# Patent

## Title
Method of switching energy modality on a cordless RF device

## Abstract

The present disclosure is directed to an electrosurgical instrument having a housing that includes a generator configured to output electrosurgical energy and a controller configured to control the output of the generator. The instrument also includes a switch coupled to the controller and configured to provide a signal to the controller to select the energy modality of the electrosurgical energy. An indicator is also included to provide an indication of the selected energy modality.

## Background
BACKGROUND
1. Technical Field
The present disclosure relates to electrosurgical instruments used for open and endoscopic surgical procedures for sealing or fusing tissue. More particularly, the present disclosure relates to systems and methods for switching energy modalities in a cordless electrosurgical device.
2. Background of the Related Art
Energy-based tissue treatment is well known in the art. Various types of energy (e.g., electrical, ultrasonic, microwave, cryogenic, thermal, laser, etc.) are applied to tissue to achieve a desired result. Electrosurgical instruments have become widely used by surgeons in recent years. By and large, most electrosurgical instruments are hand-held instruments, e.g., electrosurgical pencils, electrosurgical forceps, endoscopic instruments such as monopolar forceps, bipolar forceps or a combination monopolar/bipolar forceps, ultrasonic hand tools, microwave probes. Such electrosurgical instruments are electrically coupled to an external electrosurgical generator. The external electrosurgical generator includes a number of switches, knobs, buttons and/or screens to control the output of the electrosurgical generator. Some electrosurgical instruments are portable and include a generator integrated therein.
SUMMARY
This description may use the phrases “in an embodiment,” “in embodiments,” “in some embodiments,” or “in other embodiments,” which may each refer to one or more of the same or different embodiments in accordance with the present disclosure. For the purposes of this description, a phrase in the form “A/B” means A or B. For the purposes of the description, a phrase in the form “A and/or B” means “(A), (B), or (A and B)”. For the purposes of this description, a phrase in the form “at least one of A, B, or C” means “(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)”.
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 that is closer to the user or generator and the term “distal” refers to the end of the apparatus that is farther away from the user or generator. 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 of the present disclosure described herein.
Electromagnetic (EM) energy is generally classified by increasing frequency or decreasing wavelength into radio waves, microwaves, infrared, visible light, ultraviolet, X-rays and gamma-rays. As used herein, the term “microwave” generally refers to electromagnetic waves in the frequency range of 300 megahertz (MHz) (3×108 cycles/second) to 300 gigahertz (GHz) (3×1011 cycles/second). As used herein, the term “RF” generally refers to electromagnetic waves having a lower frequency than microwaves. As used herein, the term “ultrasound” generally refers to cyclic sound pressure with a frequency greater than the upper limit of human hearing. The terms “tissue” and “vessel” may be used interchangeably since it is believed that the present disclosure may be employed to seal and cut tissue or seal and cut vessels utilizing the same principles described herein.
The phrase “electrosurgical instrument” may refer to any instrument configured to output electrosurgical energy such as electrosurgical pencils, electrosurgical forceps, endoscopic instruments such as monopolar forceps, bipolar forceps or a combination monopolar/bipolar forceps, ultrasonic hand tools, microwave probes. The phrase “electrosurgical energy” may refer to energy used to perform a surgical procedure such as electromagnetic energy or acoustic energy. The phrase “end effector” may refer to any device capable of emitting electromagnetic energy or acoustic energy to treat tissue within the vicinity of the end effector. Types of end effector may include antennas, ultrasonic transducers, electrodes, jaw members, probes, acoustic waveguides, combinations thereof or the like.
The term “generator” may refer to a device capable of providing electrosurgical energy. Such device may include a power source and electrical components (analog and/or digital components) capable of modifying the energy outputted by the power source to output energy having a desired energy modality. The phrase “energy modality” may refer to the characteristics of the outputted electrosurgical energy. Such characteristics may include an energy mode, which includes the type of energy (e.g., RF, microwave, ultrasound, etc.) and/or waveform (e.g., sine wave, square wave, triangle wave, sawtooth wave, composite waves, etc.), and/or energy level.
The term “switch” may refer to a device for making, breaking or changing the connections in an electrical circuit. Switches used herein may include multi-positional switches, digital switches and/or analog switches that may be disposable or reposable.
The term “indicator” may refer to one or more audio or visual devices that provide information to a user or any other person in the vicinity of the indicator. Example of indicators include, but are not limited to, speakers, light emitted diodes, neon lamps, video displays, printed markers, etc.
The electrosurgical instruments herein may utilize one or more sensors configured to detect one or more properties of tissue and/or the ambient environment. Such properties include, but are not limited to: tissue impedance, tissue type, tissue clarity, tissue compliance, temperature of the tissue or jaw members, water content in tissue, jaw opening angle, water motility in tissue, energy delivery, and jaw closure pressure.
The electrosurgical instruments used herein may also utilize a controller to receive various inputs from a number of switches and or sensors and control the energy modality of the energy outputted by the electrosurgical instrument. The controller may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in a memory. The controller may include multiple processors and/or multicore central processing units (CPUs) and may include any type of processor, such as a microprocessor, digital signal processor, microcontroller, or the like.
Any of the herein described methods, programs, algorithms or codes may be converted to a programming language or computer program. A “Programming Language” and “Computer Program” is any-language used to specify instructions to a computer, and includes (but is not limited to) these languages and their derivatives: Assembler, Basic, Batch files, BCPL, C, C+, C++, Delphi, Fortran, lava, JavaScript, Machine code, operating system command languages, Pascal, Pearl, PU1, scripting languages, Visual Basic, metalanguages which themselves specify programs, and all first, second, third, fourth, and fifth generation computer languages. Also included are database and other data schemas, and any other meta-languages. For the purposes of this definition, no distinction is made between languages which are interpreted, compiled, or use both compiled and interpreted approaches. For the purposes of this definition, no distinction is made between compiled and source versions of a program. Thus reference to a program, where the programming language could exist in more than one state (such as source, compiled, object, or linked) is a reference to any and all states. The definition also encompasses the actual instructions and the intent of those instructions.
Any of the herein described methods, programs, algorithms or codes may be contained on one or more machine-readable media or memory. The term “memory” may include a mechanism that provides (i.e., stores and/or transmits) information in a form readable by a machine such a processor, computer, or a digital processing device. For example, a memory may include a read only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, or any other volatile or non-volatile memory storage device. Code or instructions contained thereon can be represented by carrier wave signals, infrared signals, digital signals, and by other like signals.
In an aspect of the present disclosure, an electrosurgical instrument is provided. The electrosurgical instrument includes a housing having a generator configured to output electrosurgical energy and a controller configured to control the output of the generator. The electrosurgical instrument also includes a switch coupled to the controller and configured to provide a signal to the controller to select the energy modality of the electrosurgical energy. An indicator is also included in the electrosurgical instrument to provide an indication of the selected energy modality.
The energy modality may include an energy level and the indicator provides an indication of the energy level or the energy modality may include an energy mode and the indicator provides an indication of the energy mode. Alternatively, the energy modality may include an energy level and an energy mode and the indicator provides an indication of the energy level and the energy mode. The indicator may be an audio device or a visual device such as a light emitting diode.
The housing may include a recess defined therein and the switch is disposed in the recess. The housing may include a rib surrounding the switch. The housing may also include a cover disposed over the switch that is configured to be opened in order to operate the switch.
The electrosurgical instrument may include a safety configured to prevent adjustment of the switch, wherein the switch is only operable when the safety is de-activated.
The switch may be a multi-position switch, a rotary switch that may include a potentiometer. The switch may be integrated into the housing or removable coupled from the housing.
The instrument may also include a memory having a plurality of energy modalities stored thereon.
In another aspect of the present disclosure, an electrosurgical instrument may be provided that includes a housing having a generator configured to output electrosurgical energy and a controller configured to control the output of the generator. The electrosurgical instrument also includes a touch screen coupled to the controller and configured to provide a signal to the controller to select the energy modality of the electrosurgical energy.
The energy modality may include an energy level and the touch screen provides an indication of the energy level or the energy modality may include an energy mode and the touch screen provides an indication of the energy mode. Alternatively, the energy modality may include an energy level and an energy mode and the touch screen provides an indication of the energy level and the energy mode.
The touch screen is configured to receive clinician identification information and/or patient identification information. The touch screen may be configured to display information corresponding to the clinician identification information and/or the patient identification information.
The touch screen may also be configured to receive biometric information. The electrosurgical instrument may also include a memory having biometric information stored thereon and the controller compares the received biometric information to the biometric information stored in a memory.
The electrosurgical instrument may also include a memory having a plurality of energy modalities stored thereon.
In yet another aspect of the present disclosure, an electrosurgical instrument may be provided having a housing including a generator configured to output electrosurgical energy, an end effector coupled to the generator and configured to output electrosurgical energy to tissue, and a control unit coupled to the housing. The control unit includes a controller configured to control the output of the generator and a touch screen coupled to the controller and configured to provide a signal to the controller to select the energy modality of the electrosurgical energy.
The control unit may be removably coupled to the housing.
The energy modality may include an energy level and the touch screen provides an indication of the energy level or the energy modality may include an energy mode and the touch screen provides an indication of the energy mode. Alternatively, the energy modality may include an energy level and an energy mode and the touch screen provides an indication of the energy level and the energy mode.
The touch screen may also be configured to receive biometric information. The electrosurgical instrument may also include a memory having biometric information stored thereon and the controller compares the received biometric information to the biometric information stored in a memory.
The electrosurgical instrument may also include a memory having a plurality of energy modalities stored thereon.



BRIEF DESCRIPTION OF THE DRAWINGS
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
FIG. 1 is a system block diagram of an electrosurgical instrument;
FIGS. 2A-2I depict various electrosurgical instruments according to embodiments of the present disclosure;
FIG. 3 is a system block diagram of an electrosurgical instrument according to another embodiment of the present disclosure;
FIG. 4 is a perspective view of an electrosurgical instrument of the electrosurgical instrument of FIG. 3;
FIG. 5 is a system block diagram of an electrosurgical instrument according to another embodiment of the present disclosure; and
FIG. 6 is a perspective view of an electrosurgical instrument of the electrosurgical instrument of FIG. 5.



DETAILED DESCRIPTION
Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, the disclosed embodiments 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 present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures.
The present disclosure is directed to an electrosurgical instrument that allows a user to change an energy level in a sterile environment. The electrosurgical instrument includes a switch disposed on the housing to control the energy level. The switch may be disposed on the housing for a one handed or two handed operation. Visual or audible indicators may be provided to indicate the energy level. Additionally, physical characteristics, as will be described below, may be integrated with the switch to minimize inadvertent activation of the switch.
Turning to FIG. 1, a system block diagram of an electrosurgical instrument is shown generally as 100. Instrument 100 includes a generator 102 configured to output electrosurgical energy to end effector 104. End effector 104 outputs the electrosurgical energy to tissue within the vicinity of end effector 104. Instrument 100 also includes a controller 106 that is configured to receive various inputs and output a control signal to generator 102 to control the output of generator 102. Controller 106 may receive inputs from a switch 108 that controls the energy modality of the electrosurgical energy, an activation button 110 that controls application of the electrosurgical energy, and/or sensors 112. Controller 106 is coupled to a memory 118 that has programs and/or algorithms used to control the output of the electrosurgical instrument 100 (e.g., open loop or closed loop feedback programs). Memory 118 may also store a number of programs for controlling the energy modality of the electrosurgical energy. Memory 118 may be a separate component or integrated into controller 106. Controller 106 also controls indicator 114 to output an audible or visual indication upon activation of the electrosurgical instrument 100 or upon a change of energy modality by switch 108.
FIGS. 2A-2I depict various electrosurgical instruments in accordance with various embodiments of the present disclosure. The electrosurgical instruments depicted in FIGS. 2A-2I include a housing 150 that includes generator 102, controller 106, switch 108, and activation button 110. Housing 150 may also include one or more sensors 112. Switch 108 may be permanently fixed to housing 150 or removably coupled to housing 150. Switch 108 may also be reposable or disposable. The switches may also be ergonomically dimensioned and/or disposed on the electrosurgical instrument.
Turning to FIG. 2A, housing 150 includes a multi-position switch 202 that is operated by the clinician to adjust the output of the energy level. Housing 150 may also include one or more indicators that provide the clinician with information regarding the energy level associated with the position of the switch. For instance, indicator 204 may be provided with numerous bars of varying length to indicate the energy level. Alternatively, indicator 206 may be provided text indicating “HIGH” and “LOW” to inform a clinician of which way the switch should be moved to increase or decrease the energy level.
FIG. 2B depicts a housing 150 having a switch 212. Switch 212 may be an analog switch (e.g., a potentiometer) that allows a user to adjust the energy level in small increments to finely tune the energy output. Switch 212 may include an indicator 214 such as a line or an arrow to indicate the energy level being outputted. Alternatively, an indicator 216 may be provided to indicate an energy level being outputting by the electrosurgical instrument. As shown in FIG. 2B, indicator 216 has series of dots that indicate the energy level where an increase in the number of dots indicates an increase in the energy level.
FIG. 2C depicts a housing 150 having a multi-position switch 222 used to control the energy mode of the electrosurgical energy outputted from generator 102. When switch 222 is moved from a first position to a second position, controller 106 determines which energy modality has been selected by a user. Controller 106 then controls generator 102 to output electrosurgical energy having the energy modality selected by the clinician. An indicator 224 is provided to inform the user of which energy modality corresponds to the position of switch 222. Alternatively, as shown in FIG. 2D, a rotary switch 232 may be provided having the modes printed thereon. An arrow 234 is printed next to rotary switch 232 to indicate which energy modality is being selected by the switch.
Any of the switches described above in FIGS. 2A-2D can be used to select a combination of an energy level and an energy mode. The indicators described above can be used to indicate the selected energy level and energy mode. Such indicators may be printed on the electrosurgical instrument or may be a device that emits light (e.g., LEDs).
In order to prevent a clinician from accidentally changing the intensity level or energy modality by inadvertently moving the switches described above in FIGS. 2A-2D, one or more safety devices and/or methods may be provided as shown in FIGS. 2E-2H. The safety devices and/or methods shown in FIGS. 2E-H may be combined with any of the switches described above with regard to FIGS. 2A-2D. For instance, as shown in FIG. 2E, a rib 244 is provided surrounding the outer edges of switch 242. Although FIG. 2E shows rib 244 surrounding the entire switch 242, rib 244 may be disposed along one edge, two edges, or three edges of the switch 242. Alternatively, rib 244 may be constructed to conform to any size or shape corresponding to the switch 242 being used. By placing rib 244 around switch 242, a clinician is prevented from inadvertently adjusting the energy modality of the electrosurgical energy.
FIG. 2F depicts another safety device according to another embodiment of the present disclosure. As shown in FIG. 2F, housing 150 includes a recess 152 therein. Switch 252 is disposed within recess 152 to prevent a clinician from inadvertently adjusting the energy modality of the electrosurgical energy. A safety shield 254 may also be provided to cover switch 252. Thus, when a clinician wants to switch the energy modality, the clinician would have to open safety shield 254 before adjusting switch 252. Safety shield 254 may be opened by sliding or pivoting safety shield 254.
FIG. 2G depicts another safety device according to another embodiment of the present disclosure. As shown in FIG. 2G, a safety 264 is provided on housing 150. Safety 264 may be a mechanical switch (e.g., a slider or push button), a pair of electrical contacts, or a capacitance switch. In operation, a clinician is prevented from adjusting switch 262 unless the clinician de-activates safety 264 concurrently.
FIG. 2H depicts a method of preventing inadvertent adjustment of switch 272 according to another embodiment of the present disclosure. As shown in FIG. 2H, switch 272 is placed on top of housing 150 away from a handle 154. By placing switch 272 on top of housing 150, a clinician would have to use a different hand to adjust the energy modality or energy level. Any of the switches described above can be placed in the location of switch 272 shown in FIG. 2H.
FIG. 2I depicts a switch 282 according to another embodiment of the present disclosure. Switch 282 is a touch switch (e.g., a capacitance switch) that only needs to be touched in order to operate the switch. A clinician may slide his/her finger up and down the switch 282 to change the energy level or intensity. Alternatively, each successive tap of the touch switch 282 may adjust the energy modality or energy level. An indicator 284 may be provided to inform the clinician of the energy level or modality. Indicator 284 may include a number of LEDs or other visual indicators to indicate the energy level or modality.
Any of the switches described above may be permanently fixed to housing 150 or removable coupled to housing 150. Any of the switches may also be reposable or disposable.
FIGS. 3 and 4 depict an electrosurgical instrument 300 according to another embodiment of the present disclosure. Electrosurgical instrument 300 includes a generator 102, end effector 104, activation button 110, sensors 112 controller 106, indicator 114, and memory 118 as described above with respect to FIG. 1. Further, instrument 300 also includes a touch screen 302 that controls electrosurgical instrument 300. Touch screen 302 may display various visual buttons 322 that allow a user to control the energy level and/or modality. Buttons 322 may cause instrument 300 to output energy having a selected energy level and/or modality. Alternatively, buttons 322 may open up a menu of options to select different energy levels and/or modalities. Buttons 322 may also be used to display information in display area 324 including, but not limited to, device information, energy output, sensor readings, duration of the electrosurgical procedure, waveform, energy level, energy modality.
Touch screen 302 may also be used to gather password information, clinician identification information, patient identification information, or biometric information to prevent unauthorized use of the instrument 300. Before, performing a procedure, a clinician may have to enter a password using a virtual keyboard displayed on touch screen 302. The virtual key board may display numeric characters such as 0-9, letters A-Z or a combination thereof. The virtual keyboard may also display a keypad similar to a telephone keypad that has letters corresponding to numbers.
The virtual keyboard may also be used to input a clinician identification information and/or patient identification information to keep records of the procedures performed on each patient by each clinician. Entering the clinician identification information and/or patient identification information may also call up specific programs or algorithms to be used during the electrosurgical procedure associated with the clinician and/or patient. The programs may be stored on memory 118 or they may be stored in a server (not shown) that communicates with electrosurgical instrument 300 via a standard network protocol. When the information is entered, touch screen 302 may display a list of patients to select from, a list of energy modalities to choose from, list of energy levels to use, or any other information that may be used during the electrosurgical procedure.
In another embodiment, touch screen 302 may be used to collect biometric information instead of entering clinician identification information and/or patient identification information. A clinician and/or patient can press one of his/her fingers on touch screen 302. Touch screen 302 captures an image of the fingerprint and compares it to a fingerprint stored in memory 118 or with a fingerprint stored in a server (not shown). If the image captured by touch screen 302 matches a stored fingerprint, the electrosurgical device is configured to be used as described above.
FIGS. 5 and 6 depict an alternative embodiment of the electrosurgical device shown in FIGS. 3 and 4. As shown in FIGS. 5 and 6, instrument 500 includes a generator 102, end effector 104, activation button 110, sensors 112, and interface 514. A control unit 502 is removable coupled to instrument 500. Control unit 502 may be disposable or reposable and includes a controller 106, indicator 114 (e.g., speaker), memory 118, and interface 512. When control unit 502 is coupled to instrument 500, interface 512 is coupled to interface 514. This allows control unit 502 to exercise control over the components of instrument 500 as well as allowing sensors 112 to send signals to controller 106.
While several embodiments of the disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. The claims can encompass embodiments in hardware, software, or a combination thereof. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. A handheld electrosurgical instrument, comprising:
a housing including a generator configured to output electrosurgical energy;
an elongated shaft directly coupled to the housing;
an end effector disposed at a distal portion of the elongated shaft;
a handle assembly coupled to the housing; and
a control unit removably and directly coupled to the housing, the control unit including:
a controller configured to control the output of the generator; and
a touch screen configured to permit a user to select an energy modality of the electrosurgical energy and to provide a signal to the controller based on the selected energy modality.

2. The handheld electrosurgical instrument according to claim 1, wherein the energy modality includes an energy level and the touch screen provides an indication of the energy level.

3. The handheld electrosurgical instrument according to claim 1, wherein the energy modality includes an energy mode and the touch screen provides an indication of the energy mode.

4. The handheld electrosurgical instrument according to claim 1, wherein the energy modality includes an energy level and an energy mode and the touch screen provides an indication of the energy level and the energy mode.

5. The handheld electrosurgical instrument according to claim 1, wherein the touch screen is configured to receive clinician identification information and/or patient identification information.

6. The handheld electrosurgical instrument according to claim 5, where the touch screen displays information corresponding to the clinician identification information and/or the patient identification information.

7. The handheld electrosurgical instrument according to claim 1, wherein the touch screen is configured to receive biometric information.

8. The handheld electrosurgical instrument according to claim 7, further comprising a memory having biometric information stored thereon and the controller compares the received biometric information to the biometric information stored in a memory.

9. The handheld electrosurgical instrument according to claim 1, further comprising a memory having a plurality of energy modalities stored thereon.

10. The handheld electrosurgical instrument according to claim 1, further comprising an end effector operably coupled to the housing.

11. The handheld electrosurgical instrument according to claim 10, wherein the end effector is coupled to the generator and is configured to output electrosurgical energy to tissue.