Applying stimulation to enable circumferential ablation during RF ablation of RDN

Abstract

Systems and methods for performing a treatment procedure include navigating a treatment device to a target tissue; applying a first stimulus to the target tissue via a stimulus delivery element to retract the target tissue around the treatment device; and applying a first therapy to the target tissue retracted around the treatment device to denervate the target tissue.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 406,547, filed on September 14, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to systems and methods that enable positioning of a therapeutic device within luminal tissue to create a complete circumferential ablation during a treatment procedure.In certain aspects, the present disclosure relates to methods and systems for denervating sympathetic nerves in or around vascular tissue. Background Art

[0003] Catheters have been proposed for various medical procedures. For example, catheters can be configured to deliver neuromodulation (e.g., denervation) therapy to tissue sites to change the activity of nerves at or near tissue sites. Nerves can be, for example, sympathetic nerves. The sympathetic nervous system (SNS) is the main involuntary body control system usually associated with stress response. Chronic overactivation of the SNS is a maladaptive reaction that can drive the progression of many disease states. For example, overactivation of sympathetic nerves in and around the kidney, liver, visceral and mesenteric arteries has been confirmed in experiments and humans as a possible cause of the complex pathophysiology of arrhythmias, hypertension, volume overload states (e.g., heart failure) and progressive renal disease and a variety of other disease states.

[0004] To address some of these disease states, percutaneous renal denervation has been developed, which is a current method of treating disease states such as hypertension caused by overactivation of sympathetic nerves near the renal arteries. In one type of renal denervation procedure, clinicians deliver energy (such as radiofrequency) to the wall of the renal artery to cut off the sympathetic nerves in or near the tissue of the renal artery. Similar procedures using ultrasound, chemotherapy, and cryotherapy have been developed. The purpose of these therapies is to reduce or eliminate the activity of the sympathetic nerves around the renal artery, which has been shown to be effective in treating hypertension without the side effects of other therapies. Despite the efficacy of renal and other arterial denervation or neuromodulation procedures, improvements in systems and methods for performing these procedures are always desired. Summary of the invention

[0005] One aspect of the present disclosure relates to a method for performing a treatment protocol. The method includes navigating a treatment device to a target tissue. The method also includes applying a first stimulus to the target tissue via a stimulation delivery element to retract the target tissue around the treatment device. The method also includes applying a first therapy to the target tissue retracted around the treatment device to denervate the target tissue. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.

[0006] Specific implementations of this aspect of the present disclosure may include one or more of the following features. The method also includes applying a second stimulus to the target tissue via a stimulation delivery element after the therapy is applied to the target tissue. The method also includes observing the application of the first stimulus and the second stimulus to assess the retraction of the target tissue. The therapy may be applied after confirming the retraction of the target tissue after applying the first stimulus. The method also includes applying the second therapy when the retraction of the target tissue observed from the second stimulus exceeds a threshold. The first stimulus may be applied during the application of the first therapy. The method also includes observing the application of the first stimulus and the first therapy to assess the retraction of the target tissue. Relaxation of the target tissue below the threshold may indicate successful denervation of the target tissue. The first stimulation modality is selected from a group including: bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical, and combinations thereof. The first therapy modality is selected from a group including: monopolar or bipolar radiofrequency (RD), microwave, ultrasound, chemical, cryogenic, and combinations thereof. Specific implementations of the described techniques may include hardware, methods or processes, or computer software on a computer-accessible medium, including software, firmware, hardware, or a combination thereof installed on a system, which, in operation, causes the system to perform actions. One or more computer programs may 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.

[0007] Another aspect of the present disclosure relates to a system for denervation of target tissue. The system includes an elongated catheter, a therapy delivery element operably combined with the elongated catheter, and a stimulation delivery element operably combined with the elongated catheter. The system includes a stimulation source connected to the stimulation delivery element, wherein the stimulation applied via at least one stimulation delivery element causes the target tissue to retract on the elongated catheter so that the elongated catheter is centered in the target tissue. The system also includes a therapy source connected to the therapy delivery element, wherein the application of therapy denervates the neural tissue of the target tissue. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods and systems described herein.

[0008] Specific implementations of this aspect of the present disclosure may include one or more of the following features. The system for denervation also includes two stimulation delivery elements formed on the elongated catheter. The system for denervation also includes a second stimulation delivery element formed on the guide catheter. The stimulation delivery element can also be formed on the guide wire. The therapy source and the stimulation source can also be a single electrical generator. The therapy source modality can be selected from the group including: monopolar or bipolar radio frequency (RF), microwave, ultrasound, chemical, cryogenic and their combinations. The stimulation source modality can be selected from the group including: bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulse, biphasic pulse, multiphasic pulse, chemical and their combinations. The system for denervation also includes a shape memory portion, which is configured to change the shape of the elongated catheter into a helical configuration so that the therapy delivery element contacts the target tissue. The therapy element can be composed of one or more monopolar RF electrodes formed on the elongated catheter, so that the change in shape causes the electrodes in a spaced relationship to contact the target tissue. The system for denervation can include a balloon, wherein the inflation of the balloon fixes the elongated catheter relative to the target tissue. The therapy delivery element may be a plurality of RF electrodes formed on the balloon. The therapy delivery element may be a microwave antenna within the balloon. The therapy delivery element may be a plurality of ultrasonic transducers formed on the balloon. The therapy delivery element may be one or more needles for injecting a chemical or cryoablative medium into the target tissue. The system for denervation also includes a computer, the computer including a memory, the memory having an application stored thereon, which, when executed by a processor: causes the stimulation element to apply stimulation close to the target tissue to retract the muscle fibers of the target tissue; causes the therapy element to apply therapy to the target tissue; and when it is determined that the target tissue has been successfully denervated, stops applying therapy to stop. Specific implementations of the described techniques may include hardware, methods or processes, or computer software on a computer accessible medium, including software, firmware, hardware, or a combination thereof installed on the system, which software, firmware, hardware, or a combination thereof causes the system to perform actions in operation. One or more computer programs may be configured to perform specific operations or actions by including instructions that, when executed by a data processing device, cause the device to perform an action.

[0009] Also disclosed herein are systems and methods for performing a treatment procedure, comprising: navigating a treatment device to a target tissue; applying a first stimulation to the target tissue via a stimulation delivery element to cause the target tissue to retract around the treatment device; and applying a first therapy to the target tissue retracted around the treatment device to denervate the target tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Various aspects and embodiments of the present disclosure are described below with reference to the accompanying drawings, in which:

[0011] Figure 1 is a schematic diagram of a treatment system provided according to the present disclosure;

[0012] Figure 2 yes Figure 1 A schematic diagram of a workstation of a treatment system;

[0013] Figure 3 yes Figure 1 A perspective view of a treatment device of a treatment system;

[0014] Figure 4 yes Figure 3 A perspective view of a therapeutic device shown advanced within a portion of a patient's anatomy and in a deployed state;

[0015] Figure 5 yes Figure 3 A perspective view of a treatment device of FIG. 1 showing tissue retraction around a portion of the treatment device;

[0016] Figure 6 According to the present disclosure Figure 1 A perspective view of another embodiment of a therapeutic device of the system;

[0017] Figure 7 is a flow chart illustrating a method of performing a treatment protocol according to the present disclosure;

[0018] Figure 8 is a flow chart illustrating another method of performing a treatment protocol according to the present disclosure;

[0019] Fig. 9 is a flow chart illustrating yet another method of performing a treatment protocol in accordance with the present disclosure. DETAILED DESCRIPTION

[0020] The present disclosure relates to treatment systems and methods for denervation or neuromodulation of nerves, such as sympathetic nerves, located in and around blood vessels and other luminal tissues. In order to enhance the therapeutic effect, the treatment system is configured to apply stimulation to the blood vessels or other luminal tissues. The stimulation triggers the nerves, including, for example, sympathetic nerves in and around the blood vessels, causing the muscle tissue within the blood vessels to retract. The retraction of the muscle tissue in the blood vessels causes a change in the diameter of the blood vessels. The change in diameter centers a treatment device (e.g., a catheter) in the blood vessel. The centering of the treatment device promotes good contact of the therapy application portion (e.g., a radiofrequency electrode) on the inner wall of the blood vessel. As a result, with good contact of the therapy application portion, a more complete therapy (e.g., complete circumferential ablation) can be achieved, thereby promoting more complete denervation of the sympathetic nerves outside the blood vessel wall and resulting in a more consistent and alleviated disease state of the patient (e.g., reduced hypertension).

[0021] The therapeutic device contemplated in the present disclosure can apply one or more therapeutic modalities in a variety of therapeutic modalities. For example, the therapeutic modalities considered within the scope of the present disclosure include monopolar or bipolar radiofrequency, microwave, cryogenics, ultrasound, chemistry and other modalities yet to be developed. Any of these therapeutic modalities can be incorporated into a therapeutic device (such as a catheter), which is configured to navigate to a desired position in the patient's body. The catheter configured to deliver one or more therapeutic modalities in these therapeutic modalities can be navigated percutaneously, such as via femoral artery navigation, to reach the blood vessels of the aorta, including the celiac artery, hepatic artery, visceral artery, mesenteric artery, renal artery and other arteries weakened by sympathetic nerves or close to one or more sympathetic ganglia. This catheter can also be placed in one or more blood vessels or another luminal tissue in the blood vessels identified above by laparoscope, without departing from the scope of the present disclosure. In addition, when used in conjunction with the balloon catheter embodiment, the retraction of the muscle tissue in the blood vessel enables the balloon of standard size to be used in blood vessels of different sizes. As described in more detail below, the balloon is a non-compliant balloon, i.e., its diameter once inflated does not change due to pressure applied from outside the balloon (e.g., due to recoil of the vessel in which the balloon is placed). As a result, recoil ensures that the balloon, and in particular the therapy elements (e.g., electrodes) formed thereon, are in good contact with the vessel wall, and consistent circumferential ablation can be performed in accordance with the present disclosure.

[0022] The therapeutic device is also configured to deliver stimulation to blood vessels or other luminal tissues. This stimulation can take a variety of forms, including electrical muscle stimulation (EMS) and chemical stimulation (e.g., local application of vasoconstrictors). EMS energy can be one or more of direct current (DC), alternating current (AC), pulsed AC or DC, and a combination of the two. In certain aspects described in more detail below, the stimulation energy is biphasic or multiphasic pulsed DC. The amplitude, frequency, pulse width, and duration of the stimulation energy can be selected to ensure the retraction of the muscle tissue of the luminal tissue without damaging the luminal tissue, muscle, or nerves that trigger retraction. In the case of chemical stimulation, the vasoconstrictor can be selected from, for example, epinephrine, norepinephrine, phenylephrine, and others known to those skilled in the art, and the dosage can be selected to achieve acute contraction in a specific time frame or a continuous structure that is relieved when denervation therapy is completed.

[0023] As described above, one of the goals of stimulation is to cause the blood vessels or other luminal tissues surrounding the therapy application portion of the treatment device 50 to retract, such as Figure 5As shown. In the case where the treatment device includes multiple therapy application portions (e.g., multiple RF electrodes), the therapy application portions can be arranged in a spaced relationship with each other. In addition, in the case where separate stimulation application portions are used, the stimulation application portions can also be spaced apart from each other and from the therapy application portion. For example, in the case where the therapy application portion is located between two stimulation application portions, the retraction of the blood vessel or other luminal tissue promotes the contact of the therapy application portion with the wall of the blood vessel or other luminal tissue.

[0024] With partial contraction of tissue surrounding the therapeutic device for therapy application, the therapeutic device is centered within a vessel or other luminal tissue such that delivery of therapy achieves a desired ablation pattern (e.g., circumferential ablation) to ensure complete denervation of sympathetic nerves surrounding the vessel or other luminal tissue of the target tissue.

[0025] For the relative placement of the therapy application portion and the stimulation application portion of the treatment device, a variety of options are considered. As described above, two or more stimulation portions can be placed so that the therapy application portion is located between them. Alternatively, multiple stimulation portions can be used and dispersed between the therapy application portions. In addition, a single stimulation application portion can be used. In another embodiment, one or more of the stimulation application portions can be arranged on a component separated from the treatment device, such as a guide wire, a guide sheath, a second catheter, etc.

[0026] The treatment device is coupled to a therapy source and a stimulation source, but it is contemplated that the therapy source and the stimulation source may be the same and capable of generating both therapy and stimulation. For example, the electrical generator may be configured to generate biphasic or multiphasic DC pulses to supply the stimulation application portion of the treatment device and to supply monopolar RF energy to the therapy application portion. Additionally or alternatively, the modalities used for therapy and stimulation may be similar, as described above, or very different, such as chemical stimulation (local vasoconstrictor application) versus cryoablation therapy. Any combination of the above-described therapy modalities and stimulation modalities is contemplated within the scope of the present disclosure.

[0027] According to various aspects of the present disclosure, the treatment device can be navigated in one configuration (e.g., linear), and once it reaches the desired position, it is unfolded or actuated to achieve a second configuration (e.g., an expanded balloon or shape memory spiral shape, etc.). The second configuration can be achieved before or after the stimulation is applied. Regardless of when it is applied, according to the present disclosure, the retraction of the blood vessel or other luminal tissue acts on the treatment device and may exert pressure on the treatment device, thereby potentially changing the shape of the treatment device. As described above, this retraction of the blood vessel or luminal tissue ensures that the therapy application part is in close contact with the inner wall of the blood vessel or luminal tissue, thereby ensuring the efficacy of the therapy. The application of stimulation can also be performed multiple times before, during, and after the therapy is applied. In addition, the application of stimulation can be used to evaluate the effectiveness of the denervation procedure. After successful denervation, the application of stimulation can result in limited retraction or no retraction of the blood vessel or other luminal tissue because the nerves that stimulate the muscle tissue of the blood vessel or luminal tissue have been cut off and cannot trigger the retraction of the muscle tissue.

[0028] For ease of description, most of the descriptions in the following description focus on the implementation of electrical stimulation and RF denervation. Although those skilled in the art will recognize, the methods and systems described herein may employ any of the therapy modalities and stimulation modalities described herein. Similarly, the following description focuses on navigating to the renal artery and applying stimulation and therapy to the renal artery to denervate the sympathetic nerves in, around, and near the renal artery. However, the present disclosure is not limited thereto, and can be used to denervate nerves accessible via any blood vessel or other luminal tissue (e.g., bile duct).

[0029] Now turning to the attached figure, Figure 1 A therapy system 10 in accordance with the present disclosure is shown. As will be described in further detail below, the therapy system 10 enables navigation of a treatment device 50 to a desired location within a patient's anatomy (e.g., a patient's renal artery), delivery of stimulation to the renal artery, causing retraction of the renal artery, and denervation of sympathetic nerves in and around the renal artery.

[0030] Therapy system 10 includes a workstation 20, a treatment device 50 operably coupled to the workstation 20, and an imaging device 70, which may be operably coupled to the workstation 20. Patient "P" is shown lying on an operating table 12 with treatment device 50 inserted through a portion of the patient's femoral artery, although it is contemplated that treatment device 50 may be inserted into any suitable portion of the patient's vascular network that is in fluid communication with a desired vessel for therapy.

[0031] continue Figure 1 And also refer to Figure 2, the workstation 20 includes a computer 22, a therapy source 24 (e.g., an RF generator, a microwave generator, an ultrasound generator, a cryogenic medium source, a chemical source, etc.) operably coupled to the computer 22, and a stimulation source 24a operably coupled to the computer 22. Although generally described as being separate from the therapy source 24, it is contemplated that the stimulation source 24a may be integrated within the therapy source 24, as described above, and that the therapy source 24 may generate both therapy modalities and stimulation modalities.

[0032] The computer 22 is coupled to a display 26 configured to display one or more user interfaces 28. The computer 22 may be a desktop computer or a tower configuration with the display 26, or may be a laptop or other computing device. The computer 22 includes a processor 30 that executes software stored in a memory 32. The memory 32 may store one or more application programs 34 and / or algorithms 44 to be executed by the processor 30. A network interface 36 enables the workstation 20 to communicate with various 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, communication may be via an ad hoc network that enables communication with a wide area network (WAN) and / or a local area network (LAN). or wireless network. The network interface 36 can be connected to the Internet via one or more gateways, routers, and network address translation (NAT) devices. The network interface 36 can communicate with a cloud storage system 38, in which additional data, image data, and / or video can be stored. The cloud storage system 38 can be remote from the hospital or in a hospital building, such as in a control or hospital information technology room. It is contemplated that the cloud storage system 38 can also be used as a host for more robust analysis of acquired images (e.g., fluoroscopy, CT, MRI, CBCT, etc.), data, etc. (e.g., additional or enhanced data for analysis and / or comparison). The input module 40 receives input from an input device, such as a keyboard, a mouse, a voice command, a therapy source controller (e.g., a foot pedal or handheld remote control device that enables a clinician to start, terminate, and optionally adjust various operating characteristics of the therapy source 24 and / or the stimulation source 24a (including but not limited to power delivery)), etc. The output module 42 connects the processor 30 and the memory 32 to various output devices, such as a display 26. In an embodiment, display screen 26 may be a touch screen display.

[0033] The therapy source 24 generates and outputs one or more of RF energy (monopolar or bipolar), microwave energy, ultrasonic energy, cryogenic medium, or chemical ablative medium via an automatic control algorithm 44 stored on the memory 32 and / or under the control of a clinician. As can be appreciated, the therapy generated and / or output by the therapy source 24 changes the temperature of the tissue (e.g., increases or decreases the temperature) to achieve the desired denervation of the sympathetic nerves. The therapy source 24 can be configured to generate energy and / or therapy of a selected modality and magnitude for delivery to a treatment site via the treatment device 50, as will be described in further detail below. The therapy source 24 can monitor the voltage and current applied to the target tissue via the treatment device 50, and monitor the temperature of the target tissue or tissue proximate to the target tissue and / or a portion of the treatment device 50.

[0034] The stimulation source 24a generates and delivers stimulation via an automatic control algorithm 44 stored on the memory 32 or according to the instructions of a clinician, including one or more of DC, AC, pulsed AC or DC (e.g., biphasic or multiphasic pulsed DC) and combinations of these. Similarly, the stimulation source may store cryogenic or chemical media to apply those stimulation modalities. As will be appreciated, the stimulation generated and / or delivered by the stimulation source 24a over a period of time achieves the retraction of muscle tissue or other luminal tissue of the blood vessel to reduce the diameter. The magnitude or amount of the stimulation generated and / or delivered by the stimulation source 24a ensures that the tissue is not damaged, but only stimulates the nerves to achieve the desired muscle retraction and reduction in the diameter of the blood vessel or luminal tissue. As described above, the stimulation source 24a can deliver stimulation having a different modality than the therapy delivered by the therapy source 24.

[0035] Figure 3 and Figure 4 One embodiment of a treatment device 50 according to the present disclosure is depicted. The treatment device 50 includes an elongated shaft 52 having a handle 54 disposed on a proximal end portion 52a of the elongated shaft 52. The treatment device 50 includes a treatment portion 56, such as Figure 3 The therapy delivery element of the RF electrode 58 is shown located at the treatment portion. The elongated shaft 52 of the treatment device 50 is configured to be advanced within a portion of the patient's vasculature, such as a femoral artery or other suitable portion of the patient's vascular network in fluid communication with the patient's renal arteries. In an embodiment, the treatment portion 56 is configured to be extended from an initial, unexpanded state having a generally linear profile ( Figure 3 ) into a second deployed or expanded configuration, wherein the treatment portion 56 forms a generally helical and / or spiral configuration ( Figure 4), for delivering therapy at a treatment site and providing therapeutically effective electrically and / or thermally induced renal neuromodulation. In this manner, when in the second expanded configuration, the treatment portion 56, and in particular the individual electrodes 58, press against or otherwise contact the wall of the patient's vasculature tissue. Although generally described as transitioning to a helical and / or spiral configuration, it is contemplated that the treatment portion 56 may be deployed in other configurations without departing from the scope of the present disclosure. In addition, the treatment device 50 may be configurable, for example, using one or more pull wires (not shown) to adjust the configuration to facilitate contact between the electrodes 58 and the wall of the renal artery. In this way, the treatment device 50 may be capable of being placed in one, two, three, four, or more different configurations depending on the design requirements of the treatment device 50 or the location where the therapy is to be applied.

[0036] here, Figure 3 and Figure 4 5 is described in conjunction with an RF therapy device using electrodes 58. Those skilled in the art will recognize that electrodes 58 may be replaced with ultrasound transducers, ports and / or extension needles for cryogenic and chemical ablative agents, or microwave ablation antennas as described elsewhere herein without departing from the scope of the present disclosure.

[0037] like Figure 4 As depicted, the elongated shaft 52 can be configured to be received within a guide catheter 62 (e.g., a 6F guide catheter) that is used to navigate the treatment device 50 to a desired location, at which point the guide catheter 62 is retracted to expose the treatment portion 56 of the treatment device 50. As described above, retraction of the guide catheter 62 can enable the treatment portion 56 to transition from a first, undeployed state to a second, deployed or expanded state.

[0038] The elongated shaft 52 of the treatment device 50 may further include an aperture (not shown) configured to slidably receive a guidewire over which the treatment device 50 is advanced, alone or in combination with the guide catheter 62. In this manner, the guidewire is utilized to guide the treatment device to the target tissue using an over the guidewire (OTW) or rapid exchange (RX) technique, at which point the guidewire 64 may be partially or completely removed from the treatment device 50, enabling the treatment device 50 to be moved from the first undeployed state ( Figure 3 ) into a second unfolded or expanded state ( Figure 4 As described elsewhere herein, the treatment portion 56 can be automatically (e.g., via a shape memory alloy, etc.) or manually (e.g., via a pull wire controlled by a clinician) transformed from a first, undeployed state to a second, deployed state.

[0039] Continue to refer Figure 3 and Figure 4, in an embodiment where the treatment device 50 is an RF ablation catheter, the treatment portion 56 includes one or more electrodes 58 disposed on an outer surface thereof, the one or more electrodes being configured to contact a portion of the patient's vascular tissue when the treatment device 50 is placed in the second expanded configuration. Although described below with respect to the RF modality, one skilled in the art will recognize that the electrodes 58 may be replaced with ultrasonic transducers, microwave antennas, ports for delivering cryoablative or chemical media, and other devices known to other ablation and denervation modalities without departing from the scope of the present disclosure. As shown herein, the treatment device 50 includes four electrodes 58. However, the present disclosure is not limited in this regard, and the treatment device 50 may have more or fewer electrodes 58 (or therapy delivery elements of other modalities) without departing from the scope of the present disclosure.

[0040] As shown, electrodes 58 are arranged in a spaced relationship along the length of the treatment device 50 to form a treatment portion 56. As will be appreciated, these electrodes 58 (or any other modality therapy delivery element) will be in communication with the therapy source 24. As shown, the electrodes 58 are electrically connected to the therapy source 24, which generates monopolar RF energy to denervate the sympathetic nerves of the relevant blood vessels. It is contemplated that the therapy delivery elements 58 can deliver therapy independently of each other (e.g., monopolar), simultaneously, selectively, sequentially and / or between any desired combination of electrodes 58 (e.g., bipolar). In addition, in at least one aspect of the present disclosure, the electrodes 58 are used to deliver stimulation to the blood vessels. In the case of electrical energy stimulation, energy (e.g., biphasic or multiphasic DC pulses) is generated by the stimulation source 24a and transmitted to the electrodes 58, thereby causing the muscle response and retraction of the blood vessels described above.

[0041] Additionally or alternatively, the treatment device 50 may include one or more stimulation delivery elements 60 disposed on the treatment device 50. According to one aspect of the present disclosure using bipolar stimulation, stimulation energy from the stimulation source 24a is generated and applied to the tissue of the relevant blood vessel or luminal tissue. The stimulation is applied to the first stimulation delivery element 60a and is transmitted to the stimulation delivery element 60b. In the process, the signal (e.g., a biphasic or multi-phase pulsed DC signal) generated by the stimulation source is transmitted through the tissue of the blood vessel and triggers one or more nerves (e.g., sympathetic nerves) in or near the blood vessel, thereby causing the muscle tissue in the blood vessel to retract, ensuring that the electrode 58 is in contact with the wall of the blood vessel and is in the desired position for applying therapy (e.g., denervation). As shown, the first stimulation delivery element 60a is disposed proximal to the nearest electrode 58, and the second stimulation delivery element 60b is disposed distal to the farthest electrode, so that the four electrodes 58 shown are located between the first stimulation delivery element 60a and the second stimulation delivery element 60b (e.g., sandwiched by the first stimulation delivery element 60a and the second stimulation delivery element 60b).

[0042] Given this configuration, stimulation energy (e.g., biphasic or multiphasic DC pulses) is transmitted through the vessel between the first stimulation delivery element 60a and the second stimulation delivery element 60b, causing the vessel to retract at least along that length, thereby bringing the inner wall of the vessel into desired contact with the electrode 58 before therapy begins. Continuous application (e.g., a train of biphasic or multiphasic pulses) may be employed to ensure continued retraction of the vessel, thereby ensuring continued desired contact with the electrode 58 during therapy application.

[0043] In some cases when the treatment device 50 is in the second or helical configuration, the force applied to the treatment portion 56 due to the contraction of the muscle tissue of the vessel causes the length of the treatment device 50 (e.g., along the length of the tissue) to increase linearly to achieve a third configuration (e.g., a desired configuration for applying therapy), thereby creating greater and more uniform contact between the tissue of the inner wall of the vessel and the electrodes 58. With the treatment device 50 in the third configuration, the tissue and particularly the sympathetic nerves can better receive the delivered therapy to achieve a circumferential therapy pattern around the vessel, thereby ensuring that no matter where the sympathetic nerve is found along the vessel, it has been severed. In addition, the circumferential pattern has a longitudinal offset, which helps ensure that the tissue of the vessel (including the muscle) does not receive too much therapy and cause necrosis of any portion of the vessel.

[0044] As can be appreciated, if monopolar stimulation is applied to the blood vessel via stimulation delivery element 60a or 60b, either stimulation delivery element can be replaced with an electrode return pad (not shown). A return pad can be used in addition to first stimulation delivery element 60a and second stimulation delivery element 60b, or as an alternative to one of first stimulation delivery element 60a or second stimulation delivery element 60b.

[0045] It may be necessary to apply stimulation to the tissue multiple times, depending on the amount of tissue retraction around the treatment device 50 or the efficacy of the therapy being delivered. In this manner, if it is determined that the tissue is not contacting around the treatment device 50 as desired, one or more stimulations may be applied until retraction or an amount of retraction is achieved. Retraction of vascular or luminal tissue over the treatment device 50 may be confirmed using intraoperative imaging such as fluoroscopy, but other imaging modalities may also be used, including ultrasound, computed tomography, cone beam computed tomography, MRI, and others. Figure 1 As shown, an imaging device 70 (e.g., fluoroscopy) is operably coupled to a display 72 and / or workstation 20. The output of the imaging device can be used to observe the navigation and placement of the treatment device 50 at the desired location. To aid in observation, the treatment device 50 or, for example, the electrodes 58 can be formed of or coated with a radiopaque material to improve their resolution in the image.

[0046] The radiopaque dye injected into the patient P facilitates observation of the retraction of the blood vessel or luminal tissue. By imaging the blood vessel before and after the application of the stimulation (e.g., observed under live fluoroscopy), the clinician can observe the effect and decide whether more stimulation is needed or whether therapy can be started. To further assist in the effect of the stimulation, the treatment device 50 may include one or more sensors, such as pressure sensors, fiber Bragg gratings, strain gauges, etc. (not shown) to provide further indications of the retraction of the muscle tissue of the blood vessel or luminal tissue. The retraction measured by the one or more sensors may be compared to one or more predetermined thresholds, and an indication may be provided on the user interface 28 in the display 26 of the computing device 20, indicating to the clinician that sufficient retraction has been observed and therapy may be started, or that insufficient retraction has been observed and further stimulation or placement adjustments may be recommended before therapy is applied.

[0047] The duration of stimulation and therapy can be pre-programmed and stored in the control algorithm 44 stored on the computing device 20, or can be manually applied and adjusted based on the above-mentioned live imaging. In the case where stimulation and therapy are application-driven, these can also be dynamic based on feedback from one or more sensors on the treatment device 50. For example, the magnitude and duration of stimulation can be changed until sufficient retraction of muscle tissue is observed. In one embodiment, stimulation is repeatedly applied during the procedure to ensure retraction of muscle tissue, therapy is applied while stimulation is also applied (or at least in the case of muscle tissue retraction), and the procedure can be terminated when it is observed that the blood vessel or luminal tissue no longer retracts despite continuous stimulation. This failure of retraction indicates that nerves, especially sympathetic nerves, have been denervated and the procedure is successful. As will be understood, the process can be limited by one or more safety measures, such as observing the total energy delivered, the temperature of the blood vessel wall, and others, to ensure that even if successful denervation is not achieved, the patient and the treated tissue will not be unnecessarily harmed. A lookup table or data of predetermined thresholds may be maintained within the memory 32 and accessed during a procedure by the control algorithm 44 or other suitable application stored on the memory, and an alert may be presented on the user interface 28 .

[0048] Although not shown, the treatment device 50 can be operably coupled to an irrigation source (not shown). The irrigation source can cool the vessel wall during therapy application to prevent necrosis. In addition, the irrigation can provide a medium through which the stimulus can pass in the event that the recoil of the vessel has reduced blood flow. The irrigation flow reaches the treatment site from the guide catheter 62 or through one or more lumens formed in the treatment device 50.

[0049] As previously described, the stimulation portions 60a, 60b are formed on the treatment device 50. Alternatively, in one or more embodiments, the electrodes 58 can be used to deliver the stimulation and are themselves connected to the stimulation source 24a. However, the present disclosure is not limited thereto, and in addition to the above, one or more of the stimulation portions can be formed on the guide catheter 62 or on the guide wire 64, and the treatment device 50 is navigated to the desired position on the guide wire. In addition, in some embodiments, the stimulation can be delivered by a separate tool that is navigated internally to the desired position or can apply the stimulation from outside the patient's body to achieve the desired retraction of the blood vessel or luminal tissue.

[0050] Thus far, the treatment device 50 has been described primarily in conjunction with a shape memory configuration, wherein withdrawal of the guide catheter 62 or the guidewire releases the shape memory alloy to achieve the desired helical shape. However, as described elsewhere, the present disclosure is not limited thereto. Figure 6, the treatment device 150 may employ a balloon 152. As described above, during the navigation phase, the balloon 152 has a generally linear shape, and when in the desired position, the balloon 152 may be expanded to achieve the desired shape. The desired shape may be based on the size of the vessel or luminal tissue into which the treatment device 150 will be navigated and to which therapy will be applied. As is known in the art, a balloon may be employed to ensure contact of the RF electrode 154 and the ultrasound transducer 156 with the tissue. In addition, a balloon may be employed to center the microwave antenna 158 in the balloon 152.

[0051] In some aspects of the present disclosure, the balloon 152 may be formed of a non-elastic material such that once inflated or deployed (e.g., with saline or another liquid) to its design pressure, the balloon 152 will not stretch, elongate, or otherwise change its shape when a force is applied to the exterior of the balloon 152. In some embodiments, the balloon 152 is configured to have a standard inflated or deployed diameter. The use of a single diameter enables the use of a standardized product regardless of where the ablation is performed (e.g., renal arteries, hepatic arteries, mesenteric arteries, etc.). The inflation or deployment of the balloon 152, followed by the application of stimulation energy, causes the muscle of the vessel to retract, thereby ensuring that the vessel contacts the balloon 152 and centers the balloon 152 in the vessel. Once in this state, the application of therapy results in the formation of a circumferential ablation around the balloon 152 and on the vessel, as described elsewhere herein.

[0052] Related to the above, the balloon can be multi-chambered or have one or more fluid ports, allowing, for example, different media to flow into the balloon or different chambers of the balloon. In one example, the balloon 152 can be filled with saline surrounding the microwave antenna 158, allowing good coupling of the microwave energy emitted from the antenna to the tissue receiving the therapy. The saline also works to supercool the tissue closest to the antenna (e.g., the wall of a blood vessel) to prevent necrosis of this tissue. The balloon can also be used to limit the extent to which the cryogenic medium can act on the tissue, thereby limiting the diffusion of the cryogenic medium to only that area of ​​the balloon 152. In cryoablation and chemical ablation, the treatment device 150 can include one or more needles 159 that extend from the treatment device 150 and are fluidly connected to the therapy source 24, thereby supplying these therapies directly to the desired tissue. In this case, the balloon 152 provides a centered and stable platform for the needle 159 to leave the treatment device 150 and enter the tissue. As relevant to the present disclosure, balloon 152 may be an occlusive balloon, a non-occlusive balloon, or another configuration of a balloon that allows blood or other media to flow through a vessel or luminal tissue.

[0053] Related to the above, the treatment device 50, 150 may include multiple modalities for therapy, such that, for example, a single treatment device may include an RF electrode 154 and an ultrasound transducer 156, or an RF electrode 154 and a chemical ablation needle 159. In addition, each of these is connected to a therapy source 24 that is configured to supply the indicated therapy type. Those skilled in the art will recognize that the treatment device 150 and therapy source 24 may provide any suitable combination of therapies capable of performing a denervation protocol.

[0054] Similar to Figure 3 and Figure 4 In embodiments of the present invention, the treatment device 150 may include one or more stimulation delivery elements 160 disposed thereon. In embodiments in which bipolar stimulation is applied to tissue, the treatment device 150 may include a pair of stimulation delivery elements 160a and 160b. The first stimulation delivery element 160a may be disposed proximally of the balloon 152, and the second stimulation delivery element 160b may be disposed distally of the balloon 152, such that the balloon 152 and any therapy delivery elements disposed therein or thereon are inserted between the first stimulation delivery element 160a and the second stimulation delivery element 160b. As will be appreciated, in the case where the RF electrode 154 is placed on the balloon 152, the electrode 154 itself may act as a stimulation delivery element and no additional elements are required to provide stimulation. Similarly, the stimulation delivery element may be located on the guidewire 64, the guide catheter 62, or a separate device, as described elsewhere herein.

[0055] As with other embodiments, application of stimulation causes the vessel or luminal tissue to retract to center the treatment device 150. This retraction can cause the balloon 152 to change shape, and in some embodiments, a slight deflation can be achieved. Regardless, the retraction helps center the treatment device 150 in the vessel or luminal tissue and facilitates placement of the RF electrode 154, ultrasound transducer 156 against the tissue at the desired location, facilitates centering of the microwave antenna 158 and cryogenic features in the vessel or positioning of the needle 159 so that they can be effectively deployed for chemotherapy application.

[0056] refer to Figure 7, a method of performing a treatment protocol is shown and is generally identified by reference numeral 200. In step 202, the treatment device 50 is navigated to the target tissue. Once the treatment device 50 is positioned adjacent to the target tissue, the treatment portion may optionally be transformed from a first state to a second deployed state in step 204 so that one or more therapy delivery elements abut or otherwise contact the tissue. In step 206, stimulation is applied to the target tissue via a stimulation delivery element (e.g., 60a, 60b) to cause the vascular or luminal tissue to retract around the treatment device 50, 150. In step 208, it is determined whether the vascular or luminal tissue has retracted around the treatment device 50 and / or whether such retraction is sufficient. If the vascular or luminal tissue has not retracted around the treatment device 50 or further retraction is required, the method returns to step 206 and further stimulation is applied. If the tissue has retracted around the treatment device 50, then in step 210, therapy is applied to the vascular or luminal tissue. In step 212, during the application of therapy to the tissue, it is determined whether the vascular or luminal tissue has retracted around the treatment device 50 or whether further stimulation is required to maintain tissue retraction around the treatment device 50. If it is determined that the amount of retraction is sufficient, then in step 214, application of therapy continues. If the tissue has relaxed and / or tissue retraction is no longer sufficient, then in step 216, further stimulation is applied to the tissue and the method returns to step 212. In step 218, it is determined whether application of therapy to the tissue has produced the desired results. If further therapy is required, the method returns to step 210. If further therapy is not required, the method ends at step 220. Those skilled in the art will recognize that the steps of method 200 may be repeated as many times as desired, depending on the needs of the treatment protocol being performed.

[0057] Another embodiment of the present disclosure combines Figure 8Description. Method 200 is described as a method in which stimulation can be applied intermittently during a procedure. In contrast, method 300 is a method in which stimulation is continuously applied to a target tissue (e.g., a blood vessel or other luminal tissue) during a procedure and cessation of retraction of the target tissue indicates that the therapy is successful (e.g., denervation of sympathetic nerves that achieve retraction). Method 300 begins at step 200, where the treatment device 50 / 150 is navigated to a position close to the target tissue (e.g., a renal artery, a hepatic artery, etc.). At step 304, it is optionally confirmed that the treatment device is placed close to the target tissue. For example, step 304 can be completed using fluoroscopy or other imaging modalities. Those skilled in the art will recognize that imaging of the target position can be performed throughout the procedure and used for placement confirmation. Once the treatment device 50 / 150 is positioned close to the target tissue, at step 306, stimulation is applied to the target tissue to achieve retraction of the muscle fibers, as described above. Using fluoroscopy or another imaging modality or one or more sensors as described above, retraction of the target tissue is confirmed at step 308. Once retraction of the target tissue is confirmed, therapy is started at step 310. Therapy may include applying one or more of monopolar or bipolar RF, microwave, ultrasound, cryogenics, chemical, or other modalities as described elsewhere herein. Once therapy is initiated, retraction of the target tissue is observed, for example using fluorescence imaging, and when the contraction confirmed in step 308 at step 312, the method proceeds to step 314, where therapy is stopped. If release of retraction is not observed at step 312 (via fluorescence imaging or via one or more sensors), the method proceeds to step 316, where a safety check is performed. Safety check 316 can be as simple as checking to ensure that the therapy time limit is not exceeded, the amount of energy delivered is not exceeded, or some other parameter is not exceeded. If the procedure has not timed out (or some other safety parameter has not been exceeded), method 300 returns to step 310, where therapy continues. If a safety parameter has been exceeded at step 316, such as exceeding the duration of the procedure, the procedure ends.

[0058] After stopping therapy at 314, it is determined whether there are additional treatment sites to receive therapy. If not, the procedure ends, however, if there are still one or more treatment sites to receive therapy, the treatment device is moved to one of those sites in step 320, and the process returns to optional step 304, where placement is confirmed. The procedure continues until all tissue sites have received the desired therapy.

[0059] Fig. 9 Another embodiment of the present disclosure is depicted. Fig. 9A method 400 for applying therapy to a desired location according to the present disclosure is depicted. At step 402, a stimulus is applied to a target tissue. After applying the stimulus, at step 404, retraction of the target tissue is confirmed, for example, via fluorescence imaging. At step 406, therapy is applied. The therapy may be, for example, algorithm-based, wherein an algorithm 44 on a computer 22 controls the application of therapy to the target tissue. Alternatively, the application of therapy may be manually controlled by a clinician. At step 408, therapy is terminated manually or via algorithm 44. After applying the therapy, a stimulus is applied to the target tissue at step 410. At step 412, it is assessed whether the target tissue retracts due to the stimulus applied in step 410. Step 412 may employ imaging such as fluorescence imaging or use one or more sensors as described herein. If the target tissue no longer retracts, the procedure may end. The inability of the target tissue to retract may be understood as indicating that denervation of nerves (such as sympathetic nerves of a blood vessel) has been successful. However, if retraction of the target tissue is observed at step 412 (e.g., via a sensor or imaging), the method moves to step 414 where a check is made to ensure that a safety parameter has not been exceeded. The safety parameter may be, for example, an assessment of the total duration of the procedure, the total energy delivered or removed from the tissue, or other parameters that, if exceeded, could undesirably damage tissue proximate to the target tissue. If any of these have been exceeded, the method 400 ends. If the safety parameter has not been exceeded at step 414, the method returns to step 406 for further application of therapy. In this way, therapy may be applied until successful denervation has been achieved.

[0060] Although generally described above, it is contemplated that the memory 32 may include any non-transitory computer-readable storage medium for storing data and / or software including instructions executable by the processor 30 and controlling the operation of the workstation 20 and, in some embodiments, the operation of the treatment device 50, the imaging device 70. In an embodiment, the memory 32 may include one or more storage devices, such as solid-state storage devices, for example flash memory chips. Alternatively, or in addition to the one or more solid-state storage devices, the memory 32 may include one or more mass storage devices connected to the processor 30 via a mass storage controller (not shown) and a communication bus (not shown).

[0061] Although the description of computer-readable media contained herein refers to solid-state storage devices, it should be understood by those skilled in the art that computer-readable storage media can be any available media accessible to processor 30. That is, computer-readable storage media can include non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media can include RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, DVD, Blu-ray or other optical storage devices, cassettes, magnetic tape, magnetic disk storage devices or other magnetic storage devices, or any other medium that can be used to store the desired information and can be accessed by therapy source 24.

[0062] Although several embodiments of the present disclosure have been shown in the accompanying drawings, it is not intended to limit the present disclosure thereto, as it is intended that the present disclosure be as broad as the art will allow and the specification should be read in the same manner. Therefore, the above description should not be interpreted as limiting, but merely as an illustration of the embodiments. Those skilled in the art will be able to envision other modifications within the scope and spirit of the claims appended hereto.

[0063] The following examples are a non-limiting list of clauses in accordance with one or more techniques of the present disclosure.

[0064] Embodiment 1. A method for executing a treatment procedure, the method comprising: navigating a treatment device to a target tissue; applying a first stimulation to the target tissue via a stimulation delivery element to cause the target tissue to retract around the treatment device; and applying a first therapy to the target tissue retracted around the treatment device to denervate the target tissue.

[0065] Example 2. The method of Example 1, further comprising applying a second stimulus to the target tissue via the stimulus delivery element after the applying of therapy to the target tissue.

[0066] Embodiment 3. The method according to embodiment 2 further comprises observing the application of the first stimulus and the second stimulus to evaluate the retraction of the target tissue.

[0067] Embodiment 4. The method according to embodiment 3, wherein the therapy is applied after confirming the retraction of the target tissue after applying the first stimulation.

[0068] Embodiment 5. The method of embodiment 3, further comprising determining successful denervation when no retraction or retraction below a threshold of the target tissue is observed from the second stimulation.

[0069] Example 6. The method according to Example 3, further comprising applying a second therapy when retraction of the target tissue above a threshold is observed from the second stimulation.

[0070] Embodiment 7. The method of Embodiment 1, wherein the first stimulus is applied during the application of the first therapy.

[0071] Example 8. The method according to Example 7, further comprising observing the application of the first stimulation and the first therapy to assess the retraction of the target tissue.

[0072] Example 9. The method according to Example 8, further comprising stopping the application of the first therapy upon observing relaxation of the target tissue that retracted by the application of the first stimulation, wherein relaxation of the target tissue indicates successful denervation of the target tissue.

[0073] Embodiment 10. The method of embodiment 1, wherein the first stimulation modality is selected from the group consisting of bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical, and combinations thereof.

[0074] Embodiment 11. The method of embodiment 1, wherein the first therapy modality is selected from the group consisting of monopolar or bipolar radiofrequency (RF), microwave, ultrasound, chemical, cryogenic, and combinations thereof.

[0075] Embodiment 12. A system for denervation of a target tissue, the system comprising: an elongated catheter; a therapy delivery element operably coupled to the elongated catheter; a stimulation delivery element operably coupled to the elongated catheter; a stimulation source connected to the stimulation delivery element, wherein application of stimulation via the stimulation delivery element causes the target tissue to retract on the elongated catheter so that the elongated catheter is centered in the target tissue; and a therapy source connected to the therapy delivery element, wherein application of the therapy causes denervation of neural tissue in the target tissue.

[0076] Embodiment 13. The system for denervation according to embodiment 12, further comprising two stimulation delivery elements formed on the elongated catheter.

[0077] Example 14. The system for denervation according to Example 12, further comprising a second stimulation delivery element formed on the guide catheter.

[0078] Embodiment 15. The system for denervation according to embodiment 12, wherein the stimulation delivery element is formed on the guide wire.

[0079] Example 16. The system for denervation according to Example 12, wherein the therapy source and the stimulation source are a single electrical generator.

[0080] Embodiment 17. A system for denervation according to embodiment 12, wherein the therapy source modality is selected from the group consisting of: monopolar or bipolar radiofrequency (RF), microwave, ultrasound, chemical, cryogenic, and combinations thereof.

[0081] Example 18. A system for denervation according to Example 12, wherein the stimulation source modality is selected from the group consisting of: bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical, and combinations thereof.

[0082] Embodiment 19. The system for denervation according to embodiment 12, further comprising a shape memory portion configured to change the shape of the elongated catheter into a helical configuration such that the therapy delivery element contacts the target tissue.

[0083] Example 20. A system for denervation according to Example 19, wherein the therapy element is comprised of one or more monopolar RF electrodes formed on the elongated catheter such that the change in shape causes the electrodes to contact the target tissue in a spaced relationship with each other.

[0084] Example 21. The system for denervation according to Example 12, further comprising a balloon, wherein inflation of the balloon fixes the elongated catheter relative to the target tissue.

[0085] Example 22. The system for denervation according to Example 21, wherein the therapy delivery element is a plurality of RF electrodes formed on the balloon.

[0086] Example 23. A system for denervation according to Example 21, wherein the therapy delivery element is a microwave antenna within the balloon.

[0087] Example 24. The system for denervation according to Example 21, wherein the therapy delivery element is a plurality of ultrasound transducers formed on the balloon.

[0088] Embodiment 25. A system for denervation according to Embodiment 21, wherein the therapy delivery element is one or more needles for injecting chemical or cryoablative agents into the target tissue.

[0089] Example 26. A system for denervation according to Example 21, the system also includes a computer, the computer includes a memory, and an application is stored on the memory, which, when executed by a processor: causes the stimulation element to apply stimulation close to the target tissue to cause the muscle fibers of the target tissue to retract; causes the therapy element to apply therapy to the target tissue; and when it is determined that the target tissue has been successfully denervated, stops applying the therapy to stop.

[0090] Further disclosed herein are the subject of the following clauses:

[0091] 1. A system for denervation of a target tissue, the system comprising:

[0092] Long and thin catheter;

[0093] a therapy delivery element operably associated with the elongate catheter;

[0094] a stimulation delivery element operably associated with the elongated catheter;

[0095] a stimulation source in communication with the stimulation delivery element, wherein stimulation applied via the stimulation delivery element causes target tissue to retract over the elongated catheter to center the elongated catheter within the target tissue; and

[0096] A therapy source is in communication with the therapy delivery element, wherein application of the therapy denervates neural tissue of the target tissue.

[0097] 2. A system for denervation according to clause 1, further comprising two stimulation delivery elements formed on the elongated catheter.

[0098] 3. A system for denervation according to clause 1 or 2, further comprising a second stimulation delivery element formed on the guide catheter.

[0099] 4. A system for denervation according to any one of clauses 1 to 3, wherein the stimulation delivery element is formed on a guide wire.

[0100] 5. A system for denervation according to any one of clauses 1 to 4, wherein the therapy source and the stimulation source are a single electrical generator.

[0101] 6. A system for denervation according to any one of clauses 1 to 5, wherein the therapy source modality is selected from the group consisting of: monopolar or bipolar radiofrequency (RF), microwave, ultrasound, chemical, cryogenic and combinations thereof.

[0102] 7. A system for denervation according to any one of clauses 1 to 6, wherein the stimulation source modality is selected from the group consisting of: bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical and combinations thereof.

[0103] 8. A system for denervation according to any one of clauses 1 to 7, further comprising a shape memory portion configured to change the shape of the elongated catheter into a helical configuration such that the therapy delivery element contacts the target tissue.

[0104] 9. A system for denervation according to claim 8, wherein the therapy element consists of one or more monopolar RF electrodes formed on the slender catheter, so that the change in shape causes the electrodes to contact the target tissue in a spaced relationship with each other.

[0105] 10. A system for denervation according to any one of clauses 1 to 9, further comprising a balloon, wherein inflation of the balloon secures the elongate catheter relative to the target tissue.

[0106] 11. A system for denervation according to clause 10, wherein the therapy delivery element is a plurality of RF electrodes formed on the balloon.

[0107] 12. A system for denervation according to clause 10, wherein the therapy delivery element is a microwave antenna within the balloon.

[0108] 13. A system for denervation according to clause 10 or 12, wherein the therapy delivery element is a plurality of ultrasound transducers formed on the balloon.

[0109] 14. A system for denervation according to clause 10 or 12, wherein the therapy delivery element is one or more needles for injecting chemical or cryoablative agents into the target tissue.

[0110] 15. A system for denervation according to any one of clauses 10 to 14, further comprising a computer, the computer comprising a memory having stored thereon an application program which, when executed by a processor:

[0111] Bringing the stimulation element close to the target tissue and applying stimulation to cause muscle fibers of the target tissue to retract;

[0112] causing the therapy element to apply therapy to the target tissue; and

[0113] When it is determined that the target tissue has been successfully denervated, application of the therapy is discontinued.

[0114] 16. A method of performing a treatment protocol, the method comprising:

[0115] navigating the therapeutic device to the target tissue;

[0116] applying a first stimulus to the target tissue via a stimulus delivery element to cause the target tissue to retract around the therapeutic device; and

[0117] A first therapy is applied to the target tissue retracted around the treatment device to denervate the target tissue.

[0118] 17. The method of clause 16, further comprising applying a second stimulus to the target tissue via the stimulus delivery element after the applying of therapy to the target tissue.

[0119] 18. The method according to clause 17, further comprising observing the application of the first stimulus and the second stimulus to assess the retraction of the target tissue.

[0120] 19. The method of clause 18, wherein the therapy is applied after confirming retraction of the target tissue after applying the first stimulus.

[0121] 20. The method of clause 18, further comprising determining successful denervation when no retraction or retraction below a threshold of the target tissue is observed from the second stimulation.

[0122] 21. The method of clause 18, further comprising applying a second therapy when retraction of the target tissue exceeding a threshold is observed from the second stimulation.

[0123] 22. The method of clause 16, wherein the first stimulation is applied during the application of the first therapy.

[0124] 23. The method according to clause 22, further comprising observing the application of the first stimulation and the first therapy to assess the retraction of the target tissue.

[0125] 24. The method according to clause 23, further comprising ceasing application of the first therapy upon observing relaxation of the target tissue retracted by the application of the first stimulus, wherein

[0126] Relaxation of the target tissue indicates successful denervation of the target tissue.

[0127] 25. The method of clause 16, wherein the first stimulation modality is selected from the group consisting of bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical, and combinations thereof.

[0128] 26. The method of clause 16, wherein the first therapy modality is selected from the group consisting of monopolar or bipolar radiofrequency (RF), microwave, ultrasound, chemical, cryogenic, and combinations thereof.

Claims

1. A system for denervation of a target tissue, the system comprising: Long and thin catheter; a therapy delivery element operably associated with the elongate catheter; a stimulation delivery element operably associated with the elongated catheter; a stimulation source in communication with the stimulation delivery element, wherein stimulation applied via the stimulation delivery element causes target tissue to retract over the elongated catheter to center the elongated catheter within the target tissue; and A therapy source is in communication with the therapy delivery element, wherein application of the therapy denervates neural tissue of the target tissue.

2. The system for denervation according to claim 1, further comprising two stimulation delivery elements formed on the elongated catheter. 3 . The system for denervation according to claim 1 , further comprising a second stimulation delivery element formed on the guide catheter.

4. The system for denervation according to any one of claims 1 to 3, wherein the stimulation delivery element is formed on a guide wire.

5. A system for denervation according to any one of claims 1 to 4, wherein the therapy source and the stimulation source are a single electrical generator.

6. The system for denervation according to any one of claims 1 to 5, wherein the therapy source modality is selected from the group consisting of: monopolar or bipolar radiofrequency (RF), microwave, ultrasound, chemical, cryogenic, and combinations thereof.

7. A system for denervation according to any one of claims 1 to 6, wherein the stimulation source modality is selected from the group consisting of: bipolar or monopolar alternating current (AC), direct current (DC), pulsed AC or DC pulses, biphasic pulses, multiphasic pulses, chemical and combinations thereof.

8. A system for denervation according to any one of claims 1 to 7, further comprising a shape memory portion configured to change the shape of the elongated catheter into a helical configuration such that the therapy delivery element contacts the target tissue.

9. A system for denervation according to claim 8, wherein the therapy element is composed of one or more monopolar RF electrodes formed on the slender catheter, so that the change in shape causes the electrodes to contact the target tissue in a spaced relationship with each other.

10. The system for denervation according to any one of claims 1 to 9, further comprising a balloon, wherein inflation of the balloon secures the elongate catheter relative to the target tissue.

11. The system for denervation according to claim 10, wherein the therapy delivery element is a plurality of RF electrodes formed on the balloon.

12. The system for denervation of claim 10, wherein the therapy delivery element is a microwave antenna within the balloon.

13. The system for denervation according to claim 10 or 12, wherein the therapy delivery element is a plurality of ultrasound transducers formed on the balloon.

14. A system for denervation according to claim 10 or 12, wherein the therapy delivery element is one or more needles for injecting a chemical or cryoablative agent into the target tissue.

15. The system for denervation according to any one of claims 10 to 14, further comprising a computer, the computer comprising a memory, an application program stored on the memory, the application program when executed by a processor: Bringing the stimulation element close to the target tissue and applying stimulation to cause muscle fibers of the target tissue to retract; causing the therapy element to apply therapy to the target tissue; as well as When it is determined that the target tissue has been successfully denervated, application of the therapy is stopped.

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