Catheter comprising non-inflatable positioning member

Abstract

In some examples, a catheter (108, 300, 400, 500, 600, 700, 800, 900, 1000, 1100) includes a catheter body (110), one or more non-inflatable positioning members (116, 316, 416, 406, 516, 606, 716, 806, 816, 916, 101, 111 6) configured to be deployed from a collapsed configuration to an expanded configuration, and one or more injection tubes (114, 314, 414, 514, 614, 814, 914, 101, 111 4) connected to the one or more non-inflatable positioning members. Each of the injection tubes defines an injection tube lumen and one or more injection ports (113, 313, 413, 513, 613, 713, 912A 912B, 1013, 1113) in fluid communication with the respective injection tube lumen. The one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the injection ports juxtaposed with a vessel wall of a patient.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 476,974, filed on December 23, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present technology involves a catheter. Background Art

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

[0004] The present disclosure describes a catheter comprising one or more non-inflatable positioning members and one or more injection tubes configured to be positioned within a patient's blood vessel to deliver a treatment to the patient. The treatment may include, for example, a neuromodulation treatment, such as renal denervation treatment. The one or more injection tubes each define at least one injection port configured to deliver a therapeutic agent (such as a chemical for ablating nerves) to the patient's blood vessel wall or other tissue. The one or more non-inflatable positioning members are configured to expand radially outward (e.g., relative to the central longitudinal axis of the catheter) within the blood vessel to, for example, position the one or more injection port tubes juxtaposed with the blood vessel wall to facilitate delivery of the therapeutic agent to the patient's tissue via the corresponding injection port. For example, the one or more non-inflatable positioning members may be configured to position the one or more injection ports to facilitate delivery of the therapeutic agent to the patient's adventitial tissue or perivascular tissue (such as renal perivascular tissue) from an intravascular position.

[0005] Various exemplary configurations of one or more non-inflatable positioning members are described herein. For example, in some examples, a catheter includes two or more syringes, and the one or more non-inflatable positioning members include at least one annular member radially inward of the two or more syringes. As another example, the one or more non-inflatable positioning members may define an expandable frame or a spiral, helical, or sinusoidal structure. Other configurations of non-inflatable positioning members are further described herein in detail.

[0006] In some examples, the present disclosure describes a catheter comprising: a catheter body defining a central longitudinal axis; one or more non-inflatable positioning members connected to the catheter body; and one or more injection tubes disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports in fluid communication with the corresponding injection tube lumen, wherein the one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the one or more injection ports in juxtaposition with a patient's blood vessel wall.

[0007] In some examples, the present disclosure describes a method comprising: guiding a catheter through a patient's vasculature to a target treatment site, wherein the catheter comprises: a catheter body; one or more non-inflatable positioning members, the one or more non-inflatable positioning members being connected to the catheter body; and one or more injection tubes, the one or more injection tubes being disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports in fluid communication with the corresponding injection tube lumen; deploying the one or more non-inflatable positioning members into an expanded configuration to position at least one of the one or more injection ports in juxtaposition with a vessel wall of the patient; and delivering treatment to the target treatment site via the one or more injection ports of the one or more injection tubes.

[0008] In some examples, the present disclosure describes a catheter comprising: a catheter body defining a catheter lumen and a central longitudinal axis; an internal member disposed within the catheter lumen; one or more non-inflatable positioning members; and one or more injection tubes connected to the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports in fluid communication with the corresponding injection tube lumen, wherein in response to movement of the internal member relative to the catheter body, the one or more non-inflatable positioning members and the one or more injection tubes are configured to move radially outward away from the central longitudinal axis.

[0009] The present invention further discloses a catheter comprising a catheter body, one or more non-inflatable positioning members configured to be deployed from a collapsed configuration to an expanded configuration, and one or more injection tubes connected to the one or more non-inflatable positioning members, wherein each of the injection tubes defines an injection tube lumen and one or more injection ports in fluid communication with the corresponding injection tube lumen, wherein the one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the injection ports in juxtaposition with a patient's blood vessel wall.

[0010] The details of one or more aspects of the present disclosure are set forth in the following drawings and the description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a schematic diagram of an exemplary medical system including a medical system.

[0012] Figure 2 yes Figure 1 Schematic diagram of the medical system within the patient's blood vessels.

[0013] Figure 3A is a conceptual diagram illustrating an exemplary catheter system including an injection tube and a non-inflatable positioning member in a collapsed configuration.

[0014] Figure 3B is shown in the expanded configuration Figure 3A Conceptual diagram of an exemplary catheter system.

[0015] Figure 4A is a conceptual diagram illustrating another exemplary catheter system including an annular non-inflatable positioning member in a collapsed configuration.

[0016] Figure 4B is shown in the expanded configuration Figure 4A Conceptual diagram of an exemplary catheter system.

[0017] Figure 5 is a conceptual diagram illustrating another exemplary catheter system including a plurality of shape memory arms connected to respective injection tubes via ribbons.

[0018] Figure 6A is a conceptual diagram illustrating another exemplary catheter system including a single annular non-inflatable positioning member.

[0019] Figure 6B The invention is shown to include a plurality of annular non-inflatable positioning members. Figure 6A Conceptual diagram of an exemplary catheter system.

[0020] Figure 7is a conceptual diagram illustrating another exemplary catheter system including at least one shape memory arm connected to a distal portion of a corresponding injector tube.

[0021] Figure 8A is a conceptual diagram illustrating a side view of another exemplary catheter system including a non-inflatable positioning member including a support frame in a partially collapsed configuration.

[0022] Figure 8B is shown in the expanded configuration Figure 8A Conceptual diagram of an exemplary catheter system.

[0023] Figure 9A is a conceptual diagram illustrating another exemplary catheter system having a non-inflatable positioning member in a collapsed configuration.

[0024] Figure 9B is shown in the expanded configuration Figure 9A Conceptual diagram of another exemplary catheter system.

[0025] Figure 10 is a conceptual diagram illustrating another exemplary catheter system including a non-inflatable positioning member defining at least one helical, spiral, or sinusoidal structure.

[0026] Figure 11 is a conceptual diagram illustrating another exemplary catheter system including a non-inflatable positioning member defining a single helical, spiral, or sinusoidal structure.

[0027] Figure 12 is a flow chart illustrating an exemplary method of delivering therapy to a patient using a catheter including a non-inflatable positioning member. DETAILED DESCRIPTION

[0028] The present disclosure describes devices, systems, and methods for performing neuromodulation, such as renal neuromodulation, using therapeutic agents, such as ablative chemical agents. Although the following examples will be primarily described with respect to renal neuromodulation, those skilled in the art will understand that the devices, systems, and methods described herein can be used to perform neuromodulation at any suitable intravascular location within a patient's body.

[0029] Conditions such as arrhythmias, hypertension, volume overload states (e.g., heart failure) and progressive nephropathy caused by overactivation of the renal sympathetic nervous system (SNS) can be alleviated by regulating the activation of overactivated nerves (neuromodulation), for example, denervation or reducing the activation of overactivated nerves. The sympathetic nerves of the kidney terminate in structures such as the renal blood vessels, juxtaglomerular apparatus, and renal tubules. Renal neuromodulation, such as renal denervation, can be accomplished using one or more of a variety of treatment modalities, including radiofrequency (RF) energy, microwave energy, ultrasonic energy, therapeutic agents, etc. When using a therapeutic agent, a neuromodulation catheter can be delivered to the patient's renal blood vessels, such as the renal artery or renal vein. The neuromodulation catheter may include at least one port through which the therapeutic agent is delivered. The therapeutic agent is selected to regulate the activity of one or more renal nerves adjacent to the renal blood vessels in which the neuromodulation catheter is positioned. For example, the therapeutic agent can be a neurotoxic chemical that is selected to chemically ablate one or more renal nerves near the renal blood vessels.

[0030] In the case of chemical denervation, the medical system can be configured to pressurize the therapeutic fluid (e.g., chemical agent and / or other therapeutic fluid) so that the therapeutic agent is delivered to the target treatment site via a catheter. In some cases, tissue ablation can be completed using relatively high pressure chemical ablation. For example, a neuromodulation procedure may involve introducing a therapeutic agent into the vessel wall at high pressure for neuromodulation of nearby nerves (e.g., renal sympathetic nerves in the case of a renal denervation procedure). In some cases, the therapeutic agent can be delivered without a needle. For example, the therapeutic agent can be delivered at relatively high pressure through one or more injection ports defined by one or more injection tubes positioned in the blood vessel, wherein the pressure is high enough to force the therapeutic agent into and / or through the vessel wall. The therapeutic agent can then diffuse around the target treatment site (e.g., nerves around the blood vessel). Exemplary pressures include, for example, 5 MPa (MPa) to 21 MPa (e.g., about 750 pounds per square inch (psi) to about 3046 psi), such as 10 MPa (or about 1450 psi).

[0031] The present disclosure describes an exemplary catheter that includes one or more injection tubes configured to be positioned, for example, within a patient's blood vessel by one or more non-inflatable positioning members, the one or more injection tubes each defining one or more injection ports that are configured to deliver a therapeutic agent to a target tissue site of the patient to achieve a therapeutic result. The one or more non-inflatable positioning members (which may also be referred to as non-inflatable expandable members) are configured to be deployed from a relatively low-profile configuration to a radially expanded configuration to position at least one of the one or more injection ports in juxtaposition with the patient's blood vessel wall. In some examples, the catheter is needle-free, such that a chemical is delivered to the patient's target tissue via relatively high-pressure needle-free injection. The medical system, as well as systems including the medical system and methods of using the medical system, can be used for any suitable medical procedure that includes delivering a therapy (e.g., a chemical agent) to a target tissue site, such as neuromodulation (e.g., denervation).

[0032] One or more non-inflatable positioning members are configured to expand radially outward, for example, relative to a central longitudinal axis of the catheter body, so as to juxtapose one or more injection tubes, each defining one or more injection ports, with the vessel wall and to maintain the injection ports against the vessel wall during high-pressure injection of chemicals. For example, at least one injection tube may be mechanically connected to the positioning member, for example via a mechanical band, adhesive, welding, etc., so that when the positioning member expands radially outward, the injection tube moves with the positioning member. Thus, in some examples, at least a portion or all of at least one of the one or more injection tubes is flexible, for example, more flexible than the one or more non-inflatable positioning members. In some examples, at least one non-inflatable positioning member is positioned in a syringe. In some examples, the non-inflatable positioning member also defines a syringe, but the catheter includes at least one other syringe separate from the non-inflatable positioning member.

[0033] In examples where the catheter includes multiple injection tubes, the injection ports of the different injection tubes may be aligned or offset longitudinally (e.g., in a direction along the longitudinal axis of the catheter). In addition, the injection ports may be circumferentially aligned or circumferentially offset. Longitudinally offset injection ports can enable delivery of therapeutic agents at multiple longitudinal positions along the blood vessel. Longitudinally aligned injection ports can help facilitate 360-degree delivery of therapeutic agents around the blood vessel. One or more positioning members are non-inflatable because, for example, they are configured to expand radially outward without the use of an inflation fluid (e.g., saline). Compared to a balloon, one or more non-inflatable positioning members are configured to enable blood to continue to flow through the blood vessel throughout the neuromodulation procedure, for example, around and distally through one or more non-inflatable positioning members.

[0034] In some examples, the non-inflatable positioning member is configured to self-expand. In addition to or in lieu of self-expanding, the non-inflatable positioning member can be configured to expand when a control member (e.g., a tube or a pull wire) connected to the non-inflatable positioning member is withdrawn in a proximal direction or advanced in a distal direction. The non-inflatable positioning member can have a shape that enables it to collapse into a relatively low-profile configuration for delivery to a target tissue site through the vascular system. For example, the non-inflatable positioning member can define a sinusoidal or tilted elliptical hoop when expanded so that the hoop can collapse into a lower-profile delivery configuration.

[0035] In some examples, the catheter includes two syringes spaced approximately 180 degrees apart. In other examples, other syringe configurations may also be used. In some examples, one or more non-inflatable positioning members and / or another portion of the catheter are configured to orient the injection ports of the syringes in a desired orientation, which may include, for example, a preferred direction of therapeutic agent delivery, e.g., away from the renal vein when the catheter is positioned in the renal artery.

[0036] In some examples, the one or more syringes include a first syringe and a second syringe, and the first syringe is configured to remain stationary, while the at least one non-inflatable positioning member is configured to move the second syringe away from the first syringe when the at least one non-inflatable positioning member expands radially outward. In some examples, the at least one non-inflatable positioning member defines a helical, spiral, or sinusoidal structure in an expanded state.

[0037] In some examples, one or more syringes and one or more non-inflatable positioning members are configured to collapse into a lower profile state by tilting toward the central longitudinal axis of the catheter body when the control member is pushed distally. The one or more non-inflatable positioning members may be configured to expand radially outward when the control member is pulled proximally. In some examples, the one or more syringes and one or more non-inflatable positioning members are configured to collapse into a lower profile state or expand radially outward when the control member is pulled proximally or pushed distally, respectively. The one or more non-inflatable positioning members may be configured to self-expand. The one or more non-inflatable positioning members may include nitinol.

[0038] The syringe can be fluidly coupled to the source of therapeutic agent using any suitable technique. In an example, the catheter body defines a catheter lumen and includes a fluid delivery tube disposed within the catheter lumen. Each of the one or more syringes can include a proximal portion disposed within the catheter lumen and in fluid communication with the fluid delivery tube. The one or more syringes can include a plurality of syringes, and each of the plurality of syringes can extend proximally from the catheter lumen and along an outer surface of the catheter body proximal to a proximal end of the one or more non-inflatable positioning members.

[0039] In some examples, the catheter body defines a catheter lumen configured to receive a control member mechanically connected to one or more non-inflatable positioning members. The control member may include a guidewire tube defining a guidewire lumen configured to receive a guidewire. In an example, the control member includes one or more pull wires disposed within the catheter lumen.

[0040] Although primarily mentioned blood vessels throughout this disclosure, the devices, systems, and techniques described herein are also applicable to other target tissue sites. Although this article describes the technology with reference to renal nerves and blood vessels in many cases, the technology is also applicable to neuromodulation at other anatomical sites and their associated nerves (e.g., spinal neuromodulation, cardiac neuromodulation, cranial neuromodulation, sacral neuromodulation, urinary neuromodulation, and / or neuromodulation techniques involving other parts of the body), and such devices and systems can be constructed (e.g., with a suitable shape and size) for such sites. For example, a catheter can be configured to deliver energy, wherein a portion of the catheter is limited to an injection port longitudinally aligned along the injection tube positioned together with a specific anatomical lumen or specific tissue (e.g., renal artery, external iliac artery, internal iliac artery, internal pudendal artery, celiac artery, mesenteric artery, superior mesenteric artery, inferior mesenteric artery, hepatic artery, splenic artery, gastric artery, left gastric artery, pancreatic artery, uterine artery, ovarian artery, testicular artery, and / or their associated arterial branches, appendages, veins, and / or other hollow anatomical structures).

[0041] As used herein, the terms "distal" and "proximal" define a position or direction relative to a treating clinician or a clinician's control device (e.g., a handle assembly). "Distal" or "distally" can refer to a position away from or in a direction away from a clinician or a clinician's control device. "Proximal" and "proximally" can refer to a position close to or in a direction toward a clinician or a clinician's control device.

[0042] Figure 1 is a schematic perspective view of an exemplary medical system 100 including a catheter system 108 comprising an elongated body 110 defining a proximal body portion 110A and a distal body portion 110B configured (e.g., by a clinician) to be positioned within a patient's blood vessel 102 ( Figure 2The non-inflatable positioning member 116 is configured to expand radially outward to, for example, help position the injection port in apposition with the vessel wall 104, help maintain the elongated body 110 and / or center the elongated body 110 within the vessel 102, help shift and / or maintain the shift between the elongated body 110 and the vessel wall 104, or any combination thereof. For example, radially outward expansion of one or more non-inflatable positioning members 116 may also cause one or more syringes 114 to also move radially outward to help position the injection port 113 in apposition with the patient's tissue.

[0043] The medical system 100 also includes a fluid delivery system 132 , a fluid delivery tube 131 in fluid communication with the syringe 114 via a therapeutic fluid flow path 128 , and a handle 166 .

[0044] Figure 2 is a schematic diagram of a portion of a medical system 100 within a patient's blood vessel 102 having a vessel wall 104. Figure 2 In the example shown, blood vessel 102 is a renal artery, and blood vessel wall 104 is a renal artery wall. However, in other examples, medical system 100 is configured to deliver therapy to other blood vessels, anatomical lumens, and / or other tissues, such as the external iliac artery, the internal iliac artery, the internal pudendal artery, the celiac artery, the mesenteric artery, the superior mesenteric artery, the inferior mesenteric artery, the hepatic artery, the splenic artery, the gastric artery, the left gastric artery, the pancreatic artery, the uterine artery, the ovarian artery, the testicular artery, and / or their associated arterial branches, appendages, veins, and / or other hollow anatomical structures of a patient.

[0045] In an example, the medical system 100 is configured to provide neuromodulation to the patient. Neuromodulation (e.g., renal neuromodulation) is the partial or complete incapacitation or other effective destruction of nerves (e.g., nerves terminating in the kidney or in structures closely associated with the kidney). Neuromodulation may include inhibiting, reducing, and / or blocking neural communication along nerve fibers (e.g., efferent and / or afferent nerve fibers). This incapacitation may be long-term (e.g., permanent or for a period of months, years, or decades) or short-term (e.g., for a period of minutes, hours, days, or weeks). Neuromodulation may include performing renal denervation by injecting a therapeutic agent (e.g., a chemical) into the renal artery with a high-pressure needle-free injection to ablate the sympathetic nerves. It is contemplated that neuromodulation contributes to a systemic reduction in sympathetic tone or power and / or benefits at least some specific organs and / or other body structures innervated by the sympathetic nerves. Therefore, it is contemplated that neuromodulation is used to treat clinical conditions associated with systemic sympathetic overactivity or hyperactivity, particularly conditions associated with central sympathetic overstimulation.

[0046] For example, renal neuromodulation can be expected to be effective in treating 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. Renal neuromodulation can be chemically induced or induced in another suitable manner or combination of manners (e.g., with one or more of electrical and thermal induction) at one or more suitable target tissues during a treatment protocol. The target site can be within or otherwise close to the renal lumen (e.g., the renal artery, ureter, renal pelvis, calyces, calyces, or another suitable structure), and the treated tissue can include tissue at least close to the renal lumen wall (e.g., close to the vessel wall 104 of the blood vessel 102). For example, with respect to the renal artery, a treatment protocol can include modulating nerves in the renal plexus that are closely located within or adjacent to the adventitia of the renal artery.

[0047] For ease of description, the following discussion will primarily focus on delivering a therapeutic agent (such as a neurotoxic chemical or another chemical agent) to a target tissue.

[0048] Each of the syringes 114 defines at least one syringe lumen (not shown) and one or more injection ports 113 in fluid communication with the corresponding syringe lumen. The catheter system 108 is configured to deliver a therapeutic agent (e.g., a fluid) to the injection ports 113 through the syringes 114. For example, as part of a neuromodulation procedure, the catheter system 108 can be used to deliver a therapeutic agent to the vessel wall 104 and / or other tissue associated with the vessel 102 via the one or more injection ports 113. Once at the target tissue, the one or more non-inflatable positioning members 116 can be expanded to move the one or more syringes 114 radially outward to position the injection ports 113 in juxtaposition with the vessel wall to facilitate therapeutic delivery of the therapeutic agent to the tissue via the injection ports 113. For example, the injection ports 113 can be configured to deliver a therapeutic agent from an intravascular location to ablate tissue in the adventitia or perivascular tissue, etc. The injection port 113 can be, for example, a needle-free injection nozzle and / or another component configured to deliver a therapeutic fluid to the target tissue. The injection port 113 can be, for example, an opening in a tube (e.g., any shape, including substantially circular, rectangular, etc.), which can but need not be reinforced. In addition, the injection ports can be equally spaced or sporadically spaced longitudinally along the injection tube 114.

[0049] The injection tube 114 is configured to withstand relatively high pressure fluid delivery. When the non-inflatable positioning member 116 is in the expanded configuration, the positioning member 116 can be configured to provide a radial force against the vessel wall 104, such that the positioning member 116 resists the force during delivery of the therapeutic agent to the target tissue and helps the injection port 113 maintain sufficient apposition with the vessel wall 104.

[0050] In an example, the injection port 113 of the injection tube 114 is configured to deliver the therapeutic agent to the adventitia and / or around the adventitia where the renal nerves are located. In an example, a therapeutic fluid is selected to neuromodulate (e.g., chemically ablate) neural tissue of the renal plexus adjacent to the renal artery. The therapeutic fluid may include, for example, an alcohol such as ethanol; distilled water; hypertonic saline; hypotonic saline; phenol; glycerol; lidocaine; bupivacaine; tetracaine; benzocaine; guanethidine; botulinum toxin; another suitable neurotoxic fluid; or a combination thereof. In some examples, the therapeutic fluid may be heated or cooled to additionally or alternatively thermally ablate neural tissue (e.g., neural tissue of the renal plexus adjacent to the renal artery).

[0051] In an example, the non-inflatable positioning member 116 is configured to expand radially outward to position at least one injection port 113 of at least one of the one or more injection tubes 114 in juxtaposition with the vessel wall 104 of the patient's blood vessel 102. In contrast to a balloon that inflates within a blood vessel and occludes the blood vessel 102, the non-inflatable positioning member 116 is not inflated by an inflation fluid (e.g., saline). Additionally, in some examples, the non-inflatable positioning member 116, when inflated, defines a gap through which blood can flow. That is, in some examples, the non-inflatable positioning member 116 does not occlude blood flow through the blood vessel 102 even when inflated, thereby allowing blood to continue to flow to, for example, an organ, and reduce the likelihood of ischemia during a neuromodulation procedure.

[0052] In addition, in contrast to some balloons, the non-inflatable positioning member 116 is configured to keep the injection port 113 exposed even in the non-inflated state. For example, when the balloon is deflated, such as during delivery to a target tissue site in a patient, the balloon can collapse and partially or even completely cover the injection port. If the balloon is not fully inflated or otherwise does not occlude the injection port during a medical procedure or even during testing of the device by a clinician before introducing the catheter into a patient, high-pressure delivery of the therapeutic agent through the injection port may adversely affect the integrity of the balloon.

[0053] In some examples, one or more (e.g., all) of the non-inflatable positioning members 116 are configured to self-expand, e.g., formed from any suitable material that expands to a predetermined shape under limited or no external pressure applied to the material. Additionally or alternatively, in some examples, one or more of the non-inflatable positioning members 116 are configured to expand and contract by pushing or pulling the member. Furthermore, the non-inflatable positioning members 116 are configured to collapse into a low-profile state. In the case of self-expanding members 116, for example, when external pressure is applied to the member 116, e.g., via a sheath, the non-inflatable positioning member 116 can assume a low-profile configuration, as discussed below. In some examples, the non-inflatable positioning member 116 comprises a shape-memory material, such as nitinol (nickel titanium). In some examples, the non-inflatable positioning member 116 can exhibit a shape-memory effect and superelasticity at different temperatures. In other examples, the non-inflatable positioning member 116 comprises another material, such as, but not limited to, stainless steel or a polymer (e.g., polyamide), instead of or in addition to the shape-memory material.

[0054] The elongated body 110 defines a central longitudinal axis L, and the non-inflatable positioning member 116 is configured to expand radially outward relative to the central longitudinal axis L (e.g., substantially perpendicular to the longitudinal axis L). In examples, the elongated body 110 is coupled to (e.g., mechanically coupled to) the non-inflatable positioning member 116 and the syringe 114. The syringe 114 can be positioned substantially external to the non-inflatable positioning member 116, such as on an outer surface of the non-inflatable positioning member 116. For example, the syringe 114 is coupled to the outer surface of the non-inflatable positioning member 116 along at least a portion aligned with the distal portion 117 of the catheter lumen 120.

[0055] In an example, the non-inflatable positioning member 116 is more rigid than the injection tubes 114, for example, so that the non-inflatable positioning member 116 can provide the force required to maintain the injection port 113 in apposition with the vessel wall during treatment delivery. Increasing the diameter (or other cross-sectional dimension) of the non-inflatable positioning member 116 can increase the overall stiffness of the catheter system 108, which may interfere with guidance through the vasculature to the target tissue site. Configuring the catheter 108 to include one or more injection tubes 114 separate from the non-inflatable positioning member 116 can help maintain a desired level of flexibility of the catheter system 108 while maintaining a relatively large diameter (or other cross-sectional dimension) of the fluid delivery lumen. The larger diameter of the fluid delivery lumen defined by the injection tubes 114 can help configure the catheter system 108 for relatively high-pressure delivery of a therapeutic agent via the injection port 113, such that the therapeutic agent can penetrate the vessel wall 104 without a needle. In contrast, for catheters in which the positioning member itself (e.g., a nitinol tube) also defines the injection port, increasing the diameter of the fluid delivery lumen can make the overall stiffness of the catheter an obstacle to guidance through the vasculature.

[0056] The catheter system 108 is configured to deliver a therapeutic agent into the syringe lumen for delivery to the patient's tissue via one or more injection ports 113 of the corresponding syringes 114. For example, the catheter system 108 may include a therapeutic agent delivery system 132 configured to provide the therapeutic agent to the injection ports 113. The syringes 114 may be fluidly connected to the therapeutic fluid delivery system 132 using any suitable technique. The catheter system 108 defines a therapeutic agent flow path 128 that fluidly couples the therapeutic fluid delivery system 132 and the syringes 114. In some examples, the syringes 114 are fluidly connected to the therapeutic fluid delivery system 132 via the catheter lumen 120 of the elongated body 110 or via a fluid flow path separate from the catheter lumen 120. For example, each of the syringes 114 may include a proximal portion disposed within the catheter lumen 120 and in fluid communication with a fluid delivery tube 131, which is fluidly coupled to the therapeutic agent delivery system 132. In an example, the catheter system 108 can be configured to start, stop, adjust, and / or substantially establish a flow rate of the therapeutic agent to adjust and / or establish increased pressure within the fluid delivery tube for high pressure chemical ablation of the vessel wall 104 .

[0057] In some examples, the therapeutic fluid delivery system 132 includes a therapeutic fluid container that defines a therapeutic fluid reservoir (not shown) configured to hold a volume of a therapeutic agent. The therapeutic fluid delivery system 132 is configured to introduce the therapeutic agent from the therapeutic fluid reservoir into the therapeutic fluid flow path 128 and into the catheter lumen 120.

[0058] For example, the therapeutic fluid delivery system 132 can be configured to pressurize the therapeutic fluid to discharge the therapeutic fluid from the therapeutic fluid reservoir into the therapeutic fluid flow path 128. The therapeutic fluid delivery system 132 can be configured such that pressurization causes the therapeutic fluid within the therapeutic fluid reservoir to substantially discharge from the therapeutic fluid reservoir 132 into the therapeutic fluid flow path 128. The therapeutic fluid flow path 128 can be configured to receive pressurized therapeutic fluid from the therapeutic fluid delivery system 132 and provide the pressurized therapeutic fluid to the syringe 114. The therapeutic fluid delivery system 132 is configured such that a clinician can pressurize the therapeutic fluid to cause delivery to a target tissue. In an example, the therapeutic fluid delivery system 132 is configured to pressurize the therapeutic fluid using a pressurized fluid, such as pressurized carbon dioxide (CO2).

[0059] The elongated body 110 defines a distal portion 110A ("distal body portion 110A") and a proximal portion 110B ("proximal body portion 110B"). Figure 1 In the example shown, a non-inflatable positioning member 116 and / or an injection tube 114 are positioned on the distal portion 110A. The non-inflatable positioning member 116 is configured to be deployed from a relatively low-profile delivery configuration to an expanded configuration, for example, to position the injection port 113 of the injection tube 114 against the vessel wall 104 at the target treatment site. In some examples, the catheter system 108 further includes an outer sheath configured to receive the elongated body 110 and / or a guidewire configured to be received within the lumen of the elongated body 110.

[0060] In some examples, system 100 includes an outer sheath that is configured to compress and maintain non-inflatable positioning member 116 in a low profile (e.g., linear) configuration. In some examples of these examples, non-inflatable positioning member 116 is configured to self-expand radially outward in response to being deployed from the outer sheath. For example, the outer sheath can be pulled away from distal portion 110A toward the proximal side and / or the elongated body 110 can be pushed out of the outer sheath toward the distal side. In addition to or in place of the outer sheath, in some examples, non-inflatable positioning member 116 is configured to be deployed into an expanded configuration from a low profile configuration by means of a control member that is configured to directly or indirectly cause the longitudinal movement of at least a portion of non-inflatable positioning member 116. For example, the control member can be the guidewire of system 100, which is configured to receive a guidewire and longitudinally move relative to at least a portion of the elongated body 110. As another example, the control member can be a push wire and / or a pull wire separated from the guidewire. The control member and the push / pull wire can be independently operated by a clinician, for example, to control the movement of the catheter system 108 and the expansion of the non-inflatable positioning member 116. For example, the clinician can advance the catheter system 108 to the target tissue site via the control member and radially expand the non-inflatable positioning member 116 via retraction or advancement of the push / pull wire. Thus, in some examples, the non-inflatable positioning member is configured to expand in response to movement of a control member (such as a push and / or pull wire, a guidewire, etc.) to which the non-inflatable positioning member 116 can be attached.

[0061] In some examples, the non-inflatable positioning member 116 supports the syringes 114 and the corresponding injection ports 113 such that, for example, expansion of the non-inflatable positioning member 116 reduces displacement between the syringes 114 and, therefore, between the injection ports 113 and the vessel wall 104. For example, one or more syringes 114 can be supported by an outer surface of the non-inflatable positioning member 116. In some examples, the elongated body 110 can be configured to support the non-inflatable positioning member 116 and the syringes 114 at a fixed longitudinal position (measured along the longitudinal axis L) on the elongated body 110 relative to the non-inflatable positioning member 116. In some examples, the non-inflatable positioning member 116 can take on various configurations, such as sinusoidal, elliptical, flat, spiral, helical, annular, an expandable stent, etc. Exemplary configurations of the non-inflatable positioning member 116 are discussed in detail in the following figures. In some examples, a radiopaque material (not shown) may be attached to any of the non-inflatable positioning member 116, injection tubes 114, and other portions of the catheter system 10 to facilitate visualization of the location of the injection port 113 using medical imaging (e.g., fluoroscopy).

[0062] In some examples, the medical system 100 (e.g., the proximal body portion 110B) includes a handle portion 166 that is configured to remain external to the patient's vasculature when the distal body portion 110A is within the patient's vasculature. The handle portion 166 can be configured to allow a clinician to guide at least the distal body portion 110A through the vasculature, allow pressurization of a therapeutic agent, and / or enable other functions of the medical system 100 that can help deliver a therapy (e.g., neuromodulation) to a patient. At least some portion of the catheter system 108 (e.g., the distal body portion 110A) can be substantially flexible such that the catheter system 108 can flex and / or bend en route to substantially position the injection tube 114 and the corresponding injection port 113 at a target location within the patient's blood vessel. Thus, although Figure 1 108 is shown as being substantially linear, but the catheter system 108 (or portions thereof) can be configured to assume a linear, curved, and / or curvilinear shape. Correspondingly, the longitudinal axis L defined by the catheter system 108 (and / or portions thereof) can be linear, curved, and / or curvilinear.

[0063] Figure 2 A portion of the medical system 100 (e.g., distal body portion 110A, injection port 113, syringes 114, and non-inflatable positioning member 116) is schematically illustrated within a vessel 102. The non-inflatable positioning member 116 is configured to expand from a relatively low-profile delivery configuration to an expanded configuration in which the non-inflatable positioning member 116 positions the injection port 113 against or proximate to a target treatment site on the vessel wall 104. That is, radially outward expansion of the non-inflatable positioning member 116 also radially expands one or more syringes 114, which positions the corresponding injection port 113 in contact with the vessel wall 104. In an example, the catheter system 108 can be configured to substantially center the distal body portion 110A within the vessel 102 (e.g., centered or nearly centered to the extent permitted by vessel symmetry) when the non-inflatable positioning member 116 is expanded to bring the syringes 114 into contact with the vessel wall 104.

[0064] In examples, the radially outward force of the radially outward expansion of the non-inflatable positioning member 116 is sufficiently strong to maintain the injection port 113 in juxtaposition with the vessel wall 104 during relatively high pressure therapeutic agent delivery, thereby enabling the therapeutic agent to pass through at least a portion of the vessel wall 104 to reach target tissue, such as a target nerve. For example, exemplary pressures for delivering the therapeutic agent include, for example, 5 megapascals (MPa) to 21 MPa, such as 10 MPa (or approximately 1450 psi).

[0065] The injection port 113 (e.g., via the injection tube 114) is configured to receive a therapeutic agent (e.g., via the therapeutic fluid flow path 128) and deliver the therapeutic agent to, for example, ablate tissue of the vessel wall 104 and / or tissue adjacent to the vessel wall 104. The catheter system 108 can be configured to pressurize the therapeutic fluid (e.g., using the therapeutic fluid delivery system 132 ( Figure 1 )) so that the injection port 113 receives the therapeutic fluid and then delivers the therapeutic fluid to the target treatment site of the blood vessel 104. The injection port 113 can transmit the delivery of the therapeutic fluid to the tissue of the patient 106 to induce one or more desired effects (e.g., neuromodulatory effects) on the localized area of the blood vessel 102 and the area adjacent to the blood vessel 102. For example, when the blood vessel 102 defines a renal artery associated with the kidney 168, the injection port 113 can induce one or more desired neuromodulatory effects on a portion of the renal plexus (RP) 170 located within or adjacent to the adventitia of the renal artery.

[0066] Figure 3A and Figure 3B 314 and a non-inflatable positioning member 316. Figure 1 and Figure 2 Examples of catheter systems 108, injection tubes 114, and non-inflatable positioning members 116. Figure 3A In the embodiment, the non-inflatable positioning member 116 is in a collapsed configuration within the outer sheath 304 and in the embodiment of the present invention. Figure 3B , the non-inflatable positioning member 316 is deployed from the outer sheath 304 and is in an expanded configuration. The non-inflatable positioning member 316 is configured to expand radially outward when deployed from the outer sheath 304. Generally speaking, in the examples described herein, deployment from the outer sheath can be achieved using any suitable technique (such as, but not limited to, withdrawing the outer sheath proximally and / or pushing the positioning member or other catheter system components distally out of the distal opening of the outer sheath). When positioned in the outer sheath 304, the outer sheath 304 applies a compressive force to the non-inflatable positioning member 316, thereby maintaining the non-inflatable positioning member 316 in a collapsed configuration. When deployed from the outer sheath 304, the non-inflatable positioning member 316 self-expands radially outward to help contact the injection tube 314 with the vessel wall.

[0067] The non-inflatable positioning member 316 can be connected to one or more other components of the catheter system 300 using any suitable technique and at any suitable location. For example, in some examples, a proximal portion of the non-inflatable positioning member 316 is connected to the guidewire tube 302 of the catheter system 300. The guidewire tube 302 is configured to receive a guidewire, for example, to help guide the catheter system 300 to a target tissue site within the patient's vasculature. As another example, the non-inflatable positioning member 316 is not directly connected to the guidewire tube 302, but rather extends only along a portion of the guidewire tube 302.

[0068] exist Figure 3A In the example shown, the non-inflatable positioning member 316 includes a plurality of shape memory arms, such as two, three, four, or more arms. The shape memory arms are elongated shape memory structures and can have any suitable shape and form, such as flat wires, tubular wires, etc. The non-inflatable positioning member 316 can expand radially outward so that the distal portion of the non-inflatable positioning member 316 applies a force to the injection tubes 314, thereby positioning the injection tubes 314 against the vessel wall 104 and bringing the injection port 313 into contact with or proximate to the target tissue of the vessel wall 304. The non-inflatable positioning members 316 can each contact one of the injection tubes 314 at a single point (e.g., the distal portion) or at multiple points along the length of the surface of the non-inflatable positioning member 316.

[0069] exist Figure 3A and Figure 3B In the example shown, the distal end 316A of the non-inflatable positioning member 316 is mechanically connected (e.g., via an adhesive, an attachment device, a weld, etc.) to the corresponding one or more injection tubes 314. For example, the distal end 316A of the non-inflatable positioning member 316 can be connected to one injection tube 314. As an example, each distal end 316A of the non-inflatable positioning member 316 can be mechanically connected to one of the injection tubes 313 (e.g., via a mechanical strap, an adhesive, a weld, etc.) so that when the distal end of the non-inflatable positioning member 316 moves radially away from the guidewire 302, the injection tube 314 moves with the non-inflatable positioning member 316. The non-inflatable positioning member 316 can, for example, be connected to the injection tube 314 near the injection port 313 to support high-pressure therapeutic agent delivery and offset any pressure from the target tissue delivering the therapeutic agent to the vessel wall 104. In some examples, the distal end 316A of the non-inflatable positioning member 316 can be located midway between adjacent injection ports 313 of the corresponding injection tube 314.

[0070] In some examples, the proximal end 316B of each non-inflatable positioning member 316 (e.g., the proximal end 316B of each shape memory arm) is mechanically connected to the guidewire tube 302 (e.g., via a mechanical band, adhesive, welding, etc.) so that when the distal end 316A of the non-inflatable positioning member 316 expands radially outward, the proximal end 316B of the non-inflatable positioning member 316 remains connected to the guidewire tube 302. The length of each non-inflatable positioning member 316 (measured along the longitudinal axis 315) can be selected based on the diameter of the vessel wall 104 or the diameter range (e.g., 3 millimeters (mm) to 8 mm) that the catheter system 300 is intended to use. In some examples, the non-inflatable positioning members 316 have the same length. In other examples, two or more non-inflatable positioning members 316 of the catheter system 300 have different lengths to accommodate different injection ports 113 being maintained at different longitudinal positions along the vessel wall 104.

[0071] The distal end 316A of the non-inflatable positioning member 316 is not connected to the guidewire tube 302, thereby allowing the distal end 316A to expand away from the central longitudinal axis 315, thereby causing the injection tube 314 to also expand away from the central longitudinal axis 315, thereby placing the injection tube 314 in apposition with the vessel wall. In some examples, the non-inflatable positioning member 316 is radially inward of the injection tube 314, so that the non-inflatable positioning member 316 can maintain the injection port 313 in apposition with the vessel wall 104 during delivery of the therapeutic agent to the target tissue.

[0072] The catheter system 300 may include any suitable number of injection tubes 314. Figure 3A As shown, in some examples, the exemplary catheter system 300 includes two injection tubes 314, each of which includes a corresponding injection port 313. In some examples, the injection tubes 314 are spaced approximately 180 degrees apart (e.g., 180 degrees or as close to 180 degrees as manufacturing tolerances allow). The 180-degree spacing can help facilitate delivery of the therapeutic agent around 360 degrees of the vessel wall. In other examples, the catheter system 300 includes one injection tube or three, four, or more injection tubes 314, which can be evenly distributed around the longitudinal axis 315 or can be unevenly distributed around the longitudinal axis 315. The uneven distribution can help, for example, focus delivery of the therapeutic agent to only a portion of the vessel wall 104 to target a specific neural location or reduce delivery to non-target tissue sites.

[0073] The syringes 314 can define any suitable number of injection ports 313 to enable sufficient therapeutic agent to be delivered to the target tissue site, for example, to achieve renal denervation. For example, the first syringe 314 can include three injection ports 313, and the second syringe 314 can include four injection ports 313. For example, the first syringe 314 can include a single injection port 313, and the second syringe 314 can include another single injection port 313. For example, the first syringe 314 can include ten injection ports distributed longitudinally along the length of the syringe 314, and the second syringe 314 can include ten injection ports 313 distributed longitudinally along the length of the second syringe 314.

[0074] Multiple injection ports 313 for each syringe 314 can help increase the likelihood that at least one injection port 313 will remain in contact with the target tissue of the vessel wall 104 when the non-inflatable positioning member 316 is inflated. The catheters described herein can be configured for a range of vessel sizes, for example, 3 millimeters (mm) to 8 mm in diameter. Due to these different vessel sizes, different portions of the syringe 314 can come into contact with the vessel wall 104 when the non-inflatable positioning member 316 is inflated. Therefore, including multiple injection ports 313 on each syringe 314 can help accommodate different vessel 102 sizes.

[0075] Figure 4A and Figure 4B is a conceptual diagram illustrating another exemplary catheter system 400, which is similar to Figure 3A and Figure 3B The catheter system 300 of FIG. 10 is similar to the catheter system 300 of FIG. 10 , but includes an annular member 406 as part of a non-inflatable positioning member 416. The annular member 406 may be radially inward of two or more syringes 414.

[0076] Figure 4A An exemplary collapsed configuration of the non-inflatable positioning member 416 and the annular member 406 is shown. In an example, the annular member 406 is configured to collapse into a lower profile state by tilting at least toward the central longitudinal axis 415 of the guide wire tube 402 (which may also be the central longitudinal axis of a catheter) when the non-inflatable positioning member 416 and the injection tube 414 are located within the lumen of the outer sheath 404. For example, the annular member 406 is configured to collapse into a lower profile state by tilting at least toward the central longitudinal axis 415 of the guide wire tube 402 from an expanded configuration.

[0077] like Figure 4B4. As shown in FIG. 4, annular member 406 is configured to expand radially outward toward an expanded configuration and mechanically supports injection tube 414 against vessel wall 104. In some examples, annular member 406 and other non-inflatable positioning members 416 expand radially outward into an expanded configuration when deployed from outer sheath 404. In some examples, when guidewire tube 402 is, for example, pulled toward the proximal side by a clinician, annular member 406 and non-inflatable positioning member 416 expand radially toward the expanded configuration. In some examples, a proximal force is applied to guidewire tube 402 so that annular member 406 and non-inflatable positioning member 416 are maintained under a lower profile state. When guidewire tube 406 is, for example, advanced toward the distal side by a clinician, annular member 406 and non-inflatable positioning member 416 can expand radially toward deployment (expansion) configuration.

[0078] In some examples, the annular member 406 can assume any suitable shape in the expanded configuration, e.g., approximately circular, elliptical, etc., and in some examples can be referred to as annular. The ring defined by the annular member 406 can be a closed ring or an open ring (e.g., a partial annular shape). In some examples, the annular member 406 is formed of a shape memory material such as Nitinol (nickel titanium) and is configured to self-expand into a closed shape in response to deployment from the outer sheath 304. Figure 4B In other examples, the annular member 406 comprises another material instead of or in addition to the shape memory material, such as, but not limited to, stainless steel or a polymer, and is configured to expand into a substantially uniform configuration in response to proximal (or distal) movement of the guidewire tube 402. Figure 4B In some examples, the non-inflatable positioning member 416 comprises nitinol, while the annular member 406 comprises stainless steel or a polymer. In some examples, the annular member 406 comprises a composite material comprising two or more materials, including but not limited to a combination of two or more different polymers or one or more polymers and one or more metals. The two or more materials may form a hybrid braid that defines the annular member 406.

[0079] In some examples, the ring member 406 is connected to the arm-shaped non-inflatable positioning member 416 (eg, via adhesive, attachment means, welding, etc.). In some examples, the strap (eg, Figure 5 The band 512) surrounds the corresponding injection tube and is mechanically connected to both the annular member 406 and the corresponding non-inflatable positioning member 416.

[0080] With reference to at least FIG. 3, FIG. 4 and FIG. 6 to Figure 10 In the examples described, one or more non-inflatable positioning members are configured to self-expand radially outward and / or are configured to expand radially outward with the aid of a control member. Figure 10The guidewire tube described above can be used as a control member, but in some examples, the catheter can include a control member that is distinct from, separate from, or otherwise not a guidewire tube. For example, a clinician can separately manipulate the guidewire tube to guide the exemplary catheter within a patient's vasculature and manipulate the control member to radially expand one or more non-inflatable positioning members.

[0081] Figure 5 is a conceptual diagram illustrating another exemplary catheter system 500, which is similar to Figure 3A and Figure 3B 514. The catheter system 300 of FIG. 50 is similar to the catheter system 300 of FIG. 50, but includes a frame defined by a plurality of arms 516. The arms 516 are part of the non-inflatable positioning member of the catheter system 500. The plurality of arms 516 are connected to each syringe 514 via a band 512 or using another suitable technique (e.g., adhesive, welding, etc.). Figure 5 An exemplary expanded configuration of arms 516 is shown. Arms 516 are configured to expand radially outward from a relatively low-profile configuration to an expanded configuration and mechanically support the positioning of injector tubes 514 against vessel wall 104. In some examples, arms 516 are formed of a shape memory material and expand radially outward in response to deployment from outer sheath 504 to define an expansion frame. In some examples, arms 516 are not self-expanding and are configured to expand radially outward in response to control member 502 (or a separate control member), for example, being pulled proximally or pushed distally by a clinician. In these examples, catheter system 500 does not include outer sheath 504.

[0082] The arms 516 are positioned radially inwardly of the two or more injection tubes 514 such that the radially outward force of the frame defined by the arms 516 helps maintain the injection port 513 in juxtaposition with the vessel wall. The arms 516 can have any suitable configuration. For example, the length of each of the arms 516 can depend on the size of the target treatment site and the distance from the vessel wall 104 to the central longitudinal axis 515 of the guidewire tube 505.

[0083] Furthermore, there may be any number of arms 516 connected to each syringe 514, and each syringe 514 may be connected to the same number of arms or a different number of arms. For example, there may be ten arms 516 mechanically connected to a first syringe 514 and another ten arms 516 connected to a second syringe 514, and one or more of the arms 516 connected to the first or second syringe 514 may have different sizes.

[0084] The arms 516 are mechanically connected to the syringes 514 using any suitable technique (e.g., via an adhesive, an attachment device, welding, etc.). In some examples, each arm 516 is mechanically connected to one of the two syringes 514 via a strap 512. Each strap 512 can wrap around the distal portion 517 of each respective arm 516 and the respective syringe 514. The strap 512 can have a circumference such that the strap 512 is in a fixed position relative to the syringe 514, or such that the strap 512 can freely traverse longitudinally along the syringe 514. In some examples, a clinician can use the control member 502 to control the non-inflatable positioning member 516 to expand into an expanded configuration or collapse into a collapsed configuration. For example, when the clinician pushes the control member 502 distally, the non-inflatable positioning member 516 expands into an expanded configuration, and the strap 512 can traverse along the syringe 514 until the non-inflatable positioning member 516 is in the expanded configuration. For example, the clinician pulls the control member 502 proximally to collapse the non-inflatable positioning member 516 into the collapsed configuration. In some examples, the pull wire 518 can be detached from the control member 502.

[0085] In some examples, the clinician can use the pull wire 518 to control the expansion of the non-inflatable positioning member 516 into an expanded configuration or collapse into a collapsed configuration. For example, when the clinician pulls the pull wire 518 proximally, the non-inflatable positioning member 516 collapses into a collapsed configuration, and the band 512 traverses along the injection tube 514 until the non-inflatable positioning member 516 is in the collapsed configuration. For example, the clinician can push the pull wire 518 distally to expand the non-inflatable positioning member 518 into an expanded configuration. The arm 516 can be connected to one or both of the control member 502 or the pull wire 518, for example, via an adhesive, welding, etc.

[0086] Figure 6A and Figure 6B is a conceptual diagram illustrating another exemplary catheter system 500 including at least one annular non-inflatable positioning member 606 . Figure 6A A catheter system 600 is shown including a single annular non-inflatable positioning member 606, and Figure 6B A catheter system 600 is shown including a plurality of annular non-inflatable positioning members 606 distributed along the longitudinal axis of the catheter.

[0087] The catheter system 600 is similar to Figure 4A and Figure 4B The catheter system 400 of FIG. 4 is shown, but the non-inflatable positioning member does not include arms. The annular non-inflatable positioning member 606 is radially inward of and attached to the injection tubes 614, each of which defines at least one injection port 613. Figure 6AIn the example shown, the first portion 606A of the positioning member 606 and the second portion 606B of the positioning member 606 are connected (e.g., via a mechanical strap, adhesive, welding, etc.) to the corresponding syringes 614. In some examples, each annular member 606 is connected to the syringes 614 via a strap (e.g., strap 512) that surrounds each annular non-inflatable positioning member 606 and the corresponding syringe 614.

[0088] In some examples, the annular non-inflatable positioning member 606 is connected to any number of injection tubes 614 (e.g., three, four, or more). In an example, the circumference of each annular member 606 may have a range of values, and each annular non-inflatable positioning member 606 may have the same or different circumferences (or other maximum cross-sectional dimensions) relative to each other. The annular non-inflatable positioning member 606 may have any suitable shape and form, for example, it may be elliptical, circular, oval, etc. In an example, there may be any number of annular non-inflatable positioning members 606, which are distributed longitudinally along the guidewire tube 602 and are placed in contact with the injection tube 614 at any position (e.g., near the injection port 613) to offset any pressure from delivering the therapeutic agent to the target treatment site of the vessel wall 104. For example, the annular non-inflatable positioning member 606 may be adjacent to the injection port 613 or directly below the injection port, or two annular members 606 may be adjacent to the injection port 613 or on opposite sides of the injection port.

[0089] In some examples, the annular non-inflatable positioning member 606 is self-expanding and is configured to expand radially outward when deployed from the outer sheath 604. When positioned in the outer sheath 604, the outer sheath 604 applies a compressive force to the annular non-inflatable positioning member 606, thereby maintaining the annular non-inflatable positioning member 606 in a collapsed configuration ( Figure 6A or Figure 6B When in the collapsed configuration, each annular non-inflatable positioning member 606 can contact the guidewire tube 602. When deployed from the outer sheath 604, the annular non-inflatable positioning member 606 self-expands radially outward to help the injection tube 614 contact the vessel wall 104.

[0090] In other examples, in addition to or in lieu of self-expansion, the annular non-inflatable positioning member 606 is configured to expand radially outward in response to proximal or distal movement of the guidewire tube 602 or a separate control member.

[0091] Figure 7 is a conceptual diagram illustrating another exemplary catheter system 700, which is similar to Figure 6A and Figure 6B7. The catheter system 600 of FIG. 6 is similar to the catheter system 600 of FIG. 6 , but includes at least one shape memory arm 712 connected to a distal portion 717 of a corresponding injector tube 714. The annular member 706 can be substantially similar to the annular member 606. In some examples, the shape memory arms 712 are mechanically connected (e.g., via an adhesive, an attachment device, a weld, etc.) to the injector tube 704 at the distal portion 717. The annular member 706 is mechanically connected (e.g., via an adhesive, an attachment device, a weld, etc.) to the injector tube 714. In some examples, the shape memory arms 712 are configured to expand radially outward and mechanically support the annular member 706 to position the injector tube 714 against the vessel wall 104. For example, the shape memory arms 712 can mechanically support the distal portion 717 of the injector tube 714, while the annular member 706 supports the proximal portion (relative to the distal portion 717) of the injector tube 714 to position the injector tube 714 against the vessel wall 104.

[0092] In some examples, the shape memory arms 712 are self-expanding and are configured to expand radially outward when deployed from the outer sheath 604. In other examples, in addition to or in place of self-expanding, the shape memory arms 712 are configured to expand radially outward in response to the proximal or distal movement of the guidewire tube 702 or a separate control member. In some examples, the shape memory arms 712 provide additional (in addition to the annular member 706) radially outward force to the injection tube 714. For example, the shape memory arms 712 are configured to apply a radially outward force to the distal portion 717 of the injection tube 714 so that when the guidewire tube 702 is pulled toward the proximal side, when the annular member 706 expands into the expanded configuration, the annular member has a smaller resistance from the injection tube 714. In some examples, when the clinician collapses the annular ring 706 and the injection tubes 714 into the outer sheath 704, the shape memory arms 712 help balance the proximal force applied by the clinician along the guidewire tube 702 across the injection tubes 714 and the annular member 706, e.g., to facilitate unbiased collapse of the system 700.

[0093] Figure 8A and Figure 8B is a conceptual diagram illustrating another exemplary catheter system 800 including a non-inflatable positioning member including a support frame 816 . Figure 8A A catheter system 800 is shown including a support frame 816 in an expanded configuration, and Figure 8B Catheter system 800 is shown including support frame 816 in an expanded configuration.

[0094] The support frame 816 includes an outer frame portion 812 and an annular member 806 radially inward of the outer frame portion 812. The outer frame portion 812 supports the injection tubes 814 and also applies a radially outward force to the injection tubes 814. In some examples, the outer frame portion 812 is configured to support the annular member 806 to position the injection tubes 814 against the vessel wall 104. The annular member 806 is configured to help move the outer frame portion 812 from a collapsed configuration (including Figure 8A partially collapsed configuration) toward Figure 8B In some examples, the annular member 806 and the outer frame portion 812 are radially expanded outwards toward the expanded configuration in response to the guide wire tube 802, for example, being pulled toward the proximal side by a clinician. In some examples, the guide wire tube 802 is connected to the outer frame portion 812 via an adhesive, an attachment device, welding, etc.

[0095] In some examples, the annular member 806 facilitates the outer frame portion 812 to be fully or almost fully expanded into an expanded configuration. For example, in a fully expanded configuration, a plane 817 (for ease of illustration, shown as only one dimension) defined by each annular member 806 can be separated from the central longitudinal axis 815 of the guidewire tube 802 by an angle 818. Angle 818 can be up to about 90 degrees. Angling the annular member 806 at an angle 818 (e.g., 90 degrees or less than 90 degrees) can, for example, promote the collapse of the support frame 816 by reducing the amount of force required to collapse the support frame 816 and / or by allowing the annular member 806 to collapse over a wider area of the support frame 816.

[0096] In examples, the annular member 806 defines any suitable annular shape in the expanded configuration, e.g., approximately circular, elliptical, etc., which can be a closed loop or an open loop. In some examples, the annular member 806 and the outer frame portion 812 comprise a shape memory material (such as Nitinol (nickel titanium)) and are configured to self-expand, e.g., in response to deployment from the outer sheath 804. In other examples, the annular member 806 and the outer frame portion 812 comprise another material instead of or in addition to the shape memory material, such as, but not limited to, stainless steel or a polymer. In some examples, the outer frame portion 812 comprises Nitinol, and the annular member 806 comprises stainless steel or a polymer. In some examples, the annular member 806 is connected to the outer frame portion 812 (e.g., via an adhesive, an attachment device, welding, etc.). In some examples, the band (e.g., Figure 5The band 512) surrounds the corresponding annular member 806 and is mechanically connected to both the outer frame portion 812 and the injection tube 814.

[0097] As discussed above, in some examples, the catheter system includes a first non-inflatable positioning member that is connected to the first syringe and is configured to remain relatively fixed (e.g., in a linear configuration), while a second non-inflatable positioning member connected to the second syringe expands away from the first non-inflatable positioning member (e.g., to define a non-linear configuration). The radially outward expansion of the second non-inflatable positioning member moves the second syringe away from the first syringe. In some examples, the first syringe is not connected to the positioning member and can remain relatively fixed, while the non-inflatable positioning member expands to move the second syringe away from the first syringe.

[0098] Figure 9A and Figure 9B is a conceptual diagram illustrating an exemplary catheter system 900 that includes a first syringe and a second syringe that is configured to move away from the first syringe, for example, while the first syringe remains relatively stationary and / or in a linear configuration. The catheter system 900 includes a guidewire 902, an outer sheath 904, a first syringe 914A and a second syringe 914B (each having a corresponding injection port 912A and 912B), and a non-inflatable positioning member 916.

[0099] Figure 9A An exemplary collapsed configuration of the non-inflatable positioning member 916 is shown. In an example, the non-inflatable positioning member 916 is configured to be compressed when the non-inflatable positioning member 916 and the injection tube 914 are located within the lumen of the outer sheath 904 by at least Figure 9B The expanded configuration is shown collapsed to a lower profile state as it moves toward the central longitudinal axis 915 of the guidewire 902 (which may also be the central longitudinal axis of the catheter).

[0100] like Figure 9B As shown, the non-inflatable positioning member 916 is configured to self-expand radially outward into an expanded configuration, thereby moving the second syringe 914B away from the first syringe 914A, which remains substantially linear relative to the second syringe 914B. Figure 9B In the example shown, the non-inflatable positioning member 916 is connected to the second syringe 914B and is not connected to the first syringe 914 A. For example, when the non-inflatable positioning member 916 is expanded from a relatively low-profile collapsed configuration to an expanded configuration, the non-inflatable positioning member 916 expands radially outward to position the second syringe 914B against the vessel wall 104, while the first syringe 914A remains relatively fixed and / or linear, e.g., against the vessel wall.

[0101] For example, the first injection tube 914A is connected to the guidewire tube 902, which does not move with the non-inflatable positioning member 916. Maintaining the first injection tube 914A relatively fixed and / or linear can increase the ease and predictability of positioning the injection port 912A in juxtaposition with the target treatment site. For example, even when the non-inflatable positioning member 916 is expanded, the injection port 912A along the injection tube 914A will remain in contact with the vessel wall 104. In contrast, whether the injection port 912B of the injection tube 914B will directly contact the vessel wall 104 may depend on the size of the vessel and the position of the apex of the non-inflatable positioning member 916. In an example, the force of the non-inflatable positioning member 916 extending radially outward to position the injection tube 914B against the vessel wall 104 also positions the first injection tube 914A against another portion of the vessel wall 104. The injection tubes 914A and 914B may include any suitable number of injection ports.

[0102] In some examples, one or more of first injector tube 914A, second injector tube 914B, and non-inflatable positioning member 916 are tapered at distal portion 917, distal portion 918, and distal portion 919, respectively. The tapering of distal locations 917, 918, and 919 can facilitate guiding catheter system 900 through vessel 102.

[0103] In some examples, both the proximal portion 916A and the distal portion 916B of the non-inflatable positioning member 916 are permanently connected (e.g., via an adhesive, an attachment device, a weld, etc.) to the guidewire 902. In some examples, the first syringe 914A is permanently connected (e.g., via an adhesive, an attachment device, a weld, etc.) to the guidewire 902 along the longitudinal length of the first syringe 914A. To return the non-inflatable positioning member 916 and the syringes 914 to the collapsed configuration, the catheter system 900 can be pulled proximally and / or the sheath 904 can be pushed distally until the non-inflatable positioning member 916 and the syringes 914 are within the lumen of the sheath 904.

[0104] In other examples of catheter system 900, either injection tube 914A or 914B can be eliminated. For example, in examples where catheter system 900 includes injection tube 914A but not injection tube 914B, non-inflatable positioning member 916 can help maintain injection port 912A defined by injection tube 914B in apposition with vessel wall 104 during relatively high pressure injection of therapeutic agent through injection tube 914A and port 912A.

[0105] The non-inflatable positioning member 916 and other non-inflatable positioning members described herein can be formed of any suitable material or materials. In some examples, the non-inflatable positioning member 916 includes a braided shaft. The braided shaft can include any suitable material, such as a polymer or nitinol braid. Compared to a non-braided configuration, the braided shaft can increase the ease of, for example, guiding through a blood vessel 102 or delivering a therapeutic agent to a target treatment site by increasing pushability, steerability, high torque maneuverability, burst pressure resistance from therapeutic agent delivery, kink resistance, etc. In some examples, the non-inflatable positioning member 916 includes a nitinol tube having a cross-sectional area of approximately 0.030 mm × 0.035 mm (0.012 inches (in) × 0.014 in), 0.025 mm × 0.030 mm (0.010 in × 0.012 in), etc. In some examples, the non-inflatable positioning member 916 comprises a polyimide tube and nitinol strips (e.g., any suitable number of nitinol strips, including one, two, or more) and / or nitinol wires (e.g., any suitable number of nitinol wires, including one, two, or more).

[0106] Injection tubes 914A and 914B may define any suitable number of injection ports to enable sufficient therapeutic agent to be delivered to the target treatment site, for example, to achieve renal denervation. In one example, injection tube 914A may include three injection ports 913, and injection tube 914B may include four injection ports 913. In another example, injection tube 914A may include a single injection port 913, and injection tube 914B may include another single injection port 913. In another example, injection tube 914A may not include any injection port 913, and injection tube 914B may include one injection port 913.

[0107] As discussed above, in some examples, the non-inflatable positioning member is positioned radially inward of one or even all of the syringes to enable the positioning member to bias the syringes radially outward, such as against a vessel wall. As discussed above, the non-inflatable positioning member may include one or more arms (e.g., Figures 3A to 5 As shown), annular configuration (e.g., as Figure 4A 、 Figure 4B and Figures 6A to 8B As shown), frame-like structures (e.g., Figure 8A and Figure 8B ), etc., or may include another suitable configuration. For example, as shown in reference Figure 10 As discussed, the non-inflatable positioning member can have a helical, spiral, or sinusoidal configuration and be connected to one or more injection tubes. The helical, spiral, or sinusoidal non-inflatable positioning member is configured to expand radially outward to facilitate positioning one or more injection ports defined by the one or more injection tubes in apposition to the vessel wall 104.

[0108] Figure 10 1 is a conceptual diagram illustrating an exemplary catheter system 1000 that includes non-inflatable positioning members 1016A and 1016B that define a spiral, helical, or sinusoidal structure in an expanded configuration. The catheter system 1000 includes a guidewire tube 1002, a sheath 1004, injection tubes 1014A and 1014B, and non-inflatable positioning members 1016A, 1016B. Rather than having one or more non-inflatable positioning members for each injection tube as described with reference to some other examples, the catheter system 1000 includes a common non-inflatable positioning member 1016A, 1016B for multiple injection tubes 1014A and 1014B. The non-inflatable positioning members 1016A, 1016B are configured to expand radially outward from a collapsed configuration to an expanded configuration and mechanically support the positioning of multiple injection tubes 1014A, 1014B against the vessel wall 104.

[0109] The non-inflatable positioning members 1016A, 1016B define a spiral, helical, or sinusoidal structure in the expanded configuration. In some examples, the non-inflatable positioning members 1016A, 1016B are arranged so that the corresponding peaks of the non-inflatable positioning members 1016A, 1016B are offset from each other. For example, the spiral or helical structures can be rotated and / or longitudinally shifted relative to each other. For example, the non-inflatable positioning members 1016A, 1016B can have a substantially similar (e.g., identical except for manufacturing tolerances) configuration, and the non-inflatable positioning member 1016B can be rotated about 15 degrees to about 180 degrees, such as 90 degrees to 180 degrees, relative to the positioning member 1016A around the central longitudinal axis 1015, and / or longitudinally shifted from the non-inflatable positioning member 1016A along the longitudinal axis 1015. In other examples, the non-inflatable positioning members 1016A, 1016B may define other shapes, such as sinusoidal or other curvilinear shapes, that facilitate positioning the injection ports of the plurality of injection tubes against the vessel wall 104 during relatively high pressure delivery of therapeutic agents through the injection ports.

[0110] In some examples, there are two non-inflatable positioning members 1016A, 1016B, only one positioning member 1016A or 1016B, or more than two (e.g., three, four, or more) non-inflatable positioning members. In some examples, non-inflatable positioning member 1016A and non-inflatable positioning member 1016B are each connected to respective injection tubes 1014A and 1014B at at least two locations 1012A and 1012B. For example, non-inflatable positioning member 1016A is connected to injection tube 1014A at location 1012A and location 1012B. Non-inflatable positioning members 1016A, 1016B can be connected to injection tubes 1014A, 1014B using any suitable technique (e.g., via mechanical straps, adhesives, welding, etc.).

[0111] In some examples, the non-inflatable positioning members 1016A, 1016B are configured to self-expand from a relatively low-profile configuration (eg, a relatively linear configuration) to a substantially flat configuration when deployed from the outer sheath 1004. Figure 10 Additionally or alternatively, the non-inflatable positioning members 1016A, 1016B may be configured to be inflated into a Figure 10 In the expanded configuration shown, the control member may include a guidewire tube 1002 or a separate control member, such as a push / pull wire.

[0112] For example, the non-inflatable positioning members 1016A, 1016B can be mechanically connected to the guidewire tube 1002 at the distal portions 1003 of the non-inflatable positioning members 1016A, 1016B such that when the guidewire tube 1002 moves along the longitudinal axis 1015, the distal portions 1003 of the positioning members 1016A, 1016B also move. In some of these examples, to expand the positioning members 1016A, 1016B radially outward, the clinician (manually or with the aid of a device) can proximally withdraw the guidewire tube 1002 to longitudinally move the distal portions 1003 of the positioning members 1016A, 1016B toward the sheath 1004 and expand the positioning members 1016A, 1016B radially outward.

[0113] Connection to the respective injection tubes 1014A, 1014B at locations 1012A, 1012B and to the guidewire tube 1002 at the distal portion 1003 facilitates expansion of the non-inflatable positioning member 1016A into an expanded configuration when the exterior of the sheath 1004 is pulled proximally and the guidewire tube 1002 is pushed distally, for example by a clinician.

[0114] In some examples, the band (e.g., Figure 5The band 512 of each position 1012A and 1012B surrounds the non-inflatable positioning members 1016A, 1016B and the injection tubes 1014A, 1014B. The band at position 1012 may have a circumference so that the band can freely traverse longitudinally along the corresponding injection tube 1014. For example, when the guidewire tube 1002 is pushed distally so that the non-inflatable positioning member 1016 expands into an expanded configuration, the band can traverse along the injection tube 1014 so that the non-inflatable positioning member 1016 expands into an expanded configuration. Alternatively, the circumference of the band at at least one position in the position 1012 can make the band position along the injection tube 1014 relatively fixed, or minimize the longitudinal movement along the injection tubes 1014A, 1014B. In some examples, the non-inflatable positioning member 1012A is connected (e.g., via mechanical straps, adhesives, welds, bands, etc.) to the injection tube 1014A and is relatively fixed, and the non-inflatable positioning member 1012B is connected to the injection tube 1014B via a band and freely traverses longitudinally along the injection tube 1014B.

[0115] exist Figure 10 In the example shown, the syringes 1012A, 1012B are connected to the positioning members 1016A, 1016B at a midpoint along the length of the syringes (measured along their respective longitudinal axes). Figure 11 As shown, the syringes can be connected to positioning members 1016A, 1016B at their respective distal ends.

[0116] Figure 11 is a conceptual diagram illustrating an exemplary catheter system 1100, which includes a guidewire tube 1102, a sheath 1104, injection tubes 1114A and 1114B with corresponding injection ports 1113A and 1113B, and a non-inflatable positioning member 1116. The non-inflatable positioning member 1116 is similar to Figure 10 One or both of the positioning members 1016A, 1016B and define a spiral, helical or other curved configuration when in the expanded configuration. In other examples, the catheter system 1100 may include one or more other positioning members, for example, as shown in FIG. Figure 10 As stated.

[0117] Figure 11 An exemplary expanded configuration of the non-inflatable positioning member 1116 is shown. In an example, the non-inflatable positioning member 1116 is configured to expand radially outward toward the expanded configuration and position the injector tubes 1114 against the vessel wall 104.

[0118] The non-inflatable positioning member 1116 is connected (e.g., via adhesive, attachment means, welding, etc.) to the two injection tubes 1114A and 1114B at respective locations at or near the peaks of the respective curves 1116A and 1116B of the expanded non-inflatable positioning member 1116. In some examples, each injection tube 1114 defines a tapered distal end 1112A and 1112B at which the non-inflatable positioning member 1116 is connected to the injection tube 1114. The tapered distal end 1112 can be connected to the non-inflatable positioning member 1116 distal to the peaks of the respective curves 1116A and 1116B of the non-inflatable positioning member 1116.

[0119] In some examples, injection ports 1113A and 1113B are positioned at or near bends 1112A and 1112B, respectively. For example, injection ports 1113A and 1113B and surfaces of injection tubes 1114A and 1114B proximate to injection ports 1113A and 1113B may contact vessel wall 104, rather than relatively long longitudinal segments of the injection tubes contacting vessel wall 104.

[0120] and Figure 10 As in the example of FIG. 1004 , in some examples, the non-inflatable positioning member 1116 is configured to self-expand from a relatively low-profile configuration (e.g., a relatively linear configuration) to a relatively low-profile configuration (e.g., a relatively linear configuration) when deployed from the outer sheath 1004. Figure 11 Additionally or alternatively, the non-inflatable positioning member 1116 can be configured to be inflated into a Figure 11 In the expanded configuration shown, the control member may include a guidewire tube 1102 or a separate control member, such as a push / pull wire.

[0121] For example, Figure 11 As shown, the guidewire tube 1102 is mechanically connected to the non-inflatable positioning member 1116 and is configured to expand the non-inflatable positioning member 1116 radially outward in response to proximal movement. In some examples, the non-inflatable positioning member 1116 is connected to the guidewire tube 1102 at the distal portion 1103 of the non-inflatable positioning member 1116.

[0122] Figure 12 is a flow chart illustrating an exemplary process for delivering a therapeutic agent to a patient using a catheter (e.g., catheter system 108) having a non-inflatable positioning member (e.g., non-inflatable positioning member 116) configured to expand into an expanded configuration. Figure 12 While primarily described with respect to delivery of therapeutic agents to a target treatment site within a patient's renal blood vessels, the exemplary procedures may be used for other target treatment sites and / or for use in other cavities within a patient's body. Figure 12 Mainly about Figure 1The catheter system 108 is described, but Figure 12 The method can be used with any of the catheters described herein and other catheters that include one or more non-inflatable positioning members that are configured to be deployed into a radially expanded configuration to position one or more injection ports defined by one or more injection tubes in apposition with a vessel wall.

[0123] In some examples, the catheter system 108 is positioned in the renal artery and can employ a non-inflatable positioning member 116 to expand radially outward toward the target treatment site, thereby positioning the injection port 113 of the injection tube 114 in juxtaposition with the target treatment site. This can help increase the likelihood that the therapeutic agent or other fluid will be delivered to the intended tissue site in the patient's body, successfully penetrate the vessel wall, and offset any pressure from the delivery of the therapeutic agent. The catheter system 108 can also reduce the amount of time required for a clinician to align and orient the catheter system 108 within the vasculature and reduce overall medical procedure time.

[0124] The clinician can introduce the catheter system 108 into the patient's vasculature (1202). For example, the clinician can make an incision in the patient's skin at an insertion site to access the patient's blood vessel (e.g., femoral artery, radial artery, brachial artery, etc.). The clinician can then insert at least the distal portion 108A of the catheter system 108 into the blood vessel 102 with the non-inflatable positioning member 116 in a collapsed configuration. In some examples, the non-inflatable positioning member 116 and the syringe 114 are in a collapsed configuration within the outer sheath 304 or are maintained in the collapsed configuration by a control member.

[0125] The clinician can guide the catheter system 108 through the patient's vascular system to the target treatment site (1204). The clinician can use one or more imaging techniques such as X-ray imaging, fluoroscopy, etc. to guide the catheter system 108. In some examples, the clinician advances the catheter system 108 (e.g., via OTW technology, rapid exchange technology, etc.) by a guidewire disposed in the vascular system. In some examples, the clinician uses a guidewire tube 302 or other control member (e.g., a push wire and / or a pull wire) to help guide the catheter system 108 to the target tissue site in the patient's vascular system. The clinician can advance the catheter system 108 in the vascular system until the distal portion 108A arrives at the target treatment site. In some examples, with respect to renal neuromodulation, the clinician advances the catheter system 108 from a transradial artery entry point on the patient to the patient's renal artery.

[0126] The clinician can align the injection port 113 of the injection tube 114 with the target treatment site, for example, by advancing or retracting the catheter system 108 within the vasculature. The clinician can identify the preferred position of the distal portion 108A within the vasculature by identifying the position of a radiopaque marker on the catheter system 108.

[0127] The clinician can transform the non-inflatable positioning member 116 of the catheter 102 into an expanded configuration (1206). For example, the clinician can withdraw the outer sheath 304 that is compressing at least the non-inflatable positioning member 116 and the injection tube 114 toward the proximal side, and / or push the non-inflatable positioning member 116 and the injection tube 114 toward the distal side relative to the outer sheath 304 to deploy the non-inflatable positioning member 116 and the injection tube 114 from the distal opening of the outer sheath 304. When deployed from the outer sheath 304, the non-inflatable positioning member 116 self-expands radially outward to help contact the injection port 113 of the injection tube 114 with the vessel wall 104. As another example, the clinician can push the guidewire tube 302 toward the proximal side to expand the non-inflatable positioning member 116 radially outward. Alternatively, the clinician can push the guidewire tube 302 toward the distal side to expand the non-inflatable positioning member 116 radially outward. In some examples, expanding the non-inflatable positioning member 116 includes moving the second injection tube 114 into apposition with the wall of the blood vessel 104 through at least one of the one or more non-inflatable positioning members 116 while the first injection tube 114 remains relatively linear and / or fixed.

[0128] The clinician can use one or more injection ports 113 to deliver the treatment to the target treatment site (1208). In some examples, the clinician can actuate the fluid delivery system 132 to transfer the therapeutic agent to the injection port 113 through the injection tube 114 at a relatively high pressure (e.g., between 5 MPa and 18 MPa, such as 10 MPa). In some examples, the injection tube 114 may include two injection tubes spaced approximately 180 degrees apart. The pressurized therapeutic agent can exit the injection port 113 and penetrate the wall tissue juxtaposed to the injection port 113. In some examples, the therapeutic agent includes a chemical ablative agent. In some examples, with respect to renal neuromodulation, the clinician delivers the therapeutic agent to a portion of the vascular wall 104 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 therapeutic agent has been administered to the patient.

[0129] After delivering the therapeutic agent, the clinician can transform the non-inflatable positioning member 116 of the catheter system 108 into a collapsed configuration (1210). In some examples, transforming the non-inflatable positioning member 116 into the collapsed configuration includes, for example, folding the non-inflatable positioning member 116 radially inward toward the central longitudinal axis of the catheter system 108 with the aid of the outer sheath 304 or the guidewire 302. In some examples, the clinician pulls the control member proximally until the non-inflatable positioning member 116 and the syringes 114 are substantially collapsed. Additionally or alternatively, the clinician can withdraw the catheter 102 proximally into the outer sheath 304 or push the outer sheath 304 distally over the non-inflatable positioning member 116 so that the outer sheath 304 applies a compressive force to the non-inflatable positioning member 116 and the syringes 114 until the non-inflatable positioning member 116 and the syringes 114 are in the collapsed configuration within the lumen of the outer sheath 304. Once the non-inflatable positioning member 116 and the injector tubes 114 are in the collapsed configuration, the clinician can remove the catheter system 108 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 via the injection ports 113 of the injector tubes 114 .

[0130] The above detailed description of the examples of the present technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific examples of the present technology are described above for illustrative purposes, it will be appreciated 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.

[0131] 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 deviating from the scope of the disclosure.

[0132] In other examples, certain aspects of the disclosure described in the context of specific examples may be combined or omitted. Furthermore, while advantages associated with certain examples have been described in the context of those examples, other examples may also exhibit such advantages, and not all examples must exhibit such advantages to fall within the scope of the disclosure. Thus, the present disclosure and associated technology may encompass other examples not explicitly shown or described herein.

[0133] Furthermore, while techniques have been described in which a neuromodulation catheter is positioned at a single location within a single renal artery, in other examples, the neuromodulation catheter can be repositioned to a second treatment site within the single renal artery (e.g., proximal or distal to the first treatment site), can be repositioned into a branch of the single artery, can 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), can 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 can be performed using any of the techniques described herein or any other suitable renal neuromodulation techniques, or any combination thereof.

[0134] Furthermore, unless the word "or" is expressly limited to mean only a single item in addition to the 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. Additionally, unless otherwise indicated, the terms "about" or "approximately" when preceding a value should be interpreted to mean ±10% of the value. Additionally, the term "comprising" is used throughout to mean 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.

[0135] Various examples of the present disclosure have been described. Any combination of the described systems, operations, or functions is contemplated.

[0136] The following examples are a non-limiting list of clauses in accordance with one or more techniques of this disclosure.

[0137] Example 1. A catheter comprising: a catheter body defining a central longitudinal axis; one or more non-inflatable positioning members connected to the catheter body; and one or more injection tubes disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports fluidically connected to the corresponding injection tube lumen, wherein the one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the one or more injection ports juxtaposed with a patient's blood vessel wall.

[0138] Example 2. The catheter of Example 1, wherein the one or more non-inflatable positioning members comprise a shape memory material.

[0139] Example 3. The catheter of Example 2, wherein the shape memory material comprises nitinol.

[0140] Example 4. A catheter according to any one of Examples 1 to 3, wherein each of the one or more non-inflatable positioning members is mechanically connected to an injection tube of the one or more injection tubes by a band that surrounds the corresponding non-inflatable positioning member and the corresponding injection tube.

[0141] Example 5. A catheter according to any one of Examples 1 to 4, wherein the one or more injection tubes include two or more injection tubes, and wherein the one or more non-inflatable positioning members include at least one annular member radially inside the two or more injection tubes.

[0142] Example 6. A catheter according to Example 5, wherein the one or more non-inflatable positioning members include an expandable frame, wherein the one or more injection tubes are mechanically connected to the expandable frame, and wherein the at least one annular member is configured to cause the expandable frame to expand radially outward.

[0143] Example 7. The catheter of Example 5 or Example 6, wherein the at least one annular member comprises a plurality of annular members distributed longitudinally along the two or more injection tubes.

[0144] Embodiment 8. The catheter of any one of Embodiments 5 to 7, wherein the at least one annular member is elliptical in shape.

[0145] Example 9. The catheter of any one of Examples 5 to 8, wherein the at least one annular member is configured to collapse to a lower profile state by tilting at least toward the central longitudinal axis.

[0146] Example 10. A catheter according to any one of Examples 1 to 9, wherein the one or more injection tubes include a first injection tube and a second injection tube, and wherein the first injection tube is configured to remain substantially linear and the second injection tube is configured to move away from the first injection tube when the one or more non-inflatable positioning members expand radially outward.

[0147] Example 11. The catheter of any of Examples 1 to 4, wherein at least one of the one or more non-inflatable positioning members defines a helical, spiral, or sinusoidal structure in the expanded configuration.

[0148] Example 12. A catheter according to Example 11, wherein the one or more injection tubes and the one or more non-inflatable positioning members are configured to collapse into a lower profile state by tilting at least toward the central longitudinal axis of the catheter body when the control member is pushed distally.

[0149] Example 13. The catheter of Example 12, wherein the one or more non-inflatable positioning members are configured to expand radially outward when the control member is pulled proximally.

[0150] Example 14. A catheter according to any one of Examples 1 to 13, wherein the one or more non-inflatable positioning members are further configured to maintain the one or more injection ports against the blood vessel wall during high-pressure injection of chemicals through the injection tube lumen and discharge from the one or more injection ports.

[0151] Example 15. The catheter of Example 1, wherein each of the one or more non-inflatable positioning members is located within the one or more injection tubes.

[0152] Example 16. The catheter of any one of Examples 1 to 15, wherein at least a portion of at least one of the one or more injection tubes is flexible.

[0153] Example 17. The catheter of any one of Examples 1 to 16, wherein the one or more injection tubes comprises a plurality of injection tubes, and the injection ports of the plurality of injection tubes are longitudinally aligned.

[0154] Example 18. The catheter of any one of Examples 1 to 17, wherein the one or more non-inflatable positioning members are configured to self-expand.

[0155] Example 19. The catheter of any one of Examples 1 to 18, wherein the one or more injection tubes include two injection tubes positioned 180 degrees apart.

[0156] Example 20. A catheter according to any one of Examples 1 to 19, wherein the catheter body defines a catheter lumen, the catheter further comprising a fluid delivery tube disposed within the catheter lumen, wherein each of the one or more injection tubes comprises a proximal portion disposed within the catheter lumen and fluidically connected to the fluid delivery tube.

[0157] Example 21. A catheter according to any one of Examples 1 to 20, wherein the one or more injection tubes include a plurality of injection tubes, and wherein each of the plurality of injection tubes exits the catheter lumen and extends along the outer surface of the catheter body proximal to the proximal end of the one or more non-inflatable positioning members.

[0158] Example 22. A catheter according to any one of Examples 1 to 21, wherein the catheter body defines a catheter lumen, and the catheter further includes a control member disposed within the catheter lumen, the control member being connected to the one or more non-inflatable positioning members and being configured to cause the one or more non-inflatable positioning members to expand radially outward.

[0159] Example 23. The catheter of Example 22, wherein the control member comprises a guidewire tube defining a guidewire lumen configured to receive a guidewire.

[0160] Example 24. A catheter according to any one of Example 22 or Example 23, wherein the control member comprises one or more pull wires disposed within the lumen of the catheter, wherein the one or more non-inflatable positioning members are configured to expand radially outward in response to proximal movement of at least one of the one or more pull wires.

[0161] Example 25. A method comprising: guiding a catheter through a patient's vascular system to a target treatment site, wherein the catheter comprises: a catheter body; one or more non-inflatable positioning members, the one or more non-inflatable positioning members being connected to the catheter body; and one or more injection tubes, the one or more injection tubes being disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports in fluid communication with the corresponding injection tube lumen; deploying the one or more non-inflatable positioning members into an expanded configuration to position at least one of the one or more injection ports in juxtaposition with the patient's blood vessel wall; and delivering treatment to the target treatment site via the one or more injection ports of the one or more injection tubes.

[0162] Example 26. The method of Example 25, wherein delivering the treatment to the target treatment site comprises delivering the therapeutic agent to the patient's tissue via the one or more injection ports of the one or more injection tubes.

[0163] Example 27. The method of Example 26, wherein the therapeutic agent comprises a chemical ablative agent.

[0164] Embodiment 28. The method of any one of embodiments 25 to 27, wherein the one or more injection tubes comprise two injection tubes positioned 180 degrees apart.

[0165] Example 29. The method according to any one of Examples 25 to 28 further includes transforming the one or more non-inflatable positioning members from the expanded configuration to the collapsed configuration, wherein transforming the one or more non-inflatable positioning members from the expanded configuration to the collapsed configuration includes causing the one or more non-inflatable positioning members to collapse radially inward toward the central longitudinal axis of the catheter body.

[0166] Example 30. A method according to any one of Examples 25 to 29, wherein the catheter body defines a catheter lumen, the catheter further comprising a control member disposed within the catheter lumen, the control member connected to the one or more non-inflatable positioning members, wherein expanding the one or more non-inflatable positioning members comprises pulling the control member proximally to expand the one or more non-inflatable positioning members radially outward.

[0167] Example 31. The method of Example 30, wherein the control member comprises a guidewire tube defining a guidewire lumen configured to receive a guidewire.

[0168] Example 32. A method according to any one of Examples 25 to 31, wherein the target treatment site includes a first target treatment site, the method further comprising: transforming the one or more non-inflatable positioning members from the expanded configuration to the collapsed configuration; guiding the catheter through the vascular system of the patient to a second target treatment site; deploying the one or more non-inflatable positioning members from the collapsed configuration to the expanded configuration at the second target treatment site; and delivering the treatment to the second target treatment site via the one or more injection ports of the one or more injection tubes.

[0169] Embodiment 33. The method of any one of Embodiments 25 to 32, wherein the one or more non-inflatable positioning members comprise a shape memory material.

[0170] Example 34. A method according to any one of Examples 25 to 33, wherein the one or more injection tubes include a first injection tube and a second injection tube, wherein expanding the one or more non-inflatable positioning members includes deploying at least one of the one or more non-inflatable positioning members to move the second injection tube away from the first injection tube while the first injection tube remains substantially stationary.

[0171] Example 35. A catheter comprising: a catheter body defining a catheter lumen and a central longitudinal axis; an internal member disposed within the catheter lumen; one or more non-inflatable positioning members; and one or more injection tubes connected to the one or more non-inflatable positioning members, each of the one or more injection tubes defining an injection tube lumen and one or more injection ports fluidically connected to the corresponding injection tube lumen, wherein in response to movement of the internal member relative to the catheter body, the one or more non-inflatable positioning members and the one or more injection tubes are configured to move radially outward away from the central longitudinal axis.

[0172] Example 36. The catheter of Example 35, wherein the one or more non-inflatable positioning members comprise a shape memory material.

[0173] Example 37. A catheter according to Example 35 or Example 36, wherein the one or more injection tubes include a first injection tube and a second injection tube, and wherein the first injection tube is configured to remain substantially linear and the second injection tube moves radially away from the first injection tube when the one or more non-inflatable positioning members move radially outward away from the central longitudinal axis.

[0174] Example 38. The catheter of Examples 35 to 37, wherein at least one of the one or more non-inflatable positioning members defines a helical, spiral, or sinusoidal structure in an expanded state.

[0175] Further disclosed herein are the subject of the following provisions:

[0176] 1. A catheter, comprising:

[0177] a catheter body defining a central longitudinal axis;

[0178] one or more non-inflatable positioning members connected to the catheter body; and

[0179] one or more injection tubes disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining a syringe lumen and one or more injection ports in fluid communication with the corresponding syringe lumen,

[0180] Wherein the one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the one or more injection ports in apposition with a wall of a blood vessel of a patient.

[0181] 2. The catheter of clause 1 , wherein the one or more non-inflatable positioning members comprise a shape memory material.

[0182] 3. The catheter of clause 2, wherein the shape memory material comprises nitinol.

[0183] 4. A catheter according to any one of clauses 1 to 3, wherein each of the one or more non-inflatable positioning members is mechanically connected to an injection tube of the one or more injection tubes by a band that surrounds the corresponding non-inflatable positioning member and the corresponding injection tube.

[0184] 5. A catheter according to any one of clauses 1 to 4, wherein the one or more injection tubes include two or more injection tubes, and wherein the one or more non-inflatable positioning members include at least one annular member radially inside the two or more injection tubes.

[0185] 6. A catheter according to claim 5, wherein the one or more non-inflatable positioning members include an expandable frame, wherein the one or more injection tubes are mechanically connected to the expandable frame, and wherein the at least one annular member is configured to cause the expandable frame to expand radially outward.

[0186] 7. The catheter according to clause 5 or clause 6, wherein the at least one annular member comprises a plurality of annular members, the plurality of annular members being distributed longitudinally along the two or more injection tubes.

[0187] 8. The catheter according to any of clauses 5 to 7, wherein the at least one annular member is elliptical in shape.

[0188] 9. The catheter of any one of clauses 5 to 8, wherein the at least one annular member is configured to collapse into a lower profile state by tilting at least towards the central longitudinal axis.

[0189] 10. The catheter of any one of clauses 1 to 9, wherein the one or more injection tubes include a first injection tube and a second injection tube, and wherein the first injection tube is configured to remain substantially linear and the second injection tube is configured to remain substantially linear when the one or more injection tubes are

[0190] A plurality of non-inflatable positioning members move away from the first syringe when expanded radially outward.

[0191] 11. The catheter of any one of clauses 1 to 4, wherein at least one of the one or more non-inflatable positioning members defines a helical, spiral, or sinusoidal structure in the expanded configuration.

[0192] 12. A catheter according to claim 11, wherein the one or more injection tubes and the one or more non-inflatable positioning members are configured to collapse into a lower profile state by tilting at least toward the central longitudinal axis of the catheter body when the control member is pushed distally.

[0193] 13. The catheter of clause 12, wherein the one or more non-inflatable positioning members are configured to expand radially outward when the control member is pulled proximally.

[0194] 14. A catheter according to any one of clauses 1 to 13, wherein the one or more non-inflatable positioning members are further configured to maintain the one or more injection ports against the blood vessel wall during high-pressure injection of chemicals through the injection tube lumen and discharge from the one or more injection ports.

[0195] 15. The catheter of any one of clauses 1 to 14, wherein the one or more non-inflatable positioning members are configured to self-expand.

Claims

1. A catheter, comprising: a catheter body defining a central longitudinal axis; one or more non-inflatable positioning members connected to the catheter body; and one or more injection tubes disposed on an outer surface of the one or more non-inflatable positioning members, each of the one or more injection tubes defining a syringe lumen and one or more injection ports in fluid communication with the corresponding syringe lumen, Wherein the one or more non-inflatable positioning members are configured to expand radially outward to position at least one of the one or more injection ports in apposition with a wall of a blood vessel of a patient.

2. The catheter of claim 1, wherein the one or more non-inflatable positioning members comprise a shape memory material.

3. The catheter of claim 2, wherein the shape memory material comprises Nitinol.

4. A catheter according to any one of claims 1 to 3, wherein each of the one or more non-inflatable positioning members is mechanically connected to an injection tube of the one or more injection tubes by a band that surrounds the corresponding non-inflatable positioning member and the corresponding injection tube.

5. The catheter according to any one of claims 1 to 4, wherein the one or more injection tubes include two or more injection tubes, and wherein the one or more non-inflatable positioning members include at least one annular member radially inside the two or more injection tubes.

6. A catheter according to claim 5, wherein the one or more non-inflatable positioning members include an expandable frame, wherein the one or more injection tubes are mechanically connected to the expandable frame, and wherein the at least one annular member is configured to cause the expandable frame to expand radially outward.

7. The catheter according to claim 5 or claim 6, wherein the at least one annular member comprises a plurality of annular members, the plurality of annular members being distributed longitudinally along the two or more injection tubes.

8. The catheter according to any one of claims 5 to 7, wherein the at least one annular member is elliptical in shape.

9. The catheter of any one of claims 5 to 8, wherein the at least one annular member is configured to collapse to a lower profile state by tilting at least toward the central longitudinal axis.

10. A catheter according to any one of claims 1 to 9, wherein the one or more injection tubes include a first injection tube and a second injection tube, and wherein the first injection tube is configured to remain substantially linear and the second injection tube is configured to move away from the first injection tube when the one or more non-inflatable positioning members expand radially outward.

11. The catheter of any one of claims 1 to 4, wherein at least one of the one or more non-inflatable positioning members defines a helical, spiral, or sinusoidal structure in the expanded configuration.

12. A catheter according to claim 11, wherein the one or more injection tubes and the one or more non-inflatable positioning members are configured to collapse into a lower profile state by tilting at least toward the central longitudinal axis of the catheter body when the control member is pushed distally.

13. The catheter of claim 12, wherein the one or more non-inflatable positioning members are configured to expand radially outward when the control member is pulled proximally.

14. The catheter of any one of claims 1 to 13, wherein the one or more non-inflatable positioning members are further configured to maintain the one or more injection ports against the blood vessel wall during high-pressure injection of chemicals through the injection tube lumen and discharge from the one or more injection ports.

15. The catheter of any one of claims 1 to 14, wherein the one or more non-inflatable positioning members are configured to self-expand.

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