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WO2025067860A1 - Système de dénervation de nerfs d'un vaisseau sanguin - Google Patents

Système de dénervation de nerfs d'un vaisseau sanguin Download PDF

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Publication number
WO2025067860A1
WO2025067860A1 PCT/EP2024/075183 EP2024075183W WO2025067860A1 WO 2025067860 A1 WO2025067860 A1 WO 2025067860A1 EP 2024075183 W EP2024075183 W EP 2024075183W WO 2025067860 A1 WO2025067860 A1 WO 2025067860A1
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Prior art keywords
therapy
blood vessel
impedance
temperature
artery
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Paul J. Coates
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Medtronic Ireland Manufacturing ULC
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Medtronic Ireland Manufacturing ULC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678—Sensing and controlling the application of energy using a threshold value upper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00755—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance

Definitions

  • This disclosure relates to systems and methods assessing efficacy of an ablation procedure.
  • the disclosure is directed to methods and systems for denervating nerves and providing feedback to physicians regarding efficacy of the denervation therapy.
  • a catheter can be configured to deliver neuromodulation (e.g., denervation) therapy to a target tissue site to modify the activity of nerves at or near the target tissue site.
  • the nerves can be, for example, sympathetic or parasympathetic nerves.
  • the sympathetic nervous system (SNS) is a primarily involuntary bodily control system typically associated with stress responses. Chronic over-activation of the SNS is a maladaptive response that can drive the progression of many disease states.
  • excessive activation of the renal SNS has been identified experimentally and in humans as a likely contributor to the complex pathophysiology of arrhythmias, hypertension, states of volume overload (e.g., heart failure), and progressive renal disease.
  • Percutaneous renal denervation is a minimally invasive procedure that can be used to treat hypertension and other diseases caused by over-activation of the SNS.
  • a clinician delivers stimuli or energy, such as radiofrequency, ultrasound, cooling, or other energy to a treatment site to reduce activity of nerves surrounding a blood vessel.
  • the stimuli or energy delivered to the treatment site may provide various therapeutic effects through alteration of sympathetic nerve activity.
  • One aspect of the disclosure is directed to a method of performing a therapeutic procedure.
  • the method includes applying a nerve denervation therapy to a wall of a blood vessel.
  • the method also includes monitoring an impedance of tissue of the blood vessel.
  • the method also includes calculating a linearly scaled impedance value from the monitored impedance of the blood vessel.
  • the method also includes determining that a value associated with the linearly scaled impedance exceeds a threshold.
  • the method also includes ending application of the therapy.
  • the method also includes displaying on a user interface an indication of efficacy of the nerve denervation therapy.
  • Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.
  • Implementations of this aspect of the disclosure may include one or more of the following features.
  • the method further including determining that the therapy has timed out.
  • the threshold is a value of linearly scaled impedance indicative of an efficacious therapy.
  • the method further including detecting a temperature of the blood vessel.
  • the detected temperature of the blood vessel is a temperature of an electrode.
  • the temperature of the electrode approximates the temperature of the blood vessel wall.
  • the threshold is a difference between the detected temperature and the linearly scaled impedance.
  • the threshold is an integral value of the difference of the linearly scaled impedance and the detected temperature over a period of time.
  • the therapy is a monopolar radiofrequency therapy, a bipolar radiofrequency therapy, a microwave therapy, or an ultrasound therapy.
  • the method further including calculating the monitored impedance of the tissue of the blood vessel from a current and a voltage of a therapy source generating the nerve denervation therapy.
  • the method further including navigating a therapeutic device to a location within one or more of a renal artery, a celiac artery, a hepatic artery, a splanchnic artery, or a mesenteric artery. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
  • a second aspect of the disclosure is directed to a system for denervation of nerves of a blood vessel.
  • the system includes a therapeutic device configured for navigation within a blood vessel of a patient.
  • the system also includes a plurality of electrodes formed on a distal portion of the therapeutic device and configured to selectively contact a wall of the blood vessel; a therapy source in electrical communication with the plurality of electrodes.
  • the system also includes a computing device including a memory and a processor and storing thereon instructions that when executed:, calculate an impedance of tissue of the blood vessel, monitor the impedance of the tissue of the blood vessel during application therapy to the blood vessel wall, calculate a linearly scaled impedance value from the monitored impedance of the tissue of the blood vessel, determine that a value associated with of the linearly scaled impedance exceeds a threshold, end application of the therapy, and display on a user interface an indication of efficacy of a nerve denervation therapy.
  • a computing device including a memory and a processor and storing thereon instructions that when executed:, calculate an impedance of tissue of the blood vessel, monitor the impedance of the tissue of the blood vessel during application therapy to the blood vessel wall, calculate a linearly scaled impedance value from the monitored impedance of the tissue of the blood vessel, determine that a value associated with of the linearly scaled impedance exceeds a threshold, end application of the therapy, and display on a user interface
  • Implementations of this aspect of the disclosure may include one or more of the following features.
  • the system further including instructions stored in the memory that when executed by the processor determine that the therapy has timed out.
  • the threshold is a value of linearly scaled impedance indicative of an efficacious therapy.
  • the system further including a sensor in communication with the electrode and configured to determine a temperature of the electrode; The temperature of the electrode approximates the temperature of the blood vessel wall.
  • the threshold is a difference between the detected temperature and the linearly scaled impedance.
  • the threshold is an integral value of the difference of the linearly scaled impedance and the detected temperature over a period of time.
  • the therapy source and the therapeutic device are configured to apply a monopolar radiofrequency therapy, a bipolar radiofrequency therapy, a microwave therapy, or an ultrasound therapy.
  • the therapeutic device is configured for navigation to a location within one or more of a renal artery, a celiac artery, a hepatic artery, a splanchnic artery, or a mesenteric artery.
  • Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
  • One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
  • a system and method of performing a therapeutic procedure including applying a nerve denervation therapy to a wall of a blood vessel, monitoring an impedance of tissue of the blood vessel, ending application of the therapy, and displaying on a user interface an indication of efficacy of the nerve denervation therapy.
  • FIG. l is a schematic diagram of a therapy system provided in accordance with the disclosure.
  • FIG. 2 is a schematic view of a workstation of the therapy system of FIG. 1;
  • FIG. 3 is a perspective view of a therapeutic device of the therapy system of FIG.
  • FIG. 4 is a plot a change in impedance measured by the therapeutic device of FIG. 3 compared to a change in measured temperature of the medium in which the therapeutic device is placed;
  • FIG. 5 A is a plot of in vivo impedance data measured by the therapeutic device of FIG. 1;
  • FIG. 5B is a plot of in vivo temperature data measured by the therapeutic device of FIG. 1;
  • FIG. 6 A depicts the impedance data of FIG. 5 A, following a linear function transform, overlaid on the temperature data of FIG. 5B;
  • FIG. 6B depicts plot of the rolling average data of FIG. 6 A.
  • FIG. 7 is a method of assessing efficacy of application of therapy in accordance with the disclosure.
  • This disclosure is directed to therapeutic systems and methods and particularly ablation systems and methods.
  • the disclosure is directed to therapeutic systems and methods for denervation or neuromodulation of nerves such as the sympathetic, or parasympathetic, nerves.
  • Some aspects of the disclosure are directed to ablation and denervation of unmyelinated nerve fibers in and around blood vessels and other luminal tissues.
  • this disclosure is directed to systems and methods that provide intra-procedure and post procedure feedback on the efficacy of the therapy.
  • the devices, systems, and techniques described herein may be used in conjunction with neuromodulation (e.g., denervation) performed from within any suitable anatomical lumen that has nerves adjacent to the anatomical lumen.
  • Example anatomical lumens include the celiac trunk and its branches (including the common hepatic artery and its branches (including the gastroduodenal artery and its branches, the right gastric artery and its branches, and the proper hepatic artery and its branches), the left gastric artery and its branches, and the splenic artery and its branches), the superior mesenteric artery and its branches, the gonadal artery and its branches, the inferior mesenteric artery and its branches, and the like.
  • the celiac trunk and its branches including the common hepatic artery and its branches (including the gastroduodenal artery and its branches, the right gastric artery and its branches, and the proper hepatic artery and its branches), the left gastric artery and its branches, and the
  • the disclosure primarily describes neuromodulation (e.g., denervation) from within one or more arteries
  • the devices, systems, and techniques of the disclosure also may be applied to neuromodulation from within one or more veins, such as a renal vein and its branches, a hepatic vein and its branches, an intercostal vein and its branches, or the like.
  • the devices, systems, and techniques described herein may be used to perform neuromodulation (e.g., denervation) from within two or more anatomical lumens, e.g., in the renal arteries and the common hepatic artery, or any other combination of two or more anatomical lumens, either simultaneously or sequentially.
  • systems, devices, and methods described herein may be useful in conjunction with neuromodulation (e.g., denervation) within a body lumen other than a vessel, for extravascular neuromodulation and/or for use in conjunction with therapies other than neuromodulation.
  • neuromodulation e.g., denervation
  • FIG. 1 illustrates a therapy system provided in accordance with the present disclosure and generally identified by reference numeral 10.
  • therapy system 10 may be used in connection with a C-arm imaging system or other imaging station, which may facilitate navigation of a therapeutic device 50 to a desired location within the patient’ s anatomy (e.g. , the patient’ s renal artery), application of denervation therapy to the tissue adjacent the renal artery to denervate sympathetic nerves within the tissue, and monitoring of impedance and temperature for use in evaluating the denervation therapy.
  • a C-arm imaging system or other imaging station may facilitate navigation of a therapeutic device 50 to a desired location within the patient’ s anatomy (e.g. , the patient’ s renal artery), application of denervation therapy to the tissue adjacent the renal artery to denervate sympathetic nerves within the tissue, and monitoring of impedance and temperature for use in evaluating the denervation therapy.
  • the therapy system 10 includes a workstation 20 and a therapeutic device 50 operably coupled to the workstation 20.
  • the therapy system 10 may be used with an imaging device 70, which may be operably coupled to a display 72.
  • the patient “P” is shown lying on an operating table 12 with the therapeutic device 50 inserted through a portion of the patient’s femoral artery, although it is contemplated that the therapeutic device 50 may be inserted into any suitable portion of the patient’s vascular network that is in fluid communication with a desired blood vessel for therapy.
  • the therapy system 10 may employ any suitable number of therapeutic devices 50.
  • the therapeutic devices 50 may employ the same or different therapy modalities and be operably coupled to the workstation 20. Further, the therapeutic device 50 may employ a guidewire or a guide catheter 58 (FIG. 3) without departing from the scope of the disclosure.
  • the workstation 20 includes a computer 22 and a therapy source 24 (e.g., one or more of an RF generator, a microwave generator, an ultrasound generator, a cryogenic medium source, a chemical source, etc.) operably coupled to the computer 22.
  • a therapy source 24 e.g., one or more of an RF generator, a microwave generator, an ultrasound generator, a cryogenic medium source, a chemical source, etc.
  • the computer 22 and therapy source 24 are integrated in a single component and may be referred to as a generator.
  • the computer is coupled to a display 26 that is configured to display one or more user interfaces 28.
  • the computer 22 may be a desktop computer or a tower configuration with display 26 or may include a laptop computer or other computing device.
  • the computer 22 includes a processor 30 which executes software stored in a memory 32.
  • the memory 32 may store one or more applications 34 and/or algorithms 44 to be executed by the processor 30.
  • a network interface 36 enables the workstation 20 to communicate with a variety of other devices and systems via the internet.
  • the network interface 36 may connect the workstation 20 to the Internet via a wired or wireless connection. Additionally, or alternatively, the communication may be via an ad hoc Bluetooth® or wireless network enabling communication with a wide- area network (WAN) and/or a local area network (LAN).
  • WAN wide- area network
  • LAN local area network
  • the network interface 36 may connect to the Internet via one or more gateways, routers, and network address translation (NAT) devices.
  • the network interface 36 may communicate with a cloud storage system 38, in which further data, image data, and/or videos may be stored.
  • the cloud storage system 38 may be remote from or on the premises of the hospital such as in a control or hospital information technology room. It is envisioned that the cloud storage system 38 could also serve as a host for more robust analysis of acquired images (e.g., fluoroscopic, computed tomography (CT), magnetic resonance imaging (MRI), cone-beam computed tomography (CBCT), etc.), data, etc. (e.g., additional or reinforcement data for analysis and/or comparison).
  • CT computed tomography
  • MRI magnetic resonance imaging
  • CBCT cone-beam computed tomography
  • An input module 40 receives inputs from an input device such as a keyboard, a mouse, voice commands, an energy source controller (e.g., a foot pedal or handheld remote-control device that enables the clinician to initiate, terminate, and optionally, adjust various operational characteristics of the therapy source 24 and/or stimulation source 24a, including, but not limited to, power delivery), amongst others.
  • An output module 42 connects the processor 30 and the memory 32 to a variety of output devices such as the display 26.
  • the display 26 may be a touchscreen display.
  • the therapy source 24 generates and outputs one or more of RF energy (monopolar or bipolar), microwave energy, ultrasound energy, cryogenic medium, or chemical ablation medium via an automated control algorithm 44 stored on the memory 32 and/or under the control of a clinician.
  • RF energy monopolar or bipolar
  • microwave energy microwave energy
  • ultrasound energy e.g., ultrasound energy
  • cryogenic medium e.g., cryogenic medium
  • chemical ablation medium e.g., a temperature of the tissue (e.g., increase or decrease the temperature) to achieve the desired denervation of the nerves.
  • the therapy source 24 may be configured to produce a selected modality and magnitude of energy and/or therapy for delivery to the treatment site via the therapeutic device 50, as will be described in further detail hereinbelow.
  • the therapy source 24 may sense voltage and current applied to target tissue via the therapeutic device 50.
  • one or more sensors on the therapeutic device 50 may monitor the temperature of the target tissue or tissue proximate the target tissue, and/or a portion of the therapeutic device 50. Utilizing the sensed voltage and current applied to the tissue, an application 34 on the computer 22 calculates an impedance of the tissue through which therapeutic or guidance energy is transmitted to provide an indication of the status of the tissue. This status, as will be described in greater detail below, may be output to the display 26 on one or more user interfaces 28 to provide a clinician with both intraprocedural and post-procedural feedback regarding the therapy.
  • FIG. 3 depicts one embodiment of a therapeutic device 50 in accordance with the disclosure.
  • the therapeutic device 50 includes an elongated shaft 52 having a handle (not shown) disposed on a proximal end portion of the elongated shaft 52.
  • the therapeutic device 50 includes an energy delivery assembly 54 at which one or more therapy electrodes 56 are located.
  • the elongated shaft 52 of the therapeutic device 50 is configured to be advanced over a guide wire (not shown) within a portion of the patient’s vasculature, such as a femoral artery or other suitable portion of patient’s vascular network that is in fluid communication with the patient’s renal artery.
  • the energy delivery assembly 54 is configured to be transformed from an initial, undeployed configuration having a generally linear profile, to a second, deployed or expanded configuration, where the energy delivery assembly 54 forms a generally spiral and/or helical configuration for delivering energy to a site for either or both application of a stimulation signal or therapeutic energy at the treatment site.
  • therapeutic energy should be construed to include cryogenic cooling to the treatment site to achieve a thermally induced neuromodulation.
  • the energy delivery assembly 54, and in particular, the individual electrodes 56 is pressed against or otherwise contacts the walls of the patient’s vasculature tissue.
  • the energy delivery assembly 54 may be deployed in other configurations without departing from the scope of the present disclosure.
  • the therapeutic device 50 may be configurable, for example, using one or more pull wires (not shown) to adjust the configuration to promote contact between the electrodes 56 and the wall of the renal artery.
  • the therapeutic device 50 may be capable of being placed in one, two, three, four, or more different configurations depending upon the design needs of the therapeutic device 50 or the location at which therapy is to be applied.
  • the elongated shaft 52 is configured to be received within a portion of a guide catheter or guide sheath (such as a 6F guide catheter) 58 that is utilized to navigate the therapeutic device 50 to a desired location.
  • a guide catheter or guide sheath such as a 6F guide catheter
  • the guide catheter 58 is inserted into an access point such as the femoral artery to gain access to the vascular system.
  • the guide catheter 58 is advanced to the desired location, for example to cannulate a renal artery.
  • a guide wire (not shown) is advanced through the guide catheter 58 and to a location where therapy is to be applied (i.e., beyond a distal end of the guide catheter 58) and into the desired blood vessel (e.g., the renal artery).
  • the therapeutic device 50 is then advanced over the guide wire to the location where the therapy is to be applied, exposing the electrodes 56.
  • the guide wire 50 is then retracted within the therapeutic device 50 and the guide catheter 58. Retraction of the guide wire within the therapeutic device 50 causes the energy the delivery assembly 54 of the therapeutic device 50 to transition from the first, undeployed and generally straight configuration, to the second, deployed or expanded configuration (as shown in FIG. 3).
  • a sensor 60 may be incorporated into the guide sheath 58 or the shaft 62 for detection of physiological parameters of the patient.
  • the physiological parameter is blood pressure though other parameters may be employed without departing from the scope of the disclosure.
  • the guide catheter 58 may be retracted relative to the therapeutic device 50 to achieve a desired placement of the electrodes 56.
  • the guide wire is not required, and the placement described herein above may be achieved without the use of the guide wire (e.g., with only a guide catheter).
  • the elongated shaft 52 of the therapeutic device 50 may further include an aperture (not shown) at a distal end thereof and configured to slidably receive a guidewire over which the therapeutic device 50, either alone or in combination with the guide catheter 58, are advanced.
  • the guidewire is utilized to guide the therapeutic device 50 to the target tissue using over-the-wire (OTW) or rapid exchange (RX) techniques, at which point the guide wire may be partially or fully removed from the therapeutic device 50, enabling the therapeutic device 50 to transition from the first, undeployed configuration, to the second, deployed or expanded configuration (FIG. 3).
  • OW over-the-wire
  • RX rapid exchange
  • the therapeutic device 50 may transition from the first, undeployed configuration to the second, deployed configuration automatically (e.g., via a shape memory alloy, etc.) or manually (e.g., via pull wires, guide wire manipulation, etc. that is controlled by the clinician).
  • the energy delivery assembly 54 includes one or more electrodes 56 disposed on an outer surface thereof that are configured to contact a portion of the patient’s vascular tissue when the therapeutic device 50 is placed in the second, expanded configuration.
  • the therapeutic device 50 includes four electrodes 56.
  • the present disclosure is not so limited and the therapeutic device 50 may have more or fewer electrodes 56 without departing from the scope of the present disclosure.
  • the electrodes 56 may be replaced with ultrasound transducers, microwave antennae, ports for delivery of cryoablation medium or chemical medium and other implements and/or ablation and denervation modalities without departing from the scope of the present disclosure.
  • the electrodes 56 are disposed in spaced relation to one another along a length of the therapeutic device 50 forming the energy delivery assembly 54. As will be appreciated, these electrodes 56 are in communication with both the therapy source 24 and the stimulation source 24a. In one example the therapy source 24 produces, monopolar RF energy to denervate the sympathetic nerves of the relevant blood vessel.
  • the electrodes 56 may deliver RF energy independently of one another, simultaneously, selectively, or sequentially and in electrical communication with a ground pad (not shown) to enable the application of monopolar RF energy for therapy. Additionally or alternatively, RF energy may be applied between any desired combination of the electrodes 56, without requiring the use of a ground pad (e.g., bipolar).
  • Therapy e.g., RF, microwave, or ultrasound energy
  • tissue receiving the energy e.g., blood vessel wall
  • the impedance of the tissue through which the energy is passed can be calculated by the therapy source 24 or the computer 22 operably connected thereto.
  • the impedance of the tissue can be calculated.
  • FIG. 4 depicts two plots observed during an experimental application of energy to a therapeutic device 50 when placed in a saline bath.
  • the first plot depicts linearly scaled impedances observed during the application of therapeutic energy while the second plot depicts the changes in temperature observed as a result of the application of energy.
  • Linearly scaling of the impedance values is achieved with use of the linear equation (1) and temperature and impedance values at two times (t and (t 2 ):
  • LSI m*I +c
  • two time points are selected (t and (t 2 ). These may be specific times during the application of therapy (e.g., at 5s and 20s) or they may be ranges of times (e.g., 5-10s and 15-20s).
  • temperature and impedance values are determined to provide T Ii values and T 2 , 1 2 values. Where ranges of times are utilized average temperature and impedance values across that range of time can be calculated.
  • m (T 2 - T /(I 2 - 1
  • Equation 1 T 2 - m*I 2
  • the Linearly scaled impedance can be calculated using Equation (2) at any time for which there is impedance data.
  • temperature and the linearly scaled impedance correlate nearly perfectly (i.e., rises in linearly scaled impedance are highly correlated with rises in temperature).
  • therapeutic energy e.g., ablation or denervation energy
  • the blood vessels e.g., the renal arteries
  • the impedance is no longer purely a function of temperature.
  • impedance is a function of degree of contact of the electrodes 56 to blood vessel wall. Blood in the blood vessel is generally more conductive than the tissue of the blood vessel wall, thus as the degrees of electrode 56 surface area contacting with the blood vessel wall changes, the impedance will vary.
  • Another cause for change in impedance experienced in- vivo when applying therapy is the permanent and irreversible tissue damage caused by the application of therapeutic energy.
  • this permanent tissue damage is the dehydration of the cells of the blood vessel wall and other tissues of the blood vessel (including the nerves being targeted for denervation. The dehydration of these tissues permanently changes the tissue impedance even when the temperature of the tissue returns to baseline. To provide an accurate and useful feedback mechanism for clinicians to utilize during procedures, these more complicated relationships must be considered.
  • each electrode may incorporate a thermistor or other temperature sensor (not shown) enabling the monitoring of the temperature of the electrodes 56.
  • the electrodes 56 directly contact the inner wall of a blood vessel or other luminal tissues, thus as energy is passed through the electrodes 56, heating the adjacent causing the electrodes 56 themselves to begin to heat.
  • the thermistor, thermocouple or other temperature sensor in communication with the electrode 56, generates a signal that is received by the therapy source 24 and provides an indication of the temperature of the electrode 56.
  • the temperature of the electrode 56 closely approximates the temperature of the tissue of the blood vessel directly adjacent the electrode 56.
  • the temperature of the electrode 56 as measured by the temperature sensor which is an approximation of the temperature of the tissue receiving the therapy can be compared to the linearly scaled impedance data to assess the efficacy of the therapy.
  • FIG. 5A depicts impedance data acquired from in vivo application of therapeutic energy to a blood vessel wall of a patient. As with FIG. 4 the therapeutic energy is applied via the electrodes 56 starting at the 10 second mark of the plot and terminates at about the 70 second mark. The depicted oscillations in the data of the plot are associated with the heartbeat of the patient and reflect changes in the degree of contact of the electrodes 56 with the blood vessel wall.
  • FIG. 5A depicts impedance data acquired from in vivo application of therapeutic energy to a blood vessel wall of a patient. As with FIG. 4 the therapeutic energy is applied via the electrodes 56 starting at the 10 second mark of the plot and terminates at about the 70 second mark. The depicted oscillations in the data of the plot are associated with the heartbeat of the patient and reflect changes in the
  • 5B depicts a plot of the temperature of the electrode during the same period of application of therapeutic energy to the blood vessel of the patient.
  • oscillations are also seen in the plotted temperature data.
  • the oscillations only begin after application of the therapeutic energy (e.g., ablation) begins.
  • the application of the therapeutic energy begins (at the 10 second mark in the plot) a temperature gradient is established between the blood vessel wall and the blood flowing through blood vessel.
  • the blood vessel wall is warmer than blood flowing through the blood vessel.
  • the pulsatile flow of body temperature blood through the blood vessel (e.g., the renal artery) and varying degree of electrode 56 contact with the tissue of the blood vessel wall causes a thermal convection capacity of the blood to vary with time resulting the observed oscillations in the plot.
  • the oscillations observed in the plots of FIGS. 5A and 5B a correlation or relationship between the impedance data and the temperature data can be observed.
  • FIG. 6 A depicts the impedance data of FIG. 5 A after application of a linear function transform plotted over the temperature data of FIG. 5B.
  • FIG. 6B depicts the same data as FIG. 6A when transformed into rolling average values during the application of therapeutic energy via the electrodes 56 to the blood vessel wall.
  • the oscillations are smoothed by reducing the impact of changes in electrode 56 contact with the blood vessel wall caused by the patient’s heartbeat and changes in blood vessel diameter.
  • the linearly scaled impedance data, as depicted in FIG. 6B, and particularly the tracking error can be utilized to provide information to the clinician regarding the efficacy of the application of therapeutic energy to the blood vessel wall. Additionally or alternatively, the tracking error depicted in FIG. 6B can be utilized to provide a therapy endpoint. When the tracking error reaches a set value, therapy may be ceased as the magnitude of the tracking error (e.g., the impedance magnitude) indicates a temperature of a certain magnitude has been achieved in tissue beyond the blood vessel wall. This provides an indication of the efficacy of the therapy.
  • the magnitude of the tracking error e.g., the impedance magnitude
  • FIG. 7 depicts a flow chart showing a method 700 in accordance with the disclosure.
  • the therapeutic device 50 is placed at a desired location within the patient (e.g., in a renal or hepatic artery). As part of the placement, the therapeutic device 50 may be advanced from the catheter 58 and the therapeutic device 50 allowed to expand such that the electrodes 56 are in contact with an inner wall of the blood vessel.
  • the therapy (e.g., RF, microwave, ultrasound, etc. ablation) is applied to the blood vessel wall to denervate the nerves within and beyond the blood vessel wall.
  • the impedance of the tissue through which the therapy is passing is monitored.
  • the linearly scaled impedance is calculated at step 708.
  • a determination is made whether the linearly scaled impedance has exceeded a threshold (e.g., a threshold indicating an efficacious therapy has been applied).
  • the threshold may be a threshold difference between the linearly scaled impedance and a detected temperature at the electrodes 56, as described above.
  • step 712 the therapy application ends and then to step 714 where an efficacy indicator is displayed on the user interface 28 on display 26.
  • step 716 a determination is made whether a therapy has timed out (e.g., therapy has been applied for more than 60 seconds). If yes, the method moves to step 712, and the application of therapy ends, and an efficacy indicator is displayed at step 714. If, however, the therapy has not timed out, then the method returns to step 704 and the application of therapy continues.
  • a therapy has timed out e.g., therapy has been applied for more than 60 seconds
  • the linearly scaled impedance calculated at step 708 may be compared to a temperature value that is indicative of an effective therapy, thus even if a programmed duration for therapy application (e.g., 60 seconds) has not been reached but the requisite temperature to indicate an efficacious denervation has been reached the method can be stopped and the application of unnecessary therapy can be minimized.
  • a programmed duration for therapy application e.g. 60 seconds
  • the determination that a linearly scaled impedance exceeds a threshold may be a more complex determination where an integral over time of a difference between the calculated linearly scaled impedance and a temperature of the electrodes 56 (an approximation of the temperature of the blood vessel wall), as described above, is employed. When the difference exceeds a threshold, the method moves to step 712 and ends application of therapy.
  • step 714 if the efficacy indicator is sufficient that the clinician believes a complete therapy has been achieved, the method may return to step 702 for positioning in another location in the same or a different blood vessel and the method 700 may be repeated. Alternatively, if the efficacy indicator is such that it signals to the clinician that the therapy was inefficacious or insufficiently efficacious then the method 700 may return to step 710 where therapy is again applied. This may be repeated until at step 714 an effective therapy has been achieved, or until the application of more therapy is not altering the indicator of efficacy at which point the clinician may cease the method 700.
  • an indicator of the efficacy of the therapy be displayed on the UI 28.
  • This indicator may be as simple as a color-coded display where a red indicator signals an inefficacious or incomplete therapy, and a green indicator signals an efficacious therapy. Additionally or alternatively, the indicator may be more granular, and based on the monitored impedance, a percentage of completeness of the therapy may be displayed. This may be coupled with more colors, where red is 0-50% complete, orange is 50-75% complete, yellow is 75-95% complete, and green is greater than 95% complete.
  • the UI 21 may display a rolling indicator of the impedance value during the application of therapy at step 704 and the calculation of the linearly scaled impedance at step 708.
  • the clinician may observe the changes in impedance during the procedure and assess whether to terminate method 700 on their own during the procedure.
  • Other indicators may include written words on the UI 28, audible sounds to indicate efficacy of the therapy, and combinations of each of these without departing from the scope of the disclosure.
  • the therapeutic devices 50 contemplated in this disclosure can apply one or more of a variety of therapeutic modalities.
  • the therapeutic modalities considered within the scope of this disclosure include monopolar or bipolar radiofrequency, microwave, ultrasound, and other yet to be developed modalities. Any of these therapy modalities may be incorporated into a therapeutic device 50, which is configured for navigation to a desired location within the patient.
  • the therapeutic device 50 is configured to deliver one or more of these therapeutic modalities may be percutaneously navigated, for example via the femoral artery, to reach the blood vessels of the aorta including the renal arteries, celiac artery, hepatic arteries, splanchnic arteries, mesenteric arteries, and others that are enervated with sympathetic nerves or are proximate one or more sympathetic nerve ganglia.
  • a catheter may also be laparoscopically placed in one or more of the above-identified blood vessels, or another luminal tissue without departing from the scope of the present disclosure.
  • the therapeutic device may be navigated within the vessels or luminal tissue in one configuration (e.g., a linear configuration) and once located at a desired location, deployed or otherwise actuated to achieve a second configuration.
  • one configuration e.g., a linear configuration
  • the therapeutic device 50 has been primarily described in connection with a shape memory construction where exit from a guide catheter 58 frees the shape memory alloy to achieve a desired spiral shape of the and place the electrodes 56 against the blood vessel walls.
  • the present disclosure is not so limited and the therapeutic device 50 may be formed such that the electrodes are placed on a balloon or other mechanism to achieve the desired contact with the blood vessel walls without departing from the scope of the disclosure.
  • the memory 32 may include any non-transitory computer-readable storage media for storing data and/or software including instructions that are executable by the processor 30 and which control the operation of the workstation 20 and, in some embodiments, may also control the operation of the therapeutic device 50.
  • memory 32 may include one or more storage devices such as solid-state storage devices, e.g., flash memory chips.
  • the memory 32 may include one or more mass storage devices connected to the processor 30 through a mass storage controller (not shown) and a communications bus (not shown).
  • computer-readable media refers to solid-state storage. It should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 30. That is, computer readable storage media may include non-transitory, volatile, and non-volatile, removable, and nonremovable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data.
  • computer-readable storage media may include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which may be used to store the desired information, and which may be accessed by the workstation 20.
  • Example 1 A method of performing a therapeutic procedure, comprising: applying a nerve denervation therapy to a wall of a blood vessel; monitoring an impedance of tissue of the blood vessel; calculating a linearly scaled impedance value from the monitored impedance of the blood vessel; determining that a value associated with the linearly scaled impedance exceeds a threshold; ending application of the therapy; and displaying on a user interface an indication of efficacy of the nerve denervation therapy.
  • Example 2 The method of example 1, further comprising determining that the therapy has timed out.
  • Example 3 The method of example 1 or 2 wherein the threshold is a value of linearly scaled impedance indicative of an efficacious therapy.
  • Example 4 The method of example 1 or 2, further comprising detecting a temperature of the blood vessel.
  • Example 5 The method of example 4, wherein the detected temperature of the blood vessel is a temperature of an electrode.
  • Example 6 The method of example 5, wherein the temperature of the electrode approximates the temperature of the blood vessel wall.
  • Example 7 The method of any one of examples 4 to 6, further comprising comparing the linear scaled impedance value to the detected temperature of the blood vessel, wherein the threshold is a difference between the detected temperature and the linearly scaled impedance.
  • Example 8 The method of any one of examples 4 to 7, wherein the threshold is an integral value of the difference of the linearly scaled impedance and the detected temperature over a period of time.
  • Example 9 The method of any one of the preceding examples, wherein the therapy is a monopolar radiofrequency therapy, a bipolar radiofrequency therapy, a microwave therapy, or an ultrasound therapy.
  • Example 10 The method of any one of the preceding examples, further comprising calculating the monitored impedance of the tissue of the blood vessel from a current and a voltage of a therapy source generating the nerve denervation therapy.
  • Example 11 The method of any one of the preceding examples, further comprising navigating a therapeutic device to a location within one or more of a renal artery, a celiac artery, a hepatic artery, a splanchnic artery, or a mesenteric artery.
  • Example 12 A system for denervation of nerves of a blood vessel comprising: a therapeutic device configured for navigation within a blood vessel of a patient; a plurality of electrodes formed on a distal portion of the therapeutic device and configured to selectively contact a wall of the blood vessel; a therapy source in electrical communication with the plurality of electrodes; and a computing device including a memory and a processor and storing thereon instructions that when executed: calculate an impedance of tissue of the blood vessel; monitor the impedance of the tissue of the blood vessel during application therapy to the blood vessel wall; calculate a linearly scaled impedance value from the monitored impedance of the tissue of the blood vessel; determine that a value associated with of the linearly scaled impedance exceeds a threshold; end application of the therapy; and display on a user interface an indication of efficacy of a nerve denervation therapy.
  • Example 13 The system of example 12, further comprising instructions stored in the memory that when executed by the processor determine that the therapy has timed out.
  • Example 14 The system of example 12 or 13, wherein the threshold is a value of linearly scaled impedance indicative of an efficacious therapy.
  • Example 15 The system of example 12, further comprising a sensor in communication with the electrode and configured to determine a temperature of the electrode.
  • Example 16 The system of example 15, wherein the temperature of the electrode approximates the temperature of the blood vessel wall.
  • Example 17 The system of example 15 or 16, further comprising instructions stored in the memory that when executed by the processor compare the linear scaled impedance value to the detected temperature of the blood vessel, wherein the threshold is a difference between the detected temperature and the linearly scaled impedance.
  • Example 18 The system of any one of examples 15 to 17, wherein the threshold is an integral value of the difference of the linearly scaled impedance and the detected temperature over a period of time.
  • Example 19 The system of any one of examples 12 to 18, wherein the therapy source and the therapeutic device are configured to apply a monopolar radiofrequency therapy, a bipolar radiofrequency therapy, a microwave therapy, or an ultrasound therapy.
  • Example 20 The system of any one of examples 12 to 19, wherein the therapeutic device is configured for navigation to a location within one or more of a renal artery, a celiac artery, a hepatic artery, a splanchnic artery, or a mesenteric artery.

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Abstract

L'invention concerne un système et un procédé de réalisation d'une procédure thérapeutique, comprenant l'application d'une thérapie de dénervation à une paroi d'un vaisseau sanguin, la surveillance d'une impédance du tissu du vaisseau sanguin, l'arrêt de l'application de la thérapie, et l'affichage sur une interface utilisateur d'une indication d'efficacité de la thérapie de dénervation.
PCT/EP2024/075183 2023-09-29 2024-09-10 Système de dénervation de nerfs d'un vaisseau sanguin Pending WO2025067860A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0694291B1 (fr) * 1994-07-28 2001-10-31 Ethicon Endo-Surgery, Inc. Dispositif pour le traitement électrochirurgical de tissu
US20090062873A1 (en) * 2006-06-28 2009-03-05 Ardian, Inc. Methods and systems for thermally-induced renal neuromodulation
US20090306648A1 (en) * 2008-06-10 2009-12-10 Podhajsky Ronald J System and Method for Output Control of Electrosurgical Generator
US20120101538A1 (en) * 2010-10-25 2012-04-26 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US20170215794A1 (en) * 2016-02-01 2017-08-03 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for monitoring and evaluating neuromodulation therapy
US20210186609A1 (en) * 2018-08-13 2021-06-24 The University Of Sydney Catheter ablation device with impedance monitoring

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0694291B1 (fr) * 1994-07-28 2001-10-31 Ethicon Endo-Surgery, Inc. Dispositif pour le traitement électrochirurgical de tissu
US20090062873A1 (en) * 2006-06-28 2009-03-05 Ardian, Inc. Methods and systems for thermally-induced renal neuromodulation
US20090306648A1 (en) * 2008-06-10 2009-12-10 Podhajsky Ronald J System and Method for Output Control of Electrosurgical Generator
US20120101538A1 (en) * 2010-10-25 2012-04-26 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US20170215794A1 (en) * 2016-02-01 2017-08-03 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for monitoring and evaluating neuromodulation therapy
US20210186609A1 (en) * 2018-08-13 2021-06-24 The University Of Sydney Catheter ablation device with impedance monitoring

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