Catheter configured to be preferentially curved

Abstract

A catheter includes: a catheter body (108) defining a catheter lumen; an expandable member (111) connected to the catheter body; and an injection tube (214, 224) disposed on an outer surface of the expandable member (111). The injection tube (214, 224) defines an injection lumen and an injection port (228) in fluid communication with the injection lumen. The catheter body (108) is configured to flex preferentially in a first direction than in a second direction when the catheter is positioned in a vasculature of a patient.

Description

Technical Field

[0001] The present technology involves a catheter. Background Art

[0002] Catheters including one or more therapeutic elements have been proposed for use in various medical procedures, including neuromodulation procedures. For example, some catheters include energy delivery elements, fluid delivery elements, cryogenic elements, or other therapeutic elements. Summary of the invention

[0003] The present disclosure describes a catheter including a catheter body that is configured to bend preferentially in a first direction than in a second direction. In some examples, the catheter includes a therapy delivery element, and the preferential bending of the catheter body enables the catheter to position the therapy delivery element in a predetermined orientation within the patient's vascular system, for example to facilitate delivery of neuromodulation therapy (e.g., radio frequency (RF), ultrasound or microwave energy, chemical agents, thermal therapies such as cryotherapy) in a specific direction within the vascular system. For example, in some examples, the catheter includes one or more injection tubes, each of which defines one or more corresponding injection ports, and the preferential bending of the catheter body enables the catheter to position one or more injection ports in a predetermined orientation within the patient's vascular system, for example to facilitate delivery of therapeutic agents in a specific direction within the vascular system. In some examples, the catheter includes an expandable member connected to the catheter body, and the one or more injection tubes are disposed on the outer surface of the expandable member.

[0004] In some examples, the catheter can include a self-orienting member configured to cause the catheter body to bend preferentially in a first direction over a second direction. The self-orienting member can be disposed within the catheter lumen or can be part of the catheter body.

[0005] The configuration of the catheter described in the present disclosure can improve the guidance and / or orientation of the catheter within the patient's vasculature by ensuring that the distal portion of the catheter is oriented in a predetermined direction when the distal portion of the catheter is guided around a bend in the vasculature. In some examples, the preferential bending of the catheter can facilitate delivery of therapy toward or away from a specific anatomical feature of the patient.

[0006] In some examples, the catheters described herein may be used for neuromodulation within a vessel or within a body lumen or cavity other than a vessel, for extravascular neuromodulation, for neuromodulation of non-renal nerves, and / or for therapies other than neuromodulation.

[0007] In some examples, the present disclosure describes a catheter comprising: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port fluidically connected to the injection lumen, wherein the catheter body is configured to bend preferentially in a first direction than in a second direction when the catheter is positioned in a bend in a patient's vascular system.

[0008] In some examples, the present disclosure describes a catheter comprising: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port fluidically connected to the injection lumen, wherein the catheter body is configured to orient the injection port in a predetermined orientation relative to an anatomical feature of the patient when the catheter is positioned in the patient's vascular system.

[0009] In some examples, the present disclosure describes a method for delivering therapy to tissue of a patient, the method comprising: guiding a catheter through the patient's vascular system to a target treatment site, wherein the catheter comprises: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port fluidly connected to the injection lumen, wherein the catheter body is configured to bend preferentially in a first direction than in a second direction when the catheter is positioned in the vascular system; expanding the expandable member of the catheter from a collapsed configuration to an expanded configuration; and delivering the therapy to the target treatment site via the injection port.

[0010] In some examples, the present disclosure describes a catheter comprising: a catheter body; and a neuromodulatory element disposed on a distal portion of the catheter body, wherein the catheter body is configured to bend preferentially in a first direction over a second direction when the catheter is positioned in a bend in a patient's vasculature.

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

[0012] Referring to the drawings, elements with the same reference numerals represent similar elements throughout.

[0013] Figure 1is a partially schematic illustration of an exemplary catheter including an expandable member and one or more injection tubes, each injection tube defining one or more injection ports.

[0014] Figure 2A is an example Figure 1 Conceptual diagram of a cross-sectional view of the proximal portion of a catheter, the cross section being taken along Figure 1 The line AA in the figure is intercepted.

[0015] Figure 2B is an example Figure 1 Conceptual diagram of a cross-sectional view of the distal portion of a catheter, the cross section being taken along Figure 1 The line AA in the figure is intercepted.

[0016] Figure 3 is an example Figure 2B 2 is a conceptual diagram of a cross-sectional view of an exemplary distal portion of a catheter, the cross section being taken along line BB in FIG. 2 .

[0017] Figure 4A is an example Figure 2A and Figure 2B Conceptual illustration of an exemplary self-orienting member of a catheter.

[0018] Figure 4B is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member, the cross section being taken along Figure 4A Intercepted by line CC in .

[0019] Figure 4C is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member, the cross section being taken along Figure 4A The line DD in is intercepted.

[0020] Figure 4D is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member, the cross section being taken along Figure 4A Intercepted by line EE.

[0021] Figure 4E is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member, the cross section being taken along Figure 4A Intercepted by line FF in.

[0022] Figure 4F is an example Figure 4A Conceptual illustration of another cross-sectional view of an exemplary self-orienting member, the cross section being taken along Figure 4A Intercepted by line FF in.

[0023] Figure 5Ais an example Figure 1 A conceptual diagram of a cross-sectional view of another exemplary distal portion of a catheter of Figure 1 The line AA in the figure is intercepted.

[0024] Figure 5B is an example Figure 5A Conceptual diagram of an exemplary cross-sectional view of the distal portion of a catheter, the cross section being taken along Figure 5A Intercepted by line GG in .

[0025] Figure 5C is an example Figure 5A A conceptual diagram of another example of a cross-sectional view of the distal portion of a catheter, the cross section being taken along Figure 5A Intercepted by line GG in .

[0026] Figure 6 is a flow chart illustrating an exemplary method of delivering therapy to a patient using a catheter configured to preferentially bend.

[0027] Figure 7 is a partially schematic illustration of another exemplary catheter including a neuromodulation element.

[0028] Figure 8 is to use Figure 1 A conceptual illustration of an exemplary method of accessing a renal artery with a catheter and modulating a renal nerve.

[0029] Fig. 9 is a conceptual diagram of an exemplary sympathetic nervous system (SNS), illustrating how the brain communicates with the body via the SNS.

[0030] Fig.10 is an enlarged anatomical view of the nerves innervating the left kidney to form the renal plexus surrounding the left renal artery.

[0031] Fig.11 is an anatomical view of the human body depicting the efferent and afferent neural communications between the brain and kidneys.

[0032] Fig.12 is a conceptual view of the human body depicting the efferent and afferent neural communications between the brain and kidneys.

[0033] Fig.13 is an anatomical view of the human arterial vasculature.

[0034] Fig.14 An anatomical view of the human venous vasculature. DETAILED DESCRIPTION

[0035] Neuromodulation therapy (e.g., tissue ablation, tissue denervation, etc.) can be accomplished by delivering electrical energy, ultrasonic energy, and / or thermal energy to the target tissue site and / or by delivering a chemical agent to the target tissue site. For example, neuromodulation therapy may include denervation therapy, which is used to make the nerve inert, inactive, or completely or partially reduced in function in other ways, such as by ablation or injury of the nerve. After denervation, the transmission of nerve signals along the target nerve may be reduced or even prevented. Denervation of overactive nerves may provide therapeutic benefits to patients. For example, renal denervation can alleviate symptoms associated with overstimulation of renal sympathetic nerves. In some examples, neuromodulation therapy (e.g., denervation energy or chemical agents) is delivered via a catheter disposed in a blood vessel (e.g., a renal artery) close to the target nerve. The catheter may be configured to be positioned intravascularly in a blood vessel or other anatomical lumen to deliver energy or stimulation. Energy or stimulation may include, for example, at least one of radio frequency (RF) stimulation, thermal stimulation, cryogenic stimulation, microwave stimulation, ultrasonic stimulation, or other forms of energy or stimulation.

[0036] In the examples described herein, the catheter includes a therapy delivery element, which is configured to deliver neuromodulation therapy or another type of therapy to the patient's tissue. For example, the therapy delivery element can be configured to deliver using RF or microwave energy, chemical reagents, cryotherapy, ultrasonic energy, etc. Clinicians can guide the catheter through the patient's vascular system to reach the target treatment site. Once the clinician determines that the catheter is located at the treatment site (for example, via one or more imaging techniques such as X-ray imaging, fluoroscopy, etc.), the clinician can deliver therapy to the target treatment site via the therapy delivery element. In some examples, one or more anatomical features of the patient (for example, adjacent blood vessels) may be relatively close to the target treatment site to which the clinician does not want to apply neuromodulation therapy. In order to minimize or even prevent the application of neuromodulation energy or stimulation to the anatomical features, the clinician may need to rotate the catheter in the vascular system. Due to the length of the catheter and the material forming the catheter, when the catheter is positioned in the vascular system, it may be relatively difficult and inaccurate to rotate the catheter, and may cause the delivery of unexpected therapy to one or more anatomical features. In addition, for some catheters that are flexible enough to reach certain locations (such as the renal artery) from the radial artery entry point, the catheter may not show a good torque response.

[0037] The exemplary catheter described in the present disclosure is configured to improve the guidance and orientation of the therapy delivery element or other features of the catheter in the patient's vascular system. The exemplary catheter is configured to promote the orientation of the therapy delivery element (or other features) of the catheter by making the therapy delivery element at least automatically self-orient (such as by being configured to make the therapy delivery element preferentially bend) when the catheter extends around the bend in the vascular system. For example, based on the knowledge of the anatomical structure of the patient near the target treatment site (for example, the direction and degree of the bend of the vascular system), the catheter is configured to make one or more electrodes, one or more ultrasonic transducers, one or more heat-conducting surfaces of the balloon, one or more injection ports, etc. away from certain anatomical features and / or self-orient toward certain anatomical features. This can help reduce the possibility of neuromodulation energy or other stimulation being delivered to the unexpected tissue site in the patient's body. The exemplary catheter can also reduce the amount of time required for the clinician to align and orient the catheter in the vascular system, and reduce the overall medical procedure time.

[0038] The therapy delivery element of the catheter can be configured to deliver therapy in a specific direction (rather than, for example, 360 degrees around the catheter) using any suitable technology. For example, in the case of electrical energy, such as for RF ablation or microwave ablation, the therapy delivery element may include one or more directional electrodes, such as segmented electrodes extending only partially around the periphery of the catheter, partially electrically insulated to functionally achieve electrical energy delivery in a specific direction. Ring electrodes, etc. As another example, in the case of ultrasonic energy, the ultrasonic transducer may be configured to deliver ultrasonic energy in a specific direction less than 360 degrees around the catheter, or may be positioned in a balloon configured to guide ultrasonic energy in a specific direction. In the case of chemical ablation, as described below, one or more injection ports may be positioned along the catheter to deliver therapeutic agents in a specific direction less than 360 degrees around the catheter. As another example, in the case of cryoablation, a balloon may be used to deliver a cooling fluid to the patient's tissue, and the balloon may be partially thermally insulated to facilitate the delivery of cooling fluid in a specific direction less than 360 degrees around the catheter.

[0039] In some examples, high pressure chemical ablation can be used to accomplish tissue neuromodulation (e.g., tissue ablation, tissue denervation, etc.). For example, a neuromodulation procedure may involve the introduction of a therapeutic agent at high pressure into a blood vessel wall for neuromodulation of nearby nerves (e.g., renal sympathetic nerves in the case of a renal denervation procedure). The catheter can be used to perform a needle-free injection of a therapeutic agent at a target treatment site of a patient (e.g., as part of a neuromodulation procedure). Needle-free injection can be performed by delivering a high pressure therapeutic agent through an injection tube positioned in a blood vessel (e.g., a catheter body lumen or a tube separate from the catheter body lumen) to force the therapeutic agent into and / or through the blood vessel wall. The chemical can then diffuse around the target treatment site (e.g., nerves surrounding the blood vessel). In some examples, needle-free injection can be used to perform a denervation procedure (e.g., a renal denervation procedure).

[0040] In the examples described herein, the catheter includes a therapy delivery element, the therapy delivery element including at least one injection tube and an expandable member, the at least one injection tube defining one or more injection ports, the one or more injection ports being configured to deliver a therapeutic agent to the patient's tissue, the expandable member being configured to position the one or more injection ports in contact with the patient's tissue. In order to minimize or even prevent the application of a therapeutic agent to an anatomical feature, the clinician may need to rotate the catheter within the vascular system. As described above, when the catheter is positioned within the vascular system, rotating the catheter may be relatively difficult and inaccurate, and may result in unintended therapy delivery to one or more anatomical features.

[0041] Some exemplary catheters described in the present disclosure are configured to improve the guidance and orientation of one or more injection ports of the catheter in the patient's vascular system. The exemplary catheter is configured to promote the orientation of the therapy delivery element of the catheter by making one or more injection ports at least automatically self-orient (such as by being configured to make one or more injection ports preferentially bend) when the catheter extends around the bend in the vascular system. For example, based on the knowledge of the anatomical structure of the patient near the target treatment site, the catheter can make one or more injection ports away from certain anatomical features and / or self-orient toward certain anatomical features. This can help reduce the possibility of therapeutic agents or other fluids being delivered to unexpected tissue sites in the patient's body. The exemplary catheter can also reduce the amount of time required for the clinician to align and orient the catheter in the vascular system, and reduce the overall medical procedure time.

[0042] In some examples, the catheters described herein can be used for neuromodulation within a blood vessel or within a body cavity other than a blood vessel, for neuromodulation outside a blood vessel, for neuromodulation of non-renal nerves, and / or for treatments other than neuromodulation. In addition, although neuromodulation is primarily mentioned herein, particularly needle-free fluid delivery neuromodulation, the catheters described herein can be used for other neuromodulation modalities, as well as for medical procedures other than neuromodulation, including ablation of other targets.

[0043] Although some exemplary catheters are described herein with respect to the delivery of therapeutic agents (e.g., chemical ablative agents), the description herein is also applicable to other modalities of neuromodulation therapy, including but not limited to RF ablation, ultrasound ablation, microwave ablation, cryoablation, etc.

[0044] Figure 1 1 is a partial schematic diagram of an exemplary catheter 102 including a handle 104, an elongated body 108 attached to the handle 104, and at least one therapy delivery element 110 carried by the elongated body 108. The handle 104 may include a delivery port 105 configured to receive a fluid (e.g., an ablative chemical or other therapeutic agent) delivered via the therapy delivery element 110. The therapy delivery element 110 includes an expandable member 111 and one or more injection tubes (in Figure 2A and Figure 2B ), the one or more injection tubes extend at least partially along the outer surface of the expandable member 111. The elongated body 108 includes a distal portion 108A and a proximal portion 108B. The distal portion 108A includes a distal end 112 of the catheter 102 and a therapy delivery element 110. In some examples, the therapy delivery element 110 may be positioned proximate to the distal end 112. The catheter 102 can be part of a medical system 100 that includes one or more other components, such as a fluid container for storing a therapeutic agent and a medical device configured to facilitate relatively high-pressure delivery of the therapeutic agent from the fluid container to the patient's tissue via the catheter 102.

[0045] As used herein, the terms "distal" and "proximal" define a position or direction relative to a treating clinician or clinician's controls (e.g., a handle assembly). "Distal" or "distally" may refer to a position away from or in a direction away from a clinician or clinician's controls. "Proximal" and "proximally" may refer to a position near or in a direction toward a clinician or clinician's controls. For example, a distal portion 108A of the elongated body 108 refers to a portion of the elongated body 108 at a position relatively away from a clinician, and a proximal portion 108B of the elongated body 108 refers to a portion of the elongated body 108 at a position relatively near a clinician. In some examples, the distal portion 108A is the distal-most portion of the catheter 102, including the distal end of the catheter 102.

[0046] The elongated body 108 has any suitable outer diameter, and the outer diameter may be constant along the length of the elongated body 108, or may vary along the length of the elongated body 108. In some examples, the elongated body 108 may be 2 French, 3 French, 4 French, 5 French, 6 French, or 7 French, or other suitable sizes. The outer layer of the elongated body 108 may be formed of any suitable material or combination of materials, such as, but not limited to, one or more of nylon or thermoplastics such as polyethylene terephthalate (PET), polyparaxylene, polyvinyl chloride (PVC), polyethylene, ethylene chlorotrifluoroethylene (ECTFE), or polyvinylidene fluoride (PVDF).

[0047] The therapy delivery element 110 includes one or more injection tubes positioned along the outer surface of the expandable element 111 (in Figure 2A and Figure 2B ), the one or more injection tubes are configured to deliver a therapeutic agent at a target tissue site (also referred to herein as a "target area") in a patient's body when the distal portion 108A is positioned proximate to the target tissue site. The therapeutic agent can be a fluid. In some examples, although needle-free fluid delivery is primarily referred to herein, in other examples, the therapy delivery element 110 can be configured to deliver other types of therapy (e.g., energy, such as but not limited to ultrasound energy, microwave energy, radiofrequency energy, electrical stimulation, etc.) in addition to fluids and / or deliver fluids via other structures (e.g., fluid delivery using a needle).

[0048] The syringe is configured to deliver fluid from the proximal portion 108B (e.g., delivery port 105) of the catheter to the distal portion 108A, and discharge the therapeutic agent from one or more injection ports of the syringe at a relatively high pressure. The pressure can be selected so that the therapeutic agent can penetrate the patient's vascular wall, such as whether or not a needle is used to pierce the vascular wall. Exemplary pressures include, for example, 5 megapascals (MPa) to 18MPa (e.g., about 750 pounds per square inch (psi) to about 2500psi), such as 10MPa (or about 10.34psi). One or more syringes may be at least partially disposed in the elongated body 108 and / or may be completely positioned outside the elongated body 108. In some examples, the delivery port 105 may be close to the handle 104 or defined by the handle.

[0049] The expandable member 111 is configured to expand radially outward when an inflation fluid (e.g., saline) is delivered to the interior volume of the expandable member 111 via the inflation lumen of the catheter 102. The expandable member 111 can be, for example, a balloon (e.g., a compliant balloon). In some examples, when expanded, the expandable member 111 is symmetrical (e.g., radially symmetrical and / or longitudinally symmetrical). In some examples, when expanded, the expandable member 111 is longitudinally asymmetrical along the longitudinal axis 106 and / or radially asymmetrical about the longitudinal axis 106.

[0050] Although the present invention mainly describes examples in which the expandable member 111 includes a balloon, in other examples, the expandable member 111 may include different types of expandable structures. For example, the expandable member 111 may include an expandable frame configured to expand radially outward relative to the elongated body 108, such as an expandable basket-like or stent-like structure. The expandable frame can be self-expanding (e.g., formed of one or more shape memory materials such as nitinol) or can be configured to be expanded with a balloon. The expandable frame can define one or more openings through which blood can flow through the expandable member 111 when the expandable member 111 expands with the patient's blood vessel.

[0051] As reference Figure 2A and Figure 2BAs discussed in further detail, the elongated body 108 includes an outer catheter body that defines an outer catheter lumen. In some examples, the outer catheter lumen is an inflation lumen that is in fluid communication with the inner volume of the expandable member 111. A clinician can introduce an inflation fluid into the inner volume of the expandable member 111 and / or withdraw inflation fluid from the inner volume of the expandable member via the outer catheter lumen (e.g., via a port on the proximal portion 108B). In some examples, the port may be accessible to or defined by the handle 104. In other examples, an inflation tube that is separate from the outer catheter body (e.g., extending through the outer catheter lumen) can be used to deliver inflation fluid to the inner volume of the expandable member 111 to expand the expandable member 111 to an expanded state.

[0052] Introducing an inflation fluid into the inner volume of the expandable member 111 causes the expandable member 111 to expand from a relatively low-profile collapsed configuration to an expanded configuration. The inflation fluid (also referred to as a "fluid") is biocompatible. In some examples, the fluid can be a liquid, such as sterile water or saline. In addition, in some examples, the fluid includes, for example, a contrast agent mixed with sterile water. The fluid can be removed from the inner volume of the expandable member 111 to transform the expandable member 111 from an expanded configuration to a collapsed configuration. A clinician can transform the expandable member 111 between an expanded configuration and a collapsed configuration, for example to guide the catheter 102 between multiple target areas and deliver therapeutic agents at multiple target areas.

[0053] In some examples, catheter 102 is configured to accommodate multiple vessel diameters. For example, a renal vessel may have a diameter between about 3 mm and about 8 mm. Other vessels may have other diameters. Distal portion 108A may accommodate different vessel diameters because expandable member 111 is configured to expand to different diameters. In this way, a single catheter 102 may be used to deliver therapy to vessels having different diameters (e.g., in a range between about 2 mm and about 10 mm, such as a diameter in a range of about 3 mm to 8 mm).

[0054] The distal portion 108A of the elongated body 108 is configured to be advanced within a hollow anatomical structure (e.g., a blood vessel) of a human patient to position the therapy delivery element 110 within or otherwise proximate to a target region (e.g., a target treatment site) of the hollow anatomical structure. For example, the elongated body 108 can be configured to position the therapy delivery element 110 within a blood vessel, a ureter, a urethra, a duct, an airway, or another naturally occurring lumen in the human body. The examples described herein focus on anatomical structures that are blood vessels such as renal blood vessels, but it should be understood that similar techniques can be used for other hollow anatomical structures.

[0055] In some examples, intravascular delivery of catheter 102 includes placing a guidewire ( Figure 1The catheter 102 is percutaneously inserted into a patient's blood vessel and the elongated body 108 is moved along a guidewire or another guide member until the therapy delivery element 110 reaches the target treatment site (e.g., the renal artery). For example, the catheter 102 may include a guidewire tube or another structure defining a guidewire lumen that is configured to receive a guidewire for delivery of the catheter 102 using an overall exchange (OTW) or rapid exchange (RX) technique. In yet other examples, the catheter 102 may be configured for delivery via an inner catheter or sheath ( Figure 1 In addition to or in lieu of the inner guide member, in some examples, the catheter 102 is a manipulable catheter (e.g., having one or more pull wires connected to the distal portion 108A and manipulable by a clinician) or is configured to be a non-manipulable catheter for use without a guidewire. Thus, in some examples, the inner member may be a guide wire (e.g., a guidewire, etc.) that may be disposed on an outer surface of the elongated body 108 of the catheter 102 or extend within the lumen of the catheter 102.

[0056] Once the target treatment site is reached, the clinician can transform the expandable member 111 from a collapsed configuration to an expanded configuration by at least, for example, introducing a fluid into the inner volume of the expandable member 111 via the outer catheter lumen or via an inner tube disposed within the outer catheter lumen. Once the expandable member 111 is in the expanded configuration, the clinician can operate the medical device to deliver a therapeutic agent to the target treatment site via one or more injection tubes disposed on the expandable member 111. The therapeutic agent can, for example, provide or promote neuromodulation therapy at the target treatment site. For ease of description, the following discussion will focus primarily on the delivery of therapeutic agents. However, it should be understood that the catheter 102 may include elements configured to deliver other types of therapies (e.g., acupuncture chemical ablation, radiofrequency (RF) ablation, microwave ablation, ultrasonic ablation, cryoablation, etc.).

[0057] Figure 2A is an example Figure 1 A conceptual diagram of a partial cross-sectional view of a proximal portion of the catheter 102, the cross section being taken along Figure 1 The line AA in is intercepted. Figure 2A, the handle 104 may include a connector 202 and a housing 204 including a delivery port 105. The housing 204 is directly or indirectly mechanically connected to the proximal portion 108B of the elongated body 108. Thus, a clinician can manipulate the elongated body 108 by at least manipulating the housing 204 (e.g., pushing the housing 204 distally relative to the patient, withdrawing the housing 204 proximally relative to the patient, rotating the housing 204 around the longitudinal axis of the elongated body 108, etc.). The elongated body 108 defines a catheter lumen in which one or more injection tubes 224 are positioned. The inner tube 214 is also positioned in the catheter lumen defined by the elongated body 108.

[0058] The catheter 102 is configured to bend (also referred to as bending or flexing in some examples) preferentially in one direction over at least one other direction, which may be a direction orthogonal to the direction of preferential bending or another direction. The catheter 102 may preferentially bend to facilitate orientation of a therapy delivery element of the catheter 102 (e.g., one or more injection ports of the injection tube 224) within the patient's vasculature. For example, based on knowledge of the patient's anatomical structure near a target treatment site, such as the location of one or more bends in the vasculature, the elongated body 108 may be configured to preferentially bend in a particular direction and may self-orient the injection port away from certain anatomical features and / or toward certain anatomical features. The elongated body 108 may have a suitable configuration to facilitate preferential bending of the catheter 102. In some examples, the elongated body 108 includes a structure configured to preferentially bend and / or self-orient the elongated body 108, referred to herein as a self-orienting member 216. For example, in some examples, such as Figure 2A As illustrated in FIG. 8 , the elongated body 108 includes a self-orienting member 216 , which may be separate from and attached to the elongated body 108 , or may be integrally formed with the elongated body 108 .

[0059] The connector 202 can be attached to the proximal end 208 of the housing 204 (e.g., a hub) and can be in fluid communication with the syringes 224. The syringes 224 are configured to deliver therapeutic agents to the patient's tissue via one or more injection ports defined by the syringes. For example, each syringe 224 can define one or more injection ports, and in some examples, injections for some or all of the syringes 224 can be located at the distal portion of the respective syringes 224.

[0060] The connector 202 is configured to fluidly connect the syringe 224 to a pressure source (e.g., a compressor, a pump, a gas tank, etc.) and a source of therapeutic agent of the system 100 to facilitate delivery of the therapeutic agent to the patient's tissue via one or more injection ports of the syringe 224. The connector 202 may be permanently and / or removably fluidly connected to the proximal portion of the syringe 224. In some examples, the connector 202 is attached to the housing 204 or is detachable from the housing 204.

[0061] The housing 204 includes a delivery port 105 that is in fluid communication with the inner volume of the expandable member 111. The clinician can deliver fluid from the inner volume 232 ( Figure 2B ) to introduce and / or withdraw inflation fluid. For example, the delivery port 105 can be in fluid communication with the catheter lumen (directly or indirectly), which defines a fluid pathway between the delivery port 105 and the inner volume 232 of the expandable member 111. As another example, the catheter 102 can also include an inner tube 214 that is in fluid communication with the inner volume of the expandable member 111. The inner tube 214 can enter the housing 204 and the catheter lumen through the port 105, and the clinician can access the inner tube 214 through the injection port 105.

[0062] Additionally, the handle 104 may include Figure 2A One or more components not shown in the diagram include, but are not limited to, structures that facilitate delivery of a therapeutic agent to tissue via therapy delivery element 110. For example, handle 104 may include a trigger for initiating delivery of a therapeutic agent into one or more syringes 214, a visualization window, a safety collar, a cam clamp, etc. A clinician may manipulate the one or more components to deliver a therapeutic agent thereto, inspect the therapeutic agent within handle 104, prevent unintended delivery of a therapeutic agent, etc. In some examples, elongated body 108 may be secured to housing 204, for example, via a cam clamp disposed on housing 204.

[0063] Figure 2B is an example Figure 1 A conceptual diagram of a cross-sectional view of the distal portion of the catheter 102, the cross section being taken along Figure 1 The distal portion 108A of the elongated body 108 may be connected to the proximal end of the expandable member 111. In some examples, such as Figure 2B As illustrated in FIG. 2 , the elongated body 108 includes a self-orienting member 216 . At least a portion of the guidewire tube 212 , the inner tube 214 , and the injection tube 124 may be disposed within a distal portion of the catheter lumen 211 .

[0064] The guidewire tube 212 can extend through the expandable member 111 and can be connected to the distal end 112 of the catheter 102. The guidewire tube 212 defines a guidewire lumen, which is configured to receive one or more inner members (e.g., guidewires, guide members, etc.). The clinician can guide the catheter 102 through the patient's vascular system by means of the inner member received in the guidewire tube 212. In some examples, the proximal opening of the guidewire tube 212 is located at the handle 104 and / or at a point close to the handle 104. In other examples, the proximal opening of the guidewire tube 212 is located at a point away from the handle 104 (e.g., via the RX port). The guidewire tube 212 may include a relatively flexible material (e.g., a relatively soft polymer such as high-density polyethylene (HDPE)) and may include a lubricated lumen. In some examples, the guidewire tube 212 may include multiple layers (e.g., two layers, three layers, or more than three layers). In some examples, the inner layer (e.g., innermost layer) of the guide wire tube 212 includes a relatively flexible material (e.g., HDPE), and the outer layer (e.g., outermost layer) of the guide wire tube 212 includes nylon, which includes but is not limited to PEBAX (e.g., PEBAX 55 or PEBAX 63). Nylon may include, for example, softer PEBAX (e.g., PEBAX 40 or PEBAX 45) and / or harder PEBAX (e.g., PEBAX 70 or PEBAX 72).

[0065] The injection tube 224 is disposed within the catheter lumen 211. The injection tube 224 may exit the catheter lumen 211 at a point proximate to the expandable member 111, and the outer portion 226 of the injection tube 224 may be disposed on the outer surface of the expandable member 111. The outer portion 226 of each injection tube defines one or more injection ports 228. In some examples, when the expandable member 111 is in an expanded configuration and in a patient's blood vessel, the expandable member 111 positions the outer portion 226 and / or the injection port 228 to be juxtaposed with the vessel wall. When the expandable member 111 transitions to a collapsed configuration, the outer portion 226 may remain connected to the outer surface of the expandable member 111 and may contract radially inwardly away from the vessel wall along the edge of the expandable member 111. In some examples, the outer portion 226 may include one or more radiopaque markers to facilitate visualization of the injection port 228 and to help deliver therapy to the patient's tissue.

[0066] like Figure 2B, at least a portion of the elongated body 108 includes a self-orienting member 216. A distal end 222 of the self-orienting member 216 may be disposed within another portion of the elongated body 108 (e.g., an outer catheter body 218 of the elongated body 108). The self-orienting member 216 may be advanced and / or retracted within the lumen of the outer catheter body 218. The outer catheter body 218 may be connected to the proximal end of the expandable member 111. In other examples, the self-orienting member 216 may be permanently connected to the elongated body 108.

[0067] The self-orienting member 216 is configured to place the outer portion 226 and injection port 228 of the injection tube 224 in a predictable orientation when placed within the vasculature of the patient by at least preferentially bending while the elongated body 108 is disposed within the vasculature of the patient. For example, when a portion of the elongated body 108 including the self-orienting member 216 is positioned around a bend in a blood vessel, the self-orienting member 216 bends the elongated body 108 in a predictable direction so that the injection port 228 can be oriented away from and / or toward certain anatomical features. For example, when the distal portion 108A of the catheter 102 is disposed within a blood vessel of the patient, the self-orienting member 216 can position the outer portion 226 and injection port 228 away from a particular anatomical feature of the patient. In some examples, when the distal portion 108A is disposed within the vasculature, the self-orienting member 216 preferentially bends at least the distal portion 108A of the catheter 102. In some examples, the orientation of outer portion 226 and injection port 228 may include, for example, a rotational orientation of outer portion 226 and injection port 228 within a blood vessel. The rotational orientation may be defined by the radial position of outer portion 226 and injection port 228 along a cross-section of the blood vessel wall.

[0068] Self-orienting member 216 has any suitable configuration that facilitates preferential bending of elongated body 108 as elongated body 108 extends around a bend in a patient's vasculature. In some examples, distal portion 222 of self-orienting member 216 defines a taper in the distal direction. Distal portion 222 of self-orienting member 216 is configured to preferentially bend by at least more easily bending in a first direction and resisting bending in a second direction, as described in more detail below. In some examples, as described in more detail below, Figure 2B , the self-orienting member 216 includes a hypotube, and a distal portion 222 of a spline is attached to the distal end of the hypotube. For example, the spline may be welded to the distal end of the hypotube or may be integrally formed from the hypotube, such as by laser cutting the hypotube to form the spline.

[0069] In some examples, self-orienting member 216 is formed of a shape memory material (such as, but not limited to, a shape memory metal alloy such as Nitinol). In other examples, self-orienting member 216 is formed of a non-shape memory material, and the configuration (e.g., geometry) of self-orienting member 216 configures the self-orienting member to bend preferentially in one direction over at least one other direction.

[0070] In examples where the catheter 102 does not include a self-orienting member 216 but is still configured to bend preferentially in one direction over another, the cross-sectional composition of the elongated body 108 and / or the outer catheter body 218 enables the elongated body 108 to self-orient and / or preferentially bend, for example as described below with reference to FIG. 4A to FIG. 5C discussed in further detail.

[0071] In some examples, the preferential bending and / or self-orientation of the elongated body 108 is user-selected. For example, a clinician may select the elongated body 108 from a plurality of available elongated bodies having different predetermined bending orientations relative to the injection port 228 of the catheter based at least in part on the preferential bending of a particular elongated body. The clinician may determine the preferential bending and / or self-orientation based at least in part on the location of the target treatment site in the patient, the insertion site of the catheter, and / or anatomical features to be avoided. For example, a clinician may select a catheter that preferentially bends, self-orients, or has a predetermined orientation that orients the injection port 228 away from the renal vein for use in neuromodulation therapy directed to the wall tissue of the renal vessel.

[0072] Figure 3 is an example Figure 2B Conceptual diagram of a cross-sectional view of the distal portion 108A of the catheter 102, the cross section being taken along a direction orthogonal to the longitudinal axis 106. Figure 2B The outer catheter body 218 defines the outer catheter lumen 302. Figure 3 In the example shown, the injection tube 224, the guidewire tube 212, the inner tube 214, and the self-orienting member 216 are disposed within the outer catheter lumen 302. The outer catheter body 218 can have any suitable thickness defined in a radial direction between an outer surface of the outer catheter body 218 and an inner surface of the outer catheter body 218 defining the outer catheter lumen 302. In some examples, the outer catheter body 218 has a thickness of about 0.05 millimeters (mm) to about 0.3 mm (e.g., about 0.002 inches to about 0.010 inches).

[0073] The injection tube 224 defines an injection tube lumen 304. The injection tube lumen 304 can hold a therapeutic agent and is in fluid communication with the injection port 228. In some examples, the injection tube lumen 304 of a single injection tube 224 is in fluid communication with a plurality of external portions 226 disposed on the expandable member 111. That is, in some examples, the injection tube 224 can be divided into a plurality of external portions 226. In these examples, the external portions 226 can be considered to be corresponding injection tubes 224, each of which defines one or more injection lumens. In other examples, each injection tube 224 defines a corresponding injection lumen 304 that is fluidly separated from the injection lumen 304 of another injection tube 224 over the entire length of the injection tube 224. The injection tube 224 can have any suitable configuration that facilitates relatively high pressure fluid injection and facilitates the delivery catheter 102 to pass through the patient's vascular system to reach the target site. In some examples, the injection tube 224 can withstand at least 18 MPa and can resist frequent changes in pressure.

[0074] The guidewire tube 212 defines a guidewire lumen 306. As discussed above, a clinician can access the guidewire lumen 306, for example, via a rapid exchange (RX) port disposed along the elongated body 108 or at a point closer to the proximal end of the catheter 102 or at the proximal end of the catheter. The inner tube 214 defines an inner tube lumen 308, which, as discussed above, can be used to deliver and remove inflation fluid from the inner volume 232 of the expandable member 111. However, in some examples, the catheter 102 does not include the inner tube 214, and the inflation fluid is delivered to the inner volume 232 of the expandable member via the outer catheter lumen 302.

[0075] Figure 4A is an example Figure 2A and Figure 2B 1. Conceptual diagram of an exemplary self-orienting member 216 of a catheter 102 of FIG. The self-orienting member 216 includes a distal portion 222 that tapers from a first point 402 to a distal end 404 such that a profile of the distal portion 222 decreases in a distal direction. In some examples, the self-orienting member 216 includes a first member 401 (e.g., a hypotube) extending to the first point 402 and a second member 403 (e.g., a spline) attached to the first member 401 at the first point 402 and extending to the distal end 404. However, in other examples, the first member 401 is cut to define a second member (e.g., a cut in a hypotube) that can define the first point 402.

[0076] The self-orienting member 216 may have any suitable size, which may depend on the intended target tissue site of the catheter 102, the type of therapy being delivered, etc. For example, in some examples, such as some examples where the catheter 102 is configured to deliver a therapeutic agent to tissue via an intravascular location, the self-orienting member 216 may have an outer diameter of about 0.5 mm to about 1.5 mm (e.g., about 0.02 inches to about 0.06 inches) and an inner diameter of 0.38 mm to about 1.4 mm (e.g., about 0.015 inches to about 0.055 inches). For example, the self-orienting member 216 may have a wall thickness (e.g., the thickness of the self-orienting member 216 between the outer surface of the self-orienting member 216 and the inner surface of the self-orienting member 216 defining the lumen) of about 0.0125 mm to about 0.077 mm (e.g., about 0.0005 inches to about 0.003 inches). In some examples, the relatively larger diameter self-orienting member 216 may include one or more features to increase the flexibility of the self-orienting tube 216. For example, self-orienting member 216 may include one or more cuts (eg, a spiral cut, multiple radial cuts, etc.) to increase the flexibility of the self-orienting member along its length.

[0077] In some examples, the self-orienting member 216 has an overall length of about 10 centimeters (cm) to about 35 cm (e.g., about 3.9 inches to about 13.8 inches). In some examples, the self-orienting member 216 may be included in the length of the elongated body 108 of about 10 cm to about 35 cm (e.g., about 3.9 inches to about 13.8 inches) near the proximal end of the expandable member 111, for example to facilitate positioning the injection port 228 to be juxtaposed with the vessel wall in a predictable orientation. In some examples, the self-orienting member 216 may be shorter, for example, having an overall length of about 4 cm to about 5 cm (e.g., about 1.57 inches to about 1.97 inches). The overall length of the self-orienting member 216 may be measured from its most proximal end to its most distal end.

[0078] Figure 4B is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member 216, the cross section being taken along Figure 4A Intercepted by line CC in . Figure 4C is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member 216, the cross section being taken along Figure 4A The line DD in is intercepted. Figure 4D is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member 216, the cross section being taken along Figure 4A Intercepted by line EE. Figure 4E is an example Figure 4A Conceptual illustration of a cross-sectional view of an exemplary self-orienting member 216, the cross section being taken along Figure 4A Intercepted by line FF in. Figure 4F is an example Figure 4A Conceptual illustration of another cross-sectional view of an exemplary self-orienting member 216, the cross section being taken along Figure 4A Intercepted by line FF in. FIG. 4B to FIG. 4F Each of the cross-sections shown is taken in a direction orthogonal to the longitudinal axis 106 .

[0079] like FIG. 4B to FIG. 4F As illustrated, the cross-section of the self-orienting member 216 changes as the self-orienting member 216 tapers from the first portion 402 toward the distal end 404. Figure 4B The circular cross section shown is transformed into FIG. 4C to FIG. 4E The partial circular cross section shown is transformed into Figure 4F 404. The partially annular cross-section is substantially similar to the rectangular cross-section illustrated in FIG. In other examples, the partially annular cross-section may have a curved cross-section at the distal end 404. Figure 4D The partial annular cross-section ratio of the self-orienting member 216 in Figure 4C The partial annular cross-section of the self-orienting member 216 in the embodiment subtends a smaller angle, and Figure 4E The partial annular cross-section ratio of the self-orienting member 216 in Figure 4D The cross-section shown subtends a smaller angle.

[0080] The cross section can have a maximum dimension, referred to herein as width 412 (e.g., along major axis 410), of about 0.30 mm to about 0.80 mm (e.g., about 0.010 inches to about 0.0030 inches). In some examples, the cross section can have a width 412 between about 0.25 mm and about 0.8 mm. In some examples, once the self-orienting member 216 has been tapered to Figure 4F 406, but may maintain rigidity in response to forces orthogonal to force 406. Self-orienting member 216 is configured to maintain rigidity in response to forces orthogonal to force 406, which may help maintain a desired level of pushability of self-orienting member 216 during guidance of elongated body 108 to a target tissue site. Self-orienting member 216 may be configured to maintain rigidity in response to forces orthogonal to force 406, which may help ensure that self-orienting member 216 preferentially bends and / or self-orients to a predictable orientation.

[0081] like Figure 4F As shown, the distal end 222 of the self-orienting member 216 defines a major axis 410 and a minor axis 408. The major axis 410 can be parallel to the longer edge of the cross-section of the distal end 222, and the minor axis 408 can be orthogonal to the major axis 410. Figure 4F As illustrated in , the self-orienting member 216 can bend, deflect and / or deform preferentially in the direction of the minor axis 408 and resist bending in the direction of the major axis 410, such as by maintaining rigidity in the direction of the major axis 410.

[0082] In some examples, force 406 is applied at the centerline of the cross-section of self-orienting member 216, for example, by interaction between elongated body 108 and the vessel wall. In some examples, force 406 is applied anywhere along self-orienting member 216 and in the direction of minor axis 408.

[0083] As discussed above, by including a self-orienting member 216 disposed within a lumen (e.g., outer catheter lumen 302) defined by the elongated body 108, the catheter 102 can be configured to flex preferentially in one direction over another. FIG. 5A to FIG. 5C As discussed in more detail in , the catheter 102 can be configured to flex preferentially in one direction over at least one other direction by including one or more self-orienting structures within the slender body 108 to configure the slender body 108 to flex preferentially in one direction over at least one other direction or otherwise configuring the slender body 108 to flex preferentially in one direction over at least one other direction.

[0084] Figure 5A is an example Figure 1 A conceptual diagram of a cross-sectional view of another exemplary distal portion 108A of a catheter 102, the cross section being taken along Figure 1 The elongated body 108 is taken along line AA in FIG. The elongated body 108 includes an outer catheter body 502, which defines an outer catheter lumen 504. The outer catheter body 502 may be connected to the proximal end of the expandable member 111. The outer catheter lumen 504 may include an injection tube 224, a guidewire tube 212, and / or an inner tube 214. The outer catheter body 502 has a structure that causes the elongated body 108 to bend preferentially in one direction than in another direction when the catheter 102 traverses a bend in a patient's blood vessel. In some examples, the outer catheter body 502 includes a structure that causes the outer catheter body 502 to self-orient (e.g., to a predetermined orientation) within a blood vessel. The structure of the outer catheter body 502 causes the outer catheter body 502 to self-orient when the catheter 102 traverses a bend in a patient's blood vessel. As Figure 5A As illustrated in FIG. 5 , the outer catheter body 502 of the elongated body 108 can be a self-orienting member.

[0085] Figure 5B is an example Figure 5A A conceptual diagram of an example cross-sectional view of a distal portion 108A of a catheter 102, the cross section being taken along Figure 5A Intercepted by line GG in . Figure 5C is an example Figure 5AA conceptual diagram of another example cross-sectional view of the distal portion 108A of the catheter 102, the cross section being taken along Figure 5A Intercepted by line GG in . Figure 5B and Figure 5C The cross-sectional view illustrated in FIG. 1 is orthogonal to the longitudinal axis 106 of the catheter 102. Figure 5B and Figure 5C Only a cross-section of the outer catheter body 502 is illustrated, but according to one or more other examples described herein, the injection tube 224, the guidewire tube 212 and / or the inner tube 214 may be disposed within the outer catheter body 502 (e.g., within the outer catheter lumen 504).

[0086] like Figure 5B , the outer catheter body 502 defines an outer catheter lumen 504 and includes a first circumferential portion 506 and a second circumferential portion 508. The first circumferential portion 506 and the second circumferential portion 508 are completely opposite to the periphery of the cross section of the outer catheter body 502 together. In other examples, the catheter body 502 may include one or more additional circumferential portions, which are completely opposite to the periphery of the cross section of the outer catheter body 502 together with the first circumferential portion 506 and the second circumferential portion 508. The outer catheter body 502 is configured to preferentially bend or deflect along the axis 505 in response to the force 406. The outer catheter body 502 can resist bending and / or maintain rigidity in a direction orthogonal to the longitudinal axis 106. The outer catheter body 502 can have a width of about 0.05mm to about 0.15mm (e.g., about 0.002 inches to about 0.005 inches) from the outer surface to the outer catheter lumen.

[0087] exist Figure 5B In the example shown, the first circumferential portion 506 extends along a majority of the outer periphery of the annular cross-section of the outer catheter body 502. The first portion 506 and the second portion 508 are configured to have different properties (e.g., different hardness or flexibility) to promote preferential flexing of the outer catheter body 502 in one direction over another. In some examples, the first portion 506 and the second portion 508 both include biocompatible polymers, including but not limited to Pebax (e.g., Pebax 55, etc.), but the second portion 508 includes a harder biocompatible polymer than the material in the first portion 506, such as but not limited to harder Pebax (e.g., Pebax 63, etc.). In some examples, the first portion 506 and the second portion 508 may include a braid formed of a polymer, wherein the biocompatible polymer forms individual strands that are braided together to form the outer catheter body 502. In the second portion 508, strands of a relatively soft polymer may be braided along the edges of strands of a relatively hard polymer to form the second portion 508.

[0088] In other examples, the first circumferential portion 506 and the second circumferential portion 508 may exhibit different properties to enable the catheter 102 to be bent preferentially in one direction over another using other techniques. Figure 5C , in some examples, the second portion 508 includes a plurality of inserts 510 configured to increase the stiffness of the second portion 508 relative to the first portion 506. The inserts 510 may be, for example, longitudinal strands of relatively rigid (compared to the first circumferential portion 506) material. In some examples, the longitudinal strands may be oriented substantially linearly or nonlinearly. In at least this example, the first portion 506 and the second portion 508 may each include one or more relatively soft materials, including but not limited to relatively soft biocompatible polymers (e.g., Pebax 55, etc.). The second portion 508 may also include an insert 510 arranged parallel to the longitudinal axis 106. The insert 510 may include a more rigid material, such as, but not limited to, a metal alloy (e.g., Nitinol, etc.).

[0089] In response to the force 406, the second portion 508 is configured to bend and / or deflect toward and / or away from the longitudinal axis 106. The second portion 508 may also resist bending and / or deflection in a direction orthogonal to the longitudinal axis 106.

[0090] Figure 6 is a flow chart illustrating an exemplary process for delivering therapy to a patient using a catheter (eg, catheter 102) configured to preferentially bend. Figure 6 The therapy delivery is described primarily with respect to a target treatment site within a patient's renal blood vessel, but the exemplary process can be used for other target treatment sites and / or for other cavities in the patient's body. In some examples, the catheter 102 can be disposed in the renal artery and can be preferentially bent and / or self-oriented away from the renal vein and prevent unintended therapy delivery to the renal vein. This can help reduce the likelihood that therapeutic agents or other fluids are delivered to unintended tissue sites (e.g., the renal vein) in the patient's body. The catheter 102 can also reduce the amount of time required for a clinician to align and orient the catheter 102 within the vasculature and reduce overall medical procedure time.

[0091] The clinician may insert the catheter 102 into the patient's vascular system (602). The clinician may make an incision in the patient's skin at the insertion site on the patient to reach the patient's blood vessel. The clinician may then insert at least the distal portion 108A of the catheter 102 into the blood vessel. In some examples, the clinician may insert the catheter 102 into the vascular system without positioning the expandable member 111 and / or the injection tube 224 in a user-determined orientation prior to insertion into the patient's body. Once inserted into the vascular system, the elongated body 108 of the catheter 102 may automatically self-orient and / or preferentially bend the expandable member 111 and / or the injection tube 224 into a desired configuration that enables more targeted delivery of the therapeutic agent to the target tissue site. Due to the self-orienting member 216 within the elongated body 108 and / or the structure of the elongated body 108, the elongated body 108 may automatically self-orient and / or preferentially bend.

[0092] The clinician can guide the catheter 102 through the patient's vasculature to the target treatment site (604). The clinician can use one or more imaging techniques such as X-ray imaging, fluoroscopy, etc. to guide the catheter 102. In some examples, the clinician advances the catheter 102 on a guide member disposed within the vasculature (e.g., via OTW technology, rapid exchange technology, etc.). When the clinician encounters a bend within the patient's vasculature, the clinician can advance the distal portion 108A around the bend, and the elongated body 108 will preferentially bend and / or self-orient the expandable member 111 and / or the injection tube 224 to a user-determined orientation. The clinician can advance the catheter 102 within the vasculature until the distal portion 108A reaches the target treatment site. In some examples, with respect to renal neuromodulation, the clinician can advance the catheter 102 from a transradial artery entry point on the patient to the patient's renal artery.

[0093] The clinician can align the expandable member 111 and / or the injection port 228 of the injection tube 224 with the target treatment site, for example, by advancing or retracting the catheter 102 within the vasculature. The expandable member 111 and / or the injection port 228 can be automatically oriented in a preferred direction relative to the target tissue site due to the elongated body 108. For example, the preferred direction can orient the injection port 228 away from one or more anatomical features near the target treatment site. For example, if the target treatment site is located within the patient's renal artery, the user-determined orientation can face the injection port 228 away from the renal vein.

[0094] The clinician may transform the expandable member 111 of the catheter 102 into an expanded configuration (606). The clinician may insert an inflation fluid into the inner volume 232 of the expandable member 111. In some examples, the clinician inserts the inflation fluid into the inner volume 232 via the inner tube 214 (e.g., via a proximal end of the inner tube 214 disposed within or near the handle 104) and / or the catheter lumen of the elongated body 108 (e.g., the catheter lumen 302, the outer catheter lumen 504, etc.). The clinician may insert the inflation fluid into the expandable member 111 until the expandable member 111 is in the expanded configuration. When the expandable member 111 is transformed into the expanded configuration, the outer surface of the expandable member 111 may expand radially outward from the elongated body 108. In the expanded configuration, the expandable member 111 may place the injection port 228 in juxtaposition with the wall tissue at the target treatment site.

[0095] The clinician can use one or more injection ports 228 on the distal portion 108A of the catheter 102 to deliver therapy to the target treatment site (608). The clinician can actuate the catheter delivery system 100 to transmit the therapeutic agent through the injection tube 224 at a relatively high pressure (e.g., between about 5 MPa and about 18 MPa). The pressurized therapeutic agent can leave the injection port 228 and penetrate the wall tissue juxtaposed with the injection port 228. In some examples, with respect to renal neuromodulation, the clinician can deliver the therapeutic agent to a portion of the wall tissue of the renal artery that is dorsal to the renal vein. The clinician can continue to deliver the therapeutic agent to the target treatment site until the clinician determines that a user-determined amount of the therapeutic agent has been administered to the patient.

[0096] The clinician can transform the expandable member 111 of the catheter 102 into the collapsed configuration (610). The clinician can remove the inflation fluid from the inner volume 232 of the expandable member 111. The clinician can remove the inflation fluid via the inner tube 214 and / or the catheter lumen (e.g., the catheter lumen 302, the outer catheter lumen 504, etc.). Once the expandable member 111 is in the collapsed configuration, the clinician can remove the catheter 102 from the vasculature and / or guide the distal portion 108A to a second target treatment site in the patient and deliver therapy to the second treatment site.

[0097] Figure 7 702 includes a neuromodulatory element 704. Although some exemplary catheters (e.g., Figure 1 The catheter 102 of the embodiment of the present invention includes a therapy delivery element 110 having an expandable member (e.g., expandable member 111), but other exemplary catheters (e.g., Figure 7 ) includes a therapy delivery element 704 without an expandable member 111 and can be configured to preferentially bend and / or self-orient within the patient's vasculature. Figure 7 Also described are examples in which therapy delivery element 704 may be configured to deliver therapeutic agents or other types of neuromodulation therapies, such as, but not limited to, RF energy, microwave energy, ultrasound energy, cryoablation therapy, and the like.

[0098] The therapy delivery element 704 is configured to deliver neuromodulation therapy to the patient's tissue and may include, but is not limited to, one or more energy delivery elements (e.g., electrodes, ultrasonic transducers, etc.), fluid delivery elements (e.g., needles), or cryogenic elements. The therapy delivery element 704 may be configured to deliver neuromodulation therapy to a target treatment site that, for example, extends only partially or completely around the circumference of a blood vessel. For example, the area of ​​influence of the therapy delivered by the therapy delivery element 704 may extend less than 360 degrees around the circumference of the blood vessel. The area of ​​influence may correspond to a therapy delivery area on the therapy delivery element 704. The therapy delivery area may correspond to, for example, an active area of ​​an energy delivery element or a cryogenic element, placement of an injection device (e.g., a needle) for a fluid delivery element, etc. In some examples, the therapy delivery area extends partially (e.g., less than 360 degrees) around the circumference of the neuromodulation element 704.

[0099] For example, in accordance with other similar structures within the catheter 102 as described herein, the catheter 702 is configured to bend (also referred to as flex) preferentially in one direction over at least one other direction. The catheter 702 may be flexed preferentially to facilitate orientation of the area of ​​influence of the therapy delivery element 704 within the vasculature of the patient. For example, based on knowledge of the patient's anatomy near the target treatment site, such as the location of one or more bends in the vasculature, the elongated body 108 of the catheter 702 may be configured to bend preferentially in a particular direction and may orient the neuromodulation element 704 away from certain anatomical features and / or toward certain anatomical features (e.g., in accordance with other examples described herein).

[0100] For example, the catheter 702 may preferentially bend and / or self-orient to orient the needle of the therapy delivery element 704 away from certain anatomical structures of the patient (e.g., the renal vein) and toward a target treatment site within a blood vessel (e.g., within a renal artery). In some examples, the catheter 702 may preferentially bend to orient the energy-active area of ​​an ultrasound transducer, electrode, or another energy delivery element away from certain anatomical structures of the patient and toward the target treatment site. In some examples, the catheter 702 may preferentially bend in a particular direction to orient the active area of ​​a cryogenic delivery element away from certain anatomical features of the patient and toward the target treatment site.

[0101] Figure 8 It is used to utilize Figure 1 A conceptual diagram of an exemplary procedure for catheterizing the renal artery and modulating the renal nerves. Figure 8The use of catheter 102 for renal neuromodulation is illustrated, but catheter 102 may also be used for other therapies and treatments within another vessel or other hollow anatomical body in the human body. Catheter 102 is configured to deliver energy (e.g., radiofrequency energy, ultrasound energy, electrical stimulation energy, etc.) to one or more target treatment sites within a renal vessel. Catheter 102 provides access to the renal plexus (RP) through an intravascular path (P), such as a percutaneous access site in the femoral artery (shown), brachial artery, radial artery, or axillary artery to a target treatment site within a corresponding renal artery (RA). By manipulating the proximal portion 108B of the elongated body 108 from outside the intravascular path (P), a clinician can advance at least the distal portion 108A of the elongated body 108 through the sometimes tortuous intravascular path (P), and remotely manipulate the distal portion 108A ( Figure 1 ). The distal portion 108A can be remotely manipulated by a clinician using the handle 104.

[0102] exist Figure 8 In the illustrated example, the distal portion 108A is delivered intravascularly to the treatment site using an inner member 136 in an overall exchange (OTW) technique. The inner member 136 may be inside the catheter 102 (e.g., a guidewire, an inner catheter, etc.) or outside the catheter 102 (e.g., an outer sleeve, etc.). In some examples, the inner member 136 is a guide wire. The catheter 102 may define a channel for receiving the inner member 136 so that the catheter 102 is delivered using the OTW or RX technique. At the treatment site, the inner member 136 may be at least partially withdrawn or removed relative to the catheter 102, and the distal portion 108A may be transformed into an expanded configuration (e.g., a spiral configuration, a helical configuration, etc.) for delivering ultrasonic energy. In other examples, the elongated body 108 may be self-controllable so that the therapy delivery element 110 may be delivered to the target treatment site without the help of the inner member 136.

[0103] Renal neuromodulation refers to the partial or complete incapacitation or other effective destruction of the nerves supplying the kidney (e.g., nerves terminating in the kidney). In particular, renal neuromodulation may include inhibiting, reducing and / or blocking neural communication along the nerve fibers (e.g., efferent and / or afferent nerve fibers) of the kidney. This incapacitation may 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 the systemic reduction of sympathetic tone or power and / or benefit at least some specific organs and / or other body structures innervated by the sympathetic nerves. Therefore, renal neuromodulation is expected to be used to treat clinical conditions associated with central sympathetic overstimulation. For example, renal neuromodulation is expected to add beneficial effects to conditions such as hypertension, heart failure, acute myocardial infarction, metabolic syndrome, insulin resistance, diabetes, left ventricular hypertrophy, chronic and end-stage renal disease, inappropriate fluid retention in heart failure, cardiorenal syndrome, polycystic kidney disease, polycystic ovary syndrome, osteoporosis, erectile dysfunction, and sudden death.

[0104] Renal neuromodulation may be induced electrically or in another suitable manner by delivering energy (RF energy, ultrasonic energy, microwave energy, etc.). The target treatment site may be located within the renal lumen (e.g., renal artery, ureter, renal pelvis, renal calyx, renal calyx, or another suitable structure) or otherwise close to the renal lumen, and the target treatment site may include tissue at least close to the renal lumen wall. For example, with respect to the renal artery, the treatment protocol may include regulating nerves in the renal plexus, which are closely located within or adjacent to the adventitia of the renal artery. The following discussion provides further details on patient anatomy and physiology because it may involve renal denervation therapy. This section is intended to supplement and expand the previous discussion on relevant anatomy and physiology, and to provide additional context for the disclosed technology and the therapeutic benefits associated with renal denervation. For example, several properties of the renal blood vessels may affect the design of target treatment devices and associated methods for achieving renal neuromodulation via intravascular access, and put forward specific design requirements for such devices. Specific design requirements may include access to the renal artery, positioning of the distal portion 108A within the renal artery, delivering therapy to target tissue, and / or utilizing the therapy delivery device to effectively modulate the renal nerves.

[0105] As mentioned above, the sympathetic nervous system (SNS) is a branch of the autonomic nervous system and the enteric nervous system and the parasympathetic nervous system. It is always active at the basal level (referred to as sympathetic tone), and becomes more active during the stress period. Like the rest of the nervous system, the sympathetic nervous system operates through a series of interconnected neurons. Sympathetic neurons are frequently considered to be a part of the peripheral nervous system (PNS), although many are located in the central nervous system (CNS). The sympathetic neurons of the spinal cord (which are a part of the CNS) communicate with peripheral sympathetic neurons through a series of sympathetic ganglia. In the ganglion, the spinal cord sympathetic neurons connect peripheral sympathetic neurons by synapses. Therefore, the spinal cord sympathetic neurons are referred to as presynaptic (or preganglionic) neurons, and the peripheral sympathetic neurons are referred to as postsynaptic (or postganglionic neurons).

[0106] At 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 noradrenaline (norepinephrine). Long-term activation may trigger the adrenal medulla to release epinephrine.

[0107] Once released, norepinephrine and epinephrine bind to adrenergic receptors on peripheral tissues. Binding to adrenergic receptors causes neuronal and hormonal responses. Physiological manifestations include pupil dilation, increased heart rate, occasional vomiting, and increased blood pressure. Increased sweating is also due to binding to cholinergic receptors in sweat glands.

[0108] The sympathetic nervous system is responsible for up-regulating and down-regulating many homeostatic mechanisms in living organisms. The fibers from the SNS dominate the tissues in almost every organ system, providing at least some physiological regulatory functions, as diverse as pupil diameter, intestinal peristalsis and urine output. This reaction is also referred to as the sympathetic-adrenal response of the body, because the preganglionic sympathetic nerve fibers (and all other sympathetic nerve fibers) that terminate in the adrenal medulla secrete acetylcholine, which activates the secretion of adrenaline (adrenaline) (epinephrine), and activates norepinephrine (noradrenaline) to a lesser extent. Therefore, this reaction that mainly acts on the cardiovascular system is directly mediated via the pulse transmitted by the sympathetic nervous system, and indirectly mediated via the catecholamines secreted by the adrenal medulla.

[0109] Science generally views the SNS as an autoregulatory system, that is, a system that operates without the intervention of the conscious mind. Some evolutionary theorists believe that the sympathetic nervous system operated in early organisms to maintain survival because the sympathetic nervous system is responsible for initiating the body's actions. An example of this initiation is the spontaneous increase in sympathetic outflow in the moments before waking up, in preparation for action.

[0110] Fig. 9 is a conceptual diagram of an exemplary sympathetic nervous system (SNS), illustrating how the brain communicates with the body via the SNS. Fig. 9 As shown, SNS provides a neural network that allows the brain to communicate with the body. Sympathetic nerves originate from the inside of the spine, for example, in the middle lateral cell row (or lateral angle) towards the middle of the spinal cord, starting from the first thoracic segment of the spinal cord, and are considered to extend to the second lumbar segment or the third lumbar segment. Because SNS cells begin in the thoracic and lumbar regions of the spinal cord, SNS is said to have thoracolumbar outflow. The axons of the sympathetic nerves leave the spinal cord by anterior rootlets / roots. Axons pass near the spinal (sensory) ganglion, and axons enter the anterior ramus of the spinal nerves there. However, unlike somatic nerve innervation, axons are separated by white branch connectors, and these white branch connectors are connected to the paravertebral ganglia (which are located near the spine) or prevertebral ganglia (which are located near the aortic bifurcation) extending along the edge of the spine.

[0111] In order to reach the target organs and glands, axons should travel long distances in the body, and to accomplish this, many axons relay their message to a second cell through synaptic transmission. The end of the axon connects to the dendrites of the second cell across a space, the synapse. The first cell (presynaptic cell) sends a neurotransmitter across the synaptic cleft, where it activates the second cell (postsynaptic cell). The message is then transmitted to the final destination.

[0112] In the SNS and other components of the peripheral nervous system, these synapses are formed at the sites discussed above called ganglia. The cells that send their fibers to the ganglion are called preganglionic cells, and the cells whose fibers leave the ganglion are called postganglionic cells. As mentioned previously, the preganglionic cells of the SNS are located between the first thoracic (T1) segment and the third lumbar (L3) segment of the spinal cord. The cell bodies of the postganglionic cells are located in the ganglia and send their axons to the target organs or glands.

[0113] The ganglia include not only the sympathetic trunks, but also the cervical ganglia (superior, middle, and inferior) which send sympathetic nerve fibers to the head and thoracic organs, and the celiac and mesenteric ganglia which send sympathetic nerve fibers to the intestines.

[0114] Fig.10 is an enlarged anatomical view of the nerves that innervate the left kidney to form the renal plexus surrounding the left renal artery. Fig.10As shown, the kidney is dominated by the renal plexus (RP) closely associated with the renal artery. The renal plexus (RP) is an autonomic plexus surrounding the renal artery and 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. The fibers contributing to the renal plexus (RP) arise from the celiac ganglion, superior mesenteric ganglion, aortic renal ganglion and aortic plexus. The renal plexus (RP), also referred to as the renal nerve, mainly comprises sympathetic components. There is no (or at least very little) parasympathetic innervation of the kidney.

[0115] Preganglionic neuron cell bodies are located in the middle lateral cell rows of the spinal cord. Preganglionic axons pass through the paravertebral ganglia to become smaller splanchnic nerves, the smallest splanchnic nerves, the first lumbar splanchnic nerves, the second lumbar splanchnic nerves and travel to the celiac ganglion, the superior mesenteric ganglion and the aortic renal ganglion. Postganglionic neuron cell bodies exit the celiac ganglion, the superior mesenteric ganglion and the aortic renal ganglion to arrive at the renal plexus (RP), and are distributed on the renal blood vessels.

[0116] Messages travel through the SNS in a two-way stream. Efferent messages may trigger simultaneous changes in different parts of the body. For example, the sympathetic nervous system can increase heart rate, dilate bronchial passages, decrease motility (movement) of the large intestine, constrict blood vessels, increase peristalsis in the esophagus, cause pupil dilation, piloerection (goose bumps), and sweating (diaphoresis), or increase blood pressure. Afferent messages carry signals from various organs and sensory receptors in the body to other organs, especially the brain.

[0117] Hypertension, heart failure, and chronic kidney disease are some of the many disease states caused by chronic activation of the SNS, particularly the renal sympathetic nervous system. Chronic activation of the SNS is a maladaptive 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.

[0118] As mentioned above, the renal sympathetic nervous system has been identified experimentally and in humans as a major contributor to the complex pathophysiology of hypertension, volume overload states (such as heart failure) and progressive renal disease. Studies using radiotracer dilution methods to measure the overflow of norepinephrine from the kidney to plasma have shown an increased renal norepinephrine (NE) overflow rate in patients with essential hypertension, especially in young hypertensive subjects, which, together with the increased NE overflow rate from the heart, is consistent with the hemodynamic profile common in early hypertension and characterized by increased heart rate, cardiac output and renal vascular resistance. It is now known that essential hypertension is usually neurogenic, often with significant sympathetic nervous system overactivity.

[0119] Activation of cardiorenal sympathetic nerve activity is even more pronounced in heart failure, as demonstrated by an exaggerated increase in NE overflow from the heart and kidneys to the plasma in the patient group. Consistent with this view, a strong negative predictive value of renal sympathetic activation for all-cause mortality and cardiac transplantation was recently demonstrated in patients with congestive heart failure, which was independent of total sympathetic activity, glomerular filtration rate, and left ventricular ejection fraction. These findings support the view that therapeutic regimens designed to reduce renal sympathetic stimulation have the potential to improve survival of patients with heart failure.

[0120] Both chronic kidney disease and end-stage renal disease in some patients are characterized by elevated sympathetic activation. In patients with end-stage renal disease, plasma levels of norepinephrine above the median have been shown to predict both all-cause mortality and mortality caused by cardiovascular disease. This is true for patients with diabetes or contrast-induced nephropathy. There is convincing evidence that sensory afferent signals from the diseased kidney are the main contributing factors to the initiation and maintenance of elevated central sympathetic outflow in this patient group; this promotes the occurrence of the well-known adverse consequences of chronic sympathetic overactivity, such as hypertension, left ventricular hypertrophy, ventricular arrhythmias, sudden cardiac death, insulin resistance, diabetes, and metabolic syndrome.

[0121] The sympathetic nerves of the kidney terminate in the renal blood vessels, juxtaglomerular apparatus, and renal tubules. Stimulation of the renal sympathetic nerves results in increased renin release, sodium (Na + ) reabsorption increases and renal blood flow decreases. These components of the neural regulation of renal function are greatly stimulated in the disease state characterized by increased sympathetic tone, and significantly promote the rise of blood pressure in hypertensive patients. The reduction of renal blood flow and glomerular filtration rate caused by renal sympathetic efferent stimulation may be the basis of renal function loss in cardiorenal syndrome, which is a renal dysfunction in the form of progressive complications of chronic heart failure, with a clinical course that fluctuates with the clinical condition and treatment of the patient usually. The pharmacological strategy that hinders the consequences of renal efferent sympathetic stimulation includes centrally acting sympathetic drugs, beta blockers (intended to reduce renin release), angiotensin converting enzyme inhibitors and receptor blockers (intended to block angiotensin II and aldosterone activation caused by renin release) and diuretics (intended to counteract sodium and water retention mediated by renal sympathetics). However, current pharmacological strategies can have significant limitations, including limited efficacy, compliance issues, side effects, etc.

[0122] The kidney communicates with the entire structure of the central nervous system through renal sensory afferent nerves. Several forms of "renal injury" may induce activation of sensory afferent signals. For example, renal ischemia, reduced stroke volume or renal blood flow, or abundant adenosine enzymes can trigger activation of afferent nerve communication.

[0123] Fig.11is an anatomical view of the human body depicting the efferent and afferent neural communications between the brain and kidneys. Fig.12 is a conceptual view of the human body, depicting the efferent and afferent neural communications between the brain and kidneys. Fig.11 and Fig.12 As shown, afferent communications can be from the kidney to the brain, or from one kidney to another kidney (via the central nervous system). These afferent signals are centrally integrated and may result in increased sympathetic outflow. This sympathetic drive is directed to the kidney, thereby activating the RAAS and inducing increased renin secretion, sodium retention, volume retention, and vasoconstriction. Central sympathetic overactivity also affects other organs and body structures innervated by the sympathetic nerves, such as the heart and peripheral vascular system, resulting in the described side effects of sympathetic activation, several aspects of which also contribute to the increase in blood pressure.

[0124] Thus, physiology suggests that: (i) modulation of tissue with efferent sympathetic nerves will reduce inappropriate renin release, salt retention, and reduction in renal blood flow; and (ii) modulation of tissue with afferent sensory nerves will reduce systemic contributions to hypertension and other disease states associated with increased central sympathetic tone through its direct effects on the posterior hypothalamus and contralateral kidney. In addition to the central hypotensive effects of afferent renal denervation, reductions in central sympathetic outflow to various other sympathetically innervated organs such as the heart and vascular system are expected.

[0125] As provided above, renal denervation may be valuable in the treatment of several clinical conditions characterized by increased activity in general and in particular 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 the reduction in afferent nerve signals contributes to a systemic decrease in sympathetic tone / excitation, renal denervation may also be used to treat other conditions associated with systemic sympathetic hyperactivity. Therefore, renal denervation may also benefit other organs and body structures innervated by sympathetic nerves, including Fig.11 For example, as previously discussed, reduction of central sympathetic drive can reduce insulin resistance, which afflicts people with metabolic syndrome and type II diabetes. Additionally, patients with osteoporosis can also be sympathetically activated and may also benefit from downregulation of sympathetic drive that accompanies renal denervation.

[0126] In accordance with the present technology, neuromodulation of the left and / or right renal plexus (RP), which is closely associated with the left and / or right renal arteries, may be achieved via intravascular access. Fig.13 This is an anatomical view of the human arterial vasculature. Fig.13As shown, blood moved by the contraction of the heart is transported from the left ventricle of the heart through the aorta. The aorta passes through the chest and descends, 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, pass through the left and right legs, and connect with the left and right femoral arteries.

[0127] Fig.14 This is an anatomical view of the human venous vasculature. Fig.14 As shown, blood collects in the veins and returns to the heart, passing through the femoral vein into the iliac vein and into the inferior vena cava. The inferior vena cava branches into the left and right renal arteries. Above the renal veins, the inferior vena cava ascends to deliver blood to the right atrium of the heart. From the right atrium, blood is pumped through the right ventricle into the lungs, where it is oxygenated. From the lungs, oxygenated blood is delivered to the left atrium. From the left atrium, oxygenated blood is delivered through the left ventricle back to the aorta.

[0128] The femoral artery can be accessed and cannulated at the base of the femoral triangle just below the midpoint of the inguinal ligament. A catheter can be inserted percutaneously through this access site into the femoral artery, through the iliac arteries and aorta, and placed into the left or right renal artery. This includes an intravascular approach that provides minimally invasive access to the respective renal artery and / or other renal vessels.

[0129] The wrist, upper arm, and shoulder regions provide other locations for introducing a catheter into the arterial system. For example, catheterization of the radial artery, brachial artery, or axillary artery can be used for selected cases. The catheter (e.g., catheter 102) introduced via these entry points can be passed through the subclavian artery on the left side (or via the subclavian artery and brachiocephalic artery on the right side), through the aortic arch, down along the descending aorta, and into the renal artery using standard angiographic techniques. Other entry sites may also be used to enter the arterial system.

[0130] Since neuromodulation of the left and / or right renal plexus (RP) can be achieved through intravascular access according to the present technology, the properties and characteristics of the renal vasculature can impose constraints and / or inform the design of devices, systems and methods for achieving such renal neuromodulation. Some of these properties and characteristics may vary over time across patient populations and / or within a particular patient, as well as in response to disease states such as hypertension, chronic kidney disease, vascular disease, end-stage renal disease, insulin resistance, diabetes, metabolic syndrome, etc. As explained herein, these properties and characteristics may have some impact on the efficacy of the procedure and the specific design of the intravascular device. Properties of interest may include, for example, material / mechanical, spatial, fluid dynamic / hemodynamic and / or thermodynamic properties.

[0131] As previously discussed, a catheter can be percutaneously advanced into the left or right renal artery via a minimally invasive intravascular approach. However, minimally invasive renal artery access can be challenging, for example, because the renal artery is often extremely tortuous, may have a relatively small diameter, and / or may have a relatively short length, as compared to some other arteries that are routinely accessed using a catheter. In addition, renal artery atherosclerosis is common in many patients, especially those who have

[0132] Patients with cardiovascular disease. Renal artery anatomy may also vary significantly from patient to patient, further complicating minimally invasive access. For example, significant inter-patient variability can be seen in relative tortuosity, diameter, length, and / or atherosclerotic plaque load, as well as in the angle of departure of the renal arteries from the aorta. In addition, some patients include multiple left and / or right renal arteries. Devices, systems, and methods for achieving renal neuromodulation via intravascular access should take into account these and other aspects of renal artery anatomy and its variation across patient populations when minimally invasively accessing the renal arteries.

[0133] In addition to complicating renal artery access, details of the renal anatomy also complicate the establishment of stable contact between the neuromodulation device and the luminal surface or wall of the renal artery. For example, the small space within the renal artery and the tortuosity of the artery may impede guidance. Furthermore, establishing consistent contact is complicated by patient motion, respiration, and / or the cardiac cycle, as these factors may cause significant movement of the renal artery relative to the aorta, and the cardiac cycle may temporarily dilate the renal artery (i.e., cause the arterial wall to pulsate).

[0134] The neuromodulation device may also be configured to allow the distal portion 108A and the therapy delivery element 110 ( Figure 1 ) Adjustable positioning and repositioning within the renal artery, as the location of treatment can also affect clinical efficacy. Additionally, variable positioning and repositioning of the neuromodulation device may prove useful in cases where the renal artery is particularly tortuous or where there are proximal branch vessels to the main renal artery vessel, making treatment in certain locations challenging.

[0135] As discussed above, the device positioned in the renal artery should be configured so that the expandable distal portion 108A of the catheter 102 can closely contact the vessel wall and / or at least partially extend through the vessel wall. The renal artery vessel diameter DRA is generally in the range of about 2mm to 10mm, wherein the DRA of most patient populations is about 4mm to about 8mm and the average value is about 6mm. The renal artery vessel length LRA between the mouth of the aorta / renal artery junction and its distal branches is generally in the range of about 5mm to 70mm, and a considerable portion of the patient population is in the range of about 20mm to 50mm. Since the target renal plexus is embedded in the adventitia of the renal artery, the composite intima-media thickness IMT (i.e., the radial outward distance from the luminal surface of the artery to the adventitia containing the target neural structure) is also significant, and is generally in the range of about 0.5mm to 2.5mm, with an average value of about 1.5mm. Although a certain depth of treatment is important to reach the target neural fibers, treatment should not be too deep (eg, >10 mm from the inner wall of the artery) to avoid non-target tissue and anatomical structures, such as the anatomy of the digestive system of the psoas muscle.

[0136] An additional property of the renal artery that may be of interest is the degree of movement of the kidney relative to the aorta, induced by respiration and / or blood flow pulsatility. The patient's kidney at the distal end of the renal artery may move up to 10 centimeters toward the skull with respiratory excursions. This can impart significant movement to the renal artery connecting the aorta and the kidney, requiring the neuromodulatory device to have a unique balance of rigidity and flexibility to maintain contact between the energy delivery element and the vessel wall during the respiratory cycle. In addition, the take-off angle between the renal artery and the aorta can vary significantly between patients, and can also vary dynamically within the patient's body, for example due to renal motion. The take-off angle can typically be in the range of about 30° to 135°.

[0137] The above detailed description of examples of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific examples of the present technology are described above for illustrative purposes, it should be recognized by those skilled in the relevant art that various equivalent modifications may be made within the scope of the present 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 additional examples. All references cited herein are incorporated herein by reference as if fully listed herein.

[0138] From the foregoing, it will be appreciated that specific examples of the disclosure have been described herein for purposes of illustration, but that various modifications may be made without departing from the scope of the disclosure.

[0139] In other examples, certain aspects of the disclosure described in the context of a particular example may be combined or omitted. In addition, although the advantages associated with certain examples have been described in the context of these examples, other examples may also present such advantages, and not all examples must present such advantages to fall within the scope of the disclosure. Therefore, the present disclosure and associated technology may encompass other examples not explicitly shown or described herein.

[0140] Furthermore, although techniques have been described in which the neuromodulation catheter is positioned at a single location within a single renal artery, in other examples, the neuromodulation catheter may be repositioned to a second treatment site within the single renal artery (e.g., proximal or distal to the first treatment site), may be repositioned into a branch of the single artery, may be repositioned into a different renal vessel on the same side of the patient (e.g., a renal vessel associated with the same kidney of the patient), may be repositioned into a renal vessel on the other 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.

[0141] Furthermore, unless the word "or" is expressly limited to mean only a single item in addition to other items in a list of two or more items, "or" used in such a list may be interpreted to include: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, unless otherwise indicated, the terms "about" or "approximately" when preceding a value should be interpreted to mean ±10% of the value. Furthermore, the term "comprising" is used throughout to mean including at least the listed features, such that any greater number of the same features and / or additional types of other features are not excluded.

[0142] Various aspects of the disclosure have been described, such as in the following examples. These and other aspects are within the scope of the claims.

[0143] Embodiment 1: A catheter comprises: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port connected to the injection lumen fluid, wherein the catheter body is configured to bend preferentially in a first direction than in a second direction when the catheter is positioned in a bend in a patient's vascular system.

[0144] Embodiment 2: The catheter of Embodiment 1, wherein the catheter body comprises a self-orienting member configured to induce preferential bending.

[0145] Embodiment 3: The catheter of Embodiment 2, wherein the self-orienting member is configured to deform relative to a first axis of the self-orienting member, and wherein the self-orienting member is configured to maintain rigidity relative to a second axis of the self-orienting member, the second axis being orthogonal to the first axis.

[0146] Embodiment 4: The catheter of Embodiment 3, wherein the first axis is the minor axis of the cross-section of the self-orienting member, and wherein the second axis is the major axis of the cross-section of the self-orienting member.

[0147] Embodiment 5: The catheter of any one of Embodiments 2 to 4, wherein the self-orienting member comprises a hypotube and splines extending from a distal end of the hypotube.

[0148] Embodiment 6: The catheter of Embodiment 5, wherein the spline is welded to the distal end of the hypotube.

[0149] Embodiment 7: The catheter according to any one of Embodiments 5 or 6, wherein the spline has a curved cross-section.

[0150] Embodiment 8: The catheter of any one of Embodiments 5 or 6, wherein the spline has a rectangular cross-section.

[0151] Embodiment 9: The catheter of any one of Embodiments 5 to 8, wherein at least one of the hypotube and the spline comprises a metal alloy.

[0152] Embodiment 10: The catheter according to any one of embodiments 1 to 9, further comprising an inner tube disposed within the lumen of the catheter, the inner tube defining an inner lumen in fluid communication with the expandable member.

[0153] Embodiment 11: The catheter of any one of Embodiments 1 to 10, wherein the distal portion of the injection tube defines the injection port.

[0154] Embodiment 12: The catheter of any one of Embodiments 1 to 11, wherein the preferential bend configures the catheter body to self-orient the injection port in a predetermined orientation relative to an anatomical feature of the patient when the catheter is positioned in the vasculature of the patient.

[0155] Embodiment 13: The catheter of Embodiment 12, wherein the anatomical feature comprises a renal vein, and wherein in the predetermined orientation, the injection port faces away from the renal vein.

[0156] Embodiment 14: The catheter of any one of Embodiments 12 or 13, wherein the catheter body is configured to self-orient the injection port in the predetermined orientation as the catheter extends around the bend in the vasculature of the patient.

[0157] Embodiment 15: The catheter of any one of Embodiments 1 to 14, wherein the first direction corresponds to a first plane orthogonal to a longitudinal axis of the catheter, and wherein the second direction corresponds to a second plane parallel to the longitudinal axis.

[0158] Embodiment 16: The catheter of any one of Embodiments 1 to 15, wherein the catheter is configured to deliver therapy to the tissue by introducing a therapeutic agent from at least the injection port and into the tissue of the patient.

[0159] Embodiment 17: A catheter according to any one of Embodiments 1 to 16, wherein the catheter body comprises: a self-orienting member, which is configured to cause the preferential bending, and the self-orienting member comprises: a first polymer, which is arranged around a first portion of a cross-section of the self-orienting member; and a second polymer, which is arranged around a second portion of the cross-section of the self-orienting member, wherein the second polymer is more rigid than the first polymer.

[0160] Embodiment 18: The catheter of Embodiment 17, wherein the first portion of the cross-section comprises a majority of the cross-section of the self-orienting member.

[0161] Embodiment 19: A catheter according to any one of embodiments 1 to 16, wherein the catheter body comprises a braid, the braid comprising a plurality of first strands and a plurality of second strands, the plurality of first strands comprising a first material, the plurality of second strands comprising a second material, and wherein the second material is more rigid than the first material.

[0162] Embodiment 20: The catheter of Embodiment 19, wherein the first material comprises a polymer.

[0163] Embodiment 21: The catheter of any of Embodiments 19 or 20, wherein the second material comprises a metal alloy.

[0164] Embodiment 22: The catheter according to any one of embodiments 1 to 21, further comprising a guidewire tube disposed within the inner lumen of the catheter, the guidewire tube defining a guidewire inner lumen configured to receive a guide member.

[0165] Embodiment 23: The catheter of any one of Embodiments 1 to 22, wherein the self-orienting member has a length between 10 centimeters and 40 centimeters.

[0166] Embodiment 24: The catheter of any one of Embodiments 1 to 23, further comprising a radiopaque marker disposed on a distal portion of the injection tube.

[0167] Example 25: A catheter comprising: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port fluidically connected to the injection lumen, wherein the catheter body is configured to orient the injection port in a predetermined orientation relative to an anatomical feature of the patient when the catheter is positioned in the patient's vascular system.

[0168] Embodiment 26: The catheter of Embodiment 25, wherein the catheter body comprises a self-orienting member configured to cause self-orientation of the injection port.

[0169] Example 27: The catheter of Example 26, wherein the self-orienting member is configured to deform relative to a first axis of the self-orienting member, and wherein the self-orienting member is configured to maintain rigidity relative to a second axis of the self-orienting member, the second axis being orthogonal to the first axis.

[0170] Embodiment 28: The catheter of Embodiment 27, wherein the first axis is the minor axis of the cross-section of the self-orienting member, and wherein the second axis is the major axis of the cross-section of the self-orienting member.

[0171] Embodiment 29: The catheter of any one of Embodiments 26 to 28, wherein the self-orienting member comprises a hypotube and splines extending from a distal end of the hypotube.

[0172] Embodiment 30: The catheter of Embodiment 29, wherein the spline is welded to the distal end of the hypotube.

[0173] Embodiment 31: A catheter according to any one of Embodiments 29 or 30, wherein the spline has a curved cross-section.

[0174] Embodiment 32: A catheter according to any one of Embodiments 29 or 30, wherein the spline has a rectangular cross-section.

[0175] Embodiment 33: The catheter of any one of Embodiments 29 to 32, wherein at least one of the hypotube and the spline comprises a metal alloy.

[0176] Embodiment 34: The catheter according to any one of embodiments 25 to 33, further comprising an inner tube disposed within the lumen of the catheter, the inner tube defining an inner lumen in fluid communication with the expandable member.

[0177] Embodiment 35: The catheter of any one of Embodiments 25 to 34, wherein the distal portion of the injection tube defines the injection port.

[0178] Embodiment 36: The catheter of any one of Embodiments 25 to 35, wherein the anatomical feature comprises a renal vein, and wherein in the predetermined orientation, the injection port faces away from the renal vein.

[0179] Embodiment 37: The catheter of any one of Embodiments 25 to 36, wherein the catheter body is configured to self-orient the injection port in the predetermined orientation when the catheter is guided around a bend in the vasculature of the patient.

[0180] Embodiment 38: The catheter of any one of Embodiments 25 to 37, wherein the catheter is configured to deliver therapy to the tissue by introducing a therapeutic agent from at least the injection port of the injection tube and into the tissue of the patient.

[0181] Example 39: A method for delivering therapy to tissue of a patient, the method comprising: guiding a catheter through the patient's vascular system to a target treatment site, wherein the catheter comprises: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port connected to a fluid in the injection lumen, wherein the catheter body is configured to bend preferentially in a first direction than in a second direction when the catheter is positioned in the vascular system; expanding the expandable member of the catheter from a collapsed configuration to an expanded configuration; and delivering the therapy to the target treatment site via the injection port.

[0182] Embodiment 40: The method of Embodiment 39, wherein the catheter body comprises a self-orienting member configured to induce preferential bending.

[0183] Embodiment 41: A method according to Embodiment 40, wherein the self-orienting member is configured to deform relative to a first axis of the self-orienting member, and wherein the self-orienting member is configured to maintain rigidity relative to a second axis of the self-orienting member, the second axis being orthogonal to the first axis.

[0184] Embodiment 42: A method according to Embodiment 41, wherein the first axis is the minor axis of the cross-section of the self-orienting member, and wherein the second axis is the major axis of the cross-section of the self-orienting member.

[0185] Embodiment 43: A method according to any one of Embodiments 40 to 42, wherein the self-orienting member comprises a hypotube and splines extending from a distal end of the hypotube.

[0186] Embodiment 44: The method according to embodiment 43, wherein the spline is welded to the distal end of the sea wave tube.

[0187] Embodiment 45: The method according to any one of Embodiments 43 or 44, wherein the spline has a curved cross-section.

[0188] Embodiment 46: The method according to any one of Embodiments 43 or 44, wherein the spline has a rectangular cross-section.

[0189] Embodiment 47: The method of any one of Embodiments 43 to 46, wherein at least one of the hypotube and the spline comprises a metal alloy.

[0190] Embodiment 48: The method of any one of Embodiments 39 to 47, wherein the catheter further comprises an inner tube disposed within the lumen of the catheter, the inner tube defining an inner lumen in fluid communication with the expandable member.

[0191] Example 49: The method of Example 48, wherein expanding the expandable member comprises delivering a fluid through the lumen and into the expandable member.

[0192] Example 50: A method according to any one of Examples 39 to 49, wherein guiding the catheter through the vascular system of the patient includes causing the catheter to traverse a bend in the vascular system, wherein when the catheter traverses the bend in the vascular system, the catheter body causes the injection port to self-orient in a predetermined orientation relative to an anatomical feature of the patient.

[0193] Embodiment 51: The method of Embodiment 50, wherein the anatomical feature comprises a renal vein, and wherein in the predetermined orientation, the injection port faces away from the renal vein.

[0194] Example 52: A method according to any one of Examples 50 or 51, wherein guiding the catheter through the patient's vascular system includes causing the catheter to traverse a bend in the vascular system, wherein when the catheter traverses the bend in the vascular system, the catheter body causes the injection port to self-orient in the predetermined orientation.

[0195] Embodiment 53: A method according to any one of Embodiments 39 to 52, wherein the first direction corresponds to a first plane orthogonal to the longitudinal axis of the catheter, and wherein the second direction corresponds to a second plane parallel to the longitudinal axis.

[0196] Embodiment 54: The method of any one of Embodiments 39 to 53, wherein delivering the therapy to the target treatment site via the injection port comprises introducing a therapeutic agent from the injection port of the injection tube and into the tissue.

[0197] Example 55: According to the method described in any one of Examples 39 to 54, the method also includes: collapsing the expandable member from the expanded configuration to the collapsed configuration; guiding the catheter through the vascular system of the patient to a second target treatment site; expanding the expandable member from the collapsed configuration to the expanded configuration; and delivering the therapy to the second target treatment site via the injection port.

[0198] Embodiment 56: A method according to any one of Embodiments 29 to 55, wherein the catheter body comprises a first polymer disposed around a first portion of the cross-section of the self-orienting member and a second polymer disposed around a second portion of the cross-section of the self-orienting member, wherein the second polymer is more rigid than the first polymer.

[0199] Embodiment 57: A method according to Embodiment 56, wherein the first portion of the cross-section includes a majority of the cross-section of the self-orienting member, and wherein the second portion includes a minority of the cross-section of the self-orienting member.

[0200] Embodiment 58: A method according to any one of Embodiments 39 to 57, wherein the catheter body comprises a braid, the braid comprising a plurality of first strands and a plurality of second strands, the plurality of first strands comprising a first material, the plurality of second strands comprising a second material, and wherein the second material is more rigid than the first material.

[0201] Embodiment 59: The method of Embodiment 58, wherein the first material comprises a polymer.

[0202] Embodiment 60: The method of any one of Embodiments 58 and 59, wherein the second material comprises a metal alloy.

[0203] Embodiment 61: According to the method of any one of Embodiments 39 to 60, the catheter further comprises a guidewire tube disposed within the inner lumen of the catheter, the guidewire tube defining a guidewire inner lumen configured to receive a guide member.

[0204] Embodiment 62: The method of any one of Embodiments 39 to 61, wherein the self-orienting member has a length between 10 centimeters and 40 centimeters.

[0205] Example 63: A method according to any one of Examples 39 to 62, wherein the catheter further includes a radiopaque marker disposed on the distal portion of the injection tube.

[0206] Example 64: A catheter comprising: a catheter body; and a neuromodulatory element disposed on a distal portion of the catheter body, wherein the catheter body is configured to bend preferentially in a first direction over a second direction when the catheter is positioned in a bend in a patient's vascular system.

[0207] Embodiment 65: The catheter of Embodiment 64, wherein the catheter body comprises a self-orienting member configured to induce the preferential bending.

[0208] Example 66: A catheter according to Example 65, wherein the self-orienting member is configured to deform relative to a first axis of the self-orienting member, and wherein the self-orienting member is configured to maintain rigidity relative to a second axis of the self-orienting member, the second axis being orthogonal to the first axis.

[0209] Embodiment 67: The catheter of Embodiment 66, wherein the first axis is the minor axis of the cross-section of the self-orienting member, and wherein the second axis is the major axis of the cross-section of the self-orienting member.

[0210] Example 68: A catheter according to any one of Examples 65 to 67, wherein the self-orienting member includes a hypotube and a spline extending from the distal end of the hypotube.

[0211] Example 69: The catheter of Example 68, wherein the spline is welded to the distal end of the hypotube.

[0212] Embodiment 70: A catheter according to any one of Embodiments 68 or 69, wherein the spline has a curved cross-section.

[0213] Embodiment 71: A catheter according to any of Embodiments 69 or 70, wherein the spline has a rectangular cross-section.

[0214] Embodiment 72: The catheter of any one of Embodiments 69 to 71, wherein at least one of the hypotube and the spline comprises a metal alloy.

[0215] Embodiment 73: The catheter of any one of Embodiments 64 to 72, wherein the neuromodulation element is configured to deliver neuromodulation therapy to an area of ​​influence, and wherein the area of ​​influence extends less than 360 degrees around the circumference of the patient's blood vessel.

[0216] Example 74: The catheter of any one of Examples 64 to 73, wherein the preferential bend configures the catheter body to self-orient the therapy delivery region on the neuromodulatory element in a predetermined orientation relative to an anatomical feature of the patient when the catheter is positioned in the vasculature of the patient.

[0217] Embodiment 75: The catheter of Embodiment 74, wherein the anatomical feature comprises a renal vein, and wherein in the predetermined orientation, the injection port faces away from the renal vein.

[0218] Example 76: The catheter of any one of Examples 74 or 75, wherein the catheter body is configured to self-orient the therapy delivery region in the predetermined orientation as the catheter extends around the bend in the vasculature of the patient.

[0219] Embodiment 77: The catheter of any one of Embodiments 74 to 76, wherein the therapy delivery region on the neuromodulation element extends less than 360 degrees around the circumference of the neuromodulation element.

[0220] Embodiment 78: A catheter according to any one of Embodiments 64 to 77, wherein the first direction corresponds to a first plane orthogonal to the longitudinal axis of the catheter, and wherein the second direction corresponds to a second plane parallel to the longitudinal axis.

[0221] Example 79: The catheter of any one of Examples 64 to 78, wherein the catheter is configured to deliver therapy to the tissue of the patient by introducing at least a therapeutic agent from the neuromodulatory element into the tissue.

[0222] Example 80: The catheter of any one of Examples 64 to 78, wherein the neuromodulation element comprises one or more electrodes, and wherein the one or more electrodes are configured to deliver therapy to the patient's tissue.

[0223] Example 81: The catheter of Example 80, wherein the one or more electrodes are configured to deliver radiofrequency (RF) energy to the tissue.

[0224] Embodiment 82: The catheter of Embodiment 80, wherein the one or more electrodes are configured to deliver microwave energy to the tissue.

[0225] Example 83: The catheter of Example 80, wherein the one or more electrodes are configured to deliver ultrasonic energy to the tissue.

[0226] Example 84: The catheter of any one of Examples 64-78, wherein the neuromodulation element comprises an expandable member, and wherein the expandable member is configured to deliver cryogenic energy to the patient's tissue.

[0227] Embodiment 85: A catheter according to any one of Embodiments 64 to 84, wherein the catheter body comprises: a self-orienting member configured to cause the preferential bending, the self-orienting member comprising: a first polymer disposed around a first portion of a cross-section of the self-orienting member; and a second polymer disposed around a second portion of the cross-section of the self-orienting member, wherein the second polymer is more rigid than the first polymer.

[0228] Embodiment 86: The catheter of Embodiment 85, wherein the first portion of the cross-section comprises a majority of the cross-section of the self-orienting member.

[0229] Embodiment 87: A catheter according to any one of Embodiments 64 to 86, wherein the catheter body comprises a braid, the braid comprising a plurality of first strands and a plurality of second strands, the plurality of first strands comprising a first material, the plurality of second strands comprising a second material, and wherein the second material is more rigid than the first material.

[0230] Embodiment 88: The catheter of Embodiment 87, wherein the first material comprises a polymer.

[0231] Embodiment 89: A catheter according to any of Embodiments 87 or 88, wherein the second material comprises a metal alloy.

[0232] Embodiment 90: The catheter according to any one of embodiments 64 to 89, wherein the catheter body defines a catheter lumen, and wherein a guidewire tube is disposed within the catheter lumen, the guidewire tube defining a guidewire lumen configured to receive a guide member.

[0233] Embodiment 91: The catheter of any one of Embodiments 64 to 90, wherein the self-orienting member has a length between 10 centimeters and 40 centimeters.

[0234] Example 92: According to any one of Examples 64 to 91, the catheter also includes a radiopaque marker disposed on the distal portion of the catheter body.

Claims

1. A catheter, comprising: a catheter body defining a catheter lumen; an expandable member connected to the catheter body; and an injection tube disposed on an outer surface of the expandable member, the injection tube defining an injection lumen and an injection port in fluid communication with the injection lumen, Wherein the catheter body is configured to bend preferentially in a first direction over a second direction when the catheter is positioned in a bend in the vasculature of a patient.

2. A catheter according to claim 1, wherein the catheter body includes a self-orienting member, the self-orienting member is configured to cause preferential bending, wherein the self-orienting member is configured to deform relative to a first axis of the self-orienting member, and wherein the self-orienting member is configured to maintain rigidity relative to a second axis of the self-orienting member, the second axis being orthogonal to the first axis.

3. The catheter of claim 2, wherein the first axis is a minor axis of a cross-section of the self-orienting member, and wherein the second axis is a major axis of the cross-section of the self-orienting member.

4. The catheter of claim 2 or 3, wherein the self-orienting member comprises a hypotube and splines extending from a distal end of the hypotube. The catheter according to claim 4 , wherein the spline has a curved cross-section or a rectangular cross-section.

6. The catheter of claim 4 or 5, wherein at least one of the hypotube or the splines comprises a metal alloy.

7. The catheter of any one of claims 1 to 6, wherein a distal portion of the injection tube defines the injection port.

8. The catheter of any one of claims 1 to 7, wherein the preferential bend configures the catheter body to self-orient the injection port in a predetermined orientation relative to an anatomical feature of the patient when the catheter is positioned in the vasculature of the patient.

9. The catheter of claim 8, wherein the anatomical feature comprises a renal vein, and wherein in the predetermined orientation, the injection port faces away from the renal vein.

10. The catheter of claim 8 or 9, wherein the catheter body is configured to self-orient the injection port in the predetermined orientation as the catheter extends around the bend in the vasculature of the patient.

11. The catheter of any one of claims 1 to 10, wherein the first direction corresponds to a first plane orthogonal to a longitudinal axis of the catheter, and wherein the second direction corresponds to a second plane parallel to the longitudinal axis.

12. The catheter of any one of claims 1 to 11, wherein the catheter is configured to deliver therapy to the tissue by introducing a therapeutic agent from at least the injection port and into the tissue of the patient.

13. The catheter according to any one of claims 1 to 12, wherein the catheter body comprises: A self-orienting member, the self-orienting member being configured to induce the preferential bending, the self-orienting member comprising: a first polymer disposed around a first portion of a cross-section of the self-orienting member; and A second polymer is disposed around a second portion of the cross-section of the self-orienting member, wherein the second polymer is more rigid than the first polymer.

14. The catheter of claim 13, wherein the first portion of the cross-section comprises a majority of the cross-section of the self-orienting member.

15. The catheter of any one of claims 1 to 14, wherein the catheter body comprises a braid, the braid comprising a plurality of first strands and a plurality of second strands, the plurality of first strands comprising a first material, the plurality of second strands comprising a second material, and wherein the second material is more rigid than the first material, and wherein: The first material comprises a polymer; or The second material comprises a metal alloy; or The first material comprises a polymer and the second material comprises a metal alloy.

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