Renal denervation treatment guidance using hemodynamics for co-registration and related systems, devices, methods

Abstract

An apparatus includes a processor in communication with an intravascular catheter or guidewire. The processor controls the catheter or guidewire to obtain intravascular sensor measurements within a renal artery of a patient and computes hemodynamic values based on the intravascular sensor measurements. The hemodynamic values are associated with a suitability of the patient for a renal denervation treatment or an expected responsiveness of the patient to the treatment. The processor also performs a co-registration of the hemodynamic values with a first X-ray image of the renal artery with contrast within the renal artery and outputs a screen display to a display configured to guide a user with respect to the renal denervation treatment. The screen display includes the first X-ray image of the renal artery and a representation of at least one of the hemodynamic values positioned proximate to at least one corresponding location along a length of the renal artery.

Description

Technical Field

[0001] This article describes systems, devices, and methods for co-registering renal angiography with intravascular hemodynamic measurements during renal denervation (RDN) procedures. This RDN hemodynamic co-registration system has specific, but non-exclusive, utility in improving the speed and effectiveness of renal denervation procedures. Background Technology

[0002] Renal denervation (RDN) is a promising procedure for managing hypertension that cannot be adequately managed with antihypertensive medications. Studies have demonstrated its effectiveness, with a response rate of approximately two-thirds of patients showing a reduction in systolic blood pressure of 5 mmHg or more. However, studies have also shown varying levels of efficacy, with a subset (currently estimated at approximately 30%) showing no or negative response to the procedure. This non-response may be due to a combination of physiological factors and / or inadequate treatment implementation.

[0003] The information included in the background section of this specification, including any references cited herein and any descriptions or discussions thereof, is included for technical reference purposes only and should not be considered as subject matter that would bind the scope of this disclosure. Summary of the Invention

[0004] A hemodynamic co-registration system for renal denervation (RDN) is disclosed, enabling clinicians to predict which treatment sites are likely to respond well to RDN procedures and / or determine the success or completion status of ongoing RDN procedures. This disclosure relates to projecting co-registered hemodynamic data onto fluoroscopic images of the renal artery during an RDN procedure. Currently, renal denervation (RDN) procedures are performed intravascularly under fluoroscopic guidance, with little available information regarding the correct location for performing the RDN procedure or the tissue adjacent to the artery. Invasive intravascular measurements (e.g., invasive pulse wave velocity (iPWV)) can be used to assess the chances of success for an RDN procedure, and variations in these parameters along the renal artery can affect the efficacy of the RDN procedure and thus help guide users at which sites they should or should not use one or more RDN treatment devices. The RDN hemodynamic co-registration system disclosed herein has specific, but non-exclusive, utility for determining the site suitability, expected success, and / or completion status of a renal denervation procedure.

[0005] This summary is provided to introduce some of the concepts in a simplified form, which will be further illustrated in the detailed description below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A broader presentation of the features, details, utility, and advantages of the RDN hemodynamic co-registration system as defined in the claims will be provided in the written description of various aspects of the following disclosure and illustrated in the accompanying drawings. Attached Figure Description

[0006] The illustrative aspects of this disclosure will be described with reference to the accompanying drawings, in which: Figure 1A It is a schematic diagram in the form of a block diagram of an example intravascular sensing system based on various aspects of this disclosure.

[0007] Figure 1B It is a schematic diagram in the form of a block diagram of an example intravascular sensing system based on various aspects of this disclosure.

[0008] Figure 2 This is a schematic diagram of the processor circuitry according to various aspects of this disclosure.

[0009] Figure 3 This is a schematic diagram illustrating the retraction of an intravascular sensing guidewire through the left renal artery of the left kidney, according to various aspects of this disclosure.

[0010] Figure 4 It is a schematic diagram of X-ray images of the renal artery tree with contrast agent according to various aspects of this disclosure.

[0011] Figure 5 It is a schematic diagram in the form of a block diagram representing an example hemodynamic parameter measurement process based on various aspects of this disclosure.

[0012] Figure 6A It is a schematic diagram representing the joint registration of hemodynamic parameter measurements based on various aspects of this disclosure with angiographic route images of the renal artery tree.

[0013] Figure 6B It is a schematic diagram representing the joint registration of the original sensor measurement results from various aspects of this disclosure with the angiographic route map image of the renal artery tree.

[0014] Figure 7 This is a common registration screen display of an example RDN hemodynamic common registration system based on various aspects of this disclosure.

[0015] Figure 8This is a common registration screen display of an example RDN hemodynamic common registration system based on various aspects of this disclosure.

[0016] Figure 9 This is a common registration screen display of an example RDN hemodynamic common registration system based on various aspects of this disclosure.

[0017] Figure 10 This is a common registration screen display of an example RDN hemodynamic common registration system based on various aspects of this disclosure.

[0018] Figure 11 The graph illustrates the relationship between RDN results and iPWV measurements, based on various aspects of this disclosure.

[0019] Figure 12 It is a schematic diagram in the form of a flowchart illustrating an example RDN hemodynamic co-registration method based on various aspects of this disclosure.

[0020] Figure 13 It is a schematic diagram in the form of a flowchart illustrating an example RDN hemodynamic co-registration method based on various aspects of this disclosure.

[0021] Figure 14 It is a schematic diagram in the form of a block diagram representing an example RDN hemodynamic co-registration process based on various aspects of this disclosure.

[0022] Figure 15 It is a schematic diagram in the form of a block diagram representing an example RDN hemodynamic co-registration process based on various aspects of this disclosure.

[0023] Figure 16 It is a schematic diagram of the renal vascular system of a patient according to various aspects of this disclosure, wherein the renal denervation processing device is located in the left renal artery of the left kidney. Detailed Implementation

[0024] According to at least one aspect of this disclosure, an RDN hemodynamic co-registration system is provided, which enables clinicians to predict which treatment sites are likely to show a good response to RDN treatment and / or determine the success or completion of ongoing RDN treatment.

[0025] Renal denervation (RDN) is an emerging approach for managing hypertension that cannot be adequately addressed with antihypertensive medications. Studies have demonstrated its effectiveness, with a response rate of approximately two-thirds of patients showing a reduction in systolic blood pressure of 5 mmHg or more. Hemodynamic parameters are currently being investigated to determine if they can help predict patients more likely to respond to RDN. These parameters can include renal pulse wave velocity and renal resistance. A combination of multiple factors may improve predictive ability. Non-invasive measurements such as baseline blood pressure do not yield very definitive conclusions. However, one study reported that invasive pulse wave velocity (iPWV) is an independent predictor of blood pressure response after RDN, using a cutoff value of 14.4 m / s. Patients with iPWV below this cutoff value had a stronger response. Hemodynamic parameters such as iPWV may not be directly measurable and are calculated from directly measurable variables such as pressure and flow rate. Other hemodynamic parameters that can be calculated and co-registered include, but are not limited to, heart rate, volumetric flow rate, blood flow velocity, vascular resistance or impedance, pulsatility, arterial stiffness, renal resistance, and changes in arterial diameter.

[0026] Currently, clinicians cannot view hemodynamic data that may affect a patient's response to RDN before and during the RDN procedure. The RDN hemodynamic co-registration system disclosed in this disclosure brings relevant hemodynamic information to the angiography monitor for easy viewing by the operator during the renal denervation procedure.

[0027] Prior to RDN intervention, clinicians can assess flow velocity in the renal artery using a Doppler guidewire or a pressure-flow combination guidewire. Changes in this flow velocity, renal artery resistance, renal artery resistance reserve, multifactorial index, and / or these measurements before and after intervention can be displayed on a screen. Alternatively, changes in these measurements before and after physiological changes can be displayed on a screen.

[0028] This can be accomplished in a manner similar to displaying instantaneous waverless ratio (iFR) in systems assessing coronary arteries. The display used to predict RDN responders can, for example, place the index location directly on the angiographic map at the location where the index was measured. The index itself (iPWV, renal resistance, or others) can be provided on screen with guidance on interpreting the value, which is associated with either a good treatment response, a minimal treatment response, or no treatment response. The graph can also show the variability of the measurement across artery length. The output can also be overlaid onto existing relevant graphs from publications as a background for prediction.

[0029] On the other hand, hemodynamics can be assessed before and after changes in physiological state by using medication, stimulation of the renal nerve bundle, mechanical stimulation of the renal artery, or stimulation of the sympathetic nervous system at another anatomical location (e.g., the carotid body). In this regard, hemodynamic parameters can be assessed at baseline and compared with the same hemodynamic parameters after a change in physiological state. This comparison can include the ratio between baseline and the change in physiological state, subtraction or addition between two measurements, multiplication of the measurement by other physiological parameters of the patient (e.g., arterial blood pressure, mean BP, systolic BP, or diastolic BP), multiplication of the measurement by other patient data (e.g., BMI, age, weight), or any combination of these comparisons. Such comparisons between hemodynamic measurements can then be visualized by angiography adjacent to the renal artery tree.

[0030] This disclosure presents intravascular sensing data and hemodynamic parameters calculated therefrom on a fluoroscopic or angiographic view that a physician is using to guide an RDN procedure. The location of the renal nerve relative to the renal artery helps clinicians performing RDN better position their treatment devices for successful nerve ablation. The RDN hemodynamic co-registration system includes fluoroscopic or angiographic views of the renal artery tree acquired during the procedure.

[0031] This disclosure greatly facilitates the execution of interventional procedures (such as renal denervation) by improving clinicians' understanding of where interventions are most effective. The RDN hemodynamic co-registration system disclosed herein, implemented on a processor communicating with one or more sensors, provides practical detection and measurement of the patient's renal nerves, their proximity to the renal arteries, and their potential responses to RDN interventions. This improved situational awareness transforms a blind medical procedure with a 70% success rate into one that can accurately predict and even measure success in real time, determining whether further intervention is needed without the conventional waiting of days or weeks to observe a decrease in the patient's hypertension. This unconventional approach improves the function of the renal denervation system by increasing the success rate of RDN interventions and by providing the information needed to execute procedures only where the renal nerve bundles are likely to be affected.

[0032] The RDN hemodynamic co-registration system can be implemented, at least in part, as a process viewable on a display and operated by a control process executed on a processor that accepts user input from a keyboard, mouse, or touchscreen interface and communicates with one or more sensors. In this respect, the control process performs certain specific operations in response to different inputs or selections made at different times. Some outputs of the RDN hemodynamic co-registration system can be printed, displayed on a display, indicated by light or sound, or otherwise communicated to a human operator. Certain structures, functions, and operations of the processor, display, sensors, and user input system are known in the art, while other structures, functions, and operations are detailed herein to particularly implement novel features or aspects of this disclosure.

[0033] These descriptions are provided for illustrative purposes only and should not be construed as limiting the scope of the RDN hemodynamic co-registration system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0034] This disclosure relates to U.S. Provisional Applications filed March 15, 2024, namely US63 / 565843 (titled "Catheter-Based Procedures With Procedure Room Detection Of Biomarkers In Patient Blood And Associated Devices, Systems, And Methods"), US63 / 565640 (titled "Multi-Factor Renal Denervation Index For Patient Suitability and / or Expected Responsiveness To Renal Denervation Treatment"), US63 / 565624 (titled "Renal NerveBundle Co-Registration With X-Ray Image For Renal Denervation Treatment Guidance"), and US63 / 565589 (titled "Renal Denervation Treatment Assessment Using Ambulatory Blood Pressure"), all of which were filed on March 15, 2024. The above items are incorporated herein by reference in their entirety.

[0035] To facilitate an understanding of the principles of this disclosure, reference will now be made to aspects illustrated in the accompanying drawings, and specific language will be used to describe these aspects. However, it should be understood that this is not intended to limit the scope of this disclosure. Any changes and further modifications to the devices, systems, and methods described in this disclosure, as well as any further application of the principles of this disclosure, are fully contemplated and included in this disclosure, as would normally occur to those skilled in the art to which this disclosure pertains. In particular, it is fully contemplated that features, components, and / or steps described with respect to one aspect can be combined with features, components, and / or steps described with respect to other aspects of this disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0036] Figure 1A This is a schematic diagram in block form of an example intravascular sensing system 100 according to various aspects of this disclosure. Figure 1A In the example shown, the intravascular sensing system 100 includes two intravascular catheters or guidewires 150. The first intravascular catheter or guidewire 150 includes a first sensor type 152 and a flexible elongated member 154. The second intravascular catheter or guidewire 150 includes a second sensor type 156 and a second flexible elongated member 158. In this example, the first intravascular catheter or guidewire 150 is a blood flow sensing guidewire, and the second intravascular catheter or guidewire 150 is a pressure sensing catheter; however, other arrangements are possible and explicitly fall within the scope of this disclosure. The first and second intravascular catheters or guidewires 150 are connected to and communicate electrically and data with an intravascular sensing console 160. The intravascular sensing console 160 includes a processor 162, a memory 164, a user input device 166, and a display 168.

[0037] Figure 1B This is a schematic diagram in block form of an example intravascular sensing system 100 according to various aspects of this disclosure. Figure 1B In the example shown, the intravascular sensing system 100 includes a single intravascular catheter or guidewire 150, which includes a first sensor type 152, a second sensor type 156, and a flexible elongated member 154. In this example, the intravascular catheter or guidewire 150 is a combined pressure-sensing and blood flow-sensing guidewire, but other arrangements are possible and explicitly fall within the scope of this disclosure. The intravascular catheter or guidewire 150 is connected to and communicates electrically and data with an intravascular sensing console 160. The intravascular sensing console 160 includes a processor 162, a memory 164, a user input device 166, and a display 168.

[0038] The block diagrams provided herein are for illustrative purposes; those skilled in the art will recognize numerous variations that still fall within the scope of this disclosure. For example, any step described herein may optionally include outputting information related to that step to a user, and thus can represent an improvement of the user interface relative to the prior art by providing information that would not otherwise be available.

[0039] Similarly, block diagrams can illustrate a specific arrangement of components, modules, services, steps, processes, or layers that generate a particular data flow. It should be understood that some embodiments of the systems disclosed herein may include additional components, some components shown may not exist in some embodiments, and the arrangement of components may differ from that shown, thereby generating different data flows while still performing the methods described herein.

[0040] Figure 2 This is a schematic diagram of processor circuitry 250 according to various aspects of this disclosure. Processor circuitry 250 may be implemented in the in-cavity sensing system 100, or in other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as required for implementing the method. As shown, processor circuitry 250 may include processor 260, memory 264, and communication module 268. These components may communicate directly or indirectly with each other (e.g., via one or more buses).

[0041] Processor 260 may include any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, or general-purpose computing device, reduced instruction set computing (RISC) device, application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other related logic devices, including mechanical computers and quantum computers. Processor 260 may also include another hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 260 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0042] Memory 264 may include cache memory (e.g., the cache memory of processor 260), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one aspect, memory 264 includes a non-transient computer-readable medium. Memory 264 may store instructions 266. The instructions may be computer-readable and computer-executable. Instructions 266 may include instructions that, when executed by processor 260, cause processor 260 to perform some or all of the operations described herein. The instructions may encode some or all of the steps as executed by processor circuitry and as defined in the methods herein. In some embodiments, the instructions encode steps that invoke the execution of method steps, without encoding at least some steps (e.g., calculating and / or performing co-registration) themselves. Preferably, in this case, the instructions also encode steps for receiving / or generating a display screen and steps for outputting the display screen to a display device. Optionally, in this case, the instructions also encode control over the display device to output a display screen to the user. Therefore, the instructions can be local instructions (e.g., client programs) that execute on a local processor or processor circuitry, which call instructions that at least partially (e.g., perform calculations) or even completely implement the methods of the present invention (e.g., server programs). Such calls can be automatic or initiated by the user via a user interface. The local processor or processor circuitry can be separate from the processor or processor circuitry. For example, the processor circuitry can represent a network or other type of electronic system communicating with the local processor. Alternatively, the local processor can be a part of the processor or processor circuitry (e.g., included therein). Instruction 266 can also be referred to as code. The terms "instruction" and "code" should be interpreted broadly to include any type of computer-readable statement. For example, the terms "instruction" and "code" can refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instruction" and "code" can include a single computer-readable statement or many computer-readable statements. Instructions can take the form of a computer program or a computer program product.

[0043] Communication module 268 may include any electronic circuitry and / or logic circuitry to facilitate direct or indirect data communication between processor circuitry 250 and other processors or devices. In this regard, communication module 268 may be an input / output (I / O) device. In some cases, communication module 268 facilitates direct or indirect communication between processor circuitry 250 and / or various components of intravascular sensing system 100. Communication module 268 can communicate within processor circuitry 250 via various methods or protocols. Serial communication protocols may include, but are not limited to, the US Serial Protocol Interface (US SPI), internal integrated circuits (I... 2 C) Recommended standards RS-232, RS-485, Controller Area Network (CAN), Ethernet, ARINC 429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), IEEE 488, IEEE 1284, and other suitable protocols. Where appropriate, serial and parallel communication may be bridged by a Universal Asynchronous Receiver / Transmitter (UART), a Universal Synchronous Receiver / Transmitter (USART), or other suitable subsystems.

[0044] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from the circular ultrasound imaging array) can be implemented using any suitable wireless or wired communication technology, such as cable interfaces (e.g., Universal Serial Bus (USB), Micro USB, Thunderbolt, or FireWire), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections (e.g., 2G / GSM (Global System for Mobile Communications), 3G / UMTS (Universal Mobile Telecommunications System), 4G, LTE, WiMax, or 5G). For example, Bluetooth Low Energy (BLE) radios can be used to establish connections to cloud services, for data transfer, and for receiving software patches. The controller can be configured to communicate with remote servers or local devices (e.g., laptops, tablets, or handheld devices), or may include a display capable of showing status variables and other information. Information can also be transmitted on physical media (e.g., USB flash drives or memory sticks).

[0045] It should also be understood that one or more steps of the above method can be performed by one or more components of an external imaging system (e.g., a processing system, multiplexer, beamformer, signal processing unit, image processing unit, or any other suitable component of the system). For example, activating the scan sequence can be performed by a processor communicating with a multiplexer configured to select or activate one or more elements of the imaging system. The system's processing components can be integrated within the external imaging device, contained in an external console, or can be separate components.

[0046] Figure 3 This is a schematic diagram showing an intravascular sensing guidewire 150 retracted through the left renal artery 310 of the left kidney 320, according to various aspects of this disclosure. Sensing components 370, 375 of the intravascular sensing guidewire can collect data (e.g., pressure and flow data) from within the renal artery 310, thereby providing information about renal nerve function at various points along the length of the renal artery 310, which can indicate the success of RDN treatment at those locations.

[0047] The abdominal aorta (330), left renal vein (340), right renal vein (350), and right kidney (360) are also visible.

[0048] Figure 4 This is a schematic diagram of an X-ray image 400 with contrast agent of the renal artery tree 405 according to various aspects of this disclosure. The abdominal aorta 330, left renal artery 310, left renal artery branch 410, right renal artery 350, and right renal artery branch 450 are visible. For example, X-ray images with contrast agent can be taken prior to the RDN procedure to provide a route map of the renal artery tree 405, thereby helping to guide the procedure. Superimposed on the renal artery tree 405 is... Figure 3 The retraction path 402 of the intravascular sensing device 150. Figure 4 For example, it could be a screen display that shows the renal artery tree as a roadmap image.

[0049] In some respects, instead of being based on angiography images, roadmap images can be 3D models of the renal artery tree or portions thereof constructed from CT image data.

[0050] Figure 5 This is a schematic diagram in the form of a block diagram illustrating an example hemodynamic parameter measurement process 500 based on various aspects of this disclosure. Figure 5 In the example shown, a first sensor collects a first measurement 510 (e.g., intravascular flow velocity) at a first location within the renal artery, and a second sensor collects a second measurement 520 (e.g., intravascular pressure) at the same first location. The first measurement 510 and the second measurement 520 are then used to calculate a hemodynamic parameter 530 (e.g., iPWV) at the first location.

[0051] Examples of pulse wave velocity calculations can be found, for example, in U.S. Patent No. US2019 / 0290139, filed May 19, 2017; U.S. Patent No. US20190175035, filed May 19, 2017; U.S. Patent No. US11896422, filed August 13, 2019; and U.S. Patent Publication No. US20230233168, filed January 19, 2023, all of which are incorporated herein by reference in their entirety.

[0052] Hemodynamic parameters provide information about the primary location, which can be used to assess the effectiveness of RDN treatment at that location. For example, an iPWV value below 14.4 m / s at the primary location may indicate that the primary location is suitable for RDN treatment, and that the patient will respond to treatment at that location (e.g., a decrease in systolic blood pressure of at least 5 mmHg over a 3–6 month period). It should be noted that, depending on the patient and the type of RDN treatment device, treatment may need to be performed in the main trunk and branches. Therefore, in some cases, treatment at multiple locations is necessary, rather than simply selecting between different locations.

[0053] exist Figure 5 In the example shown, a first sensor then collects a first measurement 510 (e.g., intravascular flow velocity) at a second location within the renal artery, and a second sensor collects a second measurement 520 (e.g., intravascular pressure) at the same second location. The first and second measurements 510 are then used to calculate a hemodynamic parameter 530 (e.g., iPWV) at the second location. This hemodynamic parameter provides information about the second location that can be used to assess the effectiveness of RDN treatment at that location. For example, if the iPWV value at the second location is lower than that at the first location, the second location may be more suitable for RDN treatment, while if the iPWV value at the second location is higher than that at the first location, the second location may be less suitable. This scenario could be an example of providing guidance on selecting a treatment location among different RDN treatment locations. In another scenario, both the first and second locations may be suitable for RDN treatment based on the measured parameters. Depending on the patient and the type of RDN device, treatment may need to be performed in the trunk and branches. In other words, RDN treatment may need to be performed at multiple locations. It can provide guidance for multiple locations where RDN processing is performed.

[0054] exist Figure 5 In the example shown, both the first and second sensors are intravascular. However, it should be understood that at least one of the sensors may be located outside the patient's body to measure blood flow velocity, for example, using an external ultrasound probe.

[0055] Figure 6A This is a schematic diagram 600 representing the co-registration of hemodynamic parameter measurements 610 based on various aspects of this disclosure with an angiographic route image 400 of the renal artery tree 405. Figure 6A In the example shown, the position of the first sensing element 370 is visible in frame 630 of the real-time fluorescence fluoroscopy X-ray image taken during the RDN process, and the position of the second sensing element 375 is visible in frame 635 of the real-time fluorescence fluoroscopy X-ray image. Because the first sensing element 370 and the second sensing element 375 may be located at slightly different positions on the flexible elongated member, the timing of image frames 630 and 635 may be slightly different, causing them to capture sensors 370 and 375 at the same location.

[0056] Each such location is associated with a hemodynamic parameter measurement 610 derived from the first sensor measurement 602 and the second sensor measurement 604 along the retraction path 402, such that the hemodynamic measurement 610 can be added (e.g., as a visual annotation) along with the corresponding location of the sensor 370 or 375 to the location of the hemodynamic measurement 610 on the retraction path 402 of the route map 400.

[0057] As indicated by arrow 664, because the retraction path 402 is associated with fluorescence fluoroscopy images 630 and 635, each location 641 along path 402 can be associated with one or more fluorescence fluoroscopy images 630, 635. Furthermore, because a correspondence is also established between fluorescence fluoroscopy images 630, 635 and intravascular hemodynamic measurements 610, hemodynamic measurements 610 can also be associated with location 741 along path 402, as indicated by arrow 666. Just as different fluorescence fluoroscopy images 630, 635 and hemodynamic parameter measurements 610 are associated with various locations along the retraction path 402, fluorescence fluoroscopy images 630, 635 and hemodynamic parameter measurements 610 can be associated with the same locations along the route map image 400, as indicated by arrows 668 and 669.

[0058] The results of multiple hemodynamic parameter measurements 610 differ from the results of multiple original sensor measurements 602 and 604. Figure 6B The diagram shows the common registration of the sensor measurements themselves, rather than the hemodynamic parameters derived from them.

[0059] Figure 6B 605 is a schematic diagram representing the co-registration of the original sensor measurements 610 based on various aspects of this disclosure with the angiographic route image 400 of the renal artery tree 405. Figure 6AIn the example shown, the position of the first sensing element 370 is visible in frame 630 of the real-time fluorescence fluoroscopy X-ray image taken during the RDN process, and the position of the second sensing element 375 is visible in frame 635 of the real-time fluorescence fluoroscopy X-ray image. Because the first sensing element 370 and the second sensing element 375 may be located at slightly different positions on the flexible elongated member, the timing of image frames 630 and 635 may be slightly different, causing them to capture sensors 370 and 375 at the same location.

[0060] Each such location is associated with sensor measurements 602, 604 along the retraction path 402, such that sensor measurements 602, 604 can be added (e.g., as visual annotations) to the location of sensor measurements 602, 604 on the retraction path 402 of the route map 400, along with the corresponding location of sensor 370 or 375.

[0061] As indicated by arrow 664, because the retraction path 402 is associated with fluorescence perspective images 630 and 635, each position 641 along the path 402 can be associated with one or more fluorescence perspective images 630, 635. Furthermore, because a correspondence is also established between the fluorescence perspective images 630, 635 and the sensor measurements 602, 604, the sensor measurements 602, 604 can also be associated with positions 741 along the path 402, as indicated by arrow 666. Just as different fluorescence perspective images 630, 635 and sensor measurements 602, 604 are associated with various positions along the retraction path 402, fluorescence perspective images 630, 635 and sensor measurements 602, 604 can be associated with the same positions along the route map image 400, as indicated by arrows 668 and 669.

[0062] The aspects of co-registration are described, for example, in U.S. Patent 7930014 entitled "Vascular image co-registration" and U.S. Publication 2012 / 0004537 entitled "Co-use of endoluminal data and extraluminal imaging." All of the above are incorporated herein by reference in their entirety.

[0063] Figure 7 This is an example RDN hemodynamic co-registration system co-registration screen display 700 based on various aspects of this disclosure. The screen display 700 includes a representation of a renal artery tree 405, which includes location markers 710 on the left renal artery 310 marking locations along the left renal artery 310 where hemodynamic parameter values ​​are most favorable for RDN treatment. Figure 7In the example shown, hemodynamic parameter 230 is the invasive pulse wave velocity (iPWV), and at the location marked 710, its value 720 is 12.0 m / s. Scientific literature indicates that an iPWV value of 14.4 m / s or less is associated with good RDN results. The value of iPWV can vary along the length of the renal artery. Therefore, marker 710 can, for example, identify locations where iPWV is below 14.4 m / s (or other cutoff values) to indicate good RDN results, or it can identify locations where iPWV has a minimum value along the length of the renal artery.

[0064] The screen display 700 also includes a text explanation 730 explaining why the value 720 is marked, and a graph 750 showing how the iPWV 760 changes along the pullback path over time or distance 770. The graph 750 includes a threshold line 780 indicating a cutoff value of 14.4 m / s, below which RDN treatment is more likely to be successful. Markers 710 also appear on the graph 750, allowing clinicians reviewing the screen display to understand how the graph 750 relates to the representation of the renal artery tree 405. In the example, the clinician could decide to apply RDN treatment at a longitudinal location along the left renal artery 310 identified by the location markers 710.

[0065] The screen display 700 also includes a "Understand Relevance" button 740, the operation of which will be explained below.

[0066] Figure 8 The example RDN hemodynamic co-registration system co-registration screen display 800 is based on various aspects of this disclosure. Figure 8 The screen display has 800 with Figure 7 The screen displays similar features to 700, but differs in that it also includes a numerical indicator 810, which shows hemodynamic parameter values ​​720 at different locations along the length of the renal artery 310. Figure 8 In the example shown, the numerical indicator 810 is a dot or circle, each dot or circle representing 4 m / s, such that locations with fewer dots have lower hemodynamic parameter (e.g., iPWV) values, while locations with more dots have higher hemodynamic parameter values. In the example, clinicians can choose to apply RDN treatment at one or more locations where the iPWV is represented by three or fewer dots (equivalent to a value of approximately 12 m / s), and can avoid applying treatment at locations where the iPWV is represented by four or more dots (equivalent to a value of approximately 16 m / s or higher).

[0067] The screen display 800 also includes a "Understand Relevance" button 740, the operation of which will be explained below.

[0068] Figure 9 The example RDN hemodynamic co-registration system, based on various aspects of this disclosure, is displayed on the co-registration screen at 900. Figure 9 The screen display has 900 with Figure 7 The screen displays similar features to 700, but differs in that it also includes a shaded bar 910 superimposed on the renal artery 310. The shaded bar 910, with its hue or shading at different locations along the renal artery 310, represents hemodynamic parameter values ​​720 (e.g., iPWV) at those locations. Figure 9 In the example shown, lighter shades indicate lower hemodynamic parameter values ​​720, while darker shades indicate higher hemodynamic parameter values ​​720. In this example, clinicians can choose to apply RDN treatment to one or more areas represented by lighter shades while avoiding areas represented by darker shades.

[0069] The screen display 900 also includes a "Understand Relevance" button 740, the operation of which will be explained below.

[0070] Figure 10 The example RDN hemodynamic co-registration system, based on various aspects of this disclosure, displays a co-registration screen of 1000. Figure 10 The screen display 1000 has the same Figure 7 The screen displays similar features to 700, except that it includes a threshold marker 1010 superimposed on the renal artery 310, the presence of which indicates whether the hemodynamic parameters at that location are above or below a specified threshold. Figure 10 In the example shown, threshold marker 1010 indicates a threshold where the iPWV is below 14.4 m / s for locations covered by threshold marker 1010, in association with good RDN results. In the example, clinicians can choose to apply RDN treatment to one or more locations indicated by threshold marker 1010 while avoiding locations not marked by threshold marker 1010.

[0071] The screen display 1000 also includes a "Understand Relevance" button 740, the operation of which will be explained below.

[0072] Figure 11A graph 1100 illustrates the relationship between RDN results (e.g., measured changes in dynamic systolic blood pressure 1110 (SBP, measured in mmHg) 6 months after RDN treatment) and measured values ​​of iPWV 1120 (e.g., in m / s), based on various aspects of this disclosure. This graph includes multiple historical data points 1130, a correlation fitted line or curve 1140, and current patient measurements 1150. As can be seen in graph 1100, a correlation exists between blood pressure decrease 1110 and iPWV 1120 for iPWV values ​​below 14.4 m / s. Graph 1100 may be derived from scientific literature, for example, and may be generated when a user (e.g., a clinician) presses... Figure 7-10 The screen display or pop-up window that appears when the "Understand Relevance" button is shown.

[0073] Figure 12 This is a schematic diagram in the form of a flowchart illustrating an example RDN hemodynamic co-registration method 1200 based on various aspects of this disclosure. It should be understood that the steps of method 1200 can be... Figure 12 The different sequences of execution shown may provide additional steps before, during, and after the steps, and / or some of the described steps may be replaced or omitted in other embodiments. One or more steps of method 1200 may be performed by one or more devices and / or systems described herein (e.g., components of system 100 and / or processor circuitry 250).

[0074] In step 1210, method 1200 includes receiving a first X-ray image (e.g., a roadmap image) of the renal artery containing contrast agent fluid within the renal artery. Then, execution proceeds to step 1220.

[0075] In step 1220, method 1200 includes receiving a series of second X-ray images (e.g., real-time fluorescence fluoroscopy images) during the movement of an intravascular catheter or guidewire through the renal artery, in which no contrast agent fluid is present within the artery. The process then proceeds to step 1230.

[0076] In step 1230, method 1200 includes controlling at least one intravascular catheter or guidewire to obtain first sensor measurements and second sensor measurements (e.g., intravascular blood flow velocity and blood pressure) during the movement of the intravascular catheter or guidewire through the renal artery. Then, execution proceeds to step 1240.

[0077] In step 1240, method 1200 includes calculating hemodynamic parameter values ​​(e.g., iPWV values) using measurements from the first sensor and the second sensor. Then execution proceeds to step 1250.

[0078] In step 1250, method 1200 includes performing co-registration between hemodynamic parameter values ​​and a first X-ray image (e.g., a roadmap image) of the renal artery. Execution then proceeds to step 1260.

[0079] In step 1260, method 1200 includes generating a screen display to guide the user to perform RDN treatment on the renal artery. Then execution proceeds to step 1270.

[0080] In step 1270, method 1200 includes outputting a screen display to a monitor (e.g., Figure 1A or Figure 1B (The monitor is 168). Then proceed to step 1280.

[0081] In step 1280, method 1200 includes a clinician performing RDN treatment based on user guidance provided in a screen display. Method 1200 is now complete.

[0082] This document provides flowcharts for illustrative purposes; those skilled in the art will recognize numerous variations that still fall within the scope of this disclosure. For example, any step described herein may optionally include outputting information related to that step to the user, and thus can represent an improvement of the user interface relative to the prior art by providing information that would not otherwise be available.

[0083] Similarly, the logic of a flowchart can be shown as sequential. However, similar logic can be parallel, massively parallel, object-oriented, real-time, event-driven, cellular automata, or other methods, while implementing the same or similar functionality. To execute the methods described herein, a processor can divide each step described herein into multiple machine instructions, and these instructions can be executed at rates of hundreds, thousands, millions, or billions per second, either on a single processor or across multiple processors. This rapid execution may be necessary to execute the method in real-time or near real-time as described herein. For example, measurement, co-registration, and display steps can occur in real-time during the RDN process.

[0084] Figure 13 It is a schematic diagram in the form of a flowchart of an example RDN hemodynamic co-registration method 1300 based on various aspects of this disclosure.

[0085] In step 1310, method 1300 includes: performing co-registration between hemodynamic parameter values ​​and contrast-enhanced X-ray images (e.g., roadmap images) of the renal artery prior to RDN treatment, and generating / displaying a screen display 1320 prior to RDN treatment. Then, proceed to step 1330.

[0086] In step 1330, method 1300 includes a clinician performing an RDN procedure (e.g., at a favorable location indicated by a screen display 1320). The procedure then proceeds to step 1340.

[0087] In step 1340, method 1300 includes: after RDN treatment, performing co-registration between hemodynamic parameter values ​​and contrast-enhanced X-ray images (e.g., roadmap images) of the renal artery, and generating / displaying a post-RDN treatment screen display 1350. In this example, the change in hemodynamic parameter values ​​along the length of the renal artery between the pre-treatment display 1320 and the post-treatment display 1350 can indicate the success or failure of the RDN procedure and can indicate whether the treatment is complete or whether further treatment is required. Method 1300 is now complete.

[0088] Figure 14 It is a schematic diagram in the form of a block diagram of an example RDN hemodynamic co-registration process 1400 based on various aspects of this disclosure.

[0089] Baseline measurements from the first sensor 1410 (e.g., intravascular flow velocity) and the second sensor 1420 (e.g., intravascular pressure) are used to calculate baseline hemodynamic parameters 1430 (e.g., iPWV). A stimulus (e.g., physical, electrical, or pharmacological stimulation of the renal nerve or the whole body) is then applied, altering the patient's physiological parameters (e.g., by increasing heart rate and blood pressure). During this stimulus, or shortly after the stimulus has taken effect, the post-stimulation hemodynamic parameters 1430 (e.g., iPWV) are calculated using the post-stimulation measurements from the first sensor 1410 (e.g., intravascular flow velocity) and the post-stimulation second sensor 1420 (e.g., intravascular pressure). Next, a comparison 1470 is generated between the baseline hemodynamic parameters and the post-stimulation hemodynamic parameters. This comparison can provide information about the patient's suitability for RDN treatment or the success or completion status of ongoing RDN treatment. For example, if the iPWV changes with stimulation, the patient may be suitable for RDN, while if the iPWV does not change with stimulation in a statistically significant manner, this may indicate that sufficient ablation energy has been applied to the renal nerve and further ablation is unlikely to significantly alter the RDN outcome.

[0090] Comparison of 1470 can be a ratio, a difference, or other form.

[0091] Figure 15 This is a schematic diagram in the form of a block diagram of an example RDN hemodynamic co-registration process 1500 based on various aspects of this disclosure. Figure 15 In the example, Figure 14The hemodynamic parameter comparison 1470 can be performed at multiple locations. Performing a first comparison 1510 at a first location and a second comparison 1520 at a second location can provide location-specific information about the renal nerve status at that location. For example, if the hemodynamic parameters change with stimulation at location 1 but do not change with stimulation at location 2, this may indicate that location 1 is suitable for RDN treatment, while location 2 is either unsuitable for RDN treatment or has been adequately treated, and the patient will not benefit from further ablation of the nerve at location 2.

[0092] Figure 16 This is a schematic diagram representing a patient's renal vascular system 1600 according to various aspects of this disclosure, wherein a renal denervation treatment device 1610 is located in the left renal artery 1620 of the left kidney 1640. In an example, the renal denervation treatment device 1610 may include a catheter 1650 having a renal denervation tool (e.g., electrode, balloon, etc.) that delivers energy to damage the renal nerve in order to lower the patient's blood pressure. Depending on the implementation, the delivered energy may be electrical, chemical, thermal, cold, etc. The renal denervation treatment device 1610 may, for example, enter the renal artery 1620 via the abdominal aorta 1660. The renal vein 1630 is also visible. Renal denervation may be performed based on the guidance described herein.

[0093] A system of one or more computers can be configured to perform specific operations or actions by installing software, firmware, hardware, or combinations thereof on the system, which, in operation, causes the system to perform actions. One or more computer programs can be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform actions. One general aspect includes an apparatus comprising processor circuitry configured to communicate with at least one intravascular catheter or guidewire, wherein the processor circuitry is configured to: control at least one intravascular catheter or guidewire to acquire multiple intravascular sensor measurements associated with blood within a patient's renal artery during movement along the length of the renal artery; calculate multiple hemodynamic parameter values ​​based on the multiple intravascular sensor measurements, wherein the multiple hemodynamic parameter values ​​are associated with at least one of the patient's suitability for renal denervation treatment or the patient's expected responsiveness to renal denervation treatment; perform a common registration between the multiple hemodynamic parameter values; and a first X-ray image of the renal artery acquired with contrast agent fluid present within the renal artery; and output a screen display to a display configured to guide a user regarding the renal denervation treatment, wherein the screen display may include: the first X-ray image of the renal artery; and a representation of at least one hemodynamic parameter value located at at least one corresponding position along the length of the renal artery in the first X-ray image. Other examples of this aspect include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of these methods.

[0094] The implementation may include one or more of the following features. In some aspects, the screen display may include graphs showing the variation of multiple hemodynamic parameters over time or distance. In some aspects, the screen display may include a first X-ray image superimposed with multiple representations of multiple hemodynamic parameter values, wherein each representation is located at the same position as a corresponding hemodynamic parameter value among the multiple hemodynamic parameter values. In some aspects, each representation may include multiple dots proportional to the values ​​of the corresponding hemodynamic parameter values ​​among the multiple hemodynamic parameter values. In some aspects, each representation may include a color or shade corresponding to the value of the corresponding hemodynamic parameter value among the multiple hemodynamic parameter values. In some aspects, the screen display may also include location markers indicating the location along the renal artery. In some aspects, the location along the renal artery is the location where the corresponding hemodynamic parameter value among the multiple hemodynamic parameter values ​​has a minimum or maximum value. In some aspects, the location along the renal artery is the location where the corresponding hemodynamic parameter value among the multiple hemodynamic parameter values ​​crosses a threshold. In some aspects, the multiple intravascular sensor measurements may include: multiple first intravascular sensor measurements; and multiple second intravascular measurements. In some aspects, the screen display may also include a graph relating blood pressure changes to at least one hemodynamic parameter value. In some aspects, after performing co-registration between multiple hemodynamic parameter values ​​and the first X-ray image, the multiple hemodynamic parameter values ​​are associated with multiple locations along the length of the renal artery. In some aspects, the multiple hemodynamic parameter values ​​may include at least one of the following: invasive pulse wave velocity (iPWV), heart rate, renal resistance, or blood flow velocity. In some aspects, the processor circuitry is configured to perform co-registration between multiple intravascular sensor measurements and the first X-ray image, separately from the co-registration between the multiple hemodynamic parameter values ​​and the first X-ray image of the renal artery. In some aspects, to perform co-registration between multiple hemodynamic parameter values ​​and a first X-ray image of the renal artery, processor circuitry is configured to: receive the first X-ray image of the renal artery; receive multiple second X-ray images of the renal artery during movement of at least one intravascular catheter or guidewire, wherein the multiple second X-ray images are acquired without contrast agent fluid within the renal artery and depict multiple positions of the at least one intravascular catheter or guidewire during movement; and perform co-registration between the multiple hemodynamic parameter values ​​and the first X-ray image of the renal artery using the multiple second X-ray images. Embodiments of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0095] One general aspect includes a method. The method includes: controlling at least one intravascular catheter or guidewire using processor circuitry to acquire multiple intravascular sensor measurements associated with blood within a patient's renal artery during movement along its length; calculating multiple hemodynamic parameter values ​​based on the multiple intravascular sensor measurements using the processor circuitry, wherein the multiple hemodynamic parameter values ​​are associated with at least one of the patient's suitability for a renal denervation procedure or the patient's expected responsiveness to a renal denervation procedure using the processor circuitry; performing a common registration between the multiple hemodynamic parameter values ​​and an X-ray image of the renal artery acquired with contrast agent fluid present within the renal artery using the processor circuitry; and outputting a screen display to a display in communication with the processor circuitry, the screen display being configured to guide a user regarding the renal denervation procedure, wherein the screen display may include: the X-ray image of the renal artery; and a representation of at least one hemodynamic parameter value located at at least one corresponding location along the length of the renal artery in the adjacent X-ray image. Other examples of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each of which is configured to perform actions of these methods.

[0096] Therefore, it can be seen that the RDN hemodynamic co-registration system advantageously provides a means for determining the most favorable location for RDN treatment within the left or right renal artery in real time during the procedure. The RDN hemodynamic co-registration system also provides a means of determining whether the RDN procedure is complete (e.g., whether the renal nerve bundle at the desired location has been adequately ablated). Clinicians can use this screen display to determine whether RDN treatment is complete or whether further treatment is needed to adequately ablate the renal nerve fiber bundle at the desired location.

[0097] Many variations are possible based on the examples and aspects described above. For example, other variables besides those listed in this paper can be used, and other sensors or sensor types can be employed. The techniques described in this paper can be used not only before and during medical interventions, but also at other times, to provide measures that can indicate a patient's health or disease status.

[0098] Therefore, the logical operations constituting the various aspects of the technology described herein are referred to differently as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these logical operations can occur, be performed, or be arranged in any order, unless expressly required otherwise in the claims or the language of the claims inherently necessitates a specific order.

[0099] All directional expressions (e.g., up, down, inside, outside, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal) are used for illustrative purposes only to aid the reader in understanding the claimed subject matter and do not impose limitations, particularly on the location, orientation, or use of the RDN hemodynamic co-registration system. Connectivity expressions (e.g., attachment, coupling, connection, engagement, or “communicating with”) should be interpreted broadly and, unless otherwise stated, can include intermediate components between sets of elements and relative movement between elements. Thus, connectivity expressions do not necessarily mean that two elements are directly connected and in a fixed relationship with each other. The term “or” should be interpreted as “and / or” rather than “exclusive or”. The word “comprising” does not exclude other elements or steps, and the quantifiers “a” or “an” do not exclude a plurality. Unless otherwise stated in the claims, the values ​​stated should be interpreted as illustrative only and should not be considered restrictive.

[0100] The foregoing specification, examples, and data provide a complete description of the structure and use of exemplary aspects of the RDN hemodynamic co-registration system as defined in the claims. Although various aspects of the claimed subject matter have been described above with a degree of specificity or by reference to one or more individual aspects, many changes can be made to the disclosed aspects by those skilled in the art without departing from the spirit or scope of the claimed subject matter.

[0101] Other aspects are also envisioned. All content contained in the foregoing description and shown in the accompanying drawings is intended to be illustrative of specific aspects and not restrictive. Changes in detail or structure may be made without departing from the essential elements of the subject matter as defined in the foregoing claims.

[0102] Additional embodiments.

[0103] Example 1: An apparatus comprising: A processor circuit configured to communicate with at least one intravascular catheter or guidewire, wherein the processor circuit is configured to: The at least one intravascular catheter or guidewire is controlled to obtain multiple intravascular sensor measurements associated with the blood within the patient's renal artery during movement along the length of the renal artery; Multiple hemodynamic parameter values ​​are calculated based on the measurements from the multiple intravascular sensors, wherein the multiple hemodynamic parameter values ​​are associated with at least one of the patient’s suitability for renal denervation treatment or the patient’s expected responsiveness to the renal denervation treatment. Perform a common registration between the following two: The values ​​of the plurality of hemodynamic parameters; and A first X-ray image of the renal artery obtained with contrast agent fluid present inside the renal artery; and Output a screen display to a monitor, the screen display being configured to guide the user regarding the renal denervation procedure, wherein the screen display includes: The first X-ray image of the renal artery; and The representation of at least one hemodynamic parameter value is located at at least one corresponding position adjacent to the length of the renal artery in the first X-ray image.

[0104] Example 2: The device according to Example 1, wherein the screen displays a graph showing the changes of the plurality of hemodynamic parameters over time or distance.

[0105] Example 3: The apparatus according to Example 1, wherein the screen displays a first X-ray image including a plurality of representations of the plurality of hemodynamic parameter values ​​superimposed on it, wherein each of the plurality of representations is located at the same position as the hemodynamic parameter value among the plurality of hemodynamic parameter values.

[0106] Example 4: The apparatus according to Example 3, wherein each represents a plurality of dots that are proportional to the values ​​of the corresponding hemodynamic parameter values ​​among the plurality of hemodynamic parameter values.

[0107] Example 5: The apparatus according to Example 3, wherein each representation includes a color or shade corresponding to the value of the corresponding hemodynamic parameter among the plurality of hemodynamic parameter values.

[0108] Example 6: The apparatus as described in Example 3, wherein the screen display further includes a location marker indicating the location along the renal artery.

[0109] Example 7: The apparatus according to Example 6, wherein the position along the renal artery is the position where the corresponding hemodynamic parameter value among the plurality of hemodynamic parameter values ​​has a minimum or maximum value.

[0110] Example 8: The apparatus according to Example 6, wherein the position along the renal artery is the position where the corresponding hemodynamic parameter value among the plurality of hemodynamic parameter values ​​crosses a threshold.

[0111] Example 9: The device according to Example 1, wherein the measured values ​​of the plurality of intravascular sensors include: Measurement results from multiple first intravascular sensors; and Multiple intravascular measurements in the second vessel.

[0112] Example 10: The apparatus according to Example 1, wherein the screen display further includes a graph relating blood pressure changes to the value of the at least one hemodynamic parameter.

[0113] Example 11: The apparatus according to Example 1, wherein, after performing co-registration between the plurality of hemodynamic parameter values ​​and the first X-ray image, the plurality of hemodynamic parameter values ​​are respectively associated with a plurality of locations along the length of the renal artery.

[0114] Example 12: The apparatus according to Example 1, wherein the plurality of hemodynamic parameter values ​​include at least one of the following: Changes in invasive pulse wave velocity (iPWV), heart rate, volumetric flow rate, blood flow velocity, vascular resistance or impedance, pulsatility, arterial stiffness, renal resistance, or arterial diameter.

[0115] Example 13: The apparatus according to Example 1, wherein the processor circuit is configured to perform the co-registration between the plurality of intravascular sensor measurements and the first X-ray image separately from the co-registration between the plurality of hemodynamic parameter values ​​and the first X-ray image of the renal artery.

[0116] Example 14. The apparatus according to Example 1, wherein, in order to perform the co-registration between the plurality of hemodynamic parameter values ​​and the first X-ray image of the renal artery, the processor circuit is configured to: Receive the first X-ray image of the renal artery; Multiple second X-ray images of the renal artery are received during the movement of the at least one intravascular catheter or guidewire, wherein the multiple second X-ray images are obtained without the contrast agent fluid inside the renal artery and describe multiple positions of the at least one intravascular catheter or guidewire during the movement; The co-registration between the multiple hemodynamic parameter values ​​and the first X-ray image of the renal artery is performed by using the multiple second X-ray images.

[0117] Example 15: A method comprising: A processor circuit is used to control at least one intravascular catheter or guidewire to obtain multiple intravascular sensor measurements associated with the blood within the patient's renal artery during movement along the length of the renal artery; The processor circuitry calculates multiple hemodynamic parameter values ​​based on measurements from multiple intravascular sensors, wherein the multiple hemodynamic parameter values ​​are associated with at least one of the patient’s suitability for renal denervation treatment or the patient’s expected responsiveness to the renal denervation treatment. The processor circuitry is used to perform a common registration between the following two: The values ​​of the plurality of hemodynamic parameters; and X-ray images of the renal artery obtained with contrast agent fluid present inside the artery; and Output a screen display to a display in communication with the processor circuitry, the screen display being configured to guide the user regarding the renal denervation procedure, wherein the screen display includes: The X-ray image of the renal artery; and The representation of at least one hemodynamic parameter value, which is located at at least one corresponding position in the X-ray image along the length of the renal artery.

Claims

1. A processor circuit configured to communicate with at least one intravascular catheter or guidewire, wherein, The processor circuit is configured as follows: Multiple hemodynamic parameter values ​​are calculated based on multiple intravascular sensor measurements obtained by the at least one intravascular catheter or guidewire during movement along the length of the renal artery, which are associated with the blood within the patient's renal artery. The multiple hemodynamic parameter values ​​are associated with at least one of the patient's suitability for the renal denervation procedure or the patient's expected responsiveness to the renal denervation procedure. Perform a common registration between the following two: The values ​​of the plurality of hemodynamic parameters; and A first X-ray image of the renal artery obtained with contrast agent fluid present inside the renal artery; and Output a screen display to a monitor, the screen display being configured to guide the user regarding the renal denervation procedure, wherein the screen display includes: The first X-ray image of the renal artery; and The representation of at least one hemodynamic parameter value is located at at least one corresponding position adjacent to the length of the renal artery in the first X-ray image.

2. The processor circuit according to claim 1, wherein, The screen displays graphs showing how the multiple hemodynamic parameters change over time or distance.

3. The processor circuit according to claim 1 or 2, wherein, The screen display includes a first X-ray image comprising multiple representations of the plurality of hemodynamic parameter values ​​superimposed on it, wherein each of the plurality of representations is located at the same position as one of the plurality of hemodynamic parameter values.

4. The processor circuit according to claim 3, wherein, Each representation includes multiple dots that are proportional to the values ​​of the corresponding hemodynamic parameters among the multiple hemodynamic parameter values.

5. The processor circuit according to claim 3, wherein, Each representation includes a color or shade corresponding to the numerical value of the corresponding hemodynamic parameter among the plurality of hemodynamic parameter values.

6. The processor circuit according to any one of claims 1 to 3, wherein, The screen display also includes a location marker indicating the position along the renal artery, wherein the position along the renal artery is the location where the corresponding hemodynamic parameter value among the plurality of hemodynamic parameter values ​​has a minimum or maximum value.

7. The processor circuit according to claim 6, wherein, The screen display also includes a location marker indicating the position along the renal artery, wherein the position along the renal artery is the position where the corresponding hemodynamic parameter value among the plurality of hemodynamic parameter values ​​crosses a threshold.

8. The processor circuit according to any one of claims 1 to 7, wherein, The screen display also includes a graph that correlates blood pressure changes with the value of the at least one hemodynamic parameter.

9. The processor circuit according to any one of claims 1 to 8, wherein, After performing the co-registration between the plurality of hemodynamic parameter values ​​and the first X-ray image, the plurality of hemodynamic parameter values ​​are associated with a plurality of locations along the length of the renal artery.

10. The processor circuit according to any one of claims 1 to 9, wherein, The plurality of hemodynamic parameter values ​​include at least one of the following: Invasive pulse wave velocity (iPWV), heart rate, volumetric flow rate, blood flow velocity, vascular resistance or impedance, pulsatility, arterial stiffness, renal resistance, or changes in arterial diameter.

11. The processor circuit according to any one of claims 1 to 10, wherein, The processor circuitry is configured to perform the co-registration between the multiple intravascular sensor measurements and the first X-ray image, separately from the co-registration between the multiple hemodynamic parameter values ​​and the first X-ray image of the renal artery.

12. The processor circuit according to any one of claims 1 to 11, wherein, In order to perform the co-registration between the plurality of hemodynamic parameter values ​​and the first X-ray image of the renal artery, the processor circuitry is configured to: Receive the first X-ray image of the renal artery; Multiple second X-ray images of the renal artery are received during the movement of the at least one intravascular catheter or guidewire, wherein the multiple second X-ray images are obtained without the contrast agent fluid inside the renal artery and describe multiple positions of the at least one intravascular catheter or guidewire during the movement; The co-registration between the multiple hemodynamic parameter values ​​and the first X-ray image of the renal artery is performed by using the multiple second X-ray images.

13. An apparatus comprising: - The processor circuit according to any one of claims 1 to 12; as well as - A display or at least one of the at least one intravascular catheter or guidewire, the at least one intravascular catheter or guidewire being configured to acquire multiple intravascular sensor measurements associated with blood within the patient's renal artery during movement along the length of the renal artery.

14. A method comprising: The processor circuitry calculates multiple hemodynamic parameter values ​​based on multiple intravascular sensor measurements associated with blood within the patient's renal artery, obtained by the at least one intravascular catheter or guidewire during movement along the length of the renal artery. The multiple hemodynamic parameter values ​​are associated with at least one of the patient's suitability for renal denervation treatment or the patient's expected responsiveness to the renal denervation treatment. The processor circuitry is used to perform a common registration between the following two: The values ​​of the plurality of hemodynamic parameters; and X-ray images of the renal artery obtained with contrast agent fluid present inside the artery; and Output a screen display to a display in communication with the processor circuitry, the screen display being configured to guide the user regarding the renal denervation procedure, wherein the screen display includes: The X-ray image of the renal artery; and A representation of at least one hemodynamic parameter value, located at at least one corresponding position in the adjacent X-ray image along the length of the renal artery; and Optionally, the display device can be controlled to output a display screen to the user.

15. A computer program comprising instructions executable by a processor or processor circuitry, the instructions encoding the steps of the method according to claim 14.

16. A computer program comprising instructions executable by a processor or processor circuitry, the instructions encoding the steps of invoking the method of claim 14; encoding control of a display device to output the display screen to a user; and optionally, encoding output of the screen display to the display device.

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