Modulation of renal denervation energy delivery

Abstract

Methods, systems, devices, components, and apparatuses for renal denervation. The treatment component includes a first sensor configured to detect a first temperature or a first impedance. The treatment component includes a first energy delivery element configured to deliver energy to the vessel wall. The treatment component includes a processor. The processor is configured to determine a heart rate based on the first temperature or the first impedance. The processor is configured to determine that the heart rate is less than a threshold heart rate indicating a slowing of the heart rate. The processor is configured to control the first energy delivery element to regulate the delivery of energy to the vessel wall.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 62 / 928,860, filed October 31, 2019, entitled “Adjustment of Renal Denervation Energy Delivery,” the entire contents of which are incorporated herein by reference. Background Technology 1. Technical Field

[0004] This specification relates to a system, apparatus, method, and / or device for regulating renal denervation energy delivery during renal denervation to prevent bradycardia in patients. 2. Background Technology

[0006] An adult's resting heart rate is approximately 60 to 100 beats per minute. A small percentage of patients experience transient bradycardia during renal denervation. Bradycardia is when the heart beats at a slower than normal rate. If a patient has bradycardia, their heart beats less than 60 times per minute. Bradycardia can be a serious problem if the heart cannot pump enough oxygenated blood into the body.

[0007] During renal denervation, a nurse, physician, technician, or other hospital staff (or “clinician”) uses stimulation or energy, such as radiofrequency, ultrasound, cooling, or other energy, to ablate within the renal artery. This reduces the activity of the perivascular nerves, which has been shown to result in lower blood pressure and other potential benefits. The clinician may monitor the patient’s heart rate during renal denervation to prevent and / or detect bradycardia using separate standard medical equipment. For example, in some patients, renal denervation may cause bradycardia due to stimulation of the vagus nerve (or some other autonomic nerve that is different from the target sympathetic nerve). If a slowing of the heart rate is detected that could lead to bradycardia, the clinician may choose to stop the ablation procedure to prevent further decrease in heart rate. If the slowing is significant, the clinician may administer medications or pharmacology, such as atropine, to increase the heart rate and prevent further decrease. These actions of stopping the procedure or administering treatment may prolong the procedure and / or lead to its termination. However, these procedural adjustments are not automatic and require continuous monitoring of the patient's heart rate by the clinician, who must take steps in response, such as communicating with another clinician, to address the heart rate changes leading to the delay in effective treatment. Treatment delays can result in additional hemodynamic complications for the patient due to reduced cardiac output secondary to a low heart rate. Furthermore, a lower heart rate can lead to reduced blood flow through the ablated vessel, potentially causing thermal damage to the vessel wall by the ablation system, as these systems typically rely on strong arterial blood flow to convectively cool energy delivery elements, such as radiofrequency electrodes.

[0008] Stopping ablation of a specific electrode or multiple electrodes after bradycardia is detected can also be effective, as bradycardia may be caused by only one or a few electrodes operating simultaneously. Therefore, there is a need for a system, device, and / or method that automatically detects a patient's heart rate and manages, regulates, or otherwise controls energy output to prevent, detect, and / or otherwise manage changes in the patient's heart rate. Summary of the Invention

[0009] Typically, one aspect of the subject matter described in this specification is embodied in a treatment assembly for renal denervation. The treatment assembly includes a first sensor configured to continuously detect a first temperature or a first impedance at a first location in the vessel wall. The treatment assembly includes a first energy delivery element configured to deliver energy to nerves in the vessel wall. The treatment assembly includes a processor coupled to the first sensor and the first energy delivery element. The processor is configured to determine a heart rate based on the first temperature or the first impedance at the first location in the vessel wall. The processor is configured to determine a heart rate less than a threshold heart rate indicating a slowing heart rate or to track a rate of change in heart rate indicating a slowing heart rate. The processor is configured to control the first energy delivery element to modulate energy delivery to nerves in the vessel wall.

[0010] These and other implementations may optionally include one or more of the following features. The processor may be configured to shut down the first energy delivery element when the heart rate is less than the threshold heart rate. The treatment component may include a second energy delivery element. The second energy delivery element may be configured to deliver a second amount of energy to a second location on the blood vessel wall. The first energy delivery element may be configured to deliver a first amount of energy to a first location on the blood vessel wall.

[0011] The processor can be configured to shut down both the first and second energy delivery elements. The processor can be configured to cycle through the first and second energy delivery elements to determine the cause of the bradycardia. The processor can be configured to shut down one of the first or second energy delivery elements based on the cause of the bradycardia. The processor can be configured to turn on the other of the first or second energy delivery elements based on the cause of the bradycardia. The processor can be configured to provide a notification or indication to a clinician on a display that the heart rate is below a threshold heart rate and to obtain confirmation to continue determining the cause of the bradycardia.

[0012] The treatment assembly may include a second sensor. The second sensor may be configured to detect a second temperature at a second location on the vessel wall. The processor may be configured to further determine a heart rate based on the second temperature at the second location on the vessel wall. The treatment assembly may include a catheter coupled to the first sensor and the first energy delivery element. The catheter is configured to be inserted into a blood vessel. The blood vessel may be a renal artery, and the first sensor may be coupled to the first energy delivery element. The treatment assembly may include a radio frequency generator. The radio frequency generator may be configured to deliver energy to the first energy delivery element. The energy may be a radio frequency (RF) signal, and the first energy delivery element may be an electrode.

[0013] In another aspect, the subject matter is embodied in a therapeutic assembly for renal denervation. The therapeutic assembly includes multiple sensors. The multiple sensors include a first sensor configured to detect a first temperature at a first location on the vessel wall. The therapeutic assembly includes multiple electrodes. The multiple electrodes are configured to deliver energy to the vessel wall. The therapeutic assembly includes a processor coupled to the multiple sensors and the multiple electrodes. The processor is configured to determine a heart rate based on the first temperature at the first location on the vessel wall. The processor is configured to determine that the heart rate is less than a threshold heart rate indicating slowing of the heart rate. The processor is configured to turn off one of the multiple electrodes to prevent bradycardia.

[0014] On the other hand, the subject matter is embodied in a method for managing a patient's heart rate during renal denervation. The method includes measuring sensor data at a location on the vessel wall via sensors. The method includes determining the patient's heart rate based on the sensor data via a processor. The method includes determining, via the processor, that the heart rate is less than a threshold heart rate indicating a slowing of the heart rate. The method includes controlling, via the processor and using one or more electrodes, the amount of energy delivered to the location on the vessel wall.

[0015] Attached Figure Description

[0016] Other systems, methods, features, and advantages of the present invention will be or will become apparent to those skilled in the art upon examination of the following drawings and detailed description. All such additional systems, methods, features, and advantages are intended to be included within this specification, falling within the scope of the invention, and protected by the appended claims. The components shown in the drawings are not necessarily drawn to scale and may be exaggerated to better illustrate the essential features of the invention. In the drawings, the same reference numerals denote the same parts in different views.

[0017] Figure 1 An example concept diagram of a therapeutic component according to an aspect of the present invention is shown.

[0018] Figure 2A The invention illustrates a low-profile delivery configuration according to an aspect thereof. Figure 1 An example of an exemplary renal denervation device for therapeutic components.

[0019] Figure 2B An aspect according to the invention is shown Figure 1 An example of an exemplary renal denervation device for therapeutic components, wherein the device is an extended, unfolded configuration.

[0020] Figure 3 According to aspects of the present invention Figure 1 A block diagram of the instance generator for the treatment component.

[0021] Figure 4 According to aspects of the invention, it is used for controlling delivery to Figure 1 A flowchart illustrating an instance of the energy delivery process of one or more energy delivery elements in a therapeutic component.

[0022] Figure 5 An aspect according to the invention is shown Figure 1 An exemplary renal denervation device for therapeutic components, the device being an extended, unfolded configuration within a blood vessel.

[0023] Figure 6 It is used according to aspects of the present invention. Figure 1 The flowchart illustrates an instance of the treatment component determining the cause of a slowed heart rate.

[0024] Figure 7 It is for use according to aspects of the invention. Figure 1 The flowchart illustrates an instance of the treatment component performing different operations at different threshold heart rates.

[0025] Figure 8 The use of aspects according to the invention is shown. Figure 1 The temperature of the treatment component measured at the treatment site.

[0026] Figure 9 The use of aspects according to the invention is shown. Figure 1 The impedance of the treatment component measured at the treatment site.

[0027] Figure 10 This is the use of aspects of the invention. Figure 1 The temperature of the therapeutic component was measured and the derivative of the measured impedance was measured. Detailed Implementation

[0028] This document discloses systems, devices, methods, and / or apparatuses for therapeutic components including a renal denervation device that controls the amount of energy delivered from each energy delivery element (such as an electrode) to prevent bradycardia, such as that occurring during renal denervation. The renal denervation device has one or more integrated sensors that measure the temperature and / or impedance of a blood vessel wall (such as a renal artery) and use the temperature and / or impedance to determine the patient's heart rate. If the renal denervation device detects that the heart rate is slowing down to the point that bradycardia may be possible, the renal denervation device can automatically adjust the amount of energy delivered through each of the one or more energy delivery elements to prevent the heart rate from slowing down. The renal denervation device automatically controls the amount of energy delivered, therefore there is little or no delay in responding to a slowing heart rate to prevent bradycardia.

[0029] Other benefits and advantages include independent control of each energy delivery element. A renal denervation device can have multiple energy delivery elements positioned within the vessel wall or at different locations along the vessel wall. The energy delivery to each energy delivery element can be independently controlled. The device can be turned on, off, and / or regulated to adjust the amount delivered through each element, allowing for optimized blood pressure treatment while maintaining a normal heart rate to prevent bradycardia.

[0030] Furthermore, the renal denervation device can have one or more sensors. These sensors can be integrated within the renal denervation device. The device determines the patient's heart rate based on sensor data (e.g., temperature or impedance at the treatment site). Therefore, clinicians do not need a separate device to monitor the patient's heart rate. Since clinicians do not need to monitor a separate device and then communicate to regulate energy delivery, the regulation of energy delivered via the energy delivery element is automatic, reducing the delay in responding to a slowed heart rate. By reducing this delay, the renal denervation device can rapidly regulate energy delivery and avoid the need to administer drugs, such as atropine, to increase heart rate and prevent bradycardia.

[0031] Figure 1 Treatment component 100 is shown. Treatment component 100 performs renal denervation within the renal artery of a human patient. Renal denervation is a minimally invasive surgical procedure for treating refractory hypertension. Treatment component 100 includes a renal denervation device 102 and / or a generator 104. The renal denervation device 102 may include any means of delivering energy or stimulation to a target nerve (such as the renal nerve of the renal artery) within the vessel wall. The energy or stimulation may include at least one of, for example, radiofrequency stimulation, thermal stimulation, cryostimulation, microwave stimulation, ultrasound stimulation, or other forms of energy or stimulation.

[0032] The renal denervation device 102 includes a catheter 108, one or more energy delivery elements 110, such as electrodes, and / or one or more sensors 112. The renal denervation device 102 may have an elongated shaft 114 with a handle 116. The elongated shaft 114 with the handle 116 can be used to guide and / or advance the distal portion of the catheter 108 through a blood vessel of a patient (e.g., a human patient) to a target location in the blood vessel and to remotely manipulate the distal portion of the catheter 108. The catheter 108 may be configured in a low profile (e.g., ...). Figure 1 The catheter 108, in a substantially straight configuration as shown, is delivered intravascularly to a patient (e.g., into a patient's blood vessel). The catheter 108 can be longer than one meter. Upon delivery into the blood vessel and to the target location along the vessel, the catheter 108 can unfold into an extended deployment configuration, such as a generally helical or spiral configuration or other suitable configuration, where one or more energy delivery elements 110 (such as one or more electrodes) can contact the blood vessel, for example... Figure 5 As shown. In its extended, deployed state, the renal denervation device 102 can deliver energy to the treatment site and provide therapeutically effective electrically and / or thermally induced denervation to nerves within the blood vessel wall. Figure 2A-2B The deployment of the renal denervation device 102 is shown. Specifically, Figure 2A The conduit 108 is shown in a low-profile configuration, and Figure 2B The conduit 108 is shown in an extended, deployed configuration.

[0033] The catheter 108 may have a distal tip 202. The distal tip 202 points towards the lumen of the blood vessel. The distal tip 202 may have a high-density marking band 204. The high-density marking band 204 allows clinicians to identify the distal tip 202 of the catheter 108 under fluoroscopic guidance. The length of the distal portion of the catheter 108 may be approximately 4-5 cm, and the length of the distal tip 202 may be approximately 1-2 cm.

[0034] The catheter 108 may have a filament 206 within its lumen. When the catheter 108 is in a low-profile configuration, the distal tip 202 allows the filament 206 to extend outward and away from the distal tip 202 and be advanced through the blood vessel to the target location within the vessel. As the filament 206 retracts within the distal tip 202 and enters the catheter 108, the catheter 108 transitions from a low-profile configuration (such as a substantially straight configuration, e.g., as...) Figure 2A (As shown) Change shape to an expanded unfolded configuration (such as a general spiral or helical configuration, for example, as Figure 2B shown).

[0035] The renal denervation device 102 has one or more energy delivery elements 110. The one or more energy delivery elements 110 may include electrodes, such as radio frequency (RF) electrodes, radio frequency (RF) probes, thermal probes, cryoprobes, microwave probes, ultrasound probes, light sources, or chemical injectors. The one or more energy delivery elements 110 may be positioned on the distal portion of the catheter 108. The one or more energy delivery elements 110 may include multiple energy delivery elements 110, such as energy delivery elements 110a-d, for example, such as... Figure 2A , 2B As shown in Figure 5, or any other N number of energy delivery elements 110. When in a helical configuration, the energy delivery elements 110a-d can be arranged approximately 90 degrees apart relative to the longitudinal axis passing through the center of the catheter 108. The energy delivery elements 110 can be spaced apart from each other at any suitable distance, and the spacing can vary based on the application of the treatment component 100 and its intended use.

[0036] When multiple energy delivery elements 110 are present, each energy delivery element 110 can deliver power to the treatment site independently, simultaneously, selectively, and / or sequentially. Multiple energy delivery elements 110 can deliver power in any desired combination of one or more energy delivery elements 110.

[0037] One or more energy delivery elements 110 may be introduced into a blood vessel (such as a renal artery) and advanced along the vessel, and may be positioned at different intervals and / or locations along the vessel wall in an extended deployment configuration to contact the vessel. For example, a first energy delivery element 110a may contact the vessel wall 504 at a first position 502a, a second energy delivery element 110b may contact the vessel wall 504 at a second position 502b, a third energy delivery element 110c may contact the vessel wall 504 at a third position 502c, and a fourth energy delivery element 110d may contact the vessel wall 504 at a fourth position 502d. The renal denervation device 102 may deliver energy through one or more energy delivery elements 110 at the treatment site and provide therapeutically effective electrically and / or thermally induced denervation.

[0038] The renal denervation device 102 may include one or more sensors 112. The one or more sensors 112 may measure one or more parameters at or near the treatment site. The one or more parameters may include the temperature of one or more energy delivery elements 110 and / or the temperature at or near the treatment site. For example, the one or more sensors 112 may be temperature sensors that measure the temperature at a location on the blood vessel wall. Each of the one or more sensors 112 may be coupled to or integrated with a corresponding one of the one or more energy delivery elements 110. For example, sensor 112a may be integrated with energy delivery element 110a, sensor 112b may be integrated with energy delivery element 110b, sensor 112c may be integrated with energy delivery element 110c, and sensor 112d may be integrated with energy delivery element 110d, for example, as... Figure 2B As shown. This temperature can be used to interpolate a patient's heart rate.

[0039] In another example, one or more sensors 112 may be another type of sensor that measures different parameters, such as impedance, pressure, optics, flow rate, or the amount of a chemical substance. Impedance can be measured from one electrode to another. The treatment component 100 may similarly use different parameters, such as impedance, pressure, optics, flow rate, or the amount of a chemical substance, to determine heart rate. Other sensors or methods may also be developed to monitor heart rate directly through the renal denervation device 102.

[0040] One or more sensors 112 may be located near or within the energy delivery element 110. For example, the energy delivery element 110 may be an electrode with two wires. One wire may be made of copper, and the other may be made of a copper-nickel alloy. The wires may transmit signals from the sensors 112 or deliver energy to the energy delivery element.

[0041] This signal can be a temperature signal indicating the temperature of the blood vessel. The two wires can measure temperature using the thermocouple effect. There may be a voltage gap between the two wires, and the voltage across the gap will change as blood flow at the treatment site changes, leading to temperature variations. For example, when there is more blood flow at the treatment site, a cooling effect occurs, resulting in a lower temperature; conversely, when there is less blood flow, a heating effect occurs, resulting in a higher temperature. The voltage across the voltage gap can be measured and correlated with the temperature at the treatment site.

[0042] In some implementations, one or more sensors 112 can measure temperature at independent locations remote from one or more energy delivery elements 110. For example, the treatment assembly 100 may have a separate heating element or other attachment solely for measuring temperature changes associated with changes in blood flow. This heating element may be independent of the one or more energy delivery elements 110 that heat the tissue, so the renal denervation device 102 can determine heart rate, e.g., through continuous heart rate measurement, even when RF energy is not delivered to the tissue. This attachment may be a branched accessory, or the sensor may be attached externally to the catheter 108 and connected back to the power source and integrated with it.

[0043] In some implementations, one or more sensors 112 can measure or calculate impedance at or near the treatment site. For example, one or more sensors 112 can measure impedance from a first energy delivery element to a second energy delivery element (such as from an ablation electrode to a dispersing electrode). In another example, one or more sensors 112 can measure the voltage across a voltage gap between two wires and calculate impedance based on the current and the measured voltage. The renal denervation device 102 can use temperature, impedance, and / or other parameters detected or obtained from the sensors to monitor heart rate.

[0044] The treatment components may include a heart rate monitoring device 120. The heart rate monitoring device 120 may be a personal medical device, a wearable device such as a smartwatch, or other device that measures a patient's heart rate. The heart rate monitoring device 120 may sense or detect a patient's heartbeat and / or heart rate and transmit the patient's heartbeat and / or heart rate to the renal denervation device 102 and / or generator 104 via wired or wireless networks (such as a local area network (LAN), wide area network (WAN), cellular network, digital short range communication (DSRC), the Internet, or combinations thereof).

[0045] The treatment component includes a generator 104. Generator 104 may be a radiofrequency generator or other generator that delivers denervation stimulation or energy to the vessel wall at the treatment site via one or more energy delivery elements 110. Denervation stimulation may include non-electrical stimulation, such as chemical stimulation, light stimulation, thermal stimulation, cooling stimulation, microwave stimulation, or other forms of stimulation. Generator 104 may have cables, wires, and / or cables that are conductive and pass through the lumen of catheter 108 and are electrically coupled to one or more energy delivery elements 110. In some implementations, generator 104 may have separate wires and / or cables electrically coupled to a corresponding energy delivery element 110 of the one or more energy delivery elements 110, such that each energy delivery element 110 can operate independently of the other elements. For example, generator 104 may have multiple separate channels, such as four radiofrequency (RF) channels, to independently deliver RF energy to one or more energy delivery elements 110a-d and to independently control and monitor each energy delivery element 110a-d. Generator 104 can generate energy that is ultimately transmitted via electrical wires to one or more energy delivery elements 110.

[0046] Generator 104 may have one or more processors 302, memory 304, user interface 118 and / or power supply 308, for example, Figure 3 As shown. One or more processors 302 may be electrically coupled to memory 304, user interface 118, and / or power supply 308. One or more processors 302 may include one or more controllers that respectively acquire temperature and / or impedance signals indicative of temperature and / or impedance at the treatment site and determine the heart rate based on the temperature and / or impedance signals. Once the heart rate is determined, one or more processors 302 may control the state of each of one or more energy delivery elements 110 and the amount of energy delivered to each of the one or more energy delivery elements 110 by power supply 308. One or more processors may be coupled to memory 304 and execute instructions stored in memory 304.

[0047] Generator 104 may have memory 304. Memory 304 may be coupled to one or more processors 302 and store instructions executed by one or more processors 302. Memory 304 may include one or more of random access memory (RAM), read-only memory (ROM), or other volatile or non-volatile memory. Memory 304 may be non-transient memory or data storage device, such as a hard disk drive, solid-state drive, hybrid disk drive, or other suitable data storage, and may further store machine-readable instructions that can be loaded and executed by one or more processors 302.

[0048] Generator 104 may have a power supply 308, such as an RF generator or other power supply. Power supply 308 provides energy of a selected form and magnitude for delivery to the treatment site via renal denervation device 102. Generator 104 may have a user interface 118. Generator 104 may receive input via user interface 118, such as the delivery of energy of a selected form and magnitude to each of one or more energy delivery elements 110.

[0049] User interface 118 may include input / output devices that receive user input from user interface elements, buttons, dial pads, microphones, keyboards, or touchscreens. User interface 118 may provide output to output devices such as displays, speakers, audio and / or visual indicators, or refreshable Braille displays. Output devices may display alarms or notifications or other information to clinicians and / or acknowledgements of status and / or commands from clinicians. Output devices may be audio output devices that output audio indicators to be provided to clinicians for notifications or information.

[0050] Figure 4 This is a flowchart of a process 400 for controlling the energy delivered to one or more energy delivery elements 110 to prevent bradycardia. One or more computers or one or more data processing devices, properly programmed and / or using one or more other components (such as one or more sensors 112 and / or one or more energy delivery elements 110), for example... Figure 1 The processor 302 of the generator 104 of the treatment component 100 can implement the process 400.

[0051] The treatment assembly 100 may include a generator 104 that controls the delivery of energy to one or more energy delivery elements 110 of the renal denervation device 102. The generator 104 of the treatment assembly 100 receives user input (402) instructing the renal denervation device 102 to initialize. The generator 104 may receive user input via a user interface 118, which may be an instruction to start the generator 104, causing the generator 104 to start or initialize to deliver energy to the renal denervation device 102 and to deliver energy to one or more treatment sites within a blood vessel 504 via one or more energy delivery elements 110.

[0052] Once activated, the treatment component 100 can deliver a first amount of energy (404) via one or more energy delivery elements 110. The generator 104 can linearly or non-linearly ramp up or increase the energy to the first amount during the initial phase until the energy reaches the first amount. When multiple energy delivery elements 110a-b are present (such as a first energy delivery element 110a, a second energy delivery element 110b, a third energy delivery element 110c, and / or a fourth energy delivery element 110d, for example, ...), Figure 5As shown, generator 104 can deliver a first amount of energy to a plurality of energy delivery elements 110a-b. When catheter 108 is in an extended, deployed state within the blood vessel, the plurality of energy delivery elements 110a-d can be arranged to contact the vessel wall and at an angle of approximately 90 degrees relative to the longitudinal axis of the center of the spiral or helical configuration.

[0053] During energy delivery, the treatment component 100 can measure, detect, acquire, or determine one or more parameters (406) at the treatment site. The one or more parameters may be the temperature of one or more energy delivery elements 110, the temperature at or near the treatment site, and / or the impedance at or near the treatment site. The treatment component 100 can measure, detect, acquire, or determine a single parameter or multiple parameters at the treatment site.

[0054] The treatment assembly 100 may use one or more sensors 112 to measure the temperature of one or more energy delivery elements 110, the temperature at the treatment site along the blood vessel wall, and / or the impedance at the treatment site. For example, the treatment assembly 100 may measure the voltage change across a voltage gap between two wires within an energy delivery element to determine the temperature. In another example, the treatment assembly 100 may measure the impedance of a signal transmitted between two energy delivery elements or sensors, such as the impedance of a signal between an energy delivery element and a sensor, to determine the impedance or to calculate the impedance using the voltage and current across the voltage gap.

[0055] One or more sensors 112 may include multiple temperature sensors or multiple impedance sensors, each positioned within a corresponding energy delivery element 110. Each of the multiple temperature sensors or multiple impedance sensors can independently measure the temperature or impedance at a corresponding location along the wall of the blood vessel 504 that is in contact with the temperature sensor or impedance sensor, respectively. For example, energy delivery element 110a may be coupled to sensor 112a at a first location 502a along the blood vessel 504, and energy delivery element 110b may be coupled to another sensor 112b at a second location 502b along the blood vessel 504. Sensor 112a may measure a first temperature or a first impedance at the first location, while another sensor 112b may measure a second temperature or a second impedance at the second location 502b. Any number of sensors 112 can be used to calculate the temperature or impedance at any number of locations.

[0056] The treatment component can calculate or determine one or more parameter values ​​related to one or more parameters (407). One or more parameter values ​​are related to, correspond to, and / or based on one or more parameters. One or more parameter values ​​can be calculated based on one or more parameters. For example, one or more parameter values ​​can be the peak (or maximum inflection point), trough (or minimum inflection point), cycle time (or frequency or period), and / or derivative (or rate of change) of the corresponding parameter (such as temperature or impedance at the treatment site).

[0057] The treatment component 100 can be used, for example, as Figure 8 One or more sensors 112 of the illustrated renal denervation device 102 acquire, detect, or determine temperature signals indicating the temperature of the treatment site, and / or can use, for example, Figure 9 One or more sensors 112 of the illustrated renal denervation device 102 acquire, detect, or determine impedance signals indicating impedance at the treatment site. The treatment assembly 100 can use temperature and / or impedance signals to calculate other parameter values ​​corresponding to the temperature and / or impedance signals.

[0058] Temperature can be determined by multiple sensors at multiple locations along the vessel wall, or by a single sensor at a single location along the vessel wall. The treatment component 100 can calculate or determine when temperature 802 reaches one or more peak temperatures 804a-d over a period of time. The one or more peak temperatures 804a-d can be a maximum inflection point where temperature 802 reaches its maximum value and transitions from an increasing temperature to a decreasing temperature over a period of time. The treatment component 100 can calculate or determine when temperature 802 reaches one or more trough temperatures 808a-d. The one or more trough temperatures 808 can be a minimum inflection point where temperature 802 reaches its minimum value and transitions from a decreasing temperature to an increasing temperature over a period of time.

[0059] Once the treatment component 100 calculates or determines when temperature 802 reaches two or more peak temperatures 804a-d and / or two or more trough temperatures 808a-d, the treatment component 100 can measure the time period between two or more consecutive peak temperatures 804a-d or two or more consecutive trough temperatures 808a-d. The calculated or determined time period can be associated with and correspond to the temperature change cycle 806. A consecutive peak temperature is the next peak temperature immediately following the current peak temperature, and a consecutive trough temperature is the next trough temperature immediately following the current trough temperature.

[0060] The treatment component 100 can calculate the first or second derivative of temperature, which indicates the rate of temperature change. For example, the treatment component 100 can calculate the first derivative 1002 of temperature 802, for example, as... Figure 10As shown, the first derivative 1002 can be the slope between two or more temperatures measured at different times, which can indicate the rate of change of temperature 802.

[0061] Impedance can be measured by sensor 112 or other sensors, such as a patch sensor, which receives the impedance signal from energy delivery element 110. Treatment component 100 can calculate or determine when impedance 902 reaches one or more peak impedances 904a-d. The one or more peak impedances 904a-d can be the maximum inflection point where impedance 902 increases to its maximum value and then decreases. Treatment component 100 can calculate or determine when impedance 902 reaches one or more valley impedances 908a-d. The one or more valley impedances 908a-d can be the minimum inflection point where impedance 902 decreases to its minimum value and then increases.

[0062] Once the treatment component 100 calculates or determines when impedance 902 reaches two or more peak impedances 904a-d and / or two or more trough impedances 908a-d, the treatment component 100 can measure the time interval between two or more consecutive peak impedances 904a-d and / or two or more consecutive trough impedances 908a-d. The calculated or determined time interval can be associated with and correspond to the impedance change cycle 906. A consecutive peak impedance is the next peak impedance immediately following the current peak impedance, and a consecutive trough impedance is the next trough impedance immediately following the current trough impedance. The peaks and troughs of temperature and / or impedance reflect the contraction and relaxation of the myocardium, such as between systole and diastole. By measuring the cycle time of temperature and / or impedance, the treatment component 100 can calculate the heart rate.

[0063] The treatment component 100 can calculate the first or second derivative of the impedance, which indicates the rate of change of impedance. For example, the treatment component 100 can calculate the first derivative 1004 of the impedance 902, for example, as... Figure 10 As shown. The first derivative 1004 can be the slope between two or more impedances measured at different times, which can indicate the rate of change of impedance 902.

[0064] The treatment component determines the patient's heart rate (408). The patient's heart rate may be determined based on one or more parameters and / or one or more parameter values, such as based on temperature, impedance, and / or one or more parameter values ​​calculated or determined based on temperature and / or impedance. The patient's heart rate may be determined based on a single parameter (such as temperature or impedance), a single parameter value (such as the temperature change period or impedance change period), or a combination of one or more parameters and / or one or more parameter values ​​(such as the temperature change period and impedance change period and / or the first derivative of temperature and impedance).

[0065] Blood flow within the renal artery is highly pulsating; therefore, the temperature and / or impedance within the renal artery oscillate and / or change rhythmically. Thus, during systole, when the heart is pumping blood—that is, during the heartbeat phase where the myocardium contracts and pumps blood from the heart chambers into the arteries—the pulse of blood through the vessel enhances heat transfer and cools one or more energy delivery elements 110, the treatment site, and / or one or more sensors 112, defining the minimum temperature of circulation. Furthermore, as blood pulses through the vessel, the vessel diameter expands, which may result in a smaller contact area between the energy delivery element 110 and the vessel wall, and a larger contact area with the blood, resulting in a lower impedance than the vessel wall and thus a lower impedance, defining the minimum impedance of circulation. During diastole, the heartbeat phase where the heart muscle relaxes and allows the heart chambers to fill with blood, blood flow is minimal and the cooling effect is lowest, defining the maximum temperature of circulation. Furthermore, as blood is drawn into the chambers of the myocardium, the vessel diameter may constrict. This can result in a larger contact area between the energy delivery element 110 and the vessel wall, leading to a higher impedance than the blood, and a smaller contact area with the blood, also resulting in a higher impedance, thus defining the maximum impedance of the circulation. Therefore, temperature change cycles and / or impedance change cycles can indicate heart rate, as each temperature change cycle 806 or each impedance change cycle 906 can reflect the heartbeat, and the number or amount or duration of cycles per unit temperature or impedance can reflect the heart rate.

[0066] In some implementations, the treatment component can determine the heart rate using the first or second derivative of temperature and / or impedance, or other statistical or mathematical measurements. Other statistical or mathematical measurements may include identifying minimum temperature inflection points (or troughs) and / or maximum temperature inflection points (or peaks) when the temperature or impedance cycle exceeds a threshold (such as the average value), or when the slope or tangent of the temperature or impedance value reverses. Temperature and / or impedance signals can be collected at a frequency of approximately 5 Hz or faster, allowing sufficient data to be gathered to determine the heart rate.

[0067] For example, such as Figure 10As shown, after the treatment component 100 determines or calculates the first derivative 1002 of temperature 802 and / or the first derivative 1004 of impedance 902, the treatment component 100 can obtain one or more corresponding thresholds 1006a-b and compare the first derivative 1002 of temperature 802 and / or the first derivative 1004 of impedance 902 with one or more corresponding thresholds 1006a-b. Threshold 1006a can be a threshold temperature rate (e.g., Celsius or Fahrenheit / second), and threshold 1006b can be a threshold impedance rate (e.g., ohms / second). The treatment component 100 can determine when the first derivative 1002 of temperature 802 increases beyond the threshold temperature rate and / or when the first derivative 1004 of impedance 902 increases beyond the threshold impedance rate to identify when a heartbeat occurs. The treatment component 100 can divide the number of heartbeats by the duration of the detection interval to calculate the heart rate. In another example, the treatment component 100 may similarly use the second derivative of temperature 802 and / or the second derivative of impedance 902 to compare with one or more corresponding thresholds to detect a heartbeat, and then use the heartbeat to calculate the heart rate. In some implementations, the treatment component 100 may use a low-pass filter of the signal with a cutoff value of, for example, approximately 20 or 30 Hz to improve the performance of signal detection.

[0068] In some implementations, the treatment component 100 can obtain the patient's heart rate from the heart rate monitoring device 120. For example, the heart rate monitoring device 120 can provide a heartbeat signal to the generator 104, and the generator 104 can calculate the heart rate based on the number of heartbeats during the detection interval. In another example, the heart rate monitoring device 120 can determine the heart rate, and the generator 104 can receive a heart rate signal indicating the patient's heart rate from the heart rate monitoring device 120.

[0069] The treatment component 100 can determine any changes in the patient's heart rate (410). The treatment component 100 compares the heart rate over a period of time to identify a trend or direction of the heart rate during that time period, such as a period of approximately 5 seconds. If the heart rate increases over a period of time, the treatment component 100 can determine that the heart rate is increasing, and if the heart rate decreases over a period of time, the treatment component 100 can determine that the heart rate is decreasing. In some implementations, the treatment component calculates the changes in heart rate. If the slope is positive, the heart rate is increasing; if the slope is negative, the heart rate is decreasing. If the slope is flat or close to 0, the heart rate may be constant.

[0070] The treatment component 100 determines whether the heart rate exceeds a threshold heart rate and / or whether there is a change in heart rate (412). The treatment component can establish a normal heart rate range, which can be the average of the patient's heart rate when the patient is normal or over a period of time when not under renal denervation. Even when energy is not delivered to the tissue, the treatment component 100 can use the heart rate monitoring device 120 to obtain the heart rate.

[0071] The treatment component 100 can determine that the heart rate is below a threshold heart rate and / or is slowing down. The threshold heart rate can be pre-configured, user-configured, obtained from another device, and / or an approximation or estimate of the percentage decrease in the patient's normal heart rate over a period of time, such as approximately 7%-12% of the patient's normal heart rate. The normal heart rate may have been previously stored in memory 304 and later retrieved from memory 304 by the processor 302.

[0072] Treatment component 100 compares the heart rate to a threshold heart rate. Treatment component 100 can identify when the heart rate is below the threshold heart rate and / or is decreasing, and can perform different actions, such as notifying a clinician via user interface 118, turning off or disabling energy delivery to one or more energy delivery elements 110, and / or identifying one or more energy delivery elements 110 that cause the heart rate to slow when it is below the threshold heart rate. In some implementations, treatment component 100 may perform one or more of the different actions only when the heart rate is below the threshold heart rate and is not increasing, because if the heart rate is increasing, the current course of action or remedy may be effective and does not necessarily need to be changed. Treatment component 100 can perform different actions when different heart rate thresholds are exceeded.

[0073] Otherwise, when the heart rate is not less than the threshold heart rate and / or is increasing, the treatment component 100 may continue to monitor one or more parameters at the treatment site (406). Figure 7 It further describes how different actions are implemented when different heart rate thresholds are exceeded.

[0074] In some implementations, when the treatment component 100 detects a heart rate greater than a threshold heart rate (which is greater than a normal heart rate), the treatment component 100 may reduce energy delivery to one or more energy delivery elements 110 to lower the temperature of one or more energy delivery elements 110. When the heart rate is greater than the threshold heart rate, this may indicate that the patient is in excessive pain, and energy delivery should be stopped and / or the patient's sedation level should be checked.

[0075] When the heart rate exceeds a threshold heart rate and / or changes in heart rate, the treatment component 100 can notify the clinician (414). For example, when the heart rate is below a threshold heart rate and / or is slowing down, the notification can indicate that bradycardia, a heart rate below a threshold heart rate, and / or slow heart rate may be occurring or is about to occur. The notification can instruct the clinician to perform actions or instruct the clinician that the treatment component 100 can shut down or otherwise regulate or control energy delivery to the treatment site through one or more energy delivery elements 110. In some implementations, the treatment component 100 can request confirmation from user input from the clinician to allow the treatment component 100 to shut down or otherwise regulate or control energy delivery to the treatment site through one or more energy delivery elements 110 before changing the settings for delivering energy to the treatment site.

[0076] The treatment component 100 can identify or recognize one or more energy delivery elements 110 (416) that cause the heart rate to exceed a threshold heart rate. For example, energy delivered through one or more energy delivery elements 110 can cause the heart rate to drop below the threshold heart rate, and therefore the treatment component 100 can cycle through one or more energy delivery elements 110 to identify the cause of the slowed heart rate. Figure 6 The process 600 for determining the cause of bradycardia is further described. By identifying one or more energy delivery elements 110 that are causing the decrease in heart rate, the treatment component 100 can shut down a particular energy delivery element 110 to prevent bradycardia, while continuing treatment at the treatment site with another of the one or more energy delivery elements 110.

[0077] The treatment component 100 controls the delivery of energy through one or more energy delivery elements 110 (418). The treatment component 100 may control the energy delivery in response to user input confirming that a clinician wants to continue modulating the energy at the treatment site, or it may do so automatically. Since the one or more energy delivery elements 110 can be controlled independently, the treatment component 100 may turn off, disable, or otherwise stop the delivery of energy to all or some of the one or more energy delivery elements 110. For example, the treatment component 100 may turn off, disable, or otherwise stop the delivery of energy only to a group of energy delivery elements identified as causing bradycardia. In another instance, the treatment component 100 may turn off, disable, or otherwise stop the delivery of all energy to one or more energy delivery elements 110. In some implementations, control of energy delivery may include adjusting the amount of energy delivered to each of the one or more energy delivery elements 110, such as decreasing or increasing the amount of energy delivered. For example, the treatment component 100 may reduce the energy delivered by the one or more energy delivery elements 110 from a first amount to a second amount less than the first amount to prevent bradycardia.

[0078] Once the treatment component 100 controls energy delivery, such as stopping energy delivery, the treatment component 100 can notify the clinician (420). This notification may indicate that renal denervation has stopped or has increased or decreased due to a slowed heart rate. This allows the clinician to wait for the heart rate to recover or to apply atropine or other treatments or pharmacology to artificially increase the heart rate. After the treatment component 100 has notified the clinician and / or has adjusted or controlled energy delivery (406), the treatment component 100 can continue to monitor parameters corresponding to the heart rate.

[0079] Figure 6 This is a flowchart of a process 600 used to determine the cause of a slowed heart rate. One or more computers or one or more data processing devices, such as… Figure 1 The processor 302 of the treatment component 100 can implement process 600. The treatment component 100 can determine the cause of the slowed heart rate in response to a slowed heart rate and / or can actively identify any actions that may eventually lead to a slowed heart rate.

[0080] When the treatment component 100 determines that the heart rate is below a threshold heart rate, the heart rate is slowing down, and / or during initialization, the treatment component 100 may disable, shut down, or stop all one or more energy delivery elements 110 to ensure that no energy is delivered to the treatment site and to identify any potential causes of the slowed heart rate or any underlying action (602). The generator 104 may stop or prevent the power supply 308 from providing energy to the electrical leads connected to one or more energy delivery elements 110, which would stop any treatment at the treatment site. For example, the treatment component 100 may shut down the first energy delivery element 110a, the second energy delivery element 110b, the third energy delivery element 110c, and the fourth energy delivery element 110d.

[0081] The treatment assembly 100 enables a group of one or more energy delivery elements 110 to deliver energy to a treatment site (604) within a blood vessel. The group of one or more energy delivery elements 110 may be a single energy delivery element, such as energy delivery elements 110a, 110b, 110c, or 110d, or a combination of multiple energy delivery elements, such as a combination of two energy delivery elements 110a-b, or a combination of three energy delivery elements 110a-c. For example, the treatment assembly 100 may activate a first energy delivery element 110a and deactivate a second energy delivery element 110b and / or other energy delivery elements 110c-d.

[0082] Once the treatment component 100 activates a group of one or more energy delivery elements 110, the treatment component 100 can determine changes in heart rate (606). As described above, the treatment component 100 can measure temperature to determine heart rate. The treatment component 100 can compare the determined heart rate to a normal heart rate to determine whether the heart rate has changed. This allows the treatment component 100 to determine the effect or change of the activated energy delivery elements 110 on the patient's heart rate. This change can be an increase, a decrease, or no change in heart rate compared to the patient's normal heart rate when no energy delivery element 110 is able to deliver energy. The change can also be quantified based on the magnitude or amount of the change.

[0083] The treatment component 100 associates changes in heart rate or effects with a group of one or more activated energy delivery elements 110 (608). The treatment component 100 may then continue to cycle power to and / or activate different groups of one or more energy delivery elements 110 (610). Different groups may be a single energy delivery element 110a, 110b, 110c, or 110d or a combination of multiple energy delivery elements 110, which differs from previously activated energy delivery elements or combinations of energy delivery elements. The treatment component 100 cycles through different possible groups of one or more energy delivery elements 110, measures heart rate changes for each different possible group, and associates the measured heart rate changes with the corresponding group of one or more energy delivery elements 110.

[0084] Once the corresponding changes in heart rate of different possible groups of one or more energy delivery elements 110 have been measured, the therapeutic component can determine which of the one or more energy delivery elements 110 is causing changes (such as slowing) in the heart by identifying which combination of one or more energy delivery elements 110, upon activation, causes a slowing of the heart rate or otherwise reduces the heart rate. Thus, triggers or causes of bradycardia can be identified, such as stimulation of autonomic nerves that differ from the target sympathetic nervous system.

[0085] Because each energy delivery element 110 is located at a specific location and / or site along the vessel wall, the treatment component 100 can be able to identify and store potential locations of autonomic nerves (such as the vagus nerve, i.e., based on analysis of the activation of different groups of one or more energy delivery elements 110, distinct from the target sympathetic nerve). For example, a group of one or more energy delivery elements 110 may cause the greatest change, such as a maximum slowing of heart rate, upon activation, which could be the cause of the heart rate change. Therefore, the corresponding location of the identified one or more energy delivery elements 110 can approximate the location where autonomic nerves (such as the vagus nerve) may be located, resulting in a slowing of heart rate when stimulation or energy is applied. At a minimum, the treatment component 100 can provide feedback to a physician or other healthcare professional, allowing the physician or other healthcare professional to view the location on a fluoroscope and note areas that are not ablated.

[0086] In some implementations, the treatment component 100 may cycle through all combinations of single or multiple energy delivery elements 110. In other implementations, the treatment component 100 continues to cycle through different groups only if disabling the energy delivery elements 110 does not stop the decrease or reduction of heart rate.

[0087] The treatment component 100 can turn off, shut down, or otherwise disable energy delivery elements 110 (612) identified as a cause of bradycardia (such as slow heart rate). The treatment component 100 can also turn on, activate, or otherwise enable other energy delivery elements 110 not identified as causing bradycardia. This can prevent bradycardia and restore the heart rate to normal. The location of the disabled energy delivery elements 110 can be recorded, displayed, or otherwise made available to the clinician so that, as the catheter 108 moves within the blood vessel, an appropriate group of one or more energy delivery elements 110 can be enabled / disabled to avoid stimulation at locations identified as potentially inhabited by the autonomic nervous system. In some implementations, the analysis and cycling of different energy delivery elements 110 can be repeated as the catheter 108 is moved.

[0088] The treatment component 100 can identify and display potential autonomic pathways (614) based on locations identified as potential sites for the vagus nerve during multiple consecutive ablations. The ablation procedure can be repeated, and locations identified as potential vagal pathways can be stored and mapped during consecutive ablations. Potential pathways can be displayed on the user interface 118 or other displays to allow prediction of areas to be avoided within the patient's body.

[0089] Figure 7 This is a flowchart of a process 700 involving the execution of different actions at different threshold heart rates. One or more computers or one or more data processing devices, such as… Figure 1 The processor 302 of the treatment component 100 can implement process 700.

[0090] As described above, the treatment component 100 determines the heart rate (702). Once the treatment component 100 determines the heart rate, it can determine whether the heart rate is less than a first threshold heart rate (704). The first threshold heart rate can be approximately 7%–12% lower than the patient's normal heart rate. The patient's normal heart rate can be the average of the patient's heart rate when no energy is delivered or applied, and is typically between 60 and 100 heartbeats per minute when the patient is at rest.

[0091] When the treatment component 100 determines that the heart rate is below a first threshold heart rate, the treatment component 100 may notify the clinician that the heart rate is below normal (706). This notification may indicate that the heart rate is slowing down. The notification may instruct the treatment component 100 to identify the cause of the slowing and shut down one, some, or all of the energy delivery elements 110 to prevent further slowing if the clinician does not take action and the heart rate continues to decrease. Otherwise, if the heart rate is greater than or equal to the first threshold heart rate, the treatment component 100 may continue to monitor the heart rate during energy delivery.

[0092] The treatment component 100 can determine whether the heart rate is below a second threshold heart rate (708). The second threshold heart rate can be approximately 17%–22% lower than the normal heart rate and can indicate an increased severity of heart rate slowing compared to the first threshold heart rate.

[0093] When the treatment component 100 determines that the heart rate is less than a second threshold heart rate, the treatment component 100 can determine the cause of the bradycardia (710). The treatment component 100 can notify the clinician that the treatment component 100 intends to determine the cause of the bradycardia and / or automatically determine the cause of the bradycardia, for example, as described above and in Figure 6 As shown in the diagram. Otherwise, if the heart rate is greater than or equal to the second threshold heart rate, the treatment component 100 may continue to monitor the heart rate and / or continue to perform any previous actions. The treatment component 100 may stop, turn off, or otherwise disable the energy delivery element 110 (712) determined to be causing a slowing of the heart rate.

[0094] The treatment component 100 can determine whether the heart rate is below a third threshold heart rate (714). The third threshold heart rate can be approximately 27%–32% lower than the normal heart rate and can indicate an increased severity of heart rate slowing compared to the first and second threshold heart rates.

[0095] When the treatment component 100 determines that the heart rate is less than a third threshold heart rate, the treatment component 100 may disable or turn off all (716) one or more energy delivery elements 110. In some implementations, the treatment component 100 may also indicate or notify the clinician of the possibility of bradycardia and recommend treatment, such as administration of atropine, to increase the patient's heart rate (718).

[0096] Exemplary embodiments of the present invention have been disclosed in an illustrative manner. Therefore, the terminology used throughout should be read in a non-limiting manner. While those skilled in the art will conceive of minor modifications to the teachings herein, it should be understood that the scope intended to be limited to all such embodiments that reasonably fall within the scope of improvements of the technology contributed herein, and that scope should not be limited except as provided in the appended claims and their equivalents.

Claims

1. A therapy assembly for renal denervation, comprising: a first sensor configured to continuously detect a first temperature or a first impedance at a first location of a blood vessel wall; a first energy delivery element configured to deliver energy to the blood vessel wall; and a processor coupled to the sensor and the first energy delivery element and configured to: determine a heart rate based on the first temperature or the first impedance at the first location of the blood vessel wall, determine that the heart rate is less than a threshold heart rate, the threshold heart rate indicating that the heart rate is slowing, and control the first energy delivery element to adjust the delivery of energy to the blood vessel wall, and the assembly further comprising: a second energy delivery element configured to deliver a second amount of energy to a second location on the blood vessel wall, wherein the first energy delivery element is configured to deliver a first amount of energy to the first location of the blood vessel wall, wherein the processor is configured to: turn off the first energy delivery element and the second energy delivery element; cycle the first energy delivery element and second energy delivery element to determine a cause of the heart rate slowing; turn off one of the first energy delivery element or the second energy delivery element based on the cause of the heart rate slowing; and turn on the other of the first energy delivery element or the second energy delivery element based on the cause of the heart rate slowing. To control the first energy delivery element, the processor is configured to disable the first energy delivery element when the heart rate is less than the threshold heart rate.

2. The treatment assembly of claim 1, wherein, the processor is configured to:

3. The treatment assembly of claim 1, wherein, provide a notification or an indication to a clinician on a display that the heart rate is below the threshold heart rate; and obtain a confirmation to continue determining the cause of the heart rate slowing.

4. The therapy assembly of claim 1, further comprising: a second sensor configured to detect a second temperature at a second location of the blood vessel wall, wherein the processor is configured to determine the heart rate further based on the second temperature at the second location of the blood vessel wall.

5. The therapy assembly of claim 1, further comprising: a catheter coupled to the first sensor and the first energy delivery element and configured to be intravascularly inserted into the blood vessel, wherein the blood vessel is a renal artery and wherein the first sensor is coupled to the first energy delivery element.

6. The therapy assembly of claim 5, further comprising: a radio frequency generator configured to deliver the energy to the first energy delivery element, wherein the energy is a radio frequency (RF) signal, wherein the first energy delivery element is an electrode.

7. The therapy assembly for renal denervation of claim 1, wherein: the assembly comprises a plurality of sensors, the plurality of sensors including the first sensor; ​ and wherein the assembly includes a plurality of energy delivery elements configured as electrodes configured to deliver energy to the blood vessel wall, the plurality of energy delivery elements including the first energy delivery element and the second energy delivery element; and wherein the processor is coupled to the plurality of sensors and the electrodes and is configured to: turn off one of the electrodes to prevent bradycardia, the processor is configured to determine a cause of the slowing of the heart rate when the heart rate is less than the threshold heart rate, and wherein the processor is configured to cycle through the electrodes to determine the cause of the slowing of the heart rate.

8. The treatment assembly of claim 7, wherein, the processor independently controls an amount of energy delivered by each of the electrodes.

9. The treatment assembly of claim 7, wherein, the processor is configured to turn on, turn off, or adjust the amount of energy delivered by each of the electrodes.

10. The treatment assembly of claim 7, wherein the electrodes include a first electrode configured to deliver the first amount of energy to the first location on the blood vessel wall and a second electrode configured to deliver the second amount of energy to the second location on the blood vessel wall.

11. The treatment assembly of claim 7, wherein, the plurality of sensors include a second sensor configured to detect a second temperature at a second location of the blood vessel wall, wherein the processor is configured to determine the heart rate further based on the second temperature at the second location of the blood vessel wall.

12. The treatment assembly of claim 7, further comprising: a catheter coupled to the plurality of sensors and the electrodes and configured to be inserted intravascularly into the blood vessel, wherein the blood vessel is a renal artery, and wherein the plurality of sensors are coupled to corresponding ones of the electrodes.

13. The treatment assembly of claim 7, further comprising: a radio frequency generator configured to deliver the energy to the electrodes.

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