System and method for directing energy to tissue
09770284 · 2017-09-26
Assignee
Inventors
Cpc classification
A61B2018/124
HUMAN NECESSITIES
A61B18/1442
HUMAN NECESSITIES
International classification
Abstract
An electrosurgical system includes an electrosurgical power generating source, an energy applicator operably associated with the electrosurgical power generating source, a processor unit, and a data acquisition module configured to receive a reflected signal. The processor unit is disposed in operative communication with the data acquisition module and adapted to determine a tissue desiccation rate around at least a portion of the energy applicator based on one or more signals received from the data acquisition module.
Claims
1. An electrosurgical system, comprising: an electrosurgical energy source including an output stage; an energy applicator configured to couple to the electrosurgical energy source; a data acquisition module including a diplexer and a dual directional coupler, the data acquisition module separate from and operably coupled to the energy applicator, wherein the diplexer is configured to: receive a reflected signal generated by transmission of electrosurgical energy from the energy applicator to tissue; generate a first signal based on the received reflected signal; receive electrosurgical energy generated by the electrosurgical energy source from the output stage: and wherein the dual directional coupler is configured to receive the first signal and generate a second signal based on the first signal; and a processor operably coupled to the diplexer and the dual directional coupler of the data acquisition module and configured to calculate a desiccation rate based on the second signal and adjust electrosurgical energy output by the electrosurgical energy source based on the calculated desiccation rate.
2. The electrosurgical system of claim 1, wherein the reflected signal is transmitted by the energy applicator to the data acquisition module.
3. The electrosurgical system of claim 1, wherein the energy applicator includes a microwave antenna.
4. The electrosurgical system of claim 1, wherein the processor is configured to control at least one operating parameter of the electrosurgical energy source based on the calculated desiccation rate.
5. A method for monitoring tissue desiccation, comprising: applying electrosurgical energy to tissue via an energy applicator to generate a reflected signal; transmitting the reflected signal to a diplexer of a data acquisition module, wherein the data acquisition module is separate from the energy applicator; generating, with the diplexer, a first signal based on the reflected signal; receiving, with a dual directional coupler of the data acquisition module, the first signal; generating, with the dual directional coupler, a second signal based on the first signal; calculating a desiccation rate based on the second signal; and adjusting the applied electrosurgical energy based on the calculated desiccation rate.
6. The method of monitoring tissue desiccation of claim 5, further comprising controlling at least one operating parameter of an electrosurgical energy source coupled to the energy applicator based on the calculated desiccation rate.
7. The method of monitoring tissue desiccation of claim 5, wherein applying electrosurgical energy to the tissue via the energy applicator includes applying microwave energy to tissue via the energy applicator.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Objects and features of the presently-disclosed data acquisition module operably associated with an energy applicator, electrosurgical power generating source operably associated therewith, and electrosurgical systems including the same, and methods of directing energy to tissue will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:
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DETAILED DESCRIPTION
(14) Hereinafter, embodiments of the presently-disclosed data acquisition module operably associated with an energy applicator, electrosurgical power generating source operably associated therewith, and electrosurgical systems including the same, and the presently-disclosed methods of directing energy to tissue, are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the device, or component thereof, closer to the user and the term “distal” refers to that portion of the device, or component thereof, farther from the user.
(15) This description may use the phrases “in an embodiment,” “in embodiments,” “in some embodiments,” or “in other embodiments,” which may each refer to one or more of the same or different embodiments in accordance with the present disclosure.
(16) Electromagnetic energy is generally classified by increasing energy or decreasing wavelength into radio waves, microwaves, infrared, visible light, ultraviolet, X-rays and gamma-rays. As it is used in this description, “microwave” generally refers to electromagnetic waves in the frequency range of 300 megahertz (MHz) (3×10.sup.8 cycles/second) to 300 gigahertz (GHz) (3×10.sup.11 cycles/second).
(17) As it is used in this description, “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation assisted resection. As it is used in this description, “energy applicator” generally refers to any device that can be used to transfer energy from a power generating source, such as a microwave or RF electrosurgical generator, to tissue. As it is used in this description, “transmission line” generally refers to any transmission medium that can be used for the propagation of signals from one point to another.
(18) For the purposes herein, the term “electrosurgical desiccation” or, simply, “desiccation”, is intended to encompass any tissue desiccation procedure, including electrosurgical coagulation, desiccation, vessel sealing, and tissue fusion. As it is used in this description, the term “thermal spread” refers generally to the heat transfer (e.g., heat conduction, heat convection or electrical current dissipation) traveling along the periphery of the electrically-conductive, tissue-contacting surfaces.
(19) Various embodiments of the present disclosure provide a data acquisition module operably associated with an energy applicator. Various embodiments of the present disclosure provide electrosurgical systems and instruments suitable for sealing, cauterizing, coagulating/desiccating and/or cutting vessels and vascular tissue, ablating tissue, or otherwise modifying a tissue or organ of a patient, wherein the presently-disclosed data acquisition module receives a reflected signal from an energy applicator and provides a signal used to determine the rate of desiccation of tissue, which, in turn, may be used to determine one or more operating parameters of an electrosurgical power generating source.
(20) Various embodiments of the presently-disclosed electrosurgical systems and instruments use the frequency of a signal reflected from target tissue to determine the rate of desiccation of tissue and/or hydration level of the tissue around at least a portion of an energy applicator. Embodiments may be implemented using electromagnetic radiation at RF or microwave frequencies or at other frequencies.
(21) In accordance with embodiments of the present disclosure, one or more operating parameters of an electrosurgical power generating source are adjusted and/or controlled based on the determined desiccation rate, e.g., to maintain a proper desiccation rate, or to determine when tissue has been completely desiccated and/or the procedure has been completed.
(22) Various embodiments of the presently-disclosed electrosurgical systems employ a secondary frequency, wherein the secondary frequency is different than the primary power source frequency, to determine a type of tissue, a condition of tissue, and/or a tissue response. In accordance with embodiments of the present disclosure, a secondary frequency may be used to assist in determining when the energy applicator has been removed from the target tissue, which may trigger safety procedures and/or controls, e.g., control that reduces power level and/or shuts off the power delivery to the energy applicator.
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(24) The instrument 2 is connected via a transmission line, e.g., supply line 4, to an active terminal 23 of the electrosurgical power generating source 20, allowing the instrument 2 to coagulate, ablate and/or otherwise treat tissue. The energy is returned to the electrosurgical power generating source 20 through a return electrode 6 via a transmission line, e.g., return line 8, which is connected to a return terminal 22 of the power generating source 20. In some embodiments, the active terminal 23 and the return terminal 22 may be configured to interface with plugs (not shown) associated with the instrument 2 and the return electrode 6, respectively, e.g., disposed at the ends of the supply line 4 and the return line 8, respectively.
(25) The system 1 may include a plurality of return electrodes 6 that are arranged to minimize the chances of tissue damage by maximizing the overall contact area with the patient P. The power generating source 20 and the return electrode 6 may additionally, or alternatively, be configured for monitoring so-called “tissue-to-patient” contact to ensure that sufficient contact exists therebetween to further minimize chances of tissue damage. The active electrode may be used to operate in a liquid environment, wherein the tissue is submerged in an electrolyte solution.
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(28) Feedline 110 electrically connects the antenna assembly 12 via the transmission line 15 to the electrosurgical power generating source 28, and may include a coaxial cable, which may be semi-rigid or flexible. Feedline 110 may be cooled by fluid, e.g., saline or water, to improve power handling, and may include a stainless steel catheter. Transmission line 15 may additionally, or alternatively, provide a conduit (not shown) configured to provide coolant from a coolant source 18 to the probe 100.
(29) Antenna assembly 112, as shown in
(30) In some variations, the antenna assembly 112 includes a distal radiating portion 105 and a proximal radiating portion 140. In some embodiments, a junction 130 couples the proximal radiating portion 140 and the distal radiating portion 105. In some embodiments, the distal and proximal radiating portions 105, 140 align at the junction 130, which is generally made of a dielectric material, e.g., adhesives, and are also supported by the inner conductor that extends at least partially through the distal radiating portion 105. In some embodiments, the antenna assembly 112 may be provided with a coolant chamber (not shown). Additionally, the junction 130 may include coolant inflow and outflow ports (not shown) to facilitate the flow of coolant into, and out of, the coolant chamber. In some embodiments, the antenna assembly 112 may be provided with an outer jacket (not shown) disposed about the distal radiating portion 105, the junction 130 and/or the proximal radiating portion 140. The outer jacket may be a water cooled catheter formed of a material having low electrical conductivity.
(31) During microwave ablation, e.g., using the electrosurgical system 10, the probe 100 is inserted into or placed adjacent to tissue and microwave energy is supplied thereto. Probe 100 may be placed percutaneously or atop tissue, e.g., using conventional surgical techniques by surgical staff. A clinician may pre-determine the length of time that microwave energy is to be applied. The duration of microwave energy application using the probe 100 may depend on the progress of the heat distribution within the tissue area that is to be destroyed and/or the surrounding tissue.
(32) A plurality of probes 100 may be placed in variously arranged configurations to substantially simultaneously ablate a target tissue region, making faster procedures possible. Multiple probes 100 can be used to synergistically create a large ablation or to ablate separate sites simultaneously. Ablation volume is correlated with antenna design, antenna performance, number of energy applicators used simultaneously, ablation time and wattage, and tissue characteristics, e.g., time impedance.
(33) In operation, microwave energy having a wavelength, lambda (λ), is transmitted through the antenna assembly 112, e.g., along the proximal and distal radiating portions 140, 105, and radiated into the surrounding medium, e.g., tissue. The length of the antenna for efficient radiation may be dependent on the effective wavelength, λ.sub.eff, which is dependent upon the dielectric properties of the treated medium. Antenna assembly 112 through which microwave energy is transmitted at a wavelength, λ, may have differing effective wavelengths, λ.sub.eff, depending upon the surrounding medium, e.g., liver tissue, as opposed to breast tissue.
(34) According to an embodiment of the present disclosure, an energy applicator shown generally as 400 in
(35) The visual assistance provided by the indicia graduation marks 580 may allow the surgeon to selectively position the antenna assembly 412 in tissue. Antenna assembly 412 is similar to the antenna assembly 112 shown in
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(37) The DC power supply 527 is connected to an AC power source (not shown) and includes a high-voltage DC power supply, e.g., to provide high-voltage DC power via a transmission line 529 to an RF output stage 528 of the power generating source 500, and may include a low-voltage power supply, e.g., to provide power to various components of the power generating source 500 (e.g., input controls, displays, etc.).
(38) RF output stage 528 converts the high-voltage DC power into RF energy. The RF energy output by the RF output stage 528 is supplied via a transmission line 533 to a diplexer 530. The diplexer 530 is a multi-port network. In some embodiments, as shown in
(39) The RF output stage 528 is capable of generating waveforms (e.g., sinusoidal, square, or any type of AC waveform) of high RF energy. The RF output stage 528 may be configured to generate a plurality of waveforms having various duty cycles, peak voltages, crest factors, and other suitable parameters. Certain types of waveforms are suitable for specific electrosurgical modes. For instance, the RF output stage 528 may generate a 100% duty cycle sinusoidal waveform in cut mode, which is normally suitable for ablating, fusing and dissecting tissue. The RF output stage 528 may generate a 1-25% duty cycle waveform in coagulation mode, which is normally suitable for cauterizing tissue to stop bleeding.
(40) In some embodiments, as shown in
(41) The electrosurgical power generating source 500 may include a plurality of connectors to accommodate various types of electrosurgical instruments, such as without limitation, instrument 2 shown in
(42) The controller 524 includes a processor unit 525 operably connected to a memory 526, which may be any device or medium that can store code and/or data). The processor unit 525 may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in a computer-readable storage medium (e.g., memory 526). In some embodiments, the processor unit 525 is communicatively coupled to the DC power supply 527 and/or the RF output stage 528 allowing the processor unit 525 to control the output of the power generating source 500. In some embodiments, the processor unit 525 is configured to control the output of the power generating source 500 according to open and/or closed control loop schemes.
(43) In a closed feedback control loop configuration, sensor circuitry 522 and/or the sensor circuit 570 may each include a plurality of sensors. In some embodiments, the sensor circuitry 522 may be the main sensor in the feedback control loop. The sensor circuitry 522 may additionally be used in conjunction with the sensor circuit 570 for measuring a variety of tissue and/or energy properties (e.g., tissue impedance, tissue temperature, output current and/or voltage, voltage and current passing through the tissue, etc.) provide feedback to the controller 524. The sensor circuit 570 may also be used to determine if the instrument (e.g., instrument 2 shown in
(44) In some embodiments, as shown in
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(46) In some embodiments, as shown in
(47) Processing unit 82 may be communicatively coupled to a user interface 81. User interface 81 may include a display (not shown), such as without limitation a flat panel graphic LCD (liquid crystal display). User interface 81 may additionally, or alternatively, include one or more controls 83 that may include without limitation a switch (e.g., pushbutton switch, toggle switch, slide switch) and/or a continuous actuator (e.g., rotary or linear potentiometer, rotary or linear encoder). In some embodiments, one or more controls 83 may have a dedicated function, e.g., display contrast, power on/off, and the like. One or more controls 83 may have a function that may vary in accordance with an operational mode of the electrosurgical power generating source 28.
(48) In some embodiments, a storage device 88 is operably coupled to the processing unit 82, and may include random-access memory (RAM), read-only memory (ROM), and/or non-volatile memory (NV-RAM, Flash, and disc-based storage). Storage device 88 may include a set of program instructions executable on the processor 82 for executing a method for displaying and controlling ablation patterns in accordance with the present disclosure. Power generating source 28 may include a data interface 90 that is configured to provide a communications link to an external device 91. In an embodiment, the data interface 90 may be any of a USB interface, a memory card slot (e.g., SD slot), and/or a network interface (e.g., 100BaseT Ethernet interface or an 802.11 “Wi-Fi” interface). External device 91 may be any of a USB device (e.g., a memory stick), a memory card (e.g., an SD card), and/or a network-connected device (e.g., computer or server).
(49) Processing unit 82 may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in a memory, e.g., storage device 88 or external device 91. Generator assembly 10 may also include a database 84 communicatively coupled to the processing unit 82 and configured to store and retrieve data, e.g., parameters associated with one or energy applicators (e.g., energy applicator 400). Parameters stored in the database 84 in connection with an energy applicator, or energy applicator array assembly, may include, but are not limited to, energy applicator (or applicator array assembly) identifier, energy applicator (or applicator array assembly) dimensions, a frequency, an ablation length (e.g., in relation to a radiating section length), an ablation diameter, a gap distance at the feed point (e.g. in relation to an ablation geometry), a temporal coefficient, a shape metric, and/or a frequency metric. Database 84 may be maintained at least in part by data provided by the external device 91 via the data interface 90. For example without limitation, energy applicator data and/or other data may be uploaded from the external device 91 to the database 84 via the data interface 90.
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(52) In some embodiments, as shown in
(53) Hereinafter, methods of directing energy to tissue are described with reference to
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(55) In step 1120, energy from the electrosurgical power generating source 28 is transmitted through the energy applicator 400 to the target tissue “T”. The electrosurgical power generating source 28 may be capable of generating energy at RF or microwave frequencies or at other frequencies.
(56) In step 1130, a signal reflected from the target tissue “T” is transmitted to the data acquisition module 590. A cable assembly 19 may electrically-couple the energy applicator 400 to the data acquisition module 590.
(57) In step 1140, one or more operating parameters associated with the electrosurgical power generating source 28 are determined based on a tissue desiccation rate which is determined by the processor unit 82 based on at least one signal received from the data acquisition module 590. Some examples of operating parameters associated with an electrosurgical power generating source 28 that may be determined include temperature, impedance, power, current, voltage, mode of operation, and duration of application of electromagnetic energy.
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(59) In step 1220, energy from the electrosurgical power generating source 500 is transmitted through the energy applicator 400 to the target tissue “T”.
(60) In step 1230, data including a frequency of a signal reflected from the target tissue “T” is acquired.
(61) In step 1240, a tissue desiccation rate is calculated as a function of the frequency of the signal reflected from the target tissue “T”.
(62) In step 1250, one or more operating parameters associated with the electrosurgical power generating source are determined based on the calculated tissue desiccation rate. In some embodiments, the position of the energy applicator may be adjusted based on the calculated tissue desiccation rate. For example, an energy applicator with a directional radiation pattern may be rotated either manually, or automatically, based on the calculated specific absorption rate, e.g., to avoid ablating sensitive structures, such as large vessels, healthy organs or sensitive membrane barriers.
(63) The above-described electrosurgical systems for treating tissue and methods of directing energy to a target tissue may be suitable for various open and endoscopic surgical procedures.
(64) In the above-described embodiments, signals reflected by a target tissue are transmitted from an energy applicator to a data acquisition module, which may be operably associated with one or more components of an electrosurgical power generating source. The above-described energy applicators may be inserted into or placed adjacent to tissue. The above-described data acquisition module receives a reflected signal and provides a signal that may be used to determine the rate of desiccation of tissue and/or to determine one or more operating parameters of an electrosurgical power generating source.
(65) Various embodiments of the above-disclosed electrosurgical systems employ a secondary frequency, wherein the secondary frequency is different than the primary power source frequency, to determine a type of tissue, a condition of tissue, and/or a tissue response. In the above-described embodiments, a secondary frequency may be used to assist in determining when the energy applicator has been removed from the target tissue, which may trigger safety procedures and/or controls, e.g., control that reduces power level and/or shuts off the power delivery to the energy applicator.
(66) Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.