# Patent

## Title
Management of voltage standing wave ratio at skin surface during microwave ablation

## Abstract

A dielectric spacer for use during microwave ablation of tissue is disclosed. The dielectric spacer includes a housing having a predetermined thickness and a skin-contacting bottom surface. The housing is configured to be filled with a dielectric material having a predetermined dielectric permittivity. The housing is further configured to be placed on the tissue in proximity with at least one microwave antenna assembly, wherein the thickness and the dielectric permittivity are configured to shift a maximum voltage standing wave ratio of the at least one microwave antenna assembly.

## Background
BACKGROUND
1. Technical Field
The present disclosure relates generally to microwave antennas. More particularly, the present disclosure is directed to systems and methods for shifting voltage standing wave ratio at the tissue surface to reduce the amount microwave energy being deposited at the surface.
2. Background of Related Art
Treatment of certain diseases requires destruction of malignant tissue growths (e.g., tumors). It is known that tumor cells denature at elevated temperatures that are slightly lower than temperatures injurious to surrounding healthy cells. Therefore, known treatment methods, such as hyperthermia therapy, heat tumor cells to temperatures above 41° C., while maintaining adjacent healthy cells at lower temperatures to avoid irreversible cell damage. Such methods involve applying electromagnetic radiation to heat tissue and include ablation and coagulation of tissue. In particular, microwave energy is used to coagulate and/or ablate tissue to denature or kill the cancerous cells.
Microwave energy is applied via microwave ablation antennas that penetrate tissue to reach tumors. There are several types of microwave antennas, such as monopole and dipole, in which microwave energy radiates perpendicularly from the axis of the conductor. A monopole antenna includes a single, elongated microwave conductor whereas a dipole antenna includes two conductors. In a dipole antenna, the conductors may be in a coaxial configuration including an inner conductor and an outer conductor separated by a dielectric portion. More specifically, dipole microwave antennas may have a long, thin inner conductor that extends along a longitudinal axis of the antenna and is surrounded by an outer conductor. In certain variations, a portion or portions of the outer conductor may be selectively removed to provide more effective outward radiation of energy. This type of microwave antenna construction is typically referred to as a “leaky waveguide” or “leaky coaxial” antenna.
Conventional microwave antennas operate at a single frequency allowing for creation of similarly shaped lesions (e.g., spherical, oblong, etc.). Some antennas are capable of radiating energy inside as well as outside tissue, due to well-tuned impedance matching. In some instances this may result in inadvertent radiation at the tissue surface.
SUMMARY
According to one embodiment of the present disclosure, a dielectric spacer for use during microwave ablation of tissue is disclosed. The dielectric spacer includes a housing having a predetermined thickness and a skin-contacting bottom surface. The housing is configured to be filled with a dielectric material having a predetermined dielectric permittivity. The housing is further configured to be placed on the tissue in proximity with at least one microwave antenna assembly, wherein the thickness and the dielectric permittivity are configured to shift a maximum voltage standing wave ratio of the at least one microwave antenna assembly.
According to another embodiment of the present disclosure, a dielectric spacer for use during microwave ablation of tissue is disclosed. The dielectric spacer includes a gel layer formed from a dielectric, elastic, shape-memory gel. The dielectric spacer also includes first and second substrates selected from at least one of film and foam and formed from a dielectric polymer. The first substrate is disposed on a top surface of the gel layer and the second substrate is disposed on a bottom surface of the gel layer, wherein the gel layer and the first and second substrates are configured to be perforated by at least one antenna assembly.
According to a further embodiment of the present disclosure a dielectric spacer for use during microwave ablation of tissue is disclosed. The dielectric spacer includes an inflatable, conformable housing having a skin-contacting bottom surface and configured to be inflated to a predetermined thickness. The housing is configured to be filled with a dielectric material having a predetermined dielectric permittivity. The housing is further configured to be placed on the tissue in proximity with at least one microwave antenna assembly, wherein the thickness and the dielectric permittivity are configured to shift a maximum voltage standing wave ratio of the at least one microwave antenna assembly.



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 is a schematic diagram of an ablation system according to the present disclosure;
FIG. 2 is a cross-sectional view of an antenna assembly of FIG. 1 showing specific absorption rate with an unshifted voltage standing wave ratio according to the present disclosure;
FIG. 3 is a cross-sectional view of an antenna assembly of FIG. 1 showing specific absorption rate with a shifted voltage standing wave ratio according to the present disclosure;
FIG. 4 is a perspective, cross-sectional view of a dielectric spacer according to one embodiment of the present disclosure;
FIG. 5 is a perspective, cross-sectional view of a dielectric spacer according to another embodiment the present disclosure;
FIG. 6 is a side, cross-sectional view of a dielectric spacer according to a further embodiment the present disclosure;
FIG. 7 is a perspective, cross-sectional view of a multi-probe dielectric spacer according to one embodiment the present disclosure;
FIG. 8 is a perspective, cross-sectional view of a multi-probe dielectric spacer according to another embodiment the present disclosure;
FIG. 9 is a perspective view of a dielectric insert according to one embodiment the present disclosure;
FIG. 10 is a perspective view of a dielectric insert according to another embodiment the present disclosure;
FIG. 11 is a perspective view of a dielectric spacer according to one embodiment the present disclosure;
FIG. 12A is a perspective view of a dielectric spacer apparatus according to an embodiment of the present disclosure; and
FIG. 12B is a side, cross-sectional view of the dielectric spacer of FIG. 12A;



DETAILED DESCRIPTION
Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
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 500 MHz to about 10,000 MHz. In the illustrated embodiment, the antenna assembly 12 includes a radiating section 18 connected by feedline 20 (or shaft) to the cable 16. The feedline 20 may be connected to a hub 22, which is connected to the cable 16 through a cable connector 19. The hub 22 may have a variety of suitable shapes, e.g., cylindrical, rectangular, etc.
The feedline 20 may be coaxial and may include an inner conductor surrounded by an inner insulator, which is, in turn, surrounded by an outer conductor (e.g., a cylindrical conducting sheath). The inner and outer conductors are coupled to the cable 16 via the connector 19. The inner conductor and outer conductor may be constructed of copper, gold, stainless steel or other conductive metals with similar conductivity values. The metals may be plated with other materials, e.g., other conductive materials, to improve their properties, e.g., to improve conductivity or decrease energy loss, etc. In one embodiment, the feedline 20 may be formed from a coaxial, semi-rigid or flexible cable having a wire with a 0.047′′ outer diameter rated for 50 Ohms.
The connection hub 22 also couples the antenna assembly 12 to a cooling system 13. The connection hub 22 includes 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 allowing a coolant fluid 37 to circulate from ports 30 and 32 around the antenna assembly 12. The ports 30 and 32 are also coupled to a supply pump 34 that is, in turn, coupled to a supply tank 36 via supply lines 86 and 88, respectively. 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 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 liquid and gas. The coolant fluid 37 provides for dielectric impedance buffering for the antenna assembly 12. This allows for radiation of significant amounts of power while the antenna assembly 12 is partially inserted in the tissue or exposed to air.
During operation, one or more of the antenna assemblies 12 are inserted into tissue through the skin. In a percutaneous application, the interface between the air and the tissue at the insertion point determines the locations of voltage standing wave ratio (“VSWR”) maximums along the transmission path. A VSWR maximum forms at the insertion point due to the dramatic change in impedance between air and tissue, significantly increasing the specific absorption rate (“SAR”) when compared with VSWR minimums. FIG. 2 illustrates the SAR profile of the antenna assembly 12 being inserted in the tissue “T” having a VSWR maximum at the insertion point. This results in the increased radiation of microwave energy at the insertion point as illustrated by the ablation volume “V.”
The present disclosure provides for a system and method of shifting the VSWR to effectively match the impedance of the tissue “T” on the surface thereof. This involves shifting the location of the VSWR maximum nearest the tissue surface into a material placed in proximity thereof. More specifically, the present disclosure provides for a dielectric spacer 90 (FIG. 4) formed from a material that matches the impedance of the tissue “T” allowing for the shifting of the VSWR and thereby spreading out the SAR profile as shown in FIG. 3. More specifically, the SAR is minimized at the surface of the tissue “T” due to the shift in VSWR maximum into the spacer 90. In addition, the VSWR minimum is shifted to the interface between the spacer 90 and the tissue “T,” thereby minimizing the effects of microwave energy at the surface.
FIG. 4 illustrates the dielectric spacer 90 having a substantially toroidal shape. The spacer 90 may be formed from a solid dielectric material having a dielectric permittivity from about 2 ∈r to about 80 ∈f. The disclosed dielectric permittivity values provide one illustrative embodiment and are dependant on the dimensions of the material (e.g., dielectric spacer 90) as well as the frequency of the energy supplied thereto and its thickness. The lower end of dielectric materials may include plastics, polymers (e.g., PTFE), and combination thereof. Upper end of dielectric material may include ceramics. In one embodiment, materials of various dielectric properties may be mixed (e.g., ceramic particles embedded in polymer gels). In another embodiment, the spacer 90 may include a rigid housing 92. The housing 92 has a predetermined thickness “d” that is selected based on the frequency of the microwave energy being supplied by the antenna assemblies 12 as well as the dielectric permittivity of the dielectric material of the spacer 90. The distance “d” is selected to shift the VSWR by the predetermined amount, such that the minimum VSWR is at the surface of the tissue “T.”
The housing 92 may be filled with any suitable dielectric liquid or deformable material such as water, saline, dielectric gels, powders, etc. and mixtures thereof. If a dielectric liquid is used, the dielectric may be the coolant fluid 37. More specifically, the spacer 90 may be coupled to the cooling system 13 via supply lines 97 and 99, which may be directly coupled to the pump or may be integrated with the supply lines 86 and 88 of the antenna assembly 12.
In one embodiment, the spacer 90 may include one or more skin temperature monitoring devices 93, such as thermal probes, thermocouples, thermistors, optical fibers and the like, to monitor skin surface temperature. The temperature monitoring devices 93 are coupled to the cooling system 13 and provide the temperature measurements or indicators thereto. The cooling system 13 then controls the flow and the temperature (e.g., cooling) of the coolant fluid 37 based on the temperature measured at the surface of the tissue “T.” In other words, the cooling system 13 increases the flow of the coolant fluid 37 and/or decreases the temperature of the coolant fluid 37 when the temperature of the tissue “T” increases and vice versa.
The spacer 90 also includes an aperture 91 defined therein for insertion of the antenna assembly 12 therethrough and into the tissue “T.” The aperture 91 may be sized to be in frictional contact with the antenna assembly 12, thereby preventing movement of the antenna assembly 12 while allowing for relatively easier insertion therethrough.
The spacer 90 may also include one or more fastening elements 98 disposed on a skin-contacting bottom surface 94. The elements 98 may be hooks, barbs and other tissue-penetrating elements suitable for retaining the spacer 90. The spacer 90 may also include an adhesive layer 95 disposed on the bottom surface 94 thereof. In one embodiment, a protective film may be disposed over the adhesive layer 95 to protect the adhesive prior to use.
FIG. 5 shows another embodiment of a dielectric spacer 100 which is shaped as a bolus having a flexible expandable housing 102. The housing 102 includes an aperture 101 defined therein for insertion of the antenna assembly 12 therethrough and into the tissue “T.” The aperture 101 may be sized to be in frictional contact with the antenna assembly 12 thereby preventing movement of the antenna assembly 12 while allowing for relatively easier insertion. The housing 102 may be filled with any suitable dielectric liquid or deformable material such as water, saline, dielectric gels, and mixtures thereof. If a dielectric liquid is utilized, the housing 102 may be coupled to the coolant system 13 to provide for circulation of the coolant fluid 37 and may also include one or more temperature monitoring devices (not explicitly shown) to provide for temperature-based cooling thereof as described above with respect to the spacer 90.
In one embodiment, the spacer 100 may include one or more skin temperature monitoring devices 103 disposed internally or externally, such as thermal probes, thermocouples, thermistors, optical fibers and the like, to monitor skin surface temperature. The temperature monitoring devices 103 are coupled to the cooling system 13 and provide the temperature measurements or indicators thereto. The cooling system 13 then controls the flow and the temperature (e.g., cooling) of the coolant fluid 37 based on the temperature measured at the surface of the tissue “T.” In other words, the cooling system 13 increases the flow of the coolant fluid 37 and/or decreases the temperature of the coolant fluid 37 when the temperature of the tissue “T” increases and vice versa.
The flexible expandable structure of the housing 102 allows the spacer 100 to conform to the tissue. The conforming nature of the spacer 100 allows for the inflation of the spacer 100 to desired dimensions, namely, to a predetermined thickness “d” that is selected based on the frequency of the microwave energy being supplied by the antenna assemblies 12. The distance “d” is selected to shift the VSWR by the predetermined amount, such that the minimum VSWR is at the surface of the tissue “T.” In addition, the conforming nature of the housing 102 allows the aperture 101 to be shifted within the spacer 100 to provide for various angles of insertion of the antenna assembly 12 therethrough.
In another embodiment, the spacer 100 may be used with multiple probes, which obviates the need for the aperture 101. The spacer 100 may be placed in proximity of (e.g., between) a plurality of antenna assemblies 12 as shown in FIG. 6. Ablations involving multiple probes, namely, simultaneous application of microwave energy through a plurality of antenna assemblies 12 provide additional risk of VSWR occurrence. In other words, a VSWR maximum occurs at the tissue-air boundary around and between the antenna assemblies 12, which has the potential to cause skin burns in high-power and/or long-duration microwave applications. Ablations using a plurality of antenna assemblies 12 are particularly susceptible to causing high power absorption rates near the surface due to the potential for so-called “two-wire” line energy propagation from the radiating sections 18. Thus, placement of the spacer 100 between the plurality of antenna assemblies 12 shifts the VSWR maximum away from the surface of the tissue “T” as shown in FIG. 3 and described above with respect thereto.
FIG. 7 shows another embodiment of a dielectric spacer 110 having a substantially toroidal shape. The dielectric spacer 110 may also have a granular (e.g., triangular) shape as shown in FIG. 8. The spacer 110 may be formed from a solid dielectric material having a dielectric permittivity from about 2 ∈r to about 80 ∈r. In another embodiment, the spacer 110 may include a rigid housing 112. The housing 112 has a predetermined thickness “d” that is selected based on the frequency of the microwave energy being supplied by the antenna assemblies 12. The distance “d” is selected to shift the VSWR by the predetermined amount, such that the minimum VSWR is at the surface of the tissue “T.”
The housing 112 may be filled with any suitable dielectric liquid or deformable material such as water, saline, dielectric gels, and mixtures thereof. If a dielectric liquid is utilized, the housing 112 may be coupled to the coolant system 13 to provide for circulation of the coolant fluid 37 and may also include one or more temperature monitoring devices to provide for temperature-based cooling thereof as described above with respect to the spacer 90.
The spacer 110 includes two or more apertures 111 defined therethrough for insertion of the antenna assemblies 12 and into the tissue “T.” In one embodiment, any number of apertures 111 may be disposed within the spacer 110 to accommodate a desired number of the antenna assemblies 12. The apertures 111 may be sized to be in frictional contact with the antenna assemblies 12 thereby preventing movement of the antenna assemblies 12 while allowing for relatively easier insertion.
The spacer 110 may also include one or more fastening elements 118 disposed on a skin-contacting bottom surface 114. The elements 118 may be hooks, barbs and other tissue-penetrating elements suitable for retaining the spacer 110. The spacer 110 may also include an adhesive layer 115 disposed on the bottom surface 114 thereof. In one embodiment, a protective film may be disposed over the adhesive layer 115 to protect the adhesive prior to use.
The spacer 110 also includes a centrally disposed chamber 116 having a substantially cylindrical shape and a removable dielectric insert 117 as shown in FIG. 9. The apertures 111 are disposed radially around the chamber 116. The dielectric insert 117 also has a substantially cylindrical shape suitable for insertion into the chamber 116 and may be sized to be in frictional contact with the chamber 116. In another embodiment, the chamber 116 and the dielectric insert 117 may be of any suitable symmetrical shape configured to shift the VSWR.
The dielectric insert 117 may be formed from a solid dielectric material having a dielectric permittivity from about 2 ∈r to about 80 ∈r. The removable insert 117 configuration allows for use of various inserts 117 to provide for a suitable impedance match with the tissue “T.” The insert 117 may be specifically designed for use with specific tissue types (e.g., liver, lung, kidney, bone, etc.) as well as the operational frequency of the generator 14.
FIG. 10 shows another embodiment of a removable dielectric insert 118 having two or more stackable subassemblies 119 and 120. The first subassembly 119 is formed from a dielectric material having a first dielectric permittivity from about 2 ∈r to about 80 ∈r. The second subassembly 120 is formed from a dielectric material having a second dielectric permittivity from about 2 ∈r to about 80 ∈r. The first and second subassembly 119 and 120 may frictionally fit together (e.g., female and male connectors) to form the removable dielectric insert 118. The insert 118 provides additional flexibility in selecting specific material to find the ideal impedance match with the tissue “T” to shift the VSWR.
FIG. 11 shows another embodiment of a dielectric spacer 140 having a substantially disk-like shape. The spacer 140 has a multi-layered structure and includes a gel layer 142 disposed between a top substrate 144 and a bottom substrate 146 (e.g., the top substrate 144 disposed on a top surface of the gel layer 142 and the bottom substrate 146 disposed on a bottom surface of the gel layer 142). The gel layer 142 may be formed from a dielectric, elastic, shape-memory gel, such as hydrogels or adhesives or other polymer-based materials having a dielectric permittivity from about 2 ∈r to about 30 ∈r. The dielectric properties of the gel layer 142 shift the VSWR thereby avoiding heat damage to the surface of the tissue “T” as shown in FIG. 3.
The substrates 144 and 146 may be formed from any type of dielectric polymer-based material, such as polyurethane. The substrates 144 and 146 may be formed as a film or a foam suitable for penetration by the antennas assemblies 12. In one embodiment, the substrates 144 and 146 may be formed from thermal paper for indicating changes in the temperature of the tissue “T.” The spacer 140 may also include an adhesive layer 145 disposed on a skin-contact bottom surface 147 of the bottom substrate 146. In one embodiment, a protective film may be disposed over the adhesive layer 145 to protect the adhesive prior to use.
In one embodiment, the substrates 144 and 146 and the gel layer 142 may have one or more openings (not explicitly shown) defined therein to facilitate insertion of the antenna assemblies 12. In another embodiment, the substrates 144 and 146 and the gel layer 142 may be contiguous such that the antenna assemblies 12 perforate the multiple layers during insertion. The gel and/or adhesives of the gel layer 142 maintains the antenna assemblies 12 at the desired depth thereby preventing displacement thereof during ablation.
FIGS. 12A-12B show a dielectric spacer 220 for shifting the VSWR of an antenna assembly 222 within the tissue “T” (FIG. 12A). The dielectric spacer 220 may be formed from a dielectric, elastic, shape-memory gel, such as hydrogels or adhesives or other polymer-based materials having a dielectric permittivity from about 2 ∈r to about 80 ∈r. In one embodiment, the dielectric spacer 220 may be formed from various particles (e.g., polymer, ceramic, etc.) mixed with the hydrogels or adhesives. The dielectric spacer 220 may be utilized as a formed (e.g., gel layer 142) or unformed gel layer (as shown) for insertion of the antenna assembly 222 therethrough.
In one embodiment, the dielectric spacer 220 may be formed from an adhesive amorphous putty that may be molded under pressure but is still capable of retaining its shape. In other words, the putty may be shaped from a first configuration into a subsequent configuration for securing the antenna assembly 222 therein. In one embodiment, the amorphous putty may be a viscoelastic polymer composition having a siloxane polymer, a crystalline material and one or more thixotropic agents to reduce liquid properties thereof and enable the amorphous putty to hold its shape.
During use, the dielectric spacer 220 is placed onto the tissue “T” and the antenna assembly 222 is inserted therethrough perforating the dielectric spacer 200. The viscoelastic properties of the spacer 220 allow the antenna assembly 222 to easily penetrate therethrough and into the tissue “T” as shown in FIG. 12B. Since the putty of the spacer 220 is adhesive, the putty secures the spacer 220 to the tissue “T” and maintains the position of the antenna assembly 222 therein. The above-discussed embodiments of dielectric spacers may also be utilized with a spreadable dielectric gel layer (e.g., ultrasound gel, petroleum gel, etc.) to provide for additional VSWR shifting.
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 dielectric spacer comprising:
a housing configured to be disposed about a microwave needle, the microwave needle at least partially insertable in tissue, the housing having a predetermined thickness, an upper surface, a skin-contacting bottom surface, and a first predetermined dielectric permittivity, the housing defining a first space therein, the first space including a dielectric material having a second predetermined dielectric permittivity, the housing including at least one second space separated from the first space by a barrier, the at least one second space defining an aperture through the upper surface of the housing and the skin-contacting bottom surface, the at least one aperture shaped to engage an outer surface of the at least one microwave needle,
wherein the thickness of the housing, the first dielectric permittivity of the housing, and the second dielectric permittivity of the dielectric material are configured to reduce an amplitude of a standing wave proximate the tissue surface when the microwave needle is at least partially inserted into tissue.

2. A dielectric spacer according to claim 1, wherein the at least one second space is shaped to frictionally engage an outer surface of the at least one microwave needle.

3. A dielectric spacer according to claim 1, wherein the skin-contacting bottom surface includes at least one fastening element adapted for penetrating tissue and securing the dielectric spacer to the tissue.

4. A dielectric spacer according to claim 1, wherein the dielectric material is a coolant fluid selected from the group consisting of water and saline and the housing is coupled to a cooling system configured to circulate the coolant fluid through the housing.

5. A dielectric spacer according to claim 4, further comprising at least one temperature monitoring device configured to measure temperature of the tissue.

6. A dielectric spacer according to claim 5, wherein the cooling system adjusts at least one of flow rate and temperature of the coolant fluid as a function of the measured temperature by the at least one temperature monitoring device.

7. A dielectric spacer according to claim 1, further comprising a chamber defined through the housing, the chamber creating an opening in the housing that is configured to receive a dielectric insert.

8. A dielectric spacer according to claim 7, wherein the dielectric insert includes a first subassembly formed from a dielectric material having a first dielectric permittivity and a second subassembly formed from a dielectric material having a second dielectric permittivity.

9. A dielectric spacer according to claim 1, wherein the housing further includes an adhesive layer disposed on the skin-contacting bottom surface thereof.