Patent Application
20210169565
Radiofrequency (RF) energy is used in a wide range of surgical procedures because it provides efficient tissue resection and coagulation and relatively easy access to the target tissues through a portal or cannula. Present electrosurgical devices used for electrosurgical tissue treatment in procedures with somewhat divergent design requirements can be problematic; design requirements driven by procedures involving a variety tissue types, in varying locations with access from differing angles along narrow anatomies and having differing coagulation requirements for example. Solutions often require a plurality of electrosurgical devices or alternatively a single device that inadequately covers the spectrum of needs. This difficulty arises often when using electrosurgical techniques for tissue ablation, particularly in otolaryngological, arthroscopic, arthroplasty, general and spinal procedures. In addition, conventional electrosurgical devices tend to operate at very high tissue temperatures, and induce much tissue damage with postoperative tissue necrosis and degeneration of the remaining tissues described as a side effect. Molecular dissociation using an ionized vapor layer (such as COBLATION® brand products available from Smith & Nephew, Inc.) has been reported to operate at lower temperatures and possibly reduce tissue damage.
Accordingly, improved systems and methods are still desired for precise tissue removal in narrow anatomies via low temperature electrosurgical treatment of tissue. In particular, improved systems including a single device that accesses narrow anatomies in a variety of locations, and provides a plurality of tissue treatment modes or varying levels of coagulation would provide a competitive advantage.
Various embodiments are directed to a method and a design for a system that enables a single hand piece to provide a broad range of effects by combining plasma surgery, thermal electrodes and bipolar coagulation using saline delivery. Some embodiments may include a dual RF generator applied to a hand piece with at least three electrodes. Such systems may be used for various open surgical applications, including but not limited to ear nose and throat (ENT) surgery and also for soft tissue management during total or partial knee or hip arthroplasty.
An embodiment of an electrosurgical wand is disclosed for soft tissue cutting and hemostasis including a handle on a proximal end of the electrosurgical wand with an elongate shaft coupled to the handle and extending distally from the handle along a longitudinal axis. The wand also includes at least three electrodes disposed on a distal end of the wand, including a blade electrode having a length measured parallel to a longitudinal axis of wand, the length running parallel to the longitudinal axis for a portion of the length. The blade electrode may curve toward the longitudinal axis at the distal end of the wand. The wand also includes a second electrode having a length measured parallel to the longitudinal axis of wand, the length running parallel to the longitudinal axis for a portion of the length and parallel to the blade electrode; and a third electrode also having a length measured parallel to the longitudinal axis of wand, the length running parallel to the longitudinal axis for a portion of the length and parallel to the blade electrode and second electrode. The second and third electrode may each have a plurality of apertures therethrough, in operational relationship to at least one fluid delivery channel within the wand. All of the electrodes may define surface areas different from each other. Second and third electrodes both terminate in rounded distal ends. The second electrode may include a first bulbous projection having a first axis that intersects the longitudinal axis of the wand and forming an acute angle opening toward the distal end of the wand; and the third electrode may include a second bulbous projection having a second axis that intersects the longitudinal axis of the wand and forms an acute angle opening toward the distal end of the wand. The first and second axes are parallel. The blade electrode may also have apertures there-through configured to provide additional asperities for the field intensities to improve cutting.
A system is also disclosed, including an electrosurgical controller that includes a processor, a memory coupled to the processor, a first Radiofrequency (RF) generator operatively coupled to the processor, the RF generator comprising a first active and first return terminal, and a second RF generator operatively coupled to the processor, the RF generator comprising a second active and second return terminal. The controller also includes a wand connector that couples to a connector of an electrosurgical wand, the wand connector comprising a plurality of electrical pins. Additionally, the controller includes a multiplexer circuit configured to selectively couple at least one of the first and second active terminals and at least one of the first and second return terminals to at least one of the plurality of electrical pins in communication with the voltage generators. This system also includes a peristaltic pump comprising a rotor coupled to an electric motor; the electric motor operatively coupled to the processor, and may be part of the controller enclosure or separated. The system also includes an electrosurgical wand with a handle and an elongate shaft extending distally from the handle along a longitudinal central axis. At least three electrodes are disposed on a distal end of the wand, and are independently electrically coupled to the controller, such that at least one electrode may be an active electrode with respect to either RF energy generator, and at least one electrode may be a return electrode. A first electrode of the at least three electrodes may be coupled to the first RF generator as an active electrode, a second electrode of the at least three electrodes may be coupled to the second RF generator as an active electrode, and a third electrode of the at least three electrodes may be coupled to both the first and second RF generator as a return electrode. The first RF generator may be configured to provide a first signal to the first electrode sufficient to cut or ablate tissue; while the second RF generator may be configured to simultaneously provide a second signal to the second electrode sufficient to coagulate tissue. The first signal may be a voltage controlled wave signal, and the second signal may be a power control wave signal. The first RF generator may be configured to amplitude modulate the voltage-controlled square wave signal applied to the first electrode to implement both ablation and controlled hemostasis at the first electrode. The at least three electrodes of the wand may include a blade electrode having a length measured parallel to a longitudinal axis of wand, the length running parallel to the longitudinal axis for a portion of the length. The blade electrode may curve toward the longitudinal axis at the distal end of the wand. A second electrode may be disposed on the opposite side of the wand from the blade electrode; and a third electrode may be disposed between the blade electrode and the second electrode. The second electrode may be a conformal electrode, conforming to an outside surface of the wand and spanning the outside surface opposite the blade electrode and the third electrode may be a conformal electrode, conforming to an outside surface of the wand, a portion of the third electrode spanning the outside surface between the blade electrode and the second electrode. The second electrode may include a first bulbous projection having a first axis that intersects the longitudinal axis of the wand and also form an acute angle, opening toward the distal end of the wand; and the third electrode may have a second bulbous projection having a second axis that intersects the longitudinal axis of the wand, the second axis also forming an acute angle, opening toward the distal end of the wand. The first and second axes may be parallel. The second electrode may have an extension portion that extends along a first side of the wand from the first bulbous projection. The third electrode may comprises an extension portion that extends along a second side of the wand from the second bulbous projection, the second side of the wand opposite the first side of the wand.
A method of treating tissues with an electrosurgical wand in a variety of orientations is also described, including positioning an electrosurgical wand in a first orientation, so that a first and a second electrode of the electrosurgical wand is adjacent a target tissue and applying electrical energy between the first and second electrode. The first electrode is a blade electrode configured to cut tissue, and wherein the first and second electrodes define a first and second length respectively that runs parallel to a longitudinal axis of wand. The second electrode further comprises a curve at the distal portion so as to terminate in a rounded end that is at an acute angle to the longitudinal axis of the wand. Responsive to the electrical energy localized plasma is formed proximate to the blade electrode so as to ablate, by the localized plasma, and molecularly dissociate a first portion of the first target tissue. The electrosurgical wand is then placed in a second orientation such that the rounded end of the second electrode and a rounded end of a third electrode are adjacent the target tissue, and while the electrosurgical wand is in the second orientation electrical energy is applied between the second and third electrode. The second and third electrodes are approximately equivalently spaced from the target tissue and the energy applied forms a thermal effect adjacent the second and third electrode so as to coagulate the target tissue. The method may also include a further step of ceasing the step of applying electrical energy between the first and second electrode while in the first orientation and then applying electrical energy between the first and second electrode so as to coagulate tissue effect adjacent the first and second electrode. The method may also include the step of ceasing applying electrical energy between the first and second electrode to form localized plasma while in the first orientation and then applying electrical energy between the first, second and third electrode and forming a thermal effect adjacent the first, second and third to coagulate the target tissue. The method may also include applying a modulated voltage output, modulated between a voltage sufficient to form localized plasma and a voltage sufficient to extinguish the plasma. The method may also include flowing an electrically conductive fluid through an aperture through the second electrode at a first flow rate while the wand is in the first orientation and while the electrosurgical wand is in the second orientation flowing an electrically conductive fluid through an aperture disposed through the second electrode and through an aperture disposed through the third electrode at a second flowrate, different than the first flow rate.
At least some of the various embodiments combine the benefits of the three modalities into one single product, and therefore should provide an ease of use and cash savings for the practitioners and the institutions.
For a detailed description of example embodiments, reference will now be made to the accompanying drawings in which:
Various terms are used to refer to particular system components. Different companies may refer to a component by different names—this document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . .” Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.
Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural references unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement serves as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Lastly, it is to be appreciated that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
“Ablation” shall mean removal of tissue based on tissue interaction with plasma.
“Plasma” shall mean a low temperature gas formed of vapor bubbles or a vapor layer that is capable of emitting an ionized discharge.
“Active electrode” shall mean an electrode of an electrosurgical wand which produces an electrically-induced tissue-altering effect when brought into contact with, or close proximity to, a tissue targeted for treatment.
“Return electrode” shall mean an electrode of an electrosurgical wand which serves to provide a current flow path for electrical charges with respect to an active electrode, and/or an electrode of an electrical surgical wand which does not itself produce an electrically-induced tissue-altering effect on tissue targeted for treatment.
“Thermal electrode” shall mean an electrode of an electrosurgical wand which serves to provide a current flow path for electrical charges with respect to a second electrode that may be an active electrode, producing an electrically-induced thermal tissue-altering effect adjacent the thermal electrode on tissue targeted for treatment.
“Pulsing” shall mean a modulated output energy of the AC voltage signal generated and delivered to at least one electrode on the wand, wherein the output energy modulates between an output energy sufficient to form an ionized vapor layer at the at least one electrode and an output energy that allows the ionized vapor layer to extinguish.
“Blending” or “blended cut” shall mean providing tissue cutting with concomitant hemostasis. When in a bipolar mode, this may be achieved with two electrodes of unequal ratio of electrode surface areas in operational relationship with tissue (setting up an active and a thermal electrode), and/or this may include a pulsing output (defined above) between two electrodes (of equal or unequal surface area ratios). Additionally/alternatively a third electrode may be present, and a first energy output defining a first tissue effect may be delivered to a first electrode and a second energy output defining a different tissue effect may be delivered to a second electrode. The first and second energy outputs may include an ablative output, a coagulating output or a pulsing output.
Where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.
The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.
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Still referring to
In some embodiments the electrosurgical system 100 also comprises a foot pedal assembly 134. The foot pedal assembly 134 may comprise one or more pedal devices 136 and 138, a flexible multi-conductor cable 140 and a pedal connector 142. While only two pedal devices 136 and 138 are shown, one or more pedal devices may be implemented. The enclosure 122 of the controller 104 may comprise a corresponding connector 144 that couples to the pedal connector 142. A physician may use the foot pedal assembly 134 to control various aspects of the controller 104, such as the mode of ablation. For example, pedal device 136 may be used for on-off control of the application of radio frequency (RF) energy to the wand 102. Further, pedal device 138 may be used to control and/or set the mode of operation of the electrosurgical system. For example, actuation of pedal device 138 may switch between ablation mode and coagulation mode, or between pure cut mode with minimal hemostasis and a blended and/or pulsed ablation mode providing varying levels of concomitant hemostasis as will be described later.
The electrosurgical system 100 of the various embodiments implements ablation which employs Coblation® technology. In particular, the assignee of the present disclosure is the owner of Coblation® technology. Coblation® technology involves the application of at least one radio frequency (RF) signal between one or more active electrodes and one or more return electrodes of the wand 102 to develop high electric field intensities in the vicinity of the target tissue. The electric field intensities may be sufficient to vaporize an electrically conductive fluid over at least a portion of the one or more active electrodes in the region between the one or more active electrodes and the target tissue. The electrically conductive fluid may be inherently present in the body, such as blood, or in some cases extracellular or intracellular fluid. In other embodiments, the electrically conductive fluid may be a liquid or gas, such as isotonic saline. In some embodiments, as shown, the electrically conductive fluid is delivered in the vicinity of the active electrode and/or to the target site by a delivery system.
When the electrically conductive fluid is heated to the point that the atoms of the fluid vaporize faster than the atoms recondense, a gas is formed. When sufficient energy is applied to the gas, the atoms collide with each other causing a release of electrons in the process, and an ionized gas or plasma is formed (the so-called “fourth state of matter”). Stated otherwise, plasmas may be formed by heating a gas and ionizing the gas by driving an electric current through the gas, or by directing electromagnetic waves into the gas. The methods of plasma formation give energy to free electrons in the plasma directly, electron-atom collisions liberate more electrons, and the process cascades until the desired degree of ionization is achieved. A more complete description of plasma can be found in Plasma Physics, by R. I. Goldston and P. H. Rutherford of the Plasma Physics Laboratory of Princeton University (1995), the complete disclosure of which is incorporated herein by reference.
As the density of the plasma becomes sufficiently low (i.e., less than approximately 1020 atoms/cm3 for aqueous solutions), the electron mean free path increases such that subsequently injected electrons cause impact ionization within the plasma. When the ionic particles in the plasma layer have sufficient energy (e.g., 3.5 electron-Volt (eV) to 5 eV), collisions of the ionic particles with molecules that make up the target tissue break molecular bonds of the target tissue, dissociating molecules into free radicals which then combine into gaseous or liquid species. By means of the molecular dissociation (as opposed to thermal evaporation or carbonization), the target tissue is volumetrically removed through molecular dissociation of larger organic molecules into smaller molecules and/or atoms, such as hydrogen, oxygen, oxides of carbon, hydrocarbons and nitrogen compounds. The molecular dissociation completely removes the tissue structure, as opposed to dehydrating the tissue material by the removal of liquid within the cells of the tissue and extracellular fluids, as occurs in related art electrosurgical desiccation and vaporization. A more detailed description of the molecular dissociation can be found in commonly assigned U.S. Pat. No. 5,697,882 the complete disclosure of which is incorporated herein by reference.
The energy density produced by electrosurgical system 100 at the distal end 108 of the wand 102 may be varied by adjusting a variety of factors, such as: the number of active electrodes; electrode size and spacing; electrode surface area; asperities and/or sharp edges on the electrode surfaces; electrode materials; applied voltage; current limiting of one or more electrodes (e.g., by placing an inductor in series with an electrode); electrical conductivity of the fluid in contact with the electrodes; density of the conductive fluid; and other factors. Accordingly, these factors can be manipulated to control the energy level of the excited electrons. Since different tissue structures have different molecular bonds, the electrosurgical system 100 may be configured to produce energy sufficient to break the molecular bonds of certain tissue but insufficient to break the molecular bonds of other tissue. For example, fatty tissue (e.g., adipose) has double bonds that require an energy level higher than 4 eV to 5 eV (i.e., on the order of about 8 eV) to break. Accordingly, the Coblation® technology in some modes of operation does not ablate such fatty tissue; however, the Coblation® technology at the lower energy levels may be used to effectively ablate cells to release the inner fat content in a liquid form. Other modes of operation may have increased energy such that the double bonds can also be broken in a similar fashion as the single bonds (e.g., increasing voltage or changing the electrode configuration to increase the current density at the electrodes). A more complete description of the various phenomena can be found in commonly assigned U.S. Pat. Nos. 6,355,032, 6,149,120 and 6,296,136, the complete disclosures of which are incorporated herein by reference.
Generally the intent of the system and varying wand-tip embodiments disclosed is to provide one wand that can provide a broad variety of functions, and may finely dissect or provide a blended cut to a first tissue while in a first configuration, and provide a different tissue effect while in a second configuration. A first example set of embodiments disclosed is configured to dissect a first tissue such as tonsil tissue while in a first configuration, and debulk (rapidly dissociate and remove) adenoids while in a second configuration. A second example set of embodiments disclosed is configured to dissect or cut through a first tissue such as skin or an outer layer while in a first configuration, and coagulate areas adjacent the first tissue while in a second configuration. A first and second configuration may be defined by a change in at least one of the following parameters; the orientation of the wand or angle of approach to the target tissue; a change of the surface areas and geometry of the active electrode in operational relationship with the target tissue or a change of electrodes placed near the target tissue; an alteration of the bend angle(s) along the wand shaft, by deformation; a change in the fluid flow rate delivered to and removed from the wand distal end; alteration of the energy output such as frequency, control mode, voltage or voltage pulses to at least one of the electrodes of the wand. The example systems may also comprise some tri-polar or multipolar wands having at least three electrodes. By way of the controller, each electrode may be interchangeably connected to at least one active and one return terminal of an RF generator of the controller defining the first and second configurations also. Thus, each electrode may be an active electrode, a thermal electrode or a return electrode, or floating for any particular surgical procedure.
As a more specific example, when removing tonsils, the active electrode requires more of a blade- or plate-style electrode (or possibly a needle-style electrode) that extends away from the spacer. An active electrode with a narrow distal tip is configured to form plasma predominantly at the very tip so as to act similarly to a blade and finely dissect tonsil tissue away from fossa. Access to grasp the tonsil is relative easy during a tonsillectomy compared to the adenoid, and so it is preferable to grasp and remove the tonsil using a secondary device, as the active electrode ablates and disconnects the tonsil from the fossa. Significant pain after a tonsillectomy is oftentimes attributed to damage to the remaining tissue bed and so very controlled dissection with limited hemostasis is preferred to manage the patient post-surgery pain. Contrary to that, grasping the adenoid is not as readily available, and so the active electrode is used to gradually dissociate the upper layers of the adenoid and remove these molecularly dissociated layers through an aspiration aperture through the active electrode and thereby debulk the adenoid. The tissue bed under the adenoids is also generally considered less sensitive to heat. Therefore when debulking adenoids, the active electrode may be larger in surface area, the tissue effect may be more aggressive (delivering a higher voltage) and fluid delivery and/or aspiration rates may be higher to enhance debulked tissue removal.
Both exposed surfaces of the return electrode 306 have fluid delivery apertures therethrough so that fluid delivery surrounds the wand and active electrode 300, improve wetting and electrical conductivity for coagulation at the distal tip, as well as for uniform plasma formation around the active electrode surface (top and bottom), which may be particularly helpful for adenoidectomy. In addition, as will be explained later, fluid flow over the first exposed portion of the return electrode may also reduce sticking when the return electrode temporarily behaves as a thermal electrode to provide hemostasis. The amount of thermal effect achieved by actively regulating the amount of flow in conjunction with different voltage settings, such that lower flow can lead to less heat and higher flow can create more heating. The inventors have also found that when a broader debulking tissue effect is desired around a larger surface of the active electrode, the wand is frequently oriented such that gravity directs more fluid to flow from the apertures 308a on the underside relative to the apertures 308b on the top side; consequently hindering the desired consistency of plasma generation around the screen portion of the active electrode. In order to balance this flow and improve plasma generation, the fluid delivery apertures 308b on the top side may be larger in diameter, or greater in quantity than the fluid delivery apertures 308a on the under-side. In some embodiments apertures 308b may be a single elongate slot, across the width of the second exposed return electrode portion 306b. Furthermore fluid delivery channel(s) or element(s) disposed within the wand and spacer 304 may be configured to preferentially direct more flow to the upper apertures 308b than lower 308a. In some embodiments, the fluid delivery channel may be split or form two separate fluid delivery elements along a substantial portion of the wand. This may ensure a high resistance electrical pathway back into the device, forcing the current path predominantly out to the electrodes and around the outer surface of the device, instead of providing an internal conductive path electrically conductive fluid.
The active electrode 300 defines a combination active electrode having a screen portion 320 and a blade portion 322, with a curved surface 324 there-between. The screen electrode 320 is configured to debulk a target tissue, and as shown, has an aperture 310 therethrough so as to aspirate this tissue. Screen portion 320 may also include surface asperities, such as protrusions, recesses or cavities; asperities serving to focus the electrical field intensity and thereby encourage plasma initiation and propagation and improved molecular dissociation of a target tissue. Shown here are a series of recesses, including a first horseshoe shaped recess 330 circumscribing the aspiration aperture and providing a series of elongate concentric edges for improved plasma formation around screen electrode 320, especially useful when debulking tissue. In order to further encourage plasma propagation between the outer edge surface of the active electrode 300 and the aspiration aperture 310, additional radially oriented edges 333 may be added, separating the horseshoe asperity into an increased number of segments, and may result in additional segments that appear similar to the separation between the horseshoe asperity 330 and recesses 332. Increased plasma formation may further ablate tissue adjacent the aspiration aperture 310 and may reduce clogging of said aperture 310 and the associated fluid aspiration element(s) downstream. The two smaller recesses 332 are continuous with and extend along the curve portion 324 of active electrode 300. Recesses all define bottom surfaces 331, spaced away from the top surface of the active screen electrode. Generally, during ablation mode, tissue is preferably kept in light contact with the active electrode 300 and therefore the effective surface area of the active electrode 300 during ablation is the top surface of the active electrode 300 and the recess edges. However while coagulating, the tissue preferably makes more firm contact with the active electrode 300 so that the tissue naturally conforms into the recesses (330, 332), effectively increasing the surface area of the active electrode to include the lower surfaces 331 as well as the upper surface, increasing coagulation efficiency. A larger surface area is preferable for effecting tissue coagulation.
The blade portion 322 is sized and shaped to easily access the transition between the fossa and tonsil tissue and may be curved so as to follow the anatomy. The blade portion 322 may extend distally and axially away from the spacer 304 at a sufficient length to access the underside of the tonsil. The blade portion 322 may be offset relative to a central long axis (A-A) of the wand distal end, and also disposed on an under side or first side of the wand tip closest to but laterally offset from the first portion of the return electrode 306a. Blade portion 322 may terminate with an angled or pointed tip 323 so as form an area of higher electric field intensities, preferentially forming plasma and thereby preferentially finely dissecting through tissue such as the tonsil from fossa. Stated otherwise the blade portion 322 is configured to form a cutting edge for dissection of the tonsil.
The second exposed portion 306b encircles the shaft to a larger extent than the first 306a as it is preferentially incorporated when the wand is used in a second orientation, so as to debulk or alternatively to coagulate tissue, across a broader surface of the active electrode 300. In the second orientation, both exposed portions of the return electrode are more equivalently parts of the current path, therefore return electrode 306 acts more as a whole (both exposed portions). In this case, the two portions of the return electrode 306 combine so as to essentially encircle a larger portion of the active electrode 320 which provides either a more uniform plasma formation and ablating tissue effect around the active electrode 300 when used to debulk adenoids, or provides a more uniform coagulating tissue effect on a larger vessel should the controller delivers a voltage configured to coagulate tissue. When coagulating tissue, such as the fossa, the screen electrode surface may be placed on tissue so that the recessed surfaces 331 are in contact with the tissue.
The portions of exposed return electrode may also differ in surface finishes, with a smoother finish on the first exposed portion 306a than the second exposed portion 306b. The inventors have found that an electro-polished surface finish is a more hydrophobic surface and has also been found to reduce tissue sticking to that surface. A rougher surface finish such as a machined or satin finish is more hydrophilic such that it may improve fluid retention on the surface, and thereby improve surface wetting, key to a uniform plasma generation. A smoother surface finish together with fluid flow on the first portion 306a therefore aids in reducing sticking during times when it acts as a thermal electrode, when sticking is more likely. Example smooth finishes range from 0.012 to 0.05 μm (micro-meters) Ra, and more hydrophilic surface finishes range from 0.8-3.2 μm Ra, where Ra is the roughness average. When placed in the second configuration where the second return electrode exposed portion 306b comes into play, the increased surface texture (rougher or satin surface) hinders the fluid from running off the surface of the second exposed portion 306b, improving surface wetting and thereby promoting a larger effective surface of return electrode around the active electrode, promoting a broader tissue effect required while debulking or alternatively when coagulating tissue.
While treating tonsils, the wand 202 may be temporarily rotated (not shown), and operated in a coagulation mode so as to treat larger vessels adjacent the tonsil. These vessels are typically a part of the fossa, or connecting the fossa to the tonsil. In this orientation a substantial portion of active electrode screen portion 320 is placed in contact with tissue bed 410 including the lower surfaces 331 of recesses. Both exposed portions of the return electrode 306a and 306b are more equivalently adjacent the fossa 415. In this coagulating configuration, electrically conductive fluid may flow from apertures 308a and 308b and help bridge a current path 416 from both exposed return electrode portions 306a and 306b around and over the active electrode 300 towards the aspiration aperture 310. Together with an RF output configured to coagulate tissue, a coagulating tissue effect across a broader surface of the active electrode 300 to seal vessels is then achieved, before possibly returning to the first orientation and continuing to dissect the tonsil tissue. In addition, the controller may alter the fluid flow rate when in coagulation mode; and may reduce the fluid flow rate relative to the dissecting or fine ablation mode.
In a second orientation, the wand is reoriented as shown in
Visible in
Similar to previously described return electrodes, third electrode 640 may encircle at least a portion of the shaft with a distal end that is shaped so as to maintain a somewhat consistent distance between the proximal portion of the active (blade) electrode 620 and also a consistent distance between a proximal portion of the secondary electrode along some portions. The third electrode 640 may be an active or a return electrode.
In an adenoid mode of operation the second electrode 630 is the active electrode, with the blade electrode potentially electrically floated. While debulking adenoids the second electrode 630 may be supplied with energy sufficient to form plasma and rapidly remove the adenoid tissue. The energy to the second or screen electrode 630 may be pulsed as discussed later to implement concomitant cutting and coagulation. Disassociated tissue may be removed through the plurality of apertures 632 through the second electrode 630.
The designated return electrode 730 may have a larger surface area than the ablation electrode 720 and is located on the opposite side of the wand distal end from the ablation electrode 720 so as to be part of the electrode circuit responsible for coagulation of the fossa during the removal of tonsils. The return electrode 730 may have apertures 732 or holes to draw fluid there through. Fluid and plasma by-products may be aspirated through the return electrode 730, or electrically conductive fluid may be delivered through these holes.
The thermal electrode 740 shown in both
The embodiment is targeted for adenoids only and has two electrodes only. The active electrode 820 is configured to debulk tissue, by molecular dissociation, as described earlier and is disposed at an angle and location that is configured for improved access to adenoid tissue. The return electrode 840 extends around and further than the active electrode 820 so as to improve the contact between the return electrode 840 and tissue and fluid adjacent the adenoid, as the wand is moved around and thereby improving the consistency of the electrode circuit that includes plasma. This is envisioned to improve the overall tissue effect while debulking the adenoids.
Controller
ROM 902 (or possibly a flash memory) stores instructions executable by the processor 900. In particular, the ROM 902 may comprise a software program that, when executed, causes the processor to sum, over various time windows, energy delivery and when needed temporarily cease or “pulse” the energy provided to ensure the rate of energy delivery does not exceed predetermined thresholds (discussed more below). The RAM 904 may be the working memory for the processor 900, where data may be temporarily stored and from which instructions may be executed. Processor 900 couples to other devices within the controller 104 by way of the digital-to-analog converter 906 (e.g., in some embodiment the RF voltage generator 916), digital outputs 908 (e.g., in some embodiment the RF voltage generator 916), digital inputs 910 (e.g., interface devices such as push button switches 132 or foot pedal assembly 134 (
Voltage generator 916 generates an alternating current (AC) voltage signal that is coupled to active electrode(s) (e.g., active electrode 200) of the example wand. In some embodiments, the voltage generator defines an active terminal 918 which couples to electrical pin 920 in the controller connector 120, electrical pin 922 in the wand connector 114, and ultimately to the active electrode(s). Likewise, the voltage generator defines a return terminal 924 which couples to electrical pin 926 in the controller connector 120, electrical pin 928 in the wand connector 114, and ultimately to the return electrode(s). Additional active terminals and/or return terminals may be used. The active terminal 918 is the terminal upon which the voltages and electrical currents are induced by the voltage generator 916, and the return terminal 924 provides a return path for electrical currents. It would be possible for the return terminal 924 to provide a common or ground being the same as the common or ground within the balance of the controller 104 (e.g., the common 930 used on push-buttons 132), but in other embodiments the voltage generator 916 may be electrically “floated” from the balance of the controller 104, and thus the return terminal 924, when measured with respect to the common or earth ground (e.g., common 930) may show a voltage; however, an electrically floated voltage generator 916 and thus the potential for voltage readings on the return terminals 924 relative to earth ground does not negate the return terminal status of the terminal 924 relative to the active terminal 918.
The AC voltage signal generated and applied between the active terminal 918 and return terminal 924 by the voltage generator 916 is RF energy that, in some embodiments, has a frequency of between about 5 kilo-Hertz (kHz) and 20 Mega-Hertz (MHz), in some cases being between about 30 kHz and 2.5 MHz, in other cases being between about 50 kHz and 500 kHz, often less than 350 kHz, and often between about 100 kHz and 200 kHz. In some applications, a frequency of about 100 kHz is useful because target tissue impedance is greater at 100 kHz.
The RMS (root mean square) voltage generated by the voltage generator 916 may be in the range from about 5 Volts (V) to 1800 V, in some cases in the range from about 10 V to 500 V, often between about 10 V to 400 V depending on the mode of ablation and active electrode size. The peak-to-peak voltage generated by the voltage generator 916 for ablation in some embodiments is a square waveform in the range of 10 V to 2000 V, in some cases in the range of 100 V to 1800 V, in other cases in the range of about 28 V to 1200 V, and often in the range of about 100 V to 740 V peak-to-peak.
The voltage and current generated by the voltage generator 916 may be delivered as a square wave voltage signal or sine wave voltage with a sufficiently high frequency (e.g., on the order of 5 kHz to 20 MHz) such that the voltage is effectively applied continuously as compared with, e.g., lasers claiming small depths of necrosis, which are pulsed about 10 Hz to 20 Hz). In addition, the duty cycle of a square wave voltage produced by the voltage generator 916 is on the order of about 50% for some embodiments (e.g., half the time as a positive voltage square signal, and half the time as a negative voltage square signal) as compared with pulsed lasers which may have a duty cycle of about 0.0001%. Although square waves are generated and provided in some embodiments, the AC voltage signal is modifiable to include such features as voltage spikes in the leading or trailing edges of each half-cycle, or the AC voltage signal is modifiable to take particular shapes (e.g., sinusoidal, triangular).
The voltage generator 916 delivers average power levels ranging from several milliwatts to hundreds of watts per electrode, depending on the mode of operation and state of the plasma proximate to the active electrode(s). The voltage generator 916 in combination with the processor 900 are configured to set a constant root mean square (RMS) voltage output from the voltage generator 916 based on the mode of operation selected by the surgeon (e.g., one or more ablation modes, coagulation mode). A description of various voltage generators 916 can be found in commonly assigned U.S. Pat. Nos. 6,142,992 and 6,235,020, the complete disclosure of both patents are incorporated herein by reference for all purposes. Reference is also made to commonly assigned U.S. Pat. No. 8,257,350, titled “METHOD AND SYSTEM OF AN ELECTROSURGICAL CONTROLLER WITH WAVE-SHAPING”, the complete disclosure of which is incorporated herein by reference as if reproduced in full below.
In some embodiments, the voltage generator 916 may be controlled by a program executing on the processor 900 by way of digital-to-analog converter 906. For example, the processor 900 may control the output voltages by providing one or more variable voltages to the voltage generator 916, where the voltages provided by the digital-to-analog converter 906 are proportional to the voltages to be generated by the voltage generator 916. In other embodiments, the processor 900 may communicate with the voltage generator by way of one or more digital output signals from the digital output converter 908, or by way of packet-based communications using the communication device 912 (the communication-based embodiments not specifically shown so as not to unduly complicate
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The RF output variables that may be independently modified by the controller 1004 may include: regulation modes (e.g., voltage regulated, power regulated, current regulated); peak or root-mean-square (RMS) voltages (e.g., selected to either develop varying intensities of electrical field and therefore varying energy levels of electrons within the plasma, or lower voltages sufficient to coagulate tissue); pulsing rates and duty cycles (e.g., interrupting the output or modulating the output may blend cutting and coagulation at a single electrode and may also reduce tissue sticking), which can also work on a regular bipolar wand; and output waveforms (e.g., sine waveform, square waveform).
The RF controller 1004 with at least two independent RF generators 1016a and 1016b are selectively coupled to at least two pins of a controller connector, and oftentimes connected to three pins (1020, 1022 and 1024) and potentially more. The pins (1020, 1022 and 1024) may be electrically coupled to at least one electrode on an electrosurgical wand. The return terminals may be permanently electrically coupled to each other and may be one input to the multiplexer.
Selection may occur using a combination of software control in communication with a multiplexer 1012. Each RF generator 1016a and 1016b is configured to selectively and potentially independently supply RF energy to electrodes on a wand. RF energy may be delivered from each independent circuit at differing potentials setting up a range of electrical field intensities at and around each electrode, as well as different waveforms (e.g., square waveforms for plasma ablation and sine waveforms for coagulation), differing frequencies, different pulsing levels or duty cycles and also different regulation modes (e.g., current regulated, voltage regulated, or power regulated). Output voltages may be high enough to develop high electric field intensities sufficient to form plasma at the electrode, or lower so as to desiccate or coagulate tissue. Pulsing or modulating the RF voltage may interrupt or reduce any vapor layer formed, so that some hemostasis occurs during the thermal phase of the cycle before a vapor layer is formed and subsequently the plasma and thereby the cutting tissue effect. Pulsing may also help reduce the sticking of tissue to the wand electrode.
Output energy from each RF generator may be delivered simultaneously with varying levels (voltages, waveforms, pulsing) relative to each other so as to supply a blended effect of both cutting and hemostasis. For example, an output configured to initiate plasma may be supplied to a first electrode from a first RF generator at the same time as an output configured to coagulate tissue is supplied from a second RF generator to a second electrode so as to provide a multi-polar blended tissue effect at the distal end of the wand. A third terminal from either or both RF generators may be selectively or fixedly assigned as a return. More specifically as an example, looking back at the wand tip embodiment in
The controller 1004 may also control the timing of each of the independent RF generators (1016a and 1016b) so that energy is delivered so as to overlap for some period of time or alternate with each other. There may also be a pre-set time delay between activating a first active electrode pair and a second active electrode pair, for example to initiate plasma at a first electrode or electrode array of a wand for a period of time, for a few seconds before activating a coagulating output between the second electrode.
The independent RF generators (1016a and 1016b) may be both software controlled with some relays or other switching system (multiplexer) included in the system to selectively couple the RF generators with the output pins in the connector. The controller program and memory may assign a range of outputs that can include “pure cutting,” “low temperature coagulation,” or cutting with a variable level of hemostasis or varying blends between cutting and hemostasis. For example, pure cutting mode may be achieved using voltage regulated output, with a uniform square waveform at a constant rate to a first cutting electrode. A level of cutting with some hemostasis may be achieved by adjusting or periodically interrupting the output described above to the first cutting electrode only. A blend including cutting with an even more hemostasis that stretches across a broader area of the wand tip may be achieved by further adjusting the interruption rate at the cutting electrode and/or activating a second electrode with RF delivery configured for hemostasis or coagulation (e.g at a second lower voltage than the voltage supplied to the cutting electrode, and possibly in a power control mode). Having independent RF generators enables a variety of RF outputs that are selectively coupled to varying electrodes on a wand so as to offer a broad range of tissue effects at each electrode (e.g., selected based on the procedure and tissue type).
Pulsing or Modulated Output
Another example mode, briefly described earlier, is a pulsed or modulated output that may by achieved with a single RF generator, similar to that described in
Moreover, and as alluded to in the previous paragraph, the pulsing is between a high voltage and a lower voltage, but not preferably zero volts. The inventors have found that pulsing between a high voltage in the range of 200-320 volts and lower voltage in the range of 10-150 volts was preferable. For the embodiments described herein, pulsing between a high voltage in the range of 250-300 volts and lower voltage in the range of 30-70 volts was more preferable, the values adjusting depending on levels of desired cutting and concomitant thermal effect. For example, pulsing between 300 volts and 70 volts would provide both aggressive cutting and hemostasis, while pulsing between 300 and 30 volts would provide aggressive cutting and reduced hemostasis. These values may vary with electrode configuration.
The theory of operation is that by pulsing, not only does the plasma extinguish (which reduces molecular disassociation and thereby the cutting action), but the vapor layer also collapses, and when the voltage rises again higher current is dissipated until the vapor layer is formed, creating more significant thermal effects and therefore provide the hemostasis. Thus, in addition to modifying the ratio of periods of time between the first cutting voltage and the second coagulating voltage, the amount of hemostasis provided from the cutting electrode is dependent to some extent upon the “low” voltage. A simultaneous hemostasis associated with a second electrode in the example dual RF system may also provide additional multipolar blended hemostasis along the wand tip. There may be advantages to using a fast pulse rate (e.g., less than 5 ms in high or low voltage) to reduce the audible and tactile nature of the pulse—or perhaps the audible and tactile feedbacks could be desirable to hear and feel for certain applications. It can be tailored to the needs of the procedure and tissue type. There could also be a randomly assigned high/low voltage duration that averages out to a desired duty cycle, such as 70% high voltage, 30% low voltage, but individual cycles may vary. This may create more of an audible “white noise” effect that hides the repetitive pulsed nature that some users may not prefer.
Modes of Operation
In example systems, the user may select “Modes” of energy output that set RF generator(s) output of the controller to pre-set output energy levels and to specific terminals depending on the instrument that is coupled to the controller. The controller may also control the rate and location of fluid delivery and fluid aspiration to and from the wand tip, in conjunction with the selectable energy outputs, and certain tissue modes or selections made by the user may trigger certain pre-set fluid flow rates to further improve the tissue effect.
For example, the controller may have a “tonsil mode.” In tonsil mode, if the user wishes for reduced hemostasis the user may select a pure cut mode (pure ablation mode) with a medium cutting speed, and a low fluid delivery flow rate. The selection may, for example, couple a first RF generator to an active and return electrode (e.g., an active electrode configured for fine dissection), with the RF generator controlled so as to supply energy sufficient to form plasma and finely dissect tissue. Selecting a blend cut mode or a hemostatic cut mode however may initiate a pulsing of the first RF generator in which the first RF generator modulates between supplying energy sufficient to form a plasma and then reducing voltage to enable the plasma to collapse, with the pulsing providing an initial heating effect while the plasma is forming and some hemostasis. As explained earlier, varying levels of cutting and hemostasis may be achieved with corresponding ratios between the cutting and hemostatic periods of the pulsing duty cycle. Alternatively or in addition to pulsing with a first RF generator, selecting a blended cut may optionally trigger energy supplied to a secondary electrode from a second RF generator (for multipolar wands coupled to a dual RF generator system) triggering a multipolar blend cut mode, the second RF generator programmed to supply an energy that coagulates tissue around the secondary electrode pair. Each mode selection may also alter the irrigation or aspiration level to and from the tissue and wand. An example Tonsil Mode chart is shown below.
When larger vessels are encountered, the wand may be rotated so as to place a different portion of an electrode, or a second active electrode adjacent the vessel and a pure coagulation mode may be selected, where no ablation is desired. Fluid delivery may be reduced during pure coagulation mode compared to ablation and blended modes.
Another envisioned mode may be an “adenoid mode” that automatically couples an electrode configured to debulk tissue to an active terminal of a first RF generator. The user may select a debulking speed that may operate so as to increase a variable associated with electrical field intensities (e.g., voltage at an electrode configured to debulk tissue) to a pre-set value programmed within a memory of the controller. Adenoid mode may also set the fluid delivery pump of the controller to a pre-set rate that may be higher than tonsil mode, so as to aid the flow of fluid around the wand distal tip and support flow of the treated tissue through an aspiration aperture. Adenoid mode may disconnect at least one pin of a controller connector so that only one RF generator is electrically coupled to an electrode pair. An example Adenoid Mode chart is shown below.
In alternative embodiments, a simplified set of modes may be offered, including high and medium ablation modes, and pure coagulation, the latter being similar to that described above.
For example, the controller may have a “high ablation” mode that may operate similarly to the adenoid mode described earlier. The user may select a debulking speed within the high ablation mode that alters a variable associated with electrical field intensities (e.g., voltage at an electrode configured to debulk tissue) to a pre-set value programmed within a memory of the controller. This high ablation mode may also set the fluid delivery pump of the controller to a pre-set rate that may be higher than other modes, so as to aid the flow of fluid around the wand distal tip and support flow of the treated tissue through an aspiration aperture. This mode may disconnect at least one pin of a controller connector so that only one RF generator is electrically coupled to an electrode pair.
Medium mode may provide options similar to the tonsil mode described earlier. The selection may, for example, couple a first RF generator to an active and return electrode (e.g., an active electrode configured for fine dissection), with the RF generator controlled so as to supply energy sufficient to form plasma and finely dissect tissue. Adjusting the level higher in medium mode may provide a purer cut mode, with less concomitant hemostasis, while adjusting the level lower may provide a more hemostatic cut mode; such as a pulsing of the first RF generator in which the first RF generator oscillates between supplying energy sufficient to form a plasma and then reducing voltage to enable the plasma to collapse, with the pulsing providing an initial heating effect while the plasma is forming and some hemostasis. Further example of blending cutting and hemostasis using a multipolar configuration may also be triggered, as described earlier in the instant specification. Each mode selection may also alter the irrigation or aspiration level to and from the tissue and wand.
Alternative Use Wands Wand Tip Embodiment
The following embodiments show an alternative set of wand-tip embodiments configured for more general procedures, providing a variety of tissue effects including both hemostasis and cutting for other procedures, such as arthroplasty and general surgery procedures. Similar to previous embodiments, these forthcoming wand-tip embodiments have a cutting or blade style portion to provide a cutting tissue effect and may have an electrode to provide concomitant hemostasis. The example systems also comprise tri-polar or multi-polar wands having at least three electrodes. By way of the controller, each electrode may be interchangeably connected to at least one active and one return terminal of an RF generator of the controller similar to some embodiments described earlier. Thus, each electrode may be an active electrode, a return electrode, or floating for any particular surgical procedure.
In some modes third electrode 1230 may be the coagulation electrode since third electrode 1230 is larger in size (surface area) than the cutting electrode 1210, and third electrode 1230 has a smooth rounded surface to coagulate a target tissue. In other modes second electrode 1220 may be the coagulating electrode. In yet still other modes, third electrode 1230 may be a debulking electrode around which ionized vapor and plasma may be formed. Second electrode 1220 may be a return electrode to provide a return path for both the cutting and coagulating electrode.
Second and third electrode may be shaped and positioned on the wand so as to maintain as consistent a distance from any edge of the intended active electrodes as possible. Second electrode 1220 may act as a return electrode at times or an active electrode at times. A consistent distance is generally thought to maintain a more consistent tissue effect along the length of an active electrode. Therefore distal edge of second electrode 1220 is curved so as to approximately follow the curved distal portion of blade electrode 1210, and a distal edge 1234 of third electrode 1230 curves so as to approximately follow and maintain a uniform distance from proximal edge 1224 of second electrode 1220. Second and third electrode define conforming electrode that wrap around the wand distal end and the rear view of wand 1200 (not shown) is a mirror image of the front view. The second electrode 1220 wraps around a bottom surface 1225 of the wand distal end while the third electrode wraps around both a top surface 1235 and bottom surface 1225, the third electrode top portion coinciding with the top surface 1235 defining a distally extending notch 1232. Second electrode 1220 also has a distally extending notch portion 1222 extending along the longitudinal axis and along both sides of the wand distal end.
The return electrode 1320 extends along the wand distal end, maintaining an approximately consistent distance from the primary electrode 1310, including a curve at the distal portion so as to terminate in a rounded, spherical or bulbous end 1322 that is at an angle to a long axis of the wand. In the embodiments of
The secondary electrode 1330 defines an upper surface of the wand distal tip, and the secondary electrode 1330 may be a distal portion of a wand shaft that encircles the wand distal end (as shown). The secondary electrode 1330 may terminate at the distal tip with a rounded or bulbous end 1332 disposed at an angle to the long axis (A-A) of the wand and parallel but spaced away from the return electrode terminus 1322. The secondary electrode 1330 may include a plurality of apertures 1334 (as shown, three on each side) fluidly coupled to a fluid flow element associated with the wand, the apertures 1334 operable to flow a fluid, and preferably to deliver an electrically conductive fluid. Fluid delivery apertures 1324 and 1334 may be disposed on the same side of the wand. As shown a plurality of fluid delivery apertures are disposed on both sides of both the return electrode 1320 and secondary electrode 1330; however the plurality of fluid delivery apertures may in some embodiments only be present on a single side.
Disposed between the two bulbous distal tips 1322 and 1332 of the secondary and return electrodes is an aperture 1340 defined by the spacer 1304, the aperture 1340 configured to aspirate fluid and plasma by-products. Wand distal end is preferably not circular but has a cross section with a smaller width than height. This keeps the instrument smaller, and improves access to tissues and visibility to the target site. As such both the return electrode and the secondary electrode are disposed on both sides, while the primary electrode 1310 bifurcates the width, disposed along the longitudinal axis A.
In use, the primary electrode 1310 may be supplied with a specific energy output to generate plasma and provide a cutting operation through tissue. When used in a tri-polar mode, the secondary electrode 1330 may be supplied a specific energy to coagulate tissues proximate to the secondary electrode 1330. The inventors envision that while the user begins to cut into tissue, minimal hemostasis may be initially required up until a certain depth of tissue, and as the primary electrode 1310 cuts deeper more hemostasis may be required. Therefore as the blade goes deeper in the tissue, the secondary electrode will naturally begin to approach tissue and become operable to coagulate, as a result of the secondary electrode's location relative to the tissue, the tissue acting as a bridge to the electrical current path. In an alternative use, the primary electrode 1310 may be supplied with a specific energy output to generate plasma and provide a cutting operation through tissue, with only the return electrode 1320 electrically coupled to an output of the controller, and upon some hemostasis being required, the output may be changed to an energy output, between the same primary and return electrodes (1310 and 1320) that coagulates tissue; an output with lower voltage, and may also be power controlled.
The instrument of
Alternatively, in a similar fashion to the tonsil and adenoid mode described earlier, alternative tissue-centric modes have also been envisioned for these later described embodiments. For example, a “Skin mode” may offer a tissue effect with low thermal effect, moderate ablation for easy cutting without peripheral damage and may be akin to a “tonsil mode” or a pure cutting mode in the table above. A “Capsule/connective tissue” mode may provide moderate thermal effect and high ablation to cut through more difficult tissues where some thermal effect is acceptable, and “muscle” mode which may provide a blended or pulsed activation to deliver high thermal effect while dissecting vascular tissues.
The asymmetry enables the secondary electrode 1430 to contact tissue closer to the tip of the device. The asymmetry also pushes the energy around the tip of the device creating a thermal effect around the cut rather than just on the sides. In example cases the surface area of the return and secondary electrodes are sized so as to balance the thermal effect on each side of the cut. The design of
In use, conductive fluid is delivered through the apertures 1424 and 1434 in both the return and secondary electrodes. As shown, the return electrode 1420 has five apertures out which fluid flows (
The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.
This application is a U.S. National Phase Entry of PCT Application Serial No. PCT/US18/032993 filed May 16, 2018 and titled “ELECTROSURGICAL SYSTEMS AND METHODS.” The PCT application claims priority to and benefit of U.S. Provisional Application No. 62/506,870, filed May 16, 2017, the contents of which are incorporated herein by reference in their entirety for all purposes.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US18/32993 | 5/16/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62506870 | May 2017 | US |
