# Patent

## Title
Flow rate verification monitor for fluid-cooled microwave ablation probe

## Abstract

A microwave ablation system includes an antenna assembly configured to deliver microwave energy from an energy source to tissue and a coolant source operably coupled to the energy source and configured to selectively provide fluid to the antenna assembly via a fluid path. The system also includes a controller operably coupled to the energy source and a piezoelectric transducer operably coupled to the fluid path to detect a force of fluid flow through the fluid path. The piezoelectric transducer is configured to generate a signal based on the detected force of fluid through the fluid path. The controller is configured to control the energy source output based on the generated signal.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation application of U.S. application Ser. No. 12/786,671, now U.S. Pat. No. 9,192,436, filed on May 25, 2010, the entire contents of which are incorporated by reference herein.


BACKGROUND
1. Technical Field
The present disclosure relates generally to microwave ablation procedures that utilize microwave surgical devices having a microwave antenna that may be inserted directly into tissue for diagnosis and treatment of diseases. More particularly, the present disclosure is directed to a system and method for monitoring correct system operation of a microwave ablation system utilizing a piezoelectric device.
2. Background of Related Art
In the treatment of diseases such as cancer, certain types of cancer cells have been found to denature at elevated temperatures (which are slightly lower than temperatures normally injurious to healthy cells.) These types of treatments, known generally as hyperthermia therapy, typically utilize electromagnetic radiation to heat diseased cells to temperatures above 41° C., while maintaining adjacent healthy cells at lower temperatures where irreversible cell destruction will not occur. Other procedures utilizing electromagnetic radiation to heat tissue also include ablation and coagulation of the tissue. Such microwave ablation procedures, e.g., such as those performed for menorrhagia, are typically done to ablate and coagulate the targeted tissue to denature or kill the tissue. Many procedures and types of devices utilizing electromagnetic radiation therapy are known in the art. Such microwave therapy is typically used in the treatment of tissue and organs such as the prostate, heart, liver, lung, kidney, and breast.
One non-invasive procedure generally involves the treatment of tissue (e.g., a tumor) underlying the skin via the use of microwave energy. The microwave energy is able to non-invasively penetrate the skin to reach the underlying tissue. However, this non-invasive procedure may result in the unwanted heating of healthy tissue. Thus, the non-invasive use of microwave energy requires a great deal of control.
Presently, there are several types of microwave probes in use, e.g., monopole, dipole, and helical. One type is a monopole antenna probe, which consists of a single, elongated microwave conductor exposed at the end of the probe. The probe is typically surrounded by a dielectric sleeve. The second type of microwave probe commonly used is a dipole antenna, which consists of a coaxial construction having an inner conductor and an outer conductor with a dielectric junction separating a portion of the inner conductor. The inner conductor may be coupled to a portion corresponding to a first dipole radiating portion, and a portion of the outer conductor may be coupled to a second dipole radiating portion. The dipole radiating portions may be configured such that one radiating portion is located proximally of the dielectric junction, and the other portion is located distally of the dielectric junction. In the monopole and dipole antenna probe, microwave energy generally radiates perpendicularly from the axis of the conductor.
The typical microwave antenna has a long, thin inner conductor that extends along the axis of the probe 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 axis of the probe. In another variation of the probe that provides for effective outward radiation of energy or heating, a portion or portions of the outer conductor can be selectively removed. This type of construction is typically referred to as a “leaky waveguide” or “leaky coaxial” antenna. Another variation on the microwave probe involves having the tip formed in a uniform spiral pattern, such as a helix, to provide the necessary configuration for effective radiation. This variation can be used to direct energy in a particular direction, e.g., perpendicular to the axis, in a forward direction (i.e., towards the distal end of the antenna), or combinations thereof.
Invasive procedures and devices have been developed in which a microwave antenna probe may be either inserted directly into a point of treatment via a normal body orifice or percutaneously inserted. Such invasive procedures and devices potentially provide better temperature control of the tissue being treated. Because of the small difference between the temperature required for denaturing malignant cells and the temperature injurious to healthy cells, a known heating pattern and predictable temperature control is important so that heating is confined to the tissue to be treated. For instance, hyperthermia treatment at the threshold temperature of about 41.5° C. generally has little effect on most malignant growth of cells. However, at slightly elevated temperatures above the approximate range of 43° C. to 45° C., thermal damage to most types of normal cells is routinely observed. Accordingly, great care must be taken not to exceed these temperatures in healthy tissue.
In the case of tissue ablation, a high radio frequency electrical current in the range of about 300 MHz to about 10 GHz is applied to a targeted tissue site to create an ablation volume, which may have a particular size and shape. Ablation volume is correlated to antenna design, antenna performance, antenna impedance, and tissue impedance. The particular type of tissue ablation procedure may dictate a particular ablation volume in order to achieve a desired surgical outcome. By way of example, and without limitation, a spinal ablation procedure may call for a longer, narrower ablation volume, whereas in a prostate ablation procedure, a more spherical ablation volume may be required.
Microwave ablation devices utilize sensors to determine if the system is working properly. However, without delivery of microwave energy, the sensors may indicate that the probe assembly status is normal. Further, defects in antenna assemblies may not be apparent except at high powers. As such, when microwave ablation system is tested using a low power routine a post manufacture defect may not be apparent. This is especially important for high power microwave ablation devices, where failures may result in extremely high temperatures.
Fluid-cooled or dielectrically-buffered microwave ablation devices may also be used in ablation procedures to cool the microwave ablation probe. Cooling the ablation probe may enhance the overall ablation pattern of antenna, and/or prevent damage to the antenna. However, during operation of the microwave ablation device, if the 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.
SUMMARY
According to an embodiment of the present disclosure, a microwave ablation system includes an antenna assembly configured to deliver microwave energy from an energy source to tissue and a coolant source operably coupled to the energy source and configured to selectively provide fluid to the antenna assembly via a fluid path. The system also includes a controller operably coupled to the energy source and a piezoelectric transducer operably coupled to the fluid path to detect a force of fluid flow through the fluid path. The piezoelectric transducer is configured to generate a signal based on the detected force of fluid through the fluid path. The controller is configured to control the energy source output based on the generated signal.
According to another embodiment of the present disclosure, a microwave ablation system includes an antenna assembly configured to deliver microwave energy from an energy source to tissue and a coolant source operably coupled to the energy source and configured to selectively provide fluid to the antenna assembly via a fluid path. The system also includes a controller operably coupled to the energy source and an insert disposed within the fluid path and configured to impart a force on a piezoelectric transducer operably coupled to the antenna assembly that is substantially equal to a force of fluid flow through the fluid path. The piezoelectric transducer is configured to generate a signal based on the force imparted thereon by the insert. The controller is configured to control the energy source output based on a comparison between the generated signal and a predetermined range.
The present disclosure also provides for a method of detecting fluid flow through a microwave ablation system. The method includes the steps of delivering microwave energy from a power source to tissue via an antenna assembly and supplying fluid from a coolant source to the antenna assembly via a fluid path. The method also includes the steps of detecting a force of fluid flow through the fluid path via a piezoelectric transducer and generating an electric signal based on the detected force of fluid flow through the fluid path. The method also includes the steps of comparing the generated signal to a predetermined range and modifying output of energy from the energy source based on the comparison between the detected force of fluid flow through the fluid path and the predetermined range.



BRIEF DESCRIPTION OF THE DRAWINGS
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
FIG. 1 shows a diagram of a microwave antenna assembly in accordance with an embodiment of the present disclosure;
FIG. 2 shows a perspective view of a distal end of the microwave antenna assembly of FIG. 1;
FIG. 3 shows a cross-sectional view of a proximal end of the microwave antenna assembly of FIG. 1;
FIG. 4 shows a system block diagram of a microwave antenna assembly according to another embodiment of the present disclosure;
FIG. 5A shows a system block diagram of a microwave antenna assembly according to another embodiment of the present disclosure; and
FIG. 5B shows the area of detail of FIG. 5A according to an embodiment of the present disclosure.



DETAILED DESCRIPTION
Embodiments of the presently disclosed apparatus are described in detail below with reference to the drawings wherein like reference numerals identify similar or identical elements in each of the several views. In the discussion that follows, the term “proximal” will refer to the portion of a structure that is closer to a user, while the term “distal” will refer to the portion of the structure that is farther from the user.
Generally, the present disclosure is directed to a microwave antenna assembly having an energy source or generator adapted to deliver energy to tissue via the antenna assembly and a coolant source for circulating a dielectric coolant fluid through the microwave antenna assembly. More particularly, the present disclosure is directed to monitoring fluid flow through the microwave antenna assembly and controlling the energy source output based on the monitored fluid flow to prevent damage to the antenna and/or harm to the clinician or patient caused by overheating of the antenna assembly.
FIG. 1 shows a microwave ablation system 10 that includes a microwave antenna assembly 12 coupled to a microwave generator 14 via a flexible coaxial cable 16. The generator 14 is configured to provide microwave energy at an operational frequency from about 300 MHz to about 6000 MHz, although other suitable frequencies are also contemplated.
In the illustrated embodiment, the antenna assembly 12 includes a radiating portion 18 connected by feedline 20 (or shaft) to the cable 16. More specifically, the antenna assembly 12 is coupled to the cable 16 through a handle enclosure 22 having an outlet fluid port 30 and an inlet fluid port 32 that are connected in fluid communication with a sheath 38. The sheath 38 encloses radiating portion 18 and feedline 20 to form a chamber 89 (FIG. 2) allowing a coolant fluid 37 to circulate about the antenna assembly 12. The ports 30 and 32 are also coupled to a supply pump 34 via supply lines 88 and 86, respectively. Supply pump 34 is, in turn, coupled to a supply tank 36 via a supply line 87. The supply pump 34 may be a peristaltic pump or any other suitable type. The supply tank 36 stores the coolant fluid 37 and, in one embodiment, may maintain the fluid 37 at a predetermined temperature. More specifically, the supply tank 36 may include a coolant unit that cools the returning liquid from the antenna assembly 12. In another embodiment, the coolant fluid 37 may be a gas and/or a mixture of fluid and gas.
FIG. 2 illustrates the radiating portion 18 of the antenna assembly 12 having a dipole antenna 40. The dipole antenna 40 is coupled to the feedline 20 that electrically connects antenna assembly 12 to the generator 14. The dipole antenna 40 includes a proximal portion 42 and a distal portion 45 interconnected at a feed point 46. The distal portion 45 and the proximal portion 42 may be either balanced (e.g., of equal lengths) or unbalanced (e.g., of unequal lengths). A dipole feed gap “G” is disposed between the proximal and distal portions 42 and 45 at the feed point 46. The gap “G” may be from about 1 mm to about 3 mm. In one embodiment, the gap “G” may be thereafter filled with a dielectric material at the feed point 46. The dielectric material may be polytetrafluoroethylene (PTFE), such as Teflon® sold by DuPont of Willmington, Del. In another embodiment, the gap “G” may be coated with a dielectric seal coating. The antenna assembly 12 also includes a choke 60 disposed around the feedline 20. The choke 60 may be a quarter-wavelength shorted choke that is shorted to the feedline 20 at the proximal end (not illustrated) of the choke 60 by soldering or other suitable methods.
Assembly 12 also includes a tip 48 at a distal end of the radiating portion 18 having a tapered end 24 that terminates, in one embodiment, at a pointed end 26 to allow for insertion into tissue with minimal resistance. In those cases where the radiating portion 18 is inserted into a pre-existing opening, tip 48 may be rounded or flat. The tip 48 may be formed from a variety of heat-resistant materials suitable for penetrating tissue, such as metals (e.g., stainless steel) and various thermoplastic materials, such as poletherimide, and polyamide thermoplastic resins.
FIG. 3 illustrates a cross-sectional view of the handle enclosure 22 of FIG. 1. Handle enclosure 22 houses an outflow chamber 52 disposed distal to an inflow chamber 54. Outflow chamber 52 and inflow chamber 54 are in fluid communication through an interconnecting lumen 56 that extends distally from a distal end of inflow chamber 54 and that houses at least a portion of the longitudinal length of feedline 20 and/or radiating portion 18. As shown in FIG. 3, feedline 20 extends distally through interconnecting lumen 56 through outflow chamber 52 and into inflow chamber 54. Outflow chamber 52 is in fluid communication with outlet fluid port 30 and inflow chamber 54 is in fluid communication with inlet fluid port 32. A return lumen 58 is disposed along at least a longitudinal portion of feedline 20 to surround at least a portion of interconnecting lumen 56 and provides fluid communication between chamber 89 and outflow chamber 52 to return coolant fluid 37 from chamber 89 to the pump 34 via outlet fluid port 30.
A distal insert 80 is disposed within outflow chamber 52 and surrounds feedline 20 along at least a portion of the longitudinal length thereof. Insert 80 is disposed at a distal end of outflow chamber 52 and defines a distal cap 81 that fluidly seals a distal end of handle enclosure 22 to prevent contaminants from entering handle enclosure 22 through outflow chamber 52. Insert 80 includes a recessed portion 82 about which an o-ring 84 is disposed to fluidly seal a portion of outflow chamber 52 that is disposed distal to outlet fluid port 30, as shown in FIG. 3.
A proximal insert 90 is disposed within inflow chamber 54 and surrounds feedline 20 along at least a portion of the longitudinal length thereof. Insert 90 abuts a proximal end of the inflow chamber 54 and includes a recessed portion 92 about which an o-ring 94 is disposed to fluidly seal a portion of inflow chamber 54 that is disposed proximal to inlet fluid port 32.
During circulation of coolant fluid 37 throughout antenna assembly 12, there exists a fluid pressure differential between the outflow chamber 52 and the inflow chamber 54. In particular, fluid pressure within the inflow chamber 54 (e.g., about 50 psi) is typically greater than fluid pressure within the outflow chamber 52 (e.g., about 0 psi). The flow of coolant fluid 37 through antenna assembly 12 may be monitored by sensing the fluid pressure that exists within the inflow chamber 54 to ensure adequate circulation of coolant fluid 37 within antenna assembly 12 during operation thereof, as will be described in more detail below.
A piezoelectric transducer 112 may be disposed between insert 90 and an abutment portion 114 of handle enclosure 22 such that transducer 112 abuts at a distal end the insert 90 and at a proximal end the abutment portion 114. Piezoelectric transducer 112 includes a suitable active material (e.g., piezoelectric ceramic, crystal, etc.) disposed between a pair of conductive elements (not explicitly shown) that generates a voltage when a mechanical stress is imparted thereon. The generated voltage between the conductive elements operates to mechanically deform the active material, thereby generating an electric field or electric signal. In this manner, transducer 112 may operate as a sensing component as well as a transmitting component. Transducer 112 transmits the electric signal to the generator 14 through any suitable electrical connection and, based on the received electric signal, the generator 14 automatically controls the operation of the ablation system 10, as discussed in greater detail below.
Since the components of inflow chamber 54 (e.g., insert 90) are not mechanically locked in place, the fluid pressure within inflow chamber 54 operates to impart a force substantially equally in all directions within inflow chamber 54 including in the proximal direction depicted by directional arrow “A” in FIG. 3. For example, the fluid pressure generated by coolant fluid 37 imparts a force on insert 90 in the direction of directional arrow “A” that is substantially equal to the fluid pressure within inflow chamber 54. This force imparted on insert 90 causes insert 90, in turn, to impart a substantially equal force on transducer 112 in the direction of arrow “A”. In response thereto, transducer 112 generates an electric field or signal to the generator 14 for controlling operation of the ablation system 10, as described in further detail below. In some embodiments, handle enclosure 22 may include any suitable mechanical components (e.g., ribs, inserts, washers, gaskets, buffers, locking components, grooves, springs, linkages, etc.) adapted to suppress or eliminate the effects of extraneous or ancillary forces (e.g., forces other than those described above) that may be transferred to or imparted on transducer 112 such as, for example, forces generated by the insertion and/or extraction of antenna assembly 12 relative to tissue. In this manner, forces imparted on and sensed by the transducer 112 are true to the fluid pressure within inflow chamber 54 due to the above-described suppression and/or elimination of extraneous forces.
With reference to FIG. 4, a microwave ablation system, shown generally as 200, according to an embodiment of the present disclosure is depicted. The system 200 includes an ablation device 202 having an antenna 203 and a handle 205 used to ablate tissue. A generator 206, which is substantially similar to power generating source 28, supplies the ablation device 202 with energy via coaxial cable 204. Ablation device is supplied with coolant or fluid from coolant supply 210 through inflow conduit 208a. The coolant fluid 37 flows through the ablation device 202 as described above and exits the ablation device via outflow conduit 208a into chamber 214. In some embodiments, conduits 208a and 208b may be replaced by a single multi-lumen conduit (not shown) having an inflow lumen for supplying the ablation device 202 with coolant and an outflow lumen for coolant to exit the ablation device 202 into the chamber 214.
As shown in FIG. 4, the microwave ablation system 200 includes a piezoelectric transducer 212 disposed in the handle 205 and configured to sense fluid pressure, as described above with respect to the embodiment of FIG. 3, for monitoring the flow rate of fluid through ablation system 200. As described above, when coolant circulation is interrupted, the ablation device tends to exhibit rapid failures. Further, when coolant circulation is too great and/or the flow rate of fluid exceeds a predetermined threshold maximum (e.g., 100 ml/min, 130 ml/min, etc.), the ablation device may be exhibiting symptoms of a fluid leak. By monitoring the flow of coolant fluid 37 through microwave ablation system 200, damage to the ablation device may be prevented.
Controller 216 is coupled to generator 206 and is configured to control generator 206 based on an input or signal received from transducer 212. Controller 216 may be a microprocessor or any suitable logic circuit able to receive an input or signal from transducer 212 and provide an output to control generator 206. Controller 216 may be operably coupled to a storage device or memory (not shown) configured to store programmable instructions, historical data, lookup tables, operating parameters, etc.
Transducer 212 may be a single device or an array of devices configured to detect operational parameters of the ablation device 202 in order to determine if the microwave ablation system 200 is functioning properly. In use, transducer 212 provides an electrical signal to the controller 216 that represents a real-time measurement or indication of fluid pressure. In some embodiments, a suitable time delay may be utilized by transducer 212 in sending the electrical signal to controller 216 such that momentary pressure transients that may occur during initial pressurization of system 200 are ignored. Controller 216 compares the electrical signal to a predetermined range. If the electrical signal is within the predetermined range, the controller 216 controls the generator 206 to continue with the ablation procedure and/or the supply ablation energy to ablation device 202. If the electrical signal is outside the predetermined range, the controller 216 controls the generator 206 to cease the ablation procedure and/or modify generator 206 output. For example, the predetermined range may be a range of fluid pressures within inflow chamber 54 (See FIG. 3) or through conduit 208a (See FIG. 5A). In one embodiment, the predetermined range of fluid pressure requirements is between about 25 psi and about 100 psi. In this scenario, the operating range of fluid pressure may be between about 35 psi and about 40 psi.
Transducer 212 may be incorporated into ablation device 202, as depicted by the illustrated embodiment, or may be coupled to ablation device 202 and/or controller 216. Transducer 212 may be placed anywhere along the fluid path of ablation system 200. For instance, transducer 212 may be placed in antenna 203, handle 205, or along the inflow conduit 208a (See FIG. 5A). The transducer 212 is configured to detect fluid pressure caused by fluid flow during startup (e.g., before microwave energy is delivered to the ablation device 202) or during an ablation procedure.
In another embodiment shown in FIG. 5A, piezoelectric transducer 212 is operably coupled to inflow conduit 208a to sense fluid pressure therethrough. In this scenario, transducer 212 is configured to operate in conjunction with microwave ablation system 200 as substantially described above with reference to FIG. 4 and will only be described to the extent necessary to explain the differences between the embodiments. In particular, as shown in FIG. 5B, transducer 212 is disposed within a cylinder 209 in fluid communication with inflow conduit 208a. In the illustrated embodiment, for example, cylinder 209 may be disposed substantially perpendicular to the fluid flow within inflow conduit 208a. When sufficient fluid flow exists through inflow conduit 208a, as depicted by directional arrows in FIG. 5B, coolant fluid 37 flows into cylinder 209 to impart a force on an insert or piston membrane 215, thereby causing piston membrane 215 to move within cylinder and translate a corresponding force on transducer 212. Piston membrane 215 may be substantially equal in diameter to the inner periphery of cylinder 209 to facilitate sliding movement of piston membrane 215 within cylinder 209 in a so-called “cylinder-piston” relationship. That is, piston membrane 215 may slide within cylinder 209 and generate a friction force on the inner surface of cylinder 209. As described above with respect to the embodiment of FIG. 4, transducer 212 provides an electrical signal to the controller 216 that represents a real-time measurement or indication of fluid pressure. Controller 216 is coupled to generator 206 and is configured to control generator 206 based on the signal received from transducer 212.
The described embodiments of the present disclosure are intended to be illustrative rather than restrictive, and are not intended to represent every embodiment of the present disclosure. Various modifications and variations can be made without departing from the spirit or scope of the disclosure as set forth in the following claims both literally and in equivalents recognized in law.

## Claims

1. A microwave antenna assembly, comprising:
a handle housing a first chamber and a second chamber disposed distal to and in fluid communication with the first chamber, the handle defining an abutment portion therein;
a feedline extending through the first and second chambers and configured to deliver microwave energy from an energy source to tissue;
a sheath enclosing at least a portion of the feedline and forming a fluid chamber between the sheath and the feedline, the fluid chamber in fluid communication with the first chamber, the sheath configured to receive a coolant fluid therethrough; and
a piezoelectric transducer disposed within the handle between the first chamber and the abutment portion and configured to detect a force of fluid flow through the first chamber and to generate a signal based on the detected force of fluid flow through the first chamber.

2. The microwave antenna assembly according to claim 1, further comprising a return lumen disposed along at least a portion of the feedline to provide fluid communication between the fluid chamber and the second chamber.

3. The microwave antenna assembly according to claim 1, further comprising an insert disposed within the first chamber adjacent the piezoelectric transducer, wherein the piezoelectric transducer is configured to detect the force of the fluid flow through the first chamber based on a force imparted thereon by the insert.

4. The microwave assembly according to claim 1, wherein the piezoelectric transducer includes a pair of conductive components and an active material disposed between the pair of conductive components, the piezoelectric transducer configured to generate a voltage in response to a force imparted on the pair of conductive components.

5. The microwave assembly according to claim 1, wherein the feedline includes an inner conductor and an outer conductor coaxially disposed about at least a portion of the inner conductor.

6. The microwave assembly according to claim 5, wherein the feedline includes a dielectric material disposed between the inner conductor and the outer conductor.

7. The microwave antenna assembly according to claim 5, wherein the inner conductor is disposed within the fluid chamber formed by the sheath.

8. The microwave assembly according to claim 1, wherein the coolant fluid is a liquid, a gas, or a combination of a liquid and a gas.