Successful treatment of pulmonary diseases such as asthma or COPD is important since these diseases represent a significant global health issue with reduced quality of life. While drug therapy (Bronchodilators, Anti-inflammatories and Leukotriene Modifiers) can be used to treat asthma, it is not always successful and very expensive. Asthma and COPD are disorders that are characterized by airway constriction and inflammation resulting in breathing difficulties. Wheezing, shortness of breath and coughing are typical symptoms.
These symptoms are caused by increased mucus production, airway inflammation and smooth muscle contraction, resulting in airway obstruction. This obstruction can be treated by injuring and scaring the bronchial walls. This remodeling of the bronchial walls stiffens the bronchia and reduces contractility. Mechanical means and heat application have been proposed as in U.S. Pat. No. 8,267,094 B2. Other approaches focus on destruction of smooth muscle cells surrounding the bronchia as described in US 2012/0143099A1 and U.S. Pat. No. 7,906,124B2. Others describe applying RF energy to the bronchial wall and thereby directly widening the bronchia through a process which is not disclosed as in U.S. Pat. No. 7,740,017B2 and U.S. Pat. No. 8,161,978B2. Whatever the process, the bronchial wall will be damaged and the procedure therefore has to be staged as described in U.S. Pat. No. 7,740,017B2. EP2405841 describes applications of heat shocks through infused agents.
Inactivating conduction of the nerves surrounding the bronchia has been proposed, in US Patent Application Publication No. 2012/0203216A1, through mechanical action, i.e., puncturing, tearing, cutting nerve tissue. In US 2011/0118725 nerve tissue ablation is proposed by applying energy (RF, HIFU, Microwave, Radiation and Thermal Energy) directly to the nerves percutaneously. It is not taught how to identify the nerve location in order to align the energy focal zone (i.e. HIFU) with the nerve location. This is an issue since nerves are too small to be visualized in vivo with standard ultrasound, CT or MRI imaging methods. Therefore, the focal zone of the energy field cannot be predictably aligned with the target or nerve location. U.S. Pat. No. 8,088,127B2 teaches to denervate by applying RF energy to the bronchial wall with the catheter positioned inside the bronchial lumen. It is proposed to protect the bronchial wall through simultaneous cooling of the wall. This is of course a very time intensive treatment approach since the RF ablation is limited to the electrode contact areas. Therefore numerous ablation zones need to be pieced together to obtain a larger ablation zone with increased probability of affecting nerves. Efficacy might be severely limited due to the relatively small treatment areas and maybe the cooling action.
However, how to selectively target predominantly nerves or smooth muscle without affecting bronchial wall and surrounding tissue is not being taught. There is a need for a device and method to selectively ablate bronchial nerves without causing damage to bronchial walls and surrounding tissues. If this can be achieved, treatments would be much easier and faster to perform. Today's multiple treatments (see U.S. Pat. No. 7,740,017B2 and Alair System description, BSX) can be reduced to a one time treatment much better tolerated by the patient. By selectively targeting nerves instead of tissue it is also likely that a more proximal single ablation of nerves (conducting signals to distal bronchial sections) will have the same clinical effect as treating the bronchial tree from proximal to distal with numerous energy applications.
In order to explain the difficulties associated with accomplishing this task without causing other damage, the anatomy of the bronchial system and nerves will be described now. Shown in
The inability to locate and target the bronchial nerves (6) makes it difficult to disconnect the bronchial nerve activity using non-surgical techniques without causing damage to the bronchial walls or causing other side effects. For example, attempts to apply energy to the bronchial nerves can cause effects such as stenosis, and necrosis. In addition, the inability to target and locate the bronchial nerves (6) makes it difficult to ensure that bronchial nerve activity has been discontinued enough to achieve an acceptable therapeutic treatment.
U.S. Pat. No. 8,088,127B2 suggests the use of a radio frequency (“RF”) emitter connected to a catheter, which is inserted in the bronchial tree. The RF emitter is placed against the bronchial wall and the RF energy is emitted to heat the nerves to a temperature that reduces the activity of bronchial nerves which happen to lie in the immediate vicinity of the emitter. In order to treat all the nerves surrounding the bronchial tubes, the RF emitter source must be repositioned around the inside of each bronchial tube section multiple times. In order to protect the bronchial wall this RF heat application is combined with a cooling application which makes the procedure even more complicated. The emitter may miss some of the bronchial nerves, leading to an incomplete treatment. Moreover, the RF energy source (electrode) must contact the bronchial wall to be able to heat the surrounding tissue and nerves, which may cause damage or necrosis to the inner lining of the bronchi despite the proposed cooling mechanism.
The US2011/0118725 Patent application also suggests the use of high-intensity focused ultrasound to deactivate the bronchial nerves. It is not clear how a High Intensity Focused Ultrasound zone can be aligned with the targeted bronchial nerves. It is difficult or impossible to align this highly focused zone with the bronchial nerves because it is difficult or impossible to visualize and target the bronchial nerves with current in vivo imaging technology, and because the bronchial nerves may lie at different radial distances and circumferential locations from the central axis of bronchi. The latter is a problem particularly in patients who have bronchi with large variations in shape or thickness. Moreover, the thin focal zone can encompass only a small segment of each bronchial nerve along the lengthwise direction of the bronchi. Since nerves damage is reversible, a small treatment zone allows the nerves to reconnect in a shorter period of time.
Ultrasound has been used to enhance cell repair, stimulate the growth of bone cells, enhance delivery of drugs to specific tissues, and to image tissue within the body. Recently, high-intensity focused ultrasound has been used to heat and ablate tumors and tissue within the body. Ablation of tissue has been performed nearly exclusively by high-intensity focused ultrasound because the emitted ultrasonic mechanical vibratory energy is focused on a specific location to allow precise in-depth tissue necrosis without affecting surrounding tissue and intervening structures that the ultrasonic mechanical vibratory energy must pass through.
U.S. Pat. No. 6,117,101, to Diederich, discusses use of highly collimated ultrasonic mechanical vibratory energy rather than high intensity focused ultrasound for ablating tissue to create a scar ring within the pulmonary vein for blocking the conduction of electrical signals to the heart.
One aspect of the invention provides an apparatus for inactivating bronchial nerves in a human or non-human mammalian subject. The apparatus according to this aspect of the invention preferably includes an electromechanical transducer adapted for insertion into the bronchial system of the mammalian subject. The electromechanical transducer desirably is arranged to transmit unfocused ultrasonic mechanical vibratory energy. The apparatus according to this aspect of the invention desirably also includes a generator circuit electrically connected to the transducer. The generator circuit most preferably is adapted to control the electromechanical transducer to transmit unfocused ultrasonic mechanical vibratory energy into an target region of at least approximately 1 cm3, encompassing the bronchial tube so that the unfocused ultrasonic mechanical vibratory energy is applied at a desired therapeutic level sufficient to inactivate conduction of bronchial nerves throughout the target region. As discussed further below, such therapeutic level is well below the level required for tissue ablation.
The apparatus may further include a catheter with a distal end and a proximal end, the transducer being mounted to the catheter adjacent the distal end, the transducer being constructed and arranged inside an inflatable bladder or balloon which will make contact with the bronchial wall. This bladder is filled with a circulating cooling fluid which serves in part to conduct ultrasonic mechanical vibratory energy from the transducer to the bronchial walls and surrounding tissue and nerves. This cooling fluid also transports excessive heat away from the transducer. About half of the electrical energy supplied to the transducer is converted into heat while roughly the other half is converted to ultrasonic energy. The catheter may have an additional expansible element such as a compliant balloon or a similar anchoring device like an expandable wire basket mounted adjacent the distal end for cooperating with the inflatable transducer-containing bladder to hold the catheter so that a longitudinal axis of the transducer remains generally parallel to the axis of the target bronchial tube section. The transducer may be adapted to transmit the ultrasonic mechanical vibratory energy in a 360° cylindrical pattern surrounding the transducer axis, and the catheter may be constructed and arranged (for instance, with the secondary expansible element) to hold the axis of the transducer generally parallel to the axis of the bronchial tube.
A method according to a further aspect of the invention desirably includes the steps of inserting an electromechanical transducer into a bronchial branch of the subject and energizing the transducer to transmit therapeutically effective unfocused ultrasonic mechanical vibratory energy into an target region of at least approximately 1 cubic centimeter encompassing the bronchial branch. The ultrasonic mechanical vibratory energy is applied with such an amplitude, frequency and duration that the energy inactivates all nerves in the target region. For example, the step of energizing the transducer may be so as to maintain the temperature of the bronchial wall below 65° C. while heating the solid tissues within the target region, including the nerves in the target region, to above 42° C.
Because the target region is relatively large, and because the tissues throughout the target region preferably reach temperatures for a certain time span sufficient to inactivate nerve conduction, the preferred methods according to this aspect of the invention can be performed successfully without determining the actual locations of the bronchial nerves, and without targeting or focusing on the bronchial nerves. The treatment can be performed without measuring the temperature of tissues. Moreover, the treatment preferably is performed without causing injury to the bronchi. The preferred methods and apparatus can inactivate relatively long segments of the bronchial nerves, so as to reduce the possibility of nerve recovery which would re-establish conduction along the inactivated segments.
Further aspects of the invention provide probes which can be used in the method and apparatus discussed above, and apparatus incorporating means for performing the steps of the methods discussed above.
Apparatus according to one embodiment of the invention (
The apparatus also includes a catheter 10 having a proximal end, a distal end and a proximal-to-distal axis which, in the condition depicted in
Catheter 10 has a compliant balloon or inflatable bladder 12 mounted at the distal end. In its inflated condition (
An electromechanical transducer 11 (
Transducer 11 is constructed so that ultrasonic mechanical waveform energy is generated by the transducer and is emitted principally from the exterior and interior surface. In order to increase efficiency, the transducer may include features arranged to reflect ultrasonic energy directed toward the interior of the transducer so that the reflected energy reinforces the ultrasonic vibrations at the exterior surface. For example, support tube and transducer may be configured so that the energy emitted from the interior surface of the transducer 11 is reflected back to enhance the overall efficiency of the transducer. In this embodiment, the ultrasonic mechanical vibratory energy generated by the transducer 11 is reflected at the interior mounting to reinforce ultrasonic mechanical vibratory energy propagating from the exterior surface of the transducer 11.
Transducer 11 is also arranged to convert ultrasonic waves vibrating the exterior surface into electrical signals which can be detected by the ultrasound detection subsystem. If the reflecting structure is not perfectly circular the widths of the reflected signal will represent the difference between a maximum internal diameter dmax and a minimum internal diameter dmin of the bronchial passageway under treatment. Stated another way, transducer 11 can act either as an ultrasonic emitter or an ultrasonic receiver. The receiving mode is of particular importance for an array type transducer, as described hereinafter with reference to
The transducer 11 is designed to operate, for example, at a frequency of approximately 1 MHz to approximately a few tens of MHz, and typically at approximately 15 MHz given the shallow location of bronchial smooth muscle and nerves. The actual frequency of the transducer 11 typically varies somewhat depending on manufacturing tolerances. The optimum actuation frequency maybe adjusted accordingly by the generator system based on a digital memory, bar code or the like affixed to the catheter.
An ultrasound system, also referred to herein as an energization circuit 100 (
A circulation device is connected to lumens (not shown) within catheter 10 which in turn are connected to bladder 12. The circulation device is arranged to circulate a liquid, preferably a sterile aqueous liquid, through the catheter 10 to the transducer 11 in the bladder 12. The circulation device may include elements for holding the circulating coolant, pumps, a refrigerating coil (not shown), for providing a supply of liquid to the interior space of the bladder 12 at a controlled temperature, desirably at or below body temperature. The control board interfaces with the circulation device to control the flow of fluid into and out of the bladder 12. For example, the control board may include motor control devices linked to drive motors associated with pumps for controlling the speed of operation of the pumps. Such motor control devices can be used, for example, where the pumps are positive displacement pumps, such as peristaltic pumps. Alternatively or additionally, the control circuit may include structures such as controllable valves connected in the fluid circuit for varying resistance of the circuit to fluid flow (not shown). The ultrasound system may further include pressure sensors, to monitor the liquid flow through the catheter 10. At least one pressure sensor monitors the flow of the liquid to the distal end of catheter 10 to determine if there is a blockage while the other monitors leaks in the catheter 10. While the balloon is in an inflated state, the pressure sensors maintain a desired pressure in the balloon preferably so that the compliant balloon occludes the bronchus.
The ultrasound system incorporates a reader for reading a machine-readable element on catheter 10 and conveying the information from such element to the control board. As discussed above, the machine-readable element on the catheter may include information such as the operating frequency and efficiency of the transducer 11 in a particular catheter 10, and the control board may use this information to set the appropriate frequency and power for exciting the transducer. Alternatively, the control board may be arranged to actuate an excitation source to measure the transducer operating frequency by energizing the transducer at a low power level while scanning the excitation frequency over a pre-determined range of frequencies for example 5.0 Mhz-15.0 Mhz, and monitoring the response of the transducer to such excitation and to select the optimal operating frequency.
The ultrasonic system may be similar to that disclosed hereinafter with reference to
A method according to an embodiment of the present invention is depicted in flowchart form in
Once the distal end of the catheter is in position within a bronchial branch, pumps bring bladder 12 to an inflated condition (steps 210 and 212 in
During treatment with ultrasonic vibrational energy (step 214 in
In another embodiment, the ultrasound system uses transducer 11 to measure the size of the bronchus. The control board and ultrasound source actuate the transducer 11 to emit short, low power signals which will be reflected by the bronchus. The ultrasonic waves in this pulse are reflected by the bronchial wall onto transducer 11 as echoes. Transducer 11 converts the echoes to echo signals. The ultrasound system then determines the size of bronchus 1 by analyzing the echo signals. For example, the ultrasound system may determine the time delay between actuation of the transducer and reception of the echoes representing the bronchial radius. The width of the return signal or echo represents the difference between dmax and dmin in case the bronchial section is not perfectly circular but oval shaped. The ultrasound system uses the measured bronchus size to set the acoustic power to be delivered by transducer 11 during application of therapeutic ultrasonic energy in later steps. For example, the control board may use a lookup table correlating a particular echo delay (and thus bronchial radius) with a particular power level. Generally, the larger the diameter, the more power should be used.
The physician then initiates the treatment through the user interface. In the treatment, the ultrasonic signal generating system or energization circuit, and particularly the control board and ultrasonic source, actuate transducer 11 to deliver therapeutically effective ultrasonic waves to an target or ultrasound treatment region 13 (
The selected operating frequency, unfocused characteristic, placement, size, and the shape of the electromechanical transducer 11 allows the entire bronchial section and bronchial nerves to lie within the “near field” region of the transducer 11. As shown in
The target region 13 is generally cylindrical and coaxial with the bronchial section treated (
As discussed above, the length of the transducer 11 may vary between about 2 mm and about 10 mm, but is preferably about 5 mm to provide a wide inactivation zone of the bronchial nerves. The diameter of the transducer 11 may vary between 1.5 mm to 3.0 mm, and is preferably less than 2.0 mm in order to allow the catheter to fit through the bronchoscope working channel. The dosage is selected not only for its therapeutic effect, but also to allow the radius of the target region 13 to be between preferably 5 mm and 10 mm in order to encompass the bronchial section treated, and adjacent bronchial nerves, all of which lie within an average radius of 5-10 mm, without transmitting damaging ultrasonic mechanical vibratory energy to collateral structures like esophagus 3 and Aorta 4 in
The power level desirably is selected so that throughout the target region, solid tissues are heated to about 42° C. or more for several seconds or more, but desirably all of the solid tissues, including the wall of the bronchus remain well below 65° C. Thus, throughout the impact region, the solid tissues (including all of the bronchial nerves) are brought to a temperature sufficient to inactivate nerve conduction but below that which causes rapid necrosis of the tissues.
Research shows that nerve damage occurs at much lower temperatures and much faster than tissue necrosis. See Bunch, Jared. T. et al. “Mechanisms of Phrenic Nerve Injury During Radiofrequency Ablation at the Pulmonary Vein Orifice, Journal of Cardiovascular Electrophysiology, Volume 16, Issue 12, pg. 1318-1325 (Dec. 8, 2005), incorporated by reference herein. Since, necrosis of tissue typically occurs at temperatures of 65° C. or higher for approximately 10 sec or longer while inactivation of nerves typically occurs when the nerves are at temperatures of 42° C. or higher for several seconds or longer, the dosage of the ultrasonic mechanical vibratory energy is chosen to keep the temperature in the target region 13 between those temperatures for several seconds or longer. In addition, the circulation of cooled liquid through the bladder 12 containing the transducer 11 may also help reduce the heat being transferred from the transducer 11 to the inner layer of the bronchus. Hence, the transmitted therapeutic unfocused ultrasonic mechanical vibratory energy does not damage the inner layer of the bronchus, providing a safer treatment.
In order to generate the therapeutic dosage of ultrasonic mechanical vibratory energy, the acoustic power output of the transducer 11 typically is approximately 10 watts to approximately 100 watts, more typically approximately 10 watts. The duration of power application typically is approximately 2 seconds to approximately a minute or more, more typically approximately 10 seconds. The optimum dosage used with a particular system to achieve the desired temperature levels has been determined by mathematical modeling and animal testing to be 100 Joules for a 5 mm bronchial lumen.
The target region 13 of the unfocused ultrasonic mechanical vibratory energy encompasses the entire bronchial section treated and closely surrounding tissues, and therefore ablates all of the bronchial nerves surrounding the bronchus. Accordingly, the placement in the bronchus of the transducer 11 may be indiscriminate in order to inactivate conduction of all the surrounding bronchial nerves 6 surrounding the bronchi in the subject.
Optionally, the physician may then reposition the catheter 10 and transducer 11 along the bronchus and reinitiate the treatment to retransmit therapeutically effective unfocused ultrasonic mechanical vibratory energy. This inactivates the bronchial nerves at an additional location along the length of the bronchial tree, and thus provides a safer and more reliable treatment. The repositioning and retransmission steps optionally can be performed multiple times. Next the physician moves the catheter 10 with the transducer 11 to the other main bronchus (le/ri) and performs the entire treatment again (step 216,
Numerous variations and combinations of the features discussed above can be utilized. For example, the ultrasound system may control the transducer 11 to transmit ultrasonic mechanical vibratory energy in a pulsed function during application of therapeutic ultrasonic energy. The pulsed function causes the electromechanical transducer 11 to emit the ultrasonic mechanical vibratory energy at a duty cycle of, for example, 50%. Pulse modulation of the ultrasonic mechanical vibratory energy is helpful in limiting the tissue temperature while increasing treatment times. The pulsed therapeutic function can also be interleaved with a diagnostic imaging mode when an ultrasound array is used instead of a cylindrical solid transducer. This way diagnostic ultrasound imaging can be obtained (quasi)simultaneously to the therapeutic treatment.
In a further variant, the bronchial diameters can be measured by techniques other than actuation of transducer as, for example, by radiographic imaging or magnetic resonance imaging or use of a separate ultrasonic measuring catheter. In this instance, the data from the separate measurement can be used to set the dose.
Bladder 12 is typically cylindrical, that is, it has a circular cross-section and a cylindrical outer surface which makes contact with the wall of the targeted bronchial section. Where the inner surface of the bronchial section being treated is non-circular, the balloon may deform under liquid pressure to conform to the bronchial surface. Ultrasound transmissibility between the bladder and the bronchial wall may be enhanced by providing the outer surface of the bladder with a layer of liquid, for instance, saline solution or biocompatible gel. This is especially advantageous if the bronchial wall is not already coated with mucous or other fluidic material. The layer of liquid on the outer surface of bladder 12 may be provided during the manufacturing process or may be provided at the time of the therapeutic treatment. In the latter case, the liquid may be sprayed onto the bladder inside the bronchial passage, using a catheter with a spray nozzle. The liquid may be provided via catheter 10, in which case the catheter is connected at a proximal end to a source of pressurized liquid.
Typically, catheter 10 is a disposable, single-use device. The catheter 10 or ultrasonic system may contain a safety device that inhibits the reuse of the catheter 10 after a single use. Such safety devices per se are known in the art.
In yet another variant, the catheter 10 itself may include a steering mechanism which allows the physician to directly steer the distal end of the catheter. In this case a bronchoscope or sheath may be omitted. Of particular advantage in this mode is insertion of an optical fiber (e.g., 130 in
Another variation may be that an ultrasonic waveform emitter unit at the distal end of the catheter, which includes the electromechanical transducer, may be positioned in adjacent structures like the pulmonary artery or the esophagus (3 in
Imaging apparatus useful in methods disclosed hereinabove includes a sheath 301 (
Sheath 301 has an interior bore or lumen (not separately designated) extending between its proximal end 320 and its distal end 330. Desirably, sheath 301 has a relatively stiff proximal wall section 341 extending from its proximal end 320 to a juncture 340, and a relatively soft distal wall section or sheath end portion 342 extending from the juncture 340 to the distal end or tip 330. One or more pull wires 344 (only one shown) are slideably mounted in the proximal wall section 341 and connected to the distal wall section or end portion 342. The pull wire 344 is linked to a pull wire control apparatus (not shown), which can be manipulated by a physician during use of the sheath 301. The structure of sheath 301 and pull wire control may be generally as shown in U.S. Patent Application Publication No. 2006-0270976 (“the '976 Publication”), the disclosure of which is incorporated by reference herein. As discussed in greater detail in the '976 Publication, transition desirably is oblique to the proximal-to-distal axis 346 of the sheath.
By combined pulling on the pull wire 344 and rotational motion, the distal end 330 of sheath 301 and therewith an ultrasound imaging plane 347 (
The apparatus further includes, in the distal wall section or sheath end portion 342, a circular array 302 of electromechanical (e.g., PZT or piezoelectric) transducer elements for ultrasound imaging. As described above, the sheath steering allows the physician to aim the sheath distal opening (at 330) in any direction and through the same steering operation to aim the ultrasound imaging plane 347 in any direction.
In order to keep the sheath wall reasonably thin printed flexible circuits 311 (see
Another desirable feature of the present imaging sheaths is to keep the overall diameter isometric (no bulge).
In order to keep the sheath wall reasonably thin the number of connections with the ultrasound imaging console has to be minimized. Therefore a multiplexer approach is employed: with two 64:16 multiplexers 12 as shown in
At the proximal end the lines are terminated in a connector 352 (
Particular attention has to be paid to the backing of array 302. For imaging purposes highly absorptive backing is desirable. This contradicts with the size requirements to keep the sheath wall acceptably thin. Accordingly, minimal backing is applied to array 302 of sheath 301. Rather than absorbing the backwards emitted ultrasound portion a diffraction layer 360 is employed to cause the backward-propagating ultrasound waves to bounce back and forth in chaotic fashion within the blood filled sheath 301. This way the backwardly emitted ultrasound is prevented from generating reverberations within the ultrasound image. Diffraction layer may be made of polyimide with a conductive layer, for example, Pyralux from DuPont.
A further variation of an combined imaging/therapy sheath, depicted in
Numerous other variations and combinations of the features discussed above can be utilized. For example, the emitter structure can be slideably mounted within the sheath so that the sheath stays in place during the procedure. In still other arrangements, several emitters might be mounted on the sheath in a chain like fashion in order to apply energy over the length of the sheath portion inserted into the organ to be treated. Again this configuration does not require a movement of the sheath during treatment. In still other embodiments, focusing apparatus, such as lenses and diffractive elements can be employed in particular for short axis focusing of the ultrasonic energy. The right atrial position in case of intra cardiac procedures allows the user to obtain real time guidance of the trans-septal puncture as well as the left atrial catheter ablation itself.
The right atrial sheath position in case of intra cardiac procedures allows the user to obtain real time guidance of the trans-septal puncture as well as the catheter ablation itself. As depicted in
All left sided cardiac interventions require a trans-septal puncture to be performed. As described above ultrasound guidance has great value since tenting of the septum clearly indicates the puncture site. Once the septum has been crossed the imaging sheath 301 can be advanced into the left atrium LA to guide the therapeutic procedure. In case of an AF treatment procedure, a distal end portion (not separately enumerated) of an ablation catheter 305 is ejected from sheath 301 and maneuvered into a pulmonary vein, e.g., left superior pulmonary vein LSPV, as shown in
An expansible structure in the form of a balloon 409 (
A tubular, cylindrical ultrasonic transducer array 412 is mounted to catheter 405 inside balloon 409. Transducer array 412 includes a plurality of electrically isolated and independently energizable piezoelectric or PZT transducer elements organized into a therapy transducer section 502 and an imaging transducer section 504 (
Electrical connection of the piezoelectric elements of array 412 with generator 415 and an imaging display or monitor 513 of a control system 456 (
The interior space 506 within balloon 409 is connected to a circulation device 416 (
Catheter 405 is deployed via a sheath 400 (
Treatment catheter 405 is advanced under ultrasound image guidance until the antrum of the selected pulmonary vein (PV) is clearly visualized. Treatment catheter is advanced further so that ultrasound transducer array 412 is positioned within the antrum of a selected pulmonary vein (PV) (step 460,
With the catheter in the operative position, the energy field 414 (
Control unit 456 includes an interface 524 for monitoring instructions input by the user via touch screen (360, 513) or keyboard and mouse (515). Signal analyzer 516 is connected to an image signal generator 526 that produces a video signal for display console 513 (or 360) and interface 524 is connected to control module 522 which interprets user directions in conjunction with the organic structures of the patient as detected, encoded and at least temporarily stored in memory 528 by analyzer 516.
As indicated above, ablation is performed preferably in stepwise fashion around a circumferential locus defined by the user or surgeon via the input ablation markers. A neighboring ablation position is chosen as indicated in
With the treatment catheter 405 and transducer array 412 in the operative position, the ultrasonic excitation source or waveform generator 415 actuates the therapy transducer section 502 of transducer array 412 to emit ultrasonic waves. Merely by way of example, the ultrasonic ablation waves (which are longitudinal compression waves) may have a frequency of about 1 MHz to a few tens of MHz, most typically about 8 MHz. The transducer typically is driven to emit, for example, about 10 watts to about 100 watts of acoustic power, most typically about 40 to 50 watts. The actuation is continued for about 10 seconds to about a minute or more, most typically about 20 seconds to about 40 seconds per lesion. Optionally, based on the ultrasound image the actuation may be repeated several times. The frequencies, power levels, and actuation times may be varied from those given above.
The various components of control unit 456 may be hard wired circuits designed to perform the specific computations discussed herein. Alternatively, control unit 456 may take the form of a generic microprocessor or computer with the components realized as generic digital circuits modified by programming to carry out the delineated functions.
The ultrasonic waves generated by the transducer array 412 propagate generally radially outwardly from the transducer elements, outwardly through the liquid within the balloon 409 to the wall of the balloon and then to the surrounding blood and tissue. The ultrasonic waves impinge on the tissues of the heart particularly on the PV antrum. Because the liquid within the balloon and the blood surrounding the balloon have approximately the same acoustic impedance, there is little or no reflection of ultrasonic waves at interfaces between the liquid within the balloon 409 and the blood outside the balloon.
Essentially all of the annulus within the PV antrum lies within the “near field” region of the transducer and particularly the therapy transducer section 502. Within this region, the outwardly spreading segmental beam 414 of ultrasonic waves tends to remain focused not only in the cross-sectional plane but also in elevation axis and has an axial length (the dimension of the beam along the catheter axis; see drawings in
The ultrasonic energy applied by the therapy transducer section 502 is effective to heat and thus necrose a section of the annulus in the PV antrum. A circular lesion formed by a continuous series of sectional ablations creates a conduction block which may be confirmed through lack of PV potentials detected with the loop sensing catheter 512. (Catheter 512 carries a series of mutually spaced sensing electrodes 524 that detect voltage potentials in the cardiac tissue.) The circumferential lesion may take on a variety of shapes (oval or more complicated shapes) and depends on the surrounding anatomy of the PV antrum. The advantage of this approach is that all anatomical variations can be safely treated by moving the ablation plane axially to avoid ablating collateral structures and or by tilting the ablation plane by bending the distal portion of ablation catheter 105.
Numerous other variations and combinations of the features discussed above can be utilized. For example, the emitter structure or transducer array 512 can be slideably mounted within the catheter so that the catheter stays in place during the treatment. In still other arrangements, several emitters might be mounted on the catheter in a chain like fashion in order to apply energy over the length of the catheter inserted into the left atrium. Again this configuration does not require a movement of the catheter during treatment. In still other embodiments, focusing devices, such as lenses and diffractive elements can be employed in case of ultrasonic energy.
The state of the lesion annulus within the PV antrum can be monitored by ultrasound imaging during the treatment. During treatment, the tissue changes its physical properties, and thus its ultrasound reflectivity when necrosed. These changes in tissue ultrasound reflectivity can be observed using ultrasonic imaging to monitor the formation of the desired lesion in the annulus within the PV antrum. Other imaging modalities which can detect heating can alternatively or additionally be used to monitor the treatment. For example, magnetic resonance imaging can detect changes in temperature. In the case of reliance on non-ultrasound imaging modalities, it is optional to include the imaging transducer section 504 as part of the ultrasound transducer array 412.
This application claims the benefit of U.S. Provisional Patent Applications No. 61/899,958 filed Nov. 5, 2013, and 61/899,568 filed Nov. 4, 2013.
Filing Document | Filing Date | Country | Kind |
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PCT/US2014/063344 | 10/31/2014 | WO | 00 |
Number | Date | Country | |
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61899568 | Nov 2013 | US | |
61899958 | Nov 2013 | US |