Electrosurgical devices having dielectric loaded coaxial aperture with distally positioned resonant structure and method of manufacturing same
10213255 ยท 2019-02-26
Assignee
Inventors
Cpc classification
A61B18/18
HUMAN NECESSITIES
H01Q1/42
ELECTRICITY
H01Q9/16
ELECTRICITY
A61B18/00
HUMAN NECESSITIES
Y10T29/49018
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
H01Q9/30
ELECTRICITY
Y10T29/49016
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
International classification
H01Q1/42
ELECTRICITY
A61B18/18
HUMAN NECESSITIES
A61B18/00
HUMAN NECESSITIES
H01Q9/16
ELECTRICITY
Abstract
An electrosurgical device for directing energy to a target volume of tissue includes a coaxial feedline having an inner conductor, an outer conductor and a dielectric material disposed therebetween. A proximal cylindrical dielectric sleeve is coupled to the inner conductor at a distal end of the coaxial feedline. A distal cylindrical dielectric sleeve is coupled to the inner conductor. First and second dielectric segments are coupled to the inner conductor and disposed between the proximal cylindrical dielectric sleeve and the distal cylindrical dielectric sleeve. The device also includes an elongated shaft overlying the proximal cylindrical dielectric sleeve, the first dielectric segment, the second dielectric segment and the distal cylindrical dielectric sleeve. The elongated shaft includes an opening defined therethrough, wherein the opening is at least partially aligned with the first dielectric segment. A balun structure is disposed on the elongated shaft, at least partially overlying the opening in the elongated shaft.
Claims
1. An electrosurgical device for delivering energy to tissue, comprising: an antenna assembly defining a longitudinal axis and including a dielectric sleeve, the dielectric sleeve including: a first dielectric segment; and a second dielectric segment configured to be coupled to the first dielectric segment about the longitudinal axis of the antenna assembly, the first and second dielectric segments cooperatively defining a longitudinal channel extending along the longitudinal axis; and a feedline including a dielectric material surrounding an inner conductor, the inner conductor including a distal portion disposed distally beyond the dielectric material, the distal portion of the inner conductor disposed within the channel defined by the first and second dielectric segments.
2. The electrosurgical device of claim 1, wherein the first and second dielectric segments each include at least one planar surface and a partial cylindrical surface.
3. The electrosurgical device of claim 2, wherein the at least one planar surface of the first dielectric segment is disposed in contact with the at least one planar surface of the second dielectric segment.
4. The electrosurgical device according to claim 1, wherein the antenna assembly further includes: a proximal cylindrical sleeve having the distal portion of the inner conductor extending therethrough; and a distal cylindrical sleeve having the distal portion of the inner conductor extending therethrough, the dielectric sleeve disposed between the proximal and distal cylindrical sleeves.
5. The electrosurgical device according to claim 4, wherein the proximal cylindrical sleeve has a dielectric constant, and the distal cylindrical sleeve has a dielectric constant that is different than the dielectric constant of the proximal cylindrical sleeve.
6. The electrosurgical device according to claim 4, wherein a dielectric constant of the distal cylindrical sleeve is greater than a dielectric constant of the proximal cylindrical sleeve.
7. The electrosurgical device according to claim 1, wherein the first dielectric segment has a dielectric constant, and the second dielectric segment has a dielectric constant that is less than the dielectric constant of the first dielectric segment.
8. The electrosurgical device according to claim 1, wherein the first dielectric segment has a diameter that is larger than a diameter of the second dielectric segment.
9. The electrosurgical device according to claim 1, wherein the feedline includes an outer conductor coaxially disposed about the inner conductor, the dielectric material disposed between the inner and outer conductors.
10. The electrosurgical device according to claim 9, wherein the dielectric material extends distally beyond the outer conductor, and the inner conductor extends distally beyond the dielectric material and the outer conductor.
11. An electrosurgical device, comprising: a feedline including an inner conductor surrounded by a dielectric material, a portion of the inner conductor extending distally beyond the dielectric material; and a dielectric sleeve including: a first dielectric segment; and a second dielectric segment configured to be coupled to the first dielectric segment, the first and second dielectric segments surrounding the portion of the inner conductor that extends distally beyond the dielectric material.
12. The electrosurgical device according to claim 11, wherein the portion of the inner conductor that extends distally beyond the dielectric material is received within a longitudinal channel defined by the first and second dielectric segments.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Objects and features of the presently disclosed antenna assemblies will become apparent to those of ordinary skill in the art when descriptions of various embodiments thereof are read with reference to the accompanying drawings, of which:
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DETAILED DESCRIPTION
(21) Hereinafter, embodiments of the presently disclosed electrosurgical device with a directional radiation pattern will be 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 that is closer to the user and the term distal refers to that portion of the apparatus that is further from the user.
(22) 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) (310.sup.8 cycles/second) to 300 gigahertz (GHz) (310.sup.11 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, transmission line generally refers to any transmission medium that can be used for the propagation of signals from one point to another.
(23) Various embodiments of the present disclosure provide electrosurgical devices for treating tissue and methods of directing electromagnetic radiation to a target volume of tissue. Embodiments may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies. An electrosurgical system including an energy applicator, according to various embodiments, is designed and configured to operate between about 500 MHz and about 10 GHz with a directional radiation pattern.
(24) Various embodiments of the presently disclosed electrosurgical device with a directional radiation pattern are suitable for microwave ablation and for use to pre-coagulate tissue for microwave ablation assisted surgical resection. Although various methods described hereinbelow are targeted toward microwave ablation and the complete destruction of target tissue, it is to be understood that methods for directing electromagnetic radiation may be used with other therapies in which the target tissue is partially destroyed or damaged, such as, for example, to prevent the conduction of electrical impulses within heart tissue. 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.
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(26) Feedline 110 may electrically connect the antenna assembly 12 via the transmission line 15 to the generator 28 and may include a coaxial cable, which may be semi-rigid or flexible. Feedline 110 may have a variable length from a proximal end of the antenna assembly 12 to a distal end of transmission line 15 ranging from a length of about one inch to about ten inches. Feedline 110 may be constructed of a variety of electrically conductive materials, e.g., copper, gold, or other conductive metals with similar conductivity values. Feedline 110 may be made of stainless steel, which generally offers the strength required to puncture tissue and/or skin. Conductive materials used to form the feedline 110 may be plated with other materials, e.g., other conductive materials, to improve their properties, e.g., to improve conductivity or decrease energy loss, etc. In some embodiments, the feedline 110 includes stainless steel, and to improve its conductivity, the stainless steel may be coated with a layer of a conductive material such as copper or gold. Feedline 110 may include an inner conductor, a dielectric material coaxially surrounding the inner conductor, and an outer conductor coaxially surrounding the dielectric material. Antenna assembly 12 may be formed from a portion of the inner conductor that extends distal of the feedline 110 into the antenna assembly 12. Feedline 110 may be cooled by fluid e.g., saline or water, to improve power handling, and may include a stainless steel catheter.
(27) In some embodiments, the power generating source 28 is configured to provide microwave energy at an operational frequency from about 500 MHz to about 2500 MHz. In other embodiments, the power generating source 28 is configured to provide microwave energy at an operational frequency from about 500 MHz to about 10 GHz. Power generating source 28 may be configured to provide various frequencies of electromagnetic energy. Transmission line 15 may additionally, or alternatively, provide a conduit (not shown) configured to provide coolant from a coolant source 18 to the probe 100.
(28) Located at the distal end of the antenna assembly 12 is an end cap or tapered portion 120, which may terminate in a sharp tip 123 to allow for insertion into tissue with minimal resistance. One example of a straight probe with a sharp tip that may be suitable for use as the energy applicator 100 is commercially available under the trademark EVIDENT offered by Covidien. The end cap or tapered portion 120 may include other shapes, such as, for example, a tip 123 that is rounded, flat, square, hexagonal, or cylindroconical.
(29) In some variations, the antenna assembly 12 includes a distal radiating portion 105 and a proximal radiating portion 140. In some embodiments, a junction 130 couples the proximal radiating portion 140 and the distal radiating portion 105. In some embodiments, the distal and proximal radiating portions 105, 140 align at the junction 130, which is generally made of a dielectric material, e.g., adhesives, and are also supported by the inner conductor that extends at least partially through the distal radiating portion 105. Junction 130, or portions thereof, may be disposed between the proximal and distal radiating portions, 140 and 105. Junction 130 may be formed from any suitable elastomeric or ceramic dielectric material by any suitable process. In some embodiments, the junction 130 is formed by overmolding and includes a thermoplastic elastomer, such as, for example, polyether block amide (e.g., PEBAX, manufactured by The Arkema Group of Colombes, France), polyetherimide (e.g., ULTEM and/or EXTEM, manufactured by SABIC Innovative Plastics of Saudi Arabia) and/or polyimide-based polymer (e.g., VESPEL, manufactured by E. I. du Pont de Nemours and Company of Wilmington, Del., United States). Junction 130 may be formed using any suitable overmolding compound by any suitable process, and may include use of a ceramic substrate.
(30) In some embodiments, the antenna assembly 12 may be provided with a coolant chamber (not shown). Additionally, the junction 130 may include coolant inflow and outflow ports (not shown) to facilitate the flow of coolant into, and out of, the coolant chamber. 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.
(31) In some embodiments, the antenna assembly 12 may be provided with an outer jacket (not shown) disposed about the distal radiating portion 105, the junction 130 and/or the proximal radiating portion 140. The outer jacket may be formed of any suitable material, such as, for example, polymeric or ceramic materials. The outer jacket may be applied by any suitable method, such as, for example, heat shrinking, overmolding, coating, spraying dipping, powder coating, baking and/or film deposition. The outer jacket may be a water cooled catheter formed of a material having low electrical conductivity.
(32) During microwave ablation, e.g., using the electrosurgical system 10, the probe 100 is inserted into or placed adjacent to tissue and microwave energy is supplied thereto. Ultrasound or computed tomography (CT) guidance may be used to accurately guide the probe 100 into the area of tissue to be treated. Probe 100 may be placed percutaneously or atop tissue, e.g., using conventional surgical techniques by surgical staff. A clinician may pre-determine the length of time that microwave energy is to be applied. Application duration may depend on many factors such as tumor size and location and whether the tumor was a secondary or primary cancer. The duration of microwave energy application using the probe 100 may depend on the progress of the heat distribution within the tissue area that is to be destroyed and/or the surrounding tissue. Single or multiple probes 100 may provide ablations in short procedure times, e.g., a few minutes, to destroy cancerous cells in the target tissue region.
(33) A plurality of probes 100 may be placed in variously arranged configurations to substantially simultaneously ablate a target tissue region, making faster procedures possible. Multiple probes 100 can be used to synergistically create a large ablation or to ablate separate sites simultaneously. Tissue ablation size and geometry is influenced by a variety of factors, such as the energy applicator design, number of energy applicators used simultaneously, time and wattage.
(34) In operation, microwave energy having a wavelength, lamda (), is transmitted through the antenna assembly 12, e.g., along the proximal and distal radiating portions 140, 105, and radiated into the surrounding medium, e.g., tissue. The length of the antenna for efficient radiation may be dependent on the effective wavelength, .sub.eff, which is dependent upon the dielectric properties of the medium being radiated into. Antenna assembly 12 through which microwave energy is transmitted at a wavelength, , may have differing effective wavelengths, .sub.eff, depending upon the surrounding medium, e.g., liver tissue, as opposed to, e.g., breast tissue.
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(36) According to an embodiment of the present disclosure, an energy applicator or probe (shown generally as 200 in
(37) At the distal end of the feedline 226, a portion of the dielectric material 222 may extend beyond the outer conductor 224. Additionally, or alternatively, a portion of the inner conductor 220 (e.g., 22 shown in
(38) As shown in
(39) Proximal cylindrical dielectric sleeve 244, first dielectric segment 284 and a second dielectric segment 274 may be formed from dielectric materials that provide an impedance match from the coaxial feedline 226. First dielectric segment 284 may be formed from a material with a dielectric constant that is higher than the dielectric constant of the second dielectric segment 274, e.g., to maximize energy radiated into the surrounding medium, e.g., tissue.
(40) In some embodiments, a proximal cylindrical dielectric sleeve 244, having a diameter D.sub.2, is coupled to the inner conductor 220. Proximal cylindrical dielectric sleeve 244 may be configured with a central channel 245 extending longitudinally therethrough to accommodate the inner conductor 220. Proximal cylindrical dielectric sleeve 244 may be formed from any suitable dielectric material. In some embodiments, the proximal cylindrical dielectric sleeve 244 is formed from a material with a dielectric constant in the range of about 2 to about 10.
(41) In some embodiments, a distal cylindrical dielectric sleeve 264, having a diameter D.sub.2, is coupled to the inner conductor 220. Distal cylindrical dielectric sleeve 264 may be formed from any suitable dielectric material. Distal cylindrical dielectric sleeve 264 may be disposed distally of the proximal cylindrical dielectric sleeve 244 and may be configured with a central channel 265 extending longitudinally therethrough to accommodate the inner conductor 220. In some embodiments, the distal cylindrical dielectric sleeve 264 is formed from a material with a dielectric constant different than the dielectric constant of the proximal cylindrical dielectric sleeve 244. Distal cylindrical dielectric sleeve 264 may be a high dielectric material, e.g., a material with a dielectric constant in the range of about 3 to about 50, to shorten the effective wavelength, .sub.eff, of energy.
(42) The length of the distal cylindrical dielectric sleeve 264 may be varied, depending on the dielectric constant of the material selected, to allow positioning of a radiating aperture (e.g., W shown in
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where c is the speed of light, f is the frequency, and .sub.r is the dielectric constant. For example, in a case where an aperture is to be positioned at a quarter wavelength, given a dielectric sleeve having a dielectric constant .sub.r, using Equation 1, the length l of the dielectric sleeve is calculated as:
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(45) In some embodiments, a first dielectric segment 284 and a second dielectric segment 274 are coupled to the inner conductor 220. As shown in
(46) In some embodiments, the first dielectric segment 284 has a substantially half-cylindrical shape, having a diameter D.sub.3, and includes a flat planar surface configured with a recess in the form of a groove 287 extending longitudinally across the flat planar surface. In some embodiments, the second dielectric segment 274 has a substantially half-cylindrical shape, having a diameter D.sub.2, and includes a flat planar surface configured with a recess in the form of a groove 277 extending longitudinally across the flat planar surface. Grooves 287 and 277 may be configured to accommodate a portion of the inner conductor 220. In some embodiments, when the first and second dielectric segments 284, 274 are coupled to the inner conductor 220, the respective flat planar surfaces of the first and second dielectric segments 284, 274 contact one another. The shape and size of the grooves 287 and 277 may be varied from the configuration depicted in
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(48) As shown in
(49) Opening 440 is made by removing a radial portion the elongated shaft 480 an optimized length back from the distal short. In some embodiments, the opening 440 is positioned to maximize directivity and coupling of microwave energy into tissue, e.g., opening 440 may be placed at the voltage maximum of the standing wave created by the shorted coaxial distal end. Opening 440 may be of any length and radial angle to achieve the desired amount of coax to free space coupling and radiation directivity.
(50) The dielectric constant of dielectric materials on either side of the opening 440, proximal or distal, may vary with distance from the opening 440 to achieve impedance match and optimal energy delivery and directivity to tissue. The dielectric materials filling the coaxial structure at the site of the opening 440 may vary in dielectric constant with shells or more complex dielectric layering to achieve the optimum antenna directivity and energy to tissue delivery.
(51) In some embodiments, the first dielectric segment 284 has a diameter D.sub.2 and the elongated shaft 480 has an outer diameter D.sub.3, where D.sub.3 is larger than D.sub.2. In such cases, the opening 440 may be filled with a nonconductive radio frequency transparent material, e.g., a glass fiber epoxy composite or polyimide. This may be accomplished in an over molding process. The window may also be created by placing a heat shrink or rigid composite sleeve along the entire antenna assembly. Some examples of dielectric material configurations at the site of the opening 440, according to some embodiments of the present disclosure, are shown in
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(54) First and second electrically-conductive sleeve members 871, 872 may overlap portions of the window 440 in the elongated shaft 480. As shown in
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(58) Energy applicator 700 may be rotatable about a longitudinal axis A-A (shown in
(59) Energy applicator 700 may include an indicia alignment mark (not shown) such as a colored strip or the like (e.g., 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) and/or indicia graduation marks (not shown) for insertion depth reference (e.g., to indicate the position of the opening W relative to the surface of the tissue T). Examples of indicia alignment mark and the indicia graduation mark embodiments are disclosed in commonly assigned U.S. patent application Ser. No. 12/476,960 filed on Jun. 2, 2009, entitled ELECTROSURGICAL DEVICES WITH DIRECTIONAL RADIATION PATTERN.
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(65) Hereinafter, a method of manufacturing an energy applicator or probe having a dielectric loaded coaxial aperture with distally positioned resonant structure, in accordance with the present disclosure, is described with reference to
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(67) In step 1820, a first dielectric member (e.g., 244 shown in
(68) In step 1830, a second dielectric member (e.g., 284 shown in
(69) In step 1840, a third dielectric member shaft (e.g., 274 shown in
(70) In step 1850, a fourth dielectric member shaft (e.g., 264 shown in
(71) In step 1860, an elongated shaft (e.g., 480 shown in
(72) In step 1870, a balun structure (e.g., 909 shown in
(73) The above-described electrosurgical devices for treating tissue and methods of directing electromagnetic radiation to a target volume of tissue may be used to provide directional microwave ablation, wherein the heating zone may be focused to one side of the electrosurgical device, thereby allowing clinicians to target small and/or hard to access tumors without having to penetrate the tumor directly or kill more healthy tissue than necessary. The presently disclosed electrosurgical devices may allow clinicians to avoid ablating or unnecessarily heating tissue structures, such as large vessels, healthy organs or vital membrane barriers, by placing the electrosurgical device between the tumor and tissue structure and directing the electromagnetic radiation toward the tumor and away from the tissue structure.
(74) 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.