US20160256219A1 - Tissue ablation system with internal and external radiation sources - Google Patents
Tissue ablation system with internal and external radiation sources Download PDFInfo
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- US20160256219A1 US20160256219A1 US15/156,436 US201615156436A US2016256219A1 US 20160256219 A1 US20160256219 A1 US 20160256219A1 US 201615156436 A US201615156436 A US 201615156436A US 2016256219 A1 US2016256219 A1 US 2016256219A1
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- energy delivery
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- ablation system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
- A61B2018/1823—Generators therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
- A61B2018/183—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves characterised by the type of antenna
- A61B2018/1838—Dipole antennas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
- A61B2018/1869—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument interstitially inserted into the body, e.g. needles
Definitions
- the present disclosure relates to apparatus and methods for providing energy to tissue and, more particularly, to devices and electromagnetic radiation delivery procedures utilizing ablation probes and methods of controlling the delivery of electromagnetic radiation to tissue.
- 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.
- microwave apparatus for use in ablation procedures include a microwave generator, which functions as an energy source, and a microwave surgical instrument having an antenna assembly for directing the energy to the target tissue.
- the microwave generator and surgical instrument are typically operatively coupled by a cable assembly having a plurality of conductors for transmitting microwave energy from the generator to the instrument, and for communicating control, feedback and identification signals between the instrument and the generator.
- Microwave energy is typically applied via antenna assemblies that can penetrate tissue.
- antenna assemblies such as monopole and dipole antenna assemblies.
- microwave energy generally radiates perpendicularly away from the axis of the conductor.
- a monopole antenna assembly includes a single, elongated conductor that transmits microwave energy.
- a typical dipole antenna assembly has two elongated conductors, which are linearly aligned and positioned end-to-end relative to one another with an electrical insulator placed therebetween. Each conductor may be about 1 ⁇ 4 of the length of a wavelength of the microwave energy, making the aggregate length of the two conductors about 1 ⁇ 2 of the wavelength of the supplied microwave energy.
- a microwave ablation system includes an energy source adapted to generate microwave energy and a plurality of energy delivery devices having a first energy delivery device configured to be inserted into tissue and to generate a non-directional ablation volume and a second energy delivery device configured to be positioned relative to the tissue and to generate a directional ablation volume.
- the system also includes a power dividing device having an input adapted to connect to the energy source and a plurality of outputs configured to be coupled to the plurality of energy delivery devices. The power dividing device is configured to selectively divide energy provided from the energy source between the plurality of energy delivery devices.
- a microwave ablation system includes a plurality of energy sources adapted to generate microwave energy and a plurality of energy delivery devices each of which is coupled to a corresponding one of the plurality of energy sources.
- the plurality of energy delivery devices includes a first energy delivery device configured to be inserted into tissue and to generate a non-directional ablation volume and a second energy delivery device configured to be positioned relative to the tissue and to generate a directional ablation volume.
- a method for providing energy to a target tissue includes the steps of coupling a plurality of energy delivery devices including a non-directional energy delivery device and a directional energy delivery device to a power dividing device having an input adapted to connect to an energy source.
- the method also includes the steps of inserting the non-directional energy delivery device into a portion of the target tissue and positioning the directional energy device at a surface of the target tissue.
- the method further includes the steps of selectively dividing energy on a plurality of channels to the plurality of the energy delivery devices and applying energy from the plurality of energy delivery devices to the target tissue.
- FIGS. 1A-1B is a schematic diagram of an electrosurgical system for treating tissue, according to an embodiment of the present disclosure
- FIGS. 2A-2B are cross-sectional views of a feedline according to the present disclosure.
- FIG. 3 is a perspective, cross-sectional view of a microwave antenna assembly according to the present disclosure
- FIG. 4 is a perspective, cross-sectional view of another embodiment of a microwave antenna assembly according to the present disclosure.
- FIG. 5 perspective, cross-sectional view of further embodiment of a microwave antenna assembly according to the present disclosure
- FIG. 6 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure.
- FIG. 7 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure.
- FIG. 8 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure.
- FIG. 9 is a block diagram illustrating a method for treating tissue, according to an embodiment of the present disclosure.
- 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).
- transmission line generally refers to any transmission medium that can be used for the propagation of signals from one point to another. Examples of suitable transmission lines include coaxial cables, waveguides, and combinations thereof.
- Electrosurgical systems for treating tissue may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies.
- Electrosurgical systems for treating tissue deliver microwave power to a plurality of electrosurgical devices.
- Electrosurgical devices, such as ablation probes, for implementing embodiments of the present disclosure may be inserted directly into tissue, inserted through a lumen, such as a vein, needle or catheter, placed into the body during surgery by a clinician, or positioned in or on the body by other suitable methods known in the art.
- FIG. 1A is a schematic diagram of an electrosurgical system 100 for treating tissue, according to one embodiment of the present disclosure.
- the electrosurgical system 100 includes an electrosurgical generator 120 for generating an output signal, a power divider 150 coupled to the electrosurgical generator 120 , and a plurality of microwave antenna assemblies (e.g., microwave antenna assemblies 130 a and 130 b ) coupled to the power divider 150 .
- the power divider 150 is coupled to a transmission line 107 that electrically connects the power divider 150 to an output 124 on the electrosurgical generator 120 .
- the microwave antenna assemblies 130 a and 130 b are coupled to transmission lines 104 a and 104 b that electrically connect the microwave antenna assemblies 130 a and 130 b to the power divider 150 , respectively.
- the transmission lines 104 a and 104 b may be coaxial and may include an inner conductor surrounded by an inner insulator, which is, in turn, surrounded by an outer conductor (e.g., a cylindrical conducting sheath).
- the transmission lines 104 a and 104 b may be formed from a coaxial, semi-rigid or flexible cable having a wire with a 0.047′′ outer diameter rated for 50 Ohms.
- feedline 103 (e.g., feedlines 103 a and 103 b ) may be a coaxial cable composed of an inner conductor 102 , an outer conductor 105 , and an inner insulator 106 interposed between inner and outer conductors 102 , 105 to electrically separate and/or isolate inner and outer conductors 102 , 105 from one another.
- Inner and outer conductors 102 , 105 may each be made of a suitable conductive material that may be semi-rigid or flexible, while inner insulator 106 may include any number of suitable non-conductive materials such as ceramic and polytetrafluoroethylene (PTFE).
- Inner and outer conductors 102 , 105 of feedline 103 may incorporate any suitable conductive material or metal, including, but not limited to, silver, copper and gold.
- inner and outer conductors 102 , 105 of feedline 103 may include a conductive or non-conductive substrate plated or coated with a suitable conductive material.
- the inner conductor 102 and outer conductor 105 may be constructed of copper, gold, stainless steel or other conductive metals with similar conductivity values.
- the electrosurgical generator 120 may include other input or output devices such as knobs, dials, switches, buttons, graphical user interfaces, displays, and the like for control, indication and/or operation.
- the electrosurgical generator 120 may be capable of generating a plurality of output signals of various frequencies that are input to the power divider 150 .
- the electrosurgical generator 120 generates a plurality of microwave signals at substantially the same frequency.
- the electrosurgical generator 120 may include a control unit (not shown) that controls operations of the electrosurgical generator 120 , such as time of operation, power output and/or the mode of electrosurgical operation, which may have been selected by the clinician.
- the generator 120 includes a microwave signal source 210 that provides a microwave frequency output signal to a microwave amplifier unit 220 .
- the microwave signal source 210 is capable of generating a plurality of output signals of various frequencies that are input to the microwave amplifier unit 220 .
- the microwave amplifier unit 220 may have any suitable input power and output power.
- the generator 120 is implemented with operating frequencies in the range of about 300 MHz to about 5 GHz, which may be useful in performing ablation procedures and/or other procedures. It is to be understood that the generator 120 may be implemented with any appropriate range of operating frequencies.
- the electrosurgical system 100 may include a footswitch (not shown) coupled to the electrosurgical generator 120 .
- the footswitch causes the electrosurgical generator 120 to generate microwave energy.
- the microwave antenna assemblies 130 a and 130 b may include knobs, dials, switches, buttons or the like (not shown) to communicate to the electrosurgical generator 120 to adjust or select from a number of configuration options for delivering energy. Utilizing knobs, dials, switches or buttons on the microwave antenna assemblies 130 a and 130 b and/or a footswitch enables the clinician to activate the electrosurgical generator 120 to energize the microwave antenna assemblies 130 a and 130 b while remaining near a patient regardless of the location of the electrosurgical generator 120 .
- electrosurgical system 100 may include a plurality of channels defined by a plurality of electrosurgical devices and a plurality of transmission lines that electrically connect the electrosurgical devices to the power divider 150 .
- the power divider 150 is capable of monitoring the phase of each channel and adjusting the phase of the signal in each channel with respect to the other channel(s) to a predetermined phase relationship.
- the power divider 150 provides a plurality of signals to the microwave antenna assemblies 130 a and 130 b in a set of phase relationships between the signals.
- the power divider 150 is illustrated as a standalone module in FIG. 1A , it is to be understood that the power divider 150 may be integrated fully or partially into the electrosurgical generator 120 , the microwave antenna assemblies 130 a and 130 b , and/or other devices.
- the power divider 150 may be a power splitter configured to split an input signal from the electrosurgical generator 120 into two or more equal phase output signals, such as a Wilkinson power splitter.
- the power divider 150 may be implemented by any suitable power divider that provides equal or unequal power split at the output ports of the microwave power divider 150 while substantially maintaining phase and amplitude balance.
- the microwave power divider 150 may be implemented using a 2-way power divider that provides equal or unequal power split at its output ports while maintaining a phase balance of less than ⁇ 45 degrees.
- Various embodiments of the power divider 150 are described in a commonly-owned U.S. Pat. No. 9,095,359 entitled “Tissue Ablation System With Energy Distribution,” the entire disclosure of which is incorporated by reference herein.
- FIG. 1B shows another embodiment of an electrosurgical system 101 for treating tissue.
- the electrosurgical system 101 includes a plurality of electrosurgical generators (e.g., electrosurgical generators 120 a and 120 b ) for generating an output signal, and a plurality of microwave antenna assemblies (e.g., microwave antenna assemblies 130 a and 130 b ).
- the microwave antenna assemblies 130 a and 130 b are coupled to transmission lines 104 a and 104 b that electrically connect the microwave antenna assemblies 130 a and 130 b to outputs 124 a and 124 b of the electrosurgical generators 120 a and 120 b , respectively.
- the electrosurgical generators 120 a and 120 b are substantially similar to the electrosurgical generator 120 of the system 100 .
- Each of the generators 120 a and 120 b includes microwave signal sources 210 a and 210 b for providing a microwave frequency output signal to microwave amplifier units 220 a and 220 b , respectively.
- the system 101 pairs each of the electrosurgical generators 120 a and 120 b with each of the corresponding microwave antenna assemblies 130 a and 130 b , thereby obviating the need for the power divider 150 of the system 100 .
- Each of the generators 120 a and 120 b may be configured to equal or unequal power while substantially maintaining phase and amplitude balance therebetween.
- one of the microwave antenna assemblies 130 a and 130 b may be a microwave antenna configured to allow direct insertion or penetration into tissue.
- the microwave antenna assemblies 130 a and 130 b may be axially rigid to allow for tissue penetration either directly into tissue or inserted through a lumen, such as, for example, a vein, needle or catheter, or otherwise positioned in the body by other suitable methods as shown in FIG. 5 .
- one of the microwave antenna assemblies 130 a and 130 b may be a so-called “window” microwave antenna suitable for directing microwave energy in a predetermined direction as shown in FIG. 3 .
- one of the microwave antenna assemblies 130 a and 130 b may be a surface microwave waveguide for directing microwave energy through the tissue surface as shown in FIG. 4 .
- the microwave power divider 150 may be implemented by any suitable power divider that divides or splits a microwave input signal into “N” number of output signals of equal or unequal power.
- the generators 120 a and 120 b may be configured in a similar manner.
- the electrosurgical systems 100 and 101 deliver microwave power to particular channels individually or any combination of one or more channels equally or unequally to facilitate selective activation of energy delivery to particular channels or combination of channels.
- a user may select channels to which energy is delivered.
- energy delivery may be divided equally (e.g., P/2) between the second and third channels and, thus, unequally between the first channel and the second and third channels since no energy is delivered to the first channel in this scenario.
- energy may be delivered to individual channels according to selected time intervals by dynamically changing the channels to which energy is delivered.
- energy may be delivered to the first channel at a time interval t 1 .
- energy is delivered to the first channel and the third channel.
- energy delivery to the first channel is stopped and energy delivery to the third channel continues.
- energy delivery to all channels is stopped.
- the microwave power divider 150 and/or the generators 120 a and 120 b may divide energy between the antenna assemblies 130 a and 130 b to tailor the size and shape of ablation lesions.
- generators 120 , 120 a and 120 b may include a suitable storage device (not shown) integrated therein that is configured to store settings or data corresponding to particular ablation geometries (e.g., ablation images, antenna tip geometries, power division settings, power amplitude settings, etc.). Based on the stored settings or data, the generators 120 a and 120 b modify delivery of microwave power and/or the microwave power divider 150 modifies the division of microwave power between the channels to achieve the desired ablation geometry.
- FIG. 3 shows an antenna assembly 300 according to one embodiment of the present disclosure.
- the antenna assembly 300 includes a feedline 302 that is coupled to one of the transmission lines 104 a and 104 b .
- the antenna assembly 300 includes a radiating section 304 including a dipole antenna 306 .
- the antenna assembly 300 also includes a dielectric shield 308 disposed about a portion of the dipole antenna 306 along the entire length thereof.
- the dielectric shield 308 may have a substantially half-cylindrical shape (e.g.,) 180°.
- the dielectric shield 308 may be made to encompass any radial angle.
- the antenna assembly 300 also includes a tip 310 having a tapered portion terminating in a sharp tip to allow for insertion into tissue with minimal resistance. In those cases where the energy applicator is inserted into a pre-existing opening, the tip 310 may be rounded or flat.
- the dielectric shield 308 and the tip 310 may be formed from a suitable polymeric material, which may include, for example, thermoplastics including reinforced or unreinforced polymers, e.g., polyamide (nylon) or polyaramid (e.g., KEVLAR® manufactured by E. I. du Pont de Nemours and Company of Wilmington, Del., United States), or any suitable polymeric composite, e.g., polymers filled with carbon particles, silica, conductive particles such as metal particles or conductive polymers, or combinations thereof.
- a suitable polymeric material which may include, for example, thermoplastics including reinforced or unreinforced polymers, e.g., polyamide (nylon) or polyaramid (e.g., KEVLAR® manufactured by E. I. du Pont de Nemours and Company of Wilmington, Del., United States), or any suitable polymeric composite, e.g., polymers filled with carbon particles, silica, conductive particles such as metal particles or conductive polymers, or combinations thereof.
- the dielectric shield 308 forms an opening or electromagnetic “window” shown generally as “W” partially defined by the longitudinal edges of the dielectric shield 308 .
- the dielectric material of the dielectric shield 308 limits the transmission of the microwave energy therethrough, which directs the microwave energy through the window “W.” This configuration allows for the antenna assembly to be used to generate non-spherical and directed ablation volumes.
- the antenna assembly 300 is a so-called “directional” antenna since the radiating section 304 is configured to emit microwave energy in a specific direction.
- Various embodiments of windowed microwave antenna assemblies are described in a commonly-owned U.S. Pat. No. 8,328,800 entitled “Directive Window Ablation Antenna With Dielectric Loading,” the entire disclosure of which is incorporated by reference herein.
- FIG. 4 shows a waveguide antenna assembly 400 according to one embodiment of the present disclosure.
- the antenna assembly 400 includes a feedline 402 that is coupled to one of the transmission lines 104 a and 104 b .
- the antenna assembly 400 includes a waveguide section 404 having a radiating cone 406 and a conical reflector 408 coupled to the inner and outer conductors of the feedline 402 , respectively.
- the radiating cone 406 and the conical reflector 408 have a generally conical shape having a truncation at a proximal apex end and are dimensioned to couple to a distal end of the feedline 402 , with the conical reflector disposed over the radiating cone 406 .
- the antenna assembly 400 also includes a dielectric shield 414 disposed on the outer surface of the conical reflector 408 along the entire length thereof.
- the antenna assembly 400 includes a membrane 405 that is disposed between the radiating cone 406 and the conical reflector 408 , which define a chamber 410 therebetween having a corresponding conical shape.
- Membrane 405 may be formed of any suitable radiofrequency-transparent material of low electrical conductivity, e.g., material that enables efficient transmissivity of microwave ablation signals to tissue from the energy delivery system, including without limitation, the conical radiating structure herein described.
- Membrane 405 may be formed from a rigid material, or may be formed from flexible and/or elastomeric material.
- the antenna assembly 400 is a so-called “directional” antenna since the waveguide section 404 is configured to emit microwave energy in a specific direction.
- the lumen 410 is filled with a dielectric material 412 which may be a dielectric fluid circulated therethrough or any type of suitable solid dielectric.
- the dielectric material 412 and the dielectric shield 414 may be formed from a suitable dielectric material similar to the material as the dielectric shield 308 .
- the antenna assembly 400 is configured for surface transmission of microwave energy.
- the antenna assembly 400 is disposed on a surface of the tissue with the surface of the membrane 405 contacting the tissue.
- the microwave energy applied to the antenna assembly 400 is directed by the waveguide section 404 into the tissue through the surface thereof.
- Various embodiments of a conical microwave antenna assemblies are described in a commonly-owned U.S. Pat. No. 8,343,145 entitled “Microwave Surface Ablation Using Conical Probe,” the entire disclosure of which is incorporated by reference herein.
- FIG. 5 shows an antenna assembly 500 according to one embodiment of the present disclosure.
- the antenna assembly 500 includes a feedline 502 that is coupled to one of the transmission lines 104 a and 104 b .
- the antenna assembly 500 includes a radiating section 504 including a dipole antenna 506 .
- the antenna assembly 500 also includes a tip 508 having a tapered portion terminating in a sharp tip to allow for insertion into tissue with minimal resistance. In those cases where the energy applicator is inserted into a pre-existing opening, the tip 508 may be rounded or flat.
- the antenna assembly 500 is a so-called “non-directional” antenna since the radiating section 504 radiates microwave energy in all directions resulting in an ablation volume that is symmetrical about a longitudinal axis defined by the antenna assembly 500 .
- the antenna assembly 500 may include a choke 510 and a sheath 512 enclosing the dipole antenna 506 .
- the sheath 512 defines a chamber 514 that may be filled with a suitable dielectric material (e.g., liquid or solid loading).
- a suitable dielectric material e.g., liquid or solid loading.
- the antenna assembly 500 is inserted into tissue and upon application of microwave energy generates substantially spherical ablation volumes based on the dielectric loading about the dipole antenna 506 .
- a choked dielectric loaded microwave antenna assemblies are described in a commonly-owned U.S. Provisional Application Ser. No. 61/023,031 entitled “Choked Dielectric Loaded Tip Dipole Microwave Antenna,” the entire disclosure of which is incorporated by reference herein.
- FIGS. 6-8 illustrate various embodiments of using a plurality of antenna assemblies 130 a and 130 b to ablate tissue.
- the present disclosure provides for systems and methods for performing microwave ablation with internal and external radiation sources simultaneously by connecting the antenna assemblies 130 a and 130 b to a single generator 120 or each of the antenna assemblies 130 a and 130 b to a corresponding generator 120 a and 120 b.
- the antenna assembly 500 is inserted into tissue and is placed directly through the center of a target tissue volume (e.g., tumor). Once energized, the antenna assembly 500 produces a symmetrical ablation volume (e.g., oval or sphere-shaped) about a longitudinal axis defined by the antenna assembly 500 . In certain situations, a symmetrical ablation volume is not well suited for ablating a non-spherical tumor. More specifically, the antenna assembly 500 is not suited for ablating the entire tumor having an irregular shape without destroying a significant portion of healthy tissue. Utilizing additional antenna assemblies 500 is not efficient either, since overlapping of the symmetrical ablation volume may not closely approximate the tumor.
- a target tissue volume e.g., tumor
- a symmetrical ablation volume e.g., oval or sphere-shaped
- directional microwave antennas e.g., external antenna assemblies 400 or windowed antenna assemblies 300
- non-directional antennas e.g., the antenna assembly 500
- combination of antenna assemblies 300 , 400 , 500 allows for generation of ablation volumes having highest conformation parameters for encompassing irregularly shaped tumors.
- FIG. 6 illustrates the use of the antenna assembly 300 and the antenna assembly 500 to ablate a tumor “T” that is partially disposed at the surface of a tissue volume “V.”
- the antenna assembly 500 is inserted through a larger portion of the tumor “T,” such that an ablation volume 550 encompasses the larger portion of the tumor “T.”
- the antenna assembly 300 is disposed on the surface of the tissue volume “V” such that the window “W” is facing a portion of the tumor “T.”
- the antenna assembly 300 generates an ablation volume 350 just beyond the surface of the tissue volume “V.”
- the ablation volume 350 overlaps with the ablation volume 550 , but also encompasses the portion of the tumor “T” that is outside of the ablation volume 550 .
- FIG. 7 illustrates the use of the antenna assembly 400 and the antenna assembly 500 to ablate the tumor “T” that is partially disposed at the surface of the tissue volume “V.”
- the antenna assembly 500 is inserted through a larger portion of the tumor “T,” such that an ablation volume 550 encompasses the larger portion of the tumor “T.”
- the antenna assembly 400 is disposed on the surface of the tissue volume “V” such that the waveguide section 404 is facing a portion of the tumor “T.”
- the antenna assembly 400 generates an ablation volume 450 just beyond the surface of the tissue volume “V.”
- the ablation volume 450 overlaps with the ablation volume 550 , but also encompasses the portion of the tumor “T” that is outside of the ablation volume 550 .
- FIG. 8 illustrates the use of the antenna assembly 300 and the antenna assembly 500 to ablate a tumor “T” that is disposed within tissue volume “V.”
- the antenna assembly 500 is inserted through a larger portion of the tumor “T,” such that an ablation volume 550 encompasses the larger portion of the tumor “T.”
- the antenna assembly 300 is also inserted into the tissue volume “V” such that the window “W” is facing a portion of the tumor “T.”
- the antenna assembly 300 generates an ablation volume 350 that overlaps with the ablation volume 550 , but also encompasses the portion of the tumor “T” that is outside of the ablation volume 550 .
- the antenna assemblies 300 and 500 may be positioned within the tissue volume “V” to avoid ablation of critical structures “S” (e.g., blood vessels).
- the directional radiation of antenna assemblies 300 and 400 supplement the non-directional radiation of the antenna assembly 500 , allowing for the achievement of the desired ablation boundaries.
- internal antennas e.g., antenna assemblies 300 and 500
- the external antennas e.g., antenna assemblies 300 and 400
- FIG. 9 illustrates a flow chart of a method according to the present disclosure.
- the antenna assembly 130 a e.g., antenna assembly 500
- the antenna assembly 130 b e.g., antenna assembly 300 or 400
- the antenna assemblies 130 a and 130 b are positioned such that the ablation volumes conform to the volume of the tumor “T” while avoiding encompassing any of the critical structures “S.”
- multiple antenna assemblies 103 and 130 b may be used to obtain various ablation volumes.
- Each of the antenna assemblies 130 a and 130 b is coupled to a single generator 120 via the power divider 150 or to a corresponding generator 120 a and 120 b .
- each of the antenna assemblies 130 a and 130 b is energized simultaneously to generate a combined ablation volume.
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Abstract
Description
- The present application is a continuation application of U.S. patent application Ser. No. 13/889,989, filed on May 8, 2013, which is a divisional application of U.S. patent application Ser. No. 12/713,641, filed on Feb. 26, 2010 (now abandoned), the entire contents of each of which are incorporated by reference herein.
- 1. Technical Field
- The present disclosure relates to apparatus and methods for providing energy to tissue and, more particularly, to devices and electromagnetic radiation delivery procedures utilizing ablation probes and methods of controlling the delivery of electromagnetic radiation to tissue.
- 2. Discussion of Related Art
- Treatment of certain diseases requires destruction of malignant 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 cancer 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, use electromagnetic radiation to 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.
- Electrosurgical devices utilizing electromagnetic radiation have been developed for a variety of uses and applications. A number of devices are available that can be used to provide high bursts of energy for short periods of time to achieve cutting and coagulative effects on various tissues. There are a number of different types of apparatus that can be used to perform ablation procedures. Typically, microwave apparatus for use in ablation procedures include a microwave generator, which functions as an energy source, and a microwave surgical instrument having an antenna assembly for directing the energy to the target tissue. The microwave generator and surgical instrument are typically operatively coupled by a cable assembly having a plurality of conductors for transmitting microwave energy from the generator to the instrument, and for communicating control, feedback and identification signals between the instrument and the generator.
- Microwave energy is typically applied via antenna assemblies that can penetrate tissue. Several types of antenna assemblies are known, such as monopole and dipole antenna assemblies. In monopole and dipole antenna assemblies, microwave energy generally radiates perpendicularly away from the axis of the conductor. A monopole antenna assembly includes a single, elongated conductor that transmits microwave energy. A typical dipole antenna assembly has two elongated conductors, which are linearly aligned and positioned end-to-end relative to one another with an electrical insulator placed therebetween. Each conductor may be about ¼ of the length of a wavelength of the microwave energy, making the aggregate length of the two conductors about ½ of the wavelength of the supplied microwave energy.
- According to one embodiment of the present disclosure a microwave ablation system is disclosed. The microwave ablation system includes an energy source adapted to generate microwave energy and a plurality of energy delivery devices having a first energy delivery device configured to be inserted into tissue and to generate a non-directional ablation volume and a second energy delivery device configured to be positioned relative to the tissue and to generate a directional ablation volume. The system also includes a power dividing device having an input adapted to connect to the energy source and a plurality of outputs configured to be coupled to the plurality of energy delivery devices. The power dividing device is configured to selectively divide energy provided from the energy source between the plurality of energy delivery devices.
- According to another embodiment of the present disclosure a microwave ablation system is disclosed. The system includes a plurality of energy sources adapted to generate microwave energy and a plurality of energy delivery devices each of which is coupled to a corresponding one of the plurality of energy sources. The plurality of energy delivery devices includes a first energy delivery device configured to be inserted into tissue and to generate a non-directional ablation volume and a second energy delivery device configured to be positioned relative to the tissue and to generate a directional ablation volume.
- A method for providing energy to a target tissue is also contemplated by the present disclosure. The method includes the steps of coupling a plurality of energy delivery devices including a non-directional energy delivery device and a directional energy delivery device to a power dividing device having an input adapted to connect to an energy source. The method also includes the steps of inserting the non-directional energy delivery device into a portion of the target tissue and positioning the directional energy device at a surface of the target tissue. The method further includes the steps of selectively dividing energy on a plurality of channels to the plurality of the energy delivery devices and applying energy from the plurality of energy delivery devices to the target tissue.
- The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
-
FIGS. 1A-1B is a schematic diagram of an electrosurgical system for treating tissue, according to an embodiment of the present disclosure; -
FIGS. 2A-2B are cross-sectional views of a feedline according to the present disclosure; -
FIG. 3 is a perspective, cross-sectional view of a microwave antenna assembly according to the present disclosure; -
FIG. 4 is a perspective, cross-sectional view of another embodiment of a microwave antenna assembly according to the present disclosure; -
FIG. 5 perspective, cross-sectional view of further embodiment of a microwave antenna assembly according to the present disclosure; -
FIG. 6 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure; -
FIG. 7 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure; -
FIG. 8 is a cross-sectional view of multiple microwave antenna disposed in tissue assemblies according to the present disclosure; and -
FIG. 9 is a block diagram illustrating a method for treating tissue, according to an embodiment of the present disclosure. - Hereinafter, embodiments of the presently disclosed tissue ablation systems 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 used herein, the term “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 used herein, the phrase “transmission line” generally refers to any transmission medium that can be used for the propagation of signals from one point to another. Examples of suitable transmission lines include coaxial cables, waveguides, and combinations thereof.
- Various embodiments of the present disclosure provide electrosurgical systems for treating tissue and methods of controlling the delivery of electromagnetic radiation to tissue. Embodiments may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies. Electrosurgical systems for treating tissue, according to various embodiments of the present disclosure, deliver microwave power to a plurality of electrosurgical devices. Electrosurgical devices, such as ablation probes, for implementing embodiments of the present disclosure may be inserted directly into tissue, inserted through a lumen, such as a vein, needle or catheter, placed into the body during surgery by a clinician, or positioned in or on the body by other suitable methods known in the art.
-
FIG. 1A is a schematic diagram of anelectrosurgical system 100 for treating tissue, according to one embodiment of the present disclosure. Referring toFIG. 1A , theelectrosurgical system 100 includes anelectrosurgical generator 120 for generating an output signal, apower divider 150 coupled to theelectrosurgical generator 120, and a plurality of microwave antenna assemblies (e.g.,microwave antenna assemblies power divider 150. Thepower divider 150 is coupled to atransmission line 107 that electrically connects thepower divider 150 to anoutput 124 on theelectrosurgical generator 120. Themicrowave antenna assemblies transmission lines microwave antenna assemblies power divider 150, respectively. - The
transmission lines transmission lines - Each of the
antenna assemblies feedlines FIGS. 2A-2B , feedline 103 (e.g.,feedlines inner conductor 102, anouter conductor 105, and aninner insulator 106 interposed between inner andouter conductors outer conductors outer conductors inner insulator 106 may include any number of suitable non-conductive materials such as ceramic and polytetrafluoroethylene (PTFE). Inner andouter conductors feedline 103 may incorporate any suitable conductive material or metal, including, but not limited to, silver, copper and gold. In certain embodiments, inner andouter conductors feedline 103 may include a conductive or non-conductive substrate plated or coated with a suitable conductive material. Theinner conductor 102 andouter conductor 105 may be constructed of copper, gold, stainless steel or other conductive metals with similar conductivity values. - The
electrosurgical generator 120 may include other input or output devices such as knobs, dials, switches, buttons, graphical user interfaces, displays, and the like for control, indication and/or operation. Theelectrosurgical generator 120 may be capable of generating a plurality of output signals of various frequencies that are input to thepower divider 150. In one embodiment, theelectrosurgical generator 120 generates a plurality of microwave signals at substantially the same frequency. Theelectrosurgical generator 120 may include a control unit (not shown) that controls operations of theelectrosurgical generator 120, such as time of operation, power output and/or the mode of electrosurgical operation, which may have been selected by the clinician. - The
generator 120 includes amicrowave signal source 210 that provides a microwave frequency output signal to amicrowave amplifier unit 220. Themicrowave signal source 210 is capable of generating a plurality of output signals of various frequencies that are input to themicrowave amplifier unit 220. Themicrowave amplifier unit 220 may have any suitable input power and output power. In an embodiment, thegenerator 120 is implemented with operating frequencies in the range of about 300 MHz to about 5 GHz, which may be useful in performing ablation procedures and/or other procedures. It is to be understood that thegenerator 120 may be implemented with any appropriate range of operating frequencies. - The
electrosurgical system 100 may include a footswitch (not shown) coupled to theelectrosurgical generator 120. When actuated, the footswitch causes theelectrosurgical generator 120 to generate microwave energy. Themicrowave antenna assemblies electrosurgical generator 120 to adjust or select from a number of configuration options for delivering energy. Utilizing knobs, dials, switches or buttons on themicrowave antenna assemblies electrosurgical generator 120 to energize themicrowave antenna assemblies electrosurgical generator 120. - Although not shown as such in
FIG. 1A ,electrosurgical system 100 may include a plurality of channels defined by a plurality of electrosurgical devices and a plurality of transmission lines that electrically connect the electrosurgical devices to thepower divider 150. In an embodiment, thepower divider 150 is capable of monitoring the phase of each channel and adjusting the phase of the signal in each channel with respect to the other channel(s) to a predetermined phase relationship. Thepower divider 150 provides a plurality of signals to themicrowave antenna assemblies power divider 150 is illustrated as a standalone module inFIG. 1A , it is to be understood that thepower divider 150 may be integrated fully or partially into theelectrosurgical generator 120, themicrowave antenna assemblies - In another embodiment, the
power divider 150 may be a power splitter configured to split an input signal from theelectrosurgical generator 120 into two or more equal phase output signals, such as a Wilkinson power splitter. Thepower divider 150 may be implemented by any suitable power divider that provides equal or unequal power split at the output ports of themicrowave power divider 150 while substantially maintaining phase and amplitude balance. For example, themicrowave power divider 150 may be implemented using a 2-way power divider that provides equal or unequal power split at its output ports while maintaining a phase balance of less than ±45 degrees. Various embodiments of thepower divider 150 are described in a commonly-owned U.S. Pat. No. 9,095,359 entitled “Tissue Ablation System With Energy Distribution,” the entire disclosure of which is incorporated by reference herein. -
FIG. 1B shows another embodiment of anelectrosurgical system 101 for treating tissue. Referring toFIG. 1B , theelectrosurgical system 101 includes a plurality of electrosurgical generators (e.g.,electrosurgical generators microwave antenna assemblies microwave antenna assemblies transmission lines microwave antenna assemblies outputs electrosurgical generators - The
electrosurgical generators electrosurgical generator 120 of thesystem 100. Each of thegenerators microwave signal sources microwave amplifier units system 101 pairs each of theelectrosurgical generators microwave antenna assemblies power divider 150 of thesystem 100. Each of thegenerators - In some embodiments, one of the
microwave antenna assemblies microwave antenna assemblies FIG. 5 . - In another embodiment, one of the
microwave antenna assemblies FIG. 3 . In a further embodiment, one of themicrowave antenna assemblies FIG. 4 . - Although the
electrosurgical systems FIGS. 1A and 1B include twomicrowave antenna assemblies microwave power divider 150 may be implemented by any suitable power divider that divides or splits a microwave input signal into “N” number of output signals of equal or unequal power. By controlling the phase of ablation probes with respect to each other, according to embodiments of the present disclosure, a desired effect on tissue between the probes is produced. In a resection procedure where a long thin ablation line may be desired, probes that are 180 degrees out of phase with respect to each other produce a desired effect on tissue. In ablation procedures using in-phase probes, according to various embodiments of the present disclosure, there may be a reduction in energy that might otherwise move between the antenna shafts toward the surface with out-of-phase probes. Otherwise, thegenerators - In another embodiment, the
electrosurgical systems 100 and 101 (e.g., either through thepower splitter 150 or throughmultiple generators - In another embodiment, the
microwave power divider 150 and/or thegenerators antenna assemblies generators generators microwave power divider 150 modifies the division of microwave power between the channels to achieve the desired ablation geometry. -
FIG. 3 shows anantenna assembly 300 according to one embodiment of the present disclosure. Theantenna assembly 300 includes afeedline 302 that is coupled to one of thetransmission lines antenna assembly 300 includes aradiating section 304 including adipole antenna 306. Theantenna assembly 300 also includes adielectric shield 308 disposed about a portion of thedipole antenna 306 along the entire length thereof. In one embodiment, thedielectric shield 308 may have a substantially half-cylindrical shape (e.g.,) 180°. In another embodiment, thedielectric shield 308 may be made to encompass any radial angle. Theantenna assembly 300 also includes atip 310 having a tapered portion terminating in a sharp tip to allow for insertion into tissue with minimal resistance. In those cases where the energy applicator is inserted into a pre-existing opening, thetip 310 may be rounded or flat. - The
dielectric shield 308 and thetip 310 may be formed from a suitable polymeric material, which may include, for example, thermoplastics including reinforced or unreinforced polymers, e.g., polyamide (nylon) or polyaramid (e.g., KEVLAR® manufactured by E. I. du Pont de Nemours and Company of Wilmington, Del., United States), or any suitable polymeric composite, e.g., polymers filled with carbon particles, silica, conductive particles such as metal particles or conductive polymers, or combinations thereof. - The
dielectric shield 308 forms an opening or electromagnetic “window” shown generally as “W” partially defined by the longitudinal edges of thedielectric shield 308. The dielectric material of thedielectric shield 308 limits the transmission of the microwave energy therethrough, which directs the microwave energy through the window “W.” This configuration allows for the antenna assembly to be used to generate non-spherical and directed ablation volumes. Theantenna assembly 300 is a so-called “directional” antenna since theradiating section 304 is configured to emit microwave energy in a specific direction. Various embodiments of windowed microwave antenna assemblies are described in a commonly-owned U.S. Pat. No. 8,328,800 entitled “Directive Window Ablation Antenna With Dielectric Loading,” the entire disclosure of which is incorporated by reference herein. -
FIG. 4 shows awaveguide antenna assembly 400 according to one embodiment of the present disclosure. Theantenna assembly 400 includes afeedline 402 that is coupled to one of thetransmission lines antenna assembly 400 includes awaveguide section 404 having a radiatingcone 406 and a conical reflector 408 coupled to the inner and outer conductors of thefeedline 402, respectively. The radiatingcone 406 and the conical reflector 408 have a generally conical shape having a truncation at a proximal apex end and are dimensioned to couple to a distal end of thefeedline 402, with the conical reflector disposed over the radiatingcone 406. Theantenna assembly 400 also includes adielectric shield 414 disposed on the outer surface of the conical reflector 408 along the entire length thereof. - The
antenna assembly 400 includes amembrane 405 that is disposed between the radiatingcone 406 and the conical reflector 408, which define achamber 410 therebetween having a corresponding conical shape.Membrane 405 may be formed of any suitable radiofrequency-transparent material of low electrical conductivity, e.g., material that enables efficient transmissivity of microwave ablation signals to tissue from the energy delivery system, including without limitation, the conical radiating structure herein described.Membrane 405 may be formed from a rigid material, or may be formed from flexible and/or elastomeric material. Theantenna assembly 400 is a so-called “directional” antenna since thewaveguide section 404 is configured to emit microwave energy in a specific direction. - The
lumen 410 is filled with adielectric material 412 which may be a dielectric fluid circulated therethrough or any type of suitable solid dielectric. Thedielectric material 412 and thedielectric shield 414 may be formed from a suitable dielectric material similar to the material as thedielectric shield 308. - The
antenna assembly 400 is configured for surface transmission of microwave energy. In use, theantenna assembly 400 is disposed on a surface of the tissue with the surface of themembrane 405 contacting the tissue. The microwave energy applied to theantenna assembly 400 is directed by thewaveguide section 404 into the tissue through the surface thereof. Various embodiments of a conical microwave antenna assemblies are described in a commonly-owned U.S. Pat. No. 8,343,145 entitled “Microwave Surface Ablation Using Conical Probe,” the entire disclosure of which is incorporated by reference herein. -
FIG. 5 shows anantenna assembly 500 according to one embodiment of the present disclosure. Theantenna assembly 500 includes afeedline 502 that is coupled to one of thetransmission lines antenna assembly 500 includes aradiating section 504 including adipole antenna 506. Theantenna assembly 500 also includes atip 508 having a tapered portion terminating in a sharp tip to allow for insertion into tissue with minimal resistance. In those cases where the energy applicator is inserted into a pre-existing opening, thetip 508 may be rounded or flat. Theantenna assembly 500 is a so-called “non-directional” antenna since theradiating section 504 radiates microwave energy in all directions resulting in an ablation volume that is symmetrical about a longitudinal axis defined by theantenna assembly 500. - In one embodiment, the
antenna assembly 500 may include achoke 510 and asheath 512 enclosing thedipole antenna 506. Thesheath 512 defines achamber 514 that may be filled with a suitable dielectric material (e.g., liquid or solid loading). In use, theantenna assembly 500 is inserted into tissue and upon application of microwave energy generates substantially spherical ablation volumes based on the dielectric loading about thedipole antenna 506. Various embodiments of a choked dielectric loaded microwave antenna assemblies are described in a commonly-owned U.S. Provisional Application Ser. No. 61/023,031 entitled “Choked Dielectric Loaded Tip Dipole Microwave Antenna,” the entire disclosure of which is incorporated by reference herein. -
FIGS. 6-8 illustrate various embodiments of using a plurality ofantenna assemblies antenna assemblies single generator 120 or each of theantenna assemblies corresponding generator - In use, the
antenna assembly 500 is inserted into tissue and is placed directly through the center of a target tissue volume (e.g., tumor). Once energized, theantenna assembly 500 produces a symmetrical ablation volume (e.g., oval or sphere-shaped) about a longitudinal axis defined by theantenna assembly 500. In certain situations, a symmetrical ablation volume is not well suited for ablating a non-spherical tumor. More specifically, theantenna assembly 500 is not suited for ablating the entire tumor having an irregular shape without destroying a significant portion of healthy tissue. Utilizingadditional antenna assemblies 500 is not efficient either, since overlapping of the symmetrical ablation volume may not closely approximate the tumor. In this situation, using directional microwave antennas (e.g.,external antenna assemblies 400 or windowed antenna assemblies 300) in conjunction with non-directional antennas (e.g., the antenna assembly 500) provides for an optimal configuration of the ablation volume with respect to the tumor. In other words, combination ofantenna assemblies -
FIG. 6 illustrates the use of theantenna assembly 300 and theantenna assembly 500 to ablate a tumor “T” that is partially disposed at the surface of a tissue volume “V.” Theantenna assembly 500 is inserted through a larger portion of the tumor “T,” such that anablation volume 550 encompasses the larger portion of the tumor “T.” Theantenna assembly 300 is disposed on the surface of the tissue volume “V” such that the window “W” is facing a portion of the tumor “T.” Theantenna assembly 300 generates anablation volume 350 just beyond the surface of the tissue volume “V.” Theablation volume 350 overlaps with theablation volume 550, but also encompasses the portion of the tumor “T” that is outside of theablation volume 550. -
FIG. 7 illustrates the use of theantenna assembly 400 and theantenna assembly 500 to ablate the tumor “T” that is partially disposed at the surface of the tissue volume “V.” Theantenna assembly 500 is inserted through a larger portion of the tumor “T,” such that anablation volume 550 encompasses the larger portion of the tumor “T.” Theantenna assembly 400 is disposed on the surface of the tissue volume “V” such that thewaveguide section 404 is facing a portion of the tumor “T.” Theantenna assembly 400 generates anablation volume 450 just beyond the surface of the tissue volume “V.” Theablation volume 450 overlaps with theablation volume 550, but also encompasses the portion of the tumor “T” that is outside of theablation volume 550. -
FIG. 8 illustrates the use of theantenna assembly 300 and theantenna assembly 500 to ablate a tumor “T” that is disposed within tissue volume “V.” Theantenna assembly 500 is inserted through a larger portion of the tumor “T,” such that anablation volume 550 encompasses the larger portion of the tumor “T.” Theantenna assembly 300 is also inserted into the tissue volume “V” such that the window “W” is facing a portion of the tumor “T.” Theantenna assembly 300 generates anablation volume 350 that overlaps with theablation volume 550, but also encompasses the portion of the tumor “T” that is outside of theablation volume 550. - Collateral damage to healthy tissue is reduced by matching the shape of the tumor “T” to the
ablation volumes FIG. 8 , theantenna assemblies antenna assemblies antenna assembly 500, allowing for the achievement of the desired ablation boundaries. In addition, internal antennas (e.g.,antenna assemblies 300 and 500) may ablate deeper tissues, while the external antennas (e.g.,antenna assemblies 300 and 400) may ablate surface tissues. -
FIG. 9 illustrates a flow chart of a method according to the present disclosure. Instep 600, theantenna assembly 130 a (e.g., antenna assembly 500) is inserted into the tissue volume “V.” Instep 602, theantenna assembly 130 b (e.g.,antenna assembly 300 or 400) is positioned or otherwise inserted into the tissue volume “V.” Theantenna assemblies multiple antenna assemblies antenna assemblies 500 and a single antenna assembly 300) may be used to obtain various ablation volumes. Each of theantenna assemblies single generator 120 via thepower divider 150 or to acorresponding generator step 604, each of theantenna assemblies - While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
Claims (19)
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US20110213353A1 (en) | 2011-09-01 |
US20130253500A1 (en) | 2013-09-26 |
US9358067B2 (en) | 2016-06-07 |
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