1. Technical Field
The following disclosure relates to an apparatus, system, and method for performing an electrosurgical procedure and, more particularly, to local optimization of electrode current densities utilizing electrode geometries.
2. Description of Related Art
It is well known in the art that electrosurgical generators are employed by surgeons in conjunction with electrosurgical instruments to perform a variety of electrosurgical surgical procedures (e.g., tonsillectomy, adenoidectomy, etc.). An electrosurgical generator generates and modulates electrosurgical energy which, in turn, is applied to the tissue by an electrosurgical instrument. Electrosurgical instruments may be either monopolar or bipolar and may be configured for open or endoscopic procedures.
Electrosurgical instruments may be implemented to ablate, seal, cauterize, coagulate, and/or desiccate tissue and, if needed, cut and/or section tissue. Typically, cutting and/or sectioning tissue is performed with a knife blade movable within a longitudinal slot located on or within one or more seal plates associated with one or more jaw members configured to receive a knife blade, or portion thereof. The longitudinal slot is normally located on or within the seal plate within a treatment zone (e.g., seal and/or coagulation zone) associated therewith. Consequently, the knife blade cuts and/or sections through the seal and/or coagulation zone during longitudinal translation of the knife blade through the longitudinal slot. In some instances, it is not desirable to cut through the zone of sealed or coagulated tissue, but rather to the left or right of the zone of sealed or coagulated tissue such as, for example, during a tonsillectomy and/or adenoidectomy procedure.
According to an embodiment of the present disclosure, an end effector assembly for use with a bipolar forceps includes a pair of opposing first and second jaw members at least one of which being movable relative to the other to grasp tissue therebetween. Each jaw member includes a pair of spaced apart, electrically conductive tissue sealing surfaces. Each tissue sealing surface is adapted to connect to a source of electrosurgical energy to conduct electrosurgical energy through tissue held therebetween to effect a tissue seal. The end effector assembly also includes an insulator disposed between each pair of electrically conductive sealing surfaces and an electrically conductive cutting element disposed within each insulator and defining a geometrical configuration including a plurality of peaks having a period that is a multiple of an operating frequency of the electrosurgical energy. The cutting elements are adapted to connect to the source of electrosurgical energy to conduct electrosurgical energy through tissue held therebetween to effect a tissue cut.
According to another embodiment of the present disclosure, an end effector assembly for use with a bipolar forceps includes a pair of opposing first and second jaw members at least one of which being movable relative to the other from a first position wherein the jaw members are disposed in spaced relation relative to one another to a second position wherein the jaw members cooperate to grasp tissue therebetween. Each jaw member includes a pair of spaced apart, electrically conductive tissue sealing surfaces extending along a length thereof. Each tissue sealing surface is adapted to connect to a source of electrosurgical energy to conduct electrosurgical energy through tissue held therebetween to effect a tissue seal. The end effector assembly also includes an insulator disposed between each pair of electrically conductive sealing surfaces and an electrically conductive cutting element disposed within the insulator of the first jaw member and in general vertical registration with an electrically conductive cutting element disposed within the insulator of the second jaw member. Each of the electrically conductive cutting elements includes a plurality of peaks offset from a plurality of peaks of the other cutting element. The number of peaks of at least one of the cutting elements is a function of a wavelength of an operating frequency of the electrosurgical energy. The cutting elements are adapted to connect to the source of electrosurgical energy to conduct electrosurgical energy through tissue held therebetween to effect a tissue cut. The cutting elements are inactive during tissue sealing and the pair of spaced apart electrically conductive sealing surfaces on the first jaw member are energized to a different potential from the corresponding pair of spaced apart electrically conductive sealing surfaces on the second jaw member such that electrosurgical energy can be transferred through the tissue to effect a tissue seal.
According to another embodiment of the present disclosure, a method of manufacturing an electrically conductive cutting element adapted to be coupled to an end effector assembly for effecting a tissue cut includes the steps of providing an electrically conductive electrode having a predetermined length and calculating a number of peaks along the predetermined length and a period based on a repetition of the peaks. The number of peaks is a function of an operating frequency of an energy source adapted to supply electrosurgical energy to the electrically conductive cutting element.
Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
For the purposes herein, vessel/tissue cutting or vessel/tissue division is believed to occur when heating of the vessel/tissue leads to expansion of intracellular and/or extra-cellular fluid, which may be accompanied by cellular vaporization, desiccation, fragmentation, collapse and/or shrinkage along a so-called “cut zone” in the vessel/tissue. By focusing the electrosurgical energy and heating in the cut zone, the cellular reactions are localized creating a fissure. Localization is achieved by regulating the vessel/tissue condition and energy delivery, which may be controlled by utilizing one or more of the various geometrical electrode configurations described herein. The cut process may also be controlled by utilizing a generator and feedback algorithm (and one or more of the hereindescribed geometrical configurations of the electrode assemblies) that increases the localization and maximizes the so-called “cutting effect”.
In general, the below-described factors contribute and/or enhance vessel/tissue division using electrosurgical energy. Each of the factors described below may be employed individually or in any combination to achieve a desired cutting effect. For the purposes herein, the term “cut effect” or “cutting effect” refers to the actual division of tissue by one or more of the electrical or electromechanical methods or mechanisms described below. The term “cutting zone” or “cut zone” refers to the region of vessel/tissue where cutting will take place. The term “cutting process” refers to steps that are implemented before, during, and/or after vessel/tissue division that tend to influence the vessel/tissue as part of achieving the cut effect.
For the purposes herein, 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 in the present disclosure.
By way of example and without limitation, factors that either alone or in combination play an important role in dividing tissue include: (1) localizing or focusing electrosurgical energy in the cut zone during the cutting process while minimizing energy effects to surrounding tissues; (2) focusing the current density in the cut zone during the cutting process; (3) creating an area of increased temperature in the cut zone during the cutting process (e.g., heating that occurs within the tissue or heating the tissue directly with a heat source); and (4) pulsing the energy delivery to influence the tissue in or around the cut zone.
Electrode assemblies described herein utilize various geometrical configurations of electrodes, cutting elements, insulators, partially conductive materials, and semiconductors to produce or enhance the cutting effect. In addition, by controlling or regulating the electrosurgical energy from the generator in any of the ways described above, tissue cutting may be initiated, enhanced, or facilitated within the tissue cutting zone.
For example, the geometrical configuration of the electrodes may be configured to produce a so-called “cut effect” that is directly related to the current density applied to a point in the tissue. The geometry of the electrodes may be configured such that the surface area ratios between the electrical poles focus electrical energy at the tissue. Moreover, optimization of the “cut effect” may be achieved by configuring the geometry of bipolar-type electrodes to include a specific number of peaks (see
Referring now to
The proximal end 14 of shaft 12 mechanically engages the rotating assembly 80 (not shown) to facilitate rotation of the electrode assembly 105. 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. Details relating to the mechanically cooperating components of the shaft 12 and the rotating assembly 80 are described in commonly-owned U.S. Pat. No. 7,156,846.
Handle assembly 30 includes a fixed handle 50 and a movable handle 40. Fixed handle 50 is integrally associated with housing 20 and, handle 40 is movable relative to fixed handle 50 to impart movement of the jaw members 110 and 120 from an open position wherein the jaw members 110 and 120 are disposed in spaced relation relative to one another, to a clamping or closed position wherein the jaw members 110 and 120 cooperate to grasp tissue therebetween. Switch assembly 70 is configured to selectively provide electrical energy to the electrode assembly 105.
Referring now to
Each shaft 112a and 112b includes a handle 117a and 117b disposed at the proximal end 114a and 114b thereof which each define a finger hole 118a and 118b, respectively, therethrough for receiving a finger of the user. Finger holes 118a and 118b facilitate movement of the shafts 112a and 112b relative to one another that, in turn, pivot the jaw members 110 and 120 from the open position wherein the jaw members 110 and 120 are disposed in spaced relation relative to one another to the clamping or closed position wherein the jaw members 110 and 120 cooperate to grasp tissue therebetween. A ratchet 130 is included for selectively locking the jaw members 110 and 120 relative to one another at various positions during pivoting.
As best seen in
One of the shafts, e.g., 112b, includes a proximal shaft connector/flange 121 that is configured to connect the forceps 100 to a source of electrosurgical energy (e.g., electrosurgical generator 500). More particularly, flange 121 mechanically secures electrosurgical cable 210 to the forceps 100 such that the user may selectively apply electrosurgical energy as needed.
As best shown in the schematic illustration of
The various electrical connections of the electrode assembly 105 are configured to provide electrical continuity to the tissue contacting surfaces 110 and 120 and the cutting element(s) 127 through the electrode assembly 105. For example, cable lead 210 may be configured to include three different leads, namely, leads 207, 208 and 209 that carry different electrical potentials. The cable leads 207, 208 and 209 are fed through shaft 112b and connect to various electrical connectors (not shown) disposed within the proximal end of the jaw member 110 which ultimately connect to the electrically conductive sealing surfaces 112 and 122 and cuffing element(s) 127.
The various electrical connections from lead 210 are dielectrically insulated from one another to allow selective and independent activation of either the tissue contacting surfaces 112 and 122 or the cutting element 127. Alternatively, the electrode assembly 105 may include a single connector that includes an internal switch (not shown) to allow selective and independent activation of the tissue contacting surfaces 112, 122 and the cutting element 127.
As best seen in
With respect to
At least one jaw member 110 and/or 120 includes an electrically conductive cutting element 127 disposed substantially within or disposed on the insulator 113, 123. As described in detail below, the cutting element 127 (in many of the embodiments described hereinafter) plays a dual role during the sealing and cutting processes, namely: 1) to provide the necessary gap distance between conductive surfaces 112a, 112b and 122a, 122b during the sealing process; and 2) to electrically energize the tissue along the previously formed tissue seal to cut the tissue along the seal. With respect to
The general characteristics of the jaw members 110 and 120 and the electrode assembly 105 will initially be described with respect to
In some embodiments, the cutting elements 127a and 127b are configured to extend from their respective insulators 113 and 123, respectively, and extend beyond the tissue contacting surfaces 112a, 112b and 122a, 122b such that the cutting elements 127a and 127b act as stop members (i.e., create a gap distance “G” (See
With respect to
In some embodiments, the geometrical configuration of the cutting elements 127a and 127b may, at least in part, determine the overall effectiveness of the tissue cut. Certain geometries of the cutting elements 127a and 127b may create higher areas of current density than other geometries. Moreover, the spacing of the return electrodes 112b and 122b to these current density affects the electrical fields through the tissue. Therefore, by configuring the cutting elements 127a and 127b and the respective insulators 113 and 123 within close proximity to one another, the current density remains high which is ideal for cutting and the instrument will not short due to accidental contact between conductive surfaces. The relative size of the cutting elements 127a and 127b and/or the size of the insulator 113 and 123 may be selectively altered depending upon a particular or desired purpose to produce a particular surgical effect.
Turning now to the embodiments of the electrode assembly 105 as disclosed herein,
Each insulator 113 and 123 is set back a predetermined distance between the sealing surfaces 112a, 112b and 122a, 122b to define a recess 149a, 149b and 159a, 159b, respectively, that as mentioned above, affects the overall current densities between the electrically activated surfaces during both the sealing and cutting phases. Cutting element 127a is disposed within and/or deposited on insulator 113 and extends inwardly therefrom to extend beyond the sealing surfaces 112a, 112b by a predetermined distance.
During sealing, the opposing sealing surfaces 112a, 122a and 112b, 122b are activated to seal the tissue disposed therebetween to create two tissue seals on either side of the insulators 113 and 123. During the cutting phase, the cutting elements 127a and 127b are energized with a first electrical potential “+” and the right opposing sealing surfaces 112b and 122b are energized with a second electrical potential “−”. This creates a concentrated electrical path between the potentials “+” and “−” through the tissue to cut the tissue between the previously formed tissue seals. Once the tissue is cut, the jaw members 110 and 120 are opened to release the two tissue halves.
With reference to
The relationship between the operating frequency of the energy source and the geometric configuration of the cutting element(s) 127a and/or 127b is illustrated by the following set of equations:
λ=f/v; (1)
wherein λ is the wavelength of the waveform defined by cutting element(s) 127a and/or 127b; f is the operating frequency (or fundamental frequency) of the output energy of the energy source (e.g., generator 500); and v is the velocity of the output energy.
Equation (1), in turn, is utilized to yield equation
d=λ/x; (2)
wherein d is a distance between any two points along the waveform defined by cutting element(s) 127a and/or 127b that may be used to define the period T of the waveform; and x is the number of peaks 131 along the waveform.
Equations (1) and (2), in turn, are utilized to yield equation
d*x=f/v; (3)
Equations (1) and (3), in turn, are utilized to yield equation
d=λ/x; (4)
wherein the number x of peaks 131 can be varied as necessary to yield the appropriate number of peaks 131 for a given length L of cutting element(s) 127a and/or 127b.
Utilizing equation (4), the current density between cutting elements 127a and 127b may be maximized by configuring each cutting element 127a and/or 127b to include the appropriate number x of peaks 131 for a given length L of cutting element 127a and/or 127b as a function of the wavelength λ of the operating frequency of the energy source (e.g., generator 500) used to produce the “cut effect”. In this manner, the “cut effect” produced by application of energy to tissue via cutting element(s) 127a and/or 127b is optimized.
When manufacturing cutting element(s) 127a and/or 127b, the “cut effect” may be optimized by using equation (4) to calculate the appropriate number of peaks x for a given length L of cutting element(s) 127a and/or 127b as a function of the operating frequency f of the energy source associated with forceps 10, 100. Conversely, the “cut effect” may be optimized by using equation (4) to calculate the appropriate operating frequency f as a function of the geometric configuration of cutting element(s) 127a and/or 127b (e.g., the number of peaks x for a given length L) and adjusting (e.g., discretely) the operating frequency of the energy source (e.g., generator 500) accordingly. That is, for example, a suitable control mechanism (not shown) may be disposed on the generator 500 to allow a user to selectively adjust the operating frequency of the generator 500 in accordance with the geometric configuration of a cutting element and/or electrode of an instrument connected to the generator 500 for purposes of sealing and/or cutting tissue utilizing the energy output of the generator 500.
In some embodiments, the current density and/or current concentration around the cutting elements 127a and 127b is based upon the particular geometrical configuration of the cutting elements 127a and 127b and the cutting elements' 127a and 127b proximity to the return electrodes, i.e., tissue contacting surfaces 112b and 122b.
In addition, the cutting element(s) 127a (and/or 127b) may be independently activated by the surgeon or automatically activated by the generator once sealing is complete. A safety algorithm may be employed to assure that an accurate and complete tissue seal is formed before cutting. An audible or visual indicator (not shown) may be employed to assure the surgeon that an accurate seal has been formed and the surgeon may be required to activate a trigger (or deactivate a safety) before cutting. For example, a smart sensor or feedback algorithm (not shown) may be employed to determine seal quality prior to cutting. The smart sensor or feedback loop may also be configured to automatically switch electrosurgical energy to the cutting element(s) 127a (and/or 127b) once the smart sensor determines that the tissue is properly sealed. In embodiments, the electrical configuration of the electrically conductive sealing surfaces 112a, 112b and 122a, 122b may be automatically or manually altered during the sealing and cutting processes to effect accurate and consistent tissue sealing and cutting.
The various geometrical configurations and electrical arrangements of the aforementioned electrode assemblies allow the surgeon to initially activate the two opposing electrically conductive tissue contacting surfaces and seal the tissue and, subsequently, selectively and independently activate the cutting element and one or more tissue contacting surfaces to cut the tissue utilizing the various above-described and shown electrode assembly configurations. Hence, the tissue is initially sealed and thereafter cut without re-grasping the tissue.
However, the cutting element and one or more tissue contacting surfaces may also be activated to simply cut tissue/vessels without initially sealing. For example, the jaw members may be positioned about tissue and the cutting element may be selectively activated to separate or simply coagulate tissue. This type of alternative embodiment may be particularly useful during certain endoscopic procedures wherein an electrosurgical pencil is typically introduced to coagulate and/or dissect tissue during the operating procedure.
A switch (e.g., switch assembly 70 shown in
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 preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
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Number | Date | Country | |
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20120029515 A1 | Feb 2012 | US |