Catheter comprising rotating member

Abstract

In some examples, a catheter includes an elongate body defining a longitudinal axis, the elongate body including an expandable portion, a treatment delivery element disposed on the expandable portion, where the expandable portion is configured to transition to an expanded configuration, and place the treatment delivery element to conform to a vessel wall at a first location, where the treatment delivery element is disposed on the expandable portion. And a rotating member proximal to and separate from the expandable portion. The rotating member is configured to expand to rotate the expandable portion about the longitudinal axis and place the therapy delivery element in conformity with the vessel wall at a second location.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 381,428, filed Oct. 28, 2022, the entire content of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present technology relates to neuromodulation therapy. BACKGROUND ART

[0003] Catheters have been proposed for various medical procedures. For example, a catheter can be configured to deliver a neuromodulation therapy to a target tissue site to alter the activity of nerves at or near the target tissue site. The nerves can be, for example, sympathetic nerves. The sympathetic nervous system (SNS) is the primary involuntary body control system typically associated with the stress response. Chronic overactivation of the SNS is an adverse adaptation that can drive the progression of many disease states. For example, overactivation of the renal SNS has been identified in experiments and humans as a possible cause of the complex pathophysiology of arrhythmias, hypertension, volume overload states (such as heart failure), and progressive kidney disease. SUMMARY OF THE INVENTION

[0004] The present disclosure describes a catheter that includes one or more rotating members configured to position a treatment delivery element of the catheter at different rotational orientations, such as at different positions around the perimeter of a blood vessel. Each rotating member is configured to expand to impart a corresponding expanded configuration to the catheter body and reposition the treatment delivery element. Each rotating member is configured to cause a expandable portion of the catheter body to rotate about a longitudinal axis when the rotating member expands. Additionally, in some examples, one or more rotating members are further configured to shorten the axial length of a distal portion of the catheter body along the longitudinal axis when the rotating member expands. Thus, expanding one or more rotating members of the catheter can enable the distal portion of the catheter to position the treatment delivery element at different longitudinal and / or radial positions around the inner perimeter of a blood vessel.

[0005] The present disclosure also describes devices, systems, and methods for neuromodulation such as renal neuromodulation.

[0006] A catheter including one or more rotating members can provide improved control of the rotation of the distal portion of the catheter within a blood vessel and improved placement of one or more treatment delivery elements at different longitudinal and / or radial positions within the blood vessel by using the torque imparted by the transformation of the one or more rotating members. The devices, systems, and methods described in the present disclosure can also reduce unintended effects on non-target tissue of a patient by improving the accuracy of placement of the treatment delivery element and reducing the likelihood of delivering treatment to non-target tissue.

[0007] In some examples, the present disclosure describes a catheter system that includes: a catheter including an elongate body defining a longitudinal axis, the elongate body including: an expandable portion; a therapeutic delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition to an expanded configuration and position the therapeutic delivery element in engagement with a vessel wall at a first location; and a rotatable member proximal to and separate from the expandable portion, the rotatable member being configured to expand to rotate the expandable portion about the longitudinal axis and position the therapeutic delivery element in engagement with the vessel wall at a second location.

[0008] In some examples, the present disclosure describes a catheter that includes: an elongate body defining a longitudinal axis, the elongate body including: an expandable portion; a therapeutic delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition from a relatively low-profile configuration to a deployed configuration and position the therapeutic delivery element in engagement with a vessel wall at a first location; and a plurality of rotatable members proximal to and separate from the expandable portion, each of the plurality of rotatable members being configured to expand to rotate the expandable portion about the longitudinal axis and position the therapeutic delivery element in engagement with the vessel wall at a corresponding one of a plurality of locations.

[0009] In some examples, the present disclosure describes a method that includes: advancing a catheter through a vasculature to a target tissue site within a patient's blood vessel, the catheter including an elongate body defining a longitudinal axis, the elongate body including: an expandable portion; a therapeutic delivery element disposed on the expandable portion; and a rotatable member proximal to and separate from the expandable portion; expanding the expandable portion to position the therapeutic delivery element in engagement with the vessel wall of the blood vessel at a first location; delivering a therapy through the vessel wall at the first location via the therapeutic delivery element to the patient's tissue; expanding the rotatable member to rotate the expandable portion within the blood vessel and position the therapeutic delivery element in engagement with the vessel wall at a second location; and delivering the therapy through the vessel wall at the second location via the therapeutic delivery element to the patient's tissue.

[0010] The present disclosure further discloses a catheter that includes an elongate body defining a longitudinal axis, the elongate body including an expandable portion, a therapeutic delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition to an expanded configuration and position the therapeutic delivery element in engagement with a vessel wall at a first location, and a rotatable member proximal to and separate from the expandable portion, wherein the rotatable member is configured to expand to rotate the expandable portion about the longitudinal axis and position the therapeutic delivery element in engagement with a vessel wall at a second location.

[0011] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objects, and advantages will be apparent from the specification, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Reference is made to the accompanying drawings, in which like reference numerals always refer to like elements.

[0013] Figure 1 is a partial schematic view of an example neuromodulation system;

[0014] Figure 2A is a conceptual diagram of an example distal portion of an elongate body of Figure 1 positioned within a blood vessel in a constricted configuration.

[0015] Figure 2B is a conceptual diagram of an example partial cross-sectional view of an example distal portion of Figure 2A taken along line A-A in Figure 2A and along a plane parallel to the longitudinal axis of the catheter body.

[0016] Figure 3A is a conceptual diagram of an example distal portion of an elongate body of Figure 1 positioned within a blood vessel in a first rotational configuration.

[0017] Figure 3B is a conceptual diagram of an example partial cross-sectional view of an example distal portion of Figure 3A taken along line B-B in Figure 3A and along a plane parallel to the longitudinal axis of the catheter body.

[0018] Figure 4A is a conceptual diagram of an example distal portion of an elongate body of Figure 1 positioned within a blood vessel in a second rotational configuration.

[0019] Figure 4B is a conceptual diagram of an example partial cross-sectional view of an example distal portion of Figure 4A taken along line D-D in Figure 4A and along a plane parallel to the longitudinal axis of the catheter body.

[0020] Figure 5A is a conceptual diagram of an example cross-sectional view of an example distal portion of Figure 3A taken along line C-C in Figure 3A and along a plane perpendicular to the longitudinal axis of the catheter body.

[0021] Figure 5B is a conceptual diagram of an example taken along Figure 4Ain line E-E and taken in a plane perpendicular to the longitudinal axis of the catheter body Figure 4A Conceptual diagram of a cross-sectional view of an exemplary distal portion

[0022] Figure 6 is a flowchart illustrating an exemplary method of repositioning the distal portion of a catheter within a blood vessel

[0023] Figure 7 is a flowchart illustrating an exemplary method of manufacturing an exemplary rotational member of a catheter

[0024] Figure 8 Illustrates exemplary techniques for accessing the renal artery and modulating renal nerves using a system according to some examples of the present disclosure Figure 1 of the system

[0025] Figure 9 is a conceptual diagram illustrating how the brain communicates with the body via the sympathetic nervous system (SNS), an example of the SNS

[0026] Figure 10 is an enlarged anatomical view of the nerves that innervate the left kidney to form the renal plexus around the left renal artery

[0027] Figure 11 is an anatomical view of the human body depicting efferent and afferent neural communication between the brain and the kidney

[0028] Figure 12 is a conceptual view of the human body depicting efferent and afferent neural communication between the brain and the kidney

[0029] Figure 13 is an anatomical view of the arterial vasculature of a human

[0030] Figure 14 is an anatomical view of the venous vasculature of a human Detailed Description

[0031] The present disclosure describes catheters, as well as systems including such catheters and methods of using such catheters, which can be used in any suitable medical procedure, including neuromodulation, such as renal neuromodulation. Although neuromodulation and renal denervation are mainly described herein, the devices, systems, and techniques described herein can be applied to other types of treatment, including other types of neuromodulation, such as neuromodulation performed on nerves other than the renal nerves, at locations other than within the renal vasculature, or on both. For example, the techniques and devices described herein can be used to perform neuromodulation of nerves adjacent to at least one of the following: (1) the renal artery and / or its branches; (2) the celiac trunk and / or its branches (including the common hepatic artery and / or its branches, the left gastric artery and / or its branches, and the splenic artery and / or its branches); (3) the superior mesenteric artery and / or its branches; (4) the inferior mesenteric artery and / or its branches; or a combination of any two or more of these arteries and / or branches. Generally speaking, the devices, systems, and techniques described herein can be used to perform neuromodulation from any suitable anatomical cavity having nerves adjacent to the anatomical cavity. In addition, the systems, devices, and methods described herein can be used for neuromodulation within body cavities other than blood vessels, for extravascular neuromodulation, and / or for treatments other than neuromodulation.

[0032] As used herein, the terms "distal" and "proximal" define a position or orientation relative to a treating clinician or the clinician's control device (e.g., a handle assembly). "Distal" or "distally" can refer to a position away from the clinician or the clinician's control device or in a direction away from the clinician or the clinician's control device. "Proximal" and "proximally" can refer to a position near the clinician or the clinician's control device or in a direction toward the clinician or the clinician's control device.

[0033] Neuromodulation, such as renal denervation, can be accomplished using one or more of a variety of treatment modalities, including delivery of radiofrequency (RF) energy, microwave energy, ultrasonic energy, thermal energy (e.g., direct thermal energy), optical energy, cryogenic cooling, chemical agents, etc. To perform intravascular neuromodulation, a neuromodulation catheter can be delivered to a patient's blood vessel, such as the renal artery. In some examples, a portion of the catheter body of the neuromodulation catheter (e.g., the distal portion) includes one or more treatment delivery elements (e.g., electrodes, ultrasonic transducers, needles, fluid injection ports, etc.). Although the distal portion of the catheter body is mainly mentioned herein, in other examples, other portions of the catheter body can include one or more treatment delivery elements.

[0034] The distal portion of the catheter body can be configured to deploy from a relatively low-profile delivery (or collapsed) configuration into an expanded configuration (e.g., a helical, spiral, basket, loop, or stent-like shape, the inflated state of a balloon, etc.). In the expanded configuration, the distal portion can be configured to position one or more treatment delivery elements in contact with the vessel wall to facilitate delivery of a treatment to the patient's tissue, e.g., tissue surrounding the vessel wall, perivascular tissue outside the vessel, etc. The expanded configuration may also be referred to herein as an inflated configuration because at least some portions of the catheter can radially expand away from the central longitudinal axis of the more proximal portion of the catheter, e.g., to bring one or more treatment delivery elements into contact with the vessel wall or other tissue of interest.

[0035] Example catheters configured for neuromodulation can include one or more treatment delivery elements (e.g., electrodes, ultrasound transducers, needles, fluid delivery ports, etc.) disposed on a portion of the example catheter. When a clinician places the distal portion at a target tissue site within the patient, the clinician can deliver a treatment to the patient's tissue via the treatment delivery elements, e.g., for a denervation procedure, etc. The clinician can deliver the treatment at different locations around the circumference of the vessel to increase the efficacy of the treatment. Although the distal portion is mainly referred to herein, the treatment delivery elements can be on any suitable portion of the catheter, and the rotational members described herein can be configured to rotate the treatment delivery elements on any suitable portion of the catheter.

[0036] One or more treatment delivery elements are configured to deliver a treatment to the patient's tissue, e.g., through the vessel wall of the vessel (e.g., to adventitial tissue or perivascular tissue outside the vessel) at selected locations around the inner perimeter of the vessel. In some examples, using a neuromodulation catheter, a clinician can deliver a neuromodulation treatment (e.g., electrical or thermal energy or a chemical) to tissue adjacent to the vessel via treatment delivery elements positioned at multiple locations around the inner perimeter of the vessel. The clinician can deliver the neuromodulation treatment to the target tissue adjacent to the vessel by delivering the treatment at multiple locations along the inner perimeter of the vessel. The multiple locations can be separated by a predetermined angle (e.g., separated by 90 degrees, separated by 180 degrees). The clinician can deliver the treatment to the multiple locations to, e.g., increase the efficacy of the treatment, reduce the likelihood of occurrence of an unintended effect, etc. When a treatment (e.g., energy or a chemical) is applied to the perimeter of the vessel, the target of the treatment or the treatment effect can occur outside the vessel.

[0037] In some examples, the catheter may not be configured to deliver therapy from a single location and / or orientation within a blood vessel to different locations at the vessel wall. For example, when inflated, the distal portion may place the therapy delivery element of the catheter at a first location among a plurality of locations, but not at a second location among the plurality of locations. A clinician may need to reposition (e.g., advance, retract, and / or rotate) the neuromodulation catheter to deliver therapy to all desired locations. In such examples, the clinician may rotate the catheter within the blood vessel to place the therapy delivery element at different locations around the perimeter (e.g., circumference) of the blood vessel. The material properties and placement of the catheter through a relatively tortuous vasculature may make it difficult for the clinician to transfer rotational force from the proximal portion of the catheter to the distal portion of the catheter or to control the rotation of the distal portion within the blood vessel.

[0038] For some neuromodulation catheters, a clinician may rotate the handle and / or the proximal portion of the catheter body to rotate the distal portion of the catheter body within the blood vessel. The clinician may apply torque to the handle and / or the proximal portion of the catheter body by rotating the handle and / or the proximal portion about the longitudinal axis of the handle and / or the proximal portion of the catheter body. The catheter body may propagate the applied torque along the length of the catheter body to the distal portion of the catheter body to rotate the distal portion and the therapy delivery element within the blood vessel (e.g., rotate about the longitudinal axis of the distal portion of the catheter body). The handle may be a different material than the catheter body, and torque transfer across different materials with different material properties may result in insufficient rotation of the distal portion of the catheter body and / or reduced ability to precisely control the rotation of the distal portion of the catheter body. Additionally, the catheter body is relatively flexible to allow the catheter body to be guided through the patient's vasculature. The flexibility of the catheter body may resist torque transfer along the catheter body and result in insufficient rotation of the distal portion of the catheter body and / or reduced ability to precisely control the rotation of the distal portion of the catheter body. In such examples, the clinician may need to over-rotate the handle and / or the proximal portion of the catheter body to rotate the distal portion of the catheter body within the blood vessel by a desired amount. For example, the clinician may need to rotate the handle and / or the proximal portion of the catheter body more than 180 degrees to rotate the distal portion of the catheter body 180 degrees. In some examples, rotation of the handle and / or the proximal portion of the catheter body by the clinician may cause pressure release within the catheter and result in over-rotation or "chatter" of the distal portion of the catheter body, such as a delayed response of the catheter to the rotational movement of the clinician, which may be caused by spring torsion.

[0039] Insufficient or excessive rotation of the distal portion of the catheter body and / or a decrease in the ability to precisely control the rotation of the distal portion of the catheter body may result in one or more difficulties in a neuromodulation procedure. For example, due to the increased difficulty in precisely manipulating the distal portion of the catheter body, a clinician may require a relatively long period of time to position the distal portion of the catheter body at a desired location. Although neuromodulation may still be effective, the efficacy of the neuromodulation treatment may be reduced if the treatment is not delivered to the intended location (e.g., a location in a blood vessel near a target nerve for ablation) and / or the treatment is delivered to an unintended location (e.g., a non-target nerve or other non-target tissue). Delivery of the neuromodulation treatment to non-target tissue may result in unintended consequences.

[0040] In the examples described herein, the catheter includes a catheter body, a treatment delivery element disposed on an expandable portion of the catheter body, and a rotation member configured to rotate the expandable portion of the catheter body. Rotation of the expandable portion may cause the treatment delivery element to rotate from a first rotational position to a different second rotational position. The rotation member may be separate from the expandable portion. For example, the rotation member may be proximal to the expandable portion and / or the distal portion of the catheter body.

[0041] The catheter body may include one or more rotation members, each rotation member being configured to rotate the treatment delivery element to a different rotational position. Expansion and / or contraction of different rotation members may cause the expandable portion of the catheter body to rotate between different rotational orientations and cause the treatment delivery element to be positioned at different rotational positions within a blood vessel. A clinician may expand and / or contract the rotation members by retracting or advancing a guide member (e.g., a guide wire, an inner catheter, an outer sheath, etc.) along the catheter body and / or by advancing the catheter body relative to the guide member. When expanded, each rotation member may define a helical, annular, lasso-shaped, circular, spiral, offset arc-shaped, wavy, or another curved or non-curved shape.

[0042] The rotation member may be configured to rotate the expandable portion of the catheter body and, in some cases, the distal portion by applying a torque to the distal portion of the catheter body in response to expansion and / or contraction of one or more rotation members to position the treatment delivery element at different locations within a blood vessel. A clinician may expand each rotation member by retracting (or otherwise causing relative movement between the guide member and the catheter body) the guide member along the catheter body to a position proximal to the respective rotation member. In some examples, when the rotation member expands from a non-expanded (e.g., compressed) configuration to the respective expanded configuration, the rotation member may shorten the axial length of the distal portion of the catheter body along the longitudinal axis. This shortening is a result of the radially outward expansion of the distal portion of the catheter body caused by the rotation member.

[0043] While some example nerve modulation catheters described herein may include a single rotatable member, other example nerve modulation catheters described herein may include two or more rotatable members. Each of the different rotatable members may be disposed along the length of the catheter and along the longitudinal axis of the catheter. One or more of the different rotatable members (e.g., a first rotatable member) may be relatively distal to another rotatable member (e.g., a second rotatable member).

[0044] The example devices, methods, and systems described herein provide several advantages over other nerve modulation catheters. Inflating the member to reposition the treatment delivery element within the vessel may allow for precise control of the placement of the treatment delivery element at multiple locations, e.g., by removing the resistance to rotation from the material properties or tortuosity of the catheter body. Precise control of the placement of the treatment delivery element may result in increased efficacy of the nerve modulation treatment and a reduced likelihood of occurrence of unintended effects as a result of the nerve modulation treatment.

[0045] Figure 1 is a partial schematic view of an example nerve modulation catheter system 100 (“system 100”). System 100 includes a nerve modulation catheter 102 that includes a handle 104, a control device ( Figure 1 not shown in the figure) and an elongate body 108 (also referred to as “catheter body 108” or “elongate member 108”) attached to the handle 104. The elongate body 108 includes a distal portion 108A and a proximal portion 108B. The distal portion 108A includes an inflatable portion 110 and a rotatable member 112 disposed proximal to the inflatable portion 110. In some examples, the inflatable portion 110 is separated from the rotatable member 112 by a relatively straight portion of the distal portion 108A. When one or more of the inflatable portion 110 or the rotatable member 112 is inflated to a respective inflated configuration, the relatively straight portion of the distal portion 108A may remain in a relatively straight or deflated configuration. In other examples, the inflatable portion 110 and the rotatable member 112 are directly adjacent to each other. The inflatable portion 110 is configured to rotate about the longitudinal axis 106 in response to inflation of the rotatable member 112.

[0046] In Figure 1In the illustrated example, catheter 102 includes one or more treatment delivery elements 114 disposed along the inflatable portion 110. Each of the treatment delivery elements 114 is configured to deliver a treatment to a patient's tissue, e.g., to perform neuromodulation on a target nerve of the patient. The treatment delivery elements 114 can include, but are not limited to, one or more electrodes configured to deliver a therapeutic agent, one or more ultrasound transducers, one or more needles, one or more heating or cryogenic treatment delivery devices (e.g., balloons), or one or more injection ports. The treatment delivery elements 114 can be connected to a treatment source (e.g., an electrical signal generator, a therapeutic agent source, a cryogenic treatment source, etc.) via electrical conductors and / or lumens defined by the elongate body 108 and / or the handle 104. Although Figure 1 catheter 102 is illustrated as having two treatment delivery elements 114, other example catheters can include a single treatment delivery element 114 or three or more treatment delivery elements 114, such as four electrodes.

[0047] The elongate body 108 can have any suitable outer diameter, and the outer diameter can be constant along the length of the elongate body 108 or can vary along the length of the elongate body 108. In some examples, the elongate body 108 can be 2 French, 3 French, 4 French, 5 French, 6 French, or 7 French, or other suitable sizes.

[0048] The distal portion 108A of the elongate body 108 is configured to be advanced within an anatomical cavity of a human patient to position the treatment delivery element 114 within the anatomical cavity or otherwise proximate to a target tissue site of the anatomical cavity. For example, the elongate body 108 can be configured to position the distal portion 108A within a blood vessel, ureter, duct, airway, or other naturally occurring lumen within the human body. The examples described herein focus on anatomical cavities such as blood vessels, such as renal blood vessels, but it should be understood that similar techniques can be used for other anatomical cavities. In certain examples, intravascular delivery of the distal portion 108A includes percutaneously inserting a guidewire ( Figure 1 not shown) into a blood vessel of the patient and moving the elongate body 108 and / or the inflatable portion 110 along the guidewire until the inflatable portion 110 reaches the target tissue site (e.g., the renal artery). For example, the distal portion 108A of the elongate body 108 can define a channel for engaging the guidewire to deliver the inflatable portion 110 using over-the-wire (OTW) or rapid exchange (RX) techniques. In other examples, the neuromodulation catheter 102 can be a steerable or non-steerable device configured for use without a guidewire. In other examples, the neuromodulation catheter 102 can be configured for delivery via a guiding member (e.g., a guiding catheter, an outer sheath ( Figure 1 not shown) or other guiding device).

[0049] In Figure 1In the illustrated example, the catheter 102 is configured to assume a relatively low-profile delivery configuration (also referred to as a collapsed configuration or a non-expanded configuration) and a radially expanded configuration, in which the distal portion 108A defines a relatively small radial extent (relatively low profile, such as a relatively linear configuration) in the relatively low-profile delivery configuration, and in which the expandable portion 110 of the distal portion 108A defines a relatively large radial extent in the radially expanded configuration. In the delivery configuration, the distal portion 108A can be delivered through a patient's vasculature to a target tissue site. The expandable portion 110 is configured to transition between a relatively low-profile (e.g., collapsed) delivery configuration and a deployed configuration, which is also referred to herein as a radially expanded configuration or an expanded configuration. The expandable portion 110 can be configured to self-expand within a patient's blood vessel, for example, via a shape memory element (e.g., a shape memory tube) of the elongate body 108. The expandable portion 110 can be constrained in the delivery configuration by a guide member. A clinician can retract the guide member proximally relative to the expandable portion 110 to release the constraint on the expandable portion 110 and cause the expandable portion 110 to transition from the delivery configuration to the expanded configuration.

[0050] In some examples, in the radially expanded configuration, the expandable portion 110 defines a helical, spiral, annular, basket, or stent-like configuration. In the radially expanded configuration, the expandable portion 110 is configured to position one or more of the plurality of treatment delivery elements 114 near the vessel wall, e.g., in abutment with the vessel wall.

[0051] In some examples, as the guide member is retracted proximally from the distal portion 108A, the expandable portion 110 can be inflated or can self-expand. A clinician can retract the guide member along the distal portion 108A to a position proximal to the expandable portion 110 and distal to the rotatable member 112 to inflate the expandable portion 110 and maintain the rotatable member 112 in the collapsed configuration. In the expanded configuration, the expandable portion 110 can place the treatment delivery element 114 at a first set of positions relative to the vessel wall (e.g., corresponding to a first rotational position).

[0052] Once at the target tissue site, the expandable portion 110 can be inflated to place the treatment delivery element 114 in abutment with the vessel wall at the target tissue site. The system 100 can then deliver, provide, or facilitate a neuromodulation treatment at the target tissue site, e.g., through the vessel wall at the target tissue site to the target tissue adjacent the vessel. The neuromodulation treatment can include, but is not limited to, radiofrequency (RF) energy, microwave energy, ultrasonic energy, therapeutic agents (e.g., chemical ablative agents), cryogenic energy, etc.

[0053] The rotating member 112 is positioned proximal to the expandable portion 110. As discussed in further detail below, the rotating member 112 can be an integrally formed part of the catheter 102, such as embedded in the wall of the elongate body 108, or can be separate from the catheter 102 and positioned within the catheter. In Figure 1 the example shown, the rotating member 112 is positioned along the distal portion 108A. However, in other examples, the rotating member 112 can be disposed on other parts of the catheter 102.

[0054] When the expandable portion 110 is in the expanded configuration, the clinician can further retract the guide member to a position proximal to the rotating member 112 to cause the corresponding rotating member 112 to expand to the expanded configuration. The expansion of the rotating member 112 applies a torque to the corresponding rotating member 112 against the expandable portion 110 and causes the expandable portion 110 to rotate from a first rotational orientation to a second rotational orientation. The rotation of the expandable portion 110 to the second rotational orientation can cause the treatment delivery element 114 to rotate to a different position along the inner perimeter of the vessel wall.

[0055] In some examples, as Figure 1 illustrated, the distal portion 108A includes one rotating member 112. In other examples, the distal portion 108A includes two or more rotating members 112 longitudinally spaced from each other, and the clinician can expand each of the two or more rotating members 112 to cause the expandable portion 110 to rotate within the vessel to two or more corresponding rotational configurations.

[0056] The expansion of each rotating member 112 can cause the expandable portion 110 to rotate within the vessel and about the longitudinal axis 106 to position the treatment delivery element 114 at different positions relative to the vessel wall corresponding to the respective rotational orientations (e.g., different circumferential positions). When expanded, each rotating member 112 can impart a corresponding expanded configuration to the distal portion 108A. The expansion of each rotating member 112 can apply a torque to the distal portion 108A and / or the portion of the expandable portion 110 distal to the respective rotating member 112 relative to the longitudinal axis 106 and cause the distal portion 108A and / or the expandable portion 110 to rotate within the vessel about the longitudinal axis 106.

[0057] Applying torque from the rotating member 112 to the expandable portion 110 can cause the portion of the distal portion 108A distal to the rotating member 112 and / or the expandable portion 110 to rotate about the longitudinal axis 106, for example, in the same direction as the torque. The rotation of the distal portion 108A and / or the expandable portion 110 can cause the treatment delivery element 114 disposed on the distal portion 108A and / or the expandable portion 110 to rotate about the longitudinal axis 106, for example, in the same direction as the torque. In some examples, the expansion of each of the one or more rotating members 112 can also shorten the axial length of the distal portion 108A along the longitudinal axis 106.

[0058] The rotating member 112 may include a shape memory material (e.g., Nitinol) that is configured to self-expand from a contracted configuration to an expanded configuration when unconstrained. The elongated body 108 may, for example, include an elongated tube (e.g., a spiral hollow strand) formed of a shape memory material and configured to expand radially away from the longitudinal axis 106 and expand the expandable portion 110 and / or one or more rotating members 112 to a corresponding expanded configuration when unconstrained by the guide member.

[0059] In some examples, the rotating member 112 may be constrained by a guide member (e.g., a guide wire disposed within a rotating member lumen defined by the rotating member 112, a sheath disposed on the distal portion 108A, a guide wire disposed in a catheter lumen, etc.). The guide member may be advanced distally along the longitudinal axis 106 and into or past the distal portion 108A to constrain the expandable portion 110 and the rotating member 112 in a collapsed delivery configuration. The guide member may be retracted / withdrawn proximally (or otherwise moved relative to the elongated body 108) to release the constraints on the expandable portion 110 and / or the rotating member 112 and transform the expandable portion 110 and / or the rotating member 112 into an expanded configuration.

[0060] Figure 2A is an example of a device positioned in a contracted configuration 200 within a blood vessel 202. Figure 1 Conceptual illustration of an example distal portion 108A of the elongated body 108 of FIG. Figure 2A As illustrated, when the distal portion 108A is in the collapsed configuration 200 (also referred to as the "delivery configuration 200"), the expandable portion 110 and the rotating member 112 assume a relatively low profile configuration having a relatively small radial extent. The treatment delivery elements 114A to 114D (collectively referred to as "treatment delivery elements 114") are arranged in a substantially horizontal position. Figure 2AIn the illustrated example, [the components] are disposed on the expandable portion 110 and separated along the longitudinal axis 106, but may have other configurations in other examples. For example, the exemplary distal portion 108A may include one to three treatment delivery elements 114 or five or more treatment delivery elements 114. In some examples, the treatment delivery element 114 may include an electrode, an ultrasound transducer, an injection port, and the like. The distal side of the expandable portion 110 may define a distal tip 206. The distal tip 206 may facilitate guiding the distal portion 108A into the blood vessel 202 within the patient's vasculature. In some examples, the distal tip 206 may be non-invasive, for example, to avoid piercing the vessel wall 204 of the blood vessel 202 during the guiding of the distal portion 108A within the blood vessel 202.

[0061] Figure 2B is illustrative along Figure 2A line A-A in [the figure] and taken along a plane parallel to the longitudinal axis 106 of the elongate body 108 Figure 2A of a conceptual diagram of a schematic cross-sectional view of the exemplary distal portion 108A.

[0062] In Figure 2B the illustrated example, the elongate body 108 includes an elongate tube 210 (e.g., a tube of shape memory material), the elongate tube including a plurality of portions, each portion configured to impart a corresponding expansion configuration to the expandable portion 110 and / or one or more rotational members 112 when expanded. As illustrated, the expandable portion 110 may overlap with one or more treatment delivery elements 114. In other examples, as Figure 2B illustrated, the rotational member 112 is positioned proximal to the expandable portion 110 and / or the treatment delivery element 114. In each of these examples, the expansion of one or more additional rotational members 112 causes additional rotation of the expandable portion 110.

[0063] Each rotating member 112 can give a corresponding expansion configuration to the portion of the distal portion 108A proximal to the expandable portion 110, and rotate the expandable portion 110 to the corresponding rotational configuration. In some examples, two or more or all of the rotating members 112 have the same or similar expansion configuration (e.g., spiral, annular, cable-shaped, circular, helical, etc.) and / or size (e.g., pitch, outer diameter, number of coils / turns, winding direction). In other examples, two or more of the expansion configurations of the corresponding expansion portion have a shape (e.g., spiral, annular, cable-shaped, circular, helical, etc.) and / or size different from one or more other expansion configurations. Each expansion configuration of one or more rotating members 112 can be configured to cause the expandable portion 110 to place one or more of the treatment delivery elements 114 at different rotational and / or longitudinal positions, for example, at different rotational and / or longitudinal positions of the corresponding rotational configuration.

[0064] The elongated tube 210 may be formed of a shape memory material (e.g., nitinol) that is configured to transition to an expanded configuration within the blood vessel 202. The elongated tube 210 may be heat set to the shape of one or more of the expanded configuration of the expandable portion 110 or the expanded configuration of the rotating member 112. For example, the elongated tube 210 may be heat set to define the expandable portion 110 and the rotating member 112 in the expanded configuration, such as Figure 1 In some examples, the shape memory material can be formed into an elongated tube (e.g., a spiral hollow strand available from Fort Wayne Metals Research Products, LLC, Fort Wayne, Indiana). tube, hypotube) and can define a catheter lumen 208.

[0065] like Figure 2BAs illustrated, the catheter lumen 208 can be configured to receive a guidewire 214. The guidewire 214 can facilitate the guidance of the elongate body 108 within a blood vessel via over-the-wire (OTW) techniques, rapid exchange (RX) techniques, and the like. In some examples, when the guidewire 214 longitudinally overlaps one or more expandable portions 110 or one or more rotatable members 112, the guidewire constrains the corresponding portions of the distal portion 108A in a collapsed configuration. The guidewire 214 is configured to be advanced distally or retracted proximally along the longitudinal axis 106 within the catheter lumen 208. A clinician can advance or retract the guidewire 214 to transition at least a portion of the expandable portion 110 and / or the rotatable member 112 into a collapsed configuration or a corresponding expanded configuration. Each of at least a portion of the expandable portion 110 and / or the rotatable member 112 can be expanded to an expanded configuration by inflation of a corresponding portion of the elongate tube 210. For example, the clinician can retract the guidewire 214 to a first position proximal to the expandable portion 110 and distal to the rotatable member 112 or otherwise aligned with the rotatable member to allow the expandable portion 110 to expand into an expanded configuration and place the treatment delivery element 114 in engagement with the vessel wall 204. The clinician can further retract the guidewire 214 to a second position proximal to at least one rotatable member 112 to allow at least one rotatable member 112 to expand and cause the expandable portion 110 to rotate about the longitudinal axis 106. The clinician can then further retract the guidewire 214 proximally to release the constraint on one or more other rotatable members 112 and cause the expandable portion 110 to further rotate about the longitudinal axis 106. Inflation of each of the one or more other rotatable members 112 can apply torque to the expandable portion 110 by the respective rotatable member 112 and cause the expandable portion 110 and the treatment delivery element 114 to rotate within the blood vessel 202.

[0066] Figure 3A is an exemplary distal portion 108A of an elongate body 108 positioned within a blood vessel 202 in a first rotational configuration 300. As Figure 1 illustrated, the expandable portion 110 transitions into a first helical, annular, or spiral shape. Although Figure 3A the exemplary expandable portion 110 illustrated in Figure 3A is configured to transition into a helical, annular, cable, circular, or spiral shape, other exemplary expandable portions can transition into a loop, basket, inflated balloon, expanded stent configuration, or other shape configured to place the treatment delivery element 114 in engagement with the vessel wall 204.

[0067] Positions 302A, 302B (also referred to as "position 302", "rotational position 302") indicate portions of the vessel wall 204 around the perimeter (e.g., circumference) of the blood vessel 202. As an example, a clinician may deliver a treatment through the vessel wall 204 at each position in position 302 to a target tissue adjacent to the blood vessel 202 to create an affected area that includes the target tissue. In some examples, the affected area may surround the entire outer circumference of the blood vessel 202. In some examples, the positions 302 have the same longitudinal position within the blood vessel 202 relative to the longitudinal axis 106, while in other examples, the positions 302 have different longitudinal positions relative to the longitudinal axis 106.

[0068] The positions 302 have different radial positions around the perimeter of the blood vessel 202, and each position in the positions 302 may be separated from another position 302 by a predetermined angle (e.g., 180 degrees, 90 degrees, etc.). In some examples, the positions 302 may be separated by 180 degrees, which may enhance the efficacy of the treatment by allowing the treatment delivery element 114 to deliver the treatment to create opposing ablation patterns around the inner perimeter of the vessel wall 204. In some examples, the predetermined angle may be separated between about 45 degrees and about 180 degrees. For a particular neuromodulation procedure, there may be two positions 302 or three or more positions 302 around the inner circumference of the blood vessel 202. The positions 302 may be evenly or unevenly disposed around the inner circumference of the vessel wall 204 such that the positions 302 are biased towards a particular portion of the inner perimeter (e.g., inner circumference) of the vessel wall 204.

[0069] The rotational member 112 is configured to rotate the expandable portion 110 into a plurality of rotational configurations. Each rotational configuration in the plurality of rotational configurations may be separated by a predetermined angle. In each rotational configuration, the expandable portion 110 may be configured to place the treatment delivery element 114 in engagement with the vessel wall 204 at different selections of the position 302.

[0070] In some examples described herein, the predetermined angle is described relative to the circumference of the blood vessel 202. In some examples, the predetermined angle can be the angle of rotation of the expandable portion 110 outside the patient when the rotating member 112 transitions from the contracted configuration to the expanded configuration (in the absence of external forces applied by the blood vessel wall, etc.). For example, these angles can be along an imaginary circle, i.e., the central longitudinal axis of the elongated body 108 that extends through the center of the imaginary circle. In some examples, the angle of rotation of the expandable portion 110 outside the patient is from about 45 degrees to about 180 degrees. The predetermined angle outside the patient can correspond to the amount of torque applied by the rotating member 112 to the expandable portion 110 due to the expansion of the rotating member 112. In some examples, depending on the size (e.g., diameter) and / or position of the blood vessel 202, the expansion of the rotating member 112 can cause the same amount of torque to rotate the expandable portion 110 by different predetermined angles. For example, the predetermined angle of rotation of the expandable portion 110 inside the blood vessel 202 can be greater than, less than, or equal to the predetermined angle of rotation of the expandable portion 110 outside the patient.

[0071] The predetermined angle can represent the effective angle of rotation of the expandable portion 110 about the longitudinal axis 106. For example, a rotation angle of 315 degrees counterclockwise about the longitudinal axis 106 has the same effective rotation angle of 45 degrees as a rotation angle of 45 degrees clockwise about the longitudinal axis 106. As another example, a rotation angle of 405 degrees clockwise about the longitudinal axis 106 has the same effective rotation angle as a rotation angle of 45 degrees clockwise about the longitudinal axis 106. The expansion of the rotating member 110 can cause the expandable portion 110 to rotate clockwise or counterclockwise about the longitudinal axis 106 until the new rotational configuration of the expandable portion 110 is separated from the previous rotational configuration by the effective rotation angle. In some examples, the expansion of the rotating member 110 can cause the expandable portion 110 to over-rotate (i.e., rotate more than 360 degrees) about the longitudinal axis 106 to place the expandable portion 110 in a new rotational configuration that is separated from the previous rotational configuration by the effective rotation angle.

[0072] When the guide wire 214 is withdrawn from the elongated body 108 to a position near the expandable portion 110, the elongated tube 210 (e.g., as Figure 2B shown) can expand and cause the expandable portion 110 to transition to the expanded configuration. When expanded, the expandable portion 110 can cause at least one of the treatment delivery elements 114 (e.g., treatment delivery element 114D) to be placed adjacent to or in contact with the blood vessel wall 204 at one or more locations at position 302 (e.g., at position 302B). The treatment delivery elements 114 are configured to deliver treatment to the target tissue of the patient through the blood vessel wall 204 at one or more locations at position 302. For example, as Figure 3AAs illustrated, the treatment delivery element 114D can be used to deliver treatment through the vessel wall 204 at location 302B.

[0073] Due to the expansion of the expandable portion 110, the distal portion 108A can be shortened by a distance 304 relative to the delivery configuration along the longitudinal axis 106, e.g., as Figure 2A and Figure 2B shown. That is, the expansion of the expandable portion 110 can cause the axial length of the distal portion 108A along the longitudinal axis 106 to decrease. In some examples, the distance 304 can be predetermined and can depend on one or more dimensions of the expansion configuration of the expandable portion 110 in the first expansion configuration, including but not limited to: the pitch, the maximum outer diameter, or the number of coils / revolutions of the expandable portion 110 in the expanded configuration, and the size (e.g., diameter) of the vessel 202.

[0074] Figure 3B is an illustration along Figure 3A line B-B in Figure 3A and along a plane parallel to the longitudinal axis 106 of the elongate body 108 of a conceptual diagram of a schematic cross-sectional view of an exemplary distal portion 108A. As Figure 3B illustrated, the guide wire 214 is retracted proximally to a first position 306 along the longitudinal axis 106. The first position 306 is proximal to the expandable portion 110 and distal to the rotating member 112. Retracting the guide wire 214 to the first position 306 releases the constraint on a portion of the elongate tube 210 that radially overlaps the expandable portion 110 and causes the expandable portion 110 to deploy into a radially expanded configuration. That is, the expandable portion 110 expands radially away from the longitudinal axis 106 into the expanded configuration.

[0075] The process for expanding the expandable portion 110 can also be reversed to contract the expandable portion 110. For example, the guide wire 214 can be configured to be advanced distally from the first position 306 toward the distal tip 206. Advancing the guide wire 214 toward the distal tip 206 causes the expandable portion 110 to transition from the expanded configuration to the contracted configuration (e.g., as Figure 2A and Figure 2B illustrated). The expandable portion 110 transitioning to the contracted configuration causes the catheter 102 to transition from the first rotational configuration 300 to the contracted configuration 200.

[0076] Figure 4A is an illustration of positioned within the vessel 202 in a second rotational configuration 400 of Figure 1Conceptual diagram of an exemplary distal portion 108A of the catheter body 108. When not constrained by proximal retraction of the guide wire 214, the rotational member 112 expands radially away from the longitudinal axis 106 and rotates the expandable portion 110 from the first rotational configuration 300 to the second rotational configuration 400. The expanded configuration of the rotational member 112 can be helical, annular, cable-shaped, circular, or spiral (as Figure 4A illustrated), offset arcuate, wavy, or another curved or non-curved shape configured to apply torque to the expandable portion 110. In the Figure 4A exemplary illustration shown, the expandable portion 110 and the rotational member 112 are separated from the relatively linear or otherwise unexpanded portion 404.

[0077] Expansion of the rotational member 112 to the expanded configuration causes the expandable portion 110 to rotate, retract, and / or advance within the blood vessel 202 relative to, for example, the first rotational configuration 300. Expansion of the rotational member 112 applies torque to the expandable portion 110 and causes the expandable portion 110 to rotate within the blood vessel 202. Rotation of the expandable portion 110 positions the treatment delivery element 114 (e.g., treatment delivery element 114D) in engagement with the vessel wall 204 at different locations 302 (e.g., location 302A) within the blood vessel 202. When the distal portion 108A is in the expanded configuration 300, the different locations 302 can correspond to the second rotational orientation 400 and can be different relative to the Figure 3A and Figure 3B locations 302 shown therein. For example, the different locations 302 can be longitudinally and / or circumferentially offset from the first location.

[0078] In some examples, as Figure 4A illustrated, when expanded, the rotational member 112 can define a helix, loop, cable, circle, spiral, etc. that rotates about the longitudinal axis 106. In some examples, the distal portion 108A can include two or more rotational members 112, each rotational member 112 defining an expanded configuration that defines a helix, loop, or spiral that winds in the same or different directions.

[0079] Expansion of the rotational member 112 can cause the distal portion 108A to shorten by a distance 402 along the axial length of the longitudinal axis 106. In some examples, the distance 402 is predetermined and is based on the pitch, outer diameter, number of coils / revolutions, and / or any other dimension of the second expanded configuration 112B, the dimensions of the blood vessel 202, and / or a predetermined amount of torque applied to the expandable portion 110. In some examples, the distance 402 is less than or equal to the length of one of the distances 304 along the longitudinal axis 106. In some examples, the distance 402 can be less than, greater than, or equal to the distance 304.

[0080] Figure 4B is illustrative of along Figure 4Aalong line D-D in and taken in a plane parallel to the longitudinal axis 106 of the elongate body 108 Figure 4A Conceptual diagrams of schematic cross-sectional views of an exemplary distal portion 108A. The guide wire 214 is configured to retract proximally along the longitudinal axis 106 to a second position 406 proximal to the rotatable member 112. The proximal retraction of the guide wire 214 to the second position 406 releases the constraint on at least one rotatable member 112 and allows the unconstrained rotatable member 112 to expand radially away from the longitudinal axis 106. Although Figure 4B the expansion of the rotatable member 112 is illustrated and described primarily with reference to a single rotatable member 112, other exemplary distal portions 108A may include two or more rotatable members 112. Each of the two or more rotatable members 112 may expand in a manner similar to that described below to rotate the expandable portion 110 into different corresponding rotational configurations. The rotatable members may be longitudinally spaced along the longitudinal axis 106 such that when the guide member is withdrawn proximally relative to the respective rotatable member, the rotatable member expands to rotate the expandable member 110.

[0081] The expansion configuration presented by the rotatable member 112 may have the same or different pitch, number of coils / revolutions, outer diameter, or other dimensions as the expansion configuration presented by the expandable portion 110. In some examples, the expanded rotatable member 112 may have a tighter pitch, fewer coils / revolutions, and / or a smaller outer diameter than the expanded expandable portion 110. The dimensions of the expanded rotatable member 112 may affect the amount of rotation (e.g., angle) of the expandable portion 110 and / or the treatment delivery element 114. In some examples, the dimensions of the expanded rotatable member 112 affect the amount of shortening, such as distance 402, of the axial length of the distal portion 108A along the longitudinal axis 106.

[0082] Figure 5A illustrates along Figure 3A line C-C in and taken in a plane orthogonal to the longitudinal axis 106 of the catheter 102 of the Figure 3A distal portion 108A in a first rotational configuration 300. Figure 5B illustrates along Figure 4A line E-E in and taken in a plane orthogonal to the longitudinal axis 106 of the distal portion 108A of the Figure 4A distal portion 108A in a second rotational configuration 400.

[0083] Figure 5A and Figure 5BIllustrates four positions 302A through 302D (collectively referred to as "position 302") on the vessel wall 204 and around the periphery of the vessel 202. The positions 302 can be selected to facilitate delivery of a treatment around a desired portion of the periphery of the vessel 202. Generally, the affected regions of each of the positions 302 can be combined to allow delivery of a treatment to the patient's tissue around the entire outer periphery of the vessel 202 at the target tissue site. Delivery of a treatment around the entire outer circumference of the vessel 202 can, for example, improve the efficacy of the treatment and / or reduce the likelihood and / or severity of any unintended outcomes by reducing the amount of treatment delivered to the target tissue site to affect the tissue around the entire outer circumference of the vessel 202 relative to delivering the treatment to relatively fewer positions 302. The vessel 202 can include two positions 302, three positions 302, or four or more positions 302 disposed around the circumference of the vessel 202.

[0084] As Figure 5A and Figure 5B Illustrated, when the rotating member 112 becomes unconstrained (e.g., by retracting the guide wire 214, outer sheath, or other guiding member along the longitudinal axis 106 to the second position 406 or retracting along the elongate body 108 to another position), the rotating member 112 can expand and cause the expandable portion 110 to rotate about the longitudinal axis 106. Expansion of the rotating member 112 applies a torque to the expandable portion 110 to rotate the expandable portion 110 from the first rotational configuration 300 to the second rotational configuration 400. In each of the different rotational configurations (e.g., the first rotational configuration 300, the second rotational configuration 400), the expandable portion 110 can place at least one of the treatment delivery elements 114 of the treatment delivery element in engagement with the vessel wall 204 of the vessel 202 at one or more of the positions 302.

[0085] In some examples, the elongate body 108 includes a locking member proximal to at least one of the rotating members 112. The locking member can include, but is not limited to, a locking stylet, a locking guide wire, a locking sheath, an expandable member (e.g., an expandable balloon), etc. The locking member can constrain a portion of the elongate body 108 proximal to at least one of the rotating members 112, e.g., to direct the torque caused by expansion of at least one of the rotating members 112 to act distally toward the expandable portion 110 and cause the expandable portion 110 to rotate about the longitudinal axis 106. In some examples, the locking member can constrain the proximal portion of the elongate body 108 to prevent torque from being transmitted to the proximal portion of the elongate body 108 and / or to prevent the proximal portion of the elongate body 108 from rotating due to expansion of at least one of the rotating members 112.

[0086] In some examples, as Figure 5A and Figure 5BAs illustrated, in one rotational configuration of the rotational configurations (e.g., the first rotational configuration 300), the treatment delivery element 114 may be disposed at a first set of predetermined positions 302 around the circumference of the blood vessel 202. When torque is applied by the rotational member 112 (e.g., due to the expansion of the rotational member 112), the expandable portion 110 may rotate to another rotational configuration of the rotational configurations (e.g., the second rotational configuration 400) and place at least one treatment delivery element 114 (e.g., treatment delivery element 114C) in engagement with the blood vessel wall 204 at a second set of positions 302 that is different from the first set. For example, the second set may include positions 302 (e.g., positions 302C, positions 302D) that are at the same rotational position but at different longitudinal positions as positions 302 previously occupied by another treatment delivery element 114 (e.g., treatment delivery element 114B, treatment delivery element 114D). In another example, the second set may include positions 302 that are at the same longitudinal position but at different rotational positions as positions 302 previously occupied by another treatment delivery element 114.

[0087] In some examples, as Figures 2A to 5B illustrated and as described above, the elongate tube 210 may be part of the elongate body 108 and / or permanently disposed within the elongate body 108. In some examples, the elongate tube 210 may be disposed within the catheter lumen defined by the elongate body 108 and may be advanced and / or retracted relative to the elongate body 108 and within the catheter lumen. In such examples, a clinician may select the elongate tube 210 from a plurality of different elongate tubes 210. Each elongate tube 210 may have a different number of expansion configurations and / or expansion configurations of different sizes, and the clinician may select the elongate tube 210 to be used within the system 100 based on the size of the target tissue region, the size of the catheter 102, the expected effect region at the target tissue region, the desired size of the expandable portion 110 upon expansion, the desired size of the rotational member 112 upon expansion, and the like.

[0088] Figure 6 is a flow diagram illustrating an example method of repositioning an example distal portion 108A of the catheter 102 within the blood vessel 202 using a rotational member (e.g., rotational member 120) as described herein. Although primarily described herein with reference to an example expandable portion 110 configured to expand into a helical, annular, or spiral shape as Figures 2A to 5B illustrated, the example method Figure 6 illustrated may be applied to example expandable portions configured to expand into other shapes (e.g., annular, basket-shaped, expanded balloon, expanded stent configuration, any other shape configured to place the treatment delivery element 114 in engagement with the blood vessel wall 204). Figure 6

[0089] The clinician may advance the distal portion 108A of the catheter 102 within the blood vessel 202 to a target tissue site (602) within the blood vessel 202. The clinician may insert a guide member (e.g., guide wire 214, guide sheath) into the patient's vasculature via an incision in the patient and direct the guide member to the target tissue site. Once the clinician determines that the guide member is at the target tissue site, the clinician may advance the catheter 102 along the guide member to the target tissue site. The clinician may use one or more imaging techniques (e.g., fluoroscopy, X-ray imaging, etc.) to direct the guide member and / or the catheter 102 within the vasculature. The elongate body 108 and / or the rotating member 112 of the catheter 102 define a catheter lumen 208 configured to hold a guide member (e.g., guide wire 214). In other examples, a guide member (e.g., sheath) may be configured to hold the elongate body 108. The guide member may be configured to constrain the rotating member 112 in a collapsed configuration when the catheter 102 is directed to the target tissue site.

[0090] The clinician may expand the expandable portion 110 to place the treatment delivery element 114 in a first position (604). The clinician may cause the expandable portion 110 of the catheter 102 to assume an expanded configuration and place at least one treatment delivery element 114 in a first position at location 302 in contact with the vessel wall 204.

[0091] The clinician may retract the guide member proximally to a first position 306 to release the constraint on the expandable portion 110. The first position 306 may be proximal to the expandable portion 110 and distal to the rotating member 112. When unconstrained, the shape memory of the first portion of the elongate tube 210 within the elongate body 108 may cause the expandable portion 110 to transition to an expanded configuration. When expanded, the expandable portion 110 may place one or more of the treatment delivery elements 114 in contact with the vessel wall 204 of the blood vessel 202 at a first set of predetermined locations 302. Expansion of the expandable portion 110 may cause the axial length of the distal portion 108A to shorten by a distance 304 along the longitudinal axis 106.

[0092] A clinician may deliver a treatment to a patient's tissue (606) at a first location. Each treatment delivery element 114 in the treatment delivery element of the catheter 102 is configured to deliver a treatment to the patient, for example, to deliver a treatment to a target nerve and / or tissue of the patient through the vessel wall 204 at location 302. Once the clinician determines that at least one treatment delivery element 114 is set at the first set of locations 302, the clinician may deliver the treatment through the vessel wall 204 at the first set of locations 302 to the target nerve and / or tissue. The treatment may include, but is not limited to, RF energy, ultrasonic energy, electrical stimulation signals, cryogenic energy, chemicals, etc. The treatment delivery element 114 may deliver the treatment to the patient's tissue by transmitting an electrical stimulation signal via an electrode, via a chemical and / or fluid injection port, etc.

[0093] The clinician may inflate the rotating member 112 to rotate at least one treatment delivery element 114 to a second position (608). The clinician may inflate the rotating member 112 to rotate the inflatable portion 110 and place at least one treatment delivery element 114 in contact with the vessel wall 204 at a second position in location 302.

[0094] The second position in location 302 may be at a radial position different from the first position in location 302 around the inner circumference of the blood vessel 202. The first rotational position and the second rotational position may be separated by a predetermined angle (e.g., by 90 degrees, by 180 degrees, etc.). The first position and the second position of location 302 may be separated by 180 degrees to increase the efficacy of the treatment. In some examples, the second position may be proximal to the first position with respect to the longitudinal axis 106 (e.g., due to the shortening of the distal portion 108A and / or the inflatable portion 110 during the inflation of the rotating member 112). In some examples, the first rotational configuration 300 and the second rotational configuration 400 may be selected such that when the treatment is delivered to the vessel wall 204 with the distal portion 108A in the rotational position, the combined affected area of the treatment may cover the tissue around the entire outer circumference of the blood vessel 202.

[0095] The clinician may inflate the rotating member 112 by at least retracting the guiding member proximally to the second position 406 to release the constraint on the rotating member 210. The rotating member 112 may be inflated and apply a torque to the inflatable portion 110. The applied torque may cause the inflatable portion 110 to rotate within the blood vessel 202 and cause at least one treatment delivery element 114 to rotate from the first position of location 302 to the second position of location 302. The inflation of the rotating member 112 may cause the distal portion 108A to shorten by a distance 402 along the axis length of the longitudinal axis 106.

[0096] The clinician can deliver therapy to the patient's tissue at the second location (610). The clinician can deliver therapy to the second location of location 302 via at least one therapy delivery element 114. In some examples, as described above, the catheter 102 can include two or more rotational members 112 and can be configured to deliver therapy at two or more rotational positions, for example, by further proximal retraction of the guide member to release constraints on additional rotational members 112 to deliver therapy.

[0097] In some examples, after the clinician delivers therapy to the patient's tissue while the catheter 102 is in the second rotational position, the clinician may transition the expandable portion 110 to the collapsed delivery configuration, such as by advancing a guide member distally along the elongated body 108 and the expandable portion 110. The clinician may then guide the catheter 102 to a second target tissue site within the patient and perform the example method described in steps 602-610 at the second target tissue site.

[0098] Figure 7 is a flow chart illustrating an example method of manufacturing an example rotating member 112 of a catheter 102. Figure 7 The example method of exemplifies the manufacture of a single rotating member 112 , but the steps of the example method may be used to manufacture two or more rotating members 112 of the example catheter 102 .

[0099] The manufacturer may form the elongated tube 210 (702). The manufacturer may form a shape memory material (e.g., nitinol) into the elongated tube 210. The elongated tube 210 may include an HHS tube, a hypotube, etc. In some examples, such as in an HHS tube, the manufacturer may wind a plurality of shape memory wires (e.g., around a mandrel) to form the elongated tube 210.

[0100] The manufacturer may form an expanded configuration (also referred to as a "first expanded configuration") of the expandable portion 110 on the elongated tube 210 (704). The manufacturer may form the first expanded configuration on the elongated tube 210 by forming a portion of the elongated tube 210 into the expanded configuration, for example, while applying heat to allow the elongated tube 210 to maintain a shape memory of the expanded configuration and to cause the expandable portion 110 to transition from the contracted configuration to the expanded configuration in response to a threshold temperature. The threshold temperature may be less than or equal to the patient's internal body temperature or the patient's average internal body temperature. When expanded, the first expanded configuration is configured to cause the expandable portion 110 to assume a radially expanded configuration and to place at least one therapeutic delivery element 114 in contact with the vessel wall 204.

[0101] The manufacturer can determine the dimensions of the first expansion configuration based at least in part on the desired dimensions of the distal portion 108A and / or the expandable portion 110 in a radially expanded configuration at one or more target tissue sites (e.g., the outer diameter, pitch, and / or number of coils / revolutions of the expandable portion 110 in a radially expanded configuration at one or more target tissue sites), the dimensions of the blood vessel 202 at one or more target tissue sites (e.g., the inner circumference of the blood vessel 202, the diameter of the blood vessel 202), the position of one or more locations 302 at the target tissue site, and / or a threshold shortening distance value of the distance 304. In some examples, the relationship between the dimensions of the expandable portion 110 in the first expansion configuration and the shortening distance 304 can be illustrated in Equation 1:

[0102] π*X*C + Y*C = Z (Equation 1).

[0103] In Equation 1, Z represents the length of the expandable portion 110 along the longitudinal axis 106 in the contracted delivery configuration, C represents the number of coils / revolutions defined by the expandable portion 110 in the first expansion configuration, Y represents the pitch of the expandable portion 110 in the first expansion configuration, and X represents the outer diameter of the expandable portion 110 in the first expansion configuration. The shortening distance 304 is represented by the term “π*X*C”. The manufacturer can determine the distance 304 and / or the dimensions of the expandable portion 110 in the first expansion configuration based at least in part on Equation 1.

[0104] The manufacturer can form the expansion configuration (706) of the rotating member 112 on the elongate tube 210. The manufacturer can form the expansion configuration of the rotating member 112 on the elongate tube 210 at a position proximal to the expansion configuration of the expandable portion 110.

[0105] The manufacturer can determine the dimensions of the expansion configuration of the rotating member 112 based at least in part on the desired rotation angle of at least one of the treatment delivery elements 114 in the treatment delivery element (e.g., greater than or equal to 45 degrees, less than or equal to 180 degrees), a threshold shortening value of the distance 402, the dimensions of the blood vessel 202 at the target tissue site, the desired torque level to be applied to the expandable portion 110, and / or the threshold torque level to be applied to the expandable portion 110. In some examples, the rotating member 112 can be configured to rotate at least one of the treatment delivery elements 114 in the treatment delivery element 90 degrees, and the distance 402 can be less than or equal to the length of the treatment delivery element 114. The manufacturer can determine the distance 402 and / or the expansion configuration of the rotating member 112 based at least in part on Equation 1 applied to the rotating member 112 in the expanded configuration.

[0106] Figure 8 Illustrates for some examples in accordance with the present disclosure for utilizing Figure 1Example techniques for a system to access the renal artery and modulate the renal nerves. Although Figure 8 illustrates the use of catheter 102 for renal nerve modulation, catheter 102 can also be used for other therapies and treatments in another blood vessel or other hollow anatomy within the human body. Catheter 102 is configured to deliver energy (e.g., RF energy, ultrasonic energy, electrical stimulation energy, etc.) to one or more target tissue sites within the renal blood vessels. Catheter 102 provides access through an intravascular path (P) into the renal plexus (RP), such as through a percutaneous access site in the femoral artery (illustrated), brachial artery, radial artery, or axillary artery to a target tissue site within the corresponding renal artery (RA). By manipulating the proximal portion 108B or the elongate body 108 from outside the intravascular path (P), a clinician can advance at least the distal portion 108A of the elongate body 108 through the sometimes tortuous intravascular path (P), and remotely manipulate the distal portion 108A of the elongate body 108 ( Figure 1 ). The distal portion 108A can be remotely manipulated by a clinician using the handle 104.

[0107] In Figure 8 the illustrated example, an inner member 136 is used in an over-the-wire (OTW) technique to deliver the distal portion 108A intravascularly to the treatment site. The inner member 136 can be inside catheter 102 (e.g., a guide wire, inner catheter, etc.) or outside catheter 102 (e.g., an outer sheath, etc.). In some examples, the inner member 136 is a guide wire. Catheter 102 can define a channel for receiving the inner member 136 for delivering catheter 102 using OTW or RX techniques. At the treatment site, the inner member 136 can be at least partially withdrawn or removed relative to catheter 102, and the distal portion 108A can be transformed into an expanded configuration (e.g., a helical configuration, a spiral configuration, etc.) for delivering a nerve modulation treatment. In other examples, the elongate body 108 can be self-manipulating such that the expandable portion 110 can be delivered to the target tissue site without the assistance of the inner member 136.

[0108] Renal neuromodulation is partial or complete disablement or other effective disruption of the nerves of the kidney (e.g., nerves terminating in or in close association with the kidney). In particular, renal neuromodulation can include inhibiting, reducing, and / or blocking neural communication along nerve fibers of the kidney (e.g., efferent and / or afferent nerve fibers). Such disablement can be long-term (e.g., permanent or lasting months, years, or decades) or short-term (e.g., lasting minutes, hours, days, or weeks). Renal neuromodulation is expected to contribute to a systemic reduction in sympathetic tone or drive and / or be beneficial to at least some specific organs and / or other body structures innervated by the sympathetic nervous system. Accordingly, renal neuromodulation is expected to be useful for treating clinical conditions associated with central sympathetic overstimulation. For example, renal neuromodulation is expected to effectively treat conditions such as hypertension, heart failure, acute myocardial infarction, metabolic syndrome, insulin resistance, diabetes, left ventricular hypertrophy, chronic and end-stage renal disease, inappropriate fluid retention in heart failure, cardiorenal syndrome, polycystic kidney disease, polycystic ovary syndrome, osteoporosis, erectile dysfunction, and sudden cardiac death.

[0109] Renal neuromodulation can be electrically induced or induced in another suitable manner by delivering energy (RF energy, ultrasound energy, microwave energy, etc.). The target tissue site can be located within the renal lumen (e.g., renal artery, ureter, renal pelvis, major calyx, minor calyx, or another suitable structure) or otherwise in proximity to the renal lumen, and the target tissue site can include tissue at least adjacent to the wall of the renal lumen. By way of example, with respect to the renal artery, a treatment protocol can include modulating the nerves in the renal plexus, which are closely located within or adjacent to the adventitia of the renal artery. The following discussion provides further details regarding patient anatomy and physiology as it may pertain to renal denervation therapy. This section is intended to supplement and expand on a previous discussion of related anatomy and physiology and to provide additional context regarding the disclosed techniques and therapeutic benefits associated with renal denervation. For example, several properties of the renal vasculature can affect the design of target tissue devices and associated methods for achieving renal neuromodulation via an intravascular access, and specific design requirements are imposed on such devices. Specific design requirements can include accessing the renal artery, positioning the distal portion 108A within the renal artery, delivering treatment to the target tissue, and / or using a treatment delivery device to effectively modulate the renal nerves.

[0110] As previously mentioned, the sympathetic nervous system (SNS) is a branch of the autonomic nervous system, as well as the enteric and parasympathetic nervous systems. It is always active at a basal level (termed sympathetic tone) and becomes more active during periods of stress. Like other parts of the nervous system, the sympathetic nervous system operates via a series of interconnected neurons. Sympathetic neurons are frequently considered part of the peripheral nervous system (PNS), although many are located within the central nervous system (CNS). Sympathetic neurons of the spinal cord (which is part of the CNS) communicate with peripheral sympathetic neurons via a series of sympathetic ganglia. Thus, within the ganglia, spinal sympathetic neurons are termed pre-synaptic (or pre-ganglionic) neurons, while peripheral sympathetic neurons are termed post-synaptic (or post-ganglionic neurons).

[0111] At the synapse within the sympathetic ganglia, pre-ganglionic sympathetic neurons release acetylcholine, which is a chemical messenger that binds to and activates nicotinic acetylcholine receptors on the post-ganglionic neurons. In response to this stimulation, post-ganglionic neurons predominantly release noradrenaline (norepinephrine). Prolonged activation may trigger the release of adrenaline from the adrenal medulla.

[0112] Once released, noradrenaline and adrenaline bind to adrenergic receptors on peripheral tissues. Binding to adrenergic receptors elicits neuronal and hormonal responses. Physiological manifestations include pupil dilation, increased heart rate, occasional vomiting, and elevated blood pressure. Increased sweating also results from binding to cholinergic receptors on sweat glands.

[0113] The sympathetic nervous system is responsible for upregulating and downregulating many homeostatic mechanisms within a living organism. Fibers from the SNS innervate tissues in nearly every organ system, providing at least some regulatory function for physiological characteristics as diverse as pupil diameter, intestinal motility, and urine output. This response is also known as the sympathetic-adrenal response of the body because pre-ganglionic sympathetic nerve fibers that terminate in the adrenal medulla (as well as all other sympathetic nerve fibers) secrete acetylcholine, which activates the secretion of adrenaline (epinephrine) and, to a lesser extent, noradrenaline (norepinephrine). Thus, this response, which acts primarily on the cardiovascular system, is mediated directly via impulses transmitted through the sympathetic nervous system and indirectly via catecholamines secreted by the adrenal medulla.

[0114] Science generally views the SNS as an autoregulatory system, that is, a system that operates without the intervention of conscious thought. Some evolutionary theorists believe that the sympathetic nervous system operated in early organisms to sustain survival because the sympathetic nervous system is responsible for initiating the body's actions. An example of such initiation is the moment before waking, when sympathetic outflow spontaneously increases in preparation for action.

[0115] Figure 9 is a conceptual diagram illustrating how the exemplary brain of the sympathetic nervous system (SNS) communicates with the body via the SNS. As Figure 9 shown, the SNS provides a neural network that allows the brain to communicate with the body. The sympathetic nerves originate inside the spinal column, for example, in the intermediolateral cell column (or lateral horn) toward the middle of the spinal cord, starting from the first thoracic segment of the spinal cord and thought to extend to the second or third lumbar segment. Because the SNS cells start in the thoracic and lumbar regions of the spinal cord, the SNS is said to have a thoracolumbar outflow. The axons of the sympathetic nerves leave the spinal cord through the anterior rami / roots. The axons pass near the spinal (sensory) ganglia, where they enter the anterior branches of the spinal nerves. However, unlike somatic innervation, the axons separate through white rami communicantes, which connect to paravertebral ganglia (which lie near the spinal column) or prevertebral ganglia (which lie near the aortic bifurcation) that extend along the side of the spinal column.

[0116] To reach the target organs and glands, the axons should travel long distances in the body, and to accomplish this, many axons relay their messages to a second cell through synaptic transmission. The end of the axon crosses a space, i.e., the synapse, and connects to the dendrite of the second cell. The first cell (presynaptic cell) sends neurotransmitters across the synaptic cleft, where it activates the second cell (postsynaptic cell). Then, the message is transmitted to the final destination.

[0117] In the SNS and other components of the peripheral nervous system, these synapses are formed at sites called ganglia as discussed above. The cells that send their fibers to the ganglia are called preganglionic cells, while the cells whose fibers leave the ganglia are called postganglionic cells. As previously mentioned, the preganglionic cells of the SNS are located between the first thoracic (T1) and third lumbar (L3) segments of the spinal cord. The cell bodies of the postganglionic cells are located in the ganglia and send their axons to the target organs or glands.

[0118] The ganglia include not only the sympathetic trunks but also the cervical ganglia (superior, middle, and inferior) that send sympathetic fibers to the head and thoracic organs, and the celiac and mesenteric ganglia that send sympathetic fibers to the intestines.

[0119] Figure 10 is an enlarged anatomical view of the nerves that innervate the left kidney to form a renal plexus around the left renal artery. As Figure 10As shown, the kidney is innervated by the renal plexus (RP) which is closely associated with the renal artery. The renal plexus (RP) is an autonomic nerve plexus that surrounds the renal artery and is embedded within the adventitia of the renal artery. The renal plexus (RP) extends along the renal artery and is embedded within the adventitia of the renal artery. Fibers contributing to the renal plexus (RP) arise from the celiac ganglion, superior mesenteric ganglion, aorticorenal ganglion, and aortic plexus. The renal plexus (RP), also known as the renal nerve, mainly contains sympathetic components. There is no (or at least very little) parasympathetic innervation of the kidney.

[0120] Preganglionic neuron cell bodies are located in the intermediolateral cell column of the spinal cord. Preganglionic axons pass through paravertebral ganglia to become the lesser splanchnic nerve, least splanchnic nerve, first lumbar splanchnic nerve, second lumbar splanchnic nerve and travel to the celiac ganglion, superior mesenteric ganglion, and aorticorenal ganglion. Postganglionic neuron cell bodies exit the celiac ganglion, superior mesenteric ganglion, and aorticorenal ganglion to reach the renal plexus (RP) and are distributed onto the renal vessels.

[0121] Messages travel through the SNS in a bidirectional flow. Efferent messages may trigger simultaneous changes in different parts of the body. For example, the sympathetic nervous system can accelerate the heart rate, dilate bronchial passages, reduce motility (movement) of the large intestine, constrict blood vessels, increase peristalsis of the esophagus, cause pupil dilation, piloerection (goosebumps), and sweating (perspiration), or raise blood pressure. Afferent messages carry signals from various organs and sensory receptors within the body to other organs, especially the brain.

[0122] Hypertension, heart failure, and chronic kidney disease are some of the disease states caused by chronic activation of the SNS, particularly the renal sympathetic nervous system. Chronic activation of the SNS is an adaptive adverse reaction that drives the progression of these disease states. Pharmacological management of the renin - angiotensin - aldosterone system (RAAS) has been a long - standing but somewhat ineffective way to reduce SNS hyperactivity.

[0123] As mentioned above, the renal sympathetic nervous system has been identified experimentally and in humans as a major cause of the complex pathophysiology leading to hypertension, volume - overload states such as heart failure, and progressive kidney disease. Studies using radioactive tracer dilution methods to measure the overflow of norepinephrine from the kidney to plasma have shown increased renal norepinephrine (NE) spillover rates in patients with essential hypertension, especially in young hypertensive subjects. This increased renal norepinephrine spillover rate from the kidney, together with increased NE spillover rate from the heart, is consistent with the hemodynamic profile commonly seen in early hypertension and characterized by increased heart rate, cardiac output, and renal vascular resistance. It is now known that essential hypertension is usually neurogenic and is often associated with significant sympathetic nervous system hyperactivity.

[0124] The activation of cardiac and renal sympathetic nerve activity is even more pronounced in heart failure, as demonstrated by the excessive increase in NE overflow from the heart and kidneys to plasma in the patient group. Consistent with this view, it has recently been shown that renal sympathetic activation has a strong negative predictive value for all-cause mortality and cardiac transplantation in patients with congestive heart failure, independent of overall sympathetic activity, glomerular filtration rate, and left ventricular ejection score. These findings support the view that treatment regimens designed to reduce renal sympathetic stimulation have the potential to improve the survival of patients with heart failure.

[0125] Both chronic and end-stage renal disease in some patients are characterized by elevated sympathetic nerve activation. In patients with end-stage renal disease, plasma levels of norepinephrine above the median have been shown to predict both all-cause mortality and death due to cardiovascular disease. This may also be the case for patients with diabetes or contrast-induced nephropathy. There is compelling evidence that afferent sensory signals originating from the diseased kidney are the major contributing factor in initiating and maintaining elevated central sympathetic outflow in this patient group; this promotes the occurrence of the well-known adverse consequences of chronic sympathetic overactivity, such as hypertension, left ventricular hypertrophy, ventricular arrhythmias, sudden cardiac death, insulin resistance, diabetes, and metabolic syndrome.

[0126] The sympathetic nerves of the kidney terminate in blood vessels, the juxtaglomerular apparatus, and the renal tubules. Stimulation of the renal sympathetic nerves results in increased renin release, increased sodium (Na + ) reabsorption, and decreased renal blood flow. These components of the neural regulation of renal function are highly stimulated in disease states characterized by increased sympathetic tone and significantly contribute to the elevation of blood pressure in hypertensive patients. The reduction in renal blood flow and glomerular filtration rate caused by renal sympathetic efferent stimulation may be the basis for the loss of renal function in cardiorenal syndrome, a form of renal dysfunction that is a progressive complication of chronic heart failure and has a clinical course that typically fluctuates with the patient's clinical status and treatment. Pharmacological strategies to impede the consequences of renal efferent sympathetic stimulation include centrally acting sympatholytic drugs, β-blockers (designed to reduce renin release), angiotensin-converting enzyme inhibitors, and receptor blockers (designed to block the activation of angiotensin II and aldosterone due to renin release), and diuretics (designed to counteract renal sympathetic-mediated sodium and water retention). However, current pharmacological strategies may have significant limitations, including limited efficacy, compliance issues, side effects, etc.

[0127] The kidney communicates with the overall structure in the central nervous system via renal afferent sensory nerves. Several forms of "renal injury" may induce the activation of afferent sensory signals. For example, renal ischemia, reduced stroke volume or renal blood flow, or adenosine abundance can trigger the activation of afferent nerve communication.

[0128] Figure 11is an anatomical view of the human body depicting efferent and afferent communication between the brain and the kidneys. Figure 12 is a conceptual view of the human body depicting efferent and afferent communication between the brain and the kidneys. As Figure 11 and Figure 12 shown, afferent communication can be from the kidneys to the brain, or can be from one kidney to the other (via the central nervous system). These afferent signals are centrally integrated and may lead to an increase in sympathetic outflow. This sympathetic drive is directed directly at the kidneys, thereby activating the RAAS and inducing an increase in renin secretion, sodium retention, volume retention, and vasoconstriction. Central sympathetic overactivity also affects other organs and body structures innervated by the sympathetic nerves, such as the heart and the peripheral vascular system, thereby causing the described side effects of sympathetic activation, several aspects of which also contribute to an increase in blood pressure.

[0129] Thus, physiology suggests that: (i) modulating the efferent sympathetic tissue will reduce inappropriate renin release, salt retention, and reduction of renal blood flow; and (ii) modulating the afferent sensory tissue will reduce the systemic contribution to hypertension and other disease states associated with increased central sympathetic tone through its direct effects on the posterior hypothalamus and the contralateral kidney. In addition to the central blood pressure-lowering effect of afferent renal denervation, a reduction in central sympathetic outflow to various other sympathetically innervated organs such as the heart and vascular system is expected.

[0130] As provided above, renal denervation may be valuable in the treatment of several clinical conditions characterized by overall increased activity and particularly increased renal sympathetic activity, such clinical conditions as hypertension, metabolic syndrome, insulin resistance, diabetes, left ventricular hypertrophy, chronic end-stage renal disease, inappropriate fluid retention in heart failure, cardiorenal syndrome, and sudden death. Since the reduction of afferent nerve signals contributes to a systemic decrease in sympathetic tone / activation, renal denervation can also be used to treat other conditions associated with excessive systemic sympathetic activity. Thus, renal denervation may also be beneficial to other organs and body structures innervated by the sympathetic nerves, including Figure 11 the organs and body structures identified in. For example, as previously discussed, a reduction in central sympathetic drive can reduce insulin resistance, which afflicts people with metabolic syndrome and type II diabetes. Additionally, patients with osteoporosis can also be sympathetically activated and may also benefit from a downregulation of sympathetic drive accompanying renal denervation.

[0131] According to the present technique, neuromodulation of the left and / or right renal plexus (RP) closely associated with the left and / or right renal artery can be achieved through an intravascular access. Figure 13 is an anatomical view of the arterial vasculature of a human. As Figure 13As shown, the blood moved by cardiac systole is delivered from the left ventricle of the heart through the aorta. The aorta travels downward through the chest and branches into the left renal artery and the right renal artery. Below the renal arteries, the aorta bifurcates into the left iliac artery and the right iliac artery. The left iliac artery and the right iliac artery travel downward respectively, pass through the left leg and the right leg, and connect with the left femoral artery and the right femoral artery.

[0132] Figure 14 is an anatomical view of the venous vasculature of a human. As Figure 14 shown, blood collects in the veins and returns to the heart, passing through the femoral vein into the iliac vein and into the inferior vena cava. The inferior vena cava branches into the left renal artery and the right renal artery. Above the renal veins, the inferior vena cava travels upward to deliver blood to the right atrium of the heart. The blood passes from the right atrium through the right ventricle and is pumped into the lungs, where it is oxygenated. The oxygenated blood is delivered from the lungs into the left atrium. The oxygenated blood is delivered back to the aorta from the left atrium through the left ventricle.

[0133] The femoral artery can be accessed and cannulated at the base of the femoral triangle directly below the midpoint of the inguinal ligament. A catheter can be percutaneously inserted into the femoral artery through this access site, passed through the iliac artery and the aorta, and placed into the left renal artery or the right renal artery. This includes an intravascular path that provides minimally invasive access to the corresponding renal artery and / or other renal vasculature.

[0134] The wrist, upper arm, and shoulder regions provide other locations for introducing a catheter into the arterial system. For example, catheterization of the radial artery, brachial artery, or axillary artery can be used in selected cases. A catheter introduced via these access points (e.g., catheter 102) can use standard angiographic techniques to pass through the subclavian artery on the left side (or via the subclavian artery and brachiocephalic artery on the right side), through the aortic arch, downward along the descending aorta, and into the renal artery. Other access sites can also be used to access the arterial system.

[0135] Since neuromodulation of the left and / or right renal plexus (RP) can be achieved by intravascular access according to the present technique, the nature and characteristics of the renal vasculature can impose constraints and / or inform the design of devices, systems, and methods for achieving such renal neuromodulation. Some of these nature and characteristics can vary over time across patient populations and / or within a particular patient, as well as in response to disease states such as hypertension, chronic kidney disease, vascular disease, end-stage renal disease, insulin resistance, diabetes, metabolic syndrome, etc. As explained herein, these nature and characteristics may have an impact on the efficacy of the procedure and the specific design of intravascular devices. The nature of interest can include, for example, material / mechanical, spatial, hydrodynamic / hemodynamic, and / or thermodynamic properties.

[0136] As previously discussed, a catheter can be advanced percutaneously through a minimally invasive endovascular path into the left or right renal artery. However, minimally invasive renal artery access can be challenging, for example, because the renal arteries are generally extremely tortuous, may have a relatively small diameter, and / or may have a relatively short length compared to some other arteries that are routinely accessed using a catheter. In addition, renal artery atherosclerosis is common in many patients, particularly those with cardiovascular disease. Renal artery anatomy can also vary significantly from patient to patient, further complicating minimally invasive access. For example, significant inter-patient differences can be seen in terms of relative tortuosity, diameter, length, and / or atherosclerotic plaque burden, as well as in terms of the takeoff angle of the renal artery from the aorta. In addition, some patients include multiple left renal arteries and / or right renal arteries. Devices, systems, and methods for achieving renal nerve modulation via an endovascular access should take into account these and other aspects of renal artery anatomy and its variation across patient populations when performing minimally invasive access to the renal artery.

[0137] In addition to complicating renal artery access, the details of renal anatomy also complicate the establishment of stable contact between a nerve modulation device and the luminal surface or wall of the renal artery. For example, the confined space within the renal artery and the tortuosity of the artery can impede navigation. In addition, establishing consistent contact is complicated by patient movement, respiration, and / or the cardiac cycle because these factors can cause significant movement of the renal artery relative to the aorta, and the cardiac cycle can transiently dilate the renal artery (i.e., cause arterial wall pulsation).

[0138] The nerve modulation device can also be configured to allow adjustable positioning and repositioning of the distal portion 108A and the inflatable portion 110 ( Figure 1 ) within the renal artery because the location of treatment can also affect clinical efficacy. Additionally, variable positioning and repositioning of the nerve modulation device can prove useful in cases where the renal artery is particularly tortuous or where there are proximal branch vessels present in the main renal artery vessel, which can make treatment at certain locations challenging.

[0139] As discussed above, a device positioned within a renal artery should be configured such that the expandable distal portion 108A of catheter 102 can closely contact the vessel wall and / or at least partially extend through the vessel wall. The renal artery vessel diameter DRA is typically in the range of about 2 mm to 10 mm, with a DRA of about 4 mm to about 8 mm for the majority of patient populations and an average of about 6 mm. The renal artery vessel length LRA between the ostium of the renal artery at the aorta / renal artery junction and its distal branches is typically in the range of about 5 mm to 70 mm, and a significant portion of the patient population is in the range of about 20 mm to 50 mm. Since the target renal plexus is embedded within the adventitia of the renal artery, the composite intima-media thickness IMT (i.e., the radial outward distance from the luminal surface of the artery to the adventitia containing the target nerve structures) is also significant and is typically in the range of about 0.5 mm to 2.5 mm, with an average of about 1.5 mm. Although a certain depth of treatment is important for reaching the target nerve fibers, the treatment should not be too deep (e.g., > 10 mm from the inner wall of the artery) to avoid non-target tissues and anatomical structures such as the digestive system of the psoas muscle.

[0140] An additional property of the renal artery that may be of interest is the degree of movement of the kidney relative to the aorta induced by respiration and / or blood flow pulsatility. The kidney of a patient located at the distal end of the renal artery can move cranially by up to 10 centimeters with respiratory excursions. This can impart significant movement to the renal artery connecting the aorta and the kidney, thus requiring a unique balance of rigidity and flexibility in a nerve modulation device to maintain contact between the energy delivery element and the vessel wall during the respiratory cycle. Additionally, the takeoff angle between the renal artery and the aorta can vary significantly between patients and can also vary dynamically within a patient, for example due to kidney movement. The takeoff angle is typically in the range of about 30° to 135°.

[0141] The above detailed description of examples of the technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. While specific examples of the technology have been described above for purposes of illustration, those skilled in the relevant art will recognize that various equivalent modifications can be made within the scope of the technology. For example, while steps are presented in a given order, alternative examples can perform the steps in a different order. Also, the various examples described herein can be combined to provide additional examples. All references cited herein are incorporated by reference as if fully set forth herein.

[0142] In view of the foregoing, it should be understood that specific examples of the disclosure have been described herein for purposes of illustration, but that various modifications can be made without departing from the scope of the disclosure.

[0143] In other examples, certain aspects of the present disclosure described in the context of a particular example may be combined or omitted. Additionally, while advantages associated with these examples have been described in the context of certain examples, other examples may also present such advantages, and not all examples must present such advantages to fall within the scope of the present disclosure. Accordingly, the present disclosure and the associated technology may cover other examples not expressly shown or described herein.

[0144] In addition, although techniques have been described for positioning a neuromodulation catheter at a single location within a single renal artery, in other examples, the neuromodulation catheter may be repositioned to a second treatment site within the single renal artery (e.g., proximal or distal to the first treatment site), may be repositioned into a branch of the single artery, may be repositioned into a different renal vessel on the ipsilateral side of the patient (e.g., a renal vessel associated with the same kidney of the patient), may be repositioned into a renal vessel on the contralateral side of the patient (e.g., a renal vessel associated with the other kidney of the patient), or any combination thereof. At each location where the neuromodulation catheter is positioned, renal neuromodulation may be performed using any of the techniques described herein or any other suitable renal neuromodulation technique or any combination thereof.

[0145] Moreover, unless the word "or" is explicitly limited to mean only a single item other than the other items in reference to a list of two or more items, "or" as used in such a list may be interpreted to include: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, unless otherwise specified, the term "about" or "approximately" when preceding a value should be interpreted to mean ±10% of the value. Additionally, the term "comprising" is used throughout to mean at least including the recited feature, such that any greater number of the same features and / or additional types of other features are not excluded.

[0146] The following examples are a non-limiting list of articles according to one or more techniques of the present disclosure.

[0147] Example 1. A catheter system, the catheter system comprising: a catheter including an elongate body defining a longitudinal axis, the elongate body including: an expandable portion; a treatment delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition to an expanded configuration and place the treatment delivery element in contact with a vessel wall at a first location; and a rotation member proximal to and separate from the expandable portion, the rotation member being configured to expand to rotate the expandable portion about the longitudinal axis and place the treatment delivery element in contact with the vessel wall at a second location.

[0148] Example 2. The catheter system according to Example 1, wherein the expandable portion is configured to expand radially away from the longitudinal axis to the expanded configuration.

[0149] Example 3. The catheter system according to any one of Examples 1 and 2, wherein the rotating member is configured to apply torque to the expandable portion to cause the expandable portion to rotate about the longitudinal axis.

[0150] Example 4. The catheter system according to any one of Examples 1 to 3, wherein the elongate body includes a distal portion that includes the expandable portion, and wherein expansion of the rotating member causes shortening of the axial length of the distal portion along the longitudinal axis.

[0151] Example 5. The catheter system according to any one of Examples 1 to 4, wherein the treatment delivery element includes an electrode.

[0152] Example 6. The catheter system according to any one of Examples 1 to 4, wherein the treatment delivery element includes an injection port.

[0153] Example 7. The catheter system according to any one of Examples 1 to 6, wherein the first position and the second position are disposed around the inner perimeter of the blood vessel and are separated by a predetermined angle.

[0154] Example 8. The catheter system according to Example 7, wherein the predetermined angle is from 45 degrees to 180 degrees.

[0155] Example 9. The catheter system according to Example 8, wherein the predetermined angle is 90 degrees.

[0156] Example 10. The catheter system according to Example 8, wherein the predetermined angle is 180 degrees.

[0157] Example 11. The catheter system according to any one of Examples 1 to 10, the catheter system further includes a guiding member configured to constrain the expandable portion and the rotating member in the contracted configuration.

[0158] Example 12. The catheter system according to Example 11, wherein the elongate body defines a catheter lumen, and wherein the guiding member is configured to be disposed within the catheter lumen.

[0159] Example 13. The catheter system according to Example 11, wherein the guiding member includes a guiding sheath defining a lumen configured to receive the catheter.

[0160] Example 14. The catheter system according to any one of Examples 11 to 13, wherein the rotating member is configured to expand to a position proximal to the rotating member in response to retraction of the guiding member.

[0161] Example 15. The catheter system according to any one of Examples 11 to 14, wherein the expandable portion is configured to expand to the expanded configuration in response to retraction of the guiding member to a position proximal to the expandable portion and distal to the rotating member, and to place the treatment delivery element in contact with the vessel wall at the first position.

[0162] Example 16. The catheter system according to any one of Examples 1 to 15, wherein the expandable portion and the rotating member are self-expanding.

[0163] Example 17. The catheter system according to any one of Examples 1 to 16, wherein the expanded configuration of the expandable portion includes a first expanded configuration that includes a first helix, loop, or coil, and wherein the rotating member is configured to expand to a second expanded configuration that includes a second helix, loop, or coil.

[0164] Example 18. The catheter system according to Example 17, wherein the first helix, loop, or coil and the second helix, loop, or coil are wound in the same direction.

[0165] Example 19. The catheter system according to Example 17, wherein the first helix, loop, or coil and the second helix, loop, or coil are wound in different directions.

[0166] Example 20. The catheter system according to any one of Examples 17 to 19, wherein the first expanded configuration defines a larger outer diameter than the second expanded configuration.

[0167] Example 21. The catheter system according to any one of Examples 1 to 20, wherein the elongate body includes an elongate tube configured to radially expand the expandable portion and the rotating member away from the longitudinal axis.

[0168] Example 22. The catheter system according to Example 21, wherein the elongate tube includes a shape memory material.

[0169] Example 23. The catheter system according to any one of Examples 1 to 22, wherein the rotating member includes a first rotating member, and the catheter system further includes a second rotating member proximal to the first rotating member, wherein the second rotating member is configured to expand to rotate the expandable portion about the longitudinal axis and to rotate the treatment delivery element from the second position to the third position.

[0170] Example 24. A catheter, the catheter comprising: an elongate body defining a longitudinal axis, the elongate body comprising: an expandable portion; a therapeutic delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition from a relatively low-profile configuration to a deployed configuration and place the therapeutic delivery element in engagement with a vessel wall at a first location; and a plurality of rotatable members proximal to and separated from the expandable portion, each of the plurality of rotatable members being configured to expand to rotate the expandable portion about the longitudinal axis and place the therapeutic delivery element in engagement with the vessel wall at a corresponding location among a plurality of locations.

[0171] Example 25. The catheter according to Example 24, wherein the expandable portion is configured to expand radially away from the longitudinal axis to the deployed configuration.

[0172] Example 26. The catheter according to any one of Examples 24 and 25, wherein each of the plurality of rotatable members is configured to apply a torque to the expandable portion to rotate the expandable portion about the longitudinal axis.

[0173] Example 27. The catheter according to any one of Examples 24 to 26, wherein the expansion of each of the plurality of rotatable members causes a shortening of the axial length of the elongate body along the longitudinal axis.

[0174] Example 28. The catheter according to any one of Examples 24 to 27, wherein at least two of the plurality of locations are separated by a predetermined angle.

[0175] Example 29. The catheter according to Example 28, wherein the predetermined angle is from 45 degrees to 180 degrees.

[0176] Example 30. The catheter according to Example 29, wherein the predetermined angle is 180 degrees.

[0177] Example 31. The catheter according to any one of Examples 24 to 30, wherein the catheter is configured to be constrained by a guiding member disposed over or within at least a portion of the elongate body.

[0178] Example 32. The catheter according to Example 31, wherein the expandable portion is configured to transition to the deployed configuration in response to the guiding member retracting to a position proximal to the expandable portion and distal to the plurality of rotatable members.

[0179] Example 33. The catheter according to Example 32, wherein the position is a first position, wherein a first rotating member of the plurality of rotating members is configured to expand to a second position proximal to the first rotating member in response to retraction of the guiding member, and wherein a second rotating member of the plurality of rotating members is configured to expand to a third position proximal to the second rotating member in response to retraction of the guiding member.

[0180] Example 34. The catheter according to any one of Examples 24 to 33, wherein the deployment configuration of the expandable portion includes a first deployment configuration defining a first spiral, loop or helix, and wherein each rotating member of the plurality of rotating members is configured to deploy to a corresponding deployment configuration among a plurality of deployment configurations, each of the plurality of deployment configurations defining a corresponding spiral, loop or helix among a plurality of spirals, loops or helices.

[0181] Example 35. The catheter according to Example 34, wherein the first spiral, loop or helix and one or more of the plurality of spirals, loops or helices are wound in the same direction.

[0182] Example 36. The catheter according to Example 34, wherein the first spiral, loop or helix and one or more of the plurality of spirals, loops or helices are wound in different directions.

[0183] Example 37. The catheter according to any one of Examples 24 to 36, wherein the elongated body includes an elongated tube configured to radially expand one or more of the expandable portions or one or more of the plurality of rotating members away from the longitudinal axis when unconstrained.

[0184] Example 38. The catheter according to Example 37, wherein the elongated tube includes a shape memory material.

[0185] Example 39. The catheter according to any one of Examples 24 to 38, wherein the expandable portion and the plurality of rotating members are configured to self-expand.

[0186] Example 40. The catheter according to any one of Examples 24 to 39, wherein the treatment delivery element includes one or more electrodes.

[0187] Example 41. The catheter according to any one of Examples 24 to 40, wherein the treatment delivery element includes one or more injection ports.

[0188] Example 2. A method, the method comprising: advancing a catheter through a vasculature to a target tissue site within a patient's blood vessel, the catheter including an elongate body defining a longitudinal axis, the elongate body including: an inflatable portion; a treatment delivery element disposed on the inflatable portion; and a rotating member proximal to and separated from the inflatable portion; inflating the inflatable portion to place the treatment delivery element in contact with the vessel wall of the blood vessel at a first position; delivering treatment through the vessel wall at the first position via the treatment delivery element to the patient's tissue; inflating the rotating member to rotate the inflatable portion within the blood vessel and place the treatment delivery element in contact with the vessel wall at a second position; and delivering the treatment through the vessel wall at the second position via the treatment delivery element to the patient's tissue.

[0189] Example 43. The method according to Example 42, wherein the first position and the second position are circumferentially disposed around the blood vessel and are separated by a predetermined angle.

[0190] Example 44. The method according to Example 43, wherein the predetermined angle is from 45 degrees to 180 degrees.

[0191] Example 45. The method according to Example 44, wherein the predetermined angle is 180 degrees.

[0192] Example 46. The method according to Example 44, wherein the predetermined angle is 90 degrees.

[0193] Example 47. The method according to any one of Examples 42 to 46, wherein inflating the rotating member includes: applying a torque to the inflatable portion to rotate the inflatable portion about the longitudinal axis.

[0194] Example 48. The method according to any one of Examples 42 to 47, wherein the elongate body includes a distal portion, the distal portion including the inflatable portion, and wherein inflating the rotating member shortens the axial length of the distal portion of the elongate body along the longitudinal axis.

[0195] Example 49. The method according to any one of Examples 42 to 48, wherein inflating the inflatable portion: includes retracting a guide member to a first position proximal to the inflatable portion and distal to the rotating member to inflate the inflatable portion to an inflated configuration.

[0196] Example 50. The method according to Example 49, wherein expanding the rotatable member comprises: retracting the guide member to a second position proximal to the rotatable member to radially expand the expandable portion away from the longitudinal axis.

[0197] Example 51. The method according to any one of Examples 42 to 50, wherein expanding the expandable portion comprises: expanding the expandable portion to a first expanded configuration including a first helix, loop or spiral, and wherein expanding the rotatable member comprises: expanding the expandable portion to a second expanded configuration including a second helix, loop or spiral.

[0198] Example 52. The method according to any one of Examples 42 to 51, wherein the catheter comprises an elongate tube disposed within the elongate body, the elongate tube comprising a shape memory material.

[0199] Example 53. The method according to Example 52, wherein the shape memory material comprises nitinol.

[0200] Example 54. A method of forming a catheter according to any one of Examples 1 to 41.

[0201] Further disclosed herein is the subject matter of the following clauses:

[0202] 1. A catheter system, the catheter system comprising:

[0203] A catheter comprising an elongate body defining a longitudinal axis, the elongate body comprising:

[0204] An expandable portion;

[0205] A treatment delivery element disposed on the expandable portion, wherein the expandable portion is configured to transition from a delivery configuration to an expanded configuration and place the treatment delivery element in contact with a vessel wall at a first location; and

[0206] A rotatable member proximal to and separate from the expandable portion, the rotatable member being configured to expand to rotate the expandable portion about the longitudinal axis and place the treatment delivery element in contact with the vessel wall at a second location.

[0207] 2. The catheter system according to clause 1, wherein the expandable portion is configured to radially expand away from the longitudinal axis to the expanded configuration.

[0208] 3. The catheter system according to any one of clauses 1 and 2, wherein the rotatable member is configured to apply a torque to the expandable portion to rotate the expandable portion about the longitudinal axis.

[0209] 4. The catheter system according to any one of clauses 1 to 3, wherein the elongate body includes a distal portion, the distal portion includes the expandable portion, and wherein expansion of the rotatable member causes shortening of the axial length of the distal portion along the longitudinal axis.

[0210] 5. The catheter system according to any one of clauses 1 to 4, wherein the treatment delivery element includes at least one of an electrode or an injection port.

[0211] 6. The catheter system according to any one of clauses 1 to 5, wherein the first position and the second position are disposed around the inner perimeter of the blood vessel and are separated by a predetermined angle.

[0212] 7. The catheter system according to clause 6, wherein the predetermined angle is between 45 degrees and 180 degrees, or wherein the predetermined angle is 90 degrees, or wherein the predetermined angle is 180 degrees.

[0213] 8. The catheter system according to any one of clauses 1 to 7, the catheter system further including a guide member configured to constrain the expandable portion in the delivery configuration and to constrain the rotatable member in the retracted configuration.

[0214] 9. The catheter system according to clause 8, wherein the elongate body defines a catheter lumen, and wherein the guide member is configured to be disposed within the catheter lumen.

[0215] 10. The catheter system according to clause 8, wherein the guide member includes a guide sheath defining a lumen configured to receive the catheter.

[0216] 11. The catheter system according to any one of clauses 8 to 10, wherein the rotatable member is configured to expand to a position proximal to the rotatable member in response to withdrawal of the guide member.

[0217] 12. The catheter system according to any one of clauses 8 to 11, wherein the expandable portion is configured to expand to the expanded configuration in response to the guide member being withdrawn to a position proximal to the expandable portion and distal to the rotatable member, and to place the treatment delivery element in contact with the vessel wall at the first position.

[0218] 13. The catheter system according to any one of clauses 1 to 12, wherein the expandable portion and the rotatable member are self-expanding.

[0219] 14. The catheter system according to any one of clauses 1 to 24, wherein the expansion configuration of the expandable portion includes a first expansion configuration, the first expansion configuration including a first helix, loop or spiral, and wherein the rotating member is configured to expand to a second expansion configuration, the second expansion configuration including a second helix, loop or spiral.

[0220] 15. The catheter system according to clause 14, wherein the first helix, loop or spiral and the second helix, loop or spiral are wound in the same direction, or wherein the first helix, loop or spiral and the second helix, loop or spiral are wound in different directions.

[0221] 16. The catheter system according to any one of clauses 14 to 15, wherein the first expansion configuration defines a larger outer diameter than the second expansion configuration.

[0222] 17. The catheter system according to any one of clauses 1 to 16, wherein the elongate body includes an elongate tube configured to expand the expandable portion and the rotating member radially away from the longitudinal axis.

[0223] 18. The catheter system according to clause 17, wherein the elongate tube comprises a shape memory material.

[0224] 19. The catheter system according to any one of clauses 1 to 18, wherein the rotating member includes a first rotating member, and the catheter system further includes a second rotating member proximal to the first rotating member, wherein the second rotating member is configured to expand to rotate the expandable portion about the longitudinal axis and to rotate the treatment delivery element from the second position to the third position.

Claims

1. A catheter system, the catheter system comprising: A catheter, the catheter including an elongate body defining a longitudinal axis, the elongate body including: An inflatable portion; A treatment delivery element disposed on the inflatable portion, wherein the inflatable portion is configured to transition from a delivery configuration to an inflated configuration and place the treatment delivery element in engagement with a vessel wall at a first location; and A rotation member proximal to and separated from the inflatable portion, the rotation member being configured to inflate to rotate the inflatable portion about the longitudinal axis and place the treatment delivery element in engagement with the vessel wall at a second location.

2. The catheter system according to claim 1, wherein the expandable portion is configured to expand radially away from the longitudinal axis to the expanded configuration.

3. The catheter system according to any one of claims 1 and 2, wherein the rotating member is configured to apply torque to the expandable portion to cause the expandable portion to rotate about the longitudinal axis.

4. The catheter system according to any one of claims 1 to 3, wherein the elongate body includes a distal portion, the distal portion including the expandable portion, and wherein expansion of the rotating member causes shortening of the axial length of the distal portion along the longitudinal axis.

5. The catheter system according to any one of claims 1 to 4, wherein the treatment delivery element includes at least one of an electrode or an injection port.

6. The catheter system according to any one of claims 1 to 5, wherein the first position and the second position are disposed around the inner perimeter of a blood vessel and are separated by a predetermined angle.

7. The catheter system according to claim 6, wherein the predetermined angle is between 45 degrees and 180 degrees, or wherein the predetermined angle is 90 degrees, or wherein the predetermined angle is 180 degrees.

8. The catheter system according to any one of claims 1 to 7, the catheter system further comprising a guiding member configured to constrain the expandable portion in the delivery configuration and to constrain the rotating member in the retracted configuration.

9. The catheter system according to claim 8, wherein the elongate body defines a catheter lumen, and wherein the guiding member is configured to be disposed within the catheter lumen.

10. The catheter system according to claim 8, wherein the guiding member includes a guiding sheath defining a lumen configured to receive the catheter.

11. The catheter system according to any one of claims 8 to 10, wherein the rotating member is configured to expand to a position proximal to the rotating member in response to retraction of the guiding member.

12. The catheter system according to any one of claims 8 to 11, wherein the expandable portion is configured to expand to the expanded configuration and place the treatment delivery element in contact with the vessel wall at the first position in response to the guide member being withdrawn to a position proximal to the expandable portion and distal to the rotating member.

13. The catheter system according to any one of claims 1 to 12, wherein the expandable portion and the rotating member are self-expanding.

14. The catheter system according to any one of claims 1 to 24, wherein the expanded configuration of the expandable portion includes a first expanded configuration that includes a first helix, loop, or coil, and wherein the rotating member is configured to expand to a second expanded configuration that includes a second helix, loop, or coil.

15. The catheter system according to claim 14, wherein the first helix, loop, or coil and the second helix, loop, or coil are wound in the same direction, or wherein the first helix, loop, or coil and the second helix, loop, or coil are wound in different directions.

16. The catheter system according to any one of claims 14 to 15, wherein the first expanded configuration defines a larger outer diameter than the second expanded configuration.

17. The catheter system according to any one of claims 1 to 16, wherein the elongate body includes an elongate tube configured to radially expand the expandable portion and the rotating member away from the longitudinal axis.

18. The catheter system according to claim 17, wherein the elongate tube comprises a shape memory material.

19. The catheter system according to any one of claims 1 to 18, wherein the rotating member includes a first rotating member, and the catheter system further includes a second rotating member proximal to the first rotating member, wherein the second rotating member is configured to expand to rotate the expandable portion about the longitudinal axis and rotate the treatment delivery element from the second position to the third position.

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