Patent Grant
10219857
n/a
The present invention relates generally to ablation systems and methods for performing targeted tissue ablation in a patient.
The present invention relates generally to ablation systems and methods for performing targeted tissue ablation in a patient. In particular, the present invention provides radiofrequency (RF) energy generators that create safe, precision lesions in tissue such as cardiac tissue.
Tissue ablation is used in numerous medical procedures to treat a patient. Ablation can be performed to remove or denature undesired tissue such as cancer cells. Ablation procedures may also involve the modification of the tissue without removal, such as to stop electrical propagation through the tissue in patients with an arrhythmia condition. Often the ablation is performed by passing energy, such as electrical energy, through one or more electrodes and causing the tissue in contact with the electrodes to heat up to an ablative temperature. Ablation procedures can be performed on patients with atrial fibrillation by ablating tissue in the heart.
Mammalian organ function typically occurs through the transmission of electrical impulses from one tissue to another. A disturbance of such electrical transmission may lead to organ malfunction. One particular area where electrical impulse transmission is critical for proper organ function is in the heart. Normal sinus rhythm of the heart begins with the sinus node generating an electrical impulse that is propagated uniformly across the right and left atria to the atrioventricular node. Atrial contraction leads to the pumping of blood into the ventricles in a manner synchronous with the pulse.
Atrial fibrillation refers to a type of cardiac arrhythmia where there is disorganized electrical conduction in the atria causing rapid uncoordinated contractions that result in ineffective pumping of blood into the ventricle and a lack of synchrony. During atrial fibrillation, the atrioventricular node receives electrical impulses from numerous locations throughout the atria instead of only from the sinus node. This overwhelms the atrioventricular node into producing an irregular and rapid heartbeat. As a result, blood pools in the atria that increases a risk for blood clot formation. The major risk factors for atrial fibrillation include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. Atrial fibrillation affects 7% of the population over age 65
Atrial fibrillation treatment options are limited. Lifestyle change only assists individuals with lifestyle related atrial fibrillation. Medication therapy assists only in the management of atrial fibrillation symptoms, may present side effects more dangerous than atrial fibrillation, and fail to cure atrial fibrillation. Electrical cardioversion attempts to restore sinus rhythm but has a high recurrence rate. In addition, if there is a blood clot in the atria, cardioversion may cause the clot to leave the heart and travel to the brain or to some other part of the body, which may lead to stroke. What are needed are new methods for treating atrial fibrillation and other conditions involving disorganized electrical conduction.
Various ablation techniques have been proposed to treat atrial fibrillation, including the Cox-Maze procedure, linear ablation of various regions of the atrium, and circumferential ablation of pulmonary vein ostia. The Cox-Maze procedure and linear ablation procedures are tedious and time-consuming, taking several hours to accomplish. Pulmonary vein ostial ablation is proving to be difficult to do, and has lead to rapid stenosis and potential occlusion of the pulmonary veins. All ablation procedures involve the risk of inadvertently damaging untargeted tissue, such as the esophagus while ablating tissue in the left atrium of the heart. There is therefore a need for improved atrial ablation products and techniques that create efficacious lesions in a safe manner.
Several unique radiofrequency (RF) energy generators and ablation catheter systems and methods are provided which map and ablate large surface areas within the heart chambers of a patient, with one or few catheter placements. Any electrocardiogram signal site (e.g. a site with aberrant signals) or combination of multiple sites that are discovered with this placement may be ablated. In alternative embodiments, the RF generators and/or ablation catheters may be used to treat non-cardiac patient tissue, such as tumor tissue.
Advantages of the invention may include one or more of the following. The system and method provide maximum flexibility, efficacy and safety. The system and method provide independent delivery of monopolar and/or bipolar RF energy to multiple (e.g. 4, 8 or 12) user selectable electrodes. Monopolar energy delivery provides lesion depth and bipolar energy delivery provides lesion fill between selected electrodes. Sequential and/or simultaneous delivery of monopolar and bipolar RF energy can provide variable-depth linear lesions with a single or a reduced number of applications of energy. The system and method provide safe, precisely controlled delivery of RF energy to tissue.
In one embodiment, a constant voltage source is utilized for all pairs of RF outputs (channels) and adjustment of the phase angle of the applied (RF) voltage produces different ratios of simultaneous and/or cumulative monopolar and bipolar energy delivered such as to create varied length and depth lesions in the tissue of a patient.
In another embodiment, a varied voltage source is utilized for all pairs of RF outputs and adjustment of the voltage amplitude or other applied voltage property produces different ratios of simultaneous and/or cumulative monopolar and bipolar energy delivered such as to create varied length and depth lesions in the tissue of a patient. In this embodiment, the duty cycle used during energy delivery may be fixed, or alternatively it may be varied such as a configuration in which a minimal duty cycle is used which incrementally increases to reach a target tissue temperature. In this embodiment, the phase shift may be fixed, such as fixed at 90° or 180° phase shift to create the bipolar energy. The RF generator of this embodiment includes variable power supply circuits for each RF output.
In yet another embodiment, varying the average “on” time of bipolar and/or monopolar power delivery is utilized for all pairs of RF outputs and adjustment of this average produces different ratios of simultaneous and/or cumulative monopolar and bipolar energy delivered such as to create varied length and depth lesions in the tissue of a patient. The ratio of bipolar fields (or combined monopolar-bipolar fields) to monopolar fields may be adjusted to achieve a desired power level and/or bipolar-monopolar ratio. Alternatively or additionally, the duty cycle ratio within the bipolar fields (or combined monopolar-bipolar fields) and the monopolar fields may be adjusted to achieve the desired power level and/or bipolar-monopolar ratio. Alternatively or additionally, the fields length of the bipolar fields (or combined monopolar-bipolar fields) and the monopolar fields may be adjusted to achieve the desired power level and/or bipolar-monopolar ratio.
The RF generators of the present invention may employ one or more energy delivery algorithms to control power delivery. In one embodiment, an algorithm provides energy at a fixed power, such as a maximum power, until the tissue to be ablated reaches a first temperature level. For temperatures above the first temperature level, power is delivered at a level determined by the actual tissue temperature. Target temperature levels and/or threshold temperatures may be adjustable by an operator of the system. In another embodiment, an algorithm employs a main control loop based on a power differential analysis and a secondary control loop based on a temperature differential analysis.
The RF generators of the present invention may employ a multiplexing module which allows an operator of the system to selectively pair RF outputs from a group of three or more RF outputs to deliver bipolar energy between the selected pair.
In another embodiment, the system and method include closed loop energy delivery for each RF output including a PID control loop which receives information from a thermocouple mounted proximate each electrode on the ablation catheter such as to provide closed loop energy delivery based on measured tissue temperature. Power delivery may be duty cycle controlled to improve lesion creation efficiency, providing low power ablations. Duty cycle control allows delivery of high peak powers while providing electrode cooling times during the off cycle. In addition, duty cycle power control simplifies design and control of multiple RF outputs utilizing different phase angles. Duty cycle energy delivery also improves temperature acquisition as data can be acquired during the off portion of the duty cycle (i.e., during the RF “quiet time”). The system and method including temperature acquisition provide fast, accurate and electrically-isolated temperature acquisition for all electrodes. Each catheter electrode may include a small mass thermocouple. The system and method provide safe, controlled energy delivery.
In yet another embodiment, the RF generator includes a first set of ablation parameters that are utilized when a first form of ablation catheter is attached to the RF outputs and a second set of ablation parameters that are utilized when a second form of ablation catheter is attached to the RF outputs.
In yet another embodiment, the RF generator includes an improved EKG interface for connecting the RF outputs to an EKG diagnostic device. When one or more ablation catheters are attached to the RF generator, the electrodes of the ablation catheter are electrically attached to the RF outputs of the RF generator. The improved EKG interface of the present invention attenuates the energy delivered to ablate tissue to a level to prevent damage to any attached EKG diagnostic device, yet allows EKG or other signals sensed by the electrodes to be transferred to the EKG diagnostic device with minimal attenuation of those signals.
According to another aspect of the invention, a system for performing an ablation procedure is described. In one embodiment, one or more ablation catheters are provided with an RF generator of the present invention. In another embodiment, a remote control is provided with the RF generator of the present invention.
One aspect of the invention provides a radio frequency tissue ablation system including a radio frequency generator. The generator has a radio frequency source, at least four independently controllable radio frequency outputs, a user interface and a controller configured to delivery radio frequency energy from the radio frequency source to the radio frequency outputs in one of at least two different output configurations in response to a configuration selection made through the user interface. In some embodiments, the controller is further configured to operate each output in either a monopolar mode or in a bipolar mode or possibly in a combination monopolar/bipolar mode, possibly in response to a configuration selection made through a user interface. The system may also include a ground pad connected to a ground source when the outputs are operated in both monopolar mode and bipolar mode.
In some embodiments, the controller is further configured to deliver radio frequency energy from the radio frequency source to the radio frequency outputs in a plurality of successive time fields each having a period. The time fields may have a duty cycle with a portion of the period when radio frequency energy is being delivered to the outputs and another portion of the period when radio frequency energy is not being delivered to the outputs. The controller may be further configured to adjust the duty cycle in response to a configuration selection made through the user interface. In some embodiments, at least one time field of the plurality of the successive time fields is monopolar for at least a portion of the period, and at least another time field of the successive time fields is bipolar for at least a portion of the period. In such embodiments, the controller may be configured to adjust a ratio of bipolar to monopolar time fields in response to a configuration selection made through the user interface. One time field may be a combination monopolar/bipolar time field. The controller may also be further configured to adjust a length of at least one time field in response to a configuration selection made through the user interface.
In some embodiments, the radio frequency source is a constant voltage source, and in some embodiments the radio frequency source is a variable voltage source, in which case the controller may be further configured to vary voltage amplitude in response to a configuration selection made through the user interface. In some embodiments the controller is further configured to adjust voltage phase angle of the RF source, possibly in response to a configuration selection made through the user interface. In some embodiments, the controller includes a time division multiplexor.
In some embodiments, the radio frequency generator further includes an electrode tool interface configured to detect an identifier of a radio frequency electrode tool connected to the interface, the controller being configured to adjust radio frequency energy delivery parameters to an radio frequency electrode tool based on the identifier detected by the interface. Such systems may also include a first radio frequency electrode tool having a first electrode configuration and second radio frequency electrode tool having a second electrode configuration different from the first electrode configuration, the first and second radio frequency electrode tools each having a connector adapted to connect to the radio frequency generator electrode tool interface, the connector of each tool having a unique identifier adapted to communicate with the radio frequency generator electrode tool interface.
Some embodiments according to this aspect of the invention have a ground pad, with the controller being configured to connect and disconnect the ground pad to a ground source in response to a configuration selection made through the user interface. In some embodiments, each output has an output line, a return line and a resistance between output line and the return line. The resistance may have a value that provides signal stability on the output during light load conditions at the output.
Another aspect of the invention provides a radio frequency ablation system having a radio frequency generator; a plurality of radio frequency electrodes; a temperature sensor; and a controller communicating with the temperature sensor to control an amount of energy delivered to the electrodes in a first portion of an energy delivery session irrespective of temperature sensed by the temperature sensor and in a second portion of the energy delivery session based on the temperature sensed by the temperature sensor. In some embodiments, the controller is configured to cease energy delivery to the electrodes when a predetermined target temperature is sensed by the temperature sensor. The system may also have a user interface adapted to set the target temperature.
In some embodiments, the controller is further configured to cease the first portion of the energy delivery session when the temperature sensor reaches a threshold temperature that is a predetermined amount lower than the target temperature. In some embodiments, the controller is configured to cease the first portion of the energy delivery session when temperature sensed by the temperature sensor reaches a threshold temperature. The system may also have a user interface adapted to set the threshold temperature.
In some embodiments, the controller is configured to independently control energy delivery to each electrode. The system may also have a temperature sensor associated with each electrode, with the controller independently communicating with each temperature sensor in the delivering step to control the amount of energy delivered to the electrodes. In some embodiments, the controller is configured to independently control energy to a pair of electrodes and at least one other electrode.
In some embodiments, the controller is configured to deliver radio frequency energy in a plurality of successive time fields each having a period and a duty cycle comprising a portion of the period when radio frequency energy is being delivered to the electrodes and another portion of the period when radio frequency energy is not being delivered to the electrodes. The controller may also be further configured to adjust the duty cycle based on monitored temperature.
Yet another aspect of the invention provides a radio frequency energy generation system for delivering radio frequency energy to a cardiac ablation catheter. In some embodiments, the system has a radio frequency generator adapted to deliver radio frequency energy in both monopolar and bipolar modes to an ablation catheter, wherein the ablation catheter has an electrode array comprising at least one electrode; an EKG monitoring unit adapted to monitor and map signals detected by the plurality of ablation catheters; and an interface unit including an inductor which couples the radio frequency generator and EKG monitoring unit to filter radio frequency signals from EKG signals received by the EKG monitoring unit.
In some embodiments, the at least one electrode is adapted to monitor the temperature of atrial tissue adjacent the electrode, and the generator generates radio frequency energy based on the temperature of the atrial tissue. There may be a plurality of electrodes, and the generator may be adapted to independently monitor the temperature of atrial tissue measured by each of the plurality of electrodes, and the radio frequency generator may be adapted to generate and deliver radio frequency energy to each of the plurality of electrodes based on the independently monitored temperatures.
In some embodiments, the EKG monitoring unit has a plurality of inputs and an inductor associated with each input. In some embodiments, the generator is adapted to deliver energy in a bipolar mode, a monopolar mode, and a combination of both bipolar and monopolar, such as in bipolar to monopolar ratios of at least 4:1, 2:1, and 1:1.
Still another aspect of the invention provides a method of delivering radio frequency ablation energy to a patient's tissue, such as heart tissue, prostate tissue, brain tissue, gall bladder tissue, uterine tissue, or tumor tissue. The method includes the steps of delivering radio frequency energy to a plurality of electrodes to heat the patient's tissue in first and second portions of an energy delivery session; monitoring temperature of the patient's tissue during the delivering step; delivering radio frequency energy at a power level in the first portion of the energy delivery session, the power level being irrespective of monitored tissue temperature; and controlling radio frequency energy delivered to the electrodes in the second portion of the energy delivery session based on monitored tissue temperature.
In some embodiments, the method includes the step of ceasing energy delivery when a predetermined target tissue temperature is reached. The method may also include the step of setting the target tissue temperature. In some embodiments, the method includes the step of ceasing the first portion of the energy delivery session when monitored tissue temperature reaches a threshold tissue temperature that is a predetermined amount lower than the target tissue temperature.
In some embodiments, the first portion of the energy delivery session ceases when a threshold tissue temperature is reached. The method may also include the step of setting the threshold tissue temperature. In some embodiments, at least one of the controlling steps includes the step of independently controlling energy delivery to each electrode or to a pair of electrodes and to at least one other electrode.
In some embodiments, the delivering step includes the step of delivering radio frequency energy in a plurality of successive time fields each having a period and a duty cycle, where the duty cycle has a portion of the period when radio frequency energy is being delivered to the electrodes and another portion of the period when radio frequency energy is not being delivered to the electrodes. In some embodiments, at least one of the controlling steps includes the step of adjusting the duty cycle.
In some embodiments, the step of controlling radio frequency energy delivered to the electrodes in the second portion of the energy delivery session includes the step of comparing a monitored temperature to a target temperature and adjusting a power goal. The delivering step may also include the step of comparing the power goal to a power limit and resetting the power goal to the power limit if the power goal exceeds the power limit.
In various embodiments of the invention, a radiofrequency generator for delivering energy to ablate tissue of a patient has at least four, at least eight, at least twelve or at least sixteen independent RF outputs configured to provide energy to four or more electrodes of an ablation catheter. In various embodiments of the generator, independent RF outputs can deliver at least monopolar, bipolar, and combination bipolar/monopolar energy.
Another embodiment of the invention is a radiofrequency generator for delivering energy to ablate tissue of a patient having a power scheme, including an algorithm, which initially delivers energy to a maximum power level until the tissue reaches a first temperature, and subsequently delivers temperature regulated power until the tissue reaches a second temperature.
Another embodiment of the invention is a radiofrequency generator for delivering energy to ablate tissue of a patient; the invention having a power scheme, including an algorithm, which delivers bipolar and monopolar and combination power to multiple RF outputs and which adjusts the bipolar to monopolar ratio by varying phase angle.
Another embodiment of the invention is a radiofrequency generator for delivering energy to ablate tissue of a patient having a power scheme, including an algorithm, which delivers bipolar and monopolar and combination power to multiple RF outputs and which adjusts the bipolar to monopolar ratio by varying the voltage source.
Another embodiment of the invention is a radiofrequency generator for delivering energy to ablate tissue of a patient has a power scheme, including an algorithm, which delivers bipolar and monopolar and combination power to multiple RF outputs and which delivers the bipolar and monopolar power in sets of multiple repeating fields and adjusts the bipolar to monopolar ratio by varying the average “on” time of the bipolar and/or monopolar power delivery within each of said sets of multiple repeating fields.
Another embodiment of the invention is a radiofrequency generator, for delivering energy to ablate tissue of a patient, having a power scheme, including an algorithm, which delivers power to multiple RF outputs with a first duty cycle percentage, and increases the duty cycle percentage to achieve a target temperature such as to maximize the off-time portion of the duty cycle.
Another embodiment of the invention is a radiofrequency generator, for delivering energy to ablate tissue of a patient, having multiple RF outputs which are configured to be selectively paired to deliver bipolar energy between the selected pair.
Another embodiment is a radiofrequency generator, for delivering energy to ablate tissue of a patient, having at least four independent temperature inputs which are configured to receive temperature information and produce four corresponding temperature signals, and at least four PID loops configured to receive the four temperature signals and regulate RF power delivery.
Another embodiment is a radiofrequency generator for delivering energy to ablate tissue of a patient, having a first set of ablation parameters configured to be utilized when a first ablation catheter is attached, and a second set of ablation parameters configured to be utilized when a second ablation catheter is attached.
Another embodiment is a radiofrequency generator for delivering energy to ablate tissue of a patient, having an EKG interface module configured to isolate an EKG monitoring unit from delivered RF energy while minimizing attenuation of EKG signals received from the electrodes of the ablation catheter.
In further embodiments of the invention, the power scheme may initially deliver energy at a maximum power level until the tissue reaches a first temperature and subsequently delivers temperature regulated power until the tissue reaches a second temperature. The first temperature may be set by an operator of the system, or may be automatically set to a temperature approximately 5° less than the second temperature. In another embodiment, the second temperature of the radiofrequency generator is set by an operator of the system. In another embodiment, both the first and second temperatures are set by an operator of the system. In yet another embodiment, the first temperature is automatically set to a temperature approximately 5° less than the second temperature.
In another embodiment, the voltage source is varied by varying the RMS voltage, and more particularly by varying the peak amplitude.
In other embodiments, the power scheme of the generator may also include an algorithm that delivers bipolar and monopolar power to multiple RF outlets, and adjusts the bipolar to monopolar ratio by varying one or more of the phase angle, voltage source, the RMS voltage and the peak amplitude. In still other embodiments, the power from the generator is delivered in multiple fields, and each field has a set duty cycle percentage. The duty cycle may be set between about 5 and about 25%. In some embodiments, the generator may have a least four, or at least 12, variable power supply circuits. In some embodiments, the power from the generator may be delivered in multiple fields, each field having an initial duty cycle percentage, said duty cycle percentage increasing to achieve a target temperature.
In alternate embodiments, the radiofrequency generator has at least four, or at least twelve variable power supply circuits.
In some embodiments, the algorithm of the power scheme delivers bipolar and/or monopolar power in sets of multiple repeating fields and the generator is adjusted by adjusting the ratio of monopolar fields to combination fields and/or bipolar fields by varying the average “on” time of the bipolar and/or monopolar power delivery within each of said sets of multiple repeating fields. The average “on” time may be adjusted by adjusting one or more of the ratio of monopolar to combination and/or bipolar fields with a set, the duty cycle ratio within one or more fields in the set, and the field length of one or more fields within the set. The RF outputs of the generator may be in-phase or out-of-phase and the systems include a ground pad that is always electrically connected. Out-of-phase energy delivery may be accomplished with a 90° or 180° phase shift.
In some embodiments, the algorithm of the power scheme may deliver power to multiple RF outputs with a first duty cycle percentage and increase the duty cycle percentage to achieve a target temperature such as to maximize the off-time portion of the duty cycle.
In some embodiments, the generator may have multiple RF outputs which are configured to be selectively paired to deliver bipolar energy between the selected pair.
In some embodiments, the generator may have at least four independent temperature inputs configured to receive temperature information and produce at least four corresponding temperature signals, and at least four PID loops configured to receive the at least four temperature signals and regulate RF power delivery.
In some embodiments, the generator may have a first set of ablation parameters configured to be utilized when a first ablation catheter is attached, and a second set of ablation parameters configured to be utilized when a second ablation catheter is attached. The power delivered is dependent on one or more parameters of the ablation catheter receiving ablation energy, said parameters selected from the group consisting of distance between two electrodes, electrode geometry, thermocouple location and combinations thereof.
In some embodiments, the RF generator may have an EKG interface module configured to isolate an EKG monitoring unit from delivered RF energy while minimizing attenuation of EKG signals received from the electrodes of the ablation catheter. The EKG interface module may include an inductor to attenuate the RF energy, which may have approximately 1000 milliHenry of inductance.
In some embodiments, the RF generator may deliver energy in monopolar or combination mode only such that the return pad remains electrically connected during energy delivery. In certain embodiments, the bipolar portion may be created with 90° or 180° phase shifted applied voltages.
In some embodiments, the generator may have a signal generator for each two RF outputs. The first signal generator may be synchronized in time with a second signal generator. Each signal generator may be under microprocessor control.
In some embodiments, the power from the generator may be duty cycle controlled, and may be adjusted in a series of discrete steps, which may be at least 256 steps. The duty cycle period may be a period of time less than the thermal time constant of the tissue to be ablated. The duty cycle period may be approximately 17 milliseconds or between 10 and 500 milliseconds and may be configured to be adjusted by an operator. In another embodiment, the duty cycle may be approximately 10%, and may be between about 5% and about 25%.
In some embodiments, the bipolar power delivered by the generator may be created by a phase shift between applied voltages, said phase shift adjustable in discrete steps, such as 16 steps. The applied voltage may be between about 20 and 200 volts RMS, more specifically 40 volts RMS, or 100 volts RMS. In some embodiments the applied voltage has a frequency of approximately 470 KHz.
In some embodiments, power delivered by the generator maybe adjustable by an operator. In some embodiments the delivered power may be adjustable between 0 and 80 watts RMS. The delivered power may be adjusted by varying phase shift; duty cycle percentage; duty cycle period; applied voltage; frequency of applied voltage; shape of applied voltage such as sinusoidal, triangular wave, or square wave shapes; connections to the return pad; voltage applied to return pad; and combinations thereof. The bipolar to monopolar ratio may be adjusted. The delivered power may be adjusted by microprocessor control. In other embodiments, the power delivered by the generator is adjusted by microprocessor control.
In some embodiments, the generator may deliver power during a set of repeating fields, said fields including an “on” time and an “off.” The set of repeating fields may include 4 or 8 fields. Each field may have a period between about 10 and 500 milliseconds, more specifically approximately 17 milliseconds. The generator may deliver power during the “on” time including at least one of monopolar power, bipolar power, and combination power. The power delivered during the “on” time may be limited to monopolar or combination power.
In some embodiments, the generator may have an algorithm that includes at least one power limit. The power limits may include multiple power limits. The first power limit may be applicable to a first ablation catheter and a second power limit applicable to a second ablation catheter. In another embodiment, the first power limit may be applicable to a first bipolar-monopolar ratio and a second power limit applicable to a second bipolar-monopolar ratio. The power limit for the greater bipolar-monopolar ratio may be less than the power limit for the lesser bipolar-monopolar ratio. The power limit may be approximately 10 watts RMS and applicable to a monopolar-only power delivery. The power limit of approximately 10 watts RMS may be applicable to a monopolar-bipolar ratio of 1:1, 2:1, or 4:1. The power limit of approximately 6 watts RMS may be applicable to a bipolar-only power delivery. A power limit of approximately 20 watts may be applicable to at least one electrode of an ablation catheter. A power limit of approximately 30 watts may be applicable to at least one electrode of an ablation catheter.
In some embodiments, the generator may have a return pad that is electrically connected to a return or common connection of all the RF outputs. The return pad may be electrically connected during all energy deliveries.
In some embodiments, the generator may provide duty cycle controlled energy delivery and one or more measurements are performed during the “off” time of a duty cycle. The measurement may be an analysis of information received from a temperature sensor. The temperature sensor may be a thermocouple of an ablation catheter. The measurement may be an analysis of information received from an EKG sensor. The EKG sensor may be an electrode of an ablation catheter.
In some embodiments, the generator may be configured to provide electrical isolation between at least one component of the generator and the patient. The electrical isolation provided may be at least 5000 volts of electrical isolation. The at least one component may be an RF output of the generator. The generator may have a temperature input configured to receive temperature information from a thermocouple, and said at least one component is said temperature input.
In some embodiments, the generator may have a temperature sensor module configured to receive temperature information from multiple temperature sensors. The temperature sensor module may include at least 4, at least 8, or at least 12 independent channels. The temperature sensor module may include multiple independent control loops configured to provide feedback to regulate power based on current temperature information received from the temperature sensors and target temperature information set by an operator of the system. In some embodiments, the target temperature information may be selected from the range of 50° C. to 70° C. In some embodiments, the generator my have a second target temperature, said second target temperature used in combination with the first target temperature by a power control algorithm of the generator. In some embodiments, the temperature sensor module may include an amplifier for each temperature input, each amplified configured to amplify the signal. The amplifier may have a gain of approximately 100. In some embodiments, the temperature ratio between the various electrodes may be controlled by adjusting each RF output's duty cycle, such as to balance the temperature across the lesion.
In some embodiments, the generator may have bipolar to monopolar power delivery controlled using time division multiplexing.
In some embodiments, the generator is configured is configured to perform cardiac procedures selected from the group consisting of atrial fibrillation procedures; supra ventricular tachycardia procedures; atrial tachycardia procedures; supra ventricular tachycardia procedures; ventricular fibrillation procedures; and combinations thereof.
In some embodiments, the generator is configured to perform tumor ablation procedures.
In some embodiments, the generator is configured to perform procedures selected from the group consisting of: prostate procedures; brain procedures; gall bladder procedures; uterus procedures; and combinations thereof.
In some embodiments, the generator further has at least one ablation catheter. In some embodiments, the ablation catheter is configured to perform a pulmonary vein ablation procedure. The ablation catheter may include at least one electrode with a mass between 30 and 50 milligrams, more specifically approximately 40 milligrams. The ablation catheter may have at least one thermocouple with a mass between 48 and 88 micrograms, more specifically approximately 68 milligrams. The ablation catheter may include at least one thermocouple constructed of wire of approximately 38 gauge. The ablation catheter may be configured to perform an atrial wall ablation procedure. The ablation catheter may include at least one electrode with a mass between 17 and 37 milligrams, more specifically approximately 27 milligrams. The ablation catheter may include at least one thermocouple with a mass between 22 and 62 micrograms, more specifically 43 micrograms. The ablation catheter may include at least one thermocouple constructed of wire of approximately 40 gauge. The ablation catheter may include at least one electrode with a wall thickness between 0.004″ and 0.010″, more specifically approximately 0.006″. The ablation catheter may include at least one electrode including a heat sink. The at least one electrode including a heat sink may be a projecting fin.
In some embodiments the generator may include a static load electrically connected to each RF amplifier configured to stabilize the RF output. The static load may be approximately 2000 ohms of impedance.
In some embodiments, the generator may include an algorithm which requires a minimum ablation energy delivery time. The minimum ablation energy delivery time may be 25, or 40 seconds.
Another embodiment of the invention is a system for delivering energy to ablate tissue of a patient, having a remote controller for the radiofrequency generator and having a radiofrequency generator. The controller has a user interface configured to allow an operator to send commands to the radiofrequency generator or to provide to an operator information received from the radiofrequency generator. The remote controller may both send commands and provide information to an operator, and the commands and/or said information may be transferred over a wired or wireless connection. The remote controller may be sterile, and may be a sterile bag configured to surround at least the housing of the remote controller. The user interface may provide the same set of commands, or may provide the same set of information, as the user interface of the RF generator.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various embodiments of the present invention, and, together with the description, serve to explain the principles of the invention. In the drawings:
Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts
The present invention provides catheters for performing targeted tissue ablation in a subject. In some embodiments, the catheters comprise a tubular body member having a proximal end and distal end and a lumen extending therebetween. The catheter is of the type used for performing intracardiac procedures, typically being introduced from the femoral vein in a patient's leg or from a vessel in the patient's neck. The catheter is introducible through a sheath and also has a steerable tip that allows positioning of the distal portion such as when the distal end of the catheter is within a heart chamber. The catheters include ablation elements mounted on a carrier assembly. The carrier assembly is attached to a coupler, which in turn is connected to a control shaft that is coaxially disposed and slidingly received within the lumen of the tubular body member. The carrier assembly is deployable by activating one or more controls on a handle of the catheter, such as to engage one or more ablation elements against cardiac tissue, typically atrial wall tissue or other endocardial tissue.
Arrays of ablation elements, such as electrode arrays, may be configured in a wide variety of ways and patterns. In particular, the present invention provides devices with electrode arrays that provide electrical energy, such as radiofrequency (RF) energy, in monopolar mode, bipolar mode or combined monopolar-bipolar mode, as well as methods for treating conditions (e.g., atrial fibrillation, supra ventricular tachycardia, atrial tachycardia, ventricular tachycardia, ventricular fibrillation, and the like) with these devices.
The normal functioning of the heart relies on proper electrical impulse generation and transmission. In certain heart diseases (e.g., atrial fibrillation) proper electrical generation and transmission are disrupted or are otherwise abnormal. In order to prevent improper impulse generation and transmission from causing an undesired condition, the ablation catheters and RF generators of the present invention may be employed.
One current method of treating cardiac arrhythmias is with catheter ablation therapy. Physicians make use of catheters to gain access into interior regions of the body. Catheters with attached electrode arrays or other ablating devices are used to create lesions that disrupt electrical pathways in cardiac tissue. In the treatment of cardiac arrhythmias, a specific area of cardiac tissue having aberrant conductive pathways, such as atrial rotors, emitting or conducting erratic electrical impulses, is initially localized. A user (e.g., a physician) directs a catheter through a main vein or artery into the interior region of the heart that is to be treated. The ablating element is next placed near the targeted cardiac tissue that is to be ablated. The physician directs energy, provided by a source external to the patient, from one ore more ablation elements to ablate the neighboring tissue and form a lesion. In general, the goal of catheter ablation therapy is to disrupt the electrical pathways in cardiac tissue to stop the emission of and/or prevent the propagation of erratic electric impulses, thereby curing the focus of the disorder. For treatment of atrial fibrillation, currently available methods and devices have shown only limited success and/or employ devices that are extremely difficult to use or otherwise impractical.
The ablation systems of the present invention allow the generation of lesions of appropriate size and shape to treat conditions involving disorganized electrical conduction (e.g., atrial fibrillation). The ablation systems of the present invention are also practical in terms of ease-of-use and limiting risk to the patient (such as in creating an efficacious lesion while minimizing damage to untargeted tissue), as well as significantly reducing procedure times. The present invention addresses this need with, for example, carrier assemblies with 3 or 4 carrier arms, carrier assemblies with forward facing electrodes, carrier assemblies with rear-facing electrodes and carrier assemblies configured in a helix or partial helix. The carrier assemblies include ablation elements such as electrodes which create spiral, radial, or other simple or complex shaped patterns of lesions in the endocardial surface of the atria by delivery of energy to tissue or other means. The electrodes may include projecting fins to improve cooling properties. The lesions created by the ablation catheters and RF generators of the present invention are suitable for inhibiting the propagation of inappropriate electrical impulses in the heart for prevention of reentrant arrhythmias, while minimizing damage to untargeted tissue, such as the esophagus or phrenic nerve of the patient.
To facilitate an understanding of the invention, a number of terms are defined below.
As used herein, the terms “subject” and “patient” refer to any animal, such as a mammal like livestock, pets, or a human. Specific examples of “subjects” and “patients” include, but are not limited, to individuals requiring medical assistance, and in particular, requiring atrial fibrillation catheter ablation treatment.
As used herein, the terms “catheter ablation” or “ablation procedures” or “ablation therapy,” and like terms, refer to what is generally known as tissue destruction procedures. Ablation is often used in treating several medical conditions, including abnormal heart rhythms. It can be performed both surgically and non-surgically. Non-surgical ablation is typically performed in a special lab called the electrophysiology (EP) laboratory. During this non-surgical procedure an ablation catheter is inserted into the heart using fluoroscopy for visualization, and then an energy delivery apparatus is used to direct energy to the heart muscle via one or more ablation elements of the ablation catheter. This energy either “disconnects” or “isolates” the pathway of the abnormal rhythm (depending on the type of ablation). It can also be used to disconnect the conductive pathway between the upper chambers (atria) and the lower chambers (ventricles) of the heart. For individuals requiring heart surgery, ablation can be performed during coronary artery bypass or valve surgery.
As used herein, the term “ablation element” refers to an energy delivery element, such as an electrode for delivering electrical energy. Ablation elements can be configured to deliver multiple types of energy, such as ultrasound energy and cryogenic energy, either simultaneously or serially. Electrodes can be constructed of a conductive plate, wire coil, or other means of conducting electrical energy through contacting tissue. In monopolar energy delivery mode, the energy is conducted from the electrode, through the tissue to a return or ground pad, such as a conductive pad attached to the back of the patient. The high concentration of energy at the electrode site causes localized tissue ablation. In bipolar energy delivery mode, the energy is conducted from a first electrode to one or more separate electrodes, relatively local to the first electrode, through the tissue between the associated electrodes. Bipolar energy delivery results in more precise, shallow lesions while monopolar delivery results in deeper lesions. Both monopolar and bipolar delivery provide advantages, and the combination of their use is one embodiment of this application.
As used herein, the term “carrier assembly” refers to a flexible carrier, on which one or more ablation elements are disposed. Carrier assemblies are not limited to any particular size, or shape, and can be configured to be constrained within an appropriately sized lumen.
As used herein, the term “carrier arm” refers to a wire-like shaft capable of interfacing with electrodes and the coupler. A carrier arm is not limited to any size or measurement. Examples include, but are not limited to: stainless steel shafts; Nitinol shafts; titanium shafts; polyurethane shafts; nylon shafts; and steel shafts. Carrier arms can be entirely flexible, or may include flexible and rigid segments.
As used herein, the term “lesion,” or “ablation lesion,” and like terms, refers to tissue that has received ablation therapy. Examples include, but are not limited to, scars, scabs, dead tissue, burned tissue and tissue with conductive pathways that have been made highly resistive or disconnected.
As used herein, the term “coagulum” refers to a blood mass or clot such as a clot which may be caused by excessive heating in blood.
As used herein, the terms “return pad” or “ground pad” interchangeably refer to a surface electrode mounted to the patient's body, typically on the patient's back. The return pad receives the RF ablation currents generated during monopolar power delivery. The return pad is sized (large enough) such that the high temperatures generated remain within a few millimeters of the specific ablation catheter's electrode delivering the monopolar power.
As used herein, the term “RF output” refers to an electrical output produced by the RF generator of the present invention. The RF output is electrically connected to a jack or other electro-mechanical connection means which allows electrical connection to one or more electrodes of an ablation catheter. The RF output provides the RF energy to the electrode to ablate tissue with bipolar and/or monopolar energy.
As used herein, the term “channel” refers to a pair of RF outputs between which bipolar energy is delivered. Each of the RF outputs in a channel may also deliver monopolar energy (simultaneous and/or sequential to bipolar energy delivery), such as when a return pad is connected.
As used herein, the term “targeted tissue” refers to tissue identified by the clinician (and/or one or more algorithms of the system) to be ablated, such as to disconnect an aberrant electrical pathway causing an arrhythmia, or other undesired tissue such as cancer tissue.
As used herein, the term “untargeted tissue” refers to tissue which is desired to avoid damage by ablation energy, such as the esophagus or phrenic nerve in an arrhythmia ablation procedure.
As used herein, the term “set ablation time” refers to a time period over which ablation energy is delivered to targeted tissue in a relatively continuous manner, to ablate that tissue. The set ablation time is set by the operator and/or automatically set by one or more algorithms of the system of the present invention.
As used herein, the term “duty cycle” refers to the proportion of time during which a component, device or system is operated. The duty cycle can be expressed as a ratio or as a percentage. A microwave oven is a good example of a product that uses duty cycle for power control. At, e.g., power level one, the oven will be on for one second, and then off for nine seconds. This cycle repeats until the timer runs out. The oven is on for one out of ten seconds, or 1/10 of the time, and its duty cycle is therefore 1/10 or 10 percent.
As used herein, the term “field” refers to a single period of a duty cycle. Each field includes an “on” time in which energy is delivered and an “off” time in which no energy is delivered. In the system of the present invention, a sequential set of fields (e.g. 2, 4, 8) have a customized power delivery scheme which repeats over time.
As used herein, the term “power delivery scheme” refers to a set of ablation parameters to be delivered during a set ablation time, and used to safely create an effective lesion in targeted tissue. Power delivery scheme parameters include but are not limited to: type (bipolar and/or monopolar) of energy delivered; voltage delivered; current delivered; frequency of energy delivery; duty cycle parameter such as duty cycle percentage or length of period; field parameter such as configuration of fields or number of fields in set that repeats; and combinations thereof.
As used herein, the term “PID”, which is an acronym for “Proportional, Integral, Derivative”, refers to a type of controller that is designed to eliminate the need for continuous operator attention. Cruise control in a car and a house thermostat are common examples of how PID-based controllers are used to automatically adjust some variable to hold the measurement at the set-point.
The present invention provides structures that embody aspects of the ablation catheter. The present invention also provides RF generators for providing ablation energy to the ablation catheters. The illustrated embodiments discuss these structures and techniques in the context of catheter-based cardiac ablation. These structures, systems, and techniques are well suited for use in the field of cardiac ablation.
However, it should be appreciated that the invention is applicable for use in other tissue ablation applications such as tumor ablation procedures. For example, the various aspects of the invention have application in procedures for ablating tissue in the prostrate, brain, gall bladder, uterus, and other regions of the body, such as regions with an accessible wall or flat tissue surface, using systems that are not necessarily catheter-based. In one embodiment, the target tissue is tumor tissue.
The multifunctional catheters and RF generators of the present invention have advantages over previous prior art devices. The accompanying figures show various embodiments of the ablation systems of the present invention. The present invention is not limited to these particular configurations.
Specific details of electrode and array designs have been given elsewhere, such as in U.S. application Ser. No. 10/997,172, filed Nov. 24, 2004, entitled “Atrial Ablation Catheter and Method of Use”, assigned to the assignee of the present invention and herein incorporated by reference in its entirety for all purposes. For the purposes of
A multiple wire cable 92 attaches RF bank 30 to the electrodes of ablation catheter 90a via electrode connection 91. (The electrodes are not shown but may be metal plates with or without projecting fins that connect to electrode connection 91 via individual wires.) In one embodiment, RF bank 30 includes twelve separate, electrically-isolated RF outputs, grouped into two outputs per channel (six channels total). Each RF output 31 is configured to provide monopolar, bipolar or a combination of monopolar and bipolar currents simultaneously. The number of RF outputs can vary as required by the design. In one embodiment, four to twelve independent RF outputs are provided, such as when the system of the present invention includes a kit of ablation catheters including at least one catheter with from four to twelve electrodes. In another embodiment, more than 16 independent RF outputs are provided, such as when the system of the present invention includes a kit of ablation catheters including at least one catheter with sixteen electrodes.
Monopolar delivery is accomplished by delivering currents that travel from an RF output 41 of bank 40 to an electrically attached electrode of an ablation catheter, through tissue to return pad 80, and back to RFG through connection 11 to which return pad 80 has been connected. Bipolar delivery is accomplished by delivering current between a first RF output 41 which has been electrically connected to a first electrode of an ablation catheter and a second RF output 41 which has been electrically connected to a second electrode of the ablation catheter, the current traveling through the tissue proximate the first and second electrodes. Combo mode energy delivery is accomplished by combining the monopolar and bipolar currents described immediately hereabove.
In one embodiment, simultaneous monopolar and bipolar currents are delivered by utilizing a constant voltage source for all pairs of RF outputs (channels). Varying the voltage phase angle between the paired electrodes can be used to adjust the magnitude of power delivered as well as adjust the ratio of monopolar to bipolar power delivery. The user (e.g. a clinician or clinician's assistant) may select or deselect RF outputs receiving energy to customize therapeutic delivery to an individual patient's needs. In another embodiment, a variable voltage source is applied to the RF outputs. In this embodiment, the voltage phase angle may be fixed (e.g. 0° phase difference for monopolar and 180° phase difference for bipolar). Alternatively, in addition to varying the voltage, the phase angle may be varied. When the phase angle is fixed, the ratio of bipolar to monopolar (or combo to monopolar) may be varied by other means, such as by adjusting the ratio of “cumulative” delivery times of the monopolar versus bipolar (or combo) currents (described in detail in reference to
In another embodiment, five different pre-set energy delivery options are provided to the user: monopolar-only, bipolar-only, and 4:1, 2:1 and 1:1 bipolar/monopolar ratios. A bipolar-only option provides the shallowest depth lesion, followed by 4:1, then 2:1, then 1:1 and then monopolar-only which provides the deepest depth lesion. The ability to precisely control lesion depth increases the safety of the system and increases procedure success rates as target tissue can be ablated near or over important structures. In an alternative embodiment, currents are delivered in either monopolar mode or combo mode (only). The embodiment which avoids bipolar-only, has been shown to provide numerous benefits including reduction of electrical noise generated by switching off the return pad circuit (e.g. to create bipolar-only mode).
In another embodiment, RFG 10 includes multiple independent PID control loops that utilize measured tissue temperature information to regulate (i.e. provide closed loop) energy delivered to an ablation catheter's electrodes. A multiple wire cable 94 attaches temperature sensor input bank 40 to the thermocouples of ablation catheter 90a via thermocouple connection 93. (The thermocouples are not shown but may be integral to the electrodes of ablation catheter 90a and electrically connected to thermocouple connection 93 via one or more wires.) In one embodiment, multiple wire cable 92 and multiple wire cable 94 are a single conduit. The PID control loops of RFG 10 receive the temperature information via temperature sensor inputs 41 of bank 40. In one embodiment, temperature sensor input bank 40 includes twelve separate, electrically-isolated temperature sensor inputs. Each temperature input 41 is configured to receive temperature information such as from a sensor such as a thermocouple. The number of temperature inputs can vary as required by the design. In one embodiment, four to twelve independent inputs are provided, such as when the system of the present invention includes a kit of ablation catheters including at least one catheter with from four to twelve thermocouples. In another embodiment, more than 16 independent temperature inputs are provided, such as when the system of the present invention includes a kit of ablation catheters including at least one catheter with at least sixteen thermocouples.
Ablation target temperatures are user-selectable and automatically achieved and maintained throughout lesion creation, regardless of blood flow conditions and/or electrode contact scenarios. Temperature target information is entered via user interface 20 of RFG 10. User interface 20 may include a touch screen display, a membrane keypad or other user input components integral to or separate from a housing of RFG 10 (refer to
In the system of one embodiment, in order to regulate power across a number of separate RF outputs 31 that utilize phase angle differences to generate bipolar currents, the utilization of a constant voltage source, in conjunction with variable duty cycle power delivery, greatly simplifies the control and regulation of power. Utilizing duty cycle power control also provides the ability to deliver high peak powers while providing electrode cooling time during the off-portion of the duty cycle. Duty cycle control is configured such that the period (“on” time plus “off” time) is much less than the thermal time constant of the tissue, such that the tissue acts as an “integrator”, continuously accumulating the heat energy while the electrodes of the ablation catheter cool during the off period. In one embodiment, the period of each duty cycle is approximately 17 msec, and the thermal time constant is much longer than 17 msec. Allowing the electrodes to cool during the off period, reduces tissue overheating which could result in “popping” or micro-explosions within the tissue, or other undesired tissue breakdown. Duty cycle periods of approximately 17 msec are applicable to the system of the present invention. Duty cycle periods that are too long result in inadequate ablation of targeted tissue. Duty cycle periods that are too short result in inadequate cooling which may cause char or other blood clots, or damage untargeted tissue. In alternative embodiment, the duty cycle periods may range from 10 msec to 500 msec, and may be adjustable by the operator of the RFG via, e.g., the user interface. Duty cycle energy delivery provides increased efficiency, effectiveness and safety during lesion creation at reduced RMS power levels.
In some embodiments, amplitude control may replace or work in conjunction with duty cycle control. If a fixed duty cycle is implemented, e.g. a 10% duty cycle, the voltage may be regulated (to an amplifier of each RF output 31), such as voltage regulated by the temperature PID loops described above to similarly achieve a target tissue temperature in a precise manner. In an additional embodiment of this varied voltage configuration, if the temperature or power limit can not be reached with a given, pre-set duty cycle, the duty cycle percentage can be increased (e.g. in small steps) until equilibrium is achieved (i.e. the varied voltage, varied duty cycle embodiment mentioned above). The duty cycle percentage chosen provides a power limit (as well as bipolar to monopolar power ratios), and the temperature achieved is regulated by varying RF amplitude (voltage) delivered to RF outputs 31, in monopolar, bipolar, or combo mode energy delivery. In one embodiment, the temperature ratio between the various electrodes can be controlled by adjusting each RF output's duty cycle, such as to balance the temperature across the lesion. By starting with a low duty cycle on-time percentage, and increasing as necessary, power delivery equilibration may be achieved while maximizing the off-time percentage. Maximizing the off-time percentage provides numerous advantages including optimized electrode cooling and tissue temperature equilibrating, as well as maximizing the time that electronic measurements can be made during the low-noise off-time, such as EKG mapping and thermocouple measurements. In some embodiments, this varied voltage control configuration involves the addition of 12 separate variable power supply circuits on RF circuit boards of RFG 10, such as to work with ablation catheters including up to 12 electrodes. The duty cycle percentage is typically set in the range of 5% to 25% depending upon the (tissue) load resistance and power required for adequate ablation. This voltage-varied configuration is an alternative method of power control that can give the same or similar clinical effects to the duty cycle power control described above.
Referring back to
More details on the system of the present invention are provided below.
Referring to
Half bridge circuits 32a and 32b each produce a square wave, e.g. a 24-volt peak-to-peak square wave. Series resonant circuits 33a and 33b each couple the high power square wave to output transformers 34a and 34b respectively. Output transformers 34a and 34b each is an isolation transformer configured to provide both patient electrical isolation and the voltage step-up required to ablate tissue. In more detail, the ablation electrodes are at patient potential, and 5000-6000 volts isolation is provided between the electrodes and earth ground. Since the input is at chassis ground, output transformers 34a and 34b each is configured to provide 5000-6000 volts isolation between its primary and secondary coils. An additional advantage of this isolation circuitry is that power can be measured without the need to isolate the measuring devices. A portion of the applicable circuitry is shown in
Series resonant circuits 33a and 33b each convert the square ware received from half bridge circuits 32a and 32b respectively, to a sine wave. These conversions are accomplished by maximizing energy coupling at the fundamental frequency chosen, e.g., at 470 kHz. This power output configuration is over 95% efficient in converting the 24 VDC input power to RF energy, as the output transformer has an efficiency close to 100%. In this configuration, half-bridge circuit 32a and 32b, series resonant circuit 33a and 33b and output transformer 34a and 34b, are configured to convert signal generator's 45 470 kHz logic level signal to two 100 VAC sine waves, each capable of delivering 100 watts. In addition, it is noted that by measuring power inputted (Pinput), outputted power (Poutput) may be obtained. In one embodiment, a current-sensing resistor is employed (not shown, but having a precise, known resistance) so inputted current (Iin) can be determined by the system. Since inputted voltage (Vin) is also known, as the power supply precisely regulates this, the system can determine Pin and thus Poutput.
As noted above, the system employs a frequency of 470 kHz (or approximately 470 kHz, noting that 500 kHz is not used as it may be reserved for a public emergency band.) The 470 kHz is generated by a PLD, signal generator 35. In particular, an oscillator provides (starts with) a higher frequency, which is then divided down to 470 kHz. The 470 kHz waveform may be generated in numerous configurations, such as with 0° phase or any other phase, such as a phase determined in 250 steps or divisions. In one embodiment, the signal for the PLD is a 5-volt digital signal with the phase information “built-in”. Signal generator 35 also generates the opposite polarity signal which may also be used to drive one or more field effect transistors (FETs) integral to half bridge circuit 32a and 32b. Signal generator 35 provides a synchronization pulse, not shown but connected to the signal generators of subsequent pairs of RF outputs also not shown; such that all the signal generators of the RFG are in synchrony (i.e. signal generator 35 is the “master”).
In one embodiment, an RF circuit board includes two circuits of
Signal generator 35 is under microprocessor control. In one embodiment, the microprocessor can set the duty cycle from all “off” to all “on” in at least 16 steps, and possibly 256 steps. In another embodiment, the microprocessor can adjust the phase of the RF output can be set from 0° to 180° in at least 4 steps, and possibly 16 steps. This adjustability allows the energy to flow to pairs of electrodes in the following ways: all monopolar from the electrodes to the return pad; all bipolar between the electrodes; and a combination of bipolar and monopolar with the ratio set by the phase difference between the electrodes.
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The ablation catheters of
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In the example shown in
In one embodiment, the generation of the combined bipolar and monopolar currents is achieved by varying the phase, as described above. In an alternative embodiment, the combined bipolar and monopolar currents are determined by time-division multiplexing and/or by alternating monopolar and bipolar fields, as will be described in detail in reference to subsequent figures.
In one exemplary system, repeating duty cycle fields are employed, each field having a similar period (duration) and each field including an “on” portion and an “off” portion. A possible field period is approximately 17 msec. During the on period, 20-100 volts RMS (typically 100 volts RMS) is delivered to the tissue. During the off period, the output of the channel is disconnected from the load. In one embodiment, a sequence of four specific duty cycle fields that repeat are provided. A first field includes monopolar energy delivery only followed by an off period; the second field includes combined monopolar and bipolar delivery (combo) followed by an off period; the third field includes monopolar energy delivery only followed by an off period; and the fourth field includes monopolar and bipolar delivery (combo), with opposite phase from that of field 2, followed by an off period. In one embodiment, by selecting the phase difference during a field, the ratio between bipolar and monopolar energy delivery can be varied from 4-to-1 to all-monopolar. Also, by switching off the connection to the return pad, and setting the phase shift to 180°, an all-bipolar mode can be produced.
Phasing Sequences
In one embodiment, the ablation signal delivered to each electrode pair from two associated RF outputs (channel) includes four fields (e.g. each of 17 ms period), the four fields repeating until ablation energy delivery is terminated. Each field is divided into an “on” time and an “off” time. This duty cycle ratio controls the amount of power delivered during each field by that RF output pair (channel). In one embodiment, during the “on” time, 100 volts RMS (at 470 kHz) is delivered to the load. During the “off” time, the output is floating, thus zero power is delivered. For example, a duty cycle of 10% would cause a power of 10 watts RMS to be delivered into a 100 ohm load during the duty cycle period (e.g. a field with 17 msec duration). If the voltages to the two electrodes are at a 0° phase difference, the bipolar voltage difference is zero volts and therefore only monopolar currents will be delivered. If the phase difference is 90°, the bipolar voltage difference is 1.414 times the monopolar voltage (EMONOPOLAR), thus the power delivered is twice the monopolar power, as shown in the equation:
Power=E2/R=(1.414*EMONOPOLAR)2/R=2*(EMONOPOLAR)2/R
If the phase difference is 180°, the voltage difference is 2 times the monopolar voltage, thus the power delivered is four times the monopolar power, as shown in the equation:
Power=E2/R=(2*EMONOPOLAR)2/R=4*(EMONOPOLAR)2/R
If the return pad is off, then only bipolar currents will be delivered. Field sequences such as are shown in
During each field, each RF output pair (channel) may deliver RF power in monopolar, bipolar or combo energy delivery. Each field may include “on” time ratios (monopolar, bipolar or combo) from 0% to 100% of the duty cycle period, typically 17 msec. In one embodiment, each energy delivery includes at least monopolar energy delivered, avoiding the need to disconnect the return pad. Continuous connection of the return pad avoids generation of electrical noise, and allows the inclusion of safety detection circuitry which requires connection of the return pad.
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In
The system of the present invention allows independent phase control of each RF output (e.g. up to 16 outputs or more), providing more sophisticated power delivery as compared to a previously developed system in which every other channel was driven at the same phase and each RF output drove two electrodes. Each of the RF outputs can be driven up to a maximum power, and ablation energy can be sent to each RF output simultaneously or sequentially. The ability to control the phase of each electrode relative to the other electrodes enables the system to generate bipolar currents as well as monopolar, as well as various combinations of these.
In the system of the present invention, each RF channel may utilize independent PID loops which process temperature information (e.g. temperature information received from a thermocouple mounted in each electrode) to modify the power delivery to that pair of RF outputs. These PID loops provide more accurate temperature-driven energy delivery than previously developed systems. One previously developed system delivered power to 12 electrodes based on temperature feedback from three zones. The electrodes were regulated to the highest temperature in the zone, which resulted in some of the electrodes ablating inefficiently (e.g. not enough power delivered).
Referring now to
Fast and accurate temperature acquisition is important in delivering the proper amount of RF energy (i.e. closed-loop control). Too much (high) energy delivery can cause coagulum and/or damage adjacent tissues and structures such as the phrenic nerve or the esophagus of the patient. Too little energy delivery can result in poor lesion creation and low therapeutic success rates. The system of the present invention provides enough RF energy to create a cardiac electrical conduction block without affecting adjacent tissues or structures. In order to acquire fast and accurate temperatures, the thermocouple mass is kept small and one or more electrodes are welded directly to the inside diameter of each of the electrodes of each ablation catheter. Placement of the thermocouple in the electrode is such that during ablation, thermocouples are located directly over the target tissue at a distance separated by the electrode wall thickness only (such as a wall thickness of 0.006″ or alternatively a wall thickness ranging from 0.004″ to 0.010″). The combination of thermocouple location, size and mounting methods provides fast and accurate tissue/electrode interface temperatures. Type T thermocouples (copper/constantan) may be employed as the temperature accuracy curve for type T is essentially linear within the temperature range used by the ablation system, i.e., body temperature through 80° C.
All thermocouples located on the ablation electrodes are at patient potential. 5000 volts of isolation is needed between the thermocouples and earth ground in order to meet patient safety regulations (e.g. IEC 601-2). The twelve temperature modules are read by microprocessor module 15 which is powered by a dc-to-dc converter with the proper voltage isolation. An RS232 serial data string is isolated with an opto-isolator. Since the RF power output is duty cycle-controlled, the temperature readings can be synchronized to the “off” period of each field. The synchronizing pulse is also supplied through an opto-isolator.
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Basic Power Control Scheme
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In one embodiment, the duty cycle (field) period is approximately 16-17 msec, such that if 10 watts RMS power is to be delivered for a specific field (entire length) and 100 watts RMS is delivered during the “on” period, the “on” period duration would be set to 1.7 msec and the “off” period duration would be set to 15.3 msec. A typical duty cycle may be about 10%, and a typical voltage applied may be about 100 volts RMS. If the nominal load (impedance of the tissue) is about 100 ohms, this 10% duty cycle would yield 100 watts RMS for the 17 msec period. In any case, a target temperature between 50° C.-70° C. (e.g., 60° C.) may be set, and the system may deliver energy to heat and ablate as described in reference to
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The secondary control loop controls the power goal and compares the actual temperature (measured) to a temperature goal. The proportional difference between the goal and the actual temperature is added to an integration register. The difference between the last temperature measured and the present temperature (the derivative) is subtracted from the integration register. The value in the integration register sets the power goal value. If the power goal value is greater than the power limit, the power goal is set to equal the power limit.
The algorithm of
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In one embodiment, remote control 500 provides full control of the RFG of the present invention, such that no other user interface is required to perform any and all functions of the RFG. In an alternative embodiment, remote control 500 provides partial control of the RFG. User interface 520 may replace a user interface integral to an RFG, or work in combination with it. In one embodiment, user interface 520 is the master control, overriding conflicting commands from a user interface of the RFG. In another embodiment, the user interface of the RFG is the master control. User interface 520 includes a bank of switches, such as a membrane keypad, and/or other user input components, to enter commands to be received by the RFG. User interface 520 further includes user output components such as indicator lights, displays such as LCD displays, and other means of presenting information to an operator of the RFG. In one embodiment, user interface 520 includes a touch screen display configured to provide information to the user and receive commands from the user.
Remote control 500 includes a housing 501, such as a plastic housing which surrounds one or more electronic modules and includes user interface 520 on its top, outer surface. In one embodiment, a bundle of wires connect remote control 500 to the RFG of the present invention, such as via a ten pin receptacle integral to the housing of the RFG. In an alternative embodiment, remote control 500 includes a wireless transceiver, not shown but possibly configured to send and receive wireless transfer of information to and from the RFG, such as via a handshaking protocol which assures accuracy of information transfer. Remote control 500 may be provided sterilized and/or may be covered with a disposable sterile bag, not shown, but configured to surround remote control 500 and at least a portion of any wires attached to remote control 500. The sterile assembly may be brought into the sterile field of a patient undergoing a sterile procedure, such as a cardiac ablation procedure to treat atrial fibrillation, or a tumor ablation procedure.
The systems of the present invention may include one or more power limits which can be integrated into software and/or hardware of the RFG. The system may employ different power limits for different ablation catheters. Alternatively or additionally, the system may employ different power limits for different bipolar-monopolar ratios. In one embodiment, the system includes power limits from Table 1 above. In one embodiment, different power limits (or sets of power limits as shown in the above table) are used for different ablation catheters. Alternatively or additionally, power limits of 20-30 Watts RMS may be used by one or more algorithms for one or more ablation catheters of the present invention. In general, ablation catheters with larger electrodes may correlate to a higher power limit than an ablation catheter with smaller electrodes. The power limits are employed to limit clinician error as well as otherwise improve safety, such as by reducing the likelihood of coagulum creation or ablation of untargeted tissue. It has been demonstrated that in the instance where one or more electrodes has limited or otherwise inadequate tissue contact, such as when a “hotspot” in the tissue may have been caused, the above power limits were successful in avoiding the creation of coagulum.
The system of the present invention may include a limit on the minimum time ablation energy is delivered. In one embodiment, a minimum energy delivery time is approximately 25 seconds. In another embodiment, a minimum energy delivery time is approximately 40 seconds.
The system of the present invention may include various means of adjusting power levels (delivered) as well as the simultaneous ratio of bipolar to monopolar power delivered. In one embodiment, time division multiplexing (TDM) is utilized to set a power level and/or a bipolar to monopolar ratio.
The system of the present invention may include one or more algorithms which adjust power delivery based on which form of ablation catheters is attached. The power delivery may be adjusted based one or more parameters of the attached ablation catheter, such parameters including but not limited to: distance between two electrodes receiving energy; electrode geometry; thermocouple location; and combinations thereof.
It should be understood that numerous other configurations of the systems, devices and methods described herein can be employed without departing from the spirit or scope of this application. It should be understood that the system includes multiple functional components, such as the RF generator and various ablation catheters of the present invention. In one embodiment, the ablation catheter consists of a catheter shaft, a carrier assembly for providing electrodes in a resiliently biased configuration, a control shaft for deploying and withdrawing the carrier assembly, and a coupler for attaching the control shaft to the carrier assembly. The carrier assembly is a support structure which is shiftable from a storage or confined configuration, such as a radially constrained configuration, to a deployed or expanded configuration. The carrier assembly can include wires, ribbons, cables and struts, made of metals, non-metals or combinations of both. The carrier assembly can be constructed of one or more materials, including both metals and non-metals. Typical metals chosen for carrier assembly construction include but are not limited to: stainless steel, Nitinol, Elgiloy™, other alloys and combinations thereof.
The ablation catheters of the present invention may include a steerable outer sheath, or may work in conjunction as a system with a separate steerable outer sheath. One or more tubular components of the ablation catheter may be steerable such as with the inclusion of a controllable pull wire at or near the distal end. The ablation catheters of the present invention may be inserted over the wire, such as via a lumen within one of the tubular conduits such as within a lumen of the tubular body member or control shaft, or alternatively the catheter may include a rapid exchange sidecar at or near its distal end, consisting of a small projection with a guidewire lumen therethrough. A guidewire lumen may be included solely for the guidewire, or may provide other functions such as a vacuum lumen for an integral suction port integrated at the distal portion of the carrier assembly.
The ablation catheters of the present invention further include one or more ablation elements. In some embodiments, one or more ablation elements are electrodes configured to deliver RF energy. Other forms of energy, alternative or in addition to RF, may be delivered, including but not limited to: acoustic energy and ultrasound energy; electromagnetic energy such as electrical, magnetic, microwave and radiofrequency energies; thermal energy such as heat and cryogenic energies; chemical energy; light energy such as infrared and visible light energies; mechanical energy; radiation; and combinations thereof. The RF generator of the present invention may further provide one of the additional energy forms described immediately hereabove, in addition to the RF energy.
One or more ablation elements may comprise a drug delivery pump or a device to cause mechanical tissue damage such as a forwardly advanceable spike or needle. The ablation elements can deliver energy individually, in combination with or in serial fashion with other ablation elements. The ablation elements can be electrically connected in parallel, in series, individually, or combinations thereof. The ablation catheter may include cooling means, such as fins or other heat sinking geometries, to prevent undesired tissue damage and/or blood clotting. The ablation elements may be constructed of various materials, such as plates of metal and coils of wire for RF energy delivery. The electrodes can take on various shapes including shapes used to focus energy such as a horn shape to focus sound energy, and shapes to assist in cooling such as a geometry providing large surface area. Electrodes can vary within a single carrier assembly, such as a spiral array of electrodes or an umbrella tip configuration wherein electrodes farthest from the central axis of the catheter have the largest major axis. Wires and other flexible conduits are attached to the ablation elements, such as electrical energy carrying wires for RF electrodes or ultrasound crystals, and tubes for cryogenic delivery.
The ablation catheter of the present invention may include a handle activating or otherwise controlling one or more functions of the ablation catheter. The handle may also include various knobs or levers, such as rotating or sliding knobs which are operably connected to advanceable conduits, or are operably connected to gear trains or cams which are connected to advanceable conduits. These controls, such as knobs use to deflect a distal portion of a conduit, or to advance or retract the carrier assembly, may include a reversible locking mechanism such that a particular tip deflection or deployment amount can be maintained through various manipulations of the system.
The ablation catheter may include one or more sensors, such as sensors used to detect chemical activity; light; electrical activity; pH; temperature; pressure; fluid flow or another physiologic parameter. These sensors can be used to map electrical activity, measure temperature, or gather other information that may be used to modify the ablation procedure. In one embodiment, one or more sensors, such as a mapping electrode, can also be used to ablate tissue.
Numerous components internal to the patient, such as the carrier assembly or electrodes, may include one or more visual markers such as radiopaque markers visible under fluoroscopy, or ultrasound markers.
Selection of the tissue to be ablated may be based on a diagnosis of aberrant conduit or conduits, or based on anatomical location. RF energy may be delivered first, followed by another energy type in the same location, such as when a single electrode can deliver more than one type of energy, such as RF and ultrasound energy. Alternatively or additionally, a first procedure may be performed utilizing one type of energy, followed by a second procedure utilizing a different form of energy. The second procedure may be performed shortly after the first procedure, such as within four hours, or at a later date such as greater than twenty-four hours after the first procedure. Numerous types of tissue can be ablated utilizing the devices, systems and methods of the present invention. For example, the various aspects of the invention have application in procedures for ablating tissue in the prostrate, brain, gall bladder, uterus, other organs and regions of the body, and a tumor, such as regions with an accessible wall or flat tissue surface. In some embodiments, heart tissue is ablated, such as left atrial tissue.
In another embodiment of the system of the present invention, an ablation catheter and a heat sensing technology are included. The heat sensing technology, includes sensor means that may be placed on the chest of the patient, the esophagus or another area in close enough proximity to the tissue being ablated to directly measure temperature effects of the ablation, such as via a temperature sensor, or indirectly such as through the use of an infrared camera. In these embodiments, the RFG includes means of receiving the temperature information from the heat sensing technology, similar to the handling of the temperature information from thermocouples of the ablation catheters. This additional temperature information can be used in one or more algorithms for power delivery, as has been described above, and particularly as a safety threshold which shuts off or otherwise decreased power delivery. A temperature threshold will depend on the location of the heat sensing technology sensor means, as well as where the ablation energy is being delivered. The threshold may be adjustable, and may be automatically configured.
Numerous kit configurations are also to be considered within the scope of this application. An ablation catheter is provided with multiple carrier assemblies. These carrier assemblies can be removed for the tubular body member of the catheter, or may include multiple tubular body members in the kit. The multiple carrier assemblies can have different patterns, different types or amounts of electrodes, and have numerous other configurations including compatibility with different forms of energy.
Though the ablation device has been described in terms of an endocardial and transcutaneous method of use, the array may be used on the heart during open heart surgery, open chest surgery, or minimally invasive thoracic surgery. Thus, during open chest surgery, a short catheter or cannula carrying the carrier assembly and its electrodes may be inserted into the heart, such as through the left atrial appendage or an incision in the atrium wall, to apply the electrodes to the tissue to be ablated. Also, the carrier assembly and its electrodes may be applied to the epicardial surface of the atrium or other areas of the heart to detect and/or ablate arrhythmogenic foci from outside the heart.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims. In addition, where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth herebelow not be construed as being order-specific unless such order specificity is expressly stated in the claim.
This application is a divisional of patent application Ser. No. 12/117,596, filed May 8, 2008, entitled RF ENERGY DELIVERY SYSTEM AND METHOD, issued on Jul. 8, 2014, as U.S. Pat. No. 8,771,269, the entirety of which is incorporated herein by reference.
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| Number | Date | Country | |
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| Child | 14297088 | US |
