF waveform in response to the measured impedance being above the set impedance threshold.

According to a further aspect of the above embodiment, the parameter that is measured is one of voltage or current and the controller is further configured to compare the measured voltage and/or current to a set voltage and/or current threshold.

A method is described but does not form part of the present invention. The method includes electrically coupling an electrosurgical instrument to an electrosurgical generator. The electrosurgical instrument includes an electrode having a polymeric dielectric coating. The method further includes controlling a power converter of the electrosurgical generator to output an RF waveform to achieve conductor breakthrough through the polymeric dielectric coating and sensing at least one parameter of the RF waveform at a sensor of the electrosurgical generator. The method further includes determining at a controller of the electrosurgical generator whether the conductor breakthrough occurred based on the at least one parameter and executing a treatment algorithm at the controller based on a determination of the conductor breakthrough.

According to one aspect of the above embodiment, determining whether the conductor breakthrough occurred further includes comparing the at least one parameter to a set threshold indicative of the conductor breakthrough. The method further includes outputting the RF waveform for a set period of time. Further, the treatment algorithm is executed based on the determination of the conductor breakthrough occurring within the set period of time.

According to another aspect of the above embodiment, the method further includes measuring impedance; and comparing the measured impedance to a set impedance threshold. The method further includes executing the treatment algorithm in response to the measured impedance being below the set impedance threshold. The method further includes adjusting a power setting of the treatment algorithm prior to the execution of the treatment algorithm in response to the measured impedance being above the set impedance threshold. The method further includes adjusting a power setting of the RF waveform in response to the measured impedance being above the set impedance threshold.

According to another aspect of the above embodiment, the method further includes measuring voltage and/or current and comparing the measured voltage and/or current to a set voltage and/or current threshold.

The above and other aspects, features, and advantages of the present electrosurgical tissue sealing instruments will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:.

Particular aspects of the present electrosurgical tissue sealing instruments are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed aspects are merely examples of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the concepts of the present disclosure in virtually any appropriately detailed structure.

Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term "proximal" refers to the end of the apparatus which is closer to the user and the term "distal" refers to the end of the apparatus which is further away from the user. The term "clinician" refers to any medical professional (i.e., doctor, surgeon, nurse, or the like) performing a medical procedure involving the use of aspects described herein.

All numerical values and ranges disclosed above may vary by some amount. Whenever a numerical range with a lower limit and an upper limit is disclosed, any number and any included range falling within the range are specifically disclosed. In particular, every range of values (of the form, "from about a to about b," or, equivalently, "from approximately a to b," or, equivalently, "from approximately a-b") disclosed herein is to be understood to set forth every number and range encompassed within the broader range of values. Unless the meaning is clearly to the contrary, all ranges set forth herein are deemed to be inclusive of the endpoints. Unless specifically stated or obvious from context, as used herein, the term "about" when used in conjunction with a stated numerical value or range denotes somewhat more or somewhat less than the stated value or range, to within a range of ± <NUM>% of that stated value or range.

As described in more detail below with reference to the accompanying figures, the present disclosure is directed to electrosurgical instruments 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 carefully controlled, allowing for desired electrical performance while providing tissue sticking reduction during tissue sealing.

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. The material may be porous to allow for electrical transmission. Among such materials are silicone and silicone resins that 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. In some embodiments, the non-stick coating is made from a composition including a siloxane, which may include hexamethyldisiloxane, tetramethylsilane, hexamethyldisilazane, or combinations thereof.

In some embodiments, the non-stick coating is a polydimethylsiloxane coating formed by plasma-enhanced chemical vapor deposition ("PECVD") of hexamethyldisiloxane ("HMDSO"). Advantageously, 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.

In some embodiments, opposing jaw members of an electrosurgical vessel sealing instrument (see <FIG> and <FIG>) include electrically conductive tissue sealing plates on which the non-stick coating is directly deposited. The application of the non-stick coating may be accomplished using any system and process capable of precisely controlling the thickness of the coating. In some embodiments, HMDSO is deposited on the sealing plates using plasma enhanced chemical vapor deposition (PECVD) or other suitable methods such as atmospheric pressure plasma enhanced chemical vapor deposition (AP-PECVD). For example, 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. One such illustrative system and process is described in commonly-owned <CIT>. 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 thickness of the non-stick coating affects the non-stick performance of the sealing plates and may affect the tissue sealing performance of the sealing plates as well. For example, if the non-stick coating is too thick, the tissue sealing performance of the sealing plates may be negatively affected. More specifically, a non-stick coating above a particular thickness (e.g., greater than about <NUM>) may create a uniform dielectric barrier or surface impedance on the sealing plates, which may negatively impact the effectiveness of tissue sensing algorithms employed by an electrosurgical generator that controls the delivery of electrosurgical energy to the vessel sealing instrument based on sensed tissue parameters (e.g., impedance, temperature, etc.) generated by the application of electrosurgical energy to the tissue via the sealing plates. If the applied non-stick coating is too thin (e.g., less than about <NUM>), the non-stick coating may not provide adequate tissue sticking reduction.

Embodiments of the present disclosure provide for disposing a non-stick coating on components of a vessel sealing instrument (e.g., sealing plates, jaw members, electrical leads, 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.

In some embodiments, a polydimethylsiloxane coating may be applied to a portion of the electrosurgical device at a thickness from about <NUM> to about <NUM>, in embodiments, the coating may be from about <NUM> to about <NUM>, and in further embodiments, from about <NUM> to about <NUM>. In a particular embodiment, the non-stick coating may be about <NUM> thick. In some embodiments, the thickness of the non-stick coating may vary such that the non-stick coating has a substantially non-uniform thickness. For example, a first portion of the non-stick coating may be about <NUM> thick and any one or more other portions of the non-stick coating may have a thickness other than about <NUM> but within the range of about <NUM> to about <NUM>, in embodiments within the range of from about <NUM> to about <NUM>, and in further embodiments, from about <NUM> to about <NUM>. In other embodiments, the non-stick coating has a substantially uniform thickness. Without wishing to be bound by any particular theory, it is believed that polydimethylsiloxane coatings in the foregoing range do not provide a complete surface seal, and that it is the lack of a complete uniform seal over the surface at these controlled thicknesses that allows the electrical algorithms of certain electrosurgical generators to perform properly. One such electrosurgical generator employing a tissue sensing algorithm is described in <CIT>. Those skilled in the art reviewing the present disclosure will readily envision other electrosurgical generators employing other algorithms.

In some embodiments, the thickness of the non-stick coating is about <NUM>% of the thickness of the sealing plate.

Turning now to <FIG>, an instrument generally identified as forceps <NUM> is for use with various surgical procedures and includes a housing <NUM>, a handle assembly <NUM>, a rotating assembly <NUM>, a trigger assembly <NUM>, and an end effector <NUM> that mutually cooperate to grasp, seal, and divide tubular vessels and vascular tissues. Forceps <NUM> includes a shaft <NUM> extending from a distal end of the housing <NUM>. The shaft <NUM> has a distal end <NUM> configured to mechanically engage the end effector <NUM> and a proximal end <NUM> that mechanically engages the housing <NUM>.

The end effector <NUM> includes opposing jaw members <NUM> and <NUM>, which cooperate to effectively grasp tissue for sealing purposes. Both jaw members <NUM> and <NUM> pivot relative to one another about a pivot pin (not shown). Alternatively, the forceps <NUM> may include a jaw member <NUM> movable relative to a stationary jaw member <NUM>, and vice versa. The jaw members <NUM> and <NUM> may be curved to facilitate manipulation of tissue and to provide better "line-of-sight" for accessing targeted tissues. A sensor <NUM> may be disposed on or proximate to at least one of the jaw members <NUM> and <NUM> for sensing tissue parameters (e.g., temperature, impedance, etc.) generated by the application of electrosurgical energy to tissue via the jaw members <NUM> and <NUM>. The sensor <NUM> may include a temperature sensor, tissue hydration sensor, impedance sensor, optical clarity sensor, jaw gap sensor, strain and/or force sensor, or the like. Through a cable (not shown) coupling the forceps <NUM> to an electrosurgical generator (not shown), sensed tissue parameters may be transmitted 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 <NUM> based on data received from the sensor <NUM>.

Examples of forceps are shown and described in <CIT> and <CIT>.

With regard to <FIG>, an open forceps <NUM> for use with various surgical procedures is shown. The forceps <NUM> includes a pair of opposing shafts <NUM> and <NUM> having an end effector <NUM> disposed at a distal end of the shafts <NUM>, <NUM>. The end effector <NUM> includes pair of opposing jaw members <NUM> and <NUM> that are connected about a pivot member <NUM> and that are movable relative to one another to grasp tissue. Each shaft <NUM> and <NUM> includes a handle <NUM> and <NUM>, respectively, to facilitate movement of the shafts <NUM> and <NUM> relative to one another to pivot the jaw members <NUM> and <NUM> between an open position, wherein the jaw members <NUM> and <NUM> are disposed in spaced relation relative to one another, and a closed position, wherein the jaw members <NUM> and <NUM> cooperate to grasp tissue there between. Similar to the forceps <NUM> shown in <FIG>, a sensor <NUM> may be disposed on or proximate to at least one of the jaw members <NUM> and <NUM> of the forceps <NUM> for sensing tissue parameters (e.g., temperature, impedance, etc.) generated by the application of electrosurgical energy to tissue via the jaw members <NUM> and <NUM>. The sensor <NUM> may include a temperature sensor, tissue hydration sensor, impedance sensor, optical clarity sensor, or the like. Through a cable (not shown) coupling the forceps <NUM> to an electrosurgical generator (not shown), sensed tissue parameters may be transmitted 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 <NUM> based on data received from the sensor <NUM>.

<FIG> and <FIG> show perspective views of the jaw members <NUM> and <NUM>, respectively, according to an embodiment of the present disclosure. The jaw members <NUM> and <NUM> may be utilized with the endoscopic forceps <NUM> (<FIG>) or the open forceps <NUM> (<FIG>) and operate similarly as described above with respect to the jaw members <NUM> and <NUM> (<FIG>) and the jaw members <NUM> and <NUM> (<FIG>). Each of the jaw members <NUM> and <NUM> include: sealing plates <NUM> and <NUM>, respectively; electrical leads 325a and 325b, respectively; and support bases <NUM> and <NUM> that extend distally from flanges <NUM> and <NUM>, respectively.

Each of the sealing plates <NUM> and <NUM> include an underside 328a and 328b, respectively, that may include a respective electrically insulative layer 330a and 330b bonded thereto or otherwise disposed thereon. The electrically insulative layers 330a and 330b operate to electrically insulate the sealing plates <NUM> and <NUM>, respectively, from the support bases <NUM> and <NUM>, respectively. Further, the electrically insulative layers 330a and 330b operate to prevent or slow the onset of corrosion of the sealing plates <NUM> and <NUM>, respectively, at least on the undersides 328a, 328b thereof. In one embodiment, the electrically insulative layers 330a and 330b may be formed from polyimide. However, in other embodiments, any suitable electrically insulative material may be utilized, such as polycarbonate, polyethylene, etc..

Additionally, each of the jaw members <NUM> and <NUM> include an outer surface 311a and 311b, respectively, that includes a non-stick (e.g., polydimethylsiloxane) coating <NUM> disposed thereon. The non-stick coating <NUM> may be disposed on selective portions of either of the jaw members <NUM> and <NUM>, or may be disposed on the entire outer surfaces 311a and 311b. In some embodiments, the non-stick coating <NUM> is disposed on a tissue-engaging surface 317a and 317b of the sealing plates <NUM> and <NUM>, respectively. The non-stick coating <NUM> operates to reduce the sticking of tissue to the sealing plates <NUM> and <NUM>, the jaw members <NUM> and <NUM>, the electrical leads 325a and 325b, and/or the surrounding insulating material.

The support bases <NUM> and <NUM> are configured to support the sealing plates <NUM> and <NUM> thereon. The sealing plates <NUM> and <NUM> may be affixed atop the support bases <NUM> and <NUM>, respectively, by any suitable method including but not limited to snap-fitting, overmolding, stamping, ultrasonic welding, laser welding, etc. The support bases <NUM> and <NUM> and the sealing plates <NUM> and <NUM> are at least partially encapsulated by insulative housings <NUM> and <NUM>, respectively, by way of an overmolding process to secure sealing plates <NUM> and <NUM> to support bases <NUM> and <NUM>, respectively. The sealing plates <NUM> and <NUM> are coupled to electrical leads 325a and 325b, respectively, via any suitable method (e.g., ultrasonic welding, crimping, soldering, etc.). The electrical leads 325a and 325b serve to deliver electrosurgical energy (e.g., from an electrosurgical energy generator) to the sealing plates <NUM> and <NUM>, respectively. More specifically, electrical lead 325a supplies a first electrical potential to sealing plate <NUM> and electrical lead 325b supplies a second electrical potential to opposing sealing plate <NUM>.

Jaw member <NUM> (and/or jaw member <NUM>) may also include a series of stop members <NUM> disposed on the tissue-engaging surface 311b of the sealing plate <NUM> to facilitate gripping and manipulation of tissue and to define a gap between the jaw members <NUM> and <NUM> during sealing and cutting of tissue. The series of stop members <NUM> may be disposed (e.g., formed, deposited, sprayed, affixed, coupled, etc.) onto the sealing plate <NUM> during manufacturing. Some or all of the stop members <NUM> may be coated with the non-stick coating <NUM> or, alternatively, may be disposed on top of the non-stick coating <NUM>.

The sealing plates <NUM> and <NUM> may include longitudinal knife slots 315a and 315b, respectively, defined there through and configured to receive a knife blade (not shown) that reciprocates through the knife slots 315a and 315b to cut tissue. The electrically insulative layers 330a and 330b disposed on the respective undersides 328a and 328b of sealing plates <NUM> and <NUM>, respectively, allow for various blade configurations such as, for example, T-shaped blades or I-shaped blades that may contact the underside of the sealing plate (and/or insulating layer) during reciprocation through knife slots 315a, 315b. That is, the electrically insulative layers 330a, 330b operate to protect both the knife blade and the undersides 328a and 328b of the sealing plates <NUM> and <NUM>, respectively, from damage or wearing. Further, in the instance that an electrically conductive knife blade is utilized (e.g., for electric tissue cutting), the electrically insulative layers 330a, 330b help to electrically insulate the sealing plates <NUM>, <NUM> from the electrically conductive knife blade.

Turning now to <FIG>, a front cross sectional view of sealing plate <NUM> is shown and will be described. Sealing plate <NUM> has a stainless steel layer <NUM>, a non-stick coating <NUM>, and, optionally, an electrically insulative layer 330a disposed on the underside 328b of the stainless steel layer <NUM>. The non-stick coating <NUM> may be applied to at least the outer surface 311a of the stainless steel layer <NUM>. Bonding electrically insulative layer 330a to stainless steel layer <NUM> may be accomplished by any suitable method including, but not limited to, applying adhesive between electrically insulative layer 330a and stainless steel layer <NUM>, using heat treatment to bond electrically insulative layer 330a to stainless steel layer <NUM>, and/or any combinations thereof. The optional electrically insulative layer 330a may have a thickness ranging from about <NUM> inches to about <NUM> inches.

The non-stick coating <NUM> may be discontinuous or continuous. In some embodiments, the discontinuity or continuity of the non-stick coating <NUM> may depend on the thickness of the non-stick coating <NUM>. In some embodiments, the non-stick coating may be continuous over the entire sealing plate <NUM>, thereby hermetically sealing the sealing plate <NUM>. In some embodiments, the non-stick coating may be discontinuous over the entire sealing plate <NUM>. The discontinuous non-stick coating may be applied intermittently on the sealing plate <NUM> using a suitable discontinuous-coating or patch-coating process. The patchiness of the discontinuous non-stick coating may allow the thickness of the discontinuous non-stick coating to be increased relative to a continuous non-stick coating while maintaining adequate non-stick performance and tissue sealing performance.

In some embodiments, the sealing plate <NUM> may be formed by bonding a sheet of electrically insulative material to a sheet of stainless steel and coating the sheet of stainless steel with a non-stick coating. Once the two materials are bonded together, and the stainless steel sheet is coated with the non-stick coating <NUM>, sealing plate <NUM> may be formed by stamping, machining, or any other suitable method used to form a sealing plate.

In some embodiments, the sealing plate <NUM> may first be formed by stamping, machining, or any other suitable method used to form a sealing plate. Once the sealing plate <NUM> is formed, the non-stick coating <NUM> is applied to the sealing plate <NUM> prior to assembling jaw member <NUM>. Once the sealing plate <NUM> is coated with the non-stick coating <NUM>, the sealing plate <NUM> may be affixed atop the support base <NUM>, secured to the support base <NUM> via the insulative housing <NUM>, and coupled to the electrical lead 325a as described above with respect to <FIG> to form the jaw member <NUM>. Optionally, once the jaw member <NUM> is formed, a non-stick coating may be applied to the other components of the jaw member <NUM> (e.g., the support base <NUM>, the insulative housing <NUM>, the electrical lead 325a, etc.). In some embodiments, a non-stick coating may be applied to other components of forceps <NUM> (<FIG>) or forceps <NUM> (<FIG>) to reduce frictional sticking associated with operation of these devices. For example, a non-stick coating may be applied to the shaft <NUM> of forceps <NUM>, to the pivot member <NUM> and opposing shafts <NUM> and <NUM> of forceps <NUM>, and/or to a knife (not shown) used with either of forceps <NUM> or forceps <NUM>.

Turning now to <FIG>, a front cross sectional view of jaw member <NUM> is shown and will be described. Jaw member <NUM> includes sealing plate <NUM> having a stainless steel layer <NUM> and, optionally, an electrically insulative layer 330a. Sealing plate <NUM> is affixed to support base <NUM> via any suitable process. Additionally, with sealing plate <NUM> secured to support base <NUM>, the combined sealing plate <NUM> and support base <NUM> is secured to insulative housing <NUM> via any suitable process. A non-stick coating <NUM> is applied to the outer surface 311a of the assembled sealing plate <NUM>, the support base <NUM>, the insulative housing <NUM>, and, optionally the electrical lead 325a (<FIG>). In some embodiments it may be useful to partially coat the outer surface 311a of the jaw member <NUM> or include thicker layers of the non-stick coating <NUM> on different portions of the outer surface 311a of the jaw member <NUM>.

Additionally or alternatively, in some embodiments, the sealing plate <NUM> may be coated with the non-stick coating <NUM> in the manner described above with respect to <FIG> and the outer surface 311a of the jaw member <NUM> may also be coated with the non-stick coating <NUM>.

Once the non-stick coating <NUM> is disposed on the sealing plates <NUM> and <NUM> and/or the jaw member <NUM>, which may be assembled with an opposing jaw member (e.g., pivotably coupled) to form an end effector (e.g., end effector <NUM> or end effector <NUM>). In some embodiments, the non-stick coating <NUM> may be disposed on the sealing plates <NUM> and <NUM> and/or the jaw member <NUM> subsequent to assembly of the end effector.

In some embodiments, a polydimethylsiloxane coating at the above-described thickness or within the above-described range of thicknesses may be combined with one or more additional coatings. For example, the one or more coatings may be disposed directly on the stainless steel layer of the sealing plate prior to the polydimethylsiloxane coating being deposited such that the polydimethylsiloxane coating is disposed directly on the one or more coatings and not directly on the stainless steel layer of the sealing plate. <CIT> describes a vessel sealing instrument having sealing plates with a HMDSO-based coating disposed over a chromium nitride ("CrN") coating.

It is envisioned that any suitable chemical vapor deposition or plasma vacuum system may be used to perform the method, such as the system disclosed in <CIT>. The non-stick coating <NUM> may be applied using the method disclosed in <CIT>.

<FIG> is a perspective view of the components of one illustrative embodiment of an electrosurgical system <NUM> according to the present disclosure. The system <NUM> may include an electrosurgical generator <NUM> configured to couple to the forceps <NUM> (<FIG>), forceps <NUM> (<FIG>), or any other suitable electrosurgical instrument. One of the jaw members <NUM> or <NUM> of the forceps <NUM> acts as an active electrode with the other jaw member being a return electrode. Electrosurgical alternating RF current is supplied to the active electrode of the forceps <NUM> by a generator <NUM> via a supply line <NUM> that is connected to an active terminal <NUM> (<FIG>) of the generator <NUM>. The alternating RF current is returned to the generator <NUM> from the return electrode via a return line <NUM> at a return terminal <NUM> (<FIG>) of the generator <NUM>. The supply line <NUM> and the return line <NUM> may be enclosed in a cable <NUM>.

The forceps <NUM> may be coupled to the generator <NUM> at a port having connections to the active and return terminals <NUM> and <NUM> (e.g., pins) via a plug (not shown) disposed at the end of the cable <NUM>, wherein the plug includes contacts from the supply and return lines <NUM>, <NUM> as described in more detail below.

With reference to <FIG>, a front face <NUM> of the generator <NUM> is shown. The generator <NUM> may include a plurality of ports <NUM>-<NUM> to accommodate various types of electrosurgical instruments (e.g., monopolar electrosurgical instrument, forceps <NUM>, forceps <NUM>, etc.).

The generator <NUM> includes a user interface <NUM> having one or more display screens <NUM>, <NUM>, <NUM> for providing the user with variety of output information (e.g., intensity settings, treatment complete indicators, etc.). Each of the screens <NUM>, <NUM>, <NUM> is associated with a corresponding port <NUM>-<NUM>. The generator <NUM> includes suitable input controls (e.g., buttons, activators, switches, touch screen, etc.) for controlling the generator <NUM>. The screens <NUM>, <NUM>, <NUM> are also configured as touch screens that display a corresponding menu for the instruments (e.g., forceps <NUM>). The user then adjusts inputs by simply touching corresponding menu options.

Screen <NUM> controls monopolar output and the devices connected to the ports <NUM> and <NUM>. Port <NUM> is configured to couple to a monopolar electrosurgical instrument and port <NUM> is configured to couple to a foot switch (not shown). The foot switch may be used to provide for additional inputs (e.g., replicating inputs of the generator <NUM>). Screen <NUM> controls monopolar and bipolar output and the devices connected to the ports <NUM> and <NUM>. Port <NUM> is configured to couple to other monopolar instruments. Port <NUM> is configured to couple to a bipolar instrument (not shown).

Screen <NUM> controls the forceps <NUM> that may be plugged into one of the ports <NUM> and <NUM>, respectively. The generator <NUM> outputs energy through the ports <NUM> and <NUM> suitable for sealing tissue grasped by the forceps <NUM>. In particular, screen <NUM> outputs a user interface that allows the user to input a user-defined intensity setting for each of the ports <NUM> and <NUM>. The user-defined setting may be any setting that allows the user to adjust one or more energy delivery parameters, such as power, current, voltage, energy, etc. or sealing parameters, such as energy rate limiters, sealing duration, etc. The user-defined setting is transmitted to a controller <NUM> (<FIG>) where the setting may be saved in memory. In embodiments, the intensity setting may be a number scale, such as for example, from one to ten or one to five. In embodiments, the intensity setting may be associated with an output curve of the generator <NUM>. The intensity settings may be specific for each forceps <NUM> being utilized, such that various instruments provide the user with a specific intensity scale corresponding to the forceps <NUM>. The active and return terminals <NUM> and <NUM> (<FIG>) may be coupled to any of the desired ports <NUM>-<NUM>.

With continued reference to <FIG>, each of the ports <NUM>-<NUM> may include a reader, such as an optical reader or a radio frequency interrogator, configured to communicate with the forceps <NUM> to extract data pertaining to the forceps <NUM>. Such data may be encoded in a barcode, an RFID tag, computer-readable storage, or any other data storage medium <NUM>, which may be disposed on the forceps <NUM> or any of its components, such as the cable <NUM>. In embodiments, the data may include whether the forceps <NUM> includes coated or uncoated jaw members <NUM> and <NUM>. In further embodiments, the data may also include properties of the coating, such as its thickness, dielectric properties, current and voltage limits, temperature limits, and the like.

<FIG> shows a schematic block diagram of the generator <NUM>, which includes a controller <NUM>, a power supply <NUM>, and a power converter <NUM>. The power supply <NUM> may be a high voltage, DC power supply connected to an AC source (e.g., line voltage) and provides high voltage, DC power to the power converter <NUM>, which then converts high voltage, DC power into RF energy and delivers the energy to the active terminal <NUM>. The energy is returned thereto via the return terminal <NUM>. The active and return terminals <NUM> and <NUM> are coupled to the power converter <NUM> through an isolation transformer <NUM>.

The power converter <NUM> is configured to operate in a plurality of modes, during which the generator <NUM> outputs corresponding waveforms having specific duty cycles, peak voltages, crest factors, etc. It is envisioned that in other embodiments, the generator <NUM> may be based on other types of suitable power supply topologies. Power converter <NUM> may be a resonant RF amplifier or a non-resonant RF amplifier, as shown. A non-resonant RF amplifier, as used herein, denotes an amplifier lacking any tuning components, i.e., inductors, capacitors, etc., disposed between the power converter and a load "Z," e.g., tissue coupled through forceps <NUM>.

The controller <NUM> includes a processor (not shown) operably connected to a memory (not shown), which may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically-erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and/or set of instructions described in the present disclosure including, but not limited to, a hardware processor, a field programmable gate array (FPGA), a digital signal processor (DSP), a central processing unit (CPU), a microprocessor, and combinations thereof. Those skilled in the art will appreciate that the processor may be substituted for by any logic control circuit adapted to perform the calculations and/or execute a set of instructions described herein.

The controller <NUM> includes an output port that is operably connected to the power supply <NUM> and/or power converter <NUM> allowing the processor to control the output of the generator <NUM> according to either open and/or closed control loop schemes. A closed loop control scheme is a feedback control loop, in which a plurality of sensors measure a variety of tissue and energy properties (e.g., tissue impedance, tissue temperature, output power, current and/or voltage, etc.), and provide feedback to the controller <NUM>. The controller <NUM> then controls the power supply <NUM> and/or power converter <NUM>, which adjusts the DC and/or power supply, respectively.

The generator <NUM> according to the present disclosure may also include a plurality of sensors (not shown). The sensors may be coupled to the power supply <NUM> and/or power converter <NUM> and may be configured to sense properties of DC current supplied to the power converter <NUM> and/or RF energy outputted by the power converter <NUM>, respectively. The controller <NUM> also receives input signals from the input controls of the generator <NUM> and/or forceps <NUM>. The controller <NUM> utilizes the input signals to adjust power outputted by the generator <NUM> and/or performs other control functions thereon.

Power converter <NUM> includes a plurality of switching elements 728a-728d arranged in an H-bridge topology. In embodiments, power converter <NUM> may be configured according to any suitable topology including, but not limited to, half-bridge, full-bridge, push-pull, and the like. Suitable switching elements include voltage-controlled devices such as transistors, field-effect transistors (FETs), combinations thereof, and the like. In embodiments, the FETs may be formed from gallium nitride, aluminum nitride, boron nitride, silicon carbide, or any other suitable wide bandgap materials. In further embodiments, the FETs may be any suitable FETs, such as conventional silicon FETs.

The controller <NUM> is in communication with both power supply <NUM> and power converter <NUM>. Controller <NUM> is configured to output control signals, which may be a pulse-width modulated ("PWM") signal, to switching elements 728a-728d as described in further detail in co-pending application published as <CIT>. In particular, controller <NUM> is configured to modulate a control signal di supplied to power supply <NUM> and control signal d<NUM> supplied to switching elements 728a-728d of power converter <NUM>. Additionally, controller <NUM> is configured to calculate power characteristics of generator <NUM>, and control generator <NUM> based at least in part on the measured power characteristics.

The controller <NUM> is configured to execute one or more vessel sealing algorithms, which control the output of the generator <NUM> to treat tissue (e.g., seal vessels). Exemplary algorithms are disclosed in commonly-owned <CIT> and <CIT>.

Algorithms according to the present disclosure may be embodied as software instructions executable by the controller <NUM>. In embodiments, an algorithm may be an impedance-based energy delivery algorithm in which energy is delivered by the generator <NUM> to the tissue until a predetermined impedance threshold is met or energy is otherwise delivered based on measured tissue impedance. In further embodiments, the sealing algorithm may include configurable parameters, which may be a value settable manually by the user or automatically by the controller <NUM> during or prior to execution of the sealing algorithms. Suitable configurable parameters include threshold values, such as completion impedance, starting impedance, and offset impedance; intensity setting, such as a current setting, and a voltage setting; and duration setting, such as maximum time of energy application. In embodiments, other parameters of the algorithms may also be adjusted, such as the parameters of algorithms disclosed in <CIT> and <CIT>.

In embodiments, the non-stick coating <NUM> of the jaw members <NUM> and <NUM> may be too thick and thus, too insulating, such that the measured impedance between the jaw members <NUM> and <NUM> would be too high for the generator <NUM> to output RF energy to treat tissue, such as seal vessels. The present disclosure provides for a plurality of algorithms executable by the controller <NUM>, which are configured to apply a sufficient amount of energy to the jaw members <NUM> and <NUM> to achieve conductor breakthrough in order to overcome excessive insulation of the non-stick coating <NUM> in situations, such as when the non-stick coating <NUM> is too thick.

The present disclosure provides for pre-treatment algorithms embodied as software instructions, which when executable by the controller <NUM>, which controls the power converter <NUM> to output an RF waveform for overcoming excessing insulation of the non-stick coating <NUM> and achieve conductor breakthrough. The generator <NUM> monitors one or more parameters that are indicative of conductor breakthrough. Once the controller <NUM> determines that conductor breakthrough has occurred, the controller <NUM> proceeds to execute a tissue treatment algorithm. If the conductor breakthrough is not achieved, the controller <NUM> prevents the generator <NUM> from outputting energy.

With reference to <FIG>, a pre-treatment algorithm for achieving conductor breakthrough in jaw members <NUM> and <NUM> or any other electrodes having the non-stick coating <NUM> is embodied as a flow chart <NUM>. Initially, the controller <NUM> signals the power converter <NUM> to output an RF waveform. The RF waveform may be a <NUM>% duty cycle continuous waveform having maximum power of about <NUM> Watts, maximum current of about <NUM> Amps, and maximum voltage of about <NUM> Volts. In further embodiments, the RF waveform may be a pulsed waveform having a duty cycle from about <NUM> % to about <NUM> %. The RF waveform is applied for a set period of time, which may be from about <NUM> msec to about <NUM> sec, and in embodiments, may be from about <NUM> msec to about <NUM> msec. The controller <NUM> continuously receives measured impedance from one or more sensors (not shown) of the generator <NUM> and compares the measured impedance to a set impedance that is indicative of achieving conductor breakthrough of the non-stick coating <NUM>. The set impedance may be settable by the user or automatically by the generator <NUM> based on the type of forceps <NUM> that is connected to the generator <NUM>.

If the measured impedance drops below the set impedance, then the controller <NUM> proceeds to execute a treatment algorithm such as sealing algorithms disclosed in <CIT> and <CIT>. If the impedance is above the set threshold, then the generator <NUM> continues to apply the RF waveform until a predetermined time limit is reached.

In embodiments, the threshold for switching to the treatment algorithm may be any other parameter, such as voltage or current. With respect to other parameters the threshold is selected that is also indicative of increasing conductivity of the jaw members <NUM> and <NUM>. Increasing conductivity corresponds to achieving conductor breakthrough. Thus, in embodiments where current and/or voltage is used as a parameter, the controller <NUM> compares the measured current and/or voltage to a set current and/or voltage threshold to determine if the measured current and/or voltage is below the set current threshold. Once the measured current and/or voltage exceeds the set current threshold, then the controller <NUM> proceeds to execute the treatment algorithm. Similarly to the impedance being used as a parameter, the generator <NUM> continues to apply the RF waveform until the set time period expires.

The controller <NUM> maintains a timer for the application of the RF waveform and compares the measured time of the timer to the set time period. In embodiments, the timer may be maintained by any other controller within or outside the generator <NUM>. If the timer has not yet expired and the impedance does not drop below the set threshold (or if current and/or voltage does not exceed the set threshold), the generator <NUM> continues to apply the RF waveform until set time period expires. If the set time period expires without the measured impedance dropping below the set threshold, or without the measured current and/or voltage exceeding the set threshold, then the pre-treatment algorithm instructs the generator <NUM> to issue a retry alert, such as instructing the user to re-grasp the tissue with the jaw members <NUM> and <NUM>.

With reference to <FIG>, another embodiment of a pre-treatment algorithm for achieving conductor breakthrough in the non-stick coating <NUM> is shown as a flow chart <NUM>. Initially, the controller <NUM> signals the power converter <NUM> to output the RF waveform, which may be the same as the RF waveform of the algorithm of the flow chart <NUM>. The RF waveform may be applied for a period of time, which may be from about <NUM> msec to about <NUM> sec, and in embodiments, may be from about <NUM> msec to about <NUM> msec. The controller <NUM> continuously receives measured impedance from sensors of the generator <NUM> and compares the measured impedance to the set impedance that is indicative of achieving conductor breakthrough of the non-stick coating <NUM>. In embodiments, the controller <NUM> may sample the measured impedance at a predetermined rate. The set impedance may be settable by the user or automatically by the generator <NUM> based on the type of forceps <NUM> connected to the generator <NUM>. Similarly to the algorithm of the flow chart <NUM>, the measured parameter and threshold may be voltage and/or current.

If the measured impedance drops below the set impedance or if the measured parameter is voltage and/or current and exceeds the set threshold, then the controller <NUM> proceeds to execute the treatment algorithm such as sealing algorithms disclosed in <CIT> and <CIT>. If the impedance is above the set threshold, then the generator <NUM> executes the treatment algorithm, but with an adjustment.

In embodiments, the treatment algorithm may include a plurality of power settings corresponding to the power of the treatment effect. Thus, a low setting, e.g., setting of <NUM>, corresponds to the lowest power setting, and a high power setting, e.g., setting of <NUM>, corresponds to the highest power setting. The power setting may be implemented in the algorithm by associating a power setting value with one or more adjustable parameters within the algorithm. In embodiments, adjustable parameters of the algorithm may include a current setting and a voltage setting at which the algorithm, when executed by the controller <NUM> outputs a treatment RF waveform. In embodiments, the controller <NUM> may store a look-up table of power setting values and one or more corresponding adjustable parameters, such that when the power setting is selected, the controller <NUM> selects corresponding parameters.

The adjustment to the treatment algorithm includes automatically selecting a suitable power setting based on the comparison of the measured impedance or other parameter to the set threshold. If the impedance is above the set threshold, then the generator <NUM> executes the treatment algorithm at a higher power setting.

In embodiments, the controller <NUM> is configured to execute the treatment algorithm at a higher power setting if the impedance is above the set threshold. The amount of the power increase is correlated to the amount of the difference between the measured impedance or other parameter and the set threshold. In further embodiments, the algorithm may adjust the power setting of the treatment algorithm if the measured impedance is also below the set threshold. Thus, if the measured impedance is substantially equal (±<NUM>%) to the set threshold, then the controller <NUM> proceeds to execute the pre-treatment algorithm without modifying the power setting. However, if the measured impedance is different from the set threshold, then the controller <NUM> executes the pre-treatment algorithm by adjusting the power setting by an adjustment value, which may be the same as a percentage difference between the measured parameter and the set threshold. In embodiments, the adjustment value may be based on a look-up table or calculated according to a transfer function by the controller <NUM>.

With reference to <FIG>, a further embodiment of a pre-treatment algorithm for achieving conductor breakthrough in the non-stick coating <NUM> is shown as a flow chart <NUM>. Initially, the controller <NUM> signals the power converter <NUM> to output an RF waveform for a set period of time, which may be similar to the waveform of the algorithms of the flow charts <NUM> and <NUM>. The RF waveform is applied for a period of time, which may be from about <NUM> msec to about <NUM> sec, and in embodiments, may be from about <NUM> msec to about <NUM> msec. The controller <NUM> continuously receives measured impedance from sensors of the generator <NUM> and compares the measured impedance to a set impedance that is indicative of achieving conductor breakthrough of the non-stick coating <NUM>. The set impedance may be settable by the user or automatically by the generator <NUM> based on the type of forceps <NUM> connected to the generator <NUM>. Similarly to the algorithms of the flow charts <NUM> and <NUM>, the measured parameter and threshold may be voltage and/or current.

If the measured impedance drops below the set impedance, then the controller <NUM> proceeds to execute a treatment algorithm such as sealing algorithms disclosed in <CIT> and <CIT>. If the impedance is above the set threshold, then the generator <NUM> continues to apply the RF waveform until set time period expires.

The controller <NUM> maintains a timer for the application of the RF waveform and compares the measured time of the timer to the set time period. If the timer has not yet expired, namely, if the measured time is below the set time period, and the impedance does not drop below the set threshold (or if current and/or voltage does not exceed the set threshold), the generator <NUM> continues to apply the RF waveform until the set time period expires.

In addition, the controller <NUM> also increases a power setting of the RF waveform. In embodiments, the power intensity may be increased incrementally and periodically. More specifically, the power intensity of the RF waveform may be increased in any suitable increment, such as by about <NUM>% of the initial power setting or discrete power amounts, such as from about <NUM> watts to about <NUM> watts, or in embodiments from about <NUM> watts to about <NUM> watts. The power setting increments may occur periodically, with each period being from about <NUM> msec to about <NUM> msec, in embodiments from about <NUM> msec to about <NUM> msec.

If the set time period expires, without the measured impedance dropping below the set threshold or without the measured current and/or voltage exceeding the set threshold, then the pre-treatment algorithm instructs the generator <NUM> to issue a retry alert, such as instructing the user to regrasp the tissue with the jaw members <NUM> and <NUM>.

Claim 1:
An electrosurgical system comprising:
an electrosurgical instrument including an electrode having a polymeric dielectric coating; and
an electrosurgical generator including:
a power converter configured to generate RF energy;
a sensor coupled to the power converter and configured to sense at least one parameter of the RF energy; and
a controller coupled to the sensor and the power converter, the controller configured to:
control the power converter to output an RF waveform to achieve conductor breakthrough through the polymeric dielectric coating;
determine whether the conductor breakthrough occurred based on the at least one parameter; and
to execute a treatment algorithm when the determination indicates that the conductor breakthrough has occurred.