Patent Publication Number: US-8968314-B2

Title: Apparatus, system and method for performing an electrosurgical procedure

Description:
BACKGROUND 
     1. Technical Field 
     The following disclosure relates to an apparatus, system, and method for performing an electrosurgical procedure and, more particularly, to an apparatus, system and method that utilizes energy to cut and/or section tissue. 
     2. Description of Related Art 
     Electrosurgical apparatuses (e.g., electrosurgical forceps) are well known in the medical arts and typically include a handle, a shaft and an end effector assembly operatively coupled to a distal end of the shaft that is configured to manipulate tissue (e.g., grasp and seal tissue). Electrosurgical forceps utilize both mechanical clamping action and electrical energy to effect hemostasis by heating the tissue and blood vessels to coagulate, cauterize, seal, cut, desiccate, and/or fulgurate tissue 
     As an alternative to open electrosurgical forceps for use with open surgical procedures, many modern surgeons use endoscopes and endoscopic electrosurgical apparatus (e.g., endoscopic forceps) for remotely accessing organs through smaller, puncture-like incisions. As a direct result thereof, patients tend to benefit from less scarring and reduced healing time. Typically, the endoscopic forceps are inserted into the patient through one or more various types of cannulas or access ports (typically having an opening that ranges from about five millimeters to about twelve millimeters) that has been made with a trocar; as can be appreciated, smaller cannulas are usually preferred. 
     Endoscopic forceps that are configured for use with small cannulas (e.g., cannulas less than five millimeters) may present design challenges for a manufacturer of endoscopic instruments. 
     SUMMARY 
     According to an embodiment of the present disclosure, an electrosurgical apparatus includes a housing having a shaft extending therefrom. The shaft includes an end effector assembly at a distal end thereof. The end effector assembly includes first and second fixed jaw members disposed in spaced relation relative to one another. An electrically conductive tissue sealing plate is operatively coupled to each of the jaw members. The electrically conductive seal plates are adapted to connect to an electrosurgical energy source and communicate with a control system. The control system is configured to regulate the delivery of electrosurgical energy from the source of electrosurgical energy to the tissue sealing plate on each of the jaw members. A guide channel is disposed between the pair of fixed jaw members and extends proximally along the shaft from the distal end thereof. A knife is disposed at a proximal end of the guide channel and is configured to selectively cut tissue in a distal direction. 
     According to another embodiment of the present disclosure, an electrosurgical apparatus includes a housing having a shaft extending therefrom. The shaft defines an end effector assembly at a distal end thereof. The end effector assembly includes first and second fixed jaw members extending from the distal end of the shaft and disposed in spaced relation relative to one another. An electrically conductive tissue sealing plate is operatively coupled to each of the jaw members. The electrically conductive seal plates are adapted to connect to an electrosurgical energy source and communicate with a control system. The control system is configured to regulate the delivery of electrosurgical energy from the source of electrosurgical energy to the tissue sealing plate on each of the jaw members. A guide channel is disposed between the pair of fixed jaw members and extends proximally along the shaft from the distal end thereof. The guide channel is configured to accommodate tissue therein. A knife is disposed at a proximal end of the guide channel and is configured to selectively cut tissue within the guide channel upon the application of a distal force to the electrosurgical apparatus. 
     The present disclosure also provides a method for performing an electrosurgical procedure. The method includes the initial step of providing an electrosurgical apparatus. The electrosurgical apparatus includes a housing having a shaft extending therefrom. The shaft includes an end effector assembly at a distal end thereof. The end effector assembly includes first and second fixed jaw members disposed in spaced relation relative to one another. An electrically conductive tissue sealing plate is operatively coupled to each of the jaw members. The electrically conductive seal plates are adapted to connect to an electrosurgical energy source and communicate with a control system. The control system is configured to regulate the delivery of electrosurgical energy from the source of electrosurgical energy to the tissue sealing plate on each of the jaw members. A guide channel is disposed between the pair of fixed jaw members and extends proximally along the shaft from the distal end thereof. A knife is disposed at a proximal end of the guide channel and is configured to selectively cut tissue in a distal direction. The method also includes the steps of providing tension to the tissue disposed between the jaw members and applying a rotational force to the end effector assembly to facilitate contact between the tissue disposed between the jaw members and the tissue sealing plates. The method also includes the step of delivering electrosurgical energy from the source of electrosurgical energy to each of the tissue sealing plates to achieve a desired tissue effect. The method also includes the step of applying a distal force to the electrosurgical apparatus to facilitate the separation of tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
       Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein: 
         FIG. 1  is a perspective view of an electrosurgical apparatus and electrosurgical generator according to an embodiment of the present disclosure; 
         FIG. 2  is a block diagram illustrating components of the system of  FIG. 1 ; 
         FIG. 3  is a schematic representation of an electrical configuration for connecting the electrosurgical apparatus to the electrosurgical generator depicted in  FIG. 1 ; 
         FIGS. 4A ,  4 B, and  4 C illustrate the electrosurgical apparatus depicted in  FIG. 1  in use; and 
         FIG. 5  is a flowchart of a method for performing an electrosurgical procedure according to an embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Detailed embodiments of the present disclosure are disclosed herein; however, it is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. 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. 
     With reference to  FIG. 1 , bipolar forceps  10  is shown for use with various electrosurgical procedures and generally includes a housing  20 , a handle assembly  30  having a pair of stationary handles  40 ,  50 , a trigger assembly  70 , a rotating assembly  80 , a shaft  12 , and an end effector assembly  100  having jaw members  110 ,  120  that mutually cooperate to seal and divide large tubular vessels and large vascular tissues. Jaw members  110 ,  120  are typically rigid, which normally keeps jaw members  110 ,  120  in an open position wherein jaw members  110 ,  120  are disposed in spaced relation relative to one another. Although the majority of the figures depict a bipolar forceps  10  for use in connection with laparoscopic or endoscopic surgical procedures, the present disclosure may be used for more traditional open surgical procedures. 
     In the drawings and in the descriptions that follow, the term “proximal,” as is traditional, will refer to the end of the forceps  10  that is closer to the user, while the term “distal” will refer to the end that is farther from the user. 
     Shaft  12  has a distal end  16  that defines the end effector assembly  100 , such that end effector assembly  100  is monolithically formed therewith, and a proximal end  14  that mechanically engages the housing  20 . In certain embodiments, end effector assembly  100  may be a separate component from shaft  12  wherein the distal end  16  of shaft is configured to mechanically engage the end effector assembly  100 . Jaw members  110 ,  120  meet at a proximal end thereof to define a longitudinal guide channel  112  therebetween that extends proximally into the distal end  16  of shaft. A knife  122  configured to separate tissue is disposed at a proximal end of guide channel  112 . As will be discussed in further detail below, an operator of forceps  10  may utilize movement of forceps  10  to guide tissue proximally along guide channel  112  to engage knife  122  and facilitate separation of the tissue through the application of a force on forceps  10  in the distal direction. 
     Forceps  10  includes an electrosurgical cable  410  that connects the forceps  10  to a source of electrosurgical energy, e.g., generator  200 , shown schematically in  FIG. 1 . As shown in  FIG. 3 , cable  410  is internally divided into cable leads  410   a ,  410   b  and  425   b  that are designed to transmit electrical potentials through their respective feed paths through the forceps  10  to the end effector assembly  100 . 
     For a more detailed description of shaft  12 , trigger assembly  70 , rotation assembly  80 , and electrosurgical cable  410  (including line-feed configurations aid/or connections) reference is made to commonly owned Patent Publication No. 2003-0229344, filed on Feb. 20, 2003, entitled VESSEL SEALER AND DIVIDER AND METHOD OF MANUFACTURING THE SAME. 
     Each of the jaw members  110 ,  120  includes an electrically conductive sealing plate  118 ,  128 , respectively, that connects to the generator  200  to communicate electrosurgical energy through the tissue held therebetween. Electrically conductive sealing plates  118 ,  128 , which act as active and return electrodes, are connected to the generator  200  through cable  410 . 
     Seal plates  118 ,  128  may be manufactured from stamped steel. This may be accomplished by stamping, by overmolding, by overmolding a stamped electrically conductive sealing plate and/or by overmolding a metal injection molded seal plate. Shaft  12  includes an insulator  117  (e.g., a coating or a sheath) disposed at least partially thereon (e.g., at distal end  16 ) such that sealing plates  118 ,  128  are substantially surrounded by the insulator  117 . Insulator  117  is formed from any suitable dielectric material, for example, polymeric materials such as polyvinyl chloride (PVC), and the like. 
     To prevent short-circuiting from occurring between the knife  122  and the seal plates  118 ,  128  distal thereto, knife  122  may be provided with an insulative material (not explicitly shown) applied thereto. Alternatively, or in addition thereto, the portion of the knife  122  that is adjacent to the seal plate may be made from a non-conductive material. 
     With continued reference to  FIG. 1 , an illustrative embodiment of an electrosurgical generator  200  (generator  200 ) is shown. Generator  200  is operatively and selectively connected to bipolar forceps  10  for performing an electrosurgical procedure. As noted above, an electrosurgical procedure may include sealing, cutting, coagulating, desiccating, and fulgurating tissue all of which may employ RF energy. Generator  200  may be configured for monopolar and/or bipolar modes of operation. Generator  200  includes suitable components, parts, and/or members needed for a control system  300  (system  300 ) to function as intended. Generator  200  generates electrosurgical energy, which may be RF (radio frequency), microwave, ultrasound, infrared, ultraviolet, laser, thermal energy or other suitable electrosurgical energy. 
     An electrosurgical module  220  generates RF energy and includes a power supply  250  for generating energy and an output stage  252  which modulates the energy that is provided to the delivery device(s), such as an end effector assembly  100 , for delivery of the modulated energy to a patient. Power supply  250  may be a high voltage DC or AC power supply for producing electrosurgical current, where control signals generated by the system  300  adjust parameters of the voltage and current output, such as magnitude and frequency. The output stage  252  may modulate the output energy (e.g., via a waveform generator) based on signals generated by the system  300  to adjust waveform parameters, e.g., waveform shape, pulse width, duty cycle, crest factor, and/or repetition rate. System  300  may be coupled to the generator module  220  by connections that may include wired and/or wireless connections for providing the control signals to the generator module  220 . 
     With reference to  FIG. 2 , system  300  is configured to, among other things, analyze parameters such as, for example, power, tissue temperature, current, voltage, impedance, etc., such that a proper tissue effect can be achieved. System  300  includes one or more processors  302  in operative communication with a control module  304  executable on the processor  302 , and is configured to, among other things, quantify electrical and thermal parameters during tissue sectioning such that when a threshold value for electrical and thermal parameters is met, the control system  300  provides a signal to a user to apply a force to tissue. Control module  304  instructs one or more modules (e.g., an output module  306 ) to transmit electrosurgical energy, which may be in the form of a wave or signal/pulse, via one or more cables (e.g., cable  410 ) to one or both of the seal plates  118 ,  128 . Electrosurgical energy may be transmitted to each of the seal plates  118 ,  128  simultaneously or consecutively. 
     One or both of the jaw members  110 ,  120  may include one or more sensors  316 . Sensors  316  are placed at predetermined locations on, in, or along surfaces of the jaw members  110 ,  120 . In embodiments, end effector assembly  100  and/or jaw members  110  and  120  may have sensors  316  placed near a proximal end and/or near a distal end of jaw members  110  and  120 , as well as along the length of jaw members  110  and  120 . 
     In one embodiment, the control module  304  processes information and/or signals (e.g., tissue impedance and/or tissue temperature data from sensors  316 ) input to the processor  302  and generates control signals for modulating the electrosurgical energy in accordance with the input information and/or signals. Information may include pre-surgical data (e.g., tissue temperature threshold values) entered prior to the electrosurgical procedure or information entered and/or obtained during the electrosurgical procedure through one or more modules (e.g., OM module  306 ) and/or other suitable device(s). The information may include requests, instructions, ideal mapping(s) (e.g., look-up-tables, continuous mappings, etc.), sensed information, and/or mode selection. 
     In one embodiment, the control module  304  regulates the generator  200  (e.g., the power supply  250  and/or the output stage  252 ) which adjusts various parameters of the electrosurgical energy delivered to the patient (via one or both of the seal plates) during the electrosurgical procedure. Parameters of the delivered electrosurgical energy that may be regulated include voltage, current, resistance, intensity, power, frequency, amplitude, and/or waveform parameters, e.g., waveform shape, pulse width, duty cycle, crest factor, and/or repetition rate of the output and/or effective energy. 
     In one embodiment, the control module  304  includes software instructions executable by the processor  302  for processing algorithms and/or data received by sensors  316 , and for outputting control signals to the generator module  220  and/or other modules. The software instructions may be stored in a storage medium such as a memory internal to the processor  302  and/or a memory accessible by the processor  302 , such as an external memory, e.g., an external hard drive, floppy diskette, CD-ROM, etc. 
     In one embodiment, the control module  304  regulates the electrosurgical energy in response to feedback information, e.g., information related to tissue condition at or proximate the surgical site. Processing of the feedback information may include determining the following: changes in the feedback information, rate of change of the feedback information, and/or relativity of the feedback information to corresponding values sensed prior to starting the procedure (pre-surgical values) in accordance with the mode, control variable(s) and ideal curve(s) selected. The control module  304  then sends control signals to the generator module  220  such as for regulating the power supply  250  and/or the output stage  252 . 
     Regulation of certain parameters of the electrosurgical energy may be based on a tissue response, such as recognition that a proper seal is achieved and/or when a predetermined threshold temperature value is achieved. Recognition of the event may automatically switch the generator  200  to a different mode of operation (e.g., “stand by” mode or “RF output mode”) and subsequently switch the generator  200  back to an original mode after the event has occurred. In embodiments, recognition of the event may automatically switch the generator  200  to a different mode of operation and subsequently shutoff the generator  200 . 
     OM  306  (shown as two modules for illustrative purposes) may be digital and/or analog circuitry that can receive instructions from and provide status to a processor  302  (via, for example, a digital-to-analog or analog-to-digital converter). OM  306  is also coupled to control module  304  to receive one or more electrosurgical energy waves at a frequency and amplitude specified by the processor  302 , and/or transmit the electrosurgical energy waves along the cable  410  to one or both of the seal plates  118 ,  128 . OM  306  can also amplify, filter, and digitally sample return signals received by sensors  316  and transmitted along cable  410 . 
     A sensor module  308  senses electromagnetic, electrical, and/or physical parameters or properties at the operating site and communicates with the control module  304  and/or output module  306  to regulate the output electrosurgical energy. The sensor module  308  may be configured to measure, i.e., “sense”, various electromagnetic, electrical, physical, and/or electromechanical conditions, such as at or proximate the operating site, including: tissue impedance, tissue temperature, and so on. For example, sensors of the sensor module  308  may include sensors  316 , such as, for example, optical sensor(s), proximity sensor(s), pressure sensor(s), tissue moisture sensor(s), temperature sensor(s), and/or real-time and RMS current and voltage sensing systems. The sensor module  308  measures one or more of these conditions continuously or in real-time such that the control module  304  can continually modulate the electrosurgical output in real-time. 
     In embodiments, sensors  316  may include a smart sensor assembly (e.g., a smart sensor, smart circuit, computer, and/or feedback loop, etc. (not explicitly shown)). For example, the smart sensor may include a feedback loop which indicates when a tissue seal is complete based upon one or more of the following parameters: tissue temperature, tissue impedance at the seal, change in impedance of the tissue over time and/or changes in the power or current applied to the tissue over time. An audible or visual feedback monitor may be employed to convey information to the surgeon regarding the overall seal quality or the completion of an effective tissue seal. 
     With reference now to  FIGS. 4A ,  4 B, and  4 C, operation of bipolar forceps  10  under the control of system  300  according to one embodiment of the present disclosure is now described. For illustrative purposes, tissue division is described subsequent to the application of electrosurgical energy for achieving a desired tissue effect (e.g., tissue sealing). With specific reference to  FIG. 4A , a user grasps tissue (for example, with a surgical implement or suitable forceps  400 ) adjacent to the operating site and outside the seal zone and applies a pulling force “F” generally normal and along the same plane as the sectioning line. Application of the pulling force “F” provides tension to the desired tissue site for subsequent sealing and sectioning. With tension provided to the desired tissue site, the operator subsequently or substantially simultaneously rotates end effector assembly  100 , as indicated by rotational arrow “R”, in either a clock-wise and/or counter clock-wise direction to cause tissue sealing plates  118 ,  128  to contact the desired tissue site. Control module  304  instructs one or more modules (e.g., OM  306 ) to transmit electrosurgical energy, which may be in the form of a wave or signal/pulse, via one or more cables (e.g., cable  410 ) to one or both of the tissue seating plates  118 ,  128  simultaneously or consecutively to effect a tissue seal. Rotation of end effector assembly  100  may be achieved via, for example, use of rotation assembly  80  and/or movement of bipolar forceps  10  relative to the tissue to cause one or more of sealing plates  118 ,  128  to contact the desired tissue site. 
     Upon reaching a desired tissue effect, such as a tissue seal, control system  300  may indicate (by way of an audio or visual feedback monitor or indicator, previously mentioned and described above) to a user that tissue is ready for sectioning. Referring specifically to  FIG. 4B , with continued application of pulling force “F” to provide tension to the desired tissue site, the operator subsequently or substantially simultaneously applies a distal force “D” to forceps  10  to guide at least a portion of the effected tissue proximally along guide channel  112  and into engagement with knife  122  to sever the effected tissue, That is, the end effector assembly  100  is pushed distally with respect to the tissue by the operator to sever tissue with knife  122 . As best shown in  FIG. 4C , the application of pulling force “F” to the severed tissue separates the unwanted tissue from the operating site with minimal impact on the seal zone. The remaining tissue at the operating site is effectively sealed and the separated tissue may be easily discarded. 
       FIG. 5  shows a method  500  for performing an electrosurgical procedure. At step  502 , an electrosurgical apparatus including a pair of rigid jaw members configured to seal tissue therebetween and including a guide channel having a knife is provided. At step  504 , a force is applied to tissue adjacent the desired tissue site generally in a normal or transverse direction to provide tension to the desired tissue site. Subsequent to or substantially simultaneously with step  504 , a rotational force is applied to an end effector assembly of the apparatus to facilitate contact between the rigid jaw members and the desired tissue site, in step  506 . In step  508 , electrosurgical energy from an electrosurgical generator is directed through tissue between the jaw members to effect a tissue seal. At step  510 , with continued application of tension to the effected tissue site via the force in the normal or transverse direction, a distal force is subsequently or substantially simultaneously applied to the apparatus to facilitate the separation of tissue. 
     In embodiments, step  506  may include the step of applying the rotational force substantially simultaneously with delivering electrosurgical energy from the source of electrosurgical energy to seal plates  118 ,  128 . 
     In embodiments, the step of applying the distal force may include the step of applying the distal force consecutively after audible or visible indication (e.g., a distinct audible tone, an illuminated LED on generator  200 ). 
     While several embodiments of the disclosure have been shown in the drawings, 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. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.