MICROWAVE ABLATION DEVICES
20210251688 · 2021-08-19
Inventors
- William J. DICKHANS (Longmont, CO, US)
- Jiagui Li (Shanghai, CN)
- Zhiwei Lin (Shanghai, CN)
- Darion R. Peterson (Longmont, CO, US)
- Wei Zhang (Shanghai, CN)
Cpc classification
A61B2018/1892
HUMAN NECESSITIES
A61B2018/00898
HUMAN NECESSITIES
A61B2018/00023
HUMAN NECESSITIES
International classification
Abstract
A microwave ablation device includes a cable assembly, a feedline, and a transmission line. The cable assembly is configured to connect to an energy source. The feedline is in electrical communication with the cable assembly and includes a first temperature sensor. The first temperature sensor is disposed at a first axial location along a length of the feedline and is configured to sense a temperature at the first axial location. The first temperature sensor extends along the length of the feedline. The transmission line extends from the first temperature sensor and is disposed parallel and in contact with an outer conductor of the feedline.
Claims
1. A microwave ablation device comprising: a cable assembly configured to connect to an energy source; a feedline in electrical communication with the cable assembly, the feedline including a first temperature sensor disposed at a first axial location of the feedline, the first temperature sensor extending along a length of the feedline and configured to sense a temperature at the first axial location; and a transmission line extending from the first temperature sensor and disposed parallel and in contact with an outer conductor of the feedline.
2. The microwave ablation device of claim 1, further comprising a balun disposed on the outer conductor, wherein the first temperature sensor is disposed proximate to the balun.
3. The microwave ablation device of claim 2, further comprising an antenna assembly electrically connected to the feedline and positioned distal to the balun, the antenna assembly including: a proximal radiating section disposed proximate to the balun; a distal radiating section disposed distal to the proximal radiating section; and a feedgap disposed between the proximal radiating section and the distal radiating section, wherein the first temperature sensor is disposed proximal to the balun.
4. The microwave ablation device of claim 2, further comprising an antenna assembly electrically connected to the feedline and disposed distal to the balun, the antenna assembly including: a proximal radiating section disposed proximate to the balun; a distal radiating section disposed distal to the proximal radiating section; and a feedgap disposed between the proximal radiating section and the distal radiating section, wherein the first temperature sensor is disposed distal to the balun and proximal to the feedgap.
5. The microwave ablation device of claim 4, wherein the feedline further includes an inner conductor, an outer conductor extending coaxially with the inner conductor, and a dielectric material disposed between the inner conductor and the outer conductor, the first temperature sensor being disposed on the outer conductor.
6. The microwave ablation device of claim 5, wherein the feedline further includes a second temperature sensor disposed at a second axial location along the length of the feedline and configured to sense a temperature at the second axial location, the first temperature sensor being disposed proximal to the second temperature sensor.
7. The microwave ablation device of claim 5, wherein the feedline further includes a plurality of second temperature sensors each disposed at a different axial locations along the length of the feedline and configured to sense a temperature at the different axial locations, the first temperature sensor being located proximal to the plurality of second temperature sensors.
8. The microwave ablation device of claim 7, wherein the plurality of second temperature sensors is arranged in an array.
9. A feedline comprising: an inner conductor; an outer conductor disposed coaxially with the inner conductor; a dielectric material disposed between the inner conductor and outer conductor; and a first temperature sensor disposed at a first axial location of the outer conductor, wherein the first temperature sensor extends along a length of the outer conductor and is configured to sense a temperature at the first axial location.
10. The feedline of claim 9, wherein the first temperature sensor is disposed on the outer conductor.
11. The feedline of claim 9, further comprising a second temperature sensor disposed at a second axial location along the length of the outer conductor and configured to sense a temperature at the second axial location, wherein the first temperature sensor is disposed proximal to the second temperature sensor.
12. The feedline of claim 9, further comprising a plurality of second temperature sensors each disposed at different axial locations along the length of the outer conductor and configured to sense a temperature at each of the different axial locations, wherein the first temperature sensor is disposed proximal to the plurality of second temperature sensors.
13. The feedline of claim 12, wherein the plurality of second temperature sensors is arranged in an array.
14. A method of manufacturing a feedline, comprising: coating a conductive wire with a dielectric material; placing a conductive material over the dielectric material; and positioning a first temperature sensor over the conductive material to form the feedline.
15. The method of claim 14, further comprising positioning a second temperature sensor over the conductive material, wherein the first temperature sensor is proximal to the second temperature sensor.
16. The method of claim 14, further comprising positioning a plurality of second temperature sensors over the conductive material, wherein the first temperature sensor is proximal to the plurality of second temperature sensors.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Objects and features of the present disclosure 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:
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
DETAILED DESCRIPTION
[0033] The present disclosure is directed to a microwave ablation device including a probe assembly with a temperature sensor and methods of manufacturing the probe assembly. In particular, the present disclosure provides a microwave ablation probe which includes a temperature sensor positioned upon and extending coaxially with the feedline. In this way, the temperature sensor may be placed more accurately within the probe to thereby provide more reliable temperature readings. As a result, the probe assembly may be more precisely controlled during an ablation procedure.
[0034] Hereinafter, embodiments of the microwave ablation device of the present disclosure 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 the portion of the apparatus or component thereof, closer to a clinician and the term “distal” refers to the portion of the apparatus, or component thereof, farther from the clinician.
[0035] With reference to
[0036] The connector assembly 18 is a cable connector suitable to operably connect the microwave ablation device 10 to the microwave generator 24. The connector may house a memory (e.g., an EEPROM) (not separately shown in
[0037] The cable assembly 13 may include a tubular member 14, which defines a lumen 15 through which a transmission line 16 and an electrical wire 17 pass. The transmission line 16 may be any suitable, flexible transmission line, and particularly a coaxial cable including an inner conductor, and an outer conductor coaxially surrounding a dielectric material. The electrical wire 17 may be any suitable electrical wire.
[0038] In an embodiment, usage monitoring may enable limiting re-use of the microwave ablation device 10 beyond a certain number of energizations or a single use of the device and/or the sensed temperatures may be analyzed. In this regard, a temperature monitoring system 90 (
[0039] Referring now to
[0040] The memory 91 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by the processor 92 and which controls the operation of the microwave ablation device 10. In an embodiment, the memory 91 stores data 97 related to ablation zone configurations, previously gathered through empirical testing, as one or more data look-up tables. Alternatively or in addition to the one or more solid-state storage devices, the memory 91 may include one or more mass storage devices connected to the processor 92 through a mass storage controller (not shown) and a communications bus (not shown). Although the description of computer-readable media contained herein refers to a solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 92. That is, computer readable storage media includes non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the microwave ablation device 10.
[0041] The memory 91 may store an application 98. The application 98 may, when executed by the processor 92, cause the processor 92 to correlate the tissue temperature and ablation zone data gathered by temperature sensors (for example, a first temperature sensor 50 and/or a second temperature sensor(s) 52 in the probe assembly 11) with the data 97 stored in the memory 91. In another embodiment, the application 98, when executed by the processor 92, may cause the temperature monitoring system 90 to calculate a proposed course of treatment, a power setting, and the duration or number of serial energy applications that will achieve a desired ablation zone effective for treating the target tissue. For example, the clinician may enter the size of the target tissue into the temperature monitoring system 90, and the system 90 provides instruction for the treatment of the target tissue. In another embodiment, the application 98, when executed by the processor 92, causes the system 90 to access the data look-up tables stored in the memory 91, and to compare the tissue temperatures and/or ablation zone temperatures sensed by the first temperature sensor 50 (
[0042] In another embodiment, the application 98 may, when executed by the processor 92, cause the display 93 to present the user interface 99. The network interface 94 may be configured to connect to a network such as a local area network (LAN) consisting of a wired network and/or a wireless network, a wide area network (WAN), a wireless mobile network, a Bluetooth network, and/or the internet. The input device 95 may be any device by means of which a user may interact with the microwave ablation device 10, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface. The output module 96 may include any connectivity port or bus, such as, for example, parallel ports, serial ports, universal serial busses (USB), or any other similar connectivity port known to those skilled in the art.
[0043] With reference to
[0044] Turning now to
[0045] The feedline 40 may be a coaxial cable or any other type of suitable transmission line. In an embodiment, as shown in
[0046] The feedline 40 may have any suitable length defined between its proximal and distal ends. In accordance with an embodiment of the present disclosure, the feedline 40 is coupled at its proximal end to the transition assembly 22 (
[0047] In an embodiment, the outer conductor 48 may be braided, for example, including three or more strands intertwined. While the outer conductor 48 is described as a braid, the actual construction is not so limited and may include other formations of outer conductors of coaxial cables as would be understood by those of ordinary skilled in the art. The feedline 40 may incorporate one or more aspects of the ablation system described in U.S. Pat. No. 9,247,992 to Ladtkow et al. entitled “Microwave Ablation Catheter and Method of Utilizing the Same,” the entire contents of which are incorporated herein by reference.
[0048] The probe assembly 11 may include a balun 60 disposed proximal to and spaced apart a suitable distance from the feedgap 78. The balun 60 generally includes a balun short 62 and a balun insulator 64, which both couple the balun 60 to the outer conductor 48 of the feedline 40. The balun short 62 may be formed as a single structure and electrically coupled to the outer conductor 48 of the feedline 40 by a suitable manner of electrical connection, for example, soldering, welding or laser welding. Also, the balun short 62 may be formed by any suitable electrically-conductive materials, for example, copper, gold, silver or other conductive metals or metal alloys. In an embodiment, the balun short 62 has a generally ring-like or truncated tubular shape. In other embodiments, the balun 60 is devoid of a balun short. The size and shape of the balun short 62 may be varied from the configuration depicted in
[0049]
[0050] A tubing member 68 including an inner layer of an electrically-conductive material 66 is illustrated. In an embodiment, the tubing member 68 may be a heat shrink tubing member, which has the capability of responding to heat and binding around an object. The heat shrink tubing member may be a thermoplastic. The electrically-conductive material 66 may be formed of any suitable electrically-conductive material, for example, metallic material. In an embodiment, the metallic material of electrically-conductive layer 66 is formed of a silver ink deposited or layered on an interior surface of the tubing member 68. The tubing member 68 may have a length from about 1 inch (25.4 mm) to about 3 inches (76.2 mm) in length. However, the shape and size of the tubing member 68 and the balun insulator 64 may be varied from the configuration depicted in
[0051] The balun 60 is connected to the antenna assembly 70. In operation, microwave energy having a wavelength lambda (λ) is transmitted through the antenna assembly 70 and radiated into the surrounding medium, for example, tissue. The length of the antenna for efficient radiation may be dependent on the effective wavelength, λ.sub.eff, which is dependent upon the dielectric properties of the treated medium. The antenna assembly 70 through which microwave energy is transmitted at a wavelength λ may have differing effective wavelengths, λ.sub.eff, depending upon the surrounding medium, e.g., liver tissue as opposed to breast tissue, lung tissue, kidney tissue, etc.
[0052] The first temperature sensor 50 is disposed on the feedline 40. In particular, the first temperature sensor 50 is coupled to the outer conductor 48 and extends generally along a longitudinal axis of the feedline 40 and terminates under the balun 60 and is held in place under the balun 60 using potting material, such as, for example, a heat resistant epoxy. The first temperature sensor 50 is in contact and parallel with an outer surface of the outer conductor 48 of the feedline 40. In an embodiment, the first temperature sensor 50 is a thermocouple and the transmission 16 is a thermocouple wire. In embodiments, the first temperature sensor 50 and the transmission 16 may be monolithically formed. The thermocouple wire 16 may be a two lead wire thermocouple wire, for example, and may be made up of an insulated (anodized) side-by-side Constantine wire and copper wire.
[0053] As illustrated in
[0054] By disposing the first temperature sensor 50 closer to the balun short 62, the temperature of the balun short 62 can be more accurately sensed to thereby permit the first temperature sensor 50 to act as a safety indicator. For instance, in response to the first temperature sensor 50 detecting a temperature that exceeds a pre-determined threshold temperature (for example, 45° C.), which can lead to unintended cell death in tissue, the system 10 may cause the generator 24 to shut down or provide an alarm as the sensed temperature approaches the pre-determined threshold temperature, thus preventing injury to the patient.
[0055] In accordance with another embodiment, the axial location of the first temperature sensor 50 along the feedline 40 may be at approximately 0.8 inch (20.32 mm), 1.0 inch (25.4 mm), 1.2 inches (30.48 mm), and 1.4 inches (35.56 mm) from the distal tip 12 of the microwave ablation device 10. The distal end of the first temperature sensor 50 may be located a specified distance from the distal radiating section 72 that provides the most accurate temperature measurements.
[0056] With reference to
[0057] The inflow tube insert 102 is disposed about a proximal end portion of the feedline 40. The transmission 16 (e.g., the proximal portion of the first temperature sensor 50) extends through a longitudinally-extending channel 108 defined through the inflow tube insert 102 and runs parallel with and along an outer surface of the outer conductor of the feedline 40. The channel 108 of the inflow tube insert 102 has a diameter large enough to accommodate both the feedline 40 and the transmission 16 while providing a space between an inner annular surface thereof and the transmission 16.
[0058]
[0059]
[0060] The feedline 40 may be manufactured using any one of numerous suitable processes. Generally, a conductive wire is provided to serve as the inner conductor 42. The conductive wire may be drawn or extruded to thereby form the inner conductor 42, which may serve as a core or center of the feedline 40. The dielectric material 46 is used to coat and thereby encapsulate the inner conductor 42, for example, by extrusion, at a secured position to form the dielectric material 46. The outer conductor 48 is then formed over the dielectric material 46. In an embodiment, a conductive material is placed around the dielectric material 46 to form the outer conductor 48, for example, by inserting the dielectric material 46, which may be shaped as a tube, or by wrapping the conductive material around the dielectric material 46.
[0061] The temperature sensor 50 is positioned adjacent the outer conductor 48. In an embodiment, a thermocouple forming a portion of the temperature sensor 50 is disposed at a desired position over a surface of the outer conductor 48, and an associated transmission line 16, which extends proximally from the thermocouple 50, is disposed such that it runs along a length of the outer conductor 48 and extends past its proximal end. The proximal ends of the inner conductor 42, the dielectric material 46, and the outer conductor 48 are aligned, such that the transmission line 16 extends past all the proximal ends of the inner conductor 42, the dielectric material 46, and the outer conductor 48.
[0062] In another embodiment in which multiple temperature sensors are included, thermocouples of each temperature sensor, for example, a first temperature sensor 50 and one or more second temperature sensors 52, are disposed at a desired position, and transmission lines 16 corresponding to each are placed along a length of the outer conductor 48 to extend past a proximal end thereof. Dielectric material 46 surrounds the inner conductor 42, for example, by extrusion. In another embodiment, the inner conductor 42 is coated with the dielectric material 46. In either case, conductive material is disposed over the inner conductor 42 and dielectric material 46 to form the outer conductor 48. The first temperature sensor 50, the one or more second temperature sensor 52, and the transmission line 16 are then secured to the outer conductor 48. The temperature sensors 50, 52 are positioned as desired.
[0063] Once manufactured, the feedline 40 and temperature sensor 50 may be further processed. For example, in an embodiment, the balun 60 is coupled to the outer conductor 48 by any suitable means at any desired location, such as proximate to the first temperature sensor 50, between the first temperature sensor 50 and the second temperature sensor(s) 52.
[0064] During operation, probe assembly 11 with the embedded temperature sensor 50 will monitor the temperature of components of the probe assembly 11 and propagate a signal that relays the measured temperature to the microwave ablation device 10, which will regulate the temperature to prevent damage to components of the probe assembly 11, and/or prevent harm to the clinician or patient.
[0065] Various embodiments of the present disclosure provide a probe assembly including an embedded temperature sensor, a balun, and a feedline. Embodiments may be suitable for utilization with hand-assisted, endoscopic, and laparoscopic surgical procedures such as Video Assisted Thoracic Surgery. Embodiments may be implemented using electromagnetic radiation at microwave frequencies, RF frequencies or at other frequencies. A microwave ablation device including the presently disclosed probe assembly is configured to operate at frequencies between about 300 MHz and about 10 GHz.
[0066] Various embodiments of the presently disclosed probe assembly including a temperature sensor, a balun, and a feedline are suitable for microwave or RF ablation and for use to pre-coagulate tissue for microwave or RF ablation-assisted surgical resection. Although various embodiments described hereinbelow are disclosed to perform microwave ablation and the complete destruction of target tissue, it is to be understood that embodiments 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 or RF electrode.
[0067] As it is used in this description, “ablation procedure” generally refers to any ablation procedure, such as, for example, microwave ablation, radiofrequency (RF) ablation, or microwave or RF ablation-assisted resection.
[0068] 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 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.
[0069] 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.
[0070] 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.