Selection of patients with hypertension for treatment with renal denervation

Abstract

The present invention discloses methods, systems, devices, assemblies and apparatus for treating hypertension in a patient using renal denervation. The treatment assembly includes an energy delivery element. The energy delivery element is configured to provide renal denervation energy to nerves within a patient's blood vessel. The treatment assembly includes a controller. The controller is coupled to the energy delivery element. The controller is configured to determine that the hypertension in the patient is orthostatic. The controller is configured to apply renal denervation energy to the patient using the energy delivery element.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 850,195, filed on May 20, 2019, entitled “METHOD FOR SELECTION OF HYPERTENSIVE PATIENTS FOR TREATMENTWITH RENAL DENERVATION,” and the entire contents of that application are hereby incorporated by reference herein. Background Art 1. Technical Field

[0004] The present description relates to systems, devices, methods and / or apparatus for identifying and selecting hypertensive patients responsive to treatment with renal denervation.

[0005] 2. Description of related technologies

[0006] Various non-invasive methods have been developed to perform renal sympathetic denervation (RDN) procedures to reduce hypertension (BP) in patients at risk of cardiovascular complications and death, which is due to inadequate control of the patient's hypertension. Renal denervation is a minimally invasive procedure for treating refractory hypertension. During renal denervation, a nurse, doctor, technician or other medical staff (or "clinician") uses stimulation or energy (such as radiofrequency, ultrasound, cooling or other energy) to perform ablation in the renal artery. This reduces the activity of the nerves around the blood vessels, which has been proven to lead to a reduction in blood pressure and other benefits. Clinicians use renal denervation devices to deliver stimulation or energy to the treatment site (e.g., through one or more electrodes of the renal denervation device). The stimulation at the treatment site can pass through the vessel wall, which can lead to various resulting RDN-related depressor effects. The resulting RDN-related depressor effects include ablation of efferent sympathetic nerves that leads to a reduction in nighttime BP, and ablation of afferent sympathetic nerves that produces central blockade of sympathetic nerve activity that leads to a reduction in daytime BP. However, not all patients with refractory or refractory hypertension can benefit from RDN. Therefore, it is useful to identify patients who may benefit from renal denervation procedures.

[0007] In addition, it is important to understand the patient's response to stimulation in order to determine the best and most effective course of treatment to be administered, thereby predicting the overall effectiveness of the administered treatment for the patient. This allows a doctor, nurse or other health care professional to adjust, modify and / or otherwise monitor and control the treatment to provide effective treatment and determine the likelihood of success of the treatment course. Therefore, the selection of patients and the determination of patient treatment are important for providing and administering effective treatment.

[0008] Therefore, there is a need for a system, device and / or method for managing, adjusting or otherwise controlling a patient's selection and administration of therapy (including the delivery of renal denervation energy) to provide effective therapy that accurately reflects the desired outcome on the parameters of the patient or disease condition. Summary of the invention

[0009] In general, one aspect of the subject matter described herein is embodied in a method for treating hypertension in a patient. The method includes determining that the patient's hypertension is orthostatic. The method includes applying renal denervation energy to the patient.

[0010] These and other embodiments may optionally include one or more of the following features. The method may include measuring the patient's baseline standing systolic blood pressure (SBP). The method may include measuring the patient's baseline supine SBP. The method may include determining that the patient's baseline standing systolic blood pressure (SBP) is at least 20 mmHg greater than the baseline supine SBP to determine that the patient's hypertension is orthostatic. The method may include determining that the patient's baseline standing systolic blood pressure (SBP) is at least 10 mmHg greater than the baseline supine SBP to determine that the patient's hypertension is orthostatic.

[0011] The method may include obtaining user input indicating the baseline standing systolic blood pressure (SBP), the baseline supine systolic blood pressure (SBP), the baseline standing diastolic blood pressure (DBP), and the baseline diastolic blood pressure (DBP). The method may include measuring the patient's baseline standing diastolic blood pressure (DBP). The method may include measuring the patient's baseline supine DBP. The method may include determining that the patient's baseline standing diastolic blood pressure (DBP) is at least 10 mmHg greater than the baseline supine DBP.

[0012] The method may include determining a number of ablations based on determining that the hypertension in the patient is orthostatic. The method may include applying the renal denervation energy or selecting a patient to be excluded for renal denervation. The application of the renal denervation energy may be based on the number of ablations and the amount of energy to be delivered in each ablation. The method may include applying the renal denervation energy intravascularly, intravascularly, or externally. The method may include applying the renal denervation energy to the patient using at least one of radiofrequency (RF) ablation, chemo, cryotherapy, or ultrasound.

[0013] The method may include determining that the patient is in a supine position. The method may include measuring the patient's supine blood pressure while the patient is in the supine position. The method may include waiting for a period of time before measuring a standing blood pressure. The method may include determining that the patient is in a standing position. The method may include measuring the patient's standing blood pressure while the patient is in the standing position. The method may include comparing the supine blood pressure with the standing blood pressure to determine whether the patient's hypertension is orthostatic. The method may include determining that the patient's hypertension is orthostatic based on the comparison. The method may include applying the renal denervation energy to the patient based on the patient's hypertension being orthostatic and a treatment model, such that the application of the renal denervation energy may be customized for the patient.

[0014] The method may include predicting the effectiveness or responsiveness of applying the renal denervation energy to the patient. The prediction may be based on a treatment model and may be performed prior to applying the renal denervation energy to the patient.

[0015] In another aspect, the subject matter is embodied in a therapeutic assembly for renal denervation. The therapeutic assembly includes an energy delivery element. The energy delivery element is configured to provide renal denervation energy to nerves within a patient's blood vessel. The therapeutic assembly includes a controller. The controller is coupled to the energy delivery element. The controller is configured to determine that the hypertension of the patient is orthostatic. The controller is configured to apply renal denervation energy to the patient using the energy delivery element.

[0016] In another aspect, the subject matter is embodied in a method for treating hypertension in a patient. The method includes measuring a supine blood pressure of the patient while the patient is in a supine position. The method includes measuring a standing blood pressure of the patient while the patient is in a standing position. The method includes comparing the supine blood pressure to the standing blood pressure. The method includes determining that the hypertension of the patient is orthostatic based on the comparison. The method includes predicting the effectiveness or responsiveness of a renal denervation therapy for the patient. The method includes providing the predicted effectiveness or the predicted responsiveness to an operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Other systems, methods, features, and advantages of the present invention will be or will become apparent to one of ordinary skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this specification, be within the scope of the present invention, and be protected by the appended claims. The component parts shown in the drawings are not necessarily drawn to scale and may be enlarged to better illustrate important features of the present invention. In the drawings, like reference numerals represent like parts throughout the different views.

[0018] Figure 1 An exemplary conceptual illustration of a treatment assembly according to one aspect of the present invention is shown.

[0019] Figure 2A A schematic diagram of a device in a thin delivery configuration according to one aspect of the present invention is shown. Figure 1 An exemplary renal denervation device having a therapeutic component.

[0020] Figure 2B FIG. 1 shows an expanded deployment configuration according to one aspect of the present invention. Figure 1 An exemplary renal denervation device having a therapeutic component.

[0021] Figure 3 FIG. 1 shows a device in an expanded deployment configuration within a blood vessel according to one aspect of the present invention. Figure 1 An exemplary renal denervation device having a therapeutic component.

[0022] Figure 4 According to one aspect of the present invention Figure 1 Block diagram of an exemplary generator of a therapeutic component.

[0023] Figure 5 is a method for controlling delivery to a Figure 1 A flow chart of an exemplary process for delivering energy to one or more energy delivery elements of a therapeutic assembly.

[0024] Figure 6 According to one aspect of the present invention, a Figure 1 A flow chart of an exemplary process for determining blood pressure in a human patient using a therapeutic component.

[0025] Figure 7 According to one aspect of the present invention, a Figure 1 Flowchart of an exemplary process for comparing the blood pressure of a human patient in a standing position and a supine position to determine whether the hypertension is orthostatic.

[0026] Figure 8 is a diagram showing the use of one aspect of the present invention Figure 1Bar graph showing an example of the blood pressure response to renal denervation in a drug-free patient at 3 months under the first definition of orthostatic hypertension within 24 hours of the treatment component.

[0027] Fig. 9 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response to renal denervation in drug-free patients at 3 months in the morning under the first definition of orthostatic hypertension of the treatment components.

[0028] Fig.10 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response of renal denervation in drug-free patients at 3 months at the peak morning under the first definition of orthostatic hypertension of the treatment components.

[0029] Fig.11 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response of renal denervation in drug-free patients at night at 3 months under the first definition of orthostatic hypertension of the treatment components.

[0030] Fig.12 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response to renal denervation in a drug-free patient during the day under the first definition of orthostatic hypertension with treatment components.

[0031] Fig.13 is the use according to one aspect of the present invention Figure 1 Tabular presentation of the statistical analysis of the interaction between treatment and orthostatic hypertension under the first definition of orthostatic hypertension for the treatment components.

[0032] Fig.14 is a summary of the use according to one aspect of the present invention Figure 1 A table of exemplary blood pressure responses for patients receiving RDN under the first definition of orthostatic hypertension for a treatment component of.

[0033] Fig.15 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response to renal denervation in a drug-free patient at 3 months under the second definition of orthostatic hypertension within 24 hours of the treatment component.

[0034] Fig.16 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph of examples of blood pressure responses to renal denervation in drug-free patients at 3 months in the morning under the second definition of orthostatic hypertension of the treatment components.

[0035] Fig.17 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph of examples of the blood pressure response to renal denervation in drug-free patients at 3 months at peak morning under the second definition of orthostatic hypertension of the treatment components.

[0036] Fig.18 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response of renal denervation in drug-free patients at night at 3 months under the second definition of orthostatic hypertension of the treatment components.

[0037] Fig.19 is a diagram showing the use of one aspect of the present invention Figure 1 Bar graph showing an example of the blood pressure response to renal denervation in a drug-free patient during the day under the second definition of orthostatic hypertension with a treatment component.

[0038] Fig. 20 is the use according to one aspect of the present invention Figure 1 Tabular presentation of the statistical analysis of the interaction between treatment and orthostatic hypertension under the second definition of orthostatic hypertension by treatment component.

[0039] Fig.21 is a summary of the use according to one aspect of the present invention Figure 1 A table of exemplary blood pressure responses for patients receiving RDN under the second definition of orthostatic hypertension for a treatment component of. DETAILED DESCRIPTION

[0040] Disclosed herein are systems, devices, methods and / or apparatus for detecting or determining the effectiveness or responsiveness of renal denervation therapy in hypertensive patients. When analyzing renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications, it was shown that renal denervation was more likely to be effective in patients with orthostatic hypertension than in patients without orthostatic hypertension, and therefore, the treatment component determines the type of hypertension to better understand the predicted effectiveness or responsiveness of renal denervation therapy.

[0041] The treatment component determines whether hypertension in the patient is orthostatic and is able to predict the effectiveness or responsiveness of renal denervation therapy for the patient. The treatment component can use the treatment model to predict the effectiveness or responsiveness of renal denervation therapy for the patient, which allows an operator such as a physician, nurse or other healthcare professional to better assess the risks and possible outcomes of renal denervation therapy for a particular patient. This minimizes the application or use of ineffective procedures and allows the operator to anticipate any necessary follow-up treatments or procedures.

[0042] Other benefits and advantages include the ability to determine the most effective application of renal denervation energy to treat a condition. The treatment component can use an analysis of the effectiveness or responsiveness of the renal denervation therapy to the patient to determine the amount of renal denervation energy to be delivered, the frequency of delivery of the renal denervation energy over a period of time, and / or the number of times the renal denervation energy should be applied. The treatment component can automatically control the delivery of the renal denervation energy based on the determined treatment process and apply the renal denervation energy to the nerves within the vessel wall to obtain a desired result, such as a reduction in a symptom, a biological parameter such as blood pressure, or a condition of the disease.

[0043] Figure 1 A therapeutic assembly 100 is shown. The therapeutic assembly 100 performs renal denervation within a renal artery of a human patient. Renal denervation is a minimally invasive procedure used to treat hypertension. The therapeutic assembly 100 may perform renal denervation within, intravascularly, or externally to a blood vessel of a human patient. For example, the therapeutic assembly 100 may be a transducer positioned externally to a human patient to deliver ultrasound energy into the body of the human patient. In another example, the therapeutic assembly 100 may include a catheter or other device such as one inserted into a human patient via a small incision.

[0044] The treatment assembly 100 includes a renal denervation device 102 and / or a generator 104. The treatment assembly 100 may include or be coupled to one or more sensors 103, such as a sphygmomanometer, a blood pressure meter, or a blood pressure monitor 103a, which can be used to measure the blood pressure of a human patient. The one or more sensors 103 that measure the blood pressure of a human patient may measure systolic blood pressure (SBP) and / or diastolic blood pressure (DBP). The SBP and / or DBP may be measured when the human patient is in a supine position and / or a standing position. The one or more sensors 103 may include a camera 103b or other position sensor. The position sensor may be a sensor that detects the position of a human patient, such as when the human patient is lying down (e.g., in a supine position) and / or standing (e.g., in a standing position). The camera 103b may capture image data of the human patient, and a processor such as a controller within the generator 104 may analyze the image data to determine the position of the human patient. The one or more sensors 103 may be integrated within the generator 104, coupled to the generator, or otherwise connected to the generator.

[0045] The renal denervation device 102 may include any device that delivers energy or stimulation to target nerves within a blood vessel wall, such as the renal nerves of a renal artery. The device that delivers energy or stimulation to the target nerves may be positioned external to the human patient, such as a transducer that emits ultrasonic energy, or may be positioned intravascularly inside a blood vessel to deliver energy or stimulation, such as the renal denervation device 102. The energy or stimulation may include, for example, at least one of radiofrequency stimulation, thermal stimulation, cryogenic stimulation, microwave stimulation, ultrasound or ultrasonic stimulation, or other forms of energy or stimulation. Regardless of the type of energy delivered, the renal denervation device 102 does not completely occlude the blood vessel, and therefore blood may continue to flow through the blood vessel.

[0046] The renal denervation device 102 may have a catheter 108 and / or one or more energy delivery elements 110 (such as electrodes) and / or one or more sensors 112 (such as temperature sensors, blood flow sensors, impedance sensors, or other sensors for interpolating characteristics of heart rate, blood flow, blood pressure, or other parameters). The renal denervation device 102 may have an elongated shaft 114 with a handle 116. The elongated shaft 114 with the handle 116 may be used to guide and / or advance the distal portion of the catheter 108 through a patient's (such as a human patient's) blood vessel to a target location in the vessel and to remotely manipulate the distal portion of the catheter 108. The catheter 108 may be in a low-profile configuration (such as Figure 1 and Figure 2A The catheter 108 may be delivered intravascularly (in a substantially straight configuration as shown) to a patient, such as a blood vessel of the patient. The length of the catheter 108 may exceed one meter. When delivered intravascularly and along a blood vessel to a target location, the catheter 108 may be deployed in an expanded deployment configuration (such as a generally spiral or helical configuration or other suitable configuration), and the one or more energy delivery elements 110 (such as one or more electrodes) may contact the blood vessel, for example, as Figure 3 In the expanded deployed state, the renal denervation device 102 can deliver energy at the treatment site and provide therapeutically effective electrical and / or thermally induced denervation to the nerves within the vessel wall. FIG. 2A to FIG. 2B The deployment of the renal denervation device 102 is shown. Specifically, Figure 2A The catheter 108 is shown in a low profile configuration, and Figure 2B Catheter 108 is shown in an expanded deployed configuration.

[0047] The catheter 108 may have a distal tip 202. The distal tip 202 points into the lumen of the blood vessel. The distal tip 202 may have a high-density marker band 204. The high-density marker band 204 allows the clinician to identify the distal tip 202 of the catheter 108 under fluoroscopy. The length of the distal tip 202 may be about 4-5 cm.

[0048] The catheter 108 may have a wire 206 within the lumen of the catheter 108. The distal tip 202 allows the wire 206 to extend out and away from the distal tip 202 when the catheter 108 is in the low-profile configuration and be advanced through the blood vessel to a target location in the blood vessel. When the wire 206 is retracted within the distal tip 202 and into the catheter 108, the catheter 108 changes shape from a low-profile configuration (such as a substantially straight configuration, for example, as shown in FIG. 1 ) to a substantially straight configuration (such as a substantially straight configuration, for example, as shown in FIG. 1 ). Figure 2A ) to an expanded deployment configuration (such as a generally spiral or spiral configuration, e.g., as shown Figure 2B shown).

[0049] 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 radiofrequency electrodes, radiofrequency probes, thermal probes, cryogenic probes, microwave probes, ultrasound probes, light sources, or chemical injectors. The one or more energy delivery elements 110 may be positioned on a distal portion of the catheter 108. The one or more energy delivery elements 110 may include a plurality of energy delivery elements 110, such as energy delivery elements 110a-d, such as Figure 2A , Figure 2B and Figure 3 When in the spiral configuration, the energy delivery elements 110a-d can be spaced approximately 90 degrees apart relative to a longitudinal axis extending through the center of the catheter 108. The energy delivery elements 110 can be spaced any suitable distance apart from one another, and the spacing can vary based on the application of the therapeutic assembly 100 and its intended use.

[0050] When multiple energy delivery elements 110 are present, each energy delivery element 110 can individually deliver power to the treatment site simultaneously, selectively, and / or sequentially. The multiple energy delivery elements 110 can deliver power in any desired combination of the one or more energy delivery elements 110. The multiple energy delivery elements 110 can include any number of energy delivery elements 110.

[0051] The one or more energy delivery elements 110 can be introduced into and advanced along a blood vessel 304, such as a renal artery, and can be positioned to contact the blood vessel 304 at different intervals and / or locations along the wall of the blood vessel 304 in an expanded deployment configuration. For example, a first energy delivery element 110a can contact the wall of the blood vessel 304 at a first location 302a, a second energy delivery element 110b can contact the wall of the blood vessel 304 at a second location 302b, a third energy delivery element 110c can contact the wall of the blood vessel 304 at a third location 302c, and a fourth energy delivery element 110d can contact the wall of the blood vessel 304 at a fourth location 302d. The renal denervation device 102 can deliver energy at a treatment site through the one or more energy delivery elements 110 and provide therapeutically effective electrically and / or thermally induced denervation.

[0052] The renal denervation device 102 may include one or more sensors 112. The one or more sensors 112 may be sensors that measure parameters such as temperature, impedance, blood pressure, optics, blood flow, or chemical content. The one or more sensors 112 may be proximal to or within the energy delivery element 110. The measured parameter may be used to interpolate another parameter. For example, the measured temperature may be used to interpolate the patient's heart rate.

[0053] Each of the one or more sensors 112 can be coupled to, integrated with, or in close proximity to a corresponding one of the one or more energy delivery elements 110. This allows each of the one or more sensors 112 to measure a parameter proximal to the energy delivery element 110 such that the parameter reflects the effect of the energy delivery element 110 on the location tissue. For example, a first sensor 112a can be integrated with a first energy delivery element 110a, a second sensor 112b can be integrated with a second energy delivery element 110b, a third sensor 112c can be integrated with a third energy delivery element 110c, and a fourth sensor 112d can be integrated with a fourth energy delivery element 110d, for example. Figure 2B shown.

[0054] For example, the energy delivery element 110 can be an electrode having two wires. One wire can be made of copper and the other wire can be made of a copper-nickel alloy. The wires can both transmit signals from the sensor 112 and also transmit energy to the energy delivery element. The signal can be a temperature signal indicating the temperature of the blood vessel, a pressure signal indicating the blood flow or blood pressure near the electrode target location.

[0055] The treatment assembly includes a generator 104. The generator 104 may be a radio frequency generator or other generator that delivers denervation stimulation or energy to the vessel wall through the one or more energy delivery elements 110 at the treatment location. Denervation stimulation may include non-electrical stimulation, such as chemical agents, optical stimulation, thermal stimulation, cooling stimulation, microwave stimulation, or other forms of stimulation. The generator 104 may have a catheter 108 that is conductive and extends through the lumen and a cable, electrical lead, and / or wire that is electrically coupled to the one or more energy delivery elements 110. In some specific implementations, the generator 104 may have a separate lead and / or wire that is electrically coupled to a corresponding energy delivery element 110 in the one or more energy delivery elements 110 so that each energy delivery element 110 can operate independently of other energy delivery elements. For example, the generator 104 may have multiple independent channels, such as four RF channels, to deliver RF energy to the energy delivery elements 110a-d individually, and to control and monitor each energy delivery element 110a-d individually. The generator 104 may generate energy that is ultimately transmitted to the one or more energy delivery elements 110 via electrical leads.

[0056] The generator 104 may have one or more processors 402, memory 404, user interface 118, network access device 410, and / or power supply 408, e.g., Figure 4 The one or more processors 402 may be electrically coupled to a memory 404, a user interface 118, and / or a power source 408. The one or more processors 402 may include one or more controllers that measure blood pressure of a human patient, develop or predict effectiveness or responsiveness of a renal denervation therapy to a human patient, and / or develop and administer a treatment process for delivering renal denervation energy.

[0057] The one or more processors 402 can control the state of each of the 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 the power source 408 to manage the course and administration of treatment at the treatment site. The one or more processors can be coupled to the memory 404 and execute instructions stored in the memory 404.

[0058] The generator 104 may have a memory 404. The memory may be coupled to the one or more processors 402 and store instructions executed by the one or more processors 402. The memory 404 may include one or more of a random access memory (RAM), a read only memory (ROM), or other volatile or non-volatile memory. The memory 404 may be a non-transitory memory or data storage device, such as a hard drive, a solid state disk drive, a hybrid disk drive, or other suitable data storage device, and may also store machine-readable instructions that may be loaded and executed by the one or more processors 402. The memory 404 may store one or more thresholds for determining whether hypertension in a human patient is orthostatic, which may affect the predicted effectiveness or responsiveness of renal denervation therapy and / or a treatment process for delivering renal denervation energy to a human patient.

[0059] The generator 104 may have a power source 408, such as an RF generator or other power source. The power source 408 provides energy in a selected form and amount for delivery to a treatment site via the renal denervation device 102. The generator 104 may have a user interface 118. The generator 104 may receive input via the user interface 118, such as a selected form and amount of energy to be delivered to each of the one or more energy delivery elements 110. The user interface 118 may receive other user inputs, including the blood pressure of a human patient and / or the position of the human patient, such as when the human patient is in a supine position or a standing position.

[0060] The user interface 118 may include an input / output device that receives user input from a user interface element, button, dial, microphone, keyboard, or touch screen. The user interface 118 may provide output to an output device such as a display, speaker, audio and / or visual indicator, or a refreshable braille display. The output device may display an alert or notification or other information and / or confirm the status and / or command from the clinician. The output device may be an audio output device that outputs an audio indicator that indicates the notification or information to be provided to the clinician.

[0061] In some implementations, a camera 103b or other position sensor can be included within the generator 104. The camera 103b or other position sensor can be used to capture data (such as image data) to determine the position of the human patient, such as whether the human patient is in a supine or standing position.

[0062] The network access device 410 may include a communication port or channel, such as a dedicated short range communication (DSRC) unit, a Wi-Fi unit, One or more of a unit, a radio frequency identification (RFID) tag or reader, or a cellular network unit for accessing a cellular network (such as 3G, 4G, or 5G). Network access device 410 can transmit data to an external database or a remote server and receive data from an external database or a remote server.

[0063] Figure 5 is a flow chart of a method 500 for controlling energy delivered to the one or more energy delivery elements 110. One or more appropriately programmed computers or one or more data processing devices (e.g., Figure 1 Process 500 may be implemented by processor 402 of generator 104 of therapeutic component 100.

[0064] The treatment assembly 100 includes a generator 104 that controls the delivery of energy to the one or more energy delivery elements 110 of the renal denervation device 102. The treatment assembly 100 can receive or obtain a treatment model (502). The treatment model can be based on an accumulation of population patient data corresponding to various characteristics or parameters of human patients, various treatments, various disease conditions, and / or the correspondence of delivered energy and / or the resulting effectiveness and / or responsiveness for each disease condition when following the corresponding treatment. The treatment model can be generated based on the population patient data, which is combined with experimental data from clinical trials (such as Figures 8 to 21 ) are generated in real time together with experimental data presented in to identify the effectiveness and / or responsiveness of renal denervation in patients with orthostatic or non-orthostatic hypertension.

[0065] The characteristics or parameters of the human patient may include demographic data, age, gender, body mass index (BMI), blood pressure values, cholesterol levels, activity levels, sleep habits and / or other characteristics or parameters of the human patient. Various treatments may be associated with the amount of energy delivered, the frequency or amount of energy delivered over a period of time, the length of the time period for the continuous delivery of energy, and / or the location and / or treatment site of the energy delivery. Disease conditions may include various diseases, such as cardiac conditions or diseases, gastrointestinal conditions or diseases, immune or respiratory conditions or diseases, and / or other conditions or diseases. The effectiveness and / or responsiveness of the delivered energy for each disease condition may include the likelihood and / or amount of improvement in parameters associated or related to the disease or condition, such as a reduction in blood pressure of about 10%-15% or a reduction in the likelihood of a cardiac condition of about 10%-15%. The treatment model relates or maps each of these factors to the other factors so that the treatment model can be used to anticipate or predict that a human patient having a particular set of characteristics or parameters (such as a particular weight, height, activity level, or other characteristics or parameters) when given a particular course of treatment (such as monthly ablations over several months) will likely result in a given effectiveness and / or responsiveness to a disease or condition, such as a reduction in the likelihood of a cardiac event.

[0066] The treatment component 100 can obtain the treatment model via user input through the user interface 118. In some implementations, the treatment component can obtain the treatment model from an external database or a remote server via the network access device 410.

[0067] Therapeutic component 100 may determine that the human patient's hypertension is orthostatic (504). Therapeutic component 100 may collect or obtain sensor data and / or user input to determine whether the patient's hypertension is orthostatic. If the hypertension is orthostatic, then the delivery of energy may be more effective in treating the patient's disease or condition. And if the hypertension is not orthostatic, then the delivery of energy may not be as effective as when the hypertension is orthostatic. Figure 6 to Figure 7 Further described are methods for determining whether hypertension in a human patient is orthostatic.

[0068] The therapeutic assembly 100 may predict the effectiveness or responsiveness of the application of renal denervation energy (506). The effectiveness or responsiveness may be based on whether the hypertension is orthostatic. Patients with orthostatic hypertension may be more responsive to the application of renal denervation energy, and therefore, the therapeutic assembly 100 may consider whether the hypertension is orthostatic when determining the effectiveness or responsiveness.

[0069] Before applying renal denervation energy to the treatment site, the treatment assembly 100 can use the treatment model to predict the effectiveness or responsiveness of the application of renal denervation energy. The effectiveness or responsiveness can be a measure, probability, and / or likelihood that the renal denervation energy can improve the disease or condition.

[0070] For example, improvement in a disease or condition can be determined by the amount of change or improvement in a parameter associated with the disease or condition, such as a reduction in blood pressure, a reduction in cholesterol, and / or other parameters when related to heart disease. Improvement in a disease or condition can be determined by the elimination or reduction of symptoms caused by the disease or condition, or the elimination or reduction of a measurable amount of the disease or condition in a human patient (as determined by a physician, nurse, or other health care professional who provides a qualitative or quantitative success, partial success, or failure in terms of the elimination or reduction of symptoms, conditions, and / or disease). The probability and / or likelihood can be quantified as a percentage of success or a percentage of failure representing the overall improvement in the condition or disease relative to no treatment or no use of renal denervation energy to govern the treatment site. As shown below Figures 8 to 21 As shown, improvements in symptoms, conditions and / or diseases are greater in orthostatic patients with hypertension.

[0071] The therapeutic assembly 100 may provide the effectiveness or responsiveness of the delivery of the renal denervation energy to a clinician, such as a physician, nurse, or other healthcare professional (508). The therapeutic assembly 100 may display the effectiveness or responsiveness on the user interface 118, such as on a display, to present the effectiveness or responsiveness of the delivery of the renal denervation energy to the clinician. When providing the effectiveness or responsiveness, the therapeutic assembly 100 may indicate the likelihood or probability of success, partial success, and / or failure of the disease or condition after the delivery of the renal denervation energy and / or predict the resulting state. This allows an operator to analyze and view the expected results of the application of the renal denervation energy before performing renal denervation therapy on a human patient.

[0072] In some implementations, while providing effectiveness or responsiveness of renal denervation energy, the therapeutic assembly 100 can simultaneously request confirmation that the clinician wishes the therapeutic assembly 100 to continue applying renal denervation energy to the treatment site. This allows the clinician to weigh the costs and benefits of applying renal denervation energy and inform the human patient of the predicted outcome of applying renal denervation energy.

[0073] The therapeutic assembly 100 may obtain user input 510. The therapeutic assembly 100 may obtain user input indicating or confirming that the clinician desires to apply renal denervation energy to the treatment site. The user input may be received via the user interface 118. This allows the clinician to confirm that the therapeutic assembly 100 should continue the renal denervation treatment.

[0074] The treatment assembly 100 may determine a treatment course, including the number, amount, and / or frequency of delivering renal denervation energy to the treatment site (512). The treatment course may also indicate a treatment site or location where the renal denervation energy should be applied or delivered. The treatment strategy, such as the aggressiveness of the treatment course, may be affected by whether the hypertension is determined to be orthostatic or non-orthostatic.

[0075] The number of times may indicate the number of different passes that a human patient must receive a treatment course to achieve the predicted effectiveness and / or responsiveness of renal denervation energy for the condition or disease of the human patient. The amount may indicate the magnitude of the amount of renal denervation energy delivered each time the renal denervation energy is applied or delivered to the human patient. The frequency may indicate the number of times and the number of time periods within each time period that renal denervation energy should be applied or delivered to the human patient within the treatment course, such as once a week over a 3 month period.

[0076] The treatment component 100 can use the treatment model and the specific characteristics, features, and parameters of the human patient to determine a treatment course. The treatment component 100 can compare the specific characteristics, features, and parameters of the human patient and identify similar patients with those same or corresponding specific characteristics, features, and parameters within the treatment model to identify the treatment course that provides the greatest likelihood or probability of success for the condition or disease. The treatment model allows the treatment component 100 to customize the treatment course for the specific human patient, which increases the individual's chance of success.

[0077] Once the treatment process is generated, the treatment assembly 100 delivers or applies renal denervation energy to the treatment site (514). The treatment assembly 100 can use the generator 104 to generate energy or stimulation for delivery at the treatment site through the one or more energy delivery elements 110. In some implementations, the treatment assembly 100 can identify that the one or more energy delivery elements 110 are positioned at the treatment site prior to the delivery of energy or stimulation. The treatment assembly 100 can deliver or apply renal denervation energy to the treatment site only when the user has confirmed that application of renal denervation energy will proceed, or can automatically deliver or apply renal denervation energy.

[0078] Figure 6 is a flow chart of a process 600 for determining the blood pressure of a human patient. One or more appropriately programmed computers or one or more data processing devices (e.g., Figure 1 Process 600 may be implemented by processor 402 of generator 104 of therapeutic component 100.

[0079] The treatment component 100 may determine or detect the position of the human patient (602). The treatment component 100 may use one or more sensors 103, such as a camera 103b, to determine or detect the position of the human patient. For example, the camera 103b may capture image data of the human patient and analyze the human patient to determine the position of the human patient, such as the orientation of the human patient. The treatment component 100 may use the orientation of the human patient to determine whether the human patient is in a standing position or a supine position. In another example, the treatment component 100 may have one or more sensors 103 coupled to the body of the human patient, which helps the treatment component 100 determine the position of the human patient (such as an orientation) to determine whether the human patient is in a standing position or a supine position.

[0080] Treatment component 100 determines that the human patient is in a supine position (604). Treatment component 100 may determine that the human patient is in a supine position based on the orientation of the human patient relative to a planar surface, such as a floor. Treatment component 100 may analyze the image data and discern the human patient and the planar surface, such as a floor, by comparing the outline or skeleton of the human patient and the planar surface to an object library to identify the human patient and the planar surface. Once discerned, the position including the orientation of the human patient may be compared to the planar surface to determine whether the human patient is parallel to the planar surface, and when the human patient is parallel to the planar surface, treatment component 100 may determine that the human patient is in a supine or lying position.

[0081] In some implementations, the treatment assembly 100 can receive user input, such as from a clinician, to determine that the human patient is in a supine position. The treatment assembly 100 can receive the user input via the user interface 118. The user input can indicate a position, including an orientation of the human patient, such as whether the human patient is in a supine position, standing up, or another position. When the user input indicates that the human patient is in a supine position, the treatment assembly 100 can determine that the human patient is in a supine position.

[0082] Once it is determined that the human patient is in the supine position, the treatment component 100 can measure, obtain or otherwise determine the supine blood pressure of the human patient (606). Supine blood pressure is the blood pressure of the human patient when the human patient is in the supine position. When the human patient is in the supine position or lying position, the supine blood pressure includes systolic blood pressure (SBP) and diastolic blood pressure (DBP). The treatment component 100 can use one or more sensors 103 (such as blood pressure monitor 103a) to obtain the supine blood pressure. When the human patient is in the supine position, the blood pressure monitor can be coupled or connected to the human patient to measure the supine blood pressure of the human patient when the human patient is in the supine position. In some specific implementations, the treatment component 100 can receive or obtain the supine blood pressure via a user input indicating the supine blood pressure on the user interface 118. For example, a clinician can use the blood pressure monitor 103a to measure the supine blood pressure and input the supine blood pressure into the treatment component 100 via the user interface 118.

[0083] After measuring and determining the supine blood pressure, therapeutic assembly 100 may wait or delay for a period of time before therapeutic assembly 100 attempts to measure the standing blood pressure (608). The period of time may be approximately 5-10 minutes to allow the physiological parameters of the human patient to transition from the supine position to the standing position. The period of time may be user-configured, user-input, or predetermined. In some implementations, therapeutic assembly 100 may request user confirmation before continuing to determine the standing blood pressure. After receiving the user confirmation, therapeutic assembly 100 may continue to determine the standing blood pressure.

[0084] After the time period, the treatment component 100 repeats determining or detecting the position of the human patient, as described above (610). The treatment component 100 then determines that the human patient is in a standing position (612). The treatment component 100 can determine that the human patient is in a standing position based on the orientation of the human patient relative to a planar surface, such as a floor. Similar to detecting a supine position, the treatment component 100 can analyze the image data and distinguish between a human patient and a planar surface (such as a floor) by comparing the outline or skeleton of the human patient and the planar surface to an object library to identify the human patient and the planar surface. However, once distinguished, the position including the orientation of the human patient can be compared to the planar surface to determine whether the human patient is perpendicular to the planar surface, and when the human patient is perpendicular to the planar surface, the treatment component 100 can determine that the human patient is in a standing position.

[0085] In some implementations, the treatment assembly 100 can receive user input, such as from a clinician, to determine that the human patient is in a standing position. The treatment assembly 100 can receive the user input via the user interface 118. The user input can indicate a position, including an orientation of the human patient, such as whether the human patient is in a supine position, a standing position, or another position. When the user input indicates that the human patient is in a standing position, the treatment assembly 100 can determine that the human patient is in a standing position.

[0086] Once it is determined that the human patient is in a standing position, the therapeutic component 100 may measure, obtain, or otherwise determine the standing blood pressure of the human patient (614). The standing blood pressure is the blood pressure of the human patient when the human patient is in a standing position. When the human patient is in a standing position, the standing blood pressure includes systolic blood pressure (SBP) and diastolic blood pressure (DBP). The therapeutic component 100 may use one or more sensors 103 (such as a blood pressure monitor 103a) to obtain the standing blood pressure. When the human patient is in a standing position, the blood pressure monitor may be coupled or connected to the human patient to measure the standing blood pressure of the human patient when the human patient is in a standing position. In some specific implementations, the therapeutic component 100 may receive or obtain the standing blood pressure via a user input indicating the standing blood pressure on the user interface 118. For example, a clinician may use the blood pressure monitor 103a to measure the standing blood pressure and input the standing blood pressure into the therapeutic component 100 via the user interface 118.

[0087] After measuring, obtaining, or otherwise determining the standing blood pressure and the supine blood pressure, therapeutic component 100 can compare the supine blood pressure to the standing blood pressure (616). Therapeutic component 100 can compare the supine systolic pressure to the standing systolic pressure and / or the supine diastolic pressure to the standing diastolic pressure. Therapeutic component 100 can use this comparison to determine whether the patient's hypertension is orthostatic. Figure 7 A comparison of blood pressures for determining whether a patient's hypertension is orthostatic is also described. In some implementations, after measuring supine and standing blood pressures, a clinician performs a comparison of standing and supine blood pressures and determines whether the patient's hypertension is orthostatic and / or whether the patient is a good candidate for renal denervation.

[0088] Figure 7 700 is a flow chart of a process for comparing the blood pressure of a human patient in a standing position and a supine position to determine whether the hypertension is orthostatic. One or more appropriately programmed computers or one or more data processing devices (e.g., Figure 1 The processor 402 of the generator 104 of the therapeutic component 100 can implement process 700. When determining whether hypertension is orthostatic, orthostatic or postural hypertension can be defined in two alternative schemes. The first definition of orthostatic hypertension requires that the patient's baseline standing systolic blood pressure (SBP) is 20mmHG or more greater than the baseline supine SBP, or the patient's baseline standing diastolic blood pressure (DBP) is 20mmHg or more greater than the baseline supine DBP. The second definition of orthostatic hypertension requires that the patient's baseline standing systolic blood pressure (DBP) is 10MMHG or more greater than the baseline supine SBP, or the patient's baseline standing diastolic blood pressure (DBP) is 10mmHG or more greater than the baseline supine DBP. The therapeutic component can implement two definitions 100 as described below to determine whether a patient has orthostatic hypertension.

[0089] When therapeutic component 100 compares standing blood pressure and supine blood pressure, therapeutic component 100 may compare the diastolic and / or systolic blood pressure of the human patient when standing and when lying down to determine whether the hypertension is orthostatic. Therapeutic component 100 determines whether the standing systolic blood pressure (SBP) is greater than a first threshold amount (702). The first threshold amount may be an amount greater than the supine SBP by at least 10 mmHG as defined by the second definition, or greater than the supine SBP by at least 20 mmHG as defined by the first definition.

[0090] When the standing SBP is greater than the first threshold amount, the therapeutic component 100 may determine that the hypertension is orthostatic (708). The therapeutic component 100 may determine that the hypertension is orthostatic when the amount is at least 10 mmHG greater than the supine SBP (as defined by the second definition), or when the amount is at least 20 mmHG greater than the supine SBP (as defined by the first definition).

[0091] Otherwise, when the standing SBP is less than or equal to the first threshold amount, the therapy component 100 determines whether the standing diastolic blood pressure (DBP) is greater than a second threshold amount (704). The second threshold amount can be an amount greater than the supine DBP by at least 10 mmHG as defined by the second definition, or an amount greater than the supine DBP by at least 20 mmHG as defined by the first definition.

[0092] When the standing DBP is greater than the second threshold amount, therapeutic assembly 100 determines that the hypertension is orthostatic (708). Therapeutic assembly 100 may determine that the hypertension is orthostatic when the amount is at least 10 mmHG greater than the supine DBP (as defined by the second definition), or when the amount is at least 20 mmHG greater than the supine DBP (as defined by the first definition).

[0093] Otherwise, when the condition is not met, the treatment component 100 determines that the hypertension is not orthostatic, as defined by the first definition or the second definition used to perform the determination (706). The determination of whether the hypertension is orthostatic affects the effectiveness and / or responsiveness of applying renal denervation energy to treat the disease or condition. The definition to be met in order to determine whether the hypertension is orthostatic can be selected via user input to the user interface 118 and / or can be pre-configured or user-configured.

[0094] Figures 8 to 21An experimental analysis of a clinical trial of renal denervation in a patient with hypertension is shown. For various use cases of blood pressure measurement, the analysis seeks the interaction between treatment (RDN or control) and orthostatic hypertension. The interaction shows the blood pressure changes of patients with orthostatic hypertension and patients without orthostatic hypertension. Various use cases use the first definition and the second definition to measure the systolic blood pressure in the following time periods at 3 months: 1) within 24 hours, 2) during the day (average 9a.m to 9p.m.), 3) during the night (average 1a.m. to 6p.m.), 4) during the morning (average 7a.m. to 9a.m.) and during the peak morning (i.e., the highest 1-hour moving average of at least 3 consecutive SBPs between 6a.m. and 10a.m.). Then, the analysis compares the response rate between RDN subjects with and without orthostatic hypertension for the same time period.

[0095] Figure 8 is a bar graph of the blood pressure response to renal denervation in drug-free patients at 3 months over 24 hours under the first definition of orthostatic hypertension. The bar graph shows that, among the number N of subjects, subjects with orthostatic hypertension showed a greater change, i.e., a reduction in SBP, when performing RDN compared to the control group over a 24 hour period compared to subjects without orthostatic hypertension when performing RDN. Thus, in patients with orthostatic hypertension, RDN was more effective in reducing SBP over a 24 hour period.

[0096] Fig. 9 is a bar graph showing the blood pressure response to renal denervation in drug-free patients at 3 months in the morning under the first definition of orthostatic hypertension. Here, subjects with orthostatic hypertension showed a greater change, i.e., a reduction in SBP, when performing RDN compared to the control group during the morning period compared to subjects without orthostatic hypertension when performing RDN. Similarly, the bar graph shows that in patients with orthostatic hypertension, RDN was more effective in reducing SBP during the morning period.

[0097] Figures 10 to 12 Similar results were shown, demonstrating the effectiveness of RDN in patients with orthostatic hypertension. Fig.10 shows the blood pressure response to renal denervation in drug-free patients at 3 months at the peak morning under the first definition, and Fig.11 The response rate of renal denervation in drug-free patients at 3 months at night under the first definition is shown. In addition, Fig.12 The blood pressure response to renal denervation in drug-free patients during the day under the first definition is shown. Figures 10 to 12, demonstrated that RDN was more effective in patients with orthostatic hypertension than in patients without orthostatic hypertension.

[0098] Fig.13 It is a tabular presentation of the statistical analysis of the interaction between the treatment of patients with orthostatic hypertension and non-orthostatic hypertension under the first definition of orthostatic hypertension. The p value is reported to identify the probability of obtaining an extreme result as an observation of the statistical hypothesis test. A smaller p value means that there is strong evidence to support the statistical significance that RDN is more effective in patients with orthostatic hypertension. A larger p value means weaker evidence or no evidence to support the statistical significance that RDN is more effective in patients with orthostatic hypertension. Generally speaking, a threshold of 0.05 is used to determine statistical significance, and therefore a p value less than or equal to 0.05 will show that statistical significance is observed, and a p value greater than 0.05 will show that there is no statistical significance. Fig.14 Response rates for patients receiving RDN under the first definition of orthostatic hypertension were also summarized.

[0099] Figures 15 to 19 is a bar graph showing the blood pressure response to renal denervation in drug-free patients at 3 months under the second definition. Fig.15 The response rate to renal denervation in drug-free patients within 24 hours under the second definition of orthostatic hypertension is shown. Figure 8 , the bar graph shows that, among the number N of subjects, subjects with orthostatic hypertension showed a greater change, i.e., a reduction in SBP, when performing RDN compared to the control group over a 24-hour period when performing RDN, compared to subjects without orthostatic hypertension when performing RDN. Thus, in patients with orthostatic hypertension, RDN is more effective in reducing SBP over a 24-hour period.

[0100] Similar to Fig. 9 , Fig.16 It was also shown that subjects with orthostatic hypertension showed a greater change, i.e., a decrease in SBP, during the morning period when performing RDN compared to subjects without orthostatic hypertension when performing RDN. And, Fig.16 It was shown that in patients with orthostatic hypertension, RDN was more effective in reducing SBP during the morning hours.

[0101] Figures 17 to 19 The blood pressure response to renal denervation in drug-free patients at 3 months under the second definition is shown at peak morning, at night, and during the day, respectively. These results demonstrate that RDN is more effective in patients with orthostatic hypertension than in patients without orthostatic hypertension.

[0102] Fig. 20is a tabular presentation summarizing the statistical analysis of the interaction between treatments in patients with orthostatic hypertension and patients with non-orthostatic hypertension under the second definition of orthostatic hypertension, and Fig.21 is a table summarizing the blood pressure response of patients receiving RDN under the second definition of orthostatic hypertension. The p-value of the null hypothesis is further verified under the second definition compared to the p-value of the null hypothesis under the first definition. That is, the null hypothesis that RDN is more effective in patients with orthostatic hypertension is further confirmed under the second definition compared to the first definition. Specifically, under the second definition, the experimental results for morning, peak morning, and nighttime have significant p-values ​​greater than 0.05, and therefore verify that RDN is more effective in patients with orthostatic hypertension during these time periods. Although Figures 8 to 21 The effectiveness or responsiveness of renal denervation for drug-free patients with orthostatic hypertension was shown, but renal denervation was also more effective for patients with orthostatic hypertension when the patients were taking one or more medications. The use of renal denervation for patients taking one or more medications can reduce the amount or number of medications that the patient is taking.

[0103] like Figures 8 to 21 As shown, the blood pressure response was experimentally taken from an exemplary sample or exploratory group of a small number of patients. Specifically, in the experimental data of the blood pressure response within 24 hours and during the daytime subgroup, significant differences between the orthostatic hypertension group and the non-orthostatic hypertension group were shown. The experimental data analyzed above are only examples of patients with a small sample size, and therefore, patients using a larger sample size will show similar significant differences in all subgroups.

[0104] Exemplary embodiments of the present invention have been disclosed in an exemplary manner. Therefore, the terms used throughout the text should be read in a non-restrictive manner. Although minor modifications to the teachings herein will occur to those skilled in the art, it should be understood that it is intended to be limited to all such embodiments that reasonably fall within the scope of the development of the art contributed by this article within the scope of the patent secured herein, and the scope should not be limited unless limited in view of the attached claims and their equivalents.

Claims

1. A system for treating hypertension in a patient, the system comprising: processor; as well as A memory storing instructions that, when executed by the processor, cause the system to perform operations including: determining that the patient's hypertension is orthostatic; and Based on determining that the patient's hypertension is orthostatic, renal denervation energy is applied to the patient.

2. The system of claim 1, wherein determining that the patient's hypertension is orthostatic comprises: Measure the patient's baseline standing systolic blood pressure (SBP); as well as The patients' baseline supine SBP was measured.

3. The system of claim 2, wherein determining that the patient's hypertension is orthostatic comprises: The patient's baseline standing systolic blood pressure (SBP) is determined to be at least 20 mmHg greater than the baseline supine SBP.

4. The system of claim 2, wherein determining that the patient's hypertension is orthostatic comprises: The patient's baseline standing systolic blood pressure (SBP) is determined to be at least 10 mmHg greater than the baseline supine SBP.

5. The system of claim 1 , wherein determining that the patient's hypertension is orthostatic comprises: Measure the patient's baseline standing diastolic blood pressure (DBP); as well as The patients' baseline supine DBP was measured.

6. The system of claim 5, wherein determining that the patient's hypertension is orthostatic comprises: The patient's baseline standing diastolic blood pressure (DBP) is determined to be at least 10 mmHg greater than the baseline supine DBP.

7. The system according to claim 1, wherein: Applying renal denervation energy to the patient based on determining that the patient's hypertension is orthostatic comprises: determining a number of ablations and an amount of energy delivered in each of the number of ablations based on determining that the hypertension of the patient is orthostatic; and The renal denervation energy is applied to the patient based on the number of the ablations and the amount of the energy delivered in each ablation.

8. The system of claim 1, wherein the renal denervation energy applied to the patient is delivered intravascularly, intravascularly, or externally.

9. The system of claim 1, wherein applying the renal denervation energy to the patient comprises using at least one of radiofrequency (RF) ablation, chemotherapy, cryotherapy, or ultrasound.

10. The system according to claim 1, wherein: Determining that the patient's hypertension is orthostatic includes: ensuring that the patient is in a supine position; When the patient is in the supine position, measuring the patient's supine blood pressure; Wait for a while before measuring standing blood pressure; ensuring that the patient is in a standing position; When the patient is in the standing position, measuring the patient's standing blood pressure; and The supine blood pressure is compared to the standing blood pressure to determine whether the patient's hypertension is orthostatic.

11. The system of claim 10, the memory further comprising instructions that, when executed by the processor, cause the system to perform operations comprising: Prior to applying the renal denervation energy to the patient, using a treatment model to predict effectiveness or responsiveness of applying the renal denervation energy to the patient; and The predicted effectiveness or the predicted responsiveness of the application of the renal denervation energy is provided to an operator.

12. The system of claim 10, wherein determining that the patient's hypertension is orthostatic is based on the comparison, and applying the renal denervation energy to the patient is based on the patient's hypertension being orthostatic and a treatment model such that the application of the renal denervation energy is customized for the patient.

13. A therapeutic assembly for renal denervation, the therapeutic assembly comprising: an energy delivery element configured to provide renal denervation energy to nerves within a blood vessel of a patient; and A controller, the controller being configured to: determining that the patient's hypertension is orthostatic, and Based on determining that the patient's hypertension is orthostatic, delivering renal denervation energy to the patient using the energy delivery element is controlled.

14. The therapeutic assembly of claim 13, further comprising: a first sensor configured to detect a position of the patient; a second sensor configured to detect blood pressure of the patient; Wherein, in order to determine that the patient's hypertension is orthostatic, the controller is configured to: using the first sensor, determining that the patient is in a supine position based on the detected position of the patient, using the second sensor, determining a supine blood pressure of the patient when the patient is in the supine position based on the detected blood pressure, using the first sensor, determining that the patient is in a standing position based on the detected position of the patient, using the second sensor, determining a standing blood pressure of the patient when the patient is in the standing position based on the detected blood pressure; as well as The supine blood pressure is compared to the standing blood pressure to determine whether the patient's hypertension is orthostatic.

15. The therapeutic assembly of claim 14, further comprising: A user interface for providing and receiving input data or output data; The controller is coupled to the user interface and is configured to: receiving user input indicating a standing blood pressure of the patient and a supine blood pressure of the patient, comparing the patient's standing blood pressure to the patient's supine blood pressure to determine whether the patient's hypertension is orthostatic, prior to applying the renal denervation energy to the patient and based on the comparison, using a treatment model to predict effectiveness or responsiveness of applying the renal denervation energy to the patient, and The predicted effectiveness or the predicted responsiveness of the application of the renal denervation energy is presented to an operator on the user interface.

16. The therapeutic assembly of claim 13, wherein to determine that the hypertension in the patient is orthostatic, the controller is configured to determine that the patient's baseline standing systolic blood pressure is at least 10 mmHg greater than a baseline supine SBP, or that the patient's baseline standing diastolic blood pressure (DBP) is at least 10 mmHg greater than the baseline supine DBP.

17. The therapeutic assembly of claim 13, wherein to determine that the hypertension in the patient is orthostatic, the controller is configured to determine that the patient's baseline standing systolic blood pressure is at least 20 mmHg greater than a baseline supine SBP, or that the patient's baseline standing diastolic blood pressure (DBP) is at least 20 mmHg greater than the baseline supine DBP.

18. A system for treating hypertension in a patient, comprising: processor; as well as A memory storing instructions that, when executed by the processor, cause the system to perform operations including: When the patient is in a supine position, measuring the patient's supine blood pressure; When the patient is in a standing position, measuring the patient's standing blood pressure; comparing the supine blood pressure with the standing blood pressure; determining that the patient's hypertension is orthostatic based on the comparing; predicting effectiveness or responsiveness of renal denervation therapy in the patient based on determining that the patient's hypertension is orthostatic; as well as The predicted validity or the predicted responsiveness is provided to an operator.

19. The system of claim 18, the memory further comprising instructions that, when executed by the processor, cause the system to perform operations comprising: determining a number of ablations and an amount of energy delivered in each of the number of ablations based on determining that the hypertension of the patient is orthostatic; and The renal denervation energy is applied to the patient based on the number of the ablations and the amount of the energy delivered in each ablation.

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