US 8,394,087 B2Grant
Optical detection of interrupted fluid flow to ablation probe
Issue Date:2013-03-12
•10 Claims
•5 Drawing Sheets
Abstract
An electrosurgical system includes an electrosurgical device adapted to direct energy to tissue and a fluid path leading to the electrosurgical device. The system also includes an optical sensor unit operably associated with the fluid path. The optical sensor unit includes a light-emitting element to generate light output and a light-receiving element to collect light outputted from the light-emitting element. The light-emitting element and the light-receiving element are disposed such that light output from the light-emitting element passes through the fluid path to the light-receiving element. The optical sensor unit is capable of detecting an air bubble in the fluid path passing through the optical sensor unit using a sensed characteristic of light collected at the light-receiving element.
Metadata
Assignee
- Vivant Medical, Inc.
Inventors
- Richard A. Willyard
- Joseph D. Brannan
Application Information
Application Number:US 12/566,299
Filing Date:2009-09-24
Priority Date:2009-09-24
Art Unit:3739
Classifications
IPC:
A61B18/18
Patent Drawings (5 sheets)
Description
Background
[0001] 1. Technical Field
[0002] The present disclosure relates to detection devices for use in electrosurgical devices and, more particularly, to systems and methods for optical detection of interrupted fluid flow to an ablation probe.
[0003] 2. Discussion of Related Art
[0004] Treatment of certain diseases requires the destruction of malignant tissue growths, e.g., tumors. Electromagnetic radiation can be used to heat and destroy tumor cells. Treatment may involve inserting ablation probes into tissues where cancerous tumors have been identified. Once the probes are positioned, electromagnetic energy is passed through the probes into surrounding tissue.
[0005] In the treatment of diseases such as cancer, certain types of tumor cells have been found to denature at elevated temperatures that are slightly lower than temperatures normally injurious to healthy cells. Known treatment methods, such as hyperthermia therapy, heat diseased cells to temperatures above 41° C. while maintaining adjacent healthy cells below the temperature at which irreversible cell destruction occurs. These methods involve applying electromagnetic radiation to heat, ablate and/or coagulate tissue. Microwave energy is sometimes utilized to perform these methods. Other procedures utilizing electromagnetic radiation to heat tissue also include coagulation, cutting and/or ablation of tissue.
[0006] 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 that functions as an energy source, and a microwave surgical instrument (e.g., microwave ablation probe) 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.
[0007] There are several types of microwave probes in use, e.g., monopole, dipole and helical, which may be used in tissue ablation applications. In monopole and dipole antenna assemblies, microwave energy generally radiates perpendicularly away from the axis of the conductor. Monopole antenna assemblies typically include a single, elongated conductor. A typical dipole antenna assembly includes two elongated conductors, which are linearly aligned and positioned end-to-end relative to one another with an electrical insulator placed therebetween. Helical antenna assemblies include a helically-shaped conductor that can be formed in various configurations. The main modes of operation of a helical antenna assembly are normal mode (broadside), in which the field radiated by the helix is maximum in a perpendicular plane to the helix axis, and axial mode (end fire), in which maximum radiation is along the helix axis.
[0008] A microwave transmission line typically includes a thin inner conductor that extends along the longitudinal axis of the transmission line and is surrounded by a dielectric material and is further surrounded by an outer conductor around the dielectric material such that the outer conductor also extends along the transmission line axis. In one variation of an antenna, a waveguiding structure, such as a length of transmission line or coaxial cable, is provided with a plurality of openings through which energy “leaks” or radiates away from the guiding structure. This type of construction is typically referred to as a “leaky coaxial” or “leaky wave” antenna.
[0009] Cooling the ablation probe may enhance the overall heating pattern of the antenna, prevent damage to the antenna and prevent harm to the clinician or patient. Because of the small temperature difference between the temperature required for denaturing malignant cells and the temperature normally injurious to healthy cells, a known heating pattern and precise temperature control is needed to lead to more predictable temperature distribution to eradicate the tumor cells while minimizing the damage to surrounding normal tissue.
[0010] Fluid cooled or dielectrically buffered microwave devices may be used in ablation procedures. During operation of a microwave ablation device, if proper cooling is not maintained, e.g., flow of coolant or buffering fluid is interrupted, the microwave ablation device may exhibit rapid failures due to the heat generated from the increased reflected power. A coolant fluid having entrained gas bubbles may be circulated from a cooling system into a microwave ablation device. When a bubble filled with even a small volume of air or multiple air bubbles in close proximity to each other are introduced into an ablation probe, e.g., when the ablation probe is operating at a high power level, the ablation probe may be susceptible to rapid failure due to overheating conditions. The time to failure is dependant on the power delivered to the antenna and degree to which coolant flow is reduced and/or the duration of the interruption.
Summary
[0011] The present disclosure relates to an electrosurgical system including an electrosurgical device adapted to direct energy to tissue and a fluid path leading to the electrosurgical device. The system also includes an optical sensor unit operably associated with the fluid path. The optical sensor unit includes a light-emitting element to generate light output and a light-receiving element to collect light outputted from the light-emitting element. The light-emitting element and the light-receiving element are disposed such that light output from the light-emitting element passes through the fluid path to the light-receiving element. The optical sensor unit is capable of detecting an air bubble in the fluid path passing through the optical sensor unit using a sensed characteristic of light collected at the light-receiving element.
[0012] The present disclosure also relates to a method of detecting an air bubble in a fluid flow including the step of providing an optical sensor unit including a light-emitting element and a light-receiving element, the optical sensor unit operably associated with a fluid path. The method also includes the steps of determining a first reference value based on air flow in the fluid path passing through the optical sensor, determining a second reference value based on fluid flow in the fluid path passing through the optical sensor unit, using the optical sensor unit to monitor the fluid flow in the fluid path to detect an air bubble in the fluid flow using at least one of the first reference value or the second reference value, and when an air bubble in the fluid flow is detected by the optical sensor unit, outputting an electrical signal from the optical sensor unit.
[0013] The present disclosure also relates to a method of detecting an air bubble in a fluid flow including the step of providing a fluid source for supplying a fluid and providing an optical sensor unit including a light-emitting element and a light-receiving element, the optical sensor unit operably associated with a first fluid path, the first fluid path leading from the fluid source to an electrosurgical device. The method also includes the steps of: performing a first calibration step by directing light from the light-emitting element through air flow in the first fluid path passing through the optical sensor unit and sensing a characteristic of light collected at the light-receiving element to determine a first reference value; performing a second calibration step by directing light from the light-emitting element through fluid flow in the first fluid path passing through the optical sensor unit and sensing a characteristic of light collected at the light-receiving element to determine a second reference value; operating the optical sensor unit to direct light from the light-emitting element through the first fluid path passing through the optical sensor unit and to sense a characteristic of light collected at the light-receiving element to determine a third reference value; and controlling an electrosurgical generator based on a comparison result of a comparison of the third reference value to the first and second reference values.
Brief Description of the Drawings
[0014] Objects and features of the presently disclosed systems and methods for optical detection of interrupted fluid flow to an electrosurgical device 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:
[0015] FIG. 1 is a schematic diagram of an electrosurgical system including a coolant supply system according to an embodiment of the present disclosure;
[0016] FIG. 2 is an enlarged view of the indicated area of detail of FIG. 1 according to an embodiment of the present disclosure;
[0017] FIG. 3 is a schematic diagram of an electrosurgical system including a coolant supply system according to another embodiment of the present disclosure;
[0018] FIG. 4 is a flowchart illustrating a method of detecting an air bubble in a fluid flow according to an embodiment of the present disclosure;
[0019] FIG. 5 is a flowchart illustrating an embodiment of the step of determining a first reference value and a second reference value of the method illustrated in FIG. 4 according to the present disclosure; and
[0020] FIG. 6 is a flowchart illustrating a method of detecting an air bubble in a fluid flow according to another embodiment of the present disclosure.
Detailed Description
[0021] Hereinafter, embodiments of the presently disclosed systems and methods for optical detection of interrupted fluid flow to an electrosurgical device are described with reference to the accompanying drawings. Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and as used in this description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to that portion of the apparatus that is closer to the user and the term “distal” refers to that portion of the apparatus that is further from the user.
[0022] Electromagnetic energy is generally classified by increasing energy or decreasing wavelength into radio waves, microwaves, infrared, visible light, ultraviolet, X-rays and gamma-rays. As it is used in this description, “microwave” generally refers to electromagnetic waves in the frequency range of 300 megahertz (MHz) (3×108 cycles/second) to 300 gigahertz (GHz) (3×1011 cycles/second). As it is used in this description, “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation-assisted resection.
[0023] Light may be regarded as an electromagnetic wave that travels in straight lines (gravity and electromagnetic influences excepted) until it is either reflected or refracted. Refraction of light occurs when a light wave travels from a medium with a given refractive index to a medium with another refractive index. As it is used in this description, “refraction” generally refers to the change in direction of a wave due to a change in its speed, as occurs when a wave passes from one medium to another. As it is used in this description, “refractive index” generally refers to a measure of how much the speed of light is reduced inside a medium, compared to the speed of light in vacuum or air.
[0024] As it is used in this description, “light source” generally refers to all illumination sources including photo-luminescent sources, fluorescent sources, phosphorescence sources, lasers, electro-luminescent sources, such as electro-luminescent lamps, and light-emitting diodes. As it is used in this description, “light-emitting diode” generally refers to any system that is capable of receiving an electrical signal and producing a color of light in response to the signal. Thus, “light-emitting diode”, as used herein, includes light-emitting diodes (LEDs) of all types, including white LEDs, infrared LEDs, ultraviolet LEDs, visible color LEDs, light-emitting polymers, semiconductor dies that produce light in response to current, organic LEDs, electro-luminescent strips, silicon based structures that emit light, and other such systems. As it is used in this description, “color” generally refers to any frequency of electromagnetic radiation, or combination of different frequencies, within the visible light spectrum, the infrared and ultraviolet areas of the spectrum, and in other areas of the electromagnetic spectrum where illumination sources may generate radiation.
[0025] As it is used in this description, “optical detector” generally refers to a device that converts an optical signal into an electrical signal. As it is used in this description, “transmission line” generally refers to any transmission medium that can be used for the propagation of signals from one point to another. As it is used in this description, “fluid” generally refers to a liquid, a gas or both.
[0026] Various embodiments of the present disclosure provide electrosurgical devices for treating tissue and systems and methods for optical detection of interrupted fluid flow to the electrosurgical devices, such as ablation probes. Embodiments may be implemented using electromagnetic radiation at microwave frequencies or at other frequencies. An electrosurgical system including an energy applicator in fluid communication with a coolant supply system, according to various embodiments, is designed and configured to operate between about 500 MHz and about 10 GHz. The coolant supply system, as described herein, may be used in conjunction with various types of devices, such as microwave antennas having either a straight or looped radiating antenna portion, etc.
[0027] Various embodiments of the presently disclosed electrosurgical systems including an energy applicator in fluid communication with a coolant supply system 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.
[0028] FIG. 1 shows an electrosurgical system 10 according to an embodiment of the present disclosure that includes an energy applicator or probe 100. An embodiment of an energy applicator, such as the probe 100 of FIG. 1 , in accordance with the present disclosure, is shown in more detail in FIG. 2 . It will be understood, however, that other probe embodiments may also be used.
[0029] Probe 100, which is described in more detail later in this disclosure, generally includes an antenna assembly 12 having a radiating portion connected by a feedline 110 (or shaft) via a transmission line 15 to a connector 16, which may further operably connect the probe 100 to a power generating source 28, e.g., a microwave or radio frequency (RF) electrosurgical generator. Feedline 110 may be coupled to a coolant port 51 to facilitate the flow of coolant or buffering fluid into, and out of, the probe 100.
[0030] Electrosurgical system 10 in accordance with an embodiment of the present disclosure includes a power generating source 28, a coolant supply system 11 adapted to provide coolant fluid “F” to the probe 100, and a sensor unit 46 capable of detecting a gas bubble in the coolant supply system 11. In some embodiments, the sensor unit 46 is electrically coupled to the power generating source 28, and may be configured to generate an alarm signal to the power generating source 28 and, in response thereto, control logic, which may be associated with the power generating source 28, may reduce the power output, e.g., for a predetermined time interval or until a manual reset switch is actuated.
[0031] In some embodiments, the coolant supply system 11 includes a coolant source 18, and may include a substantially closed loop having a first coolant path 19 leading to the probe 100 and a second coolant path 20 leading from the probe 100. The size and shape of the first coolant path 19 and the second coolant path 20 may be varied from the configuration depicted in FIG. 1 . Sensor unit 46 may be configured to detect an air bubble in close proximity to the coolant source 18.
[0032] Coolant port 51 may be in fluid communication with the coolant source 18 via the first coolant path 19 and/or the second coolant path 20. In some embodiments, the coolant supply system 11 includes a first coolant path 19 and a second coolant path 20, wherein the first coolant path 19 includes a coolant supply line 31 leading from the coolant source 18 to a coolant inlet port 52 that is defined in the coolant port 51, and the second coolant path 20 includes a coolant return line 35 leading from a coolant outlet port 53 that is defined in the coolant port 51 to the coolant source 18.
[0033] Coolant source 18 may be any suitable housing containing a reservoir of coolant fluid “F”. Coolant fluid “F” may be any suitable fluid that can be used for cooling or buffering the probe 100, e.g., deionized water, or other suitable cooling medium. Coolant fluid “F” may have dielectric properties and may provide dielectric impedance buffering for the antenna assembly 12. Coolant fluid “F” may be a conductive fluid, such as a saline solution, which may be delivered to the target tissue, e.g., to decrease impedance and allow increased power to be delivered to the target tissue. A coolant fluid “F” composition may vary depending upon desired cooling rates and the desired tissue impedance matching properties. Various fluids may be used, e.g., liquids including, but not limited to, water, saline, perfluorocarbon, such as the commercially available Fluorinert® perfluorocarbon liquid offered by Minnesota Mining and Manufacturing Company (3M), liquid chlorodifluoromethane, etc, in other variations, gases (such as nitrous oxide, nitrogen, carbon dioxide, etc.) may also be utilized as the cooling fluid. In yet another variation, a combination of liquids and/or gases, including, for example, those mentioned above, may be utilized as the coolant fluid “F”.
[0034] As shown in FIG. 1 , a fluid movement device 34 may be provided in the first coolant path 19 to move the coolant fluid “F” through the first coolant path 19. Fluid movement device 34 may include valves, pumps, power units, actuators, fittings, manifolds, etc. The position of the fluid movement device 34 may be varied from the configuration depicted in FIG. 1 . Fluid movement device 34 may additionally, or alternatively, be provided in the second coolant path 20. Although the coolant supply system 11 shown in FIG. 1 includes a single, fluid movement device 34 positioned in the first coolant path 19, various combinations of different numbers of fluid movement devices, variedly sized and variedly spaced apart from each other, may be provided in the first coolant path 19 and/or the second coolant path 20.
[0035] Sensor unit 46 may be disposed at any suitable position to allow for the detection of a gas bubble in the coolant supply system 11. In some embodiments, the sensor unit 46 is disposed such that a gas bubble in the coolant supply system 11 can be detected before the bubble can be introduced into the probe 100. Sensor unit 46 may be disposed in the first coolant path 19, and may be disposed in close proximity to the coolant source 18. In some embodiments, the sensor unit 46 is electrically coupled to the power generating source 28, and the detection of a bubble may trigger an alarm signal to the power generating source 28. Electrical characteristics of the power generating source 28 may be controlled in response to the alarm signal. In some embodiments, the electrosurgical system 10 reduces the power and/or voltage output of the power generating source 28, thereby reducing energy applicator power output to a low level, in response to the alarm signal. In some embodiments, the sensor unit 46 includes an optical detector, and may be used to monitor the coolant fluid “F” flow in the coolant supply line 31 to detect the presence of air or other gas within the coolant fluid “F” flow.
[0036] Audible indicatory means may be incorporated or associated with the electrosurgical system 10 to notify the operator of the bubble condition. In such case, the operator may take steps, e.g., perform visual inspection of the coolant fluid “F” in the coolant source 18 and/or visual inspection of the first coolant path 19, or portions thereof, to verify that the coolant supply system 11 is functioning properly. A “reset” button (not shown) may be provided to allow the power generating source 28 to return to normal mode.
[0037] In the illustrated embodiment, sensor unit 46 generally includes a light source or light-emitting element 43 (also referred to herein as optical transmitter 43) and a light receiving element 40 (also referred to herein as optical receiver 40). Optical transmitter 43 may include any suitable device configured to transmit optical signals, e.g., a light-emitting diode (LED) 42. Optical receiver 40 may include any suitable device configured to receive optical signals, e.g., a photo-diode 41. In some embodiments, an LED 42 and a photo-diode 41 are arranged on opposite sides of a coolant line, e.g., the coolant supply line 31. LED 42 may be configured to transmit either a continuous or pulsed optical signal through the coolant supply line 31. Photo-diode 41 may be positioned to receive the transmitted optical signal on the opposite side of the coolant supply line 31 from the LED 42. A fixture housing an LED 42 and photo-diode 41 pair may be provided to allow the sensor unit 46 (also referred to herein as optical detector 46) to be clipped or otherwise fastened to a portion of the coolant supply line 31, e.g., to provide reliable orientation and shield the optical detector 46 from ambient light interference.
[0038] In accordance with embodiments of the present disclosure, an air or other gas bubble may be detected by the optical detector 46 by either signal intensity or signal position at the optical receiver 40. Air and liquids have different degrees of attenuation per unit length and different refractive index values (e.g., water has a higher refractive index than air). Air has a refractive index of about 1.0003, and water has a refractive index of about 1.33. When an air bubble passes through the coolant supply line 31, the optical detector 46, according to embodiments of the present disclosure, detects the change in intensity of light collected at the photo-diode 41, compared to the intensity of light collected at the photo-diode 41 when fluid “F” passes through the coolant supply line 31. In sensor unit 46 embodiments using signal intensity to detect an air bubble, the change in intensity of light collected at the photo-diode 41 is interpreted as indicator of the presence of an air bubble.
[0039] In some embodiments, an LED 42 and a photo-diode 41 are configured to communicate when fluid “F” is present in the coolant supply line 31. When an air bubble passes through the coolant supply line 31, the varied refraction angle deflects light away from its intended photo-diode 41 and very little light impinges upon the photo-diode 41. In sensor unit 46 embodiments using signal position to detect an air bubble, the absence of light impinging upon the photo-diode 41 is interpreted as indicator of the presence of an air bubble.
[0040] A logic circuit (not shown) in the sensor unit 46 may relay information through digital or analog communication to the power generating source 28 indicating whether the optical detector 46 is in the no-bubble state or bubble state. The optical detector 46 may be a separate device that plugs into digital or analog inputs on the power generating source 28, programmed according to the communication protocol of the optical detector 46.
[0041] 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 fluid “F” from the coolant source 18 to the probe 100.
[0042] Feedline 110 may electrically connect the antenna assembly 12 via the transmission line 15 to the power generating source 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 twelve 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.
[0043] 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. In one embodiment, the feedline 110 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 110 may be cooled by fluid e.g., saline or water, to improve power handling, and may include a stainless steel catheter.
[0044] 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.
[0045] 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.
[0046] In some embodiments, the antenna assembly 12 may be provided with a coolant chamber (e.g., 337 shown in FIG. 3 ). 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”.
[0047] In some embodiments, the antenna assembly 12 may be provided with an outer jacket (e.g., 339 shown in FIG. 3 ) 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.
[0048] 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.
[0049] 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.
[0050] In operation, microwave energy having a wavelength, lambda (λ), 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, λeff, 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, λ, may have differing effective wavelengths, λeff, depending upon the surrounding medium, e.g., liver tissue as opposed to breast tissue.
[0051] FIG. 3 shows an electrosurgical system 1000 according to an embodiment of the present disclosure that includes an antenna assembly 312 substantially disposed within a sheath 338. Antenna assembly 312 is similar to the antenna assembly 12 shown in FIG. 2 and further description thereof is omitted in the interests of brevity. In some embodiments, a feedline 110 couples the antenna assembly 312 to a connection hub 322. Connection hub 322, which is described in more detail later in this disclosure, generally includes a cable connector 379 and fluid ports 330 and 332.
[0052] Sheath 338 generally includes a tubular member 339 defining a lumen into which the antenna assembly 312, or portion thereof, may be positioned. In some embodiments, the sheath 338 is disposed over and encloses the feedline 110, the proximal radiating portion 140 and the distal radiating portion 105, and may at least partially enclose the tip 123. In accordance with the embodiment shown in FIG. 3 , a coolant chamber 337 is defined between the tubular member 339 and the outer surfaces of the feedline 110, the proximal radiating portion 140 and the distal radiating portion 105. Coolant chamber 337 is adapted to circulate coolant fluid “F” therethrough, and may include baffles, multiple lumens, flow restricting devices, or other structures that may redirect, concentrate, or disperse flow depending on their shape. Examples of coolant chamber embodiments are disclosed in commonly assigned U.S. patent application Ser. No. 12/350,292 filed on Jan. 8, 2009, entitled “CHOKED DIELECTRIC LOADED TIP DIPOLE MICROWAVE ANTENNA”. The size and shape of the sheath 338 and the coolant chamber 337 extending therethrough may be varied from the configuration depicted in FIG. 3 .
[0053] Electrosurgical system 1000 in accordance with an embodiment of the present disclosure includes a power generating source 328, a coolant supply system 313 adapted to provide coolant fluid “F” via a connection hub 322 to the antenna assembly 312, and a sensor unit 346 capable of detecting a gas bubble in the coolant supply system 313 and electrically coupled via transmission lines 301 and 302 to the power generating source 328. Electrosurgical system 1000 may further include a flow-diverter apparatus 350 operably associated with the sensor unit 346 and disposed in fluid communication between the sensor unit 346 and the connection hub 322. In some embodiments, when the sensor unit 346 detects an air or other gas bubble in the coolant supply system 313, the sensor unit 346 transmits an electrical signal via transmission line 302 to the power generating source 28 and the flow-diverter apparatus 350. Sensor unit 346 and the power generating source 328 are similar to the sensor unit 46 and the power generating source 28, respectively, shown in FIG. 1 and further description thereof is omitted in the interests of brevity.
[0054] Coolant supply system 313 generally includes a coolant source 336, a first coolant path 319 leading from the coolant source 336 to the connection hub 322, and a second coolant path 320 leading from the connection hub 322 to the coolant source 336. In some embodiments, the first coolant path 319 includes a first fluid movement device 344 configured to move coolant fluid “F” through the first coolant path 319, and the second coolant path 320 includes a second fluid movement device 334 configured to move coolant fluid “F” through the second coolant path 320. Coolant source 336 stores coolant fluid “F”, and may maintain coolant fluid “F” at a predetermined temperature. For example, the coolant source 336 may include a cooling unit (not shown) that cools the returning coolant fluid “F” from the antenna assembly 312.
[0055] Connection hub 322 may have a variety of suitable shapes, e.g., cylindrical, rectangular, etc. In some embodiments, the connection hub 322 includes a cable connector 379, an outlet fluid port 330 and an inlet fluid port 332. Connection hub 322 may include a three-branch luer type connector 372 having a middle branch 374 used to house the cable connector 379 and two outer branches 376 and 378 to house the outlet and inlet fluid ports 330 and 332, respectively. Connection hub 322 may be formed of any of a variety of materials, e.g., any suitable non-conductive conformal material. Examples of non-conductive conformal materials that may be suitable for forming the connection hub 322 include polyesters, polyimides, polyamides, polyamide-imides, polyetherimides, polyacrylates, polyethylene terephthalate, polyethylene, polypropylene, polyvinylidene chloride, polysiloxanes, combinations thereof and the like.
[0056] Connection hub 322 may be adapted to be connected in fluid communication with the sheath 338. In some embodiments, the sheath 338 is coupled to the connection hub 322 and the tip 123, thereby defining a chamber 337 around the feedline 110, the proximal radiating portion 140 and the distal radiating portion 105.
[0057] In some embodiments, the first coolant path 319 includes a coolant supply line 386 leading from the coolant source 336 to the inlet fluid port 332. First fluid movement device 344 may be disposed in fluid communication between the inlet fluid port 332 and the coolant source 336. In some embodiments, the second coolant path 320 includes a coolant return line 388 leading from the outlet fluid port 330 to the coolant source 336. Second fluid movement device 334 may be disposed in fluid communication between the outlet fluid port 330 and the coolant source 336. The positions of the first fluid movement device 344 and the second fluid movement device 334, e.g., in relation to the coolant source 336, may be varied from the configuration depicted in FIG. 3 .
[0058] In some embodiments, a controller 351 associated with the flow-diverter apparatus 350 may actuate a fluid flow diverter 352 to divert coolant fluid “F” flow to a third coolant fluid path 321. Fluid flow diverter 352 may be any suitable device for selectively diverting the coolant fluid “F” flow. Third coolant fluid path 321 may lead from the flow-diverter apparatus 350 to a container 390. Controller 351 may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in a memory (not shown) of the controller 351.
[0059] In some embodiments, the flow-diverter apparatus 350 includes a valve (not shown) that includes a valve body and an electromechanical actuator operatively coupled to the valve body. Controller 351 may control fluid flow diverter 352 by activating the actuator, e.g., according to a predetermined valve control sequence. In some embodiments, a valve control sequence may involve moving the valve from a first position, in which coolant fluid “F” flows towards the connection hub 322, to a second position, in which the coolant fluid “F” having an air or other gas bubble entrained therein flows into the container 390, and returning to the first position, e.g., after a predetermined time interval, thereby re-establishing coolant fluid “F” flow towards the connection hub 322.
[0060] Hereinafter, methods of optical detection of interrupted fluid flow to an electrosurgical device, in accordance with the present disclosure, are described with reference to FIGS. 4 through 6 . It is to be understood that the steps of the methods provided herein may be performed in combination and in a different order than presented herein without departing from the scope of the disclosure.
[0061] FIG. 4 is a flowchart illustrating a method of detecting a bubble in a fluid flow according to an embodiment of the present disclosure. In step 410, an optical sensor unit (e.g., 46 shown in FIG. 1 ) is provided that includes a light-emitting element (e.g., 43 shown in FIG. 1 ) and a light-receiving element (e.g., 40 shown in FIG. 1 ). The optical sensor unit is operably associated with a fluid path (e.g., 19 shown in FIG. 1 ). In some embodiments, the light emitting element and light-receiving element are disposed such that light directed from the light-emitting element passes through the fluid path to the light-receiving element during the fluid flow in the fluid path.
[0062] In step 420, a first reference value is determined based on an air flow in the fluid path passing through the optical sensor, and a second reference value is determined based on a fluid flow in the fluid path passing through the optical sensor unit. As illustrated in FIG. 5 , step 420 may further include steps 421 and 422. In step 421, light from the light-emitting element is directed through the air flow in the fluid path passing through the optical sensor unit and a characteristic of light collected at the light-receiving element is sensed to determine the first reference value. In step 422, light from the light-emitting element is directed through the fluid flow in the fluid path passing through the optical sensor unit and a characteristic of light collected at the light-receiving element is sensed to determine the second reference value. In some embodiments, the sensed characteristic of light is an intensity of light collected at the light-receiving element. In other embodiments, the sensed characteristic of light is an absence of light incident on the light-receiving element.
[0063] In step 430, the optical sensor unit is used to monitor the fluid flow in the fluid path to detect an air bubble in the fluid flow using at least one of the first reference value or the second reference value. In sensor unit embodiments using signal intensity to detect an air bubble, the change in intensity of light collected at the light-receiving element is interpreted as indicator of the presence of an air bubble.
[0064] In step 440, when an air bubble in the fluid flow is detected by the optical sensor unit, an electrical signal is transmitted from the optical sensor unit. In some embodiments, when the sensor unit detects an air (or other gas) bubble in the coolant supply system, the sensor unit transmits an electrical signal to a power generating source (e.g., 28 shown in FIG. 1 ).
[0065] FIG. 6 is a flowchart illustrating a method of detecting a bubble in a fluid flow according to an embodiment of the present disclosure. In step 610, a fluid source (e.g., 336 shown in FIG. 3 ) for supplying a fluid (e.g., “F” shown in FIG. 3 ) is provided. The fluid source may include any suitable source, e.g., a container of coolant or dielectric-buffering fluid.
[0066] In step 620, an optical sensor unit (e.g., 346 shown in FIG. 3 ) is provided that includes a light-emitting element (e.g., 43 shown in FIG. 3 ) and a light-receiving element (e.g., 40 shown in FIG. 3 ) The optical sensor unit is operably associated with a fluid path (e.g., 319 shown in FIG. 3 ), the fluid path leading from the fluid source to an electrosurgical device (e.g., 312 shown in FIG. 3 ) operably associated with an electrosurgical generator (e.g., 328 shown in FIG. 3 ).
[0067] In step 630, a first calibration step is performed by directing light from the light-emitting element through an air flow in the fluid path passing through the optical sensor unit and a characteristic of light collected at the light-receiving element is sensed to determine a first reference value.
[0068] In step 640, a second calibration step is performed by directing light from the light-emitting element through a fluid flow in the fluid path passing through the optical sensor unit and a characteristic of light collected at the light-receiving element is sensed to determine a second reference value.
[0069] In step 650, the optical sensor unit is operated to direct light from the light-emitting element through the fluid flow in the fluid path passing through the optical sensor unit and a characteristic of light collected at the light-receiving element is sensed to determine a third reference value.
[0070] In step 660, an electrosurgical generator, which may be used to activate the electrosurgical device, is controlled based on a comparison result of a comparison of the third reference value to the first reference value and the second reference value. In some embodiments, the optical sensor unit is electrically coupled to the electrosurgical generator. Based on the comparison result, the optical sensor unit may output an electrical signal to the electrosurgical generator and, in response thereto, the power output of the electrosurgical generator may be reduced, e.g., for a predetermined time interval or until a manual reset switch is actuated. In some embodiments, the optical sensor unit outputs an electrical signal when the third reference value is determined to be substantially equal to the first reference value.
[0071] In some embodiments, the fluid flow may be diverted by a flow-diverter apparatus (e.g., 350 shown in FIG. 3 ) to a different fluid path (e.g., 321 shown in FIG. 3 ) for a predetermined period of time based on the comparison result. The predetermined period of time may be a period of time to allow for the air bubble to pass out of the fluid path (e.g., 319 shown in FIG. 3 ) that leads to the electrosurgical device and, instead, into a different fluid path (e.g., 321 shown in FIG. 3 ), e.g., leading to a container (e.g., 390 shown in FIG. 3 ). In some embodiments, the electrosurgical system (e.g., 1000 shown in FIG. 3 ) controls electrical characteristics of the electrosurgical generator to deactivate the electrosurgical device (e.g., 312 shown in FIG. 3 ) during the predetermined time period.
[0072] Although embodiments have been described in detail with reference to the accompanying drawings for the purpose of illustration and description, it is to be understood that the inventive processes and apparatus are not to be construed as limited thereby. It will be apparent to those of ordinary skill in the art that various modifications to the foregoing embodiments may be made without departing from the scope of the disclosure.
Claims
What is claimed is:
1. An electrosurgical system, comprising:
an electrosurgical device adapted to direct energy to tissue;
an electrosurgical generator for activating the electrosurgical device;
a fluid path leading to the electrosurgical device;
an optical sensor unit operably associated with the fluid path, the optical sensor unit including:
a light-emitting element to generate light output; and
a light-receiving element to collect light outputted from the light-emitting element,
wherein the light-emitting element and the light-receiving element are disposed such that light output from the light-emitting element passes through the fluid path to the light-receiving element;
wherein the optical sensor unit is capable of detecting an air bubble in the fluid path passing through the optical sensor unit using a sensed characteristic of light collected at the light-receiving element;
a flow-diverter apparatus operably associated with the optical sensor unit and disposed in fluid communication with the fluid path between the optical sensor unit and the electrosurgical device; and
a container for collecting fluid diverted by the flow-diverter apparatus.
2. The electrosurgical system of claim 1, wherein the sensed characteristic of light is an intensity of light collected at the light-receiving element.
3. The electrosurgical system of claim 1, wherein the sensed characteristic of light is an absence of light incident on the light-receiving element.
4. The electrosurgical system of claim 1, wherein electrical output of the electrosurgical generator is controlled based on an electrical signal received from the optical sensor unit, wherein the electrical signal is generated by the optical sensor unit in response to detection of an air bubble in the fluid path.
5. The electrosurgical system of claim 1, wherein the optical sensor unit outputs an electrical signal to the electrosurgical generator and the flow-diverter apparatus in response to detection of an air bubble in the fluid path.
6. The electrosurgical system of claim 5, wherein a direction of fluid flow is controlled by the flow-diverter apparatus based on the electrical signal, and electrical power output of the electrosurgical generator is controlled based on the electrical signal.
7. The electrosurgical system of claim 6, wherein the flow-diverter apparatus further includes:
a controller electrically coupled to the optical sensor unit; and
a fluid flow diverter operably associated with the controller to divert fluid flow to the container.
8. The electrosurgical system of claim 7, wherein, in response to the electrical signal from the optical sensor unit, the controller actuates the fluid flow diverter to divert fluid flow to the container.
9. The electrosurgical system of claim 8, wherein, after a predetermined time period, the controller actuates the fluid flow diverter to re-divert fluid flow to the fluid path.
10. The electrosurgical system of claim 9, wherein the controller is electrically coupled to the electrosurgical generator and adapted to output electrical signals indicative of the predetermined time period, wherein the electrosurgical generator is controlled based on the electrical signals indicative of the predetermined time period to deactivate the electrosurgical device during the predetermined time period.
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