The present invention relates to radiofrequency ablation using a magnetic resonance imaging scanner, and, more particularly to a system and method for performing radiofrequency ablation of tissue using minimal electrical circuitry and using a magnetic resonance scanner radiofrequency field as an energy source.
A variety of thermal tissue ablation techniques, including radiofrequency, microwave, laser and focused ultrasound, have been described which cause cell death by coagulation necrosis and/or apoptosis. The techniques involve heating the tissue above 60° C., leading to protein denaturation and membrane breakdown, and resulting in irreversible thermal damage. Among these techniques, percutaneous radiofrequency ablation (RFA), introduced almost two decades ago for the treatment of osteoid osteomas and later for primary and metastatic liver tumors, gained attention because it is effective, safe, minimally invasive, low in cost and far less traumatic to the patient compared to surgery, chemotherapy or radiation therapy. Its application has been expanded to many other cancers.
An imaging modality, e.g., ultrasound (US), contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI), is required to guide the placement of the RFA needle (RF applicator); US and CT are the most commonly used modalities in RFA procedures. US guidance is inexpensive and rapid because of its inherent real-time capability, but it has poor image quality. Additionally, gas bubbles sometimes produced by tissue vaporization during heating limit the utility of US to monitor the treatment. Multiple sessions are required for RFA treatment under US guidance. CT is capable of multi-planar imaging, but its poor soft tissue contrast requires the administration of an exogenous contrast agent to provide clear delineation of tumor tissue and may not permit visualization of induced coagulation. Ionizing radiation exposure of both the patient and the physician further detracts from the benefits of x-ray guidance. MRI exhibits high soft tissue contrast, and is capable of imaging tissue temperature and other thermal effects. There are fast MR imaging methods allowing near real-time monitoring of the treatment. These benefits of MRI guidance are offset by the requirement for RFA equipment which is compatible with the strong static, gradient and RF magnetic fields of the scanner, and which does not introduce noise or distortion into the images, as well as the expense of extended periods of MR scanner usage for treatment. However, with the increasing popularity of interventional MR systems, MR-guided RFA has the potential to grow dramatically in use.
There have been few reports of near real-time RFA monitoring using MR thermometry because the RFA generator can create electrical interference with MR image acquisition. The generator must be placed at a safe distance from the scanner and connected to an MR-compatible RF applicator using MR-compatible cable. Alternating between MR imaging and application of heat to prevent image artifacts would defeat the usefulness of MR thermometry because heat would be carried away by tissue perfusion and the tumor temperature would drop during the transition between imaging and heating.
Patents relating to use of MRI-guided ablation with external sources of RF energy include, for example, U.S. Pat. No. 6,701,176 to Halperin et al.; U.S. Pat. No. 6,904,307 to Karmarkar et al.; and U.S. Pat. No. 7,155,271 to Halperin et al.
A combined imaging (MRI) and heating (with RF energy) device is disclosed by Kandarpa et al. (U.S. Pat. No. 5,323,778). However, the heating device disclosed therein grounds the tissue eddy currents which are produced by the alteration of the magnetic field resulting from activation of the MRI radio frequency source. Thus the probe must be grounded, for example to the hardware of the scanner. The coupling to the scanner complicates the hardware of the device, increases the risk to the scanned subject and greatly complicates the regulatory process as it must be done as an integral component of the scanner. Additionally, the device disclosed therein requires the use of a tuned coil at its tip to serve as a receiver RF coil connected to the MRI scanner to enable the determination of its position within the patient.
Thus, there is a need for a device which does not require that the device act as a receiver RF coil and which does not use an RF coil at its tip, which does not require a separate ground, and wherein heating may be controlled mechanically in addition to electronically.
The present invention discloses a wireless device that harvests energy from the RF transmission of the scanner and has no conductive connection to another system.
There is provided, in accordance with embodiments of the present invention, a wireless heat ablation device for use inside a bore of a magnetic resonance imaging scanner. The device includes an antenna configured to wirelessly receive RF energy from the magnetic resonance imaging scanner, and a probe having an electrically conductive tip, electronically connected to the antenna, configured to receive the RF energy, and further configured to be positioned within tissue and to provide heat to the tissue by the RF energy.
In further features of the present invention, the device may also include a control unit in electrical communication with the antenna, configured for receiving the RF energy from the antenna, for coupling the received RF energy, and for sending the coupled RF energy to the probe. In some embodiments, the control unit may include an impedance matching device. In some embodiments, the control unit may include a tuning circuit. The tuning circuit may include a variable capacitor and a variable inductor, and may be configured to vary a length of the antenna. In some embodiments, the antenna has a loop circuit. The dimensions of the loop circuit may be, for example, 10-50 cm in length and width. In other embodiments, the antenna may be made of a wire. The length of the wire may be, for example, 20-80% of a wavelength of the RF signal, and the wire may in some embodiments be made of rods and joints such that the wire may be folded or expanded. In some embodiments, the electrically conductive tip is an un-insulated distal portion of a length of an insulated electrically conductive needle, hollow tube, or catheter.
There is provided, in accordance with additional embodiments of the present invention, a method of heat ablation for use inside the bore of a magnetic resonance imaging scanner. The method includes positioning a wireless heat ablation device inside the bore of the magnetic resonance imaging scanner, the magnetic resonance imaging scanner providing RF transmission at a frequency, tuning the wireless heat ablation device to approximately the frequency of the RF transmission of the scanner, receiving RF energy in the wireless heat ablation device based on the RF transmission, providing heat to a tip of the wireless heat ablation device based on the received energy, determining a treatment location for the heat ablation device by imaging a treatment area using the magnetic resonance imaging scanner, and heating the treatment location using the heated tip of the wireless heat ablation device.
In accordance with further features of the present invention, the heat may be controlled by changing the tuning of the wireless heat ablation device, by changing the average power of radiofrequency transmission of the magnetic resonance imaging scanner, or by some combination thereof.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which:
It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function.
In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be understood by those of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components and structures may not have been described in detail so as not to obscure the present invention.
Before explaining at least one embodiment of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.
MRI scanners are equipped with RF generators capable of many kilowatts of peak RF power output, and this RF power can be precisely controlled by the pulse sequence. Most of the RF power applied to the body coil of the scanner is not dissipated in the patient, but rather in the coil itself. To prevent excessive general tissue heating, specific absorption rate (SAR) monitoring is incorporated into every clinical MRI scanner. However, the overall spatial distribution of RF power dissipation in the subject may be altered by conductive structures placed within the RF coil so as to create local “hot spots” in tissue. For example, the potential of RF burns from improperly routed cables, metallic jewelry, implanted devices, EKG leads, etc., is well known. By harnessing this effect to intentionally create zones of tissue heating, we can achieve the goals of RFA by means of the scanner and passive conductive devices alone, while gaining all the benefits of intraprocedural MRI to guide and monitor the treatment.
The proposed invention for MRI-mediated radiofrequency ablation uses Faraday induction to couple RF energy from the body coil of the scanner to an RF energy capture device, which then conducts the RF energy to the treatment zone. This device can be as simple and inexpensive as a wire appropriately routed on the patient table, and terminating in a needle inserted into the tumor. The effectiveness of the device depends on its geometry and its electrical network properties, as well as the Larmor frequency and scanner coil geometry.
In the present invention a novel radiofrequency (RF) ablation device for use in magnetic resonance imaging scanners is introduced which does not require an external RF power generator or connections to any external system. This ablation device has minimal circuitry and does not require a grounding pad to complete the electrical path. This eliminates the possibility of accidental skin burns due to poor contact of the grounding pad. In effect, the capacitance of the patient's body with respect to the surroundings forms the ground path.
Reference is now made to
In the present invention, patient 100 is positionable inside bore 15 of MRI scanner 12, and a radiofrequency (RF) ablation device 16 is provided within bore 15 of MRI scanner 12, for accessing a lesion within patient 100. RF ablation device 16 is configured to receive RF energy from RF coil 108 via an antenna or other RF pickup device, and is further configured to use the RF energy to heat the lesion.
Reference is now made to
Reference is now made to
Reference is now made to
In embodiments of the present invention, the law of electromagnetic induction is employed by placing a linear or loop electrical conductor (i.e., antenna 22) in the rotating RF magnetic field of RF coil 108. By doing so, an electromotive force (EMF) is induced in antenna 22 by Faraday's law of induction, in precise analogy to an electric power generator in which an EMF is induced in a wire loop rotating in a static magnetic field. Although transformer induction and motional induction are discussed in the next two sections as distinct phenomena leading to two separate embodiments of the ablation devices, they are two complementary aspects of the single law of electromagnetic induction.
Faraday's law of transformer induction states that a changing magnetic flux through a fixed conductive RF pickup loop induces an EMF around the loop. In one embodiment shown in
I
0
=ωAB/((
X
L
−X
C)+j(R+Zin)) (1)
I
L
≈I
0(1−ΓL) (2)
where ω is the angular frequency of MRI scanner 12, B is the magnitude of the component of the magnetic flux density parallel to the loop axis, XL is the inductive reactance of the loop, R is the resistance, XC is the capacitive reactance of a capacitor used to tune the loop, Zin is the input impedance of the transmission line and ΓL is the reflection coefficient due to the impedance mismatch between the RF applicator and the tissue. The approximation symbol in Equation 2 takes account of the fact that the transmission line may be lossy, and that these usually small losses are disregarded in this analysis. Including the losses complicates the analysis but does not affect the invention. To maximize the current flow, and therefore the heating, in the tissue, a variable capacitor may be used to tune the loop to the scanner operating frequency so that the loop reactance is minimized. In addition, a better impedance match between the tissue and the transmission line would increase the heating efficiency further. However, to keep the mechanical structure of the RF applicator probe simple, no impedance matching is included at the tip in this embodiment of the invention, although it could be included and would be within the scope of the invention. It should be clear that the pickup loop of the present invention is intended to couple to the body RF coil of the scanner, rather than to the nuclear spins.
Reference is now made to
As shown in
Faraday's law of motional induction states that a moving wire within a static magnetic flux generates a motional EMF. The reverse is also true when rotating magnetic flux from the magnetic coil 106 cuts across an antenna 22 configured as a stationary wire 36 as illustrated in
f=rωB,a<z<b (3)
where magnetic flux cuts the wire only from point a to point b along the line. With this model, the current and the voltage on the line satisfy the inhomogeneous Helmholtz equation which can be solved by the Green's function method, resulting in
where g(z,z′) is the Green's function that satisfies the inhomogeneous Helmholtz equation. With the boundary conditions
I(0)=0 (6)
V(l)/I(l)=ZL (7)
the Green's function solution is:
where γ is the complex propagation constant. Using this solution, the current at the tip of the line can be approximated as
where Z is the characteristic impedance of the line.
It should be noted that the pickup portion of wire 36 is not required to be straight, and that curved and other wire configurations are all within the scope of the invention. For a wire 36 with arbitrary shape, the induced EMF at any point along the wire depends on the appropriate vector components of the RF field with respect to the wire direction at that point.
Reference is now made to
As shown in
Reference is now made to
Reference is now made to
In order to better understand the safety and performance issues related to the proposed invention, we simulated the operation of an MR-driven RFA device in the body RF coil of a 1.5 T MRI scanner. The simulation was carried out using the Remcom, Inc. (State College, Pa., USA) XFDTD 7.0 (XF7) 3D electromagnetic simulation software package, which is based on the FDTD (finite difference time domain) method. The modeled body coil had dimensions of 60 cm long and 60 cm diameter, and was a 16 rung highpass birdcage coil. It was first tuned to 1.5 T so that the field within the center of the body coil was homogenous. Then, its performance with a rectangular solid (box phantom) 7 cm tall, 31 cm long, 23 cm wide, with the electrical properties of liver tissue (dielectric constant 70.62, conductivity 0.55 S/m) placed at the isocenter was recorded as a reference. Finally, the RFA device, modeled as a simple wire which captures RF energy from the body coil by electromagnetic induction, was placed in the model geometry with its tip embedded in the box phantom corresponding to our experiments. The RFA device was modeled as PEC (perfect electrical conductor) material. The simulation grid (spatial resolution) was chosen to be 1 cm.
The unloaded simulated birdcage coil was tuned to 64.178 MHz using 40 pF capacitors on the end rings (S11=−23 dB). The calculated |B1+| field contour map was fairly homogeneous. By comparing the |B1+| fields within the simulated phantom without and with the RFA device, it was found that the body coil was highly coupled to the RFA device due to magnetic flux density cutting through the device. This agrees with experimental results (below) which show in the images a significant brightening artifact at the location of the device (most visibly at its tip) which aids in its visualization. In contrast to other inventions, the present invention includes this extremely useful characteristic of providing position information when imaging is performed, while not being physically connected to the scanner, and without the need for reception of a separate signal (e.g., from a surface RF coil or catheter RF coil). The reflection coefficient S11 of the body coil changed from −16.2 dB with the simulated phantom only to −3.6 dB with the RFA device also present. Thus it is expected that the overall field intensity averaged over the entire body RF coil volume would be lower when the device is present, possibly affecting the operation of the scanner or causing over-estimation of specific absorption rate (SAR, a measure of the RF heating effect on tissue in the MRI scanner). However, in experiments the scanner always performed normally and scanning was never interrupted by excessive reflected power. The calculated ratio of the average simulated SAR (based on a 1 g average) of the phantom with and without the RFA device was 0.21, indicating that the overall field was lower when the RFA device was present. However, the ratio of the maximum local SAR of the box phantom in the vicinity of the wire tip was 2.65. The maximum local SAR occurs at the tip of the RFA device, demonstrating that the device has a significant energy localization effect exactly as desired.
Experiments were carried out in a Siemens (Erlangen, Germany) Avanto 1.5 T scanner with a Larmor frequency of 63.64 MHz. The scanner contains a 57 cm long body coil with diameter 61 cm. For the transformer induction experiments, a pickup loop circuit was built using 5 mm adhesive copper tape on ABS sheet and high voltage nonmagnetic ceramic multilayer capacitors (American Technical Ceramics, Huntington Station, N.Y., USA). The circuit was tuned to resonance at the scanner operating frequency by checking the transmission between two magnetic pickup loops overlapped so as to have minimum mutual inductance when far from a resonant circuit. A BNC jack was inserted into the loop in series so that a nonmagnetic Teflon dielectric 50 ohm coaxial cable (part number 50HCX-15, Temp-Flex Cable, South Grafton, Mass., USA) could be connected to it. A nonmagnetic high voltage ceramic variable capacitor (part number SGNMNC3708E, Sprague-Goodman Electronics, Westbury, N.Y., USA) in series with the coaxial cable permitted the cable to be adjusted to quarter wavelength. The pickup loop circuit was placed on the patient table of the scanner and positioned near the magnet isocenter.
The end of the coaxial cable was placed into a phantom consisting of a polyethylene tub of normal saline gel made with 1% (by weight) agar to simulate tissue. The gel also contained nickel sulfate to reduce the T1 relaxation time. The input impedance of the coaxial cable when in contact with the gel was 52−j32Ω at 63.64 MHz. For all experiments, the phantom was placed next to the loop on the patient table.
A Neoptix (Quebec, Canada) T1 fiber optic temperature probe was attached 5 mm behind the tip of the cable using heat shrink tube. The probe was connected to the Neoptix Reflex fiber optic thermometer signal conditioner which sent a continuous stream of temperature readings in ASCII format to a laptop computer through a serial port. Since the Neoptix does not provide a time stamp, the time resolution between the temperature points was first measured. A flag was inserted into the captured ASCII stream by sending the “h” character to the signal conditioner (to invoke the help message which was then embedded in the data stream) immediately before and after the heating pulse sequence as a time stamp. The ASCII data was later processed in MATLAB to yield the temperature profile (temperature vs. time data) during the heating scan.
For the motional induction experiments, a 26 gauge Teflon insulated silver plated solid wire (part number 2853/1 WH005, Alpha Wire Company, Elizabeth, N.J., USA) was taped to the patient table of the scanner. A segment of wire continued to the saline agar gel phantom. The fiber optic temperature probe was attached 5 mm behind the wire. The Teflon insulation of the tip of the wire was stripped to expose 5 mm of bare conductor which was then dipped into the saline agar gel phantom.
A high RF duty cycle turbo spin echo (TSE) pulse sequence and a low RF duty cycle gradient echo (GRE) pulse sequence were used for RF excitation. The TSE sequence started with a 90° pulse, which was followed by three 150° pulses spaced by TE=8.43 ms. TR was 643 ms and the total scan duration was 110 s. The GRE used a 1 ms 25° pulse, with TR=337 ms for a total scan duration of 64 seconds.
Additional experiments were conducted with bovine liver sections obtained from the grocery. Similar results were obtained as with the gel phantom, except that readily visible ablation lesions due to irreversible thermal damage were created in the liver tissue. With a bare wire exposure of 5 mm, roughly spherical lesions of diameter 5 mm could be readily created with less than 1 min of heating, and 20 mm of bare wire created cigar-shaped lesions roughly 20 mm long. Because the liver tissue could be coagulated, the thermal profiles often exhibited a maximum temperature well below the maximum 100° C. temperature (the water boiling temperature) achievable with the gel. Cycles of buildup of coagulation (eschar) and breakthrough on the exposed wire would lead to current limiting, then continued heating, followed by more buildup, yielding heating curves with unstable limiting characteristics. To compare the ablation lesions achieved by the MRI procedure with those of conventional RFA, several lesions were produced in a liver specimen with a Valleylab CoolTip RF ablation system that is used in the clinic for tumor treatment. No saline cooling was used. The ablations were conducted by a radiologist who commonly treats tumors with RFA. Lesions of similar size and character to those produced by the MRI procedure were obtained, but typically in somewhat longer times.
The chemical shift of water protons has a well known variation with temperature of about −0.01 ppm/° C., and is the basis for the proton resonance frequency shift (PRFS) method for measuring the tissue temperature. The phase of a GRE image reflects the resonance frequency offset of water protons due to temperature changes. Therefore, brief (3.4 scan duration) single slice phase sensitive GRE images positioned to include the wire tip in the plane of the image were obtained immediately before and after heating pulse sequences. The phase of each image was unwrapped using an adaptation of the Jenkinsen phase unwrapping algorithm [M. Jenkinson, Fast, automated, n-dimensional phase-unwrapping algorithm. Magn Reson Med 49: 193-197 (2003)]. In our adaptation of the Jenkinsen method, regions of the image above a certain signal intensity threshold are segmented depending on the range of pixel phase values, segmenting the image pixels into spatial clusters. Spatially adjacent clusters are compared and conditionally combined depending on their relative phase, and whether wrapping around 180° is required. The process is repeated until only a single cluster remains. The phase difference in each pixel between the before-heating and after-heating images is scaled to yield the temperature change.
Reference is now made to
The body coil is designed to generate a uniform magnetic flux covering a cylindrical volume of length 50 cm along the longitudinal axis (z). Thus, the wire was taped from z=−25 cm to z=+25 cm (where z=0 cm means isocenter) to the magnet bore. Varying the length of the wire from 2.2 m to 1.2 m, the temperature profile was affected by the wavelength effect. Reference is now made to
The TSE pulse sequence imposes high SAR on the patient, and so we investigated using a lower RF duty cycle GRE pulse sequence. To increase the coupling between the scanner and the wire, the wire was made longer by taping to the right side of the bore, extended across the bore and taped to the left side, in both cases from z=−25 cm to z=+25 cm. A variable capacitor was soldered in series with the wire about 1 m away from the immersed wire tip to adjust the effective electrical length of the wire, providing a more convenient and reversible means to tune the transmission line. By optimizing the capacitance, it was found that 6 pF gave the maximum heating effect for this particular configuration of wire.
Reference is now made to
Reference is now made to
In vivo, blood circulation and perfusion is highly effective at removing heat deposited by the RF applicator, and reduces the heating efficiency considerably. In addition, the overall SAR to the patient is limited by U.S. Food and Drug Administration guidelines, requiring the RF applicator to be highly efficient so that relatively low SAR pulse sequences can be used. These considerations will be important when the invention is used clinically, but are not relevant to demonstrating the principles of the invention.
Both equations 1 and 9 show that using higher field scanners (which operate at higher RF frequencies) should increase the efficiency of these RFA devices. Because signal-to-noise ratio and image quality generally increase with field, performing RFA treatment at higher field should lead to shorter treatment times and better real time treatment monitoring. Some experiments were performed at a scanner static magnetic field strength of 3.0 T (RF frequency 123 MHz), demonstrating both the expected higher levels of heating, and the expected shorter wavelength transmission line effects. The use of all scanner magnetic field strengths, and the use of the invention outside of an MRI scanner but employing the above described electromagnetic induction effects to heat a needle tip are all within the scope of the invention.
By dispensing with a separate RF generator and external connecting cables, tuned loops or long wires within the scanner offer alternatives for sources of RF energy to perform ablations. The generation of an EMF to drive RF current in these devices can be described with Faraday's law of induction, based on an analogy between the rotating RF field of the body coil with the rotating coils of an electric power generator. Experiments show that sufficient heat energy can be extracted from the RF field of the scanner using typical clinical pulse sequences to meet the requirements of RF ablation. The pulse sequence RF duty cycle can be used to control the rate of heat production. Because the ablation is carried out in the MRI scanner, real time guidance is possible, and tissue temperature, perfusion, coagulation and other parameters are readily imaged. In particular, the ability to measure tissue temperature during the procedure should result in better outcomes because the temperature of the tumor margins can be directly measured. The elimination of the ground pad and other external wired connections eliminates some of the hazards of conventional RFA.
While certain features of the present invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the present invention.
This application claims priority benefit from U.S. Provisional Patent Application No. 61/343,591, filed Apr. 30, 2010, the contents of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61343591 | Apr 2010 | US |