DEVICE FOR ABLATING ARTERIAL PLAQUE

[0001] This application is a continuation-in-part of U.S. application Ser. No. 14/192,284 filed Feb. 27, 2014, which is incorporated by reference.

[0002] This application relates to ultrasonic imaging catheters for medical use. More particularly, but not exclusively, it relates to intravascular catheters having a high-frequency ultrasound imaging array that is capable of providing high-quality, real-time, forward-looking images. Alternatively or in addition, this application relates to catheters that incorporate “see-through” ablation electrodes in front of an ultrasound imaging array so as to facilitate image-guided therapy inside a body lumen.

[0003] Intravascular ultrasound (IVUS) has been successfully implemented as a visualization tool to assist in the diagnosis and treatment of vascular diseases (see e.g. Intracoronary Ultrasound, by Gary S. Mintz, MD, Taylor & Francis, 1995). However, existing intravascular ultrasound imaging devices designed for use in small lumens (e.g. coronary blood vessels) have either been unable to image in the forward direction or produced images of relatively poor quality.

[0004] Furthermore, even though the addition of therapeutic ablation functionality into an ultrasound imaging catheter has generally been proposed, commercially available IVUS catheters lack any such therapeutic functionality. Catheter diameter limitations necessitate close proximity of multiple lines carrying signals of varying frequencies, which can produce crosstalk, or electromagnetic inference. In the proposed combination of powerful radiofrequency (RF) ablation and more delicate ultrasound imaging lines, the potential crosstalk could corrupt incoming signals and detrimentally affect the efficiency of treatment and detract from the intended therapeutic functionality. Consequently, the construction of a device that has a small enough diameter to fit into a coronary artery, and yet requires 1) coaxial lines for bringing ultrasound array element signals out of the multiplexer; 2) digital lines for communicating with the embedded data processing chip; and 3) RF signal lines for driving the ablating electrodes, all required to function contemporaneously with a minimum of crosstalk, raises some challenging technical issues.

[0005] Accordingly, there is a need for intravascular devices having improved imaging capabilities and there is also a need for intravascular devices which successfully integrate high-quality imaging with the provision of ablation therapy. The present application provides systems and techniques for addressing one or both of those needs.

[0006] The present invention successfully integrates high-quality imaging with the provision of ablation therapy by physically separating the guidewire and RF signal lines from coax lines within the catheter lumen. In one preferred embodiment of a catheter, RF lines are embedded in the lumen wall of the catheter, and a septal wall is used to separate the coax lines from the guidewire lumen, minimizing crosstalk.

[0007] In a first preferred embodiment, a catheter assembly is described for providing image-guided therapy in a patient's vasculature. The distal end of an elongated catheter body, having a tubular lumen wall, is adapted for insertion into and operation within a patient's vasculature while a proximal portion remains outside said patient. An outwardly-facing set of RF electrodes and a distal-facing array of ultrasound imaging transducers are contained within the distal end of the catheter, proximal to one another. The RF electrodes are configured to transmit and receive ultrasound pulses through the ultrasound transducers, providing real-time imaging information of plaque which may be ablated by said electrodes. Additionally, the RF conductive lines connected to the RF electrodes extend longitudinally through the lumen wall of the catheter body, while coaxial conductive lines, operatively connected to the ultrasound imaging transducers, extend longitudinally through the lumen of the catheter body.

[0008] In another preferred embodiment of a catheter assembly, the distal end of an elongated, catheter body contains an outwardly facing set of RF electrodes and a data processing assembly, wherein the RF conductive lines are connected to the RF electrodes extend longitudinally through the lumen wall of the catheter body, while the data lines extend longitudinally through said catheter to said data processing assembly.

[0009] In yet another preferred embodiment of a catheter assembly, the distal end of an elongated, catheter body contains a data processing assembly with data lines extending longitudinally through the lumen wall of the catheter to said data processing assembly.

[0010] Particular catheters are described herein for use in treating obstructions in partially or totally occluded vessels, for example in peripheral or coronary arteries. These catheters combine miniature high-frequency ultrasonic imaging arrays with “see-through” RF electrodes such that the operator may enjoy substantially unobstructed direct visualization of the area undergoing treatment. In a preferred form, both the electrodes and the array are forward-facing, and the catheter may be used to tunnel through arterial obstructions under real-time visualization.

[0011] One preferred embodiment described herein is a unique high-frequency ultrasound imaging multi-dimensional array that can be utilized intravascularly to produce high-quality, real-time, forward-looking images of obstructions in blood vessels. As used herein, a multi-dimensional array is an array that has elements arranged in more than a single dimension, such as a 1.5D, 1.75D or 2D array. Multi-dimensional arrays are capable of providing spatial resolution within a volumetric field of view without needing to be relatively translated (e.g. articulated side-to-side or rotated). Other embodiments described herein may be implemented with a 1D array, which may be rotatable so as to provide a spatial resolution of a volumetric field of view. Still other embodiments include unique methods, systems, devices and apparatuses for generating and detecting ultrasound imaging information to provide real-time guidance during an ablation procedure.

[0012] One method described herein is a method of ablating plaque from an artery section, using a catheter having a longitudinal body and a distal imaging and ablation tip connected to a distal end of the longitudinal body. The tip has an ultrasound imaging array, and a distal, forward-directed face, distal to the ultrasound imaging array, and including a set of RF electrodes arranged circumferentially about the distal face. The catheter further includes a set of RF conductive lines connected to the tip and extending longitudinally through the lumen wall of the catheter, and a set of coaxial conductive lines connected to the ultrasound imaging transducers and extending longitudinally through the lumen of the catheter. Additionally, data lines may extend longitudinally through the catheter to a data processing assembly.

[0013] The catheter is connected to a data processing assembly and an image display. In the method the tip is introduced into the artery section and images the artery section in front, thereby creating imagery of the artery, which is shown on the image display. This imagery is reviewed and in reliance thereon the electrodes are selectively activated to ablate plaque, while not activating any electrode that would damage any bare arterial wall.

[0014] One object of the present invention is to provide unique multi-dimensional ultrasound arrays for high-frequency intravascular ultrasound applications.

[0015] Another object is to provide a unique catheter system that incorporates both high-frequency ultrasound visualization and selective ablation capabilities in a manner that facilitates the visualization and treatment of occluded vessels.

[0016] Another object is to provide a unique catheter system that combines forward-looking ultrasound visualization with forward-facing ablation electrodes that are substantially transparent to the ultrasound.

[0017] Further forms, objects, features, aspects, benefits, advantages, and embodiments, of the present invention shall become apparent from the detailed description and drawings provided herewith.

[0037] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.

[0038] One embodiment of the present invention includes an ultrasonic device structured for percutaneous insertion in the human body. The device includes an array of piezoelectric elements located at a distal end portion and cabling, connected to the array, that extends to a proximal end portion of the device and connects to an ultrasound imaging system. The elements in the array are designed to send and/or receive high-frequency (e.g. about 15 MHz and above) ultrasound for volumetric image generation. In a preferred form, the elements are in the form of a densely packed 2D array, for example with individual elements having length and width dimensions each less than 100 μm (i.e. element density of at least 100 elements per square millimeter), suitable for producing high-quality 3D images of an interrogated volume. In one preferred embodiment, the element dimensions are in the range of about 50 μm×50 μm for an element density of about 400 elements per square millimeter. In another preferred embodiment, the element dimensions are in the range of about 30 μm×30 μm for an element density of about 800 elements per square millimeter. This miniature densely packed array provides high resolution imaging information yet is small enough to be used in a variety of diagnostic and therapeutic applications including, but not limited to, intravascular ultrasound visualization.

[0039] In one contemplated application, the transducer elements are positioned in a catheter so as to provide a forward-facing view of tissue that is adjacent the distal tip. A number of RF ablation electrodes are incorporated on the distal tip, and cabling connected to the electrodes extends through the catheter to a proximal end portion and connects to an RF therapy system. The RF electrodes are configured to be used to ablate tissue when the operator determines, based on the ultrasound imaging information provided in real time by the array, that tissue ablation is necessary or appropriate.

[0040] In a preferred aspect, the transducer array and the electrodes are configured such that the ultrasound imaging occurs, at least partially, through the RF electrodes. The RF electrodes are positioned directly in the path of the ultrasound interrogation but are constructed such that they do not unduly attenuate the ultrasound. Rather, the electrodes comprise electrically conducting layers that are sufficiently thin that they pass a substantial fraction of the ultrasound at the relevant frequency, which is preferably in the range of 20-50 MHz, such as about 35 MHz. Modeling has confirmed that a 1-2 μm thick layer of certain metals, such as gold, titanium, aluminum, magnesium or beryllium for example, would be sufficiently transparent to ultrasound at 35 MHz. It is believed that in practice electrodes comprising up to about 4 μm thickness of these metallic conductors would also be adequately transparent to high-frequency ultrasound such that imaging can occur through the electrodes.

[0041] Certain embodiments described herein may be specifically configured for use in passing vascular occlusions. One such device includes an intravascular catheter having a proximal end, a distal end, and a distal tip. The ablation electrodes are positioned on the distal tip and an ultrasound array is located at the distal end of the catheter proximal to the electrodes. The catheter is configured to be delivered to a site of an occlusion and the array is configured to provide real-time imaging of the occlusion by transmitting and receiving ultrasound through the electrodes. The electrodes are configured to be selectively operated to deliver energy to ablate the occlusion. In use real-time images of the occlusion and the surrounding vascular walls are displayed on a monitor and the operator activates the RF electrodes to ablate plaque while advancing the catheter through the occlusion.

[0042] With reference to FIG. 1, further aspects are described in connection with system 20. System 20 is arranged to provide images internal to body B for medical diagnosis and/or medical treatment. System 20 includes a control station comprising an ultrasound imaging system 40 and an RF therapy system 50, each of which are operatively coupled to probe device 60, as well as appropriate operator input devices (e.g. keyboard and mouse or other pointing device of a standard variety) and operator display device (e.g. CRT, LCD, plasma screen, or OLED monitor).

[0043] Device 60 is configured for placement through opening O and into body B of a human patient or subject, as schematically represented in FIG. 1. Device 60 is preferably configured for insertion into a blood vessel or similar lumen L of the patient by any conventional vascular insertion technique. As illustrated in FIG. 1, device 60 includes a guide wire lumen that extends from a proximal port 42 through the distal tip 70 of the device 60, which is used to insert device 60 over a pre-inserted guidewire (not shown) via a conventional over the wire insertion technique. The guidewire exit port 199 may be spaced proximally from the distal tip, as illustrated in FIG. 10.

[0044] Device 60 may be configured with a shortened guidewire lumen so as to employ a monorail type insertion technique, or device 60 may be configured without any guidewire lumen and instead configured for insertion through the lumen of a pre-inserted guide catheter.

[0045] Referring to the schematic illustration of FIG. 10, distal tip 70 generally includes at least one imaging array 82 capable of imaging vascular tissue and one or more therapy electrodes 172, 176 capable of applying therapy to vascular tissue. The array 82 is contained within tip 70 and is spaced proximally from electrodes 172, 176, which are deposited on the outer surface of tip 70. Both the array 82 and electrodes 172, 176 define operative surfaces that are non-parallel to the longitudinal axis 100 of tip 70, which is to say they are each “forward-facing.” This allows the device to be used to image and treat vascular occlusions or plaque P in front of the tip. Optionally, one or more side-facing electrodes and/or a side-facing array may be included to allow the device 60 to be used to image and/or treat vascular structures to the side.

[0046] The array 82 is preferably configured to interrogate a volumetric image field, which refers to the interrogated volume within which imaging information can be derived. As illustrated, array 82 is a 2D array oriented generally orthogonal to the longitudinal axis 100 of the distal tip 70. In this arrangement, array 82 defines an image field that is generally conically shaped and centered about the longitudinal axis 100, as indicated by solid angle B. The image field of array 82 includes the central area (indicated by C) that is orthogonal to the operative face of the array 82 as well as the peripheral area encompassed within the angle of acceptance A. Other configurations and arrangements for the imaging array are contemplated as described more fully herein.

[0047] The electrodes 172, 176 are positioned in the image field but, as noted above, are constructed such that the ultrasound transmitted by array 82 can pass through them, which may generally be accomplished by limiting the thickness of the metallic conductor to less than 8, 7, 6, 5, 4, 3, or 2 μm. Because the electrodes 172, 176 are effectively transparent to the ultrasound, the electrodes may cover a substantial fraction of the distal portion of tip 70 so as to provide a wide area of potential treatment without detracting from the ability of the array 82 to image the relevant tissue. For example, it is contemplated that electrodes 172, 176 may collectively cover 50%-90% of the cross-sectional area C in front of array 82.

[0048] It is to be understood that the general shape of the field of view B depends on the configuration of the array and how the array is incorporated into the catheter. Various modifications may be employed to alter the size, shape, or orientation of the field of view. For example, array 82 is illustrated with an operative (distal) surface that is planar. The operative surface of array 82 may be outwardly curved or convex, which would have the effect of enlarging the boundaries of the cross-sectional area C and possibly also increasing the angle of acceptance A. Array 82 may alternatively be of concave shape, which would have the effect of narrowing the field of view.

[0049] Alternatively or in addition, the distal portion 182 of catheter tip 70 may be constructed so as to influence the field of view. In one preferred implementation, distal portion is constructed so as to operate as an ultrasound lens. For example, portion 182 may be constructed of a material that transmits ultrasound slower than the surrounding environment (e.g. body tissues) such that the beam is drawn inwardly and focused as the ultrasound passes through the distal tip portion 182. Alternatively portion 182 may be constructed of a material that transmits ultrasound faster than the surround environment so that ultrasound is defocused as it translates through the distal tip. When operating as an ultrasound lens, the radius of curvature of the outer surface of portion 182 would influence the focal length, and the radius of curvature would typically be on the order of the overall diameter of the distal tip. For example, for a 4 F catheter (1.273 mm diameter), the radius of curvature of portion 182 may be 1.5 mm.

[0050] In still further alternatives, the field of view may by altered by articulating the multidimensional array 82 within the distal tip 182. For example, rather than having array 82 stationary inside tip 70, array 82 may be mounted on the end of a micromanipulator such that the orientation of the array 82 relative to the longitudinal axis 100 may be altered. U.S. Pat. No. 7,115,092 describes a micromanipulator that may be adapted for use in articulating a 2D array.

[0051] As an alternative to a multi-dimensional array (e.g. a 1.5D, 1.75 or 2D array), a 1D array may be employed to produce imaging information. FIG. 4 schematically illustrates a 1D array implementation wherein the array is mounted on a shaft and a motor 110 or similar rotation mechanism is configured to rotate the array so as to acquire a volumetric (3D) image. In practice, it may take a longer period of time to acquire a 3D image using a mechanically rotated 1D array than it would for, for example, a stationary 2D array.

[0052] It is also to be understood that device 60 may be sized as appropriate for the intended application. When adapted for use in coronary arteries, at least the distal portion of device 60 would typically have an outer diameter ranging from 0.75 mm to 3 mm. When adapted for use in treating peripheral artery disease, the outer diameter of the distal tip 70 may be in the range of 1 to 5 mm. The overall length of the catheter may typically be about 150 cm.

[0053] Referring to FIGS. 18 and 19, in a preferred embodiment a catheter 210, according to a preferred embodiment, has a lumen wall 222, and a septal wall 221, together defining a relatively large data wire lumen 218, to accommodate many coax cables (not shown in FIGS. 18 and 19) for transmitting analog signals to the array elements and a guidewire lumen 220 for accommodating a guidewire, and separated from large lumen 218 by a septal wall. Additional wires 224 (typically 7-8) are accommodated for electronic control of IC chips at the transducer tip. These wires need not be coaxial. Additionally, four RF conductive lines 226 are embedded in the lumen wall 222. The equations governing the requirements for these wires are complex and are dependent on the conductivity of the human body being treated, from the treatment location to a grounding pad. This depends on the person being treated, and the location. Also, the type of treatment contributes to the equations' complexity. It is an interesting characteristic of the treatment that the heating of blood typically causes an air bubble or bubbles to form immediately in front of the electrodes 72, 74, causing the conductivity to the grounding pad to drop dramatically. In one preferred embodiment, the wires used have a smaller than otherwise useable diameter, and the RF current or waveform through them is limited to a maximum value, to prevent the wires from overheating. This value is great enough, however, to cause the required heating, which results in reduced conductivity through the patient's body, at which point the current is limited by this greater resistance level. In one embodiment the RF conductive lines are round in cross-section, made of copper and have a diameter chosen from the range of 50 μm to 300 μm. In another embodiment the RF conductive lines 226 are non-round in cross-section and have a cross-sectional area chosen from a range of between 7,850 to 282,750 μm². In another embodiment, lines 226 are chosen from a range of between 2,500 and 100,000 μm² cross-sectional area. Conductive lines may be flattened and oriented so as to fit more easily into lumen wall 222. Any of a range of copper alloys, gold or silver may be used for conductive lines 226. Because they are embedded directly in the lumen wall 222, there is no need for lines 226 to be otherwise insulated. Nevertheless, in some embodiments, for ease of manufacturing and other potential benefits lines 226 are insulated with a polymer coating (not shown), prior to being embedded in lumen wall 222. This coating can be made of acrylonitrile butadiene styrene (ABS), polystyrene, polyethylene terephthalate, polyethylene, polyurethane, polyamide, poly tetrafluoroethylene, polyvinyl chloride or other similar material. Lumen wall 222 may be made of silicones, polyester-based polyurethanes, polyether thermoplastic polyurethanes, plasticized PVC (polyvinyl chloride), polyamides and PTFE, among other materials.

[0054] Lubricious and biocompatible coatings (such as Parylene for example) may be additionally applied to the outside of catheter tubing to enhance catheter surface properties. Examples of firms providing extrusion services for metal reinforcing in a polymeric matrix include multi-lumen catheters are New England Catheter of Lisbon, N.H., Freudenberg Medical of Carpinteria, Calif., Mininvasive Components of Trenton, Ga.

[0055] Embedding conductive lines 226 in the lumen wall 222 serves to physically separate the lines 226 from the coax lines, which is important to avoid electromagnetic radiation from the relatively large electrode driving RF signal travelling through conductive lines 226. Even when ultrasound imaging is interleaved with RF ablation, ringing produced in line 226 has the potential for disrupting the relatively delicate signals travelling through the coaxial lines. By providing a pathway for the RF drive signal that is at a definite position and is removed, so far as is possible, from the coaxial lines, the interference is minimized. Further, lines 226 generate heat when the electrode RF signal is transmitted. Placing lines 226 at a location where this heat can be expressed away from catheter assembly 10, into relatively thermally conductive tissue or fluid, helps to avoid overheating of the lumen interior. Also, a significant level of electrical insulation to the ultrasound signal lines is provided by the shielding of the outside conductor of the coaxial cables.

[0056] The size of the coronary arteries/small peripheral arteries require a catheter in the range of 4 French, that is, one having an outer diameter 222 equal to about 1.3 mm, as well as the state of the art in coaxial cables, yield a preferred embodiment having 32 to 64 coax cables transmitting and receiving signals from the ultrasound elements. The current state of the art in micro-coaxial cables is represented by cables having center conductor with diameter 52 AWG, equivalent to 0.0008″ diameter or 23 μm. Taking into account the dielectric, outside conductor and jacket, the outside diameter of the 52 AWG coaxial is 100 μm per standard coaxial cable design. A common guidewire diameter is 0.014″ or 356 μm requiring a lumen of 0.017″ or 432 μm. Note that the discussion in this section would apply to other standard guidewire sizes (such as 0.010″ or 0.018″).

[0057] Since the imaging array of the current array is fully populated (no holes or sections missing for the purpose of accommodating a guidewire) it is required that the catheter lumen for the guidewire is eccentric with regard to the catheter (see FIGS. 18 and 19) in order for the catheter 210 to slide effectively over the guidewire.

[0058] In the geometry of FIG. 19 the entire cross-section shown would fit in 4.5 French diameter. The minimum thickness of wall 222 is 50 μm, the guidewire lumen diameter is 432 μm, and the coaxial bundle lumen is 900 μm. Given that the 52 AWG coaxial cables have diameter 100 μm, one can estimate the number of coaxial cables for the case of the preferred embodiment. The cross-sectional area of the 900 μm lumen is 0.636 mm². The area of the 52 AWG cable is 0.00785 mm². In a hexagonal close packed arrangement of the coaxials 90% of the area can be used, or (π√3)/6. The useful area of the coaxial cable is then equal to 0.5724 mm² and the number n of coaxials equals n=0.5724/0.00785 or 72. In this design we are thus able to accommodate the desired 64 or 32 coaxials as was the objective. For smaller or bigger catheter cross-sectional diameters the number of coaxial cables or the coaxial cable gauge can be varied to accommodate the dimensions.

[0059] To facilitate incorporation of the array 82 with its associated electrical components inside tip 70, a flex circuit interconnection technique may be employed. Suitable flex circuits and useful techniques for mounting piezoelectric arrays on flex circuits are generally known and described in, for example, U.S. Pat. No. 7,226,417 to Eberle and US 2004/0254471 to Hadjicostis et al.

[0060] Referring now to FIG. 2, an array assembly 81 according to one embodiment includes the array of piezoelectric elements 82, an acoustic backing layer 80, and one or more acoustic matching layers 84. The array assembly 81 is mounted to a flexible circuit substrate 94, which comprises a flexible substrate material (e.g. a polyimide film) and metallic interconnection circuitry (not shown). The interconnection circuitry comprises conductor lines deposited upon the surface of the flex circuit 94 which couples the array 82 to one or more integrated circuit chips 98, 99 each of which incorporates appropriate multiplexers, pre-amplifiers and other electrical integrated circuits such as filters, signal conditioners et al. Ultrasound cabling 96 runs proximally to electrically connect the flex circuit 94 to the ultrasound imaging system 40. The RF electrodes 72, 74, which are shown deposited on a conical distal tip, are also electrically connected to the flex circuit 94 via wires (not shown) that run through or around the array assembly 81, and RF cabling 97 electrically connects the flex circuit 94 to the RF therapy system 50. An outer sheath 62 (shown in partial cutaway for clarity) surrounds the array assembly 81 and the remainder of the components that are proximal to the electrodes 72, 74.

[0061] The flex circuit 94 is attached to a marker 92. Marker 92 provides structural rigidity to facilitate assembly, and marker 92 may be constructed of radio-opaque material and used to facilitate fluoroscopic visualization of the catheter tip.

[0062] Imaging system 40 is configured for generating and processing signals and data associated with the ultrasound transducer array 82 contained in the distal tip 70 of device 60. The transducer array 82 is preferably a multi-dimensional imaging array capable of producing high-quality 3D visualization information, and array 82 is preferably constructed by dicing a piezoelectric workpiece into the appropriate number of elements as described herein. However, system 20 may be usefully implemented with a number of different imaging arrays known in the art, for example those described in U.S. Pat. Nos. 5,857,974 and 6,962,567 to Eberle et al., U.S. Pat. No. 6,994,674 to Shelgaskow et al., and/or U.S. Pat. No. 7,156,812 to Seward et al.

[0063] Imaging system 40 connects to a coaxial cable bundle 96 that includes analog signal lines and digital control wires for bidirectional communication with array 82 via flex circuit 94. The ultrasound coaxial bundle 96 may comprise analog miniature coaxial cables (each of which typically has diameter 46-54 AWG). The gauge of the digital control wires may be about 42-50 AWG. The number of analog lines may vary from 16 to 128 with the preferred embodiment being 32 to 64. The digital control lines may typically vary from 5-20. The ultrasound cable bundle 96 terminates proximally in a multi-pin connector for ease of interface with the ultrasound imaging system 40. The multiplexers in the chips 98, 99 allow the system 40 to be able to separately address each individual element (if desired) even though the number of analog signal lines in bundle 96 may be substantially less than the number of elements in the array.

[0064] System 40 may include analog interface circuitry, Digital Signal Processors (DSP), data processors, and memory components, collectively termed a “data processing assembly.” For example, analog interface circuitry may be responsive to control signals from DSP to provide corresponding analog stimulus signals to imaging device 60. The analog circuitry and/or DSP may be provided with one or more digital-to-analog converters (DAC) and one or more analog-to-digital converters (ADC) to facilitate operation of system 20 in the manner to be described in greater detail hereinafter. The data processor may be coupled to the DSPs to bi-directionally communicate therewith, to selectively provide output to the display device, and to selectively respond to input from the operator input devices.

[0065] The data processing assembly performs in accordance with operating logic that can be defined by software programming instructions, firmware, dedicated hardware, a combination of these, or in a different manner as would occur to those skilled in the art. For a programmable form of DSPs or processors, at least a portion of this operating logic can be defined by instructions stored in a memory, which can be of a solid-state variety, electromagnetic variety, optical variety, or a combination of these forms. Programming of the DSPs and/or processors can be of a standard, static type; an adaptive type provided by neural networking, expert-assisted learning, fuzzy logic, or the like; or a combination of these.

[0066] The circuitry, DSPs, and processors can be comprised of one or more components of any type suitable to operate as described herein. Further, it should be appreciated that all or any portion of the circuitry, DSPs, and processors can be integrated together in a common device, and/or provided as multiple processing units, and/or that one or more signal filters, limiters, oscillators, format converters (such as DACs or ADCs), power supplies, or other signal operators or conditioners may be provided as appropriate to operate system 20 in the manner to be described in greater detail hereinafter. Distributed, pipelined, and/or parallel processing can be utilized as appropriate.

[0067] The imaging system activates the transducer array to acquire 3D imaging information by any number of techniques known in the art based on the configuration of the array. For example, the array 82 may be operated as a sparse array or as a fully sampled array. The array may be phased in one or both dimensions. In one form, the array 82 is operated via a synthetic aperture approach. During synthetic aperture imaging, predefined subsets of the elements in the array are activated in sequence and the resulting responses are collected to form a complete image. This approach may be employed for any type of array (e.g. 1D or multi-dimensional arrays) wherein the number of elements in the array is much greater than the corresponding number of analog signal lines. For example, if there are 32 analogue lines that are used to drive a 324-element array, then the system 40 is configured to transmit and receive with up to 32 elements at a time. The information from one group of elements (e.g. the first 32) is collected and stored, and the processes repeats with another group of elements (e.g. the second 32) until all the elements in the array have been addressed. The total information received from all the elements is then processed to produce a single image frame.

[0068] In addition to transmitting and receiving with the sub-groups of 32 elements, system 40 may also be implemented to transmit with a first sub group of elements and to receive sequentially with every other sub-group of elements. For a 324-element array, there would be ten (10) 32-element sub-groups present with 4 elements not being used. The signals received from all the receiving sub-groups in the array are called “cross products.” Collecting the cross products helps to increase overall image quality.

[0069] With reference to FIG. 2, which schematically illustrates the distal tip 70 with its proximally extending outer sheath 62 shown partially cutaway, RF Therapy subsystem 50 is designed to generate a current and send the resulting current to one or more therapy electrodes 72, 74 on the distal tip 70 of device 60. The electrodes 72, 74 are a thin metallic layer deposited on the exterior of the front end of the distal tip 70, which may have a conical (FIGS. 3-5) or smoothly curved (FIGS. 6-10) shape. The RF electrodes are electrically connected to conductive traces on the flex circuit 99 and through the flex traces to the catheter cables 97.

[0070] A cable bundle 97 connects the RF electrodes 72, 74 to the external electronic driver system, and the RF cable bundle 97 terminates proximally in a multi-pin connector to facilitate connection to the RF Therapy system 50. The number of connections may be in the range of 2 to 10.

[0071] The RF system 50 includes voltage controller(s), voltage generator(s), and a current detector(s) as well as appropriate switches and controllers for directing the current to individual ones of the therapy electrodes 72, 74. The voltage controllers set the frequency and amplitude of the voltage produced by the generators as well as its sequencing in time, which may be selected based on preset configurations, information received from the user via an input interface, or measurements performed in the system 50. The current detectors determine the amount of current sent to each therapy electrode. A temperature monitoring system may also be included to receive temperature information from a temperature sensor (not shown) near the therapy electrodes.

[0072] The current flowing from the therapy system 50 to a therapy electrode 72, 74 passes to tissue when the electrode is placed adjacent to tissue. This current spreads as it penetrates into the tissue and generates heat according to the local current density, ablating (i.e. removing) the tissue. Without intending to be bound by any theory of operation, it is believed that under appropriate conditions, the ablation process can be carried out such that plaque removal occurs essentially one cell layer at a time, reducing the chances of complications.

[0073] The timing and amount of current applied to each electrode is chosen to achieve the desired therapeutic result, which in a contemplated application would involve the controlled erosion of arterial plaque P at a suitably controlled rate of erosion (e.g. one cell layer at a time). For example, it may be preferable to apply energy in the form of short bursts (i.e. 1.0 to 2.5 J delivered over 10 ms) to achieve the spark erosion of plaque as described in Slager, J Am Coll Cardiol 1985; 5:1382-6. Energy may also be generated in the form of a 1 MHz sine wave with a 5%-25% duty cycle with a peak-to-peak voltage of 500-1000 V. The preferred operating frequency of the RF electrodes is in the range of 0.25 to 5 MHz.

[0074] The therapy electrodes 72, 74 are forward-facing, which allows the device 60 to operate in a tunneling fashion, e.g. so as to be useful in creating a passage through partially or totally occluded arteries. Electrodes 72, 74 are also preferably arranged on the distal tip 70 in spaced relation about the longitudinal axis 100 of the device 60 and configured such that each electrode can be operated individually. This allows therapy to be applied symmetrically or asymmetrically relative to the longitudinal axis 100 of the distal tip 70 device 60. Symmetric ablation would have the tendency to achieve straight ahead tunneling (i.e. in tunneling in the direction of longitudinal axis of device 60), whereas asymmetric ablation would lead to tunneling in the direction of the electrodes that are activated.

[0075] In a preferred implementation, the operator controls the therapy system 50 based on visualization information provided by the imaging system 40. For example, if the operator observes from the ultrasound images that the catheter is nearing a structure that should be avoided (i.e. an arterial wall), the operator can “turn off” or “turn down” the therapy electrodes on one side and/or increase the energy applied to the electrodes on the other side.

[0076] In one preferred embodiment, the RF therapy electrodes are constructed from a thin layer of gold, titanium, aluminum, magnesium, beryllium or any other metal or metallic material having high electrical conductivity, high sound propagation velocity and/or low density. In one form, the RF electrodes are metallic strips that are sufficiently thin that the ultrasound passes without substantial attenuation or interference, for example having a thickness less than about 8 μm, such as in the range of 0.2 to 8 μm, 0.4 to 6 μm, 0.5 to 4 μm, 0.7 to 2 μm, or 0.9 to 1.5 μm. The metallic strips may be applied by a vapor deposition technique or any other conventional process for forming a thin layer of metallic material.

[0077] In an alternative preferred embodiment, electrodes 72, 74 are made of thin film nichrome (NiCr). NiCr, which is an alloy of nickel and chrome (preferably 80% Ni/20% Cr), at thickness of a few thousand angstroms (Å) can reach a temperature of 290 C, or approximately 600 F, and can thus ablate plaque (1000 Å=0.1 μm). In one preferred embodiment NiCr electrodes having a thickness of between 0.12 to 0.17 μm are used. Because of the very thin nature of these electrodes, ultrasound can be transmitted through them with little attenuation or distortion. Computer simulations indicate that ultrasound transmission in the range of interest, 20-50 MHz, is not significantly affected. Effects begin to appear at the approximate thickness of 0.5 μm to 1 μm and above. Thin film NiCr can be deposited by using a sputter coating machine.

[0078] Referring to FIG. 17, in a further alternative preferred embodiment a catheter distal tip 210 includes electrodes 214 that are made of carbon nanotube film. In one variant, the carbon nanotube film electrodes 214 generate temperatures up to 500 C (932 F) when electrical power is applied to them. When in carbon nanotube form, electrodes 214 have a thickness of from 0.5 nanometers to 100 μm. In one preferred embodiment electrodes 214 are free-standing pressed drawn carbon nanotube film of less than 1 μm thickness, as at this thickness high temperatures can be achieved, and ultrasound can be transmitted through the electrodes 214 with acceptably low levels of attenuation or distortion, in the frequency range of 20-50 MHz. Electrodes of this type have the additional advantage of staying cool while heating neighboring tissue to temperatures resulting in tissue ablation. Another advantageous property is that nanotubes have very efficient conversion of electric power to heat thus reducing overall power that needs to be delivered to the catheter tip.

[0079] Carbon nanotube film can be bonded to the ultrasonic lens on the tip of the catheter with high temperature, low viscosity epoxy by employing a modified Papadakis jig. One approach to making an electrical connection to the nanotube electrodes 214 is shown in FIG. 17. Conductors 212 and 216, on either side of electrodes 214, cause electrical current to flow through electrodes 214. In this arrangement the electrodes are driven using bi-polar electrical waves.

[0080] If the supporting tip surface is constructed of a suitable synthetic material capable of withstanding the high temperatures generated by the electrodes, the electrode material may be deposited or applied directly onto the tip. Suitable synthetic materials include high temperature plastics (e.g. Torlon, available from Solvay Advanced Polymers LLC, Alpharetta, Ga.) or silicone rubber materials (e.g. RTV325, Eager Plastics, Inc. Chicago, Ill. or RTV 560 GE Plastics).

[0081] Alternatively or in addition, a thermal insulating layer 180 (FIGS. 8-9 and 15-16) may be provided to protect the tip 170 from damage from the heat generated by the electrodes. Layer 180 may comprise a thin layer of ceramic (such as Al₂O₃) and may be formed as a relatively uniform coating or shell covering the distal face of tip 170. The thickness of this ceramic layer 180 is sufficient to protect the substrate 182 from thermal damage due to heat generated by the electrodes 172, 176, and might be in the range of 0.5-5 μm.

[0082] It is to be understood that, as depicted in both FIGS. 9 and 16, the proximal face of tip 170 is designed to be positioned against and acoustically coupled to the distal face of the acoustic stack 81, and consequently the tip 170, as shown in FIG. 9, includes a central lumen that matches guidewire lumen 90. The provision of a central guidewire extending through the distal tip 170 may be beneficial for purposes of control and guidance, but the interruption to the array may degrade image quality. The tip 170 of FIG. 16 is designed for embodiments wherein no guidewire lumen interrupts the array 82, for example, because the guidewire exit 99 is spaced proximal to the array 82 as shown in FIG. 10.

[0083] The therapy catheters described herein can be usefully implemented with a number of different imaging arrays constructed according to a number of conventional techniques. It is preferred, however, that the array be very small and operate at high frequency such that extremely high-quality 3D imaging information is provided. Miniature high-frequency imaging arrays for use in the present therapy catheters or in any other application where ultrasonic imaging via a miniature high-frequency array would be beneficial are described in connection with FIG. 11.

[0084] A 2D acoustic stack 81 includes a diced array of piezoelectric elements 82. The elements are formed by dicing a commercially available piezoelectric work piece, for example, CTS 3257HD (CTS Electronic Components, Inc. Albuquerque, N. Mex.). A dicing saw is used to make a series of parallel cuts in a first direction (e.g. the X direction) and then in a second direction (e.g. the Y direction) and the resulting kerfs 83 are filled with a suitable material after dicing in each of the directions. A metallizing layer 110 is deposited over the distal face of the piezoelectric elements 82 to serve as a common ground electrode. The proximal face of each of the elements 82 is in electrical contact with individual signal lines 91, which extend through an acoustic backing layer 80. The proximal face of each of the elements 82 may include its own metallizing layer (not shown) to facilitate electrical connection with the individual signal lines 91, and one or more acoustic matching layers 84a, 84b are applied to the distal face of the elements 82. The flex circuit 94 has contact pads (not shown) spatially arranged to correspond to the arrangement of the individual signal lines 91 that are exposed at the proximal face of backing layer 80. Alternatively, elements 82 may be applied directly to the flex circuit 94 and the acoustic backing layer 80 may be applied to the back side of the flex circuit, in which case there is no need for signals lines 80 in the backing layer 80.

[0085] Preferably, the array 82 is diced into two directions such that the resulting elements are generally square and the pitch (i.e. the spacing between centers of adjacent elements) is less than 100 μm, preferably less than 75 μm, less than 60 μm, or about 25-50 μm. The array 82 may be constructed such that it includes at least about 100, 200, 300, 400, 500, 600, or 700 elements. The array 82 may be constructed such that element density is greater than about 100, 200, or 300 elements per mm².

[0086] A useful procedure for producing a diced one dimensional array is described in US 2004/0254471 to Hadjicostis et al., which is incorporated herein for that purpose. Similar techniques can be employed to construct a miniature multi-dimensional array. The main difference would be the introduction of an additional dicing step and the provision of suitable contact pads in the flex.

[0087] Additional details of specific embodiments are now described. As noted above, the RF electrodes 72, 74 are electrically connected to conductive traces on the flex circuits 94 and through the flex traces to the catheter cables 97. The RF traces on the flex may have width equal to 15-25 μm and thickness equal to 1-5 μm. The ultrasound and digital lines on the flex circuit 94 may have a width equal to 5-15 μm and thickness equal to 1-10 μm.

[0088] The distal end of the catheter includes the catheter tip and may have an outer diameter in the range of 0.75 to 3 mm for coronary artery treatment. The diameter of the tip may be different than the above range of values for other intravascular uses. For example, for the peripheral arterial system the tip diameter can be in the range of 1-5 mm. The catheter tip incorporates the RF electrodes 72, the ultrasound piezoelectric imaging array 82, a radio-opaque marker 92, flex-circuit interconnects (not shown, on 94), IC multiplex/pre-amp chips 98, 99 and connections to the RF and ultrasound cables.

[0089] In several of the embodiments (FIGS. 2-5) the distal end of the tip 70 has a generally conical shape with the RF electrodes 72, 74 consisting of a metallic material such as gold, or other metal having high electrical conductivity deposited on top of a solid cone. The cone incorporates an opening 90 to accommodate a guide wire. The preferred material for the conical tip is a high temperature plastic such as Torlon™; however other appropriate materials may also be used. In one embodiment the tip lumen has diameter equal to 0.017″-0.018″; in other embodiments the lumen can have diameter of 0.013″-0.014″. The RF electrodes are electrically connected to conductive traces on the flex circuits and through the flex traces to the catheter cables. The RF traces on the flex have width equal to 0.015-0.025 mm and thickness equal to 0.001-0.010 mm. The ultrasound and digital lines on the flex have width equal to 0.005-0.015 mm and thickness equal to 0.001-0.003 mm.

[0090] The ultrasound array stack 81 is located distal to the electrodes 72, 74, and may be spaced from the electrodes as shown in FIGS. 3 and 4. Alternatively, the array elements 82b may be arranged on or close to the outer surface of the cone so as to underlay the electrodes 72, 74, as shown in FIG. 5. The array stack 81 may comprise three or four layers: an acoustic backing material 80, a diced piezoelectric ceramic 82, and one or two quarter-wave matching layers 84 (84a, 84b in FIG. 11). The array 82 may be either one-dimensional or two-dimensional. The piezoelectric elements may have −6 dB bandwidth in the range 40%-100% and insertion loss less than −20 dB.

[0091] The array of piezoelectric elements are electrically connected to conductive traces on the flex circuits 94 and through the flex traces (not shown) to the catheter cables 96, 97. The flex circuits are mounted onto a radio-opaque marker for mechanical stability. The radio-opaque marker enables the user to locate the catheter tip employing x-ray detection. Custom integrated circuit (IC) chips 98, 99 are mounted by soldering to the flex circuits 94 using flip chip bonding techniques. These IC chips 98, 99 include circuits that function as multiplexers for the ultrasound signals as well as pre-amplifiers for the return ultrasound signals. The use of the IC chips as multiplexers reduces the number of cables needed to connect the array to the imaging system and the pre-amplifiers enable the effective transmission of ultrasound return signals through the coaxial cables.

[0092] FIGS. 3, 4, 5, and 7 illustrate three basic configurations of the acoustic stack. FIG. 3 depicts a planar two-dimensional (2D) array. Such an array may have 100 to 1024 elements and may be multiplexed to the coaxial bundle. A potential benefit of using a 2D array is that (a) it need not have any moving parts and (b) it has complete flexibility in acquiring 3D images in front of the catheter using electronic focusing and beam control. A potential disadvantage of using a 2D array is the introduction of electronic interconnect complexity by having a large number of elements.

[0093] FIG. 4 depicts a one-dimensional array (1D). Such an array may have 16-128 elements and may be configured for rotational motion through the employment of a wire shaft connected to an outside motor (not shown), or via a miniature motor 110 provided inside the catheter adjacent the array. A potential benefit of using a 1D array is relative ease of construction and electrical interconnect at the expense of introducing mechanical movement, additional mechanical components and longer times to acquire a 3D image. In a given orientation, a 1D array can acquire two-dimensional images of the area in front of the catheter tip. Three-dimensional images can be constructed through an incremental 180 degree rotation of the 1D array, storage of acquired 2D images and then reconstruction of 3D images through integration of the 2D images.

[0094] FIG. 5 illustrates yet another arrangement in which the transducer elements 82b are arranged in a conical pattern following the curvature of the conical tip. A conical transducer array can provide images that describe a conical surface perpendicular the cone of the tip. A potential advantage of this configuration is relative simplicity of construction at the expense of the image quality, which may be somewhat deteriorated. The number of array elements 82b in this case may range from 16-128. The RF electrodes 72, 74 in this case lie directly above the ultrasound imaging array 82b.

[0095] FIGS. 6-7 illustrate yet another embodiment of the catheter tip. The difference in this approach is that the tip of the catheter is curved. The preferred shape of the curvature is spherical however other types of curved surfaces may be employed such as ellipsoidal, paraboloidal or other. The diameter of the spherical case can be in the range of 1 mm to 10 mm. In a further refinement of the preferred embodiment, the semispherical tip can be coated with a thin ceramic material 180 (such as Al₂O₃), which is shown in FIG. 9. The thickness of this ceramic coating may be 0.5-5 μm and its purpose is to provide protection to the tip from heat damage. The material 182 of the semispherical tip may be high temperature silicone such as RTV325 produced by Eager Plastics, Inc. of Chicago, Ill. Other RTV types can be used, such as RTV 560 from GE in conjunction with the ceramic coating on the lens. The advantage of using a smoothly curved (e.g. semispherical) tip versus a conical tip is that the RTV material 182 can function as an ultrasound lens and therefore produce images of higher resolution and improved quality. The RF electrodes are again made of metal as previously described in the present application.

[0096] Yet another embodiment is one which applies in the case of the 2D array. In this case the 2D array itself can be spherically shaped, with the RF electrodes deposited outside the matching layer of the array (not shown). In this case no additional tip is required and the images will have improved sensitivity and quality. However the use of a curved 2D array provides further electronic interconnect complexity.

[0097] The preferred operating frequency of the ultrasound array elements is in the range of 15-50 MHz, for example between 20 and 35 MHz, between 20 and 40 MHz, or about 30 MHz. The phased array may have half-wavelength element spacing for optimum ultrasound beam forming. Each element may incorporate quarter wave matching layers for better transfer of power.

[0098] Reference will now be made to specific examples illustrating certain particular features of inventive embodiments. It is to be understood, however, that these examples are provided for illustration and that no limitation to the scope of the invention is intended thereby.

[0099] The pulse response, impedance, and loss were modeled on a computer for a 2D ultrasound transducer array using piezoelectric ceramic with high dielectric constant (3500∈₀) and with the following design parameters (FIGS. 12A-12C):

[0100] Array aperture: 0.9 mm

[0101] Number of elements: 324
Number of quarter λ matching layers: 2
Element impedance electrically matched to driver.
The same array element was then modeled with the addition of an intervening layer of either gold or titanium and the results are plotted in FIGS. 13A-13C and FIGS. 14A-C, respectively. The thickness of the modeled gold layer was 1 μm and the thickness of the modeled titanium layer was 1.5 μm. The modeled results demonstrate that the 1.5 μm layer of titanium (FIGS. 14A-14C) does not significantly affect the operational properties of the array and represents an effective material choice for the device disclosed herein. The 1.0 μm layer of gold (FIGS. 13A-13C), even though thinner by 33% vs. titanium, more adversely affects the array properties. In the latter case, insertion loss is worse by 10 dB and pulse ringdown is worse by approximately 0.3 μsec. Nonetheless gold appears to be a practical option, particular if corrective techniques such as frequency filtering are implemented. Despite its worse acoustic properties, gold and the other metals mentioned in this disclosure are expected to be acceptable and can have advantages relating to the metal's material properties such as easier processing, resistance to oxidize over extended operation, and biocompatibility. Additionally NiCr alloy and nanotubes have advantages when used as RF electrodes, as described elsewhere in this disclosure.

[0102] It is to be appreciated that what has been described herein includes an endoluminal catheter for providing image guided therapy in a patient's vasculature, comprising: an elongated catheter body adapted to be inserted into a patient's vasculature, the catheter body defining a distal portion operable to be inside the patient's vasculature while a proximal portion is outside the patient; a plurality of distal-facing electrodes on the distal portion for performing controlled ablation of plaque in the patient's vasculature; and a distal-facing array of ultrasound imaging transducers positioned in the catheter body proximal to the electrodes and configured to transmit and receive ultrasound pulses through the electrodes to provide real-time imaging information of plaque to be ablated by the electrodes. The array of transducers may have a characteristic operating frequency greater than 15 MHz, and the electrodes may each comprise a metallic layer having a thickness less than about 8 μm. The electrodes may be positioned on the distal tip of the catheter, which may have a conical or smoothly convex shape. A smoothly curved tip may function as a lens for the ultrasound, and its outer surface may define a radius of curvature of less than about 10 mm. The ultrasound array may be a planar phased array having an element density greater than 100 elements/mm². The ultrasound array may be a multi-dimensional array having at least 15 elements in at least one of the dimensions. The array may comprise a 1D array coupled to a rotation mechanism.

[0103] What has also been described is an endoluminal catheter for providing high-quality real-time planar (2D) or volumetric (3D) ultrasound visualization from inside a patient, comprising: an elongated catheter body adapted to be inserted into a patient's vasculature, the catheter body defining a distal portion operable to be inside the patient while a proximal portion is outside the patient; and a multi-dimensional phased array of piezoelectric elements in the distal portion of the catheter body configured to transmit and receive ultrasound pulses having a characteristic frequency greater than 20 MHz to provide real-time imaging information; wherein the array defines an element density greater than 300 elements/mm². The distal portion of the catheter may define a longitudinal axis and the array may be positioned in the distal portion of the catheter such that the longitudinal axis is within the image field of the array. The piezoelectric elements may be constructed such that they are mounted to a backing layer having a number of electrically conductive pathways extending there through, wherein the electrically conductive pathways electrically couple each of the piezoelectric elements to corresponding pads on a circuit substrate. The circuit substrate may include at least one multiplexer/pre-amplifier IC chip electrically coupled to the circuit substrate and to cabling extending to the distal portion of the catheter, wherein the number of individual signal lines in the cabling is substantially less than the number of piezoelectric elements in the array. The number of piezoelectric elements in the array may be greater than 300 while the number of individual signal lines in the cabling is less than 100. The catheter may further include one or more distal-facing electrodes.

[0104] What also has been described is a novel method comprising: providing an array coupled to cabling via a multiplexer, the array defining a number of piezoelectric elements that is greater than the number of individual signal lines in the cabling, the piezoelectric elements operable to transmit and receive ultrasound having a characteristic frequency greater than 20 MHz and defining an element density greater than 100 elements/mm²; positioning the array at a desired region within a subject's body by movement through a circulatory system, a proximal portion of the cabling being positioned outside the subject's body while the array is positioned at the desired region; ultrasonically interrogating an internal portion of the subject's body with the array; transmitting a plurality of signals between the array and equipment coupled to the proximal portion of the cabling outside the subject's body; and displaying one or more images corresponding to the internal portion as a function of the signals. The internal portion of the subject's body comprises a blood vessel or the heart. A procedure may be performed on the internal portion while displaying the one or more images. For example, the array may be positioned in a catheter and the procedure may involve activating one or more ablation electrodes positioned on an outer surface of the catheter. A plurality of selectively operable electrodes may be provided and the procedure may include selecting which ones of the electrodes to activate based on the displayed images. The interrogation may occur through a thin layer of metallic material on an outer surface of the catheter comprising a portion of an electrode or more preferably a plurality of spaced apart electrodes.

[0105] What has also been described is a novel device for performing guided tissue ablation, comprising: an elongated body having a distal portion adapted to be inserted into a lumen of a human subject while a proximal portion is outside the subject, the elongated body having a distal portion having an outer diameter less than 5 mm and configured to be positioned inside the subject's blood vessel while a proximal portion is outside the patient, the distal portion defining a distal tip; at least one therapy electrode on the distal tip operable to deliver therapeutic energy to tissue adjacent the distal tip; and a two-dimensional array of piezoelectric elements in the body proximal to the therapy electrodes and operable to transmit and receive ultrasound having a frequency greater than 20 MHz to provide real-time imaging information of tissue in front of the vascular structure near the RF electrodes; wherein the therapy electrode comprises a thin layer of metallic material or carbon nanotubes positioned such that at least a portion of the ultrasound received by the transducers and used for imaging passes through the thin layer of metallic material or carbon nanotubes. The distal tip may comprise synthetic material and a thin layer of ceramic material may be provided to thermally insulate the synthetic material from heat generated by the electrode.

[0106] Another novel method described herein includes providing an elongated body comprising an electrode in front of an ultrasound imaging array; positioning the RF electrode at a desired region within a subject's body by movement through a circulatory system; transmitting and receiving ultrasound through the RF electrode with the array to interrogate an internal portion of the subject's body; and displaying one or more images corresponding to the internal portion. The ultrasound frequency may be at least 20 MHz, and the array may be a forward-facing 2D array. The array may be operated as a fully sampled array or a sparse array. Synthetic aperture imaging and phasing in more than one direction may be employed. A plurality of electrodes may be provided, and the operator may selectively operate one of the electrodes based on the images. The electrodes may be used to ablate arterial plaque.

[0107] What has also been described is a medical device adapted to cross a vascular occlusion comprising: an intravascular catheter having a proximal end, a distal end, and a distal tip; one or more ablation electrodes on the distal tip of the catheter, wherein the electrodes are configured to deliver energy sufficient to ablate portions of the occlusion and thereby assist the catheter in crossing the occlusion; and an ultrasound array located at the distal end of the catheter proximal to the electrodes, wherein the array is configured to provide real-time imaging of the occlusion by transmitting and receiving ultrasound through the electrodes, wherein the ultrasound has a frequency greater than 15 MHz. The medical device described above, and wherein the proximal end is coupled to an ultrasound imaging system and the array is phased in at least one dimension. The array may be configured to provide real-time planar (2D) or volumetric (3D) imaging of an area distal to the distal tip.

[0108] While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.