# Patent

## Title
Specific absorption rate measurement and energy-delivery device characterization using image analysis

## Abstract

A method of controlling output of an electrosurgical power generating source includes the steps of receiving image data including tissue temperature information of a target tissue volume, calculating a specific absorption rate as a function of the tissue temperature information from the image data, and determining one or more operating parameters associated with the electrosurgical power generating source based on the calculated specific absorption rate.

## Background
BACKGROUND
1. Technical Field
The present disclosure relates to a system and method for measuring the specific absorption rate of electromagnetic energy emitted by energy-delivery devices, such as energy-emitting probes or electrodes, and, more particularly, to specific absorption rate measurement and characterization of energy-delivery devices using image analysis.
2. Discussion of Related Art
Treatment of certain diseases requires the destruction of malignant tissue growths, e.g., tumors. Electromagnetic radiation can be used to heat and destroy tumor cells. Treatment may involve inserting ablation probes into tissues where cancerous tumors have been identified. Once the probes are positioned, electromagnetic energy is passed through the probes into surrounding tissue.
In the treatment of diseases such as cancer, certain types of tumor cells have been found to denature at elevated temperatures that are slightly lower than temperatures normally injurious to healthy cells. Known treatment methods, such as hyperthermia therapy, heat diseased cells to temperatures above 41° C. while maintaining adjacent healthy cells below the temperature at which irreversible cell destruction occurs. These methods involve applying electromagnetic radiation to heat, ablate and/or coagulate tissue. Microwave energy is sometimes utilized to perform these methods. Other procedures utilizing electromagnetic radiation to heat tissue also include coagulation, cutting and/or ablation of tissue. Many procedures and types of devices utilizing electromagnetic radiation to heat tissue have been developed.
In treatment methods utilizing electromagnetic radiation, such as hyperthermia therapy, the transference or dispersion of heat generally may occur by mechanisms of radiation, conduction, and convection. Biological effects that result from heating of tissue by electromagnetic energy are often referred to as “thermal” effects. “Thermal radiation” and “radiative heat transfer” are two terms used to describe the transfer of energy in the form of electromagnetic waves (e.g., as predicted by electromagnetic wave theory) or photons (e.g., as predicted by quantum mechanics). In the context of heat transfer, the term “conduction” generally refers to the transfer of energy from more energetic to less energetic particles of substances due to interactions between the particles. The term “convection” generally refers to the energy transfer between a solid surface and an adjacent moving fluid. Convection heat transfer may be a combination of diffusion or molecular motion within the fluid and the bulk or macroscopic motion of the fluid.
The extent of tissue heating may depend on several factors including the rate at which energy is absorbed by, or dissipated in, the tissue under treatment. The electromagnetic-energy absorption rate in biological tissue may be quantified by the specific absorption rate (SAR), a measure of the energy per unit mass absorbed by tissue and is usually expressed in units of watts per kilogram (W/kg). For SAR evaluation, a simulated biological tissue or “phantom” having physical properties, e.g., dielectric constant, similar to that of the human body is generally used.
One method to determine the SAR is to measure the rate of temperature rise in tissue as a function of the specific heat capacity (often shortened to “specific heat”) of the tissue. This method requires knowledge of the specific heat of the tissue. A second method is to determine the SAR by measuring the electric field strength in tissue. This method requires knowledge of the conductivity and density values of the tissue.
The relationship between radiation and SAR may be expressed as




  
    
      
        
          SAR
          =
          
            
              1
              2
            
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where σ is the tissue electrical conductivity in units of Siemens per meter (S/m), ρ is the tissue density in units of kilograms per cubic meter (kg/m3), and |E| is the magnitude of the local electric field in units of volts per meter (V/m).

The relationship between the initial temperature rise ΔT (° C.) in tissue and the specific absorption rate may be expressed as




  
    
      
        
          
            Δ
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            T
          
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where c is the specific heat of the tissue (or phantom material) in units of Joules/kg-° C., and Δt is the time period of exposure in seconds. Substituting equation (1) into equation (2) yields a relation between the induced temperature rise in tissue and the applied electric field as





  
    
      
        
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As can be seen from the above equations, modifying the local electric-field amplitude directly affects the local energy absorption and induced temperature rise in tissue. In treatment methods such as hyperthermia therapy, it would be desirable to deposit an electric field of sufficient magnitude to heat malignant tissue to temperatures above 41° C. while limiting the SAR magnitude in nearby healthy tissue to be less than that within the tumor to keep the healthy cells below the temperature causing cell death.
SAR measurement and the characterization of energy-delivery devices may ensure clinical safety and performance of the energy-delivery devices. SAR measurement and characterization of energy-delivery devices may generate data to facilitate planning and effective execution of therapeutic hyperthermic treatments.
SUMMARY
The present disclosure relates to a method of controlling output of an electrosurgical power generating source including the steps of receiving image data including tissue temperature information of a target tissue volume, calculating a specific absorption rate as a function of the tissue temperature information from the image data, and determining one or more operating parameters associated with an electrosurgical power generating source based on the calculated specific absorption rate.
The present disclosure also relates to a method of controlling output of an electrosurgical power generating source including the initial step of providing an energy applicator including a radiating section. The energy applicator is operatively associated with an electrosurgical power generating source. The method includes the steps of positioning the radiating section of the energy applicator at a first position for delivery of energy to a target tissue volume and transmitting energy from the electrosurgical power generating source through the radiating section to the target tissue volume. The method also includes the steps of acquiring a first set of image data including tissue temperature information of the target tissue volume by imaging the target tissue volume using one or more imaging modalities, calculating a specific absorption rate as a function of the tissue temperature information obtained from the first set of image data, and controlling output of the electrosurgical generator based on the calculated specific absorption rate.



BRIEF DESCRIPTION OF THE DRAWINGS
Objects and features of the presently disclosed system and method for specific absorption rate measurement and characterization of energy-delivery devices and the presently disclosed electrosurgical system and methods for controlling output of an electrosurgical power generating source 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:
FIG. 1 is a schematic illustration of a thermal profiling system including an energy applicator array positioned for the delivery of energy to a targeted tissue area according to an embodiment of the present disclosure;
FIG. 2 is a perspective view, partially broken-away, of an embodiment of a test fixture assembly in accordance with the present disclosure;
FIG. 3 is an exploded, perspective view, partially broken-away, of the test fixture assembly of FIG. 2 shown with a thermally-sensitive medium according to an embodiment of the present disclosure;
FIG. 4 is a perspective view, partially broken-away, of test fixture assembly of FIGS. 2 and 3 according to an embodiment of the present disclosure shown with an energy applicator associated therewith;
FIG. 5 is a cross-sectional view of an embodiment of a thermally-sensitive medium including a cut-out portion in accordance with the present disclosure;
FIG. 6 is a perspective view of a support member of the test fixture assembly of FIGS. 2 through 4 according to an embodiment of the present disclosure shown with a portion of the thermally-sensitive medium of FIG. 5 associated therewith;
FIGS. 7 and 8 are partial, enlarged views schematically illustrating the thermally-sensitive medium of FIG. 5 and the energy applicator of FIG. 4 centrally aligned with the longitudinal axis of the thermally-sensitive medium's cut-out portion according to an embodiment of the present disclosure;
FIG. 9 is a schematic, longitudinal cross-sectional view of an embodiment of a thermal profiling system including the test fixture assembly of FIGS. 2 through 4 and the energy applicator and the thermally-sensitive medium of FIGS. 7 and 8 in accordance with the present disclosure;
FIG. 10 is a schematic diagram illustrating the thermally-sensitive medium of the thermal profiling system of FIG. 9 during operation according to an embodiment of the present disclosure shown with a schematically-illustrated representation of a thermal radiation pattern formed on the thermally-sensitive medium at time t equal to t1;
FIG. 11 is a schematic diagram illustrating a thresholded pattern image of a portion of the thermally-sensitive medium of FIG. 10 showing a selected temperature band at time t equal to t1 according to an embodiment of the present disclosure;
FIG. 12 is a schematic diagram illustrating the thermally-sensitive medium of the thermal profiling system of FIG. 9 during operation according to an embodiment of the present disclosure shown with a schematically-illustrated representation of a thermal radiation pattern formed on the thermally-sensitive medium at time t equal to t2;
FIG. 13 is a schematic diagram illustrating a thresholded pattern image of a portion of the thermally-sensitive medium of FIG. 12 showing a selected temperature band captured at time t equal to t2 according to an embodiment of the present disclosure;
FIG. 14 is a schematic diagram illustrating the thermally-sensitive medium of the thermal profiling system of FIG. 9 during operation according to an embodiment of the present disclosure shown with a schematically-illustrated representation of a thermal radiation pattern formed on the thermally-sensitive medium at time t equal to t3;
FIG. 15 is a schematic diagram illustrating a thresholded pattern image of a portion of the thermally-sensitive medium of FIG. 14 showing a selected temperature band at time t equal to t3 according to an embodiment of the present disclosure;
FIG. 16A is a schematic diagram illustrating a thresholded pattern image of a thermally-sensitive medium according to an embodiment of the present disclosure showing a selected temperature band at time t equal to tn;
FIG. 16B is a schematic view of the thresholded pattern image of FIG. 16A shown with contour lines at the inner and outer boundaries of the temperature band;
FIG. 17A is a schematic diagram illustrating a thresholded pattern image of a thermally-sensitive medium according to an embodiment of the present disclosure showing a selected temperature band at time t equal to tn+1;
FIG. 17B is a schematic view of the thresholded pattern image of FIG. 17A shown with contour lines connecting a set of points at the inner and outer boundaries of the temperature band;
FIGS. 18 and 19 are schematic diagrams illustrating the positional relationship between points lying on the boundary lines of the temperature band of FIGS. 16B and 17B according to an embodiment of the present disclosure;
FIG. 20 is a diagrammatic representation of a simulated radiation pattern for an energy applicator according to an embodiment of the present disclosure;
FIG. 21 is a diagrammatic representation of a simulated radiation pattern for an energy applicator according to another embodiment of the present disclosure;
FIG. 22 is a flowchart illustrating methods of controlling output of an electrosurgical power generating source according to embodiments of the present disclosure;
FIG. 23 is a flowchart illustrating a method of controlling output of an electrosurgical power generating source according to an embodiment of the present disclosure;
FIG. 24 is a flowchart illustrating a sequence of method steps for performing the step 2360 of the method illustrated in FIG. 23 according to an embodiment of the present disclosure;
FIG. 25 is a schematic diagram of an ablation system including an electrosurgical device according to an embodiment of the present disclosure;
FIG. 26 is a schematic diagram of the electrosurgical device of FIG. 25 shown with indicia graduation marks and an indicia alignment mark according to an embodiment of the present disclosure; and
FIGS. 27 and 28 are schematically-illustrated representations of simulation results showing broadside radiation patterns according to embodiments of the present disclosure.



DETAILED DESCRIPTION
Hereinafter, embodiments of the system and method for specific absorption rate (SAR) measurement and characterization of energy-delivery devices of the present disclosure and embodiments of the presently disclosed electrosurgical system and methods for controlling output of an electrosurgical power generating source 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 apparatus, or component thereof, closer to the user and the term “distal” refers to that portion of the apparatus, or component thereof, farther from the user.
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. For the purposes of this description, a phrase in the form “A/B” means A or B. For the purposes of the description, a phrase in the form “A and/or B” means “(A), (B), or (A and B)”. For the purposes of this description, a phrase in the form “at least one of A, B, or C” means “(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)”.
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) (3×108 cycles/second) to 300 gigahertz (GHz) (3×1011 cycles/second). 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.
As it is used in this description, “length” may refer to electrical length or physical length. In general, electrical length is an expression of the length of a transmission medium in terms of the wavelength of a signal propagating within the medium. Electrical length is normally expressed in terms of wavelength, radians or degrees. For example, electrical length may be expressed as a multiple or sub-multiple of the wavelength of an electromagnetic wave or electrical signal propagating within a transmission medium. The wavelength may be expressed in radians or in artificial units of angular measure, such as degrees. The electric length of a transmission medium may be expressed as its physical length multiplied by the ratio of (a) the propagation time of an electrical or electromagnetic signal through the medium to (b) the propagation time of an electromagnetic wave in free space over a distance equal to the physical length of the medium. The electrical length is in general different from the physical length. By the addition of an appropriate reactive element (capacitive or inductive), the electrical length may be made significantly shorter or longer than the physical length.
As used in this description, the term “real-time” means generally with no observable latency between data processing and display. As used in this description, “near real-time” generally refers to a relatively short time span between the time of data acquisition and display.
Various embodiments of the present disclosure provide systems and methods of directing energy to tissue in accordance with specific absorption rate data associated with an energy applicator. Embodiments may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies. An electromagnetic energy delivery device including an energy applicator array, according to various embodiments, is designed and configured to operate between about 300 MHz and about 10 GHz.
Various embodiments of the presently disclosed electrosurgical system including an energy applicator, or energy applicator array, are suitable for microwave ablation and for use to pre-coagulate tissue for microwave ablation assisted surgical resection. In addition, although the following description describes the use of a dipole microwave antenna, the teachings of the present disclosure may also apply to a monopole, helical, or other suitable type of microwave antenna (or RF electrodes).
An electrosurgical system 100 according to an embodiment of the present disclosure is shown in FIG. 1 and includes an electromagnetic energy delivery device or energy applicator array “E”. Energy applicator array “E” may include one or more energy applicators or probes. Probe thickness may be minimized, e.g., to reduce trauma to the surgical site and facilitate accurate probe placement to allow surgeons to treat target tissue with minimal damage to surrounding healthy tissue. In some embodiments, the energy applicator array “E” includes a plurality of probes. The probes may have similar or different diameters, may extend to equal or different lengths, and may have a distal end with a tapered tip. In some embodiments, the one or more probes may be provided with a coolant chamber. The probe(s) may be integrally associated with a hub (e.g., hub 34 shown in FIG. 1) that provides electrical and/or coolant connections to the probe(s). Additionally, or alternatively, the probe(s) may include coolant inflow and outflow ports to facilitate the flow of coolant into, and out of, the coolant chamber. Examples of coolant chamber and coolant inflow and outflow port embodiments are disclosed in commonly assigned U.S. patent application Ser. No. 12/401,268 filed on Mar. 10, 2009, entitled “COOLED DIELECTRICALLY BUFFERED MICROWAVE DIPOLE ANTENNA”, and U.S. Pat. No. 7,311,703, entitled “DEVICES AND METHODS FOR COOLING MICROWAVE ANTENNAS”.
In the embodiment shown in FIG. 1, the energy applicator array “E” includes three probes 1, 2 and 3 having different lengths and arranged substantially parallel to each other. Probes 1, 2 and 3 generally include a radiating section “R1”, “R2” and “R3”, respectively, operably connected by a feedline (or shaft) 1a, 2a and 3a, respectively, to an electrosurgical power generating source 16, e.g., a microwave or RF electrosurgical generator. Transmission lines 10, 11 and 12 may be provided to electrically couple the feedlines 1a, 2a and 3a, respectively, to the electrosurgical power generating source 16. Located at the distal end of each probe 1, 2 and 3 is a tip portion 1b, 2b and 3b, respectively, which may be configured to be inserted into an organ “OR” of a human body or any other body tissue. Tip portion 1b, 2b and 3b may terminate in a sharp tip to allow for insertion into tissue with minimal resistance. Tip portion 1b, 2b and 3b may include other shapes, such as, for example, a tip that is rounded, flat, square, hexagonal, or cylindroconical. The shape, size and number of probes of the energy applicator array “E” may be varied from the configuration depicted in FIG. 1.
Electrosurgical system 100 according to embodiments of the present disclosure includes a user interface 50 that may include a display device 21, such as without limitation a flat panel graphic LCD (liquid crystal display), adapted to visually display one or more user interface elements (e.g., 23, 24 and 25 shown in FIG. 1). In an embodiment, the display device 21 includes touchscreen capability, e.g., the ability to receive user input through direct physical interaction with the display device 21, e.g., by contacting the display panel of the display device 21 with a stylus or fingertip. A user interface element (e.g., 23, 24 and/or 25 shown in FIG. 1) may have a corresponding active region, such that, by touching the display panel within the active region associated with the user interface element, an input associated with the user interface element is received by the user interface 50.
User interface 50 may additionally, or alternatively, include one or more controls 22 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 an embodiment, a control 22 has a dedicated function, e.g., display contrast, power on/off, and the like. Control 22 may also have a function that may vary in accordance with an operational mode of the electrosurgical system 100. A user interface element (e.g., 23 shown in FIG. 1) may be provided to indicate the function of the control 22. Control 22 may also include an indicator, such as an illuminated indicator, e.g., a single- or variably-colored LED (light emitting diode) indicator.
In some embodiments, the electrosurgical power generating source 16 is configured to provide microwave energy at an operational frequency from about 300 MHz to about 2500 MHz. In other embodiments, the power generating source 16 is configured to provide microwave energy at an operational frequency from about 300 MHz to about 10 GHz. Power generating source 16 may be configured to provide various frequencies of electromagnetic energy.
Feedlines 1a, 2a and 3a may be formed from a suitable flexible, semi-rigid or rigid microwave conductive cable, and may connect directly to an electrosurgical power generating source 16. Feedlines 1a, 2a and 3a may have a variable length from a proximal end of the radiating sections “R1”, “R2” and “R3”, respectively, to a distal end of the transmission lines 10, 11 and 12, respectively, ranging from a length of about one inch to about twelve inches. Feedlines 1a, 2a and 3a may be made of stainless steel, which generally offers the strength required to puncture tissue and/or skin. Feedlines 1a, 2a and 3a may include an inner conductor, a dielectric material coaxially surrounding the inner conductor, and an outer conductor coaxially surrounding the dielectric material. Radiating sections “R1”, “R2” and “R3” may be formed from a portion of the inner conductor that extends distal of the feedlines 1a, 2a and 3a, respectively, into the radiating sections “R1”, “R2” and “R3”, respectively. Feedlines 1a, 2a and 3a may be cooled by fluid, e.g., saline, water or other suitable coolant fluid, to improve power handling, and may include a stainless steel catheter. Transmission lines 10, 11 and 12 may additionally, or alternatively, provide a conduit (not shown) configured to provide coolant fluid from a coolant source 32 to the energy applicator array “E”.
As shown in FIG. 1, the electrosurgical system 100 may include a reference electrode 19 (also referred to herein as a “return” electrode). Return electrode 19 may be electrically coupled via a transmission line 20 to the power generating source 16. During a procedure, the return electrode 19 may be positioned in contact with the skin of the patient or a surface of the organ “OR”. When the surgeon activates the energy applicator array “E”, the return electrode 19 and the transmission line 20 may serve as a return current path for the current flowing from the power generating source 16 through the probes 1, 2 and 3.
During microwave ablation, e.g., using the electrosurgical system 100, the energy applicator array “E” is inserted into or placed adjacent to tissue and microwave energy is supplied thereto. Ultrasound or computed tomography (CT) guidance may be used to accurately guide the energy applicator array “E” into the area of tissue to be treated. Probes 1, 2 and 3 may be placed percutaneously or surgically, 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. Application duration may depend on a variety of factors such as energy applicator design, number of energy applicators used simultaneously, tumor size and location, and whether the tumor was a secondary or primary cancer. The duration of microwave energy application using the energy applicator array “E” may depend on the progress of the heat distribution within the tissue area that is to be destroyed and/or the surrounding tissue.
FIG. 1 shows a targeted region including ablation targeted tissue represented in sectional view by the solid line “T”. It may be desirable to ablate the targeted region “T” by fully engulfing the targeted region “T” in a volume of lethal heat elevation. Targeted region “T” may be, for example, a tumor that has been detected by a medical imaging system 30.
Medical imaging system 30, according to various embodiments, includes a scanner (e.g., 15 shown in FIG. 1) of any suitable imaging modality, or other image acquisition device capable of generating input pixel data representative of an image, e.g., a digital camera or digital video recorder. Medical imaging system 30 may additionally, or alternatively, include a medical imager operable to form a visible representation of the image based on the input pixel data. Medical imaging system 30 may include a storage device such as an internal memory unit, which may include an internal memory card and removable memory. In some embodiments, the medical imaging system 30 may be a multi-modal imaging system capable of scanning using different modalities. Examples of imaging modalities that may be suitably and selectively used include X-ray systems, ultrasound (UT) systems, magnetic resonance imaging (MRI) systems, computed tomography (CT) systems, single photon emission computed tomography (SPECT), and positron emission tomography (PET) systems. Medical imaging system 30, according to embodiments of the present disclosure, may include any device capable of generating digital data representing an anatomical region of interest. Medical imaging system 30 may be a multi-modal imaging system capable of scanning tissue in a first modality to obtain first modality data and a second modality to obtain second modality data, wherein the first modality data and/or the second modality data includes tissue temperature information. The tissue temperature information acquired by the one or more imaging modalities may be determined by any suitable method, e.g., calculated from density changes within the tissue.
Image data representative of one or more images may be communicated between the medical imaging system 30 and a processor unit 26. Medical imaging system 30 and the processor unit 26 may utilize wired communication and/or wireless communication. Processor unit 26 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 (not shown) associated with the processor unit 26. Processor unit 26 may be adapted to run an operating system platform and application programs. Processor unit 26 may receive user inputs from a keyboard (not shown), a pointing device 27, e.g., a mouse, joystick or trackball, and/or other device communicatively coupled to the processor unit 26.
A scanner (e.g., 15 shown in FIG. 1) of any suitable imaging modality may additionally, or alternatively, be disposed in contact with the organ “OR” to provide image data. As an illustrative example, the two dashed lines 15A in FIG. 1 bound a region for examination by the scanner 15, e.g., a real-time ultrasonic scanner.
In FIG. 1, the dashed line 8 surrounding the targeted region “T” represents the ablation isotherm in a sectional view through the organ “OR”. Such an ablation isotherm may be that of the surface achieving possible temperatures of approximately 50° C. or greater. The shape and size of the ablation isotherm volume, as illustrated by the dashed line 8, may be influenced by a variety of factors including the configuration of the energy applicator array “E”, the geometry of the radiating sections “R1”, “R2” and “R3”, cooling of the probes 1, 2 and 3, ablation time and wattage, and tissue characteristics. Processor unit 26 may be connected to one or more display devices (e.g., 21 shown in FIG. 1) for displaying output from the processor unit 26, which may be used by the clinician to visualize the targeted region “T” and/or the ablation isotherm volume 8 in real-time or near real-time during a procedure, e.g., an ablation procedure.
In embodiments, real-time data and/or near real-time data acquired from CT scan, ultrasound, or MRI (or other scanning modality) that includes tissue temperature information may be outputted from the processor unit 26 to one or more display devices. Processor unit 26 is adapted to analyze image data including tissue temperature information to determine a specific absorption rate (SAR) around an energy applicator as a function of the tissue temperature information obtained from the image data. A possible advantage to taking SAR directly from the patient is that any tissue inconsistencies in the local area of the antenna or electrode would be detected using this SAR. Calculating SAR from the electrode or antenna as it is being used in the patient may allow detection of the beginning of a non-uniform ablation field.
In some embodiments, the patient's anatomy may be scanned by one or more of several scanning modalities, such as CT scanning, MRI scanning, ultrasound, PET scanning, etc., so as to visualize the tumor and the surrounding normal tissue. The tumor dimensions may thereby be determined and/or the location of the tumor relative to critical structures and the external anatomy may be ascertained. An optimal number and size of energy applicators might be selected so that the ablation isotherms can optimally engulf and kill the tumor with a minimal number of electrode insertions and minimal damage to surrounding healthy tissue.
Electrosurgical system 100 may include a library 200 including a plurality of thermal profiles or overlays 202-202n. As it is used in this description, “library” generally refers to any repository, databank, database, cache, storage unit and the like. Each of the overlays 202-202 may include a thermal profile that is characteristic of and/or specific to a particular energy applicator design, particular energy applicator array, and/or exposure time. Examples of overlay embodiments are disclosed in commonly assigned U.S. patent application Ser. No. 11/520,171 filed on Sep. 13, 2006, entitled “PORTABLE THERMALLY PROFILING PHANTOM AND METHOD OF USING THE SAME”, and U.S. patent application Ser. No. 11/879,061 filed on Jul. 16, 2007, entitled “SYSTEM AND METHOD FOR THERMALLY PROFILING RADIOFREQUENCY ELECTRODES”, the disclosures of which are incorporated herein by reference in their entireties.
Library 200 according to embodiments of the present disclosure may include a database 284 that is configured to store and retrieve energy applicator data, e.g., parameters associated with one or energy applicators (e.g., 1, 2 and 3 shown in FIG. 1) and/or one or more energy applicator arrays (e.g., “E” shown in FIG. 1). Parameters stored in the database 284 in connection with an energy applicator, or an energy applicator array, may include, but are not limited to, energy applicator (or energy applicator array) identifier, energy applicator (or energy applicator array) dimensions, a frequency, an ablation length (e.g., in relation to a radiating section length), an ablation diameter, a temporal coefficient, a shape metric, and/or a frequency metric. In an embodiment, ablation pattern topology may be included in the database 284, e.g., a wireframe model of an energy applicator array (e.g., 25 shown in FIG. 1) and/or a representation of a radiation pattern associated therewith.
Library 200 according to embodiments of the present disclosure may be in communicatively associated with a picture archiving and communication system (PACS) database (shown generally as 58 in FIG. 1), e.g., containing DICOM (acronym for Digital Imaging and Communications in Medicine) formatted medical images. PACS database 58 may be configured to store and retrieve image data including tissue temperature information. As shown in FIG. 1, the processor unit 26 may be communicatively associated with the PACS database 58. In accordance with one or more presently-disclosed methods, image data associated with a prior treatment of a target tissue volume is retrieved from the PACS database 58 (e.g., step 2245 shown in FIG. 22), and the SAR is calculated as a function of the tissue temperature information from the image data (e.g., step 2260 shown in FIG. 22).
Images and/or non-graphical data stored in the library 200, and/or retrievable from the PACS database 58, may be used to configure the electrosurgical system 100 and/or control operations thereof. For example, thermal profiling data associated with an energy applicator, according to embodiments of the present disclosure, may be used as a feedback tool to control an instrument's and/or clinician's motion, e.g., to allow clinicians to avoid ablating critical structures, such as large vessels, healthy organs or vital membrane barriers.
Images and/or non-graphical data stored in the library 200, and/or retrievable from the PACS database 58, may be used to facilitate planning and effective execution of a procedure, e.g., an ablation procedure. Thermal profile data associated with an energy applicator, according to embodiments of the present disclosure, may be used as a predictive display of how an ablation will occur prior to the process of ablating. Thermal profile data associated with an energy applicator, according to embodiments of the present disclosure, may be used to determine a specific absorption rate (SAR) around the energy applicator. A simulated radiation pattern for the energy applicator may be generated as a function of the SAR around the energy applicator. For example, the Pennes' bio-heat equation coupled with electrical field equations in a finite element analysis (FEA) environment generally provides a governing structure for computer simulations modeling energy deposition in biological tissues. It is envisioned and within the scope of the present disclosure that the Pennes' bio-heat equation coupled with electrical field equations in a FEA environment may be used to generate simulated radiation patterns for an energy applicator as a function of the SAR around the energy applicator. Images, simulated radiation patterns (e.g., “P1” and “P2” shown in FIGS. 20 and 21, respectively) and/or information displayed on the display device 21 of the user interface 50, for example, may be used by the clinician to better visualize and understand how to achieve more optimized results during thermal treatment of tissue, such as, for example, ablation of tissue, tumors and cancer cells.
An embodiment of a system (shown generally as 900 in FIG. 9) suitable for specific absorption rate measurement and characterization of energy-delivery devices in accordance with the present disclosure includes the test fixture assembly 300 of FIGS. 2 through 4, a thermally-sensitive, color-changing medium (e.g., 331 shown in FIGS. 3 and 4) disposed within the test fixture assembly 300, and may include a hydrogel material 304 disposed around the thermally-sensitive medium. Test fixture assembly 300 includes a housing 302 including a wall 302a, a port 303 defined in the wall 302a, and a support member 325 adapted to support at least a portion of a thermally-sensitive, color-changing medium disposed within an interior area (shown generally as 301 in FIG. 2) of the housing 302. The thermally-sensitive, color-changing medium may be a sheet or layer of thermally-sensitive paper or film, may have a single- or multi-layer structure, and may include a supporting substrate. A layer of a thermally-sensitive medium may be composed of different materials.
Housing 302 may be configured to contain a quantity of a fluid and/or gel material 304, e.g., an electrically and thermally conductive polymer, hydrogel, or other suitable transparent or substantially-transparent medium having electrical and thermal conductivity. Housing 302 includes a bottom portion 315 and a wall 302a extending upwardly from the bottom portion 315 to define an interior area or space (e.g., 301 shown in FIG. 2). Housing 302 may be fabricated from any suitable material, e.g., plastic or other moldable material, and may have a substantially rectangular or box-like shape. In embodiments, the housing 302 may include an electrically non-conductive material, e.g., plastics, such as polyethylene, polycarbonate, polyvinyl chloride (PVC), or the like. Housing 302 may be fabricated from metals, plastics, ceramics, composites, e.g., plastic-metal or ceramic-metal composites, or other materials. In some embodiments, the housing 302 is formed of a high thermal conductivity material, e.g., aluminum. The shape and size of the housing 302 may be varied from the configuration depicted in FIGS. 2 through 4. Housing 302 may have the different anatomical shapes, such as, for example, circular, ovular, kidney-shaped, liver-shaped, or lung shaped, which may allow a clinician to better visualize the potential effects of thermal treatment on a patient prior to actually performing the treatment procedure.
Housing 302, according to embodiments of the present disclosure, includes one or more ports (e.g., 303 shown in FIG. 3) defined in the housing 302 and configured to allow at least a distal portion of a probe (shown generally as 1 in FIGS. 1, 4, 7, 8 and 9) to be disposed in an interior area of the housing 302. The port(s) may be configured to accommodate different size probes.
As shown in FIG. 3, a fixture or fitting 306 may be provided to the port 303. Fitting 306 may be configured to extend through a wall 302a of the housing 302. Fitting 306 generally includes a tubular portion (e.g., 307 shown in FIG. 3) defining a passageway (e.g., 308 shown in FIG. 2) configured to selectively receive a probe (e.g., 1 shown in FIG. 4) therethrough. In embodiments, the fitting 306 may be configured to inhibit leakage of the hydrogel 304 from within the housing 302, e.g., when the probe is removed from the fitting 306. Fitting 306 may additionally, or alternatively, form a substantially fluid tight seal around the probe when the probe is inserted therethrough. Fitting 306 may be a single-use fitting. Fitting 306 may be replaceable after each use or after several uses. Fitting 306 may include, but is not limited to, a luer-type fitting, a pierceable membrane port, and the like. Guards 309 may be disposed on opposite sides of the fitting 306 to prevent inadvertent contact or disruption of the fitting 306. Test fixture assembly 300, according to embodiments of the present disclosure, may include a plurality of ports defined in the housing 302, e.g., to accommodate multiple probes. Test fixture assembly 300 may additionally, or alternatively, include a plurality of fittings 306.
In some embodiments, the test fixture assembly 300 includes a ground ring 310 disposed within the housing 302. Ground ring 310 may include any suitable electrically-conductive material, e.g., metal such as aluminum. During operation of the thermal profiling system 900, the ground ring 310 may receive and/or transmit electromagnetic energy from/to an energy applicator associated with the test fixture assembly 300. As shown in FIGS. 2 and 3, the ground ring 310 may have a shape that substantially complements the shape of the housing 302, e.g., to extend substantially around an inner perimeter of the housing 302. A ground connection 312 may be provided that is adapted to electrically connect to the ground ring 310. As shown in FIGS. 3 and 4, the ground connection 312 may extend through a wall of the housing 302, and may be used to electrically connect the ground ring 310 to an electrosurgical power generating source (e.g., 916 shown in FIG. 9). In some embodiments, the ground ring 310 may be removable. The ground ring 310 may be removed in order to reduce any reflected energy that may be caused by the presence of the ground ring 310, which may be influenced by probe configuration and operational parameters. For example, it may be desirable to remove the ground ring 310 when microwave operational frequencies are used.
Test fixture assembly 300 according to embodiments of the present disclosure includes a support member 325 disposed on and extending inwardly from an inner surface of a wall 302a of the housing 302, and may include at least one support rod 322 extending upwardly into the housing 302 from a lower surface thereof. FIG. 6 shows an embodiment of the support member 325 that includes a shelf portion 320, a recess in the form of a groove 320a defined in the planar top surface “S” of the shelf portion 320, and a shelf support member 328 coupled to the shelf portion 320. Shelf portion 320 and the shelf support member 328 may be integrally formed. As shown in FIG. 6, a channel 328a is defined in the shelf support member 328 and extends therethrough. In some embodiments, the channel 328a has a substantially cylindrical shape and the groove 320a has a substantially half-cylindrical shape, and the groove 320a may be substantially aligned with a lower, half-cylindrical portion of the channel 328a. 
FIG. 9 shows an embodiment of a thermal profiling system 900 according to the present disclosure that includes the test fixture assembly 300 of FIGS. 2 through 4 and an imaging system 918. Imaging system 918 includes an image acquisition unit 912 capable of generating image data, and may include an image processing unit 954 in communication with the image acquisition unit 912. Image acquisition unit 912 may include any suitable device capable of generating input pixel data representative of an image, e.g., a digital camera or digital video recorder. An image may have 5120 scan lines, 4096 pixels per scan lines and eight bits per pixel, for example. As described in more detail herein, at least one sheet or layer of a suitable thermally-sensitive medium 331 is disposed within an interior area (shown generally as 301 in FIG. 2) of the housing 302. Image acquisition unit 912, according to embodiments to the present disclosure, is configured to capture time-series image data of thermal radiation patterns formed on the thermally-sensitive medium 331, and may be disposed over the interior area of the housing 302 or otherwise suitably positioned to facilitate image capture of the thermally-sensitive medium 331, or portion thereof.
In some embodiments, the thermally-sensitive medium 331 may include liquid crystal (LC) thermometry paper. A plurality of sheets of the thermally-sensitive medium 331 may be provided to generate a set of thermal profiles thereon in accordance with characteristics of an energy applicator and/or parameters and/or settings of a power generating source. The shape, size and number of sheets of the thermally-sensitive medium 331 may be varied from the configuration depicted in FIGS. 3 and 4. In some embodiments, the thermally-sensitive medium 331 may have a shape that conforms to the shape of the selected housing (e.g., 302 shown in FIGS. 2 through 4) and/or the thermally-sensitive medium 331 may be shaped to allow circulation of a heated medium, e.g., hydrogel, thereabout.
Thermal profiling system 900 may include an electrosurgical power generating source 916. As shown in FIG. 9, the feedline 1a of the energy applicator 1 associated with the test fixture assembly 300 may be electrically coupled to an active port or terminal of the electrosurgical power generating source 916, and the ground connection 321 of the test fixture assembly 300 may be electrically coupled to a return port or terminal of the power generating source 916.
Thermal profiling system 900, according to embodiments of the present disclosure, may include a temperature control unit (not shown) capable of detecting the temperature of the hydrogel 304 and maintaining the hydrogel 304 at a predetermined temperature or temperature range. In accordance with embodiments of the present disclosure, the difference between the ambient temperature of the hydrogel 304 and the threshold temperature of the thermally-sensitive medium 331 is designed to be relatively small, e.g., to allow close to adiabatic conditions. For example, the thermal profiling system 900 may be configured to maintain the hydrogel 304 at a temperature of about 34.5° C., and the thermally-sensitive medium 331 may be selected to have a threshold temperature of about 35.0° C.
Thermally-sensitive medium 331 according to embodiments of the present disclosure includes a cut-out portion (e.g., 332 shown in FIG. 5) defining a void in the thermally-sensitive medium 331. The cut-out portion may be configured to substantially match the profile of an energy applicator, and may be configured to provide a gap (e.g., “G” shown in FIG. 7) between the energy applicator and the thermally-sensitive medium 331 at the edge of the cut-out portion. Thermally-sensitive medium 331 may have any suitable thermal sensitivity. In some embodiments, the thermally-sensitive medium 331 has a thermal sensitivity of about one degree Celsius. Thermally-sensitive medium 331, or portion thereof, may be disposed over at least a portion of the support member 325. Additionally, or alternatively, at least a portion of the thermally-sensitive medium 331 may be disposed over one or more support rods 322.
In some embodiments, at least a portion of the thermally-sensitive medium 331 is disposed over the shelf portion 320 and positioned to substantially align a longitudinal axis (e.g., “A-A” shown in FIG. 5) of a cut-out portion 332 with a central longitudinal axis (e.g., “A-A” shown in FIG. 6) of the channel 328a of the shelf support member 328. In some embodiments, a longitudinal axis (e.g., “A-A” shown in FIG. 5) of the cut-out portion 332 is arranged parallel to the central longitudinal axis (e.g., “A-A” shown in FIG. 6) of the channel 328a. As cooperatively shown in FIGS. 3 and 9, a fitting 306 may be provided to the port 303 defined in the wall 302a of the housing 302, wherein a tubular portion 307 of the fitting 306 may be configured to extend through the port 303 and into the channel 328a of the support member 325. Tubular portion 307 disposed within the port 303 and channel 328a may help to maintain alignment of the energy applicator (e.g., 1 shown in FIGS. 4 and 9) with respect to the cut-out portion 332 of the thermally-sensitive medium 331. Fitting 307 may be provided with a sleeve member (e.g., 308a shown in FIG. 4) substantially coaxially aligned with the tubular portion 307, e.g., to provide a resiliently compressible seal around an energy applicator portion disposed therein. The sleeve member may be formed of a compliant material, e.g., silicon, natural or synthetic rubber, or other suitable resiliently compressible material.
In some embodiments, the shelf portion 320 and one or more support rods 322 function to support a thermally-sensitive medium 331 within the housing 302. Shelf portion 320 and the support rod(s) 322, according to embodiments of the present disclosure, may be configured to support the thermally-sensitive medium 331 such that the thermally-sensitive medium 331 is maintained in a plane (e.g., “P” shown in FIG. 5) substantially parallel to a facing surface of the bottom portion 315 of the housing 302. Shelf portion 320 and the support rod(s) 322 may additionally, or alternatively, be configured to support the thermally-sensitive medium 331 such that the thermally-sensitive medium 331 is maintained in a plane substantially parallel to a plane of the shelf portion 320. Shelf portion 320 and the support rod(s) 322 may additionally, or alternatively, be configured to support the thermally-sensitive medium 331 such that a longitudinal axis (e.g., “A-A” shown in FIG. 5) of the cut-out portion 332 is substantially aligned with the central longitudinal axis (e.g., “A-A” shown in FIG. 8) of an energy applicator (e.g., 1 shown in FIG. 8) associated therewith.
Thermal profiling system 900, according to embodiments of the present disclosure, includes a transparent housing portion (e.g., “W” shown in FIG. 4) for providing viewing into the interior area of the housing 302, and may include a cover 340 configured to selectively overlie the housing 302. Cover 340, or portion thereof, may be fabricated from any suitable transparent or substantially transparent material, e.g., glass, optically transparent thermoplastics, such as polyacrylic or polycarbonate. In some embodiments, the housing 302 includes a top edge portion (e.g., 339 shown in FIG. 2), which can take any suitable shape. Cover 340 may be releaseably securable to a top edge portion of the housing 302 by any suitable fastening element, e.g., screws, bolts, pins, clips, clamps, and hinges.
As shown in FIG. 9, the thermal profiling system 900 includes an imaging system 918 operatively associated with the electrosurgical power generating source 916 and the housing 302, and may include a display device 21 electrically coupled to the electrosurgical power generating source 916. For example, the imaging system 918 may include an image acquisition unit 912 for recording the visual changes occurring in thermally-sensitive medium 331 and/or parameters and/or settings of the electrosurgical power generating source 916 (e.g., power settings, time settings, wave settings, duty-cycle settings, energy applicator 1 configuration, etc.). Imaging system 918 may be communicatively coupled to a PACS database (e.g., 58 shown in FIG. 1). Imaging system 918 may also include an image processing unit 954 to which a portable storage medium 958 may be electrically connected. Portable storage medium 958 may, among other things, allow for transfer of image data in DICOM format to a PACS database (e.g., 58 shown in FIG. 1). As shown in FIG. 9, the image processing unit 954 is electrically connected between the image acquisition unit 912 and the power generating source 916, and may be electrically connected to the display device 21.
Hereinafter, a method of measuring specific absorption rate and characterizing an energy applicator using a thermal phantom and image analysis in accordance with the present disclosure is described with reference to FIGS. 1 through 9. Test fixture assembly 300 of FIGS. 2 through 4 is provided, and a hydrogel material 304 is introduced into the interior area 301 of the housing 302 of the test fixture assembly 300. A thermally-sensitive medium 331 including a cut-out portion 332 is placed into the housing 302 containing hydrogel 304 therein, e.g., in such a manner that a color changing side of the thermally-sensitive medium 331 is facing the cover 340 or away from the bottom portion 315. Thermally-sensitive medium 331 may be positioned within the housing 302 such that at least a portion of thermally-sensitive medium 331 is placed on the shelf portion 320 of the support member 325 and/or at least a portion of thermally-sensitive medium 331 is placed on support rods 322. In one embodiment, fasteners, such as screws, may be used to secure the thermally-sensitive medium 331 to the shelf portion 320 and/or the support rods 322. With the thermally-sensitive medium 331 submerged in hydrogel 304 within the housing 302, the cover 340 may be secured to the housing 302, e.g., to substantially enclose the thermally-sensitive medium 331 within the housing 302.
The selected energy applicator (e.g., 1 shown in FIGS. 1, 4 and 9) is introduced into the housing 302 through the port 303 by placing a distal tip portion (e.g., 1b shown in FIG. 1) into a fitting 306 disposed therein and advancing the energy applicator therethrough until at least a portion of the radiating section of the energy applicator is located with the cut-out portion 332 of the thermally-sensitive medium 331. As shown in FIG. 7, the energy applicator 1 disposed in the cut-out portion 332 may be spaced apart a distance or gap “G” from the thermally-sensitive medium 331. Gap “G” may be configured to be as narrow a distance as can be achieved, without making contact between the thermally-sensitive medium 331 and the energy applicator 1. In some embodiments, the gap “G” may be about 1 millimeter. As shown in FIG. 7, the width of the gap “G” may be substantially the same around the entire periphery of the energy applicator 1, e.g., to minimize errors in the image processing and analysis stage.
Energy applicator 1 is electrically connected to an active port or terminal of electrosurgical power generating source 916, and the ground connection 312 of the test fixture assembly 300 is electrically connected to a return port or terminal of power generating source 916. Test fixture assembly 300, according to embodiments of the present disclosure, is adapted to maintain the position of at least a distal portion of the energy applicator 1 disposed within the test fixture assembly 300 such that the central longitudinal axis (e.g., “A-A” shown in FIG. 8) of the energy applicator 1 is substantially parallel to a plane (e.g., “P” shown in FIG. 5) containing the thermally-sensitive medium 331.
In some embodiments, the power generating source 916 is configured or set to a predetermined setting. For example, power generating source 916 may be set to a predetermined temperature, such as a temperature that may be used for the treatment of pain (e.g., about 42° C. or about 80° C.), a predetermined waveform, a predetermined duty cycle, a predetermined time period or duration of activation, etc.
When the energy applicator 1 is positioned within the test fixture assembly 300, the imaging system 918 may be activated to record any visual changes in the thermally-sensitive medium 331, the settings and/or parameters of the power generating source 916, and the configuration of the energy applicator 1.
According to an embodiment of the present disclosure, prior to activation of the electrosurgical power generating source 916, a temperature of the hydrogel 304 within the housing 302 is stabilized to a temperature of approximately 37° C. When the power generating source 916 is activated, electromagnetic energy communicated between the radiating section (e.g., “R1” shown in FIG. 4) of the energy applicator 1 and ground ring 310 affects the thermally-sensitive medium 331 to create a thermal image (e.g., “S1” shown in FIG. 10) thereon.
The method may further include operating the imaging system 918 to capture a time series of thermal images (e.g., “S1”, “S2” and “S3” shown in FIGS. 10, 12 and 14, respectively). For example, the temperature gradients or “halos” created on the thermally-sensitive medium 331 may be captured by the image acquisition unit 912 of the imaging system 918, and may be stored electronically in the image processing unit 954 or the portable storage medium 958 communicatively coupled thereto. As heat generated by the electromagnetic radiation emitted from energy applicator 1 affects the thermally-sensitive medium 331, the temperature gradients or “halos”, e.g., colored rings or bands, indicate areas of relatively higher temperature and areas of relatively lower temperature. It is contemplated that the particular thermally-sensitive medium 331 used may be selected so as to display only a single temperature of interest as opposed to a range of temperatures.
Additionally, the imaging system 918 may record and store the settings and/or parameters of the electrosurgical power generating source 916 (e.g., temperature, impedance, power, current, voltage, mode of operation, duration of application of electromagnetic energy, etc.) associated with the creation of the image on the thermally-sensitive medium 331.
Following the acquisition of images created on the thermally-sensitive medium 331, the power generating source 916 may be deactivated and the energy applicator 1 withdrawn from the housing 302. The used thermally-sensitive medium 331 may be removed from the housing 302 and replaced with a new or un-used thermally-sensitive medium 331. The above-described method may be repeated for the same or different set of settings and/or parameters for the power generating source 916 and/or the same or different energy applicator 1 configuration.
Thermal profiling system 900 may be used in conjunction with any suitable hypothermic and/or ablative energy system including, for example, microwave energy systems employing microwave antennas for delivering ablative energy. The above-described thermal profiling system 900 has been specifically described in relation to the characterization of a single energy applicator 1. However, it is envisioned and within the scope of the present disclosure that test fixture assembly 300 be configured to receive multiple energy applicators, e.g., two or more, and for images and/or data to be acquired thereof, in accordance with the method described above.
During use of the thermal profiling system 900, the image acquisition unit 912 of the imaging system 918 acquires a series of images of the thermally-sensitive medium 331 with color bands formed thereon disposed around the energy applicator 1. Image acquisition unit 912 may acquire a series of images with varying time delays before image acquisition. In some embodiments, the image acquisition unit 912 acquires a time series of images wherein the series of images is recorded along time at uniform time intervals.
FIGS. 10, 12 and 14 show an energy applicator 1 disposed within the cut-out portion 332 of the thermally-sensitive medium 331 with schematically-illustrated representations of thermal radiation patterns “S1”, “S2” and “S3” respectively, formed on the thermally-sensitive medium 331 during use of the thermal profiling system 900 at time t equal to t1, t2 and t3, respectively. In FIGS. 10, 12 and 14, a plurality of color bands (also referred to herein as temperature bands) are shown around the energy applicator 1. The shape, size and number of temperature bands on the thermally-sensitive medium 331 may be varied from the configurations depicted in FIGS. 10, 12 and 14.
Imaging system 918, according to various embodiments, includes an image processing unit 954 in communication with the image acquisition unit 912. A time series of image data acquired by the image acquisition unit 912 (or image data from other imaging modalities such as MRI) may be inputted and stored in a memory (not shown) of the image processing unit 954. According to embodiments of the present disclosure, one or more temperature bands (e.g., “B1”, “B2”, “B3” and/or “B4” shown in FIG. 14) may be selected, either manually by the user, e.g., using a pointing device (e.g., 27 shown in FIG. 1) and/or the touchscreen capability of a display device (e.g., 21 shown in FIG. 1), or automatically, e.g., by the image processing unit 954, for image processing to generate data for use in characterizing the energy applicator 1.
A method according to embodiments of the present disclosure includes thresholding to segment an image data by setting all pixels whose intensity values are above a predetermined threshold to a foreground value and all the remaining pixels to a background value.
FIGS. 11, 13 and 15 show thresholded pattern images “T1”, “T2” and “T3”, respectively, of a portion of the thermally-sensitive medium of FIGS. 10, 12 and 14 showing a selected temperature band “B2” at time t equal to t1, t2 and t3, respectively.
A method according to embodiments of the present disclosure includes generating image data on the basis of thresholded pattern images of the selected temperature band (e.g., “B” shown in FIGS. 16A and 17A) surrounded by an inner boundary (e.g., “IB” shown in FIGS. 16B and 17B) and/or an outer boundary (e.g., “OB” shown in FIGS. 16B and 17B).
FIG. 16A shows a selected temperature band “B” at time t equal to tn, and FIG. 17B shows the temperature band “B” at time t equal to tn+1. As illustratively shown in FIGS. 16B and 17B, thresholding of time-series image data may be used to detect an inner boundary and an outer boundary of the selected color band in each image data of the time-series image data.
An example of the positional relationships between two points lying on the boundaries of a temperature band (e.g., “B” of FIGS. 16B and 17B) is shown in FIGS. 18 and 19. For illustrative purposes, the inner and outer boundaries “L1” and “L2”, respectively, of a temperature band, at time t equal to tn (shown by the solid curved lines in FIG. 18 and the dashed curved lines in FIG. 19), and at time t equal to tn+1 (shown by the solid curved lines in FIG. 19), are plotted on a coordinate grid having equal scale units “D”. In the interest of simplicity, unit “D” may be taken to be equal to the width of the cut-out portion, for illustrative purposes. It is contemplated that other spatial data or features may be used to establish a measurement scale, such as grid lines or marks, or objects, placed on the thermally-sensitive medium prior to image acquisition, or the diameter of the energy applicator.
In FIGS. 18 and 19, each of the points “P1” and “P2” may correspond to a single pixel or to a group of pixels. Referring to FIG. 18, at time t equal to tn, the point “P1” on the inner boundary “L1” is spaced apart a length “J” from an edge point of the cut-out portion, and the point “P2” on the outer boundary “L2” is spaced apart a length “K” from an edge point of the cut-out portion. In this example, the length “J” is equal to 2 times the unit “D”. Turning now to FIG. 19, at time t equal to tn+1, the point “P1” on the inner boundary “L1” is spaced apart a length “L” from a cut-out portion edge point, and the point “P2” on the outer boundary “L2” is spaced apart a length “M” from a cut-out portion edge point. In this example, the length “L” is equal to 2.5 times the unit “D”. In the present example, it can be calculated from the coordinate grid that, from a time t equal to tn to t equal to tn+1, the point “P1” on the inner boundary “L1” of the temperature band moves, from a first position to a second position on the coordinate grid, a distance equal to one-half of the unit “D”. According to an embodiment of the present disclosure, determination of the positional change of point “P1” on the inner boundary “L1” of the temperature band provides the value of the temperature difference, ΔT, for use in calculating the specific absorption rate. The difference in time from a time t equal to tn to t equal to tn+1 may be set by the frame rate of the image acquisition device (e.g., 912 shown in FIG. 9).
The specific absorption rate (SAR) may be calculated by the following equation:




  
    
      
        
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where cp is the specific heat of the hydrogel 304 (in units of Joules/kg-° C.), ΔT is the temperature difference (° C.), and Δt is the time period in accordance with the frame rate, or a fraction or multiple thereof, in seconds.

Hereinafter, methods of controlling output of an electrosurgical power generating source are described with reference to FIGS. 22 and 23. It is to be understood that the steps of the methods provided herein may be performed in combination and in a different order than presented herein without departing from the
FIG. 22 is a flowchart illustrating methods of controlling output of an electrosurgical power generating source according to embodiments of the present disclosure. One approach, illustrated in FIG. 22, is to determine one or more operating parameters associated with an electrosurgical power generating source using image data retrieved from a medical database (e.g., image data in DICOM format stored in a PACS database). This approach may be suitable, for example, in cases where the treatment is a second treatment (or third treatment, etc.) and where data associated with a prior treatment of the target tissue volume has been stored in a database, or is otherwise retrievable. In accordance with another approach illustrated in FIG. 22, one or more operating parameters associated with an electrosurgical power generating source may be determined using real-time (or near real-time) tissue temperature data acquired from one or more imaging modalities during the procedure, e.g., an ablation procedure.
In step 2210, an energy applicator (e.g., “E” shown in FIG. 1) is positioned for delivery of energy to a target tissue volume (e.g., “T” shown in FIG. 1). The energy applicator may be inserted directly into tissue, inserted through a lumen, e.g., a vein, needle or catheter, placed into the body during surgery by a clinician, or positioned in the body by other suitable methods.
In step 2220, energy from an energy source, e.g., an electrosurgical power generating source (e.g., 16 shown in FIG. 1), is transmitted through the energy applicator to the target tissue volume.
In step 2230, image data including tissue temperature information of the target tissue volume is acquired by imaging the target tissue volume using one or more imaging modalities (e.g., 30 shown in FIG. 1). The tissue temperature information acquired by the one or more imaging modalities may be determined by any suitable method, e.g., calculated from density changes within the tissue.
In one approach, the image data including tissue temperature information is received from one or more imaging modalities, in step 2250. The specific absorption rate (SAR) is calculated as a function of the tissue temperature information from the image data, in step 2260. A possible advantage to taking SAR directly from the patient is that any tissue inconsistencies in the local area of the antenna or electrode would be detected using this SAR. Calculating SAR from the electrode or antenna as it is being used in the patient may allow detection of the beginning of a non-uniform ablation field.
The SAR calculation may be performed using equation (2), where c is the specific heat of the tissue (in units of Joules/kg-° C.), Δt is the time interval (in seconds), and ΔT is the temperature rise (in ° C.) within the time interval Δt. Equation (2) is restated below.




  
    
      
        
          
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which can be rewritten as follows:





  SAR
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In embodiments, in response to early detection of a potentially anomalous condition, e.g., detection of the beginning of a non-uniform ablation field, or under other circumstances, one or more operating parameters associated with an electrosurgical power generating source (e.g., operably associated with the electrode or antenna) may be determined based on the SAR, in step 2270. Some examples of operating parameters associated with an electrosurgical power generating source that may be determined include temperature, impedance, power, current, voltage, mode of operation, and duration of application of electromagnetic energy.
In another approach, the image data acquired by one or more imaging modalities, in step 2230, is stored in DICOM (Digital Imaging and Communications in Medicine) format in a PACS (Picture Archiving and Communication Systems) database (e.g., 58 shown in FIG. 1), in step 2240. Prior to and/or during a procedure, e.g., an ablation procedure, image data associated with a prior treatment of the target tissue volume is retrieved from the PACS database, in step 2245. As previously described above, the SAR is calculated as a function of the tissue temperature information from the image data, in step 2260. In step 2270, one or more operating parameters associated with an electrosurgical power generating source may be determined based on the SAR.
FIG. 23 is a flowchart illustrating a method of controlling output of an electrosurgical power generating source according to an embodiment of the present disclosure. In step 2310, an energy applicator (e.g., “E” shown in FIG. 1) including a radiating section (e.g., “R1” shown in FIG. 1) is provided. The energy applicator is operatively associated with an electrosurgical power generating source (e.g., 16 shown in FIG. 1).
In step 2320, the radiating section of the energy applicator is positioned at a first position for delivery of energy to a target tissue volume (e.g., “T” shown in FIG. 1). Ultrasound or computed tomography (CT) guidance may be used to accurately guide the energy applicator into the area of tissue to be treated. The energy applicator may be configured to operate with a directional radiation pattern. In some embodiments, the energy applicator is configured to operate with a broadside radiation pattern.
In step 2330, energy from the electrosurgical power generating source is transmitted through the radiating section to the target tissue volume (e.g., “T” shown in FIG. 1). In some embodiments, the electrosurgical power generating source is a microwave energy source, and may be configured to provide microwave energy at an operational frequency from about 300 MHz to about 10 GHz.
In step 2340, a first set of image data including tissue temperature information of the target tissue volume is acquired by imaging the target tissue volume using one or more imaging modalities. The tissue temperature information acquired by the one or more imaging modalities may be determined by any suitable method, e.g., calculated from density changes within the tissue.
In step 2350, a specific absorption rate (SAR) is calculated as a function of the tissue temperature information from the first set of image data. The SAR calculation may be performed using equation (2), as discussed hereinabove.
In step 2360, output of the electrosurgical generator is controlled based on the calculated SAR. In embodiments, one or more operating parameters associated with the electrosurgical power generating source may be determined based on the calculated SAR. Examples of operating parameters associated with the electrosurgical power generating source include without limitation temperature, impedance, power, current, voltage, mode of operation, and duration of application of electromagnetic energy.
FIG. 24 is a flowchart illustrating a sequence of method steps for performing the step 2360 according to an embodiment of the present disclosure. In step 2361, the calculated SAR is evaluated according to a predetermined logical routine for determining whether a need exists to change positioning of the radiating section. The predetermined logical routine may involve a variety of factors, such as, for example, heat distribution within the tissue area that is to be destroyed and/or the surrounding tissue, energy applicator design, number of energy applicators used simultaneously, time and wattage, tumor size and location, and whether the tumor was a secondary or primary cancer.
When the evaluating, in step 2361, indicates a need to change positioning of the radiating section, the method includes the step 2362 of acquiring a second set of image data including tissue temperature information of the target tissue volume by imaging the target tissue volume using one or more imaging modalities after the radiating section is positioned at the second position.
The energy applicator's radiating section's position may be changed from the first position to a second position by rotating the energy applicator about a longitudinal axis thereof and/or by repositioning the radiating section in tissue, e.g., a change in depth of the radiating section relative to a tissue surface. For example, an energy applicator with a directional radiation pattern may be rotated manually, or automatically, based on the calculated specific absorption rate, e.g., to avoid ablating sensitive structures, such as large vessels, healthy organs or vital membrane barriers. Examples of antenna assemblies rotatable about a longitudinal axis “A-A” (shown in FIG. 25) such that any elongated radiation lobes rotates therewith are disclosed in commonly assigned U.S. patent application Ser. No. 12/197,405 filed on Aug. 25, 2008, entitled “MICROWAVE ANTENNA ASSEMBLY HAVING A DIELECTRIC BODY PORTION WITH RADIAL PARTITIONS OF DIELECTRIC MATERIAL”, U.S. patent application Ser. No. 12/535,856 filed on Aug. 5, 2009, entitled “DIRECTIVE WINDOW ABLATION ANTENNA WITH DIELECTRIC LOADING”, and U.S. patent application Ser. No. 12/476,960 filed on Jun. 2, 2009, entitled “ELECTROSURGICAL DEVICES WITH DIRECTIONAL RADIATION PATTERN”, the disclosures of which are incorporated herein by reference in their entireties. Providing one or more indicia alignment marks (e.g., 810 shown in FIG. 26) and/or indicia graduation marks (e.g., 880 shown in FIG. 26) to the energy applicator may aid in repositioning of the radiating section, as described later in this disclosure.
After the second set of image data including tissue temperature information of the target tissue volume is acquired, in step 2362, according to an embodiment of the present disclosure, a SAR associated with the second set of image data is calculated as a function of the tissue temperature information obtained from the second set of image data, and one or more operating parameters associated with the electrosurgical power generating source may be determined based on the calculated SAR associated with the second set of image data. It is envisioned and within the scope of the present disclosure that the SAR may be re-calculated, e.g., based on different image data sets acquired over time, entirely independently of evaluation (if any) of the SAR to determine whether a need exists to reposition the radiating section of the energy applicator.
When the evaluating, in step 2361, does not indicate a need to change positioning of the radiating section, the method includes the step 2363 of determining one or more operating parameters associated with the electrosurgical power generating source based on the calculated SAR. Examples of operating parameters associated with the electrosurgical power generating source include without limitation temperature, impedance, power, current, voltage, mode of operation, and duration of application of electromagnetic energy.
FIG. 25 shows an electrosurgical system 700 according to an embodiment of the present disclosure that includes an electrosurgical device 500 with a directional radiation pattern. Electrosurgical device 500 is coupled to a connector 16 via a transmission line 15, which may further connect the electrosurgical device 500 to an electrosurgical power generating source 28, e.g., a microwave or RF electrosurgical generator. Electrosurgical device 500 includes an elongated body member defining a body wall surrounding a chamber, which is configured to receive at least a portion of an energy applicator therein. The body wall is provided with at least one opening 440 therethough to allow electromagnetic energy radiated from the energy applicator to transfer into a target volume of tissue. In some embodiments, the opening 440 is configured for radiating energy in a broadside radiation pattern, such as the non-limiting example directional radiation patterns shown in FIGS. 27 and 28.
During a procedure, e.g., an ablation procedure, the electrosurgical device 500 of the electrosurgical system 700 is inserted into or placed adjacent to tissue “T” and energy is supplied thereto. Electrosurgical device 500 may be selectively rotated about axis “A-A” (as indicated by the bidirectional arrow) such that the directional radiation pattern rotates therewith. In embodiments, the electrosurgical device 500 may be selectively rotated about axis “A-A” manually by the user or automatically. An actuator 95 may be operably coupled to the electrosurgical device 500 for controlling the rotation of the electrosurgical device 500 in an automatic process. Actuator 95 may be operably coupled to the electrosurgical power generating source 28 and/or a user interface (e.g., 50 shown in FIG. 1).
FIG. 26 shows an electrosurgical device 800, which is similar to the electrosurgical device 500 of FIG. 25, except for the indicia alignment mark 810 and the indicia graduation marks 880 on the proximal end of the electrosurgical device 800. Indicia alignment mark 810 and/or the indicia graduation marks 880 may be carried on or inscribed into the elongated body member of the electrosurgical device 800. In some embodiments, the electrosurgical device 800 includes a plurality of indicia graduation marks 880 defining units of linear measure, which may be inscribed substantially circumferentially about the elongated body member. Indicia graduation marks 880 may be used to indicate the relative position of the opening 440 with respect to the surface of the tissue “T”. In some embodiments, the indicia graduation marks 880 are used to indicate the position of the distal end of the opening 440 relative to the surface of the tissue “T”. Indicia graduation marks 880 may be arranged to form an incremental pattern using any standard measure of length, e.g., inches or centimeters.
In some embodiments, the electrosurgical device 800 includes an indicia alignment mark 810, e.g., a colored stripe, which is readily visible along the proximal end of the elongated body member. Indicia alignment mark 810 is positioned on the elongated body member such that the longitudinal axis of the alignment mark 810 substantially aligns with the longitudinal axis of the opening 440, to provide a visual cue to the surgeon to allow orientation of the direction of flow of the energy to coincide with the indicia alignment mark 810. As shown in FIG. 26, one or more of the indicia graduation marks 880 may overlap the indicia alignment mark 810. Numerical indicia (not shown) may be associated with the indicia graduation marks 880. The shape and size of the indicia alignment mark 810 and the indicia graduation marks 880 may be varied from the configurations depicted in FIG. 26.
FIGS. 27 and 28 are schematically-illustrated representations of simulation results showing directional radiation patterns. The illustrated results are based on a simulation that modeled operation of an electrosurgical device 600, which is configured to operate with a directional radiation pattern. Electrosurgical device 600 shown in FIGS. 27 and 28 is similar to the electrosurgical device 500 of FIG. 25 and further description thereof is omitted in the interests of brevity.
The above-described systems and methods may involve the use of data associated with image analysis of a thermal phantom for calculation of SAR (e.g., used to predict a radiation pattern emitted by an energy applicator) to facilitate planning and effective execution of a procedure, e.g., an ablation procedure.
The above-described systems and methods may involve the use of image data including tissue temperature information to calculate SAR as a function of the tissue temperature information during a procedure (e.g., used to determine one or more operating parameters associated with an electrosurgical power generating source). As described above, image data including tissue temperature information (e.g., acquired by one or more imaging modalities) may be stored in DICOM format in a PACS database, and the stored image data may be retrieved from the PACS database prior to and/or during a procedure, e.g., for use in calculating SAR during the procedure. As described above, image data including tissue temperature information may be received from one or more imaging modalities during a procedure, e.g., for use in calculating SAR during the procedure. One or more operating parameters associated with an electrosurgical power generating source may be determined using real-time (or near real-time) tissue temperature data acquired from one or more imaging modalities during the procedure, e.g., an ablation procedure.
According to various embodiments of the present disclosure, the SAR around an energy application, as determined by the above-described methods, may be used to predict a radiation pattern emitted by an energy applicator, and/or control the positioning of an electrosurgical device (e.g., rotation of a energy applicator with a directional radiation pattern to avoid ablating sensitive structures, such as large vessels, healthy organs or vital membrane barriers), and/or control an electrosurgical power generating source operatively associated with an energy applicator.
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.

## Claims

1. A method of controlling output of an electrosurgical power generating source, the method comprising:
receiving an initial time series of image data including tissue temperature information of a target tissue volume, the tissue temperature information including a plurality of temperature bands;
selecting one or more of the plurality of temperature bands at a plurality of time periods;
thresholding the initial time series of image data to detect an inner boundary and an outer boundary of the one or more selected temperature bands;
calculating a specific absorption rate (SAR); and
determining at least one operating parameter associated with the electrosurgical power generating source based on the calculated SAR;
wherein a positional transition of the inner and outer boundaries of the one or more selected temperature bands indicates a change in temperature used for calculating the SAR, the calculated SAR is evaluated according to a predetermined logical routine factoring heat distribution within a tissue area, energy applicator design, number of energy applicators used simultaneously, time, wattage, a size of a tumor, a location of a tumor, and whether the tumor is primary or secondary cancer; and
wherein the SAR is re-calculated, based on a plurality of subsequently received time series of image data, independently of the predetermined logical routine previously used.

2. The method of controlling output of the electrosurgical power generating source in accordance with claim 1, wherein the initial time series of image data is retrieved from a medical database.

3. The method of controlling output of the electrosurgical power generating source in accordance with claim 1, wherein the initial time series of image data is received from at least one imaging modality during an ablation procedure.

4. A method of controlling output of an electrosurgical power generating source, the method comprising:
positioning an energy applicator for delivery of energy to a target tissue volume;
transmitting energy from the electrosurgical power generating source through the energy applicator to the tissue target volume;
acquiring an initial time series of image data including tissue temperature information of the target tissue volume by imaging the target tissue volume using at least one imaging modality;
receiving the initial time series of image data from the at least one imaging modality;
selecting one or more of a plurality of temperature bands at a plurality of time periods;
thresholding the initial time series of image data to detect an inner boundary and an outer boundary of selected temperature bands;
calculating a specific absorption rate (SAR); and
determining at least one operating parameter associated with the electrosurgical power generating source based on the calculated SAR;
wherein a positional transition of the inner and outer boundaries of the selected temperature bands indicates a change in temperature used for calculating the SAR around the energy applicator, the calculated SAR is evaluated according to a predetermined logical routine factoring heat distribution within a tissue area, energy applicator design, number of energy applicators used simultaneously, time, wattage, a size of a tumor, a location of a tumor, and whether the tumor is primary or secondary cancer; and
wherein the SAR is re-calculated, based on a plurality of subsequently received time series of image data, independently of the predetermined logical routine previously used.

5. The method of controlling output of the electrosurgical power generating source in accordance with claim 4, wherein the at least one operating parameter associated with the electrosurgical power generating source is selected from the group consisting of temperature, impedance, power, current, voltage, mode of operation, and duration of application of electromagnetic energy.

6. A method of controlling output of an electrosurgical power generating source, the method comprising:
providing an energy applicator including a radiating section, the energy applicator operatively associated with the electrosurgical power generating source;
positioning the radiating section of the energy applicator at a first position for delivery of energy to a target tissue volume;
transmitting the energy from the electrosurgical power generating source through the radiating section to the target tissue volume;
acquiring a first set of a time series of image data including tissue temperature information of the target tissue volume by imaging the target tissue volume using at least one imaging modality;
selecting one or more of a plurality of temperature bands at a plurality of time periods;
thresholding the first set of the time series of image data to detect an inner boundary and an outer boundary of selected temperature bands;
calculating a specific absorption rate (SAR); and
controlling the output of the electrosurgical power generating source based on the calculated SAR;
wherein a positional transition of the inner and outer boundaries of the selected temperature bands indicates a change in temperature used for calculating the SAR around the energy applicator, the calculated SAR is evaluated according to a predetermined logical routine factoring heat distribution within a tissue area, energy applicator design, number of energy applicators used simultaneously, time, wattage, tumor size, a size of a tumor, a location of a tumor, and whether the tumor is primary or secondary cancer; and
wherein the SAR is re-calculated, based on a second set of a time series of image data, independently of the predetermined logical routine previously used.

7. The method of controlling output of the electrosurgical power generating source in accordance with claim 6, wherein the predetermined logical routine determines whether a need exists to change positioning of the radiating section.

8. The method of controlling output of the electrosurgical power generating source in accordance with claim 7, wherein the second set of time series of image data includes tissue temperature information of the target tissue volume.

9. The method of controlling output of the electrosurgical power generating source in accordance with claim 8, wherein the radiating section is positioned at different positions by rotating the energy applicator about a longitudinal axis thereof.

10. The method of controlling output of the electrosurgical power generating source in accordance with claim 9, wherein the energy applicator is configured to emit a directional radiation pattern that rotates therewith during rotation of the energy applicator about the longitudinal axis thereof.

11. The method of controlling output of the electrosurgical power generating source in accordance with claim 7, wherein when it is determined that there is no need to change positioning of the radiating section, the method includes determining at least one operating parameter associated with the electrosurgical power generating source based on the calculated SAR.