Neuromodulation catheter

Abstract

In some examples, a neuromodulation catheter includes an elongate body extending along a longitudinal axis, at least one therapy delivery element, and at least one reinforcement wire. The at least one therapy delivery element may be disposed on the expandable portion of the elongate body. The expandable portion may be configured to transition from a relatively low profile configuration to an expanded deployed configuration. The at least one reinforcement wire comprises a shape memory material and extends at least partially along the expandable portion.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 579,690, filed August 30, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates in its entirety to neuromodulation catheters, and to catheters comprising at least one therapeutic delivery element for neuromodulation. Background Technology

[0003] Catheters have been proposed for use in various medical procedures. For example, catheters can be configured to deliver neuromodulation therapies to target tissue sites to alter the activity of nerves at or near the target tissue site. Nerves can be, for example, the sympathetic nervous system. The sympathetic nervous system (SNS) is the primary involuntary bodily control system commonly associated with stress responses. Chronic overactivation of the SNS is an adaptive response that can drive the progression of many disease states. For example, overactivation of the renal SNS has been identified in experiments and in humans as a possible cause of the complex pathophysiology of arrhythmias, hypertension, states of volume overload (e.g., heart failure), and progressive kidney disease. Summary of the Invention

[0004] In general, this disclosure describes systems, techniques and devices for neuromodulation, and neuromodulation conduits including at least one reinforcing line configured to facilitate substantially proportional movement of at least one therapeutic delivery element.

[0005] For example, a neuromodulation catheter used in renal denervation procedures can be configured to transition from a relatively low-profile delivery configuration to a radially expanding (unfolding) configuration. For instance, the expandable portion of the catheter can be configured from a substantially straight configuration to a helical or spiral configuration that positions at least one therapeutic delivery element of the catheter against the vessel wall. The at least one therapeutic delivery element may include one or more electrodes or another energy delivery element. The proximal portion of the catheter may be coupled to a handle that can be used to manipulate the expandable portion. For example, a clinician can translate or rotate the handle to cause translation or rotation of the expandable portion.

[0006] The at least one reinforcing wire is configured, for example, to facilitate controlled or predictable rotation of the expandable portion in response to rotation of the proximal conduit portion of the neuromodulation conduit relative to the central longitudinal axis of the elongated body of the neuromodulation conduit. Compared to conduits without at least one reinforcing wire, the neuromodulation conduit according to this disclosure allows for better rotational control of the expandable portion. For example, the at least one reinforcing wire can transmit torque from the proximal portion to the expandable portion and / or resist deformation of the expandable portion, such that rotation of the proximal conduit portion results in substantially proportional rotation of the distal conduit portion. Therefore, clinicians can be able to control the orientation of at least one therapy delivery element (e.g., relative to the target therapy site). In some examples, clinicians can orient at least one therapy delivery element multiple times during a medical procedure and deliver therapy using multiple orientations or locations of at least one electrode during the procedure. For example, delivering therapy at different orientations of at least one electrode can generate circumferential (e.g., spiral or circular), arcuate, or semi-circular therapy delivery patterns.

[0007] The apparatus, system, and technology according to this disclosure can, for example, facilitate the delivery of a predetermined pattern of neuromodulation therapy at a target site by providing clinicians with sufficient control over the orientation and position of at least one therapy delivery element relative to the target site.

[0008] In some examples according to this disclosure, an example neural modulation conduit includes an elongated body extending along a longitudinal axis, at least one therapeutic delivery element, and at least one reinforcing wire. The at least one therapeutic delivery element may be disposed on an expandable portion of the elongated body. The expandable portion may be configured to transition from a relatively low-profile configuration to an expanded configuration. The at least one reinforcing wire may contain shape memory material and extend at least partially along the expandable portion.

[0009] In some examples according to this disclosure, a neuromodulation system includes a neuromodulation conduit and a control circuit configured to control the neuromodulation conduit to deliver neuromodulation therapy.

[0010] In some examples according to this disclosure, a method of forming a neuromodulation conduit includes forming an elongated body comprising at least one therapeutic delivery element disposed on an expandable portion. The expandable portion is configured to transition from a relatively low-profile configuration to an expanded configuration. The method may further include attaching at least one reinforcing wire comprising shape memory material to the elongated body such that the at least one reinforcing wire extends at least partially along the expandable portion.

[0011] In some examples according to this disclosure, a method includes traveling a neuromodulation catheter through a vascular system to a target tissue site within a patient's blood vessel. The neuromodulation catheter includes an elongated body extending along a longitudinal axis, at least one therapy delivery element disposed on an expandable portion of the elongated body, and at least one reinforcing filament. The expandable catheter portion is configured to transition from a relatively low-profile configuration to an expanded configuration. The at least one reinforcing filament may comprise a shape memory material and extends at least partially along the expandable portion. The method may further include expanding the expandable portion to position the at least one therapy delivery element at a location against the vessel wall of the blood vessel. The method may further include delivering therapy to the patient's tissue at that location via the at least one therapy delivery element through the vessel wall.

[0012] This document further discloses a neuromodulation conduit comprising an elongated body extending along a longitudinal axis, at least one therapeutic delivery element, and at least one reinforcing line, wherein the at least one therapeutic delivery element may be disposed on an expandable portion of the elongated body, wherein the expandable portion may be configured to transition from a relatively low-profile configuration to an expanded unfolded configuration, and wherein the at least one reinforcing line comprises a shape memory material and extends at least partially along the expandable portion.

[0013] Details of one or more examples of the technology disclosed herein are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages of these technologies will be apparent from the specification, drawings, and claims. Attached Figure Description

[0014] Figure 1 A frontal view of an example system including a neuromodulation catheter is shown, which includes at least one therapy delivery element and at least one reinforcing line.

[0015] Figure 2A The radially expanded (unfolded) configuration is shown. Figure 1 A partial frontal view of the expandable portion of a neuromodulation conduit.

[0016] Figure 2B It shows the radially expanded configuration. Figure 2A A partial top view of the expandable portion of the neuromodulation conduit.

[0017] Figure 3 A partial front view of an example neuromodulation conduit is shown, which includes an expandable portion extending along a first helical path and at least one reinforcing line extending along a second helical path clockwise around the first helical path.

[0018] Figure 4A partial front view of an example neuromodulation conduit is shown, which includes an expandable portion extending along a first helical path and at least one reinforcing line extending along a second helical path counterclockwise around the first helical path.

[0019] Figure 5 A partial front view of an example neuromodulation conduit is shown, which includes multiple therapy delivery elements and at least one reinforcing line extending between the distal therapy delivery elements.

[0020] Figure 6 A partial front view of an example neuromodulation conduit is shown, which includes multiple therapy delivery elements and at least one reinforcing line extending between intermediate elements of the multiple therapy delivery elements but not between the terminal therapy delivery elements.

[0021] Figure 7 A partial frontal view of an example neuromodulation catheter is shown, which includes at least one therapy delivery element and at least one reinforcing line extending proximally from the at least one therapy delivery element.

[0022] Figure 8 A cross-sectional view of an example neuromodulation conduit including at least one reinforcing line surrounded by a polymer sheath is shown, the cross-section being cut in a direction orthogonal to the longitudinal axis of the neuromodulation conduit.

[0023] Figure 9 A cross-sectional view of an example neuromodulation conduit is shown, which includes at least one reinforcing line within a polymer sheath surrounding an elongated body. The cross-section is taken in a direction orthogonal to the longitudinal axis of the neuromodulation conduit.

[0024] Figure 10 A cross-sectional view of an example neuromodulation catheter is shown, which includes at least one reinforcing line between a first polymer sheath and a second polymer sheath surrounding an elongated body.

[0025] Figure 11 A front view of an example system including a neuromodulation catheter is shown, which includes at least one therapy delivery element and at least one electrically actuable reinforcing wire.

[0026] Figure 12 A cross-sectional view of an example neuromodulation conduit including a helical hollow strand comprising at least one reinforcing line is shown, the cross-section being cut in a direction orthogonal to the longitudinal axis of the neuromodulation conduit.

[0027] Figure 13 This is a flowchart of an example technique for forming a neural modulation conduit.

[0028] Figure 14 This is a flowchart of an example technique for delivering neuromodulation therapy using a neuromodulation catheter.

[0029] Figure 15 Examples of exploitation according to this disclosure are shown. Figure 1 This is an example of a systemic technique for accessing the renal artery and modulating the renal nerves.

[0030] Figure 16 This is an example illustration of the sympathetic nervous system (SNS), showing how the brain communicates with the body via the SNS.

[0031] Figure 17 This is an enlarged anatomical view of the nerves that innervate the left kidney to form the renal plexus surrounding the left renal artery.

[0032] Figure 18 It is an anatomical view of the human body, depicting the efferent and afferent neural communication between the brain and kidneys.

[0033] Figure 19 It is a conceptual view of the human body, depicting the neural efferent and afferent communication between the brain and the kidneys.

[0034] Figure 20 It is an anatomical view of the human arterial vascular system.

[0035] Figure 21 This is an anatomical view of the human venous system. Detailed Implementation

[0036] This disclosure describes catheters, methods for forming catheters, and methods for delivering therapies, which can be used in any suitable medical procedure, including neuromodulation (e.g., renal nerve modulation). While this document primarily describes neuromodulation and renal denervation, the devices, systems, and techniques described herein can be applied to other types of therapies, including other types of neuromodulation, such as neuromodulation performed on nerves other than renal nerves, at sites other than renal vessels, or on both. Generally, the devices, systems, and techniques described herein can be used to perform neuromodulation from nerves having adjacent anatomical cavities. Furthermore, the systems, devices, and methods described herein can be used for intracavitary neuromodulation other than vascular neuromodulation, for extravascular neuromodulation, and / or for therapies other than neuromodulation.

[0037] As used herein, the terms “distal” and “proximal” define a location or orientation relative to the treating clinician or the clinician’s control device (e.g., a handle assembly). “Distal” or “distally” can refer to a location remote from or in a direction remote from the clinician or the clinician’s control device. “Proximal” and “proximal” can refer to a location near or toward the clinician or the clinician’s control device.

[0038] Neuromodulation, such as renal denervation, can be accomplished using one or more of a variety of therapeutic modalities, including delivery of radiofrequency (RF) energy, microwave energy, ultrasound energy, thermal energy (e.g., direct heat), light energy, cryocooling, chemical reagents, 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 neuromodulation catheter includes: an elongated body; and at least one therapeutic delivery element disposed on a radially expandable portion of the elongated body. The at least one therapeutic delivery element may include, for example, an electrode, an ultrasound transducer, a needle configured to deliver a chemical reagent, or a fluid injection port. While at least one therapeutic delivery element may be disposed on a distal portion of the elongated body of the neuromodulation catheter, in other examples, other portions of the elongated body may include at least one therapeutic delivery element.

[0039] The expandable portion of the catheter body is configured to unfold from a relatively low-profile configuration to a radially expanding configuration (e.g., helical, spiral, loop, etc.). In the radially expanding configuration (also referred to herein as the unfolding configuration), the expandable portion is configured to position at least one therapy delivery element against the vessel wall to facilitate therapy delivery to the patient's tissues, such as tissues surrounding the vessel wall, extravascular tissues, etc. In the expanding configuration, at least some portions of the neuromodulation catheter expand radially away from the central longitudinal axis of a more proximal portion of the neuromodulation catheter (such as the proximal portion of the elongated catheter body). This radial movement away from the central longitudinal axis allows at least one therapy delivery element to contact the vessel wall or other tissue of interest.

[0040] Clinicians can introduce the expandable portion of a catheter into the patient's anatomy, with the proximal portion of the elongated body remaining outside the patient and available for manipulation. Clinicians can move and orient at least one therapy delivery element by manipulating at least the neuromodulation catheter, for example, to orient at least one therapy delivery element relative to a target therapy site. This may include, for example, positioning the expandable portion of the catheter at the target therapy site. After the clinician has placed the expandable portion at the target tissue site within the patient and deployed the expandable portion to a radially expanded state, the clinician can deliver therapy, for example, for denervation procedures or other therapies, to the patient's tissue via at least one therapy delivery element.

[0041] In the deployed configuration of the catheter, at least one therapy delivery element may be initially placed at one of a plurality of target locations. Clinicians may need to reposition (e.g., advance distally, retract proximally, and / or rotate about a central longitudinal axis) the neuromodulation catheter to deliver therapy to other locations among the plurality of target locations. Therefore, clinicians may deliver therapy at multiple locations along and / or around the vessel to increase the efficacy of the therapy. In some examples, the multiple locations are distributed circumferentially around the vessel wall, for example, separated by predetermined angles (e.g., 90°, 120°, or 180°, or any other suitable angle). In some examples, the multiple locations are distributed longitudinally along the vessel wall. Clinicians may also seek to deliver therapy to different locations, for example, to increase the efficacy of the therapy, reduce the likelihood of unexpected effects, or to deliver uniform therapy at different locations or orientations. In such examples, clinicians may rotate the catheter within the vessel to place the therapy delivery element at different locations around the periphery (e.g., circumference) of the vessel. Therefore, clinicians can translate or rotate the proximal portion, thereby causing translation or rotation of the expandable portion, and thus causing translation or rotation of at least one therapeutic delivery element.

[0042] Clinicians can anticipate or seek symmetrical motion of the expandable portion (or at least one therapy delivery element) in response to a corresponding movement of the proximal portion, allowing for sufficient control over the orientation of at least one therapy delivery element relative to the target therapy site. For example, symmetrical motion can result in a 1:1 correspondence between the expandable portion and the proximal portion in response to rotation or translation of the proximal portion. In some examples, symmetrical motion may not achieve a 1:1 motion correspondence between the proximal portion and the expandable portion, but rather another predetermined or predictable correspondence, such as a 2:1, 3:2, 4:3, 5:4, or 3:1 correspondence, or any other correspondence.

[0043] Clinicians can rotate (e.g., at the proximal portion of the elongated body) a handle coupled to the elongated body to rotate the expandable portion within the blood vessel. Clinicians can apply torque to the handle and / or proximal portion by rotating the handle and / or proximal portion at least about the central longitudinal axis of the handle. The elongated body can propagate the applied torque along its length to the expandable portion of the catheter body to rotate the expandable portion and at least one therapy delivery element within the blood vessel (e.g., relative to the central longitudinal axis along which the elongated body extends). However, the material properties and placement of the catheter through the relatively tortuous vascular system may make it relatively difficult for clinicians to transmit rotational force from the proximal portion of the catheter to the expandable portion or to control the rotation of the expandable portion within the blood vessel in a predictable manner. Rotation of the proximal portion of the elongated body may not result in proportional rotation of the expandable portion. For example, the expandable portion may lag in rotation relative to the proximal portion due to insufficient torque transmission from the proximal portion to the expandable portion.

[0044] The handle may be made of a different material than the elongated body, and torque transmission across different materials with different material properties may result in insufficient rotation of the expandable portion and / or reduced ability to adequately control the rotation of the expandable portion of the catheter body. Furthermore, the elongated body may be relatively flexible to allow navigation through the patient's vascular system. The flexibility of the elongated body can cause it to resist torque transmission along its length. Therefore, insufficient torque transmission may be caused by the relative flexibility or compliant material of the elongated body, which may resist rotation at the expandable portion in response to rotation at the proximal portion. When deployed via the guide catheter, the neuromodulation catheter may also encounter rotational resistance within or relative to the guide catheter, making it more difficult to achieve predictable rotation of at least one therapeutic delivery element.

[0045] In such examples, clinicians may need to over-rotate the proximal portion of the handle and / or elongated body to rotate the expandable portion within the blood vessel by a predetermined amount. Therefore, to achieve the predetermined rotation of the expandable portion (and thus at least one therapeutic delivery element), clinicians may need to rotate the proximal portion significantly beyond the target rotation of the expandable portion. For example, clinicians may need to rotate the proximal portion by more than 90°, 120°, or 180° to achieve 90°, 120°, or 180° rotation of the expandable portion, respectively.

[0046] In some cases, rotation of the handle and / or the proximal portion of the elongated body by the clinician may cause stress release within the catheter and result in over-rotation or “jittering” of the expandable portion, such as a delayed response of the catheter to the clinician’s rotational movements, which may be caused by spring torsion. Insufficient or excessive rotation of the expandable portion and / or a reduced ability to precisely control the rotation of the expandable portion may lead to one or more difficulties in neuromodulation procedures. For example, due to the increased difficulty in precisely manipulating the expandable portion, clinicians may need to spend a relatively long time positioning the expandable portion to the desired location. While neuromodulation can still be effective, the efficacy of neuromodulation therapy may be reduced if the therapy is not delivered to the intended location (e.g., a location in the blood vessel near the target nerve to be ablated) and / or if the therapy is delivered to an unintended location (e.g., a non-target nerve or other non-target tissue). Delivering neuromodulation therapy to non-target tissue may lead to unintended results.

[0047] In some examples according to this disclosure, an example neuromodulation catheter includes an elongated body extending along a central longitudinal axis, at least one therapeutic delivery element, and at least one reinforcing wire. The at least one therapeutic delivery element may be disposed on an expandable portion of the elongated body, which in some examples is located at a distal portion of the elongated body. The expandable portion is configured to transition from a relatively low-profile configuration to a radially expanding configuration. In some examples, the at least one reinforcing wire comprises a shape memory material and extends at least partially along the expandable portion. The at least one reinforcing wire, either alone or independently, is insufficient to cause the expandable portion to expand, unfold, or transition to a radially expanding configuration from a relatively low-profile configuration. Without being bound by theory, the at least one reinforcing wire may facilitate the transmission of force or torque between the proximal portion of the elongated body and the expandable portion, such that corresponding movements of the expandable portion and the proximal portion are substantially proportional (e.g., one or both of translation or rotation). Therefore, the neuromodulation catheter according to this disclosure can provide clinicians with better control over the intravascular position of the expandable portion (when unfolded into a radially expanding unfolded configuration) and better control over the orientation of the at least one therapeutic delivery element within the blood vessel. Therefore, compared to neuromodulation catheters that do not include at least one reinforcing wire, the neuromodulation catheters described herein that include at least one reinforcing wire allow the corresponding neuromodulation catheters to be positioned intravascularly with less adjustment.

[0048] In some examples, at least one reinforcing line can provide a 1:1 motion correspondence between the proximal portion and the expandable portion, such that a specific amplitude of one or both of the translation or rotation of the proximal portion results in the same amplitude of one or both of the translation or rotation of the expandable portion (or at least one therapeutic delivery element). In other examples, commensurate motion may not result in a 1:1 motion correspondence, but rather in some other predictable, predetermined, or otherwise known motion correspondence between the proximal portion and the expandable portion, allowing the clinician to still move the expandable portion to a predetermined orientation by moving the proximal portion with sufficient compensating motion. At least one reinforcing line can facilitate predictable motion or orientation of the expandable portion in one or both of a relatively low-profile configuration or an expanded configuration.

[0049] Therefore, at least one reinforcing wire allows for relatively precise control of the placement of at least one therapeutic delivery element at one or more locations, for example, by removing resistance to rotation from the material properties or tortuosity of the elongated body. Control over the placement of at least one therapeutic delivery element can lead to increased efficacy of neuromodulation therapy and a reduced likelihood of unintended effects as a result of neuromodulation therapy.

[0050] At least one reinforcing wire provides sufficient mechanical connection between the proximal and distal portions of the catheter, such that movement of the proximal portion results in a predetermined or known corresponding movement of the distal portion. Compared to catheters without at least one reinforcing wire, at least one reinforcing wire provides better torque transmission without affecting electrode position or the ability to straighten the catheter. In some examples, at least one reinforcing wire comprises a shape memory material (e.g., nitinol) and mimics the shape of a shape memory member (e.g., a helical member or a helical hollow strand member) present in the distal portion of the catheter, thereby providing better torque transmission from the proximal portion to the distal portion compared to catheters without at least one reinforcing wire. In some examples, the shape memory member in the distal portion that shapes the expandable portion (e.g., in a helical shape in an unfolded configuration) is sensitive to the direction of torsion. In some such examples, at least one reinforcing wire comprising a single strand can transmit torque more predictably than the shape memory member itself. Therefore, compared to catheters that include a shape memory member but do not include at least one reinforcing wire, providing at least one reinforcing wire in addition to the shape memory member results in more proportionate movement of the expandable portion relative to the proximal portion.

[0051] Figure 1 A frontal view of an example system 10 including a neuromodulation catheter 12 is shown, which includes at least one therapy delivery element 14 and at least one reinforcing line 16.

[0052] The catheter 12 also includes a handle 18 and an elongated body 20 attached to the handle 18. That is, the handle 18 is positioned at the proximal portion of the elongated body 20. The elongated body 20 may have any suitable outer diameter, and this outer diameter may be constant along the length of the elongated body 20 or may vary along the length of the elongated body 20. In some examples, the elongated body 20 may be 2 French, 3 French, 4 French, 5 French, 6 French, or 7 French, or other suitable sizes. The elongated body 20 extends along a central longitudinal axis L and includes a distal portion 20A and a proximal portion 20B. The distal portion 20A includes an expandable portion 22. The expandable portion 22 is configured from a relatively low profile configuration ( Figure 1 As shown) transforms into a radially expanding unfolded configuration ( Figure 2A and Figure 2B (as shown in the image).

[0053] exist Figure 1 In the example shown, at least one therapeutic delivery element 14 is disposed on an expandable portion 22 of an elongated body 20. The at least one therapeutic delivery element 14 is configured to deliver a therapy to a patient's tissue, for example, to neuromodulate a target nerve in the patient. The at least one therapeutic delivery element 14 may include, but is not limited to, one or more electrodes, one or more ultrasound transducers, one or more needles configured to deliver a therapeutic agent directly or indirectly, one or more heating or freezing therapeutic delivery devices (e.g., balloons), one or more injection ports configured to deliver a therapeutic agent, or any combination thereof. In some examples, each of the at least one therapeutic delivery element 14 is an electrode. In some examples, the at least one therapeutic delivery element 14 includes a ring electrode that surrounds a portion of the elongated body 20. The at least one therapeutic delivery element 14 may be connected to a therapeutic delivery device via at least one electrical conductor and / or at least one lumen defined by the elongated body 20 and / or handle 18, the therapeutic delivery device including control circuitry and a therapeutic source (e.g., an electrical signal generator, a therapeutic agent source, a cryogenic therapeutic agent source, etc.). Figure 1 (Not shown in the image). Although Figure 1 The catheter 12 is illustrated as having four therapy delivery elements 14, but other example catheters may include one, two, three, five, or more therapy delivery elements 14. In some examples, such as Figure 1 As shown, at least one therapeutic delivery element 14 includes four electrodes, for example, four ring electrodes.

[0054] The distal portion 20A of the elongated body 20 is configured to advance within an anatomical cavity of a human patient to position at least one therapeutic delivery element 14 within or otherwise near a target tissue site within the anatomical cavity. For example, the elongated body 20 may be configured to position the distal portion 20A within a blood vessel, ureter, urethra, conduit, airway, or another naturally occurring lumen within the human body. The examples described herein focus on anatomical cavities such as blood vessels (e.g., renal vessels); however, it should be understood that similar techniques can be used for other anatomical cavities.

[0055] The neuromodulation catheter 12 can be configured for delivery via a guiding member to a target tissue site within a patient's vascular system, the guiding member including, for example, one or more of a guidewire or an outer sheath. In some examples, intravascular delivery of the distal portion 20A includes placing a guidewire ( Figure 1 (Not shown in the image) The elongated body 20 (e.g., at least the expandable portion 22) is percutaneously inserted into a patient's blood vessel and moved along the guidewire until the expandable portion 22 reaches the target tissue site (e.g., the renal artery). For example, the distal portion 20A of the elongated body 20 may define a lumen configured to receive the guidewire for delivery of the expandable portion 20 to the target tissue site using an overall over-the-wall (OTW) or rapid over-the-wall (RX) technique. In other examples, the neuromodulation catheter 12 may be a manipulable or non-manipulable device configured for use without a guidewire. In other examples, the neuromodulation catheter 12 may be configured to be used via a guiding member (e.g., a guiding catheter, an outer sheath). Figure 1 Delivery into the cavity of (not shown in the image) or other guiding devices.

[0056] The distal end of the elongated body 20 defines a distal tip 26. The distal tip 26 is configured to facilitate navigation of the distal portion 20A to a blood vessel within the patient's vascular system. In some examples, the distal tip 26 may be non-invasive, for example, to resist or avoid puncturing the blood vessel during navigation of the distal portion 20A within the blood vessel.

[0057] exist Figure 1 In the example shown, the conduit 12 is in a relatively low-profile delivery configuration, in which the distal portion 20A defines a relatively small radial range relative to an expansion (also referred to as radial expansion and / or unfolding) configuration (relatively low profile, such as a relatively linear configuration), in which the expandable portion 22 of the distal portion 20A defines a relatively large radial range (e.g., ... Figure 2A and Figure 2B(As shown). In some examples, the radial extent is measured in a direction orthogonal to the central longitudinal axis L. The distal portion 20A can be delivered to the target tissue site via the patient's vascular system in a low-profile configuration. In some examples, the expandable portion 22 is configured to self-expand within the patient's blood vessels, for example via a shape memory element (e.g., a shape memory tube or hollow helical strand) of the elongated body 20. In some examples, the expandable portion is... Figure 1 The relatively low-profile configuration shown extends along a straight line aligned with the longitudinal axis L. The expandable portion 22 can be constrained or limited within the low-profile configuration by a guide member. Clinicians can retract the guide member proximally relative to the expandable portion 22 to release the constraint on the expandable portion 22 and allow or permit the expandable portion 22 to transition from the low-profile configuration to the expansion configuration. Thus, the expandable portion 22 can be configured to expand radially away from the straight line into the expansion configuration.

[0058] Figure 2A It shows the extended configuration 22A. Figure 1 A partial front view of the expandable portion 22 of the neuromodulation conduit 12. Figure 2B A partial top view of the expandable portion 22 in expansion configuration 22A is shown. In some examples, in expansion configuration 22A, the expandable portion 22 defines a ring-shaped, spiral, helical, basket-shaped, or scaffold-like configuration. In expansion configuration 22A, the expandable portion 22 is configured to position one or more of at least one therapy delivery element 14 near the vessel wall, for example, in contact with the vessel wall.

[0059] In some examples, the expandable portion 22 can be expanded or self-expanding as the guide member retracts proximally from the distal portion 20A. Clinicians can retract the guide member along the distal portion 20A near the expandable portion 22 to induce or allow expansion of the expandable portion 22. In an expanded configuration, the expandable portion 22 can position at least one therapy delivery element 14 at a first location relative to the vessel wall (e.g., corresponding to a first rotational position). Clinicians can control the therapy delivery device to deliver, provide, or facilitate neuromodulation therapy at a target tissue site, for example, through the vessel wall to a target tissue adjacent to the vessel. Neuromodulation therapy may include, but is not limited to, radiofrequency (RF) energy, microwave energy, ultrasound energy, therapeutic agents (e.g., chemical ablation agents), cryo-energy, etc.

[0060] A clinician can rotate handle 18 or otherwise rotate the proximal portion 20B to apply torque to the distal portion 20A and rotate the expandable portion 22 about the central longitudinal axis L from a first rotational position to a second rotational position. The second rotational position is spaced at a predetermined angle from the first rotational position. In some examples, the second rotational position is at least 15°, 30°, 45°, 60°, 75°, 90°, 120°, 150°, or 180° from the first rotational position along the vessel wall. The second rotational position may be longitudinally aligned with the first rotational position (e.g., produced by a pure rotation of the expandable portion 22 without any relative longitudinal translation) or longitudinally spaced from the first rotational position (e.g., produced by a combination of rotation and longitudinal translation of the expandable portion 22). Rotating the expandable portion 22 to the second rotational position allows at least one therapy delivery element 14 to rotate along the inner periphery of the vessel wall to a different position spaced from the initial position associated with the first rotational position of the expandable portion 22. For example, applying torque from handle 18 or proximal portion 20B to expandable portion 22 can cause expandable portion 22 to rotate, for example, about longitudinal axis L in the same direction as the torque. Clinicians can control system 10 to deliver therapy at a second rotational position or after other successive rotational positions of expandable portion 22.

[0061] At least one reinforcing wire 16 is configured to allow clinicians sufficient control over the rotation of the expandable portion 22, for example, by transmitting torque from the handle 18 or proximal portion 20B to the distal portion 20A (and thus to the expandable portion 22) in a substantially proportional or predictable manner. Thus, a rotation R1 of the handle 18 can cause a substantially uniform rotation R2 of the expandable portion 22. For example, R2 can be substantially the same as R1, or within a predetermined deviation range relative to R1 (e.g., under-rotation). In some examples, R2 is within the range of 5°, or 7°, or 10°, or 15°, or 25° of R1.

[0062] In some examples, at least one reinforcing wire 16 comprises shape memory material and extends at least partially along the expandable portion 22. For example, the shape memory material may include metal, alloy, plastic, or a combination thereof. In some examples, the shape memory material includes nitinol. The at least one reinforcing wire 16 may include one, two, three, four, five, or more wires. In some examples, the at least one reinforcing wire 16 defines a single coil. In some examples, the at least one reinforcing wire 16 comprises at least one monofilament shape memory wire. In some such examples, the at least one reinforcing wire 16 consists of at least one monofilament shape memory wire. In some examples, the conduit 10 comprises only one reinforcing wire 16. For example, in addition to a monofilament shape memory wire, the conduit 10 may not include any reinforcing members extending along the expandable portion.

[0063] like Figure 1 As shown, at least one reinforcing line 16 may extend along the longitudinal axis L, for example, along a path substantially the same as that of the expandable portion 22. However, in other examples, at least one reinforcing line 16 may follow a different path. For example, at least one reinforcing line 16 may follow a zigzag, wavy, curved, helical, spiral, piecewise linear, or piecewise curved path, or a combination thereof, relative to the path along which the expandable portion 22 extends. Thus, the helical path of the expandable portion 22 in the expansion configuration 22A may be a first helical path, and at least one reinforcing line 16 may extend along a second helical path different from the first helical path. In some examples, the second helical path extends around the main helical path of the expandable portion 22 in the expansion configuration 22A.

[0064] Figure 3 A partial front view of an example neuromodulation conduit 112 is shown, which includes an expandable portion 22 extending along a first helical path P and at least one reinforcing line 116 extending along a second helical path S1 clockwise (indicated by the letter "C") surrounding the first helical path P. Specifically, the second helical path S1 is clockwise around the expandable portion 22 in a distal direction. The neuromodulation conduit 112 is substantially similar to the neuromodulation conduit 112, and the at least one reinforcing line 116 is substantially similar to the at least one reinforcing line 16, but differs in its path traversing relative to the expandable portion 22.

[0065] Figure 4 A partial front view of an example neuromodulation conduit 212 is shown, which includes an expandable portion 22 extending along a first helical path P and at least one reinforcing line 216 extending along a second helical path S2 counterclockwise (indicated by the letter "A") around the first helical path P. Specifically, the second helical path S2 is counterclockwise around the expandable portion 22 in a distal direction. The neuromodulation conduit 212 is substantially similar to the neuromodulation conduit 12, and the at least one reinforcing line 216 is substantially similar to the at least one reinforcing line 16, but differs in its path traversing relative to the expandable portion 22.

[0066] exist Figure 3 or Figure 4In this configuration, the first helical path P itself can be clockwise or counterclockwise in the distal direction along the expandable portion 22. Therefore, the chirality of the second helical path (S1 or S2) can be aligned with or opposite to the chirality of the first helical path. In some examples, the first helical path S1 has the same chirality as the second helical path S2. For example, both S1 and S2 can be clockwise or counterclockwise in the distal direction along the expandable portion 22. In the case of a relatively highly compliant expandable portion 22, aligned chirality reduces kinking or folding in the expandable portion in response to torque transmission from the handle 18 or proximal portion 20B. Conversely, in the case of a relatively non-compliant expandable portion 22, opposite chirality can facilitate retraction of the expandable portion 22 by changing from an expanded configuration 22A to a relatively low-profile configuration, while still transmitting sufficient torque to support or facilitate commensurate rotation of the expandable portion 22 relative to the handle 18 or proximal portion 20B. Therefore, in some examples, the first helical path S1 has the opposite chirality to the second helical path S2, wherein one of the first helical path S1 and the second helical path S2 is clockwise along the distal direction of the expandable portion 22, and the other of the first helical path S1 and the second helical path S2 is counterclockwise.

[0067] In some examples, at least one reinforcing wire 16 may extend along a linear path relative to the expandable member 22 in a first segment or section, and along a non-linear path (e.g., a helical path) in a second segment or section. For example, the proximal portion of at least one reinforcing wire 16 may extend along a linear path relative to the expandable member 22, and the distal portion of at least one reinforcing wire 16 may extend along a helical path relative to the expandable member 22.

[0068] Back Figure 1 In different examples, at least one reinforcing line 16 may extend along different portions of the elongated body 20. For example, as Figure 1As shown, at least one reinforcing wire 16 may extend distally along the distal portion 20A to the distal end 26. Therefore, the distal end of at least one reinforcing wire 16 may terminate at the distal end 26, while the proximal end of at least one reinforcing wire 16 may terminate near the expandable portion 22. However, in other examples, the distal end of at least one reinforcing wire 16 may terminate near the distal end 26 or near one or more of the at least one therapeutic delivery element 14. The proximal end of at least one reinforcing wire 16 may terminate at the handle 18, at a location distal to the handle 18, at a location along the proximal portion 20B, at a location along the distal portion 20A, near the at least one therapeutic delivery element 14, or at a location distal to the at least one therapeutic delivery element. In some examples where at least one therapy delivery element 14 comprises two or more therapy delivery elements, the proximal and / or distal end of at least one reinforcing wire 16 may terminate at a location between the two or more therapy delivery elements, or terminate at a location distal or proximal to any of the two or more therapy delivery elements. Thus, the position and length of at least one reinforcing wire may be modified along the elongated body 20 to provide a predetermined rotational stiffness to one or more segments of the elongated body 20.

[0069] In some examples, at least one therapy delivery element 14 includes a first therapy delivery element and a second therapy delivery element, and at least one reinforcing line 16 extends from the first therapy delivery element to the second therapy delivery element.

[0070] Figure 5 A partial front view of an example neuromodulation conduit 312 is shown, which includes a plurality of therapy delivery elements 14A, 14B, 14C, and 14D, and at least one reinforcing line 316 extending between the distal therapy delivery elements 14A and 14D. The plurality of therapy delivery elements 14 may include intermediate delivery elements 14B and 14C located between the distal therapy delivery elements 14A and 14D in a direction along the central longitudinal axis L of the conduit 312. For example, a first therapy delivery element 14A is the proximal therapy delivery element of the conduit 312, and a second therapy delivery element 14D is the distal therapy delivery element of the conduit 312. The neuromodulation conduit 312 is substantially similar to the neuromodulation conduit 12, and the at least one reinforcing line 316 is substantially similar to the at least one reinforcing line 16, but with a different length (measured along the longitudinal axis L). For example, no portion of the at least one reinforcing line 316 extends beyond the distal therapy delivery elements 14A and 14D.

[0071] Figure 6A partial front view of an example neuromodulation conduit 412 is shown, which includes a plurality of therapy delivery elements 14 and at least one reinforcing line 416 extending between intermediate elements 14B and 14C among the plurality of therapy delivery elements 14. Figure 6 In the example shown, at least one reinforcing wire 416 extends distally beyond intermediate element 14B or proximally beyond intermediate element 14C. In other examples, at least one reinforcing element 416 extends distally beyond intermediate element 14B and / or proximally beyond intermediate element 14C, but not directly to adjacent therapy delivery elements 14A and 14D, respectively. The neuromodulation conduit 412 is substantially similar to neuromodulation conduit 12, and at least one reinforcing wire 416 is substantially similar to at least one reinforcing wire 16, but of different lengths. For example, no portion of at least one reinforcing wire 416 extends beyond intermediate therapy delivery elements 14B and 14C.

[0072] Figure 7 A partial front view of an example neuromodulation conduit 512 is shown, which includes a plurality of therapy delivery elements 14 and at least one reinforcing line 516 extending proximally from at least one of the therapy delivery elements 14. The neuromodulation conduit 512 is substantially similar to the neuromodulation conduit 12, and the at least one reinforcing line 516 is substantially similar to the at least one reinforcing line 16, but differs in length. For example, no portion of the at least one reinforcing line 516 extends distally beyond the therapy delivery element 14C. In other examples, no portion of the at least one reinforcing line 516 extends distally beyond the therapy delivery element 14B, or distally beyond the therapy delivery element 14D. In these examples, the proximal end of the at least one reinforcing line 516 may terminate at a location along the expandable portion 22, or terminate near the expandable portion 22.

[0073] Back Figure 1 At least one reinforcing wire 16 can be attached to the elongated body 20 using any suitable technique. For example, at least one reinforcing wire 16 may be positioned on the surface of the expandable portion 22 and / or within the expandable portion 22. In some examples, at least one layer (e.g., a coating or sheath) may surround at least one reinforcing wire 16. (See reference...) Figures 8 to 10 Describe the other location of at least one reinforcing line.

[0074] Figure 8A cross-sectional view of an example neuromodulation conduit 612 is shown, comprising at least one reinforcing line 16 surrounded by a polymer sheath 625 positioned around an elongated body 20 (e.g., radially outer of the elongated body 20), the cross-section being taken in a direction orthogonal to the central longitudinal axis L. In some examples, the polymer sheath 625 is an outer layer of the elongated body 20, e.g., radially outerer than another layer or component of the elongated body 20. In some examples, the polymer sheath 625 is the outermost layer of the elongated body 20. The polymer sheath 625 may comprise any suitable polymer, e.g., a biocompatible polymer or a medical-grade polymer. In some examples, the polymer sheath 625 comprises polyethylene terephthalate (PET). At least one therapeutic delivery element (e.g., reference) Figure 1 At least one therapeutic delivery element 14 described may be positioned outside, within, or inside the polymer sheath 625. In some examples, the polymer sheath 625 facilitates retention of at least one reinforcing wire 16 relative to the expandable portion 22 along a predetermined path and resists or reduces separation of at least one reinforcing wire 16 from the expandable portion 22.

[0075] Figure 9 A cross-sectional view of an example neural modulation conduit 712 is shown, the cross-section being taken in a direction orthogonal to the central longitudinal axis. The conduit 712 includes at least one reinforcing line 16 within a polymer sheath 625 surrounding an elongated body 20. For example, at least one reinforcing line 16 may be positioned within the body of the polymer sheath 625.

[0076] Figure 10 A cross-sectional view of an example neural modulation conduit 812 is shown, the cross-section being taken in a direction orthogonal to the central longitudinal axis. The conduit 812 includes at least one reinforcing line 16 between a first polymer sheath 625 and a second polymer sheath 627 positioned around an elongated body 20. The second polymer sheath 627 may contain any suitable material described with reference to polymer sheath 625. The composition of the second polymer sheath 627 may be the same as or different from that of the polymer sheath 625. Figure 10 As shown, at least one reinforcing line 16 may be located at the interface between the first polymer sheath 625 and the second polymer sheath 627. In other examples, at least one reinforcing line 16 may be located within the body of the second polymer sheath 627.

[0077] In some examples, different reinforcing lines of at least one reinforcing line 16 may be located at the interface of or within one or both of the first polymer sheath 625 or the second polymer sheath 627. In some examples, a first portion (e.g., a distal or proximal portion) of at least one reinforcing line 16 may be embedded in or surrounded by the second polymer sheath 627, and a second portion of at least one reinforcing line 16 may be embedded in or surrounded by the first polymer sheath 625. In some examples, a first portion of at least one reinforcing line 16 may be embedded in or surrounded by the first polymer sheath 625 or the second polymer sheath 627, and a second portion of at least one reinforcing line 16 may not be embedded in one or both of the first polymer sheath 625 or the second polymer sheath 627.

[0078] Back Figure 1 At least one reinforcing line 16 can be passively actuated, for example, in response to changes in ambient temperature via shape memory effect. In other examples, such as reference... Figure 11 and Figure 12 The at least one reinforcing wire 16 may be actively actuated, for example, in response to electrical stimulation. For instance, electrical stimulation may generate resistive heating along the at least one reinforcing wire 16 to heat the shape memory material in the at least one reinforcing wire 16 above a threshold temperature to induce a transformation into a predetermined memory shape. In some examples, the threshold temperature is the austenite termination temperature.

[0079] Figure 11A front view of an example system 900 including a neuromodulation conduit 912 is shown. The neuromodulation conduit includes at least one therapeutic delivery element 14 and at least one electrically actuated reinforcing wire 916. System 900 is substantially similar to system 10, the neuromodulation conduit 912 is substantially similar to neuromodulation conduit 12, and the at least one reinforcing wire 916 is substantially similar to at least one reinforcing wire 16, except that it is configured to be electrically actuated. System 900 also includes control circuitry 950. Control circuitry 950 is configured to send an electrical signal to at least one reinforcing wire 916 to cause at least one reinforcing wire 916 to change shape. For example, at least one reinforcing wire 916 may be electrically actuated from an initial shape to a reinforced shape in response to a signal from control circuitry 950. In some examples, at least one reinforcing wire 916 may include two, three, or more reinforcing wires that can be individually actuated. For example, individually actuating different reinforcing wires may allow for different overall conduit shapes or curvatures, or allow for the gradual reinforcement of one or more portions of the neuromodulation conduit 912. In these examples, the reinforcing lines may have corresponding reinforcing shapes, which may be the same as (e.g., the same reinforcing shape but with different rotational orientations) or different from other reinforcing lines. In some examples, one of the initial shape and the reinforcing shape may be a linear shape, and the other of the initial shape and the reinforcing shape may be a toroidal shape, a helical shape, or a spiral shape. The control circuit 950 may be the same as or different from the control circuit that controls the delivery of therapy via at least one therapy delivery element 14.

[0080] In some examples, the expandable portion 22 includes at least one shape memory member configured to transform the expandable portion 22 from a relatively low-profile configuration to an expanded configuration 22A. The shape memory member may include a helical hollow strand, such as a helical hollow strand tube (HHS) available from Fort Wayne Metals Research Products, LLC, Fort Wayne, Indiana. ® ).

[0081] In some examples, at least one reinforcing line 916 (or at least one reinforcing line 16) is radially spaced from at least one shape memory member of the expandable portion 22. Therefore, at least one reinforcing line 916 (or at least one reinforcing line 16) can be separate from and distinct from at least one shape memory member. In other examples, at least one reinforcing line 916 (or at least one reinforcing line 16) is part of at least one shape memory member.

[0082] Figure 12A cross-sectional view of an example neural modulation conduit 1012 including a helical hollow strand 1060 comprising at least one reinforcing wire 916 is shown, the cross-section being cut in a direction orthogonal to a central longitudinal axis L. The neural modulation conduit 1012 is an example of a neural modulation conduit 12, and an example helical hollow strand 1060 is shown. The helical hollow strand 1060 includes multiple strands 1062 containing shape memory material. In some examples, the multiple strands 1062 define a hollow tubular body. At least one reinforcing wire 916 may extend along the strands 1062, or may form one of the strands 1062. At least one reinforcing wire 916 may be relatively more rigid than one or more strands or all strands of the strands 1062. At least one reinforcing wire 916 may differ from the strands 1062 in one or more aspects of composition, large diameter, or cross-sectional shape. In some examples, the strand 1062 is not electrically actuated, and only at least one reinforcing wire 916 is electrically actuated. In some examples, the strand 1062 includes three reinforcing wires 916. In some examples, the conduit 1012 may include a liner or sheath 1064. The helical hollow strand 1060 may be embedded within, spaced apart from, or in contact with, the expandable portion 1022 of the neuromodulation conduit 1012.

[0083] In some examples, at least one reinforcing wire 916 is electrically actuated. Control circuitry (e.g., control circuitry 950) can send a control signal to at least one reinforcing wire 96, which in turn can affect the configuration or shape of the helical hollow strand 1060. In some examples, the neural modulation conduit 1012 includes a plurality of thermoelectric elements 1070, and the control circuitry is configured to control an energy source to send control signals to the thermoelectric elements 1070 to generate heat, which can then induce a thermal shape memory transition in at least one reinforcing wire 916.

[0084] The example catheters according to this disclosure can be formed using any suitable technique.

[0085] Figure 13 An example technique for forming a neural modulation conduit is shown. (Although references are available...) Figure 1 The catheter 12 is described Figure 13 The techniques described herein are not applicable, but the example techniques can be used to form any conduit according to this disclosure.

[0086] In some examples, Figure 13The technique includes forming an elongated body 20, the elongated body including at least one therapeutic delivery element 14 (1102) disposed on an expandable portion 22. In some examples, forming the elongated body 20 (1102) includes attaching at least one shape memory member to the elongated body 20, wherein the at least one shape memory member is configured to transform the expandable portion 22 from a relatively low profile configuration to an expanded configuration 22A.

[0087] The technology also includes attaching at least one reinforcing wire 16 containing shape memory material to the elongated body 20 such that the at least one reinforcing wire 16 extends at least partially along the expandable portion 22 (1104). The attachment (1104) may include applying an adhesive, coating, sheath, weld, extrusion layer to one or both of the at least one reinforcing wire 16 or the elongated body 20, or attaching the at least one reinforcing wire 16 to the elongated body 16 in any other suitable manner.

[0088] The technology may also include forming a polymer sheath (1106) around at least one reinforcing line 16. For example, the polymer layer may be extruded around an elongated body 20.

[0089] Figure 14 An example technique for delivering neuromodulation therapy using a neuromodulation catheter is shown. (Although reference...) Figure 1 The catheter 12 is described Figure 14 However, the technique can be performed using any conduit according to this disclosure.

[0090] Figure 14 The technique includes traveling the neuromodulation catheter 12 through the vascular system to position at least one therapy delivery element 14 at a target tissue site within a patient's blood vessel (1202). The technique also includes unfolding the expandable portion 22 of the catheter 12 from a relatively low-profile delivery configuration to a radially expanding configuration 22A to position at least one therapy delivery element 14 in a position conforming to the vessel wall of the blood vessel (1204). In some examples, the expandable portion 22 is constrained in the low-profile configuration by a guidewire or guiding sheath, and expanding the expandable portion 22 (1204) includes retracting the guidewire or guiding sheath proximally relative to the elongated body 20 to a point close to the expandable portion 22, allowing the expandable portion 22 to unfold radially outward.

[0091] The technology also includes delivering therapies (1206) to the patient’s tissue at the location via at least one therapy delivery element 14 through the blood vessel wall.

[0092] In some examples, this position is a first position, and the technique further includes rotating the expandable portion 22 relative to the longitudinal axis L to position at least one therapy delivery element 14 in a second position against the vessel wall of the blood vessel (1208). Rotating the expandable portion (1208) may include rotating the proximal portion 20B of the elongated body 20 relative to the longitudinal axis L. In such examples, the technique further includes delivering therapy at the second position via at least one therapy delivery element 14 (1210).

[0093] Figure 15 Examples of exploitation according to this disclosure are shown. Figure 1 The system 10 is an example of a technique for entering the renal artery and regulating the renal nerves. Although Figure 15 The use of catheter 12 for renal neuromodulation is illustrated, but catheter 12 can also be used for other therapies and treatments in another blood vessel or other hollow anatomy within the human body. Catheter 12 is configured to deliver energy (e.g., RF energy, ultrasound energy, electrical stimulation energy, etc.) to one or more target tissue sites within the renal vessels. Catheter 12 provides a pathway through the intravascular pathway (P) into the renal plexus (RP), such as a percutaneous entry point in the femoral artery (shown), brachial artery, radial artery, or axillary artery, to a target tissue site within the corresponding renal artery (RA). By manipulating the proximal portion 20B or the elongated body 20 from outside the intravascular pathway (P), a clinician can advance the distal portion 20A of the elongated body 20 through the sometimes tortuous intravascular pathway (P) and remotely manipulate the distal portion 20A of the elongated body 20 (…). Figure 1 The distal portion 20A can be remotely operated by a clinician using the handle 18.

[0094] exist Figure 15 In the illustrated example, the inner member 23 is used in the overall over-the-wall (OTW) technique to deliver the distal portion 20A intravascularly to the treatment site. The inner member 23 may be inside or outside the catheter 12 (e.g., a guidewire or inner catheter). In some examples, the inner member 23 is a navigation line. The catheter 12 may define a channel for receiving the inner member 23 to deliver the catheter 12 using OTW or RX techniques. At the treatment site, the inner member 23 may be at least partially withdrawn or removed relative to the catheter 12, and the distal portion 20A may be converted into an expanded configuration (e.g., a helical or spiral configuration) for delivering ultrasound energy. In other examples, the elongated body 200 may be self-manipulating, such that at least one therapeutic delivery element 14 can be delivered to the target tissue site without the aid of the inner member 23.

[0095] Renal neuromodulation is the partial or complete incapacitation or other effective disruption of the nerves of the kidney (e.g., nerves terminating in or closely associated with the kidney). Specifically, renal neuromodulation may involve inhibiting, reducing, or blocking neural communication along nerve fibers (e.g., efferent or afferent nerve fibers) of the kidney. Such incapacitation can be long-term (e.g., permanent or lasting for months, years, or decades) or short-term (e.g., lasting for minutes, hours, days, or weeks). Renal neuromodulation is expected to contribute to a systemic reduction of sympathetic tone or activity or benefit at least some specific organs or other body structures innervated by the sympathetic nervous system. Therefore, renal neuromodulation holds promise for treating clinical conditions associated with excessive central sympathetic stimulation. For example, renal neuromodulation holds promise for effectively treating 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 death, among other conditions.

[0096] Renal neuromodulation can be induced electrically or otherwise by delivering energy (RF energy, ultrasound energy, microwave energy, etc.). Target tissue sites may be located within or near the renal lumen (e.g., the renal artery, ureter, renal pelvis, major calyces, minor calyces, or another suitable structure), and target tissue sites may include tissue at least adjacent to the renal lumen wall. For example, regarding the renal artery, treatment protocols may include modulating nerves in the renal plexus that 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 these may relate to renal denervation therapy. This section aims to supplement and expand upon the preceding discussion of the relevant anatomy and physiology and to provide additional context regarding the disclosed techniques and the therapeutic benefits associated with renal denervation. For example, several properties of the renal vascular system can influence the design of target tissue devices and associated methods for achieving renal neuromodulation via endovascular access, and impose specific design requirements on such devices. Specific design requirements may include access to the renal artery, positioning the distal portion 16a within the renal artery, delivering therapy to the target tissue, or utilizing a therapy delivery device to effectively modulate the renal nerve.

[0097] As previously mentioned, the sympathetic nervous system (SNS) is a branch of the autonomic nervous system, along with the enteric and parasympathetic nervous systems. It is always active at a basal level (known as sympathetic tension) and becomes more active during periods of stress. Like other parts of the nervous system, the sympathetic nervous system operates through a network of interconnected neurons. Sympathetic neurons are frequently considered part of the peripheral nervous system (PNS), although many reside within the central nervous system (CNS). The spinal cord's sympathetic neurons (which are part of the CNS) communicate with peripheral sympathetic neurons via a series of sympathetic ganglia. Within the ganglia, spinal sympathetic neurons are called presynaptic (or preganglionic) neurons, while peripheral sympathetic neurons are called postsynaptic (or postganglionic) neurons.

[0098] At the synapses within the sympathetic ganglia, preganglionic sympathetic neurons release acetylcholine, a chemical messenger that binds to and activates nicotinic acetylcholine receptors on postganglionic neurons. In response to this stimulation, postganglionic neurons primarily release norepinephrine. Prolonged activation may trigger the release of adrenaline from the adrenal medulla.

[0099] Once released, norepinephrine and epinephrine bind to adrenergic receptors in peripheral tissues. Binding to these receptors triggers neuronal and hormonal responses. Physiological manifestations include pupillary dilation, increased heart rate, occasional vomiting, and elevated blood pressure. Increased sweating is also due to the binding of cholinergic receptors in sweat glands.

[0100] The sympathetic nervous system is responsible for upregulating and downregulating many homeostatic mechanisms within living organisms. Fibers from the SNS innervate tissues in almost every organ system, providing regulation of at least some physiological characteristics, as diverse as pupil diameter, intestinal motility, and urine output. This response is also known as the body's sympathetic-adrenal response because preganglionic sympathetic fibers terminating in the adrenal medulla (along with all other sympathetic fibers) secrete acetylcholine, which activates the secretion of adrenaline and, to a lesser extent, norepinephrine. Thus, this response, primarily acting on the cardiovascular system, is directly mediated by impulses transmitted through the sympathetic nervous system and indirectly mediated by catecholamines secreted by the adrenal medulla.

[0101] Figure 16 This is an example illustration of the sympathetic nervous system (SNS), showing how the brain communicates with the body via the SNS. Figure 16As shown, the SNS provides a neural network that allows the brain to communicate with the body. The sympathetic nervous system originates within the spinal column, for example, in the middle lateral column (or lateral angle) of cells facing the middle of the spinal cord, beginning in the first thoracic segment and believed to extend to the second or third lumbar segment. Because SNS cells originate in the thoracic and lumbar regions of the spinal cord, the SNS is said to have thoracolumbar outflow. The axons of the sympathetic nerves leave the spinal cord via anterior small roots / 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 via white branch connectors, which connect to the paravertebral ganglia (located near the spinal column) or prevertebral ganglia (located near the aortic bifurcation) extending along the sides of the spine.

[0102] To reach target organs and glands, axons must travel long distances within the body, and to accomplish this, many axons relay their messages to second cells via synaptic transmission. The ends of the axons span the space, forming synapses, which connect to the dendrites of the second cell. The first cell (presynaptic cell) sends neurotransmitters across the synaptic cleft, where they activate the second cell (postsynaptic cell). The message is then transmitted to its final destination.

[0103] In the SNS and other components of the peripheral nervous system, these synapses form at sites discussed above called ganglia. Cells that send their fibers to the ganglia are called preganglionic cells, while those whose fibers leave the ganglia are called postganglionic cells. As previously mentioned, preganglionic cells of the SNS are located between the first thoracic (T1) and third lumbar (L3) segments of the spinal cord. Postganglionic cells have their cell bodies located within the ganglia and send their axons to target organs or glands.

[0104] Ganglia include not only the sympathetic trunk, but also the cervical ganglia (upper, middle, and lower) that send sympathetic nerve fibers to the head and thoracic organs, and the abdominal and mesenteric ganglia that send sympathetic nerve fibers to the intestines.

[0105] Figure 17 This is an enlarged anatomical view of the nerves that innervate the left kidney to form the renal plexus surrounding the left renal artery. (Example) Figure 17 As 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 in the adventitia of the renal artery. The renal plexus (RP) extends along the renal artery and is embedded in the adventitia of the renal artery. Fibers contributing to the renal plexus (RP) originate from the celiac ganglion, superior mesenteric ganglion, aortic renal ganglion, and aortic plexus. The renal plexus (RP), also known as the renal nerve, mainly contains the sympathetic component. There is no (or at least very little) parasympathetic innervation of the kidney.

[0106] Preganglionic neuron cell bodies are located in the middle lateral cell column of the spinal cord. Preganglionic axons pass through the paravertebral ganglia to become smaller visceral nerves, the smallest visceral nerve, the first lumbar visceral nerve, the second lumbar visceral nerve, and proceed to the celiac ganglion, superior mesenteric ganglion, and aortorenal ganglion. Postganglionic neuron cell bodies exit the celiac ganglion, superior mesenteric ganglion, and aortorenal ganglion to reach the renal plexus (RP) and distribute to the renal vascular system.

[0107] Messages travel bidirectionally through social networks (SNS). Outgoing messages can trigger simultaneous changes in different parts of the body. For example, the sympathetic nervous system can increase heart rate, dilate bronchial passages, reduce bowel motility, constrict blood vessels, increase esophageal peristalsis, cause pupil dilation, goosebumps, and sweating, or raise blood pressure. Incoming messages carry signals from various organs and sensory receptors within the body to other organs, especially the brain.

[0108] Hypertension, heart failure, and chronic kidney disease are among many disease states caused by chronic activation of the SNS, particularly the renal sympathetic nervous system. Chronic SNS activation is an adaptive response 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, approach to reducing SNS overactivity.

[0109] As mentioned above, the renal sympathetic nervous system has been identified, both experimentally and in humans, as a major cause of the complex pathophysiology leading to hypertension, volume overload conditions such as heart failure, and progressive kidney disease. Studies using radioactive tracer dilution methods to measure the overflow of norepinephrine from the kidneys into the plasma have shown an increased rate of renal norepinephrine (NE) spillover in patients with idiopathic hypertension, particularly in younger hypertensive subjects. This increased renal norepinephrine spillover, along with an increased rate of cardiac NE spillover, is consistent with the hemodynamic profile commonly found in early hypertension and characterized by increased heart rate, cardiac output, and renal vascular resistance. It is now known that idiopathic hypertension is often neurogenic and is typically accompanied by significant sympathetic nervous system overactivity.

[0110] Activation of cardiorenal sympathetic activity is even more pronounced in heart failure, as demonstrated by the excessive increase in NE overflow from the heart and kidneys to the plasma in the patient group. Consistent with this view, recent studies have shown strong negative predictive value of renal sympathetic activation for all-cause mortality and heart 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 survival in patients with heart failure.

[0111] Some patients with both chronic kidney disease and end-stage renal disease exhibit elevated sympathetic activation. In patients with end-stage renal disease, above-median plasma norepinephrine levels have been shown to predict both all-cause mortality and mortality from cardiovascular disease. This is also true for patients with diabetes or contrast-induced nephropathy. There is compelling evidence that sensory afferent signals originating from the diseased kidney are a major contributor to the initiation and maintenance of elevated central sympathetic outflow in this patient group; this contributes to the known adverse consequences of chronic sympathetic hyperactivity, such as hypertension, left ventricular hypertrophy, ventricular arrhythmias, sudden cardiac death, insulin resistance, diabetes, and metabolic syndrome.

[0112] The renal sympathetic nerves terminate in blood vessels, the juxtaglomerular apparatus, and the renal tubules. Stimulation of the renal sympathetic nerves leads to increased renin release, increased sodium (Na+) reabsorption, and decreased renal blood flow. These components of the neural regulation of renal function are greatly stimulated in disease states characterized by increased sympathetic tone and significantly contribute to elevated blood pressure in hypertensive patients. The decrease in renal blood flow and glomerular filtration rate caused by renal sympathetic efferent stimulation may be the basis for renal function loss in cardiorenal syndrome, a form of renal dysfunction that presents as a progressive complication of chronic heart failure and has a clinical course that typically fluctuates with the patient's clinical condition and treatment. Pharmacological strategies to block the consequences of renal efferent sympathetic stimulation include centrally acting sympathetic drugs, beta-blockers (aimed at reducing renin release), angiotensin-converting enzyme inhibitors and receptor blockers (aimed at blocking angiotensin II and aldosterone activation due to renin release), and diuretics (aimed at counteracting renal sympathetic-mediated sodium and water retention). However, current pharmacological strategies may have significant limitations, including limited efficacy, compliance issues, and side effects.

[0113] The kidneys communicate with the overall structure of the central nervous system via renal sensory afferent nerves. Several forms of “kidney injury” can induce activation of sensory afferent signals. For example, renal ischemia, stroke, reduced renal blood flow, or adenosine monophosphate can trigger activation of afferent nerve communication.

[0114] Figure 18 It is an anatomical view of the human body, depicting the efferent and afferent neural communication between the brain and kidneys. Figure 19 It is a conceptual view of the human body, depicting the neural efferent and afferent communication between the brain and kidneys. For example... Figure 18 and Figure 19As shown, afferent communication can occur from the kidneys to the brain, or from one kidney to another (via the central nervous system). These afferent signals are concentrated and 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 increased renin secretion, sodium retention, volume retention, and vasoconstriction. Central sympathetic hyperactivity also affects other organs and body structures innervated by the sympathetic nervous system, such as the heart and peripheral vascular system, resulting in the described side effects of sympathetic activation, several aspects of which also contribute to elevated blood pressure.

[0115] Therefore, physiology suggests that: (i) regulation of the tissues with efferent sympathetic nerves will reduce inappropriate renin release, salt retention, and decreased renal blood flow; and (ii) regulation of the tissues with afferent sensory nerves will reduce the systemic contribution to hypertension and other disease states associated with increased central sympathetic tension through their direct effects on the posterior hypothalamus and contralateral kidney. In addition to the central hypotensive 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.

[0116] As provided above, renal denervation may be valuable in the treatment of several clinical conditions characterized by increased overall activity, particularly renal sympathetic activity, such 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 a reduction in afferent nerve signals contributes to a systemic decrease in sympathetic tension / excitation, renal denervation can also be used to treat other conditions associated with excessive systemic sympathetic activity. Therefore, renal denervation may also be beneficial for other organs and body structures innervated by the sympathetic nervous system, including… Figure 18 The organs and body structures identified in the text. For example, as previously discussed, a decrease in central sympathetic drive can reduce insulin resistance, which afflicts people with metabolic syndrome and type 2 diabetes. Additionally, patients with osteoporosis can be sympathetically activated and may also benefit from the downregulation of sympathetic drive accompanying renal denervation.

[0117] According to this technology, neural modulation of the left or right renal plexus (RP), which is closely associated with the left or right renal artery, can be achieved through an intravascular pathway. Figure 20 It is an anatomical view of the human arterial vascular system. For example... Figure 20 As shown, blood, propelled by the heart's contractions, is pumped from the left ventricle of the heart through the aorta. The aorta descends through the chest and branches into the left and right renal arteries. Below the renal arteries, the aorta bifurcates at the left and right iliac arteries. The left and right iliac arteries descend, passing through the left and right legs respectively, and connect with the left and right femoral arteries.

[0118] Figure 21This is an anatomical view of the human venous system. For example... Figure 21 As shown, blood pools in the veins and returns to the heart, passing through the femoral vein into the iliac vein and then into the inferior vena cava. The inferior vena cava branches into the left and right renal arteries. Above the renal veins, the inferior vena cava ascends to pump blood into the right atrium of the heart. Blood from the right atrium passes through the right ventricle and is pumped into the lungs, where it is oxygenated. Oxygenated blood is then transported from the lungs to the left atrium. From the left atrium, oxygenated blood is transported back to the aorta through the left ventricle.

[0119] The femoral artery can be accessed and cannulated at the base of the femoral triangle, directly below the midpoint of the inguinal ligament. The catheter can be percutaneously inserted into the femoral artery through this access site, passing through the iliac artery and aorta, and placed into the left or right renal artery. This includes endovascular pathways that provide minimally invasive access to the corresponding renal artery or other renal vessels.

[0120] The wrist, upper arm, and shoulder regions offer other locations for catheter introduction into the arterial system. For example, catheterization via the radial, brachial, or axillary arteries can be used to select cases. Catheters introduced through these entry points (e.g., catheter 12) can be routed using standard angiography techniques through the left superior subclavian artery (or via the right superior subclavian artery and brachiocephalic artery), across the aortic arch, down the descending aorta, and into the renal arteries. Other entry sites may also be used to access the arterial system.

[0121] Since neural modulation of the left or right renal plexus (RP) can be achieved via an endovascular pathway according to this technique, the properties and characteristics of the renal vascular system can constrain or guide the design of devices, systems, and methods used to achieve such renal neural modulation. Some of these properties and characteristics may vary over time across patient populations or within a specific patient, and may also vary 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 properties and characteristics may influence the efficacy of the protocol and the specific design of the endovascular device. Properties of interest may include, for example, material / mechanical, spatial, hydrodynamic / hemodynamic, or thermodynamic properties.

[0122] As previously discussed, catheters can be percutaneously advanced into the left or right renal artery via a minimally invasive endovascular approach. However, minimally invasive renal artery access can be challenging, for example, because renal arteries are often extremely tortuous, may have a relatively small diameter, or may have a relatively short length compared to some other arteries routinely accessed using catheters. Furthermore, renal artery atherosclerosis is common in many patients, especially those with cardiovascular disease. Renal artery anatomy can also vary significantly from patient to patient, further complicating the minimally invasive approach. For example, significant inter-patient variations can be seen in relative tortuosity, diameter, length, or atherosclerotic plaque burden, as well as in the angle of flight of the renal artery from its aortic branches. In addition, some patients have multiple left or right renal arteries. Devices, systems, and methods used to achieve renal neuromodulation via endovascular access should take into account these and other aspects of renal artery anatomy and their variations across patient populations when using minimally invasive access to the renal arteries.

[0123] In addition to complicating access to the renal artery, the details of renal anatomy also complicate establishing stable contact between the neurally modulated device and the luminal surface or wall of the renal artery. For example, the narrow spaces within the renal artery and its tortuosity can hinder guidance. Furthermore, establishing consistent contact is complicated by patient movement, breathing, or cardiac cycles, as these factors can cause significant movement of the renal artery relative to the aorta, and cardiac cycles can temporarily dilate the renal artery (i.e., cause pulsation of the arterial wall).

[0124] The neuromodulation system can also be configured to allow the distal portion 20A and at least one therapy delivery element 14 ( Figure 1 Adjustable localization and repositioning within the renal artery are crucial because the location of treatment can affect clinical efficacy. Furthermore, the variable localization and repositioning of neuromodulation devices has proven useful in cases of particularly tortuous renal arteries or where proximal branches of the main renal artery exist, making treatment at certain locations challenging.

[0125] As described above, the device positioned within the renal artery can be configured such that the distal portion 20A of the catheter 12 can closely contact or at least partially extend through the vessel wall. The renal artery diameter (DRA) typically ranges from about 2 mm to 10 mm, with the majority of patients having a DRA of about 4 mm to about 8 mm and an average of about 6 mm. The renal artery length (LRA) between the orifice at the aortorenal junction and its distal branches typically ranges from about 5 mm to 70 mm, with a significant portion of the patient population having a LRA of about 20 mm to 50 mm. Because the target renal plexus is embedded within the adventitia of the renal artery, the composite intima-media thickness (IMT) (i.e., the radially outward distance from the luminal surface of the artery to the adventitia containing the target neural structures) is also significant, typically ranging from about 0.5 mm to 2.5 mm, with an average of about 1.5 mm. While a certain depth of treatment is important for reaching the target nerve fibers, 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 anatomical structures of the psoas muscles.

[0126] An additional property of interest regarding the renal artery is the degree of kidney movement relative to the aorta induced by respiration or pulsatility of blood flow. The kidney, located at the distal end of the renal artery, can move up to 10 cm toward the skull with respiratory displacement. This can impart significant movement to the renal artery connecting the aorta and kidney, thus requiring a unique balance of rigidity and flexibility in the neural modulatory apparatus to maintain contact between the energy delivery element and the vessel wall during respiratory circulation. Furthermore, the fly-off angle between the renal artery and the aorta can vary significantly among patients and can also change dynamically within the patient, for example, due to kidney movement. The fly-off angle typically ranges from approximately 30° to 135°.

[0127] The above detailed description of the examples of this technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. While specific examples of the technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications can be made within the scope of this technology. For example, although the steps are presented in a given order, alternative examples may perform the steps in a different order. The various examples described herein may also be combined to provide other examples. All references cited herein are incorporated by way of citation as if they were listed entirely herein.

[0128] Based on the foregoing, it should be understood that specific examples of this disclosure have been described herein for illustrative purposes, but various modifications may be made without departing from the scope of this disclosure.

[0129] In other examples, certain aspects of this disclosure described in the context of a particular example may be combined or omitted. Furthermore, while advantages associated with some examples have been described in the context of those examples, other examples may also present such advantages, and not all examples must present such advantages to fall within the scope of this disclosure. Therefore, this disclosure and associated techniques may cover other examples not explicitly shown or described herein.

[0130] Furthermore, although techniques for positioning the neuromodulation catheter at a single location within a single renal artery have been described, in other examples, the neuromodulation catheter may be repositioned to a second treatment site within a single renal artery (e.g., proximal or distal to the first treatment site), to a branch of the single artery, to a different renal vessel on the same side of the patient (e.g., a renal vessel associated with the same kidney of the patient), to a renal vessel on the opposite 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 techniques or any combination thereof.

[0131] Furthermore, unless the word “or” is explicitly limited to referring only to a single item other than those in a list referring to two or more items, its use in such lists may be interpreted as including: (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 terms “about” or “approximately” preceding a value shall be interpreted as referring to ±10% of the value. Furthermore, the term “including” throughout the text is used to mean that at least the enumerated features are included, without excluding any larger number of the same features and / or other features of additional types.

[0132] Various embodiments have been described. These and other embodiments are within the scope of the appended claims.

[0133] Example 1. A neuromodulation conduit comprising: an elongated body extending along a longitudinal axis, the elongated body including an expandable portion configured to transition from a relatively low profile configuration to a radially expanding configuration; at least one therapeutic delivery element disposed on the expandable portion; and at least one reinforcing line comprising a shape memory material and extending at least partially along the expandable portion.

[0134] Example 2. The neuromodulation conduit according to Example 1, wherein the expandable portion extends along a straight line aligned with the longitudinal axis in a relatively low profile configuration.

[0135] Example 3. The neuromodulation conduit according to Example 2, wherein the longitudinal axis is the central longitudinal axis of the conduit, and wherein the expandable portion is configured to expand radially away from the central longitudinal axis to the radial expansion configuration.

[0136] Example 4. A neuromodulation conduit according to any one of Examples 1 to 3, wherein the expandable portion defines an annular, helical, or spiral shape in the radial expansion configuration.

[0137] Example 5. A neuromodulation conduit according to any one of Examples 1 to 4, wherein the expandable portion extends along a first helical path in the radial expansion configuration, and wherein the at least one reinforcing line extends along a second helical path surrounding the first helical path.

[0138] Example 6. The neural modulation conduit according to Example 5, wherein the first helical path has the same chirality as the second helical path.

[0139] Example 7. The neural modulation conduit according to Example 5, wherein the first helical path has the opposite chirality to the second helical path.

[0140] Example 8. A neuromodulation conduit according to any one of Examples 1 to 7, wherein the expandable portion comprises a polymer sheath.

[0141] Example 9. The neuromodulation conduit according to Example 8, wherein the at least one reinforcing line extends along the conduit body between the polymer sheath and the elongated body.

[0142] Example 10. The neuromodulation catheter according to Example 8, wherein the polymer sheath is a first polymer sheath, wherein the expandable portion further includes a second polymer sheath surrounding the first polymer sheath, and wherein the at least one reinforcing line extends along the catheter body between the first polymer sheath and the second polymer sheath.

[0143] Example 11. A neuromodulation conduit according to any one of Examples 1 to 10, wherein the at least one therapy delivery element comprises a first therapy delivery element and a second therapy delivery element, and wherein the at least one reinforcing wire extends from the first therapy delivery element to the second therapy delivery element.

[0144] Example 12. The neuromodulation catheter according to Example 11, wherein the first therapy delivery element is the proximal therapy delivery element of the neuromodulation catheter, and wherein the second therapy delivery element is the distal therapy delivery element of the neuromodulation catheter.

[0145] Example 13. A neuromodulation conduit according to any one of Examples 1 to 12, wherein the at least one therapeutic delivery element comprises an electrode.

[0146] Example 14. The neural modulation conduit according to Example 13, wherein the electrode is a ring electrode surrounding a portion of the elongated body.

[0147] Example 15. A neuromodulation conduit according to any one of Examples 1 to 14, wherein the at least one reinforcing wire defines a single coil.

[0148] Example 16. A neuromodulation conduit according to any one of Examples 1 to 15, wherein the at least one reinforcing wire comprises at least one monofilament shape memory wire.

[0149] Example 17. A neuromodulation conduit according to any one of Examples 1 to 16, wherein the at least one reinforcing wire is composed of a single strand of shape memory wire, and wherein the neuromodulation conduit does not include any reinforcing members extending along the expandable portion other than the single strand of shape memory wire.

[0150] Example 18. A neuromodulation conduit according to any one of Examples 1 to 17, wherein the at least one reinforcing wire is electrically actuated from an initial shape to a reinforced shape.

[0151] Example 19. A neural modulation conduit according to any one of Examples 1 to 18, wherein the expandable portion includes at least one shape memory member configured to cause the expandable portion to change from the relatively low profile configuration to the expanded configuration.

[0152] Example 20. The neural modulation conduit according to Example 19, wherein the at least one reinforcing line is radially spaced from the at least one shape memory member of the expandable portion.

[0153] Example 21. A neural modulation conduit according to Example 19 or 20, wherein the shape memory component comprises a helical hollow strand.

[0154] Example 22. The neural modulation conduit according to Example 21, wherein the helical hollow strand includes the at least one reinforcing strand.

[0155] Example 23. A neuromodulation conduit comprising: an elongated body extending along a longitudinal axis, the elongated body including an expandable portion configured to transition from a relatively low profile configuration to a radially expanding configuration, the expandable portion being configured to extend along a straight line aligned with the longitudinal axis in the relatively low profile configuration, the expandable portion being configured to extend along a helical path in the radially expanding configuration; at least one therapeutic delivery element disposed on the expandable portion; and at least one reinforcing line comprising a shape memory material and extending around the expandable portion along a second helical path.

[0156] Example 24. The neuromodulation conduit according to Example 23, wherein the expandable portion includes a polymer sheath.

[0157] Example 25. A neuromodulation conduit according to Example 23 or 24, wherein the at least one therapeutic delivery element includes a ring electrode surrounding a portion of the elongated body.

[0158] Example 26. A neuromodulation system comprising: a neuromodulation conduit according to any one of claims 1 to 25; an energy source; and a control circuit configured to control the energy source to deliver neuromodulation therapy via the at least one therapy delivery element of the neuromodulation conduit.

[0159] Example 27. The neuromodulation system according to Example 26, wherein the expandable portion defines an inner lumen configured to receive a guidewire, wherein the expandable portion is configured to change from the relatively low profile configuration to the radially expanded configuration in response to the guidewire retracting proximally from the inner lumen of the expandable portion.

[0160] Example 28. The neuromodulation system according to Example 26 or 27 further includes a guide sheath defining a guide lumen configured to receive the neuromodulation catheter in the low-profile configuration, and wherein the expandable portion of the catheter is configured to change to the radially expanded configuration in response to removal of the guide sheath from around the expandable portion.

[0161] Example 29. A method of forming a neuromodulation conduit, the method comprising: forming an elongated body including at least one therapeutic delivery element disposed on an expandable portion configured to transition from a relatively low profile configuration to a radially expanding configuration; and attaching at least one reinforcing wire comprising shape memory material to the elongated body such that the at least one reinforcing wire extends at least partially along the expandable portion.

[0162] Example 30. The method according to Example 29, further comprising: forming a polymer sheath around the central longitudinal axis of the elongated body.

[0163] Example 31. The method according to Example 29 or 30, wherein forming the elongated body includes attaching at least one shape memory member to the elongated body, wherein the at least one shape memory member is configured to transform the expandable portion from the relatively low profile configuration to the radially expanding configuration.

[0164] Example 32. A method for forming a neural modulation conduit according to the present disclosure.

[0165] Example 33. A method comprising: advancing a neuromodulation catheter through a vascular system to a target tissue site within a patient's blood vessel, wherein the neuromodulation catheter includes: an elongated body extending along a longitudinal axis, the elongated body including an expandable portion configured to transition from a relatively low-profile configuration to a radially expanding configuration; at least one therapy delivery element disposed on the expandable portion; and at least one reinforcing line comprising a shape memory material and extending at least partially along the expandable portion; unfolding the expandable portion into the radially expanding configuration to position the at least one therapy delivery element at a location against the vessel wall of the blood vessel; and delivering therapy to the patient's tissue at that location through the vessel wall via the at least one therapy delivery element.

[0166] Example 34. The method according to Example 33, wherein the position is a first position, the method further includes: rotating the expandable portion relative to the longitudinal axis to place the at least one therapy delivery element in a second position against the vessel wall of the blood vessel; and delivering therapy at the second position via the at least one therapy delivery element.

[0167] Example 35. The method according to Example 34, wherein rotating the expandable portion includes rotating the proximal portion of the elongated body relative to the longitudinal axis, wherein rotating the proximal portion causes the expandable portion to rotate.

[0168] Example 36. The method according to any one of Examples 33 to 35, wherein the expandable portion is constrained in the low profile configuration by a guide wire or guide sheath, and wherein unfolding the expandable portion includes retracting the guide wire or guide sheath relative to the expandable portion from the elongated body.

[0169] Example 37. A method comprising: delivering a neuromodulation therapy via at least one therapeutic delivery element of a neuromodulation conduit according to the present disclosure.

Claims

1. A neuromodulation conduit, the neuromodulation conduit comprising: An elongated body extending along a longitudinal axis, the elongated body including an expandable portion configured to transition from a relatively low profile configuration to a radially expanding configuration; At least one therapy delivery element, said at least one therapy delivery element being disposed on said expandable portion; and At least one reinforcing line, the at least one reinforcing line comprising shape memory material and extending at least partially along the expandable portion.

2. The neuromodulation conduit of claim 1, wherein the expandable portion extends along a straight line aligned with the longitudinal axis in the relatively low profile configuration, wherein the longitudinal axis is the central longitudinal axis of the conduit, and wherein the expandable portion is configured to expand radially away from the central longitudinal axis into the radially expanded configuration.

3. The neuromodulation conduit according to claim 1 or 2, wherein the expandable portion defines an annular, helical, or spiral shape in the radial expansion configuration.

4. The neuromodulation conduit according to any one of claims 1 to 3, wherein the expandable portion extends along a first helical path in the radial expansion configuration, and wherein the at least one reinforcing line extends along a second helical path surrounding the first helical path.

5. The neuromodulation catheter according to any one of claims 1 to 4, wherein the expandable portion comprises a polymer sheath, and wherein the at least one reinforcing line extends along the catheter body between the polymer sheath and the elongated body.

6. The neuromodulation catheter according to any one of claims 1 to 4, wherein the expandable portion comprises a first polymer sheath and a second polymer sheath surrounding the first polymer sheath, and wherein the at least one reinforcing line extends along the catheter body between the first polymer sheath and the second polymer sheath.

7. The neuromodulation catheter according to any one of claims 1 to 6, wherein the at least one therapy delivery element comprises a first therapy delivery element and a second therapy delivery element, and wherein the at least one reinforcing wire extends from the first therapy delivery element to the second therapy delivery element.

8. The neuromodulation catheter according to any one of claims 1 to 7, wherein the at least one therapeutic delivery element comprises an electrode.

9. The neuromodulation conduit according to any one of claims 1 to 8, wherein the at least one reinforcing wire defines a single coil.

10. The neuromodulation conduit according to any one of claims 1 to 9, wherein the at least one reinforcing wire is electrically actuated from an initial shape to a reinforced shape.

11. The neuromodulation conduit according to any one of claims 1 to 10, wherein the expandable portion includes at least one shape memory member configured to transform the expandable portion from the relatively low profile configuration to the radially expanded configuration, and wherein the at least one reinforcing line is radially spaced from the at least one shape memory member.

12. The neuromodulation conduit according to any one of claims 1 to 10, wherein the expandable portion includes at least one shape memory member configured to transform the expandable portion from the relatively low profile configuration to the radially expanding configuration, wherein the at least one shape memory member includes a helical hollow strand, and wherein the helical hollow strand includes the at least one reinforcing line.

13. A neural modulation system, the neural modulation system comprising: The neuromodulation conduit according to any one of claims 1 to 12; Energy source; and A control circuit configured to control the energy source to deliver neuromodulation therapy via at least one therapeutic delivery element of the neuromodulation conduit.

14. A method of forming a neural modulation conduit, the method comprising: An elongated body is formed, the elongated body including at least one therapeutic delivery element disposed on an expandable portion, the expandable portion being configured to transition from a relatively low profile configuration to a radially expanding configuration; as well as At least one reinforcing wire containing shape memory material is attached to the elongated body such that the at least one reinforcing wire extends at least partially along the expandable portion.

15. The method according to claim 14, further comprising: A polymer sheath is formed around the central longitudinal axis of the elongated body.

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