Electrosurgical systems are used by physicians to perform specific functions during surgical procedures. For example, in an ablation mode electrosurgical systems use high frequency electrical energy to remove soft tissue such as sinus tissue, adipose tissue or meniscus, cartilage and/or sinovial tissue in a joint. In a coagulation mode, the electrosurgical device may aid the surgeon in reducing internal bleeding by assisting in the coagulation and/or sealing of vessels.
The electrosurgical procedures are performed using high frequency signals, as such high frequency signals provide the desired electrosurgical effect and in theory should not result in muscle or nerve stimulation of the patient. Stated another way, unwanted muscle and nerve stimulation is induced by low frequency and/or direct current (DC) signals flowing across or through muscle or nerve. Equipment constructed in accordance with the International Electrotechnical Commission (IEC) standards use DC blocking capacitance between the voltage generator of the electrosurgical controller and the patient to block DC signals flowing to or from the voltage generator.
However, in spite of being constructed in accordance with IEC standards, muscle and/or nerve stimulation is still noted in some patients.
For a detailed description of exemplary embodiments, reference will now be made to the accompanying drawings in which:
Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, companies that design and manufacture electrosurgical systems 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 electrical 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.
“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, and/or an electrode having a voltage induced thereon by a voltage generator.
“Return electrode” shall mean an electrode of an electrosurgical wand which serves to provide a current flow path for electrons 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.
“Rectifying electrical phenomenon” shall mean arcing, ionization or plasma creation proximate to an active electrode where the arcing, ionization or plasma has at least a slight electrical rectifying property.
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.
Before the various embodiments are described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made, and equivalents may be substituted, without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
The inventors of the present specification have uncovered a reason for parasitic stimulation of muscle and nerves of a patient by DC and/or low frequency signals in spite of electrosurgical systems using high frequency signals and a lumped blocking capacitance in accordance with IEC Standards.
In operation, each active electrode 106, 108 and 110 creates an electrical phenomenon 116 proximate to the active electrodes. The electrical phenomenon is in most cases an electrical arcing, ionization and/or plasma. Regardless of the precise nature of the electrical phenomenon, the electrical phenomenon has an inherent electrical rectifying characteristic, and thus is termed herein a “rectifying electrical phenomenon.” The rectifying nature of the electrical phenomenon is illustrated by the diode 118 shown within the electrical phenomenon 116; however, it is to be understood that the rectifying electrical phenomenon produces a rectifying effect associated with each active electrode when the rectifying electrical phenomenon is proximate to each active electrode. Moreover, the rectifying electrical phenomenon is neither itself a diode, nor is the rectifying electrical phenomenon as efficient at rectification as a diode coupled between the electrodes. Rather, the rectifying effect is slight, and although shown to favor electrical current flow from the return electrode 112 to the active electrode 110, in some situations rectifying electrical phenomenon favors current flow from the active electrode(s) to the return electrode(s) 112. The rectifying electrical phenomenon results in a charging of the DC blocking capacitor 114. In particular, the rectifying electrical phenomenon, when present, builds a DC bias on the capacitor 114, as illustrated by the line 120 and “plus” symbol on the capacitor 114 plate. The charge continues to accumulate through each active electrode 106, 108 and 110 during periods of time when the rectifying electrical phenomenon is proximate each active electrode, and thus may build for extended periods (relative to the period of the AC signal generated by the voltage generator).
However, the rectifying electrical phenomenon is not continuous during electrosurgical procedures. That is, the rectifying electrical phenomenon is present for a time, and then may cease for a time, depending on factors such as proximity of the active electrodes to bodily tissue, and the amount and location of conductive fluid relative to the active electrode, just to name a few. The inventors have found that during periods of time when the rectifying electrical phenomenon is absent, if an active electrode physically contacts the patient, an electrical circuit is created which discharges the charge stored on the blocking capacitor 114 through the patient.
Thus, having the DC blocking capacitance lumped as shown in
In order to at least partially address these issues, electrosurgical systems in accordance with the various embodiments distribute the DC blocking capacitance across active electrodes.
In particular, the inventors of the present specification have found that the rectifying electrical phenomenon is discontinuous during electrosurgical procedures with respect to each active electrode considered individually. That is, for a particular active electrode the rectifying electrical phenomenon randomly is present for a time, then ceases for a time, and then again present. During periods of time when the rectifying electrical phenomenon has ceased for the particular active electrode, other active electrodes may continue to have their respective rectifying electrical phenomenon present. For example, active electrode 110 may have its respective rectifying electrical phenomenon 206 present, but active electrodes 106 and 108 may not. Thus, in the illustrative situation capacitor 204 may be being charged with a DC bias voltage, while capacitors 200 and 202 retain their charge and/or discharge through the patient. The randomization of the discharge states of the capacitors 200, 202 and 204 surprisingly results in an effective capacitance seen by the patient during electrosurgical procedures lower than the sum of the capacitances in parallel, and thus lower than the electrosurgical systems in
Although the inventors do not wish to be tied to any particular physical interpretation that results in the lower effective capacitance, it is believed that a portion of the lower effective capacitance is based on the lower amount of energy that can be discharged through each active electrode. While in the systems of
The embodiments of
As shown in
Still referring to
The electrosurgical system 300 of the various embodiments may have a variety of operational modes. One such mode employs Coblation® technology. In particular, the assignee of the present disclosure is the owner of Coblation® technology. Coblation® technology involves the application of a RF signal between one or more active electrodes and one or more return electrodes of the wand 302 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 the electrically conductive fluid is delivered in the vicinity of the active electrodes and/or to the target site by the wand 302, such as by way of the internal passage and flexible tubular member 316.
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. J. 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. Often, the electrons in the plasma carry the electrical current or absorb the electromagnetic waves and, therefore, are hotter than the ionic particles. Thus, the electrons, which are carried away from the target tissue toward the active or return electrodes, carry most of the plasma's heat, enabling the ionic particles to break apart the target tissue molecules in a substantially non-thermal manner.
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.
In addition to the Coblation® mode, the electrosurgical system 300 of
The energy density produced by electrosurgical system 300 at the distal end 308 of the wand 302 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; 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 300 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 operational modes 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 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.
Still referring to
In accordance with at least some embodiments, the plurality of capacitors coupled one each in series with a respective electrical lead may be disposed within the wand 302 as shown in
In addition to the distributed capacitors, current-limiting resistors may be selected. The current-limiting resistors will have a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual active electrode in contact with a low resistance medium (e.g., saline or blood), the resistance of the current limiting resistor increases significantly, thereby reducing the power delivery from the active electrode into the low resistance medium. In some embodiments, the current limited devices may reside within the elongate shaft 306, or may reside within the cable 312.
As illustrated in
While illustrative wand connector 314 is shown to have the tab 600 and male electrical pins 602, and controller connector 320 is shown to have the slot 700 and female electrical pins 702, in alternative embodiments the wand connector has the female electrical pins and slot, and the controller connector 120 has the tab and male electrical pins. In other embodiments, the arrangement of the pins within the connectors may enable only a single orientation for connection of the connectors, and thus the tab and slot arrangement may be omitted. In yet still other embodiments, other mechanical arrangements to ensure the wand connector and controller connector couple in only one orientation may be equivalently used.
ROM 802 stores instructions executable by the processor 800. In particular, the ROM 802 may comprise a software program that implements various operation modes, as well as interfacing with the user by way of the display device 324, the foot pedal assembly 330 (
Voltage generator 816 generates selectable alternating current (AC) voltages that are applied to the electrodes of the wand 302. In some embodiments, the voltage generator defines an active terminal 824 and a return terminal 826. The active terminal 824 is the terminal upon which the voltages and electrical currents are induced by the voltage generator 816, and the return terminal 826 provides a return path for electrical currents. In some embodiments, the return terminal 826 may provide a common or ground being the same as the common or ground within the balance of the controller 304 (e.g., the common 828 used on push-buttons 826), but in other embodiments the voltage generator 816 may be electrically “floated” from the balance of the supply power in the controller 304, and thus the return terminal 826, when measured with respect to the common (e.g., common 828) within the controller 304, may show a voltage difference; however, an electrically floated voltage generator 816 and thus the potential for voltage readings on the return terminal 816 does not negate the return terminal status of the terminal 826 relative to the active terminal 824.
The voltage generated and applied between the active terminal 824 and return terminal 826 by the voltage generator 616 is a RF signal 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, preferably 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 much greater at 100 kHz. In other applications, such as procedures in or around the heart or head and neck, higher frequencies may be desirable (e.g., 400-600 kHz).
The RMS (root mean square) voltage generated by the voltage generator 816 may be in the range from about 5 Volts (V) to 1000 V, preferably being in the range from about 10 V to 500 V, often between about 10 V to 400 V depending on the active electrode size, the operating frequency and the operation mode of the particular procedure or desired effect on the tissue (i.e., contraction, coagulation, cutting or ablation). The peak-to-peak voltage generated by the voltage generator 816 for ablation or cutting in some embodiments is a square wave form in the range of 10 V to 2000 V and in some cases in the range of 100 V to 1800 V and in other cases in the range of about 28 V to 1200 V, often in the range of about 100 V to 320V peak-to-peak (again, depending on the electrode size, number of electrodes the operating frequency and the operation mode). Lower peak-to-peak voltage is used for tissue coagulation, thermal heating of tissue, or collagen contraction and may be in the range from 50 V to 1500V, preferably 100 V to 1000 V and more preferably 60 V to 130 V peak-to-peak (again, these values are computed using a square wave form).
The voltage and current generated by the voltage generator 816 may be delivered in a series of voltage pulses or AC 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 (i.e., cumulative time in any one-second interval that energy is applied) of the square wave voltage produced by the voltage generator 816 is on the order of about 50% for some embodiments 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 various embodiments may be equivalently implemented with many applied voltage waveforms (e.g., sinusoidal, triangular).
Still referring to the voltage generator 816, the voltage generator 816 delivers average power levels ranging from several milliwatts to hundreds of watts per electrode, depending on the voltage applied to the target electrode for the target tissue being treated, and/or the maximum allowed temperature selected for the wand 102. The voltage generator 816 is configured to enable a user to select the voltage level according to the specific requirements of a particular neurosurgery procedure, cardiac surgery, arthroscopic surgery, dermatological procedure, ophthalmic procedures, open surgery or other endoscopic surgery procedure. For cardiac procedures and potentially for neurosurgery, the voltage generator 816 may have a filter that filters leakage voltages at frequencies below 100 kHz, particularly voltages around 60 kHz. Alternatively, a voltage generator 816 configured for higher operating frequencies (e.g., 300 kHz to 600 kHz) may be used in certain procedures in which stray low frequency currents may be problematic. A description of one suitable voltage generator 616 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.
In accordance with at least some embodiments, the voltage generated 816 is configured to limit or interrupt current flow when low resistivity material (e.g., blood, saline or electrically conductive gel) causes a lower impedance path between the return electrode(s) and the active electrode(s). Further still, in some embodiments the voltage generator 816 is configured by the user to be a constant current source (i.e., the output voltage changes as function of the impedance encountered at the wand 302).
In some embodiments, the various operational modes of the voltage generator 816 may be controlled by way of digital-to-analog converter 806. That is, for example, the processor 800 may control the output voltage by providing a variable voltage to the voltage generator 816, where the voltage provided is proportional to the voltage generated by the voltage generator 816. In other embodiments, the processor 800 may communicate with the voltage generator by way of one or more digital output signals from the digital output 808 device, or by way of packet based communications using the communication 812 device (the alternative embodiments not specifically shown so as not to unduly complicate
In addition to controlling the output of the voltage generator 816, in accordance with at least some embodiments the controller 304 is also configured to selectively electrically couple the active terminal 824 singly or in combination to the electrodes of the wand (by way of the electrical pins of the controller connector 320). Likewise, in the various embodiments, the controller 304 is also configured to selectively electrically couple the return terminal 826 singly or in combination to the electrodes of the wand (again by way of the electrical pins of the controller connector 320). In order to perform the selective coupling, the controller 304 implements a control circuit 830, shown in dashed lines in
In accordance with at least some embodiments, at least three electrodes of the wand 302 are separately electrically coupled to the controller 304. Thus, the description of
Similarly, the electrical lead configured to couple illustrative electrode 2 couples to the normally open contact terminals for the mechanical relays K3 and K4. The other side of the normally open contact for mechanical relay K3 couples to the active terminal 824 by way of capacitor 880B, while the other side of the normally open contact for the mechanical relay K4 couples to the return terminal 826. Thus, by selectively activating mechanical relay K3 or mechanical relay K4, electrode 2 can be either an active or return electrode in the surgical procedure. Alternatively, both relays K3 and K4 can remain inactivated, and thus electrode 2 may remain unconnected. Finally with respect to the illustrative electrode 3, the electrical lead configured to couple to illustrative electrode 3 couples to the normally open contact terminals for the mechanical relays K5 and K6. The other side of the normally open contact for mechanical relay K5 couples to the active terminal 824 by way of capacitor 880C, while the opposite side of the normally open contact for the mechanical relay K6 couples to the return terminal 826. Thus, by selectively activating mechanical relay K5 or mechanical relay K6, electrode 3 can be either an active or return electrode in the surgical procedure. Alternatively, both relays can remain inactivated, and thus electrode 3 may remain unconnected.
In accordance with at least some embodiments, mechanical relays K1-K6 are selectively activated (by way of their respective coils 834) by voltage controlled switches 820. For example, when the control circuit 830 desires to couple the active terminal to electrode 1, the voltage controlled switch 820A is activated, which allows current to flow through the coil 834A of mechanical relay K1. Current flow through the coil 834 activates the relay, thus closing (making conductive) the normally open contacts. Similarly, the control circuit 830 may selectively activate any of the voltage controlled switches 820, which in turn activate respective mechanical relays K1-K6. In accordance with at least some embodiments, each mechanical relay is a part number JW1FSN-DC 12V relay available from Panasonic Corporation of Secaucus, N.J.; however, other relays may be equivalently used. Moreover, while
In vivo experiments prove that the change in capacitor configuration from a single lumped capacitance (as in
While preferred embodiments of this disclosure have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teaching herein. The embodiments described herein are exemplary only and are not limiting. Because many varying and different embodiments may be made within the scope of the present inventive concept, including equivalent structures, materials, or methods hereafter though of, and because many modifications may be made in the embodiments herein detailed in accordance with the descriptive requirements of the law, it is to be understood that the details herein are to be interpreted as illustrative and not in a limiting sense.
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Number | Date | Country | |
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20110245826 A1 | Oct 2011 | US |