Balloon medical system

Abstract

A medical system is configured to deliver a therapeutic agent to a patient using a catheter system having a balloon. The valve manifold includes a first valve configured to transition to a first valve open position based on inflation pressure of the balloon. The valve manifold includes a second valve configured to be positioned at the second valve open using an actuator. The valve manifold is configured to fluidly couple the inlet flow path and the outlet flow path to pressurize the therapeutic agent when the first valve is in the first valve open position and the second valve is in the second valve open position. The valve manifold is configured to fluidly isolate the inlet flow path from the outlet flow path when the first valve is in the first valve closed position or the second valve is in the second valve closed position.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 374,046, filed on August 31, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present technology relates to the delivery of therapeutic agents to tissues of a patient. Background Art

[0003] Some medical procedures involve delivering therapeutic agents to the patient's tissue. For example, some medical ablation procedures involve using therapeutic agents to ablate tissue near the patient's vasculature, such as nerves. As an example, a therapeutic agent can be delivered to tissue to change the activity of nerves at or near the target tissue site as part of a neuromodulation therapy. 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 responses. Chronic overactivation of the SNS is a maladaptive response 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 renal disease. Summary of the invention

[0004] The present disclosure describes a medical system configured to deliver a therapeutic agent to a patient's tissue. The medical system is configured to help reduce or even prevent pressurization of the therapeutic agent, which can reduce the amount of the therapeutic agent delivered to the patient's tissue, or even prevent the therapeutic agent from being delivered to the patient, for example, before a therapeutic delivery element of the system is positioned at a target tissue site in the patient's body as desired. As discussed below, the system is configured to control pressurization of the therapeutic agent based on the inflation pressure of a balloon used to position a therapeutic element (e.g., one or more injection ports) relative to a target tissue site in the patient's body.

[0005] The medical system includes a therapeutic element (e.g., an injection element configured to deliver a therapeutic agent) configured to deliver the therapeutic agent to a vessel wall or other tissue of a patient via a catheter including a balloon. The therapeutic agent can be used to provide, for example, a neuromodulatory therapy, such as renal denervation. The balloon is configured to expand within a vessel to, for example, help position the therapeutic element within the vessel, help occlude the vessel during a medical procedure, help maintain the catheter within the vessel, help displace the catheter and the vessel wall, and / or for other reasons. For example, the inflated balloon can be configured to help maintain the therapeutic element in juxtaposition with the vessel wall, to approximately center the catheter within the vessel, and / or to provide assistance in other ways.

[0006] In the examples described herein, the medical system is configured to deliver a therapeutic agent (e.g., a chemical agent) at a relatively high pressure. The medical system can be configured so that a clinician can pressurize the therapeutic agent for delivery to a target site in a patient's body. In an example, the catheter system is configured to control the pressurization of the therapeutic agent in the catheter based on the inflation pressure of the balloon, for example, to help the clinician assess the position of the therapeutic element before pressurization. For example, the catheter system can be configured to substantially limit and / or prevent the pressurization of the therapeutic agent in the catheter system when the inflation pressure of the balloon is below a threshold value (e.g., potentially indicating that the balloon may not position the therapeutic element against and / or in close proximity to the vessel wall). The catheter system can be configured to be able to deliver the therapeutic agent through the lumen of the catheter and ultimately deliver it from the lumen to the patient's tissue when the inflation pressure of the balloon is greater than or equal to a threshold value (e.g., potentially indicating that the balloon may have been inflated to position the therapeutic element against and / or in close proximity to the vessel wall).

[0007] In an example, a medical system includes a valve manifold configured to fluidically couple an inlet flow path and an outlet flow path to pressurize a therapeutic agent. The valve manifold includes a first valve configured to transition to a first valve open position based on an inflation pressure within an interior volume of a balloon. The valve manifold includes a second valve configured to be positioned in a second valve open position based on positioning of an actuator (e.g., by a clinician). The valve manifold is configured to fluidly couple the inlet flow path and the outlet flow path (allowing pressurization of the therapeutic agent) when the first valve is in the first valve open position (e.g., due to inflation pressure of the balloon) and the second valve is in the second valve open position (e.g., due to positioning the actuator to open the second valve by the clinician). The valve manifold is configured to fluidly isolate the inlet flow path and the outlet flow path (substantially preventing pressurization of the therapeutic agent) when the first valve is in the first valve closed position (e.g., due to a relatively low inflation pressure of the balloon) or the second valve is in the second valve closed position (e.g., due to the clinician leaving the second valve in the closed position and / or positioning the actuator to close the second valve).

[0008] In an example, a medical system includes: a first valve biased to a first valve closed position; a valve manifold defining an inlet flow path and an outlet flow path, the valve manifold defining a pressure chamber configured to cause pressure of a fluid in the pressure chamber to move the first valve from the first valve closed position to the first valve open position; a second valve; and an actuator configured to position the second valve in one of a second valve open position or a second valve closed position, wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when pressure of the fluid causes the first valve to move to the first valve open position and the actuator positions the second valve in the second valve open position, and wherein the first valve and the second valve are configured to fluidly isolate the inlet flow path and the outlet flow path when the first valve is in the first valve closed position or the actuator positions the second valve in the second valve closed position.

[0009] In an example, a method includes: pressurizing an interior volume of a balloon using an inflation fluid using an inflation catheter, wherein the inflation fluid is configured to establish a pressure in a pressure chamber of a valve manifold, the pressure sufficient to move a first valve from a first valve closed position to a first valve open position, the first valve being biased to the first valve closed position; and fluidly coupling an inlet flow path of the valve manifold to an outlet flow path of the valve manifold by transitioning at least a second valve from the second valve closed position to the second valve open position using an actuator, wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and wherein the first valve and the second valve are configured to fluidly isolate the inlet flow path and the outlet flow path when at least one of the first valve is in the first valve closed position or the second valve is in the second valve closed position.

[0010] Also disclosed herein is a medical system configured to deliver a therapeutic agent to a patient using a catheter system with a balloon, wherein a valve manifold includes a first valve configured to transition to a first valve-open position based on an inflation pressure of the balloon, wherein the valve manifold includes a second valve configured to be positioned at a second valve-open position using an actuator, wherein the valve manifold is configured to fluidically couple an inlet flow path and an outlet flow path to pressurize the therapeutic agent when the first valve is in the first valve-open position and the second valve is in the second valve-open position, wherein the valve manifold is configured to fluidically isolate the inlet flow path and the outlet flow path when the first valve is in the first valve-closed position or the second valve is in the second valve-closed position.

[0011] The details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the techniques described in the present disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a schematic diagram of an exemplary medical system including a medical device configured to deliver a therapeutic agent to tissue of a patient.

[0013] Figure 2 yes Figure 1 Schematic diagram of a medical system within a patient's blood vessels.

[0014] Figure 3 yes Figure 1 Schematic diagram of a medical system approaching a patient's renal artery.

[0015] Figure 4 yes Figure 1 Schematic diagram of a medical system in a delivery configuration.

[0016] Figure 5 yes Figure 1 Schematic diagram of a medical system with a balloon in an expanded configuration, wherein a first valve is in a first valve open position and a second valve is in a second valve closed position.

[0017] Figure 6 It depicts Figure 1 An exemplary illustration of a pressure within a balloon of a medical system and a size defined by the balloon, wherein a first valve is in a first valve open position and a second valve is in a second valve open position.

[0018] Figure 7 yes Figure 1 A perspective view of an exemplary handle of a medical system.

[0019] Figure 8 is a perspective cross-sectional view of an exemplary valve manifold of a medical system according to claim 1.

[0020] Fig. 9 is shown for use Figure 1 A flow chart of an exemplary technique for pressurizing an interior volume of a balloon using a medical system. DETAILED DESCRIPTION

[0021] The present technology relates to devices, systems and methods for delivering therapeutic agents to tissue of a patient. The therapeutic agent can be, for example, a therapeutic agent for neuromodulation such as renal neuromodulation.

[0022] Diseases such as arrhythmias, hypertension, volume overload states (e.g., heart failure) and progressive nephropathy caused by excessive activation of the renal sympathetic nervous system (SNS) can be alleviated by regulating the activation of overactivated nerves (neuromodulation), for example, denervation or reduction of overactivated nerve activation. The sympathetic nerves of the kidney terminate in structures such as renal blood vessels, juxtaglomerular apparatus and renal tubules. Overactivated nerves can be denervated by ablating the sympathetic nerve tissue in or near the renal blood vessels, for example, using therapeutic agents alone in combination with other ablative methods. Therapeutic agents can be delivered to sympathetic nerve tissues via a catheter including one or more therapeutic elements (e.g., injection ports) guided in the patient's vascular system. In the case of chemical denervation (e.g., chemical renal denervation), the medical system can be configured to pressurize the therapeutic agent so that the therapeutic agent is delivered to the target treatment site. The therapeutic agent can be pressurized, for example, to enable the therapeutic agent to penetrate the vascular wall to reach the nerves near the vascular wall.

[0023] Renal neuromodulation, such as renal denervation, can be accomplished using one or more of a variety of therapeutic modalities, including radiofrequency (RF) energy, microwave energy, ultrasound energy, therapeutic agents, and the like. When a therapeutic agent is used, a neuromodulation catheter can be delivered to a renal blood vessel, such as a renal artery, of a patient. The neuromodulation catheter may include at least one port or needle through which the therapeutic agent is delivered. The therapeutic agent may be selected to modulate the activity of one or more renal nerves adjacent to a renal artery in which the neuromodulation catheter is positioned. For example, the therapeutic agent may be a neurotoxic chemical selected to chemically ablate one or more renal nerves adjacent to a renal artery. The therapeutic agent may include one or more chemical agents, such as, but not limited to, 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.

[0024] The present disclosure describes an exemplary medical system, which includes at least one balloon configured to be positioned in a patient's body (e.g., within a patient's blood vessel) and at least one therapeutic element configured to deliver treatment to a target tissue site of the patient to achieve a treatment result. The medical system, the system including the medical system, and the method of using the medical system can be used for any suitable medical procedure including delivering a therapeutic agent to a target tissue site in combination with other treatments (e.g., ultrasound energy, microwave energy, cryotherapy, and / or radio frequency (RF) energy) via a therapeutic element alone. Therefore, although this article is primarily related to neuromodulation (e.g., denervation), the devices, systems, and methods described herein can be used with other medical procedures. The medical system is configured to be positioned (e.g., by a clinician) within a patient's blood vessel or other anatomical lumen. The at least one balloon is configured to expand within the anatomical lumen, for example, to help position the therapeutic element within the anatomical lumen, to help occlude the anatomical lumen, to help maintain the elongated body of the catheter within the anatomical lumen, to help displace the wall of the elongated body and the anatomical lumen, and / or for other reasons.

[0025] The balloon is configured to be inflated within the anatomical lumen to position the therapeutic element against and / or in close proximity to the wall of the anatomical lumen. As discussed in further detail below, the medical system is configured to help reduce or even prevent pressurization of the therapeutic agent based on the inflation state of the balloon. This can reduce the amount of therapeutic agent delivered to the patient's tissue, or even prevent the therapeutic agent from being delivered to the patient before the therapeutic delivery element of the system is positioned at the target tissue site in the patient's body as desired.

[0026] In an example, the therapeutic element includes an injection component that is configured to deliver a therapeutic agent, such as a chemical ablative agent and / or another therapeutic agent, to a target treatment site in a patient's body. The injection component can be, for example, a needle, a needle-free injection tube defining one or more injection ports, and / or another component configured to deliver the therapeutic agent. In an example, the balloon is configured to be inflated within an anatomical lumen to position the injection component against and / or in close proximity to a vessel wall when the balloon is inflated. Thus, the balloon can help substantially establish and / or maintain the therapeutic element in position relative to the target site in preparation for and / or during delivery of the therapeutic agent to the target site.

[0027] In the examples described herein, the catheter system is configured to pressurize the therapeutic agent at a proximal position of the injection component to facilitate and enable the therapeutic agent to be delivered to the target site through the lumen of the catheter. The catheter system is configured to substantially limit and / or prevent pressurization based on the inflation pressure of the balloon, for example, to help clinicians assess the position of the therapeutic element before pressurization. For example, the catheter system can be configured to substantially limit and / or prevent pressurization of the therapeutic agent when the inflation pressure of the balloon is below a threshold value (e.g., potentially indicating that the balloon may not position the therapeutic element against and / or in close proximity to the vessel wall). The catheter system can be configured to allow pressurization of the therapeutic agent when the inflation pressure of the balloon is greater than or equal to a threshold value (e.g., potentially indicating that the balloon may have been inflated to position the therapeutic element against and / or in close proximity to the vessel wall).

[0028] In an example, the catheter system is configured to pressurize the therapeutic agent using a pressurized fluid such as pressurized carbon dioxide (CO2). For example, the medical system may be configured so that the pressurized fluid acts on a pressurizing element (e.g., a piston or a diaphragm) so that the pressurizing element pressurizes the therapeutic agent. In some examples, the catheter system includes a valve manifold configured to receive the pressurized fluid via an inlet flow path and discharge the pressurized fluid via an outlet flow path (e.g., to the pressurizing element). The valve manifold is configured to fluidly couple the inlet flow path and the outlet flow path (e.g., so that the pressurized fluid can act on the pressurizing element) when the inflation pressure of the balloon indicates sufficient pressure and the clinician takes action (e.g., by positioning an actuator) to cause fluid coupling. The valve manifold is configured to substantially prevent fluid coupling when the inflation pressure of the balloon is insufficient (e.g., below a threshold) or the clinician does not take the necessary action to cause fluid coupling (e.g., the actuator is not positioned). Thus, the valve manifold is configured to coordinate the inflation pressure of the balloon with the clinician's actions to, for example, help the clinician assess the position of the therapeutic element prior to pressurizing the therapeutic agent. For example, the medical system can help the clinician assess when the balloon may have been sufficiently inflated to position the therapeutic element against and / or in close proximity to the vessel wall such that positioning the actuator (e.g., by the clinician) will cause pressurization of the therapeutic agent.

[0029] In some examples, the valve manifold includes a first valve and a second valve configured to fluidically couple an inlet flow path and an outlet flow path such that a pressurized fluid can flow through the valve manifold. The valve manifold can be configured such that fluidly coupling the inlet flow path and the outlet flow path (e.g., such that the pressurized fluid acts on a pressurizing element) requires both the first valve and the second valve to be in an open position (e.g., a fully open or partially open state). In some examples, the valve manifold is configured such that if either the first valve or the second valve is in a closed position, the valve manifold fluidly isolates the inlet flow path and the outlet flow path such that the pressurized fluid is substantially prevented (e.g., prevented or nearly prevented to the extent permitted by manufacturing tolerances) from flowing through the valve manifold (e.g., substantially prevented from acting on the pressurizing element) and pressurizing the therapeutic agent. Preventing pressurization of the therapeutic agent can reduce the amount of therapeutic agent that is inadvertently delivered to the lumen of the catheter and ultimately to the patient, or even prevent the therapeutic agent from being delivered to the lumen of the catheter.

[0030] For example, the first valve can be configured to fluidically isolate the inlet flow path and the outlet flow path when the first valve is in a closed position regardless of the position of the second valve. The second valve can be configured to fluidly isolate the inlet flow path and the outlet flow path when the second valve is in a closed position regardless of the position of the first valve. Thus, the valve manifold is configured to fluidically isolate the inlet flow path and the outlet flow path when either the first valve or the second valve is in a closed position. In some examples, the valve manifold is configured such that when the manifold fluidly couples the inlet flow path and the outlet flow path, the first valve and the second valve are fluidly coupled in series.

[0031] In an example, the valve manifold is configured such that an inflation pressure within the interior volume of the balloon that is greater than or equal to a predetermined balloon inflation pressure is sufficient to overcome the bias of the first valve. For example, the first valve may be biased in a first valve closed position such that the inlet flow path and the outlet flow path are fluidly isolated. The first valve is configured to transition from the first valve closed position to the first valve open position based on the inflation pressure of the balloon. In an example, the first valve is configured to transition from the first valve closed position to the first valve open position based on the pressure of a control fluid (e.g., a fluid different from the pressurized fluid used to pressurize the therapeutic agent). The control fluid may be, for example, an inflation fluid used to inflate the balloon, such that the pressure chamber may be in fluid communication with the interior volume of the balloon and is configured to receive the inflation fluid from the balloon.

[0032] In some examples, the valve manifold includes a pressure chamber configured such that the pressure of the control fluid indicates (e.g., is based on or varies with) the inflation pressure of the balloon. The first valve may be configured to transition from a first valve closed position to a first valve open position when the pressure of the control fluid acting on the first valve and / or another component (e.g., a diaphragm) overcomes the bias of the first valve in the first valve closed position. In an example, the valve manifold includes a biasing element such as a spring or other compression element that is configured to bias the first valve in the first valve closed position. Thus, the valve manifold is configured to transition the first valve from the first valve closed position to the first valve open position when the inflation pressure of the balloon increases to a sufficient level to overcome the bias of the first valve, such that the position of the first valve depends on the inflation pressure of the balloon.

[0033] The second valve is configured to transition between a second valve closed position and a second valve open position based on the action of a clinician. For example, the second valve may include an actuator (e.g., a manual actuator operated by a clinician) configured to transition the second valve between a second valve closed position and a second valve open position. The valve manifold is configured to fluidically isolate an inlet flow path and an outlet flow path when the second valve is in the second valve closed position regardless of the position of the first valve, so that the clinician can control the flow of pressurized fluid through the manifold. In an example, the actuator is configured to transition the second valve between a second valve closed position and a second valve open position based on physical manipulation of a component (e.g., by a clinician), such as physical manipulation of a mechanical element configured to physically translate the second valve, physical manipulation of a button or switch configured to transmit a valve position signal to the second valve, and / or another physical manipulation. Therefore, the valve manifold can be configured so that the fluid coupling inlet flow path and outlet flow path to pressurize the therapeutic agent substantially requires that the pressure in the balloon is sufficient to place the first valve in the first valve open position, and the action of the clinician causes the actuator to place the second valve in the second valve open position.

[0034] The valve manifold is configured to fluidically isolate the inlet flow path and the outlet flow path when at least one of the first valve or the second valve transitions from an open position to a closed position. For example, the first valve (e.g., due to a bias of the first valve in the first valve closed position) can be configured to transition from the first valve open position to the first valve closed position when the inflation pressure in the balloon decreases below a threshold pressure value. When the first valve is positioned in the first valve closed position, the valve manifold can fluidically isolate the inlet flow path and the outlet flow path such that the pressurized fluid is substantially unable to pressurize the therapeutic agent and / or continue to pressurize the therapeutic agent. Thus, the valve manifold can be configured to prevent and / or substantially reduce pressurization of the therapeutic agent when the inflation pressure of the balloon decreases below a threshold pressure value (e.g., due to partial and / or substantially complete deflation of the balloon when the balloon is positioned within the anatomical lumen).

[0035] Similarly, the valve manifold can be configured to prevent and / or substantially stop pressurization of the therapeutic agent when the second valve is positioned in the second valve closed position. For example, the valve manifold can be configured such that an action by a clinician (e.g., manipulation of an actuator) causes the valve manifold to fluidly isolate the inlet flow path and the outlet flow path such that the clinician can prevent and / or substantially stop pressurization of the therapeutic agent regardless of the inflation pressure of the balloon.

[0036] In an example, a medical system includes a switch configured to substantially prevent an actuator from causing a second valve to transition from a second valve closed position to a second valve open position. The medical system may be configured such that causing the second valve to transition from a second valve open position to a second valve closed position requires a change in the position of the switch (e.g., by a clinician). For example, the switch may be configured to include a locked position and a fired position. The switch may be configured to substantially prevent the actuator from transitioning the second valve to a second valve open position when in the locked position. The switch may be configured to allow the actuator to transition the second valve to a second valve open position when in the fired position. In some examples, the switch is biased (e.g., spring loaded) in the locked position so that the operation of the actuator to position the second valve in the second valve open position first requires the switch to be manipulated from the locked position to the fired position (e.g., by a clinician). Therefore, the medical system may be configured such that the clinician needs to first manipulate the bias switch before fluidly coupling the inlet flow path and the outlet flow path of the valve manifold. The sequential operation required for the switch and the actuator can provide the clinician with a guarantee that the pressurization of the therapeutic agent can occur only based on the clinician's intentional actions.

[0037] Thus, in an example described herein, a medical system includes a balloon and a catheter configured to deliver a pressurized therapeutic agent to a target site in an anatomical lumen of a patient. The medical system is configured so that a clinician can cause pressurization of the therapeutic agent using a pressurized fluid such as pressurized carbon dioxide (CO2). The medical system includes a valve manifold configured to receive the pressurized fluid via an inlet flow path and discharge the pressurized fluid to a pressurized element via an outlet flow path. The valve manifold is configured to fluidly couple the inlet flow path and the outlet flow path when the inflation pressure of the balloon indicates sufficient pressure (e.g., greater than or equal to a predetermined threshold pressure value) and the clinician takes action (e.g., by positioning a manual actuator) to cause fluid coupling. Thus, the valve manifold can be configured to substantially coordinate the inflation pressure of the balloon and the clinician's actions, for example, to help the clinician assess the position of the therapeutic element before pressurizing the therapeutic agent.

[0038] Although blood vessels are primarily mentioned throughout this disclosure, the devices, systems, and techniques described herein are also applicable to other target tissue sites. In addition, although a single balloon is primarily mentioned throughout this disclosure, the medical system described herein may include more than one balloon, such as two, three, four, or more balloons. In some examples, the balloon is configured to expand to a certain range of sizes (e.g., diameters). For example, the balloon may be a compliant balloon. The balloon may be configured to expand to define a specific size within the range based on the inflation pressure within the balloon. In some examples, the control circuit of the medical system is configured to control the size of the balloon (also referred to herein as size, such as diameter) by at least controlling the inflation pressure of the balloon. In this way, the size of the balloon can be adjusted to take into account the size of the blood vessel in which the balloon is positioned (e.g., the size of the balloon is adjusted so that the diameter of the inflated balloon enables the balloon to be juxtaposed with the blood vessel wall during the procedure). As used herein, the pressure of a fluid (e.g., inflation pressure) may refer to the static pressure of the fluid, the dynamic pressure of the fluid, or the total pressure of the fluid.

[0039] Although the present technology is described herein in many instances with reference to renal nerves and blood vessels, the present 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 may be constructed (e.g., with a suitable shape and size) for use at such sites. For example, a catheter may be configured to deliver energy with a portion of the catheter carrying a therapeutic element positioned with a specific anatomical lumen or specific tissue (e.g., a renal artery, an external iliac artery, an internal iliac artery, an internal pudendal artery, a celiac artery, a mesenteric artery, a superior mesenteric artery, an inferior mesenteric artery, a hepatic artery, a splenic artery, a gastric artery, a left gastric artery, a pancreatic artery, a uterine artery, an ovarian artery, a testicular artery, and / or their associated arterial branches, appendages, veins, and / or other hollow anatomical structures).

[0040] As used herein, the terms "distal" and "proximal" define a position or direction relative to a treating clinician or clinician's control device (e.g., a handle assembly). "Distal" or "distally" may refer to a position away from or in a direction away from a clinician or clinician's control device. "Proximal" and "proximally" may refer to a position near or in a direction toward a clinician or clinician's control device.

[0041] Figure 1 is a partially schematic diagram of an example medical system 100 configured according to an example of the present disclosure. Figure 2 is a schematic diagram of a portion of a medical system 100 within a blood vessel 102 of a patient 106 , the blood vessel 102 having a blood vessel wall 104 . Figure 3 Medical system 100 is shown being guided through the vasculature of patient 106 to a target treatment site within blood vessel 102. Figure 2 and Figure 3 In the example of , 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.

[0042] In an example, the medical system 100 is configured to provide neuromodulation to the patient 106. 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). Such 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 be expected to contribute to a systemic reduction in sympathetic tone or power and / or to benefit at least some specific organs and / or other body structures innervated by sympathetic nerves. Therefore, neuromodulation may be expected to be used to treat clinical conditions associated with systemic sympathetic overactivity or hyperactivity, particularly conditions associated with overstimulation of central sympathetic nerves.

[0043] For example, renal neuromodulation may 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 may be electrically induced, thermally induced, chemically induced, or induced in another suitable manner or combination of manners at one or more suitable target sites during a treatment procedure. The target site may be within or otherwise close to the renal lumen (e.g., a renal artery, a ureter, a renal pelvis, a calyx, a calyx, or another suitable structure), and the treated tissue may include tissue at least close to the renal lumen wall (e.g., a vessel wall 104 close to the blood vessel 102). For example, with respect to the renal artery, a treatment protocol may include modulating nerves in the renal plexus that are closely located within or adjacent to the adventitia of the renal artery.

[0044] For ease of description, the following discussion will focus primarily on delivering therapeutic agents, such as neurotoxic chemicals, to a target site. However, the medical system 100 (e.g., therapeutic element 112) may include elements or structures configured to deliver other types of treatments. For example, the medical system 100 may include one or more electrodes, one or more ultrasound transducers, a cryoablation element (e.g., a balloon), and / or other components configured to deliver energy for nerve ablation.

[0045] The medical system 100 includes a catheter system 108. The catheter system 108 includes a therapeutic element 112 configured to deliver therapy to tissue to, for example, perform neuromodulation or another procedure on a vessel wall 104 and / or other tissue associated with the vessel 102. Once at a target site within the patient 106, the therapeutic element 112 may be configured to deliver therapy using, for example, a therapeutic agent alone or in combination with RF energy, microwave energy, ultrasound energy, etc., to provide or facilitate neuromodulation therapy at the target site. For example, the therapeutic element 112 may include an injection element 113 configured to deliver a therapeutic agent to ablate tissue at the target treatment site. The injection element 113 may be, for example, a needle, an injection tube defining a needle-free injection port, and / or another component configured to deliver a therapeutic agent to the target site.

[0046] In some examples, the therapeutic element 112 is configured to at least partially penetrate and / or pierce, or cause the therapeutic agent to at least partially penetrate and / or pierce the vessel wall 104 of the blood vessel 102, so that the therapeutic agent is delivered to the target site. In other examples, the therapeutic element 112 does not include a needle and is configured to deliver a relatively high pressure therapeutic agent to the vessel wall 104 so that the therapeutic agent is delivered to the target site through at least some tissue of the vessel wall 104. For example, the therapeutic element 112 may be configured to deliver the therapeutic agent to the adventitia and / or periadventitia where the renal nerves are located. In an example, the therapeutic agent is selected to neuromodulate (e.g., chemically ablate) the neural tissue of the renal plexus adjacent to the renal artery. The therapeutic agent 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 appropriate neurotoxic fluid; or a combination thereof. In some examples, the therapeutic agent 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). For some needle-free injection examples, the system 100 is configured to pressurize the therapeutic agent to 5 megapascals (MPa) to 18 MPa (e.g., 750-2500 pounds per square inch (psi)), such as about 10 MPa (e.g., about 1500 psi), for delivery to tissue via the therapeutic element 112 (e.g., one or more injection ports).

[0047] The catheter system 108 includes a catheter body 110 that is configured to be positioned (e.g., by a clinician) within a vessel 102 of a patient 106. The catheter system 108 includes one or more expandable elements, such as a balloon 114 ("balloon 114"), that are configured to expand (e.g., by inflating) when the catheter body 110 is positioned within the vessel 102. The balloon 114 can be configured to expand to, for example, help position the therapeutic element 112 against / adjacent to the vessel wall 104, help occlude the vessel 102 during a procedure, help maintain the catheter body 110 within the vessel 102, help displace and / or maintain displacement between the catheter body 110 and the vessel wall 104, and / or for other reasons. The catheter body 110 defines a longitudinal axis L. The balloon 114 can be configured to expand radially outward relative to the longitudinal axis L (e.g., substantially perpendicular to the longitudinal axis L) when the balloon 114 is inflated within the vessel 102 of the patient 106. In an example, the catheter body 110 supports (e.g., mechanically supports) a balloon 114. In an example, the balloon 114 supports (e.g., mechanically supports) a therapeutic element 112. The therapeutic element 112 can be positioned substantially outside of the balloon 114, such as on an outer surface of the balloon 114, and / or positioned substantially inside of the balloon 114, such as within an interior volume 116 of the balloon 114 ("balloon interior volume 116").

[0048] The catheter system 108 is configured to control the inflation pressure PI within the balloon interior volume 116 to control the size (e.g., diameter) of the balloon 114. For example, the catheter system 108 can be configured to inject an inflation fluid (e.g., saline) into the balloon interior volume 116 to control the inflation pressure. In an example, the catheter system 108 includes an inflation fluid delivery system 118, such as a pump or a syringe, which is configured to drive the inflation fluid to the balloon interior volume 116. The catheter system 108 (e.g., the catheter body 110) can define an inflation fluid flow path 120 (e.g., an inflation chamber) configured to fluidly couple the inflation fluid delivery system 118 and the balloon interior volume 116. In an example, the medical system 100 includes an inflation fluid container 122 (e.g., a syringe) that defines a reservoir 124 configured to hold a certain amount of inflation fluid. The inflation fluid delivery system 118 can be configured to draw fluid from the reservoir 124 and discharge the fluid into the inflation fluid flow path 120. In an example, the catheter system 108 can be configured to start, stop, adjust, and / or substantially establish the flow rate of the inflation fluid in order to adjust and / or establish the inflation pressure PI within the balloon interior volume 116, and thus adjust and / or establish the size of the balloon 114.

[0049] In some examples, catheter system 108 includes a flow sensor 123 configured to sense a parameter indicative of a flow rate (e.g., indicative of a mass flow rate) provided by inflation fluid delivery system 118 to inflation fluid flow path 120. In some examples, catheter system 108 includes a sensor 125 configured to sense a parameter indicative of an inflation pressure PI of balloon 114.

[0050] The catheter system 108 is configured to deliver a therapeutic agent to the therapeutic element 112, such that, for example, the therapeutic element 112 (e.g., the injection element 113) delivers the therapeutic agent to the target site. In an example, the catheter system 108 includes a therapeutic agent delivery system 126, which is configured to drive the therapeutic agent to the therapeutic element 112 (e.g., the injection element 113). The catheter system 108 (e.g., the catheter body 110) defines a therapeutic agent flow path 128 (e.g., a catheter lumen) that is configured to fluidly couple the therapeutic agent delivery system 126 and the therapeutic element 112. In an example, the therapeutic agent delivery system 126 includes a therapeutic agent container 130 that defines a therapeutic agent reservoir 132 that is configured to hold a certain amount of therapeutic agent. The therapeutic agent delivery system 126 can be configured to fluidly couple the therapeutic agent reservoir 132 and the therapeutic agent flow path 128. In an example, the therapeutic agent delivery system 126 is configured to substantially discharge the therapeutic agent from the therapeutic agent reservoir 132 to the therapeutic agent flow path 128 .

[0051] The therapeutic agent delivery system 126 is configured to pressurize the therapeutic agent to discharge the therapeutic agent from the therapeutic agent reservoir 132 into the therapeutic agent flow path 128. In an example, the therapeutic agent delivery system 126 includes a pressurizing element 134 configured to pressurize (e.g., substantially increase the pressure of) the therapeutic agent within the therapeutic agent reservoir 132. The therapeutic agent delivery system 126 can be configured such that pressurization causes the therapeutic agent within the therapeutic agent reservoir 132 to be discharged from the therapeutic agent reservoir 132 into the therapeutic agent flow path 128. The therapeutic agent flow path 128 is configured to receive the pressurized therapeutic agent from the therapeutic agent delivery system 126 and provide the pressurized therapeutic agent to the therapeutic element 112 (e.g., the injection element 113).

[0052] The therapeutic agent delivery system 126 is configured so that a clinician can cause pressurization of the therapeutic agent for delivery to a target site. In an example, the therapeutic agent delivery system 126 is configured to pressurize the therapeutic agent using a pressurized fluid such as pressurized carbon dioxide (CO2). In an example, the therapeutic agent delivery system 126 includes a pressurized fluid container 136 that defines a pressurized fluid reservoir 138 configured to hold a certain amount of pressurized fluid. The therapeutic agent delivery system 126 can be configured so that when the pressurized fluid acts on the pressurizing element 134 (e.g., exerts fluid pressure on the pressurizing element 134), the pressurizing element 134 pressurizes the therapeutic agent within the therapeutic agent reservoir 132.

[0053] The catheter system 108 (e.g., the therapeutic agent delivery system 126) is configured to coordinate the inflation pressure of the balloon 114 with the clinician's actions to, for example, help the clinician assess the position of the therapeutic element prior to pressurizing the therapeutic agent (which ultimately delivers the therapeutic agent to the therapeutic agent flow path 128 and out through the therapeutic element 112). Figure 1 In the example shown in , the therapeutic agent delivery system 126 includes a valve manifold 140 that is configured to receive a pressurized fluid (e.g., from a pressurized fluid container 136) via an inlet flow path 142. The valve manifold 140 is configured to discharge the pressurized fluid (e.g., to a pressurizing element 134) via an outlet flow path 144 when the valve manifold 140 fluidly couples the inlet flow path 142 and the outlet flow path 144.

[0054] In an example, the valve manifold 140 includes a manifold body 141 that defines an inlet flow path 142 and / or an outlet flow path 144. The therapeutic agent delivery system 126 is configured to fluidly couple the inlet flow path 142 and the outlet flow path 144 when the inflation pressure of the balloon 114 indicates sufficient pressure and the clinician takes action (e.g., by positioning an actuator) to cause fluid coupling. The therapeutic agent delivery system 126 is configured to substantially prevent fluid coupling of the inlet flow path 142 and the outlet flow path 144 when the inflation pressure of the balloon may be insufficient (e.g., below a threshold) or the clinician has not taken the necessary action to cause fluid coupling (e.g., has not positioned the actuator).

[0055] In an example, the therapeutic agent delivery system 126 includes a first valve 146 and a second valve 148 configured to fluidically couple an inlet flow path 142 and an outlet flow path 144. The first valve 146 and the second valve 148 are configured to fluidically couple and / or fluidically isolate the inlet flow path 142 and the outlet flow path 144 based on the respective positions of the first valve 146 and the second valve 148. In an example, the first valve 146 is configured to establish an open position ("first valve open position") and a closed position ("first valve closed position"). The first valve 146 is configured to allow flow through the first valve 146 in the first valve open position, and substantially block (e.g., completely block or completely block to the extent allowed by manufacturing tolerances) flow through the first valve 146 in the first valve closed position. Similarly, the second valve 148 is configured to allow flow through the second valve 148 in the second valve open position, and substantially block flow through the second valve 148 in the second valve closed position.

[0056] The therapeutic agent delivery system 126 is configured such that when the first valve 146 is in the first valve open position and the second valve 148 is in the second valve open position, the valve manifold 140 fluidly couples the inlet flow path 142 and the outlet flow path 144 (e.g., such that a pressurized fluid can act on the pressurizing element 134 to pressurize the therapeutic agent). The therapeutic agent delivery system 126 is configured such that if the first valve 146 is in the first valve closed position or the second valve 148 is in the second valve closed position, the valve manifold 140 fluidly isolates the inlet flow path 142 and the outlet flow path 144 (e.g., such that a pressurized fluid is substantially prevented (e.g., prevented or nearly prevented to the extent permitted by manufacturing tolerances) from flowing through the valve manifold 140 to act on the pressurizing element 134).

[0057] The therapeutic agent delivery system 126 is configured such that the position of the first valve 146 depends on the inflation pressure within the balloon interior volume 116. In an example, the first valve 146 is configured to transition from a first valve closed position to a first valve open position (and vice versa) based on the pressure of a control fluid within a pressure chamber 150 defined by the valve manifold 140. The valve manifold 140 can be configured such that the pressure of the control fluid depends on (e.g., is proportional to) the inflation pressure within the balloon interior volume 116 of the balloon 114. For example, the therapeutic agent delivery system 126 can be configured to fluidically and / or mechanically couple the balloon interior volume 116 and the pressure chamber 150 such that the pressure of the inflation fluid within the balloon interior volume 116 causes pressure to be exerted on the control fluid within the pressure chamber 150. In an example, the control fluid within the pressure chamber 150 includes at least a portion of the inflation fluid. Thus, the therapeutic agent delivery system 126 is configured to transition the first valve 146 from a first valve closed position to a first valve open position (such that the first valve 146 can allow pressurized fluid to flow from the pressurized fluid reservoir 138 substantially through the first valve 146) based on the inflation pressure within the balloon interior volume 116.

[0058] In some examples, the therapeutic agent delivery system 126 is configured such that the position of the second valve 148 is dependent on (e.g., controlled by) an action of a clinician. In an example, the second valve 148 includes an actuator 152 configured to transition the second valve 148 between a second valve closed position and a second valve open position. The therapeutic agent delivery system 126 is configured to fluidically isolate the inlet flow path 142 and the outlet flow path 144 when the second valve 148 is in the second valve closed position regardless of the position of the first valve 146, so that the clinician can control the flow of pressurized fluid from the pressurized fluid reservoir 138 to the pressurizing element 134. For example, the actuator 152 can be configured to transition the second valve 148 between the second valve closed position and the second valve open position based on physical manipulation (e.g., by a clinician) of a mechanical element (e.g., a manual valve operator), manipulation of a button or switch, and / or another physical manipulation. Thus, the therapeutic agent delivery system 126 is configured such that fluid coupling of the inlet flow path 142 and the outlet flow path 144 to cause pressurization of the therapeutic agent substantially requires that the pressure in the balloon 114 be sufficient to place the first valve 146 in the first valve open position, and that action by the clinician cause the actuator 152 to place the second valve 148 in the second valve open position.

[0059] The catheter body 110 defines a distal portion 110A ("distal body portion 110A") and a proximal portion 110B ("proximal body portion 110B"). Figure 1, the therapeutic element 112 and / or the balloon 114 are positioned on the distal body portion 110A. In an example, the catheter system 108 is configured to present a relatively low-profile delivery configuration, wherein at least one of the distal body portion 110A and / or the balloon 114 defines a maximum cross-sectional dimension C1 (e.g., a diameter) that can be measured in a direction perpendicular to the longitudinal axis L. The dimension C1 can define a displacement sufficient to allow at least the distal body portion 110A and the balloon 114 to pass through the vasculature of the patient 106 to reach a target treatment site in the patient 106. In some examples, the distal body portion 110A is configured to position the balloon 114 and / or the therapeutic element 112 at an intraluminal (e.g., intravascular) position. In an example, the catheter system 108 is configured such that in the delivery configuration, the dimension C1 measures 2Fr (French), 3Fr, 4Fr, 5Fr, 6Fr, or 7Fr, or another suitable size. The balloon 114 is configured to expand from a delivery configuration to an expanded configuration ( Figure 2 ), for example, to position and / or stabilize the distal body portion 110A and / or the therapeutic element 112 when the distal body portion 110A positions the therapeutic element 112 at a target treatment site.

[0060] In some examples, the balloon 114 supports the therapeutic element 112 such that, for example, inflation of the balloon 114 reduces displacement between the therapeutic element 112 and the vessel wall 104. For example, the therapeutic element 112 can be supported by an outer surface 154 of the balloon 114 ("balloon outer surface 154") (e.g., an injection tube on the outer surface of the balloon 14) and / or by some portion of the balloon body 158 between and / or defining the balloon outer surface and / or the balloon inner surface of the balloon outer surface 154 and / or the inner surface 156 of the balloon 114 ("balloon inner surface 156"). In some examples, the catheter body 110 can be configured to support the therapeutic element 112 at a fixed longitudinal position (measured along the longitudinal axis L) on the catheter body 110 relative to the balloon 114. In some examples, the catheter body 110 supports the therapeutic element 112 such that the therapeutic element 112 is positioned distal to the balloon 114 (e.g., displaced from the balloon 114 in direction D) or proximal to the balloon 114 (e.g., displaced from the balloon 114 in direction P).

[0061] In an example, the medical system 100 includes a control circuit 160 configured to control the inflation pressure of the inflation fluid within the balloon interior volume 116. In some examples, the control circuit 160 is configured to receive a pressure signal indicating the inflation pressure (e.g., from the sensor 125) and cause the adjustment of the inflation pressure based on the pressure signal. For example, the control circuit 160 may be configured to receive an input indicating a pressure set point and cause the adjustment of the inflation pressure based on the pressure indicated by the pressure signal and the pressure set point (e.g., using the inflation fluid delivery system 118). The control circuit 160 may be configured to communicate with the catheter system 108 (e.g., via a communication link 161) to receive the pressure signal, adjust the inflation pressure, and / or control and / or direct other functions of the catheter system 108. In other examples, the inflation pressure of the inflation fluid within the balloon interior volume 116 is manually controlled by a clinician rather than automatically controlled by the control circuit 160.

[0062] In some examples, the catheter system 108 includes a user interface 162 configured to receive an input indicating a pressure set point from a user and provide the input to the control circuit 160 (e.g., via a control link 163). The user interface 162 may be configured to receive an indication input from a clinician and / or other user so that the clinician and / or other user can specify the desired size of the balloon 114. The user interface 162 may have any suitable configuration sufficient to receive input from the user. For example, the user interface 162 may include a button or keypad, a touch screen, a speaker configured to receive a voice command from a user, a positioning member (e.g., a dial and / or other positioning member) and / or a display (such as a liquid crystal (LCD), a light emitting diode (LED) or an organic light emitting diode (OLED)). In some examples, the user interface 162 is configured to display information such as one or more desired sizes and / or set points (e.g., the current desired size and / or set point being used by the control circuit 160, or one or more predetermined desired sizes and / or set points from which the user can select to input the desired size of the balloon 114).

[0063] The control circuit 160 and other processors, processing circuits, controllers, control circuits, etc. described herein may include any combination of the following: integrated circuits, discrete logic circuits, analog circuits, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field programmable gate arrays (FPGAs). In some examples, the control circuit 160 may include multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuits and / or analog circuits.

[0064] Although not in Figure 1 As shown in , the system 100 may also include a memory configured to store program instructions (such as software), which may include one or more program modules that can be executed by the control circuit 160. When executed by the control circuit 160, such program instructions may cause the control circuit 160 to provide the functionality attributed to the control circuit 160 herein. The program instructions may be embodied in software and / or firmware. The memory may include any volatile medium, non-volatile medium, magnetic medium, optical medium, or electrical medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), ferroelectric RAM (FRAM), flash memory, or any other digital medium.

[0065] In an example, the medical system 100 includes an imaging device 164. The imaging device 164 can implement image guidance, such as computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), or another suitable form of guidance or a combination thereof, to assist a clinician in positioning and manipulating the distal body portion 110A and the therapeutic element 112. For example, a fluoroscopy system (e.g., including a flat panel detector, x-ray, or c-arm) can be rotated to accurately visualize and identify a target treatment site. In other examples, prior to delivering the therapeutic element 112, the target treatment site can be determined using IVUS, OCT, and / or other suitable image mapping forms that can correlate the target treatment site to an identifiable anatomical structure (e.g., a spinal feature) and / or a radiopaque ruler (e.g., positioned beneath or on the patient). Additionally, in some examples, an image guidance component (e.g., IVUS, OCT) can be integrated with the catheter system 108 (e.g., catheter body 110) and / or run in parallel with the catheter system 108 to provide image guidance during positioning of the catheter system 108 (e.g., catheter body 110). The imaging device 164 can be configured to communicate with the control circuit 160, the catheter system 108, and / or other portions of the medical system 100 (e.g., via a communication link 165) to receive imaging data, provide image guidance, and / or control, assist, and / or direct other functions of the medical system 100.

[0066] 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 while 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 inflation and / or deflation of the balloon 114, allow pressurization of a therapeutic agent, allow transmission and / or control of energy delivered to the therapeutic element 112, and / or enable other functions of the medical system 100 that can help deliver therapy (e.g., neuromodulation) to the patient 106. 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 be flexed and / or bent en route to substantially position the therapeutic element 112 at a target location within a patient's blood vessel. Thus, despite the fact that the catheter system 108 is not substantially flexible, the catheter system 108 can be substantially flexible. Figure 1 108 is shown as being substantially linear, but the catheter system 108 (or a portion thereof) can be configured to present a linear, curved and / or curvilinear shape. Correspondingly, the longitudinal axis L defined by the catheter system 108 (and / or a portion thereof) can be linear, curved and / or curvilinear.

[0067] Figure 2 Schematically illustrated is a portion of a medical system 100 (e.g., distal body portion 110A, balloon 114, therapeutic element 112, and injection element 113) within a blood vessel 102 defined by a blood vessel wall 104 of a patient 106. A catheter system 108 is configured to enable inflation of balloon 114 (e.g., via inflation fluid flow path 120) when distal body portion 110A is positioned within blood vessel 102 to move catheter system 108 from a delivery configuration ( Figure 1 ) to the expanded configuration. In an example, the catheter system 108 is configured to expand the balloon 114 so that the balloon 114 defines a dimension C2 (e.g., diameter) in the expanded configuration. The dimension C2 defined in the expanded configuration can be larger than that in the delivery configuration ( Figure 1 ) In an example, the balloon 114 is configured to define the dimension C1, the dimension C2, and / or another dimension (eg, a dimension substantially perpendicular to the longitudinal axis L) based on the inflation pressure PI of the fluid within the balloon interior volume 116.

[0068] The catheter system 108 can be configured to control the inflation pressure PI so that the dimension C2 can be adjusted to accommodate the size of the vessel 102. For example, the catheter system 108 can be configured to inflate the balloon 114 so that the balloon 114 (e.g., the balloon outer surface 154) substantially contacts the vessel wall 104. The balloon 114 can be configured to position the injection element 113 juxtaposed to, proximate to, and / or within the vessel wall 104 when the balloon 114 is inflated. 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 balloon 114 is inflated to contact the vessel wall 104.

[0069] The therapeutic element 112 (e.g., injection element 113) is configured to receive a therapeutic agent (e.g., via a therapeutic agent 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 is configured to pressurize the therapeutic agent (e.g., using a therapeutic agent delivery system 126 ( Figure 1 )) to allow the therapeutic element 112 to receive the therapeutic agent. The catheter system 108 is configured to substantially limit and / or prevent pressurization of the therapeutic agent (e.g., using the valve manifold 140 ( Figure 1 )). The catheter system 108 is configured to allow pressurization of the therapeutic agent (e.g., by a clinician) when the inflation pressure PI indicates that the balloon 114 may have been inflated and / or remain sufficiently inflated to position the therapeutic element 112 and / or injection element 113 against and / or in close proximity to the vessel wall 104. The therapeutic element 112 ( Figure 1 ) can deliver a therapeutic agent to tissue of the patient 106 to induce one or more desired effects (e.g., neuromodulatory effects) at a localized region of the vessel 102 and an area adjacent to the vessel 102. For example, when the vessel 102 defines a renal artery associated with the kidney 168, the therapeutic element 112 can induce one or more desired neuromodulatory effects to a portion of the renal plexus (RP) 170 located within or adjacent to the adventitia of the renal artery.

[0070] Figure 3 A portion of a medical system 100 is shown positioned within the vasculature of a patient 106 to place a therapeutic element 112 within a blood vessel 102 . Figure 3 The description is primarily with reference to the renal artery, however similar devices, systems, and techniques may be adapted to access other anatomical lumens or tissues within the patient 106 .

[0071] The catheter system 108 (e.g., catheter body 110) can provide access to the renal plexus (RP) through an intravascular path (P), such as a percutaneous access site in the femoral artery (shown), brachial artery, radial artery, or axillary artery to a target treatment site within the blood vessel 102. By manipulating the proximal body portion 110B from outside the intravascular path (P), a clinician can advance at least the distal body portion 110A through the sometimes tortuous intravascular path (P) and remotely manipulate the distal body portion 110A. In an example, the distal body portion 110A can be remotely manipulated by a clinician using a handle portion 166.

[0072] exist Figure 3 In the example shown in FIG. 1 , the balloon 114 is delivered intravascularly to the treatment site using a guidewire 172 in an OTW technique. The catheter system 108 (e.g., the catheter body 110) may define a channel for receiving the guidewire 172 to deliver the catheter body 110 (e.g., the distal body portion 110A) using an OTW or RX technique. At the treatment site, the guidewire 172 may be at least partially withdrawn or removed, and the balloon 114 may be moved from the delivery configuration ( Figure 1 ) expands to the expanded configuration ( Figure 2 ). The balloon 114 can generally position the therapeutic element 112 (e.g., the injection element 113) relative to the blood vessel 102 to deliver energy to the blood vessel 102 and / or other anatomical lumens or tissues in the patient 106. In other examples, the balloon 114 and / or the therapeutic element 112 can be positioned within a guide sheath (e.g., a guide sheath) with or without the use of the guide wire 172. Figure 3 In an example where the medical system 100 includes a guide sheath, when the balloon 114 and / or the therapeutic element 112 are at the target treatment site, the guide sheath can be at least partially withdrawn or retracted, and the balloon 114 can be converted to an expanded configuration. In yet other examples, the catheter body 110 itself can be maneuverable so that the balloon 114 and / or the therapeutic element 112 can be delivered to the treatment site without the aid of the guidewire 172 and / or the guide sheath.

[0073] Figure 4 is a schematic diagram of a medical system 100 having a catheter system 108 in a delivery configuration within a blood vessel 102, wherein the catheter system 108 defines a dimension C1. A valve manifold 140 (eg, a manifold body 141) defines an inlet flow path 142 and an outlet flow path 144. Figure 4 , the first valve 146 is in the first valve closed position, and the second valve 148 is in the second valve closed position.

[0074] Figure 5is a schematic diagram of a medical system 100 having a catheter system 108 in an expanded configuration within a blood vessel 102, wherein a balloon 114 is inflated such that the catheter system 108 defines a dimension C2 that is greater than dimension C1. Figure 5 , the first valve 146 is in a first valve open position (eg, due to the inflation pressure PI within the balloon interior volume 116), and the second valve 148 is in a second valve closed position. Figure 6 is a schematic diagram of a medical system 100 having a catheter system 108 in an expanded configuration within a blood vessel 102. Figure 6 , the first valve 146 is in a first valve open position and the second valve 148 is in a second valve open position (eg, due to, for example, a clinician repositioning the second valve 148 using the actuator 152).

[0075] In the example, Figure 5 and Figure 6 , the catheter system 108 is configured to contact the vessel wall 104 with the balloon 114 in the expanded configuration. Dimension C1 and / or dimension C2 can be a cross-sectional dimension of the catheter system 108 (e.g., balloon 114), the cross section being taken perpendicular to the longitudinal axis L of the catheter body 110. In an example, dimension C1 and dimension C2 define displacement in a direction substantially perpendicular to the longitudinal axis L. In an example, the longitudinal axis L extends through the catheter system 108 and through the distal end 174 of the catheter body 110 ("body distal end 174"). The longitudinal axis L can extend through at least some portion of the distal body portion 110A and / or the proximal body portion 110B.

[0076] Dimension C1 and / or dimension C2 may define any suitable displacement. In addition, catheter system 108 may be configured such that dimension C1 and / or dimension C2 may define any one displacement within a range of possible displacements. For example, catheter system 108 may be configured such that balloon 114 and / or catheter body 110 define a minimum cross-sectional dimension (e.g., minimum diameter) and a maximum cross-sectional dimension (e.g., maximum diameter) depending on, for example, the inflation pressure PI within interior volume 116. Thus, although for clarity in FIG. Figure 4 , Figure 5 and Figure 6 1 and 2 as corresponding to only one displacement value, but the catheter system 108 is configured such that dimensions C1 and C2 can define any displacement greater than or equal to the minimum cross-sectional dimension and less than or equal to the maximum cross-sectional dimension.

[0077] The catheter system 108 is configured to generate an inflation pressure PI within the balloon interior volume 116 using an inflation fluid provided to the balloon interior volume 116 via an inflation fluid flow path 120. The interior volume 116 may be at least partially defined by a balloon interior surface 156. In an example, the inflation fluid flow path 120 is an inflation cavity defined by the catheter body 110 (e.g., the distal body portion 110A and / or the proximal body portion 110B). The balloon 114 is configured to expand radially outward in a direction away from the longitudinal axis L of the catheter body 110 when the inflation pressure PI is sufficient to cause expansion. The balloon 114 (e.g., the balloon body 158) may be configured to elastically expand based on the inflation pressure PI within the interior volume 116, such that an increase in the inflation pressure PI causes the balloon 114 to increase its cross-sectional diameter (e.g., from size C1 to size C2) and a decrease in the inflation pressure PI causes the balloon 114 to decrease its cross-sectional size (e.g., from size C2 to size C1). Thus, the medical system 100 is configured such that the catheter system 108 may define a first dimension (e.g., dimension C1) when the catheter system 108 is guided (e.g., by a clinician) to and / or from a target site within the blood vessel 102, and define a second dimension (e.g., dimension C2) that is larger than the first dimension to help maintain the therapeutic element 112 in juxtaposition with the blood vessel wall 104, to approximately center the catheter within the blood vessel 102, and / or to otherwise provide assistance.

[0078] The catheter system 108 is configured to deliver the therapeutic agent to a target treatment site, such as a target treatment site on or near the vessel wall 104 (e.g., within or adjacent to the adventitia) via the injection element 113. The catheter system 108 can be configured to deliver the therapeutic agent from a therapeutic agent container 130 (e.g., a therapeutic agent reservoir 132) to the injection element 113 using a therapeutic agent flow path 128. In an example, at least a portion of the therapeutic agent flow path 128 is defined by a lumen defined by the catheter body 110. The therapeutic agent container 130 can include a pressurizing element 134 (e.g., a piston) configured to facilitate pressurization of the therapeutic agent. In an example, the catheter system 108 is configured to translate the pressurizing element 134 (e.g., within the therapeutic agent reservoir 132) to pressurize the therapeutic agent within the therapeutic agent reservoir 132. The catheter system 108 is configured such that pressurization of the therapeutic agent within the therapeutic agent reservoir 132 drives the therapeutic agent element from the therapeutic agent reservoir 132 to the injection element 113 via the therapeutic agent flow path 128 , thereby causing the therapeutic element to be discharged from the injection element 113 .

[0079] The catheter system 108 is configured to pressurize the therapeutic element using a pressurized fluid for delivery to the injection element 113. In an example, the pressurized fluid is held in a pressurized fluid reservoir 138 of a pressurized fluid container 136, which may be, for example, a metal and / or polymer tank. The catheter system 108 may be configured to pressurize the therapeutic agent within the therapeutic agent reservoir 132 when the pressurized fluid contacts and exerts pressure on a pressurizing element 134. The pressurizing element 134 may be, for example, a piston, a diaphragm, a bellows, or another component configured to pressurize the therapeutic agent within the therapeutic agent reservoir 132 when the pressurized fluid exerts pressure on the pressurizing element 134. In an example, the pressurizing element 134 is a piston that is configured to translate to pressurize the therapeutic agent within the therapeutic agent reservoir 132 when the pressurized fluid contacts and exerts pressure on the piston.

[0080] The conduit system 108 is configured to deliver the pressurized fluid to the pressurizing element 134 using a valve manifold 140. In an example, the valve manifold 140 is fluidly connected in series with the pressurizing element 134 so that the pressurized fluid flows through a flow path defined by the valve manifold 140 in order to reach the pressurizing element 134. The valve manifold 140 is configured to define a flow path through which the pressurized fluid (e.g., from the pressurized fluid reservoir 138) can flow when the first valve 146 is in a first valve open position and the second valve 148 is in a second valve open position. The valve manifold 140 is configured to substantially block the flow path (e.g., fluidly isolate the pressurizing element 134 and the pressurized fluid reservoir 138) when the first valve 146 is in a first valve closed position and / or the second valve 148 is in a second valve closed position.

[0081] For example, the manifold 140 (e.g., the manifold body 141) defines an inlet flow path 142 and an outlet flow path 144. The manifold 140 is configured to fluidly couple the inlet flow path 142 and the outlet flow path 144 (e.g., using a first valve 146 and a second valve 148) such that when the manifold 140 delivers the pressurized fluid to the pressurizing element 134, the pressurized fluid flows through the inlet flow path 142 and the outlet flow path 144. The first valve 146 is configured to be in a first valve closed position when the first valve 146 is in a first valve closed position (e.g., as shown in FIG. 1 ). Figure 4 ) fluidly isolates the inlet flow path 142 and the outlet flow path 144. Similarly, the second valve 148 is configured to be closed when the second valve 148 is in the second valve closed position (e.g., Figure 4) fluidly isolates the inlet flow path 142 and the outlet flow path 144. Thus, the valve manifold 140 is configured to fluidly couple the inlet flow path 142 and the outlet flow path 144 when the first valve 146 is in the first valve open position and the second valve 148 is in the second valve open position. The valve manifold 140 is configured to fluidly isolate the inlet flow path 142 and the outlet flow path 144 when the first valve 146 is in the first valve closed position (regardless of the position of the second valve 148) or the second valve 148 is in the second valve closed position (regardless of the position of the first valve 146).

[0082] In an example, the first valve 146 includes a valve body 176 ("first valve body 176") defining a flow path 182 ("first valve flow path 182"). The first valve 146 can be configured to be closed when the first valve 146 is in a first valve closed position (e.g., Figure 4 ) fluidly isolates the inlet flow path 142 and the first valve flow path 182. The first valve 146 can be configured to fluidly isolate the inlet flow path 142 and the first valve flow path 182 when the first valve 146 is in the first valve open position (e.g., Figure 5 and Figure 6 142 and the first valve flow path 182 are fluidly coupled. In an example, the first valve body 176 defines a valve inlet 178 ("first valve inlet 178") and a valve outlet 180 ("first valve outlet 180"). The first valve body 176 may define a first valve flow path 182 such that the first valve flow path 182 is configured to allow a fluid (e.g., a pressurized fluid) to flow from the first valve inlet 178 to the first valve outlet 180. In an example, the first valve 146 fluidly isolates the first valve inlet 178 and the inlet flow path 142 (e.g., using the position of the manifold body 141) in a first valve closed position (e.g., when the first valve 146 fluidly isolates the inlet flow path 142 and the first valve flow path 182). In an example, the first valve 146 fluidly couples the first valve inlet 178 and the inlet flow path 142 in a first valve open position (e.g., when the first valve 146 fluidly couples the inlet flow path 142 and the first valve flow path 182).

[0083] In an example, the second valve 148 includes a valve body 184 ("second valve body 184") defining a flow path 190 ("second valve flow path 190"). The second valve 148 can be configured to be closed when the second valve 148 is in the second valve closed position (e.g., Figure 4 and Figure 5 ) fluidly isolates the outlet flow path 144 and the second valve flow path 190. The second valve 148 can be configured to fluidly isolate the outlet flow path 144 and the second valve flow path 190 when the second valve 148 is in the second valve open position (e.g., Figure 6180 and the second valve body 184 are fluidly coupled to the outlet flow path 144 and the second valve flow path 190. In an example, the second valve body 184 defines a valve inlet 186 ("second valve inlet 186") and a valve outlet 188 ("second valve outlet 188"). The second valve body 184 can define a second valve flow path 190 such that the second valve flow path 190 is configured to allow a fluid (e.g., a pressurized fluid) to flow from the second valve inlet 186 to the second valve outlet 188. In an example, the second valve 148 fluidly isolates the second valve outlet 188 from the outlet flow path 144 (e.g., using the position of the manifold body 141) in a second valve closed position (e.g., when the second valve 148 fluidly isolates the second valve flow path 190 from the outlet flow path 144). In an example, the second valve 148 fluidly couples the second valve outlet 188 from the outlet flow path 144 in a second valve open position (e.g., when the second valve 148 fluidly couples the second valve flow path 190 from the outlet flow path 144).

[0084] The valve manifold 140 is configured to fluidly couple the inlet flow path 142 and the outlet flow path 144 to deliver the pressurized fluid to the pressurizing element 134 using the first valve flow path 182 and the second valve flow path 190. For example, the first valve 146 and the second valve 148 can be configured such that the first valve flow path 182 and the second valve flow path 190 are fluidly coupled when the first valve 146 is in the first valve open position and the second valve 148 is in the second valve open position (e.g., Figure 6 ). Thus, the valve manifold 140 is configured to fluidly couple the inlet flow path 142 and the outlet flow path 144 to deliver the pressurized fluid to the pressurizing element 134 when the first valve 146 is in the first valve open position and the second valve 148 is in the second valve open position.

[0085] In the example shown, the first valve 146 and the second valve 148 are further configured such that if the first valve 146 is in the first valve closed position or the second valve 148 is in the second valve closed position, the first valve flow path 182 and the second valve flow path 190 are fluidly isolated from each other. Thus, the valve manifold 140 is configured to fluidly isolate the inlet flow path 142 and the outlet flow path 144 to substantially prevent the pressurized fluid from being delivered to the pressurizing element 134 when the first valve 146 is in the first valve closed position (regardless of the position of the second valve 148) or the second valve 148 is in the second valve closed position (regardless of the position of the first valve 146).

[0086] The catheter system 108 is configured to control the position of the first valve 146 based on a control pressure, wherein the control pressure is indicative of (e.g., based on and / or proportional to) a pressure PI within the balloon interior volume 116. For example, the catheter system 108 may be configured to substantially maintain the first valve 146 in a first valve closed position (e.g., fluidly isolating the inlet flow path 142 and the first valve flow path 182) when the control pressure indicative of the pressure PI is below a threshold pressure. The catheter system 108 may be configured to position the first valve 146 in a first valve open position (e.g., fluidly coupling the inlet flow path 142 and the first valve flow path 182) when the control pressure indicative of the pressure PI is equal to or greater than a pressure threshold. The catheter system 108 may be configured such that a control pressure below the pressure threshold may indicate that the balloon 114 is not sufficiently inflated within the vessel 102 (e.g., the balloon 114 may not be sufficiently inflated to position the therapeutic element 112 against and / or proximate to the vessel wall 104). The catheter system 108 may be configured such that a control pressure equal to or greater than a pressure threshold may indicate that the balloon 114 may be sufficiently inflated within the vessel 102 (e.g., the balloon 114 may be inflated to position the therapeutic element 112 against and / or proximate to the vessel wall 104).

[0087] In an example, the valve manifold 140 defines a control fluid flow path 192 that is configured to receive and / or discharge a control fluid FC. The catheter system 108 can be configured such that the control fluid FC exhibits a control pressure that is indicative of the pressure PI. For example, the control fluid flow path 192 can be configured such that the control pressure of the control fluid FC indicates (e.g., is proportional to, equal to, or otherwise based on) the pressure within the inflation fluid flow path 120 and / or the balloon interior volume 116. In some examples, the control fluid control path 192 is fluidly coupled to the inflation fluid flow path 120 (e.g., via a flow path 193 defined by the catheter body 110) and / or the balloon interior volume 116 (e.g., via a flow path 194 defined by the catheter body 110). In some examples, control fluid FC and the inflation fluid within inflation fluid path 128 and / or balloon interior volume 116 are part of a continuous fluid (e.g., a continuous bulk of fluid and / or a fluid continuum) extending between control fluid flow path 192 and inflation fluid path 128 and / or balloon interior volume 116. Catheter system 108 can be configured such that inflation pressure PI and / or changes in inflation pressure PI are transmitted as fluid pressure by the continuous fluid to control fluid flow path 192 and / or pressure chamber 150.

[0088] The pressure chamber 150 is configured to cause the control fluid FC to position the first valve 146 based on the inflation pressure PI within the balloon interior volume 116. The pressure chamber 150 can be configured such that the control fluid FC applies the control pressure substantially against the first valve 146. For example, the pressure chamber 150 can be configured such that the control pressure of the control fluid FC acts to exert a force (e.g., an opening force) on the first valve 146 tending to position the first valve 146 in the first valve open position (e.g., tending to overcome the biasing force and move the first valve 146 from Figure 4 The first valve closed position moves to Figure 5 and Figure 6 146). Thus, the valve manifold 140 is configured such that the inflation pressure of the inflation fluid within the balloon interior volume 116 may act on the first valve 146 (e.g., via the control fluid FC within the pressure chamber 150) to cause the first valve 146 to transition from the first valve closed position to the first valve open position. In an example, the pressure chamber 150 and / or the first valve 146 are configured to fluidically isolate the control fluid CF and the inflation fluid within the valve manifold 140 when the control fluid FC applies the control pressure and / or a force caused by the control pressure against the first valve 146.

[0089] For example, the pressure chamber 150 may be a volume partially defined by a movable component configured to move relative to the valve body 141 when a control pressure of the controlled fluid CF acts. The movable component may be, for example, a portion of the first valve 146, a piston, a diaphragm, and / or another component configured to move relative to the valve body 141. The valve manifold 140 may be configured such that movement of the movable component causes the first valve 146 to transition from a first valve closed position to a first valve open position. In an example, movement of the movable component causes the first valve 146 to move relative to the valve body 141.

[0090] In an example, the valve manifold 140 includes a biasing element 198 configured to bias the first valve 146 in the first valve closed position. The biasing element 198 can be configured to apply a biasing force (e.g., a closing force) that is opposite to the force applied by the control fluid FC on the first valve 146. In an example, the biasing element 198 is configured to apply a biasing force in a direction substantially opposite to the force applied by the control fluid FC on the first valve 146. The valve manifold 140 can be configured such that when the control pressure of the control fluid FC in the pressure chamber 150 is insufficient to overcome the biasing force of the biasing element 198, the biasing element 198 keeps the first valve 146 in the first valve closed position (e.g., Figure 4 ). The valve manifold 140 may be configured such that when the control pressure of the control fluid FC in the pressure chamber 150 is sufficient to overcome the biasing force of the biasing element 198 (e.g., when the control pressure is greater than or equal to a pressure threshold), the first valve 146 transitions from the first valve open position to the first valve closed position (e.g., Figure 5 and Figure 6 ). For example, when the inflation pressure PI within the balloon interior volume 116 increases (e.g., when the balloon 114 is inflated from size C1 to size C2), the control pressure of the control fluid FC within the pressure chamber 150 may increase accordingly to overcome the biasing force of the biasing element 198, so that the first valve 146 is moved from the first valve closed position (e.g., as shown in FIG. Figure 4 ) to a first valve open position (e.g., as depicted in Figure 5 and Figure 6 ).

[0091] In addition, the valve manifold 140 can be configured such that when the first valve 146 is in the first valve open position and the control pressure of the control fluid FC in the pressure chamber 150 decreases (e.g., decreases below a pressure threshold), the biasing element 198 causes the first valve 146 to transition from the first valve open position to the first valve closed position. For example, when the inflation pressure PI in the balloon interior volume 116 decreases (e.g., when the balloon 114 contracts from size C2 to size C1), the control pressure of the control fluid FC in the pressure chamber 150 can decrease accordingly, so that the biasing force of the biasing element 198 overcomes the force applied by the control pressure, thereby causing the first valve 146 to transition from the first valve open position to the first valve closed position.

[0092] Thus, the valve manifold 140 is configured to position the first valve 146 based on the inflation pressure PI within the balloon interior volume 116. The valve manifold 140 can be configured such that when the inflation pressure PI causes the control pressure of the control fluid FC within the pressure chamber 150 to equal or exceed a pressure threshold, the valve manifold 140 fluidly couples the inlet flow path 142 and the first valve flow path 182. The valve manifold 140 can be configured such that when the inflation pressure PI causes the control pressure of the control fluid FC within the pressure chamber 150 to be below the pressure threshold, the valve manifold 140 fluidly isolates the inlet flow path 142 and the first valve flow path 182.

[0093] The biasing element 198 has any suitable structure configured to bias the first valve 146 to the first valve closed position. In an example, the biasing element 198 is a compressible element (e.g., a spring). In an example, the biasing element 198 is configured to exhibit an extended configuration (e.g., Figure 4 ) and compressed state (as shown in Figure 5 and Figure 6 ). The valve manifold 140 may be configured such that when the biasing element 198 is in the extended position, the first valve 146 is in the first valve closed position, and such that when the biasing element 198 is in the compressed position, the first valve 146 is in the first valve open position. In an example, the valve manifold 140 is configured such that the position of the biasing element 198 depends on the control pressure of the control fluid FC within the pressure chamber 150.

[0094] For example, the valve manifold 140 can be configured such that when the control pressure of the control fluid FC within the pressure chamber 150 is greater than or equal to a threshold pressure, the control pressure causes the biasing element 198 to establish a compressed position (e.g., such that the valve manifold 140 fluidly couples the inlet flow path 142 and the first valve flow path 182). The valve manifold 140 can be configured such that when the control pressure of the control fluid FC within the pressure chamber 150 is less than or equal to the threshold pressure, the control pressure causes the biasing element 198 to establish an extended position (e.g., such that the valve manifold 140 fluidly isolates the inlet flow path 142 and the first valve flow path 182). Thus, in some examples, the threshold pressure for transitioning the first valve 146 from the first valve closed position to the first valve open position can be based on the amount of force that needs to be applied by the control fluid FC (e.g., to transition the biasing element 198 from the extended position to the compressed position).

[0095] In an example, the biasing element 198 is a spring or other compressible element having a spring constant that indicates the force required to establish the compression state of the biasing element 198. Therefore, the pressure threshold of the control pressure that causes the first valve 146 to transition from the first valve closed position to the first valve open position may be based on (e.g., dependent on and / or proportional to) the spring constant of the biasing element 198. The biasing element 198 may include any device configured to exert a force on the first valve 146 that is opposite to the force exerted on the first valve 146 by the control pressure of the control fluid FC, such as a spring, an electromagnet, or another device. In some examples, the valve manifold 140 may be configured so that the force required to establish the compression state of the biasing element 198 can be changed by a clinician, for example, to change the pressure threshold that causes the first valve 146 to transition from the first valve closed position to the first valve open position. For example, the valve manifold 140 may be configured to adjust the position of the spring seat biasing element 198, to control the electric field of the electromagnet (e.g., using a circuit), or to change the pressure threshold in another way.

[0096] In some examples, the first valve 146 is a spool valve. The first valve body 176 may define a valve core (e.g., a substantially cylindrical valve core) configured to translate in a first direction D1 and / or a second direction D2 within a volume 196 (e.g., a valve core barrel) defined by the valve manifold 140 (e.g., the manifold body 141). The valve core may define a first valve flow path 182 between the first valve inlet 178 and the first valve outlet 180. In some of these examples, the valve manifold 140 is configured such that the pressure of the control fluid FC within the pressure chamber 150 applies a force that tends to translate the valve core in the first direction D1 (e.g., relative to the manifold body 141) to transition the first valve 146 from the first valve closed position to the first valve open position. The valve manifold 140 can be configured such that the biasing element 198 applies a biasing force that tends to cause the valve core to translate in the second direction D2 (e.g., relative to the manifold body 141) to transition the first valve 146 from the first valve open position to the first valve closed position. The first valve 146 can be any type of valve configured to be positioned in the first valve closed position and the first valve open position, including a ball valve, a gate valve, a poppet valve, and / or another type of valve.

[0097] In some examples, the valve manifold 140 and / or the first valve 146 include a resistance element 199 (e.g., an o-ring) configured to reduce the speed (e.g., relative to the speed of the manifold body 141) at which the first valve 146 transitions from the first valve closed position to the first valve open position. The resistance element 199 can be configured to frictionally engage a surface defined by the valve manifold 140 (e.g., the surface-bounded volume 196) and / or a surface defined by the first valve 146 when the first valve 146 transitions from the first valve closed position to the first valve open position. When the control pressure of the control fluid FC causes the first valve 146 to transition from the first valve closed position to the first valve open position, the frictional engagement of the resistance element 199 can reduce the speed at which the first valve 146 transitions. In an example, the resistance element 199 is configured to fluidly isolate the pressure chamber 150 from one or more other volumes (e.g., volume 196 and / or volume 202) defined by the valve manifold 140. For example, the resistance element 199 may be configured to limit and / or substantially prevent the control fluid FC from flowing from the pressure chamber 150 to other volumes defined by the valve manifold 140 .

[0098] The catheter system 108 is configured to control the position of the second valve 148 using an actuator 152. The actuator 152 is configured to transition the second valve 148 between a second valve closed position and a second valve open position. In an example, the actuator 152 is configured to transition the second valve 148 between the second valve closed position and the second valve open position based on physical manipulation of the actuator 152 (e.g., by a clinician). For example, the actuator 152 may include a mechanical element (e.g., a manual valve operator), a button or switch, and / or another component configured to be physically manipulated to transition the second valve 148 between the second valve closed position and the second valve open position.

[0099] The catheter system 108 is configured such that when the actuator 152 (eg, due to an action by a clinician) causes the second valve 148 to establish a second valve closed position (eg, as Figure 4 and Figure 5 140 ), the valve manifold 140 fluidly isolates the outlet flow path 144 and the second valve flow path 190. The catheter system 108 is configured such that when the second valve 148 is in the second valve closed position, regardless of the position of the first valve 146, the valve manifold 140 fluidly isolates the inlet flow path 142 and the outlet flow path 144. Thus, the catheter system 108 is configured to prevent pressurized fluid from flowing from the pressurized fluid reservoir 138 to the pressurizing element 134 when the second valve 148 is in the second valve closed position regardless of the position of the first valve 146. Preventing pressurized fluid from flowing to the pressurizing element 134 when the second valve 148 is in the second valve closed position allows the clinician to control the flow of pressurized fluid through the manifold 140 even when the inflation pressure PI of the balloon 114 has positioned the first valve 146 in the first valve open position.

[0100] The valve manifold 140 is further configured such that placing the second valve 148 in the second valve open position fluidly couples the inlet flow path 142 and the outlet flow path 144 only when the first valve 146 is in the first valve open position. For example, when the pressure PI in the balloon interior volume 116 is insufficient to position the first valve 146 in the first valve open position, the valve manifold 140 continues to fluidly isolate the inlet flow path 142 and the outlet flow path 144 even when the second valve 148 is placed in the second valve open position. Thus, the valve manifold 140 is configured such that fluidly coupling the inlet flow path 142 and the outlet flow path 144 to pressurize the therapeutic agent using the pressurizing element 134 substantially requires that the inflation pressure PI in the balloon interior volume 116 is sufficient to place the first valve 146 in the first valve open position, and that the clinician's action causes the actuator 152 to place the second valve 148 in the second valve open position. The valve manifold 140 is thus configured to coordinate the inflation pressure PI with the clinician's actions to, for example, help the clinician assess the position of the therapeutic element 113 relative to the vessel wall 104 prior to initiating pressurization of the therapeutic agent using the second valve 148. The redundancy provided by the valves 146, 148 can help reduce the likelihood of inadvertent delivery of the therapeutic agent to the patient's tissue.

[0101] The second valve 148 can be any type of valve configured to be positioned in a second valve closed position and a second valve open position, including a sliding valve, a gate valve, a poppet valve, a ball valve, and / or another type of valve. In an example, the second valve 148 is a linear motion valve configured to translate in a third direction D3 and / or a fourth direction D4 within a volume 202 defined by the valve manifold 140 (e.g., the manifold body 141). For example, the second valve 148 can be configured to translate in a third direction D3 when the second valve 148 transitions from the second valve closed position to the second valve open position, and / or configured to translate in a fourth direction D4 when the second valve 148 transitions from the second valve open position to the second valve closed position. In some examples, the second valve 148 is a rotary motion valve configured to rotate relative to the manifold body 141 within the volume 202. For example, the second valve 148 can be configured to rotate in a first rotational direction about an axis defined by the second valve body 184 when the second valve 148 transitions from the second valve closed position to the second valve open position. The second valve 148 can be configured to rotate in a second rotational direction (e.g., opposite the first rotational direction) about an axis defined by the second valve body 184 when the second valve 148 transitions from the second valve open position to the second valve closed position.

[0102] Although the first direction D1 and the second direction D2 ("directions D1, D2") are Figures 4 to 6, is shown as having a particular spatial and / or angular orientation relative to the third direction D3 and the fourth direction D4 ("directions D3, D4"), such as being substantially perpendicular, but this is not required. Directions D1, D2 and directions D3, D4 may have any spatial and / or angular relationship to each other. In addition, the second direction D2 may be a direction substantially opposite to the first direction D1, or may have another spatial and / or angular orientation relative to the first direction D1. The fourth direction D4 may be a direction substantially opposite to the third direction D3, or may have another spatial and / or angular orientation relative to the third direction D3. Any of the first direction D1, the second direction D2, the third direction D3, or the fourth direction D4 may have any spatial and / or angular orientation relative to any other direction in the direction D1, the second direction D2, the third direction D3, or the fourth direction D4.

[0103] The actuator 152 is configured to exert a force on the second valve 148 (e.g., the second valve body 184) to transition the second valve 148 from the second valve closed position to the second valve open position and / or from the second valve open position to the second valve closed position. In an example, the actuator 152 is mechanically coupled (e.g., attached) to the second valve 148 (e.g., the second valve body 184). The actuator 152 may be configured to transmit a linear force and / or a rotational force from the actuator 152 to the second valve body 184. For example, when a clinician exerts a linear force and / or a rotational force on the actuator 152, the actuator 152 may transmit at least a portion of the linear force and / or the rotational force to the second valve body 184 to transition the second valve 148 between the second valve closed position and the second valve open position.

[0104] In an example, the actuator 152 is configured to be positioned in the first position (eg, as shown) when the second valve 148 is in the second valve closed position. Figure 4 and Figure 5 ). The actuator 152 can be configured to be positioned in the second position (eg, as shown in FIG. 1 ) when the second valve 148 is in the second valve open position. Figure 6). The actuator 152 may be configured to transition from the first position to the second position (and vice versa) to transition the second valve 148 from the second valve closed position to the second valve open position (and vice versa). For example, when the clinician manipulates the actuator 152 to transition the actuator 152 from the first position to the second position (and vice versa), the actuator 152 may transition the second valve 148 from the second valve closed position to the second valve open position (and vice versa). Thus, the manifold 140 may be configured such that the clinician may leave and / or position the actuator 152 in the first position to prevent and / or limit fluid coupling of the inlet flow path 142 and the outlet flow path 144 (e.g., to prevent and / or limit pressurization of the therapeutic agent within the therapeutic agent reservoir 132). Manifold 140 can be configured such that when first valve 146 is in the first valve open position, the clinician can position and / or retain actuator 152 in a second position to allow fluid coupling of inlet flow path 142 and outlet flow path 144 (e.g., causing pressurization of therapeutic agent within therapeutic agent reservoir 132).

[0105] In an example, the conduit system 108 includes a switch 204 that is configured to control the position of the actuator 152. The conduit system 108 can be configured such that fluid coupling of the inlet flow path 142 and the outlet flow path 144 (e.g., when the first valve 146 is in the first valve open position) requires first positioning the switch 204 and then positioning the actuator 152. In an example, the switch 204 includes a locked position (e.g., such as Figure 4 and Figure 5 ) and firing position (e.g., as shown in Figure 6 ). The catheter system 108 may be configured such that movement of the switch 204 from the locked position to the fired position (e.g., caused by a clinician) must precede movement of the actuator 152 from the first position to the second position (e.g., caused by a clinician). Thus, the catheter system 108 may be configured to prevent fluid coupling of the inlet flow path 142 and the outlet flow path 144 (e.g., to prevent and / or limit pressurization of the therapeutic agent within the therapeutic agent reservoir 132) until the switch 204 is moved from the locked position (e.g., by a clinician) to the fired position.

[0106] In an example, the switch 204 is configured such that the locked position substantially prevents the actuator 152 from transitioning from a first position (which positions the second valve 148 in the second valve closed position) to a second position (which positions the second valve 148 in the second valve open position). For example, the switch 204 may be configured to limit and / or prevent movement of the actuator 152 from transitioning from the first position to the second position. In an example, in the locked position, the switch 204 is configured to exert a mechanical force on the actuator 152 to limit and / or prevent movement of the actuator 152 from transitioning from the first position to the second position. The mechanical force may be a reaction force caused by a force exerted on the actuator 152, which causes the actuator 152 to exert a force on the switch 204. Thus, in the locked position, the switch 204 may substantially prevent fluid coupling of the inlet flow path 142 and the outlet flow path 144. The switch 204 can be configured such that the firing position allows (e.g., when positioned by a clinician) the actuator 152 to transition from a first position to a second position such that the actuator 152 can cause (e.g., when the first valve 146 is in the first valve open position) fluid coupling of the inlet flow path 142 and the outlet flow path 144 (e.g., causing pressurization of the therapeutic agent within the therapeutic agent reservoir 132).

[0107] In an example, the catheter system 108 includes a positioning element 206, which is configured to bias the switch 204 in a locked position. The positioning element 206 can be a compressible element, such as a spring or other compressible element. In an example, the positioning element 206 is configured to apply a position biasing force to the switch 204 in a direction that tends to position the switch 204 in the locked position. The switch 204 can be configured so that the reverse force (e.g., applied by a clinician) that overcomes the position biasing force on the switch 204 can cause the switch 204 to be converted from the locked position to the firing position. The positioning element 206 can be configured to maintain the switch 204 substantially in the locked position when there is no reverse force on the switch 204. In an example, the positioning element 206 is mechanically coupled to the switch 204 (e.g., at the first end of the positioning element 206). The positioning element 206 can be mechanically coupled to the structure 208 (e.g., at the second end of the positioning element 206). In an example, the structure 208 is configured to remain stationary relative to the manifold body 141 during movement of the first valve 146 , the second valve 148 , the actuator 152 , the switch 204 , and / or the positioning element 206 .

[0108] In some examples, the pressurized fluid container 136 includes a sealing member 210 that is configured to fluidically isolate the pressurized fluid reservoir 138 and the inlet flow path 142. The sealing member 210 (e.g., when intact) can be configured to substantially prevent the pressurized fluid from flowing from the pressurized fluid reservoir 138 to the inlet flow path 142. In an example, the catheter system 108 includes an actuation member 212 that is configured to pierce and / or otherwise act on the sealing member 210 so that the pressurized fluid reservoir 138 is fluidly coupled to the inlet flow path 142. The actuation member 212 can be configured such that movement of the actuation member 212 (e.g., by a clinician) causes the actuation member 212 to pierce and / or otherwise act on the sealing member 210 to fluidly couple the pressurized fluid reservoir 138 and the inlet flow path 142. For example, the actuation member 212 may be configured to move from a first actuation member position (e.g., relative to the sealing member 210 and / or the pressurized fluid container 136) to a second actuation member position to pierce and / or otherwise act on the sealing member 210.

[0109] In an example, the actuating member 212 includes a piercing nozzle configured to pierce and / or otherwise act on the sealing member 210. In some examples, the pressurized fluid container 136 is configured to maintain a pressure greater than 500 psi (3447 kPA) in the pressurized fluid reservoir 138, such as a pressurized fluid (e.g., CO2) having a pressure of about 700 psi (4826 kPa) to about 900 psi (6205 kPa). The conduit system 108 may include one or more pressure regulators configured to reduce and / or adjust the pressure of the pressurized fluid. For example, the conduit system 108 may include one or more pressure regulators configured to reduce and / or adjust the pressure of the pressurized fluid when the pressurized fluid flows from the pressurized fluid reservoir 138 to the valve manifold 140.

[0110] Figure 7A perspective view of a portion of an exemplary catheter system 108 is shown, including a handle portion 166 and a catheter body 110. The handle portion 166 may include a handle housing 214 that substantially surrounds and / or mechanically supports portions of the catheter system 108, such as the valve manifold 140, the pressurizing element 134, the pressurized fluid container 136, the actuator 152, the switch 204, the actuation member 212, and / or other portions of the catheter system 108. In other examples, the pressurized fluid container 136 is configured to be mechanically attached to the handle 166, for example, to extend away from the handle 166. In an example, the catheter system 108 includes a lock 216 (e.g., a lever lock) that is configured to substantially prevent movement of the actuation member 212 to prevent the actuation member 212 from piercing and / or otherwise acting on the sealing member 210 when the lock 216 is in a first lock position. In an example, the lock 216 is configured to limit and / or prevent movement of the actuation member 212 from a first actuation member position to a second actuation member position. The lock 216 may be configured to allow the actuating member 212 to pierce and / or otherwise act on the sealing member 210 when the lock 216 is in the second lock position. The lock 216 may be configured so that the clinician can move the lock 216 from the first lock position to the second lock position (and vice versa). In an example, when in the first lock position, the lock 216 is configured to apply a force (e.g., a mechanical force) on the actuating member 212 to limit and / or prevent movement of the actuating member 212 (e.g., from the first actuating member position to the second actuating member position).

[0111] Figure 8 A perspective cross-sectional view of an exemplary valve manifold 140 is shown, wherein the cross section is taken along cutting plane C. Figure 8 , portions of the manifold body 141 are shown as transparent for clarity. The valve manifold 140 includes a biasing element 198 that biases the first valve 146 in a first valve closed position such that the first valve outlet 180 is fluidly isolated from the second valve inlet 186. The valve manifold 140 is configured to receive a pressurized fluid via an inlet flow path 142.

[0112] The valve manifold 140 is configured to receive a control fluid FC (e.g., a portion of the inflation fluid) in the pressure chamber 150. The control pressure of the control fluid FC (e.g., caused by the inflation pressure PI within the balloon interior volume 116) can overcome the biasing force of the biasing element 198 and cause the first valve 146 to translate in the first direction D1, such that the first valve 146 transitions from a first valve closed position to a first valve open position. The first valve 146 can be fluidly coupled (e.g., via a first valve inlet 178) to the inlet flow path 142 and the first valve outlet 180 in the first valve open position. In an example, when the first valve 146 is in the first valve open position, the first valve inlet 178 is fluidly coupled to the second valve inlet 186, such that pressurized fluid can flow from the inlet flow path 142 to the second valve inlet 186.

[0113] The actuator 152 is configured to transition the second valve 148 from the second valve closed position to the second valve open position. When the second valve 148 is in the second valve closed position, the second valve 148 fluidly isolates the second valve inlet 186 and the outlet flow path 144 ( Figure 1 and Figures 4 to 6 When the actuator 152 positions the second valve 148 in the second valve open position (e.g., due to manipulation of the actuator 152 by a clinician), the second valve 148 fluidly couples the second valve inlet 186 and the outlet flow path 144 so that pressurized fluid can flow from the inlet flow path 142 of the manifold 140 to the outlet flow path. The manifold 140 can direct the flow of pressurized fluid to the pressurizing element 134 to pressurize the therapeutic agent within the therapeutic agent reservoir 132 ( Figure 1 and Figures 4 to 6 ).

[0114] Fig. 9 A flow chart of an exemplary technique for pressurizing the interior volume of a balloon is shown. Although reference is primarily made to system 100 and its components ( Figures 1 to 8 ) describes the technique, but in other examples the technique may be used with other systems.

[0115] The technique includes pressurizing a balloon interior volume 116 of a balloon 114 with an inflation fluid (902). The inflation fluid may establish an internal pressure PI in the balloon interior volume 116. In an example, the internal pressure PI causes a control pressure in a control fluid FC. In an example, the control fluid FC is a portion of the inflation fluid. The control pressure may be based on (e.g., dependent on and / or proportional to) the internal pressure PI.

[0116] The control pressure of the control fluid FC may cause the control fluid to exert a force on the first valve 146 of the valve manifold 140. In an example, the control pressure exerts a force on the first valve 146 in the pressure chamber 150 defined by the valve manifold 140. The control pressure may cause the first valve 146 to move from a first valve closed position to a first valve open position. The first valve 146 may include a first valve inlet 178 that is fluidly coupled to an inlet flow path 142 of the valve manifold 140 when the first valve 146 is in the first valve open position. In an example, the biasing element 198 exerts a biasing force on the first valve 146 that tends to position the first valve 146 in the first valve closed position. When the control pressure of the control fluid FC causes the first valve 146 to move from the first valve closed position to the first valve open position, the control pressure may substantially overcome the biasing force.

[0117] The technology includes fluidly coupling the inlet flow path 142 of the valve manifold to the outlet flow path 144 (904) by positioning the second valve 148 using the actuator 152. In an example, the clinician positions the actuator 152 to position the second valve 148 to the second valve open position. In an example, the actuator 152 is positioned from a first position to a second position to transition the second valve 148 from the second valve closed position to the second valve open position. In an example, the switch 204 is moved (e.g., by the clinician) from a locked position to a fired position to allow the actuator 152 to transition from the first position to the second position. The second valve 148 can fluidly couple the inlet flow path 142 and the outlet flow path 144 using the second valve flow path 190. The second valve flow path 190 can fluidly couple a second valve inlet 186 defined by the second valve body 184 and a second valve outlet 188 defined by the second valve body 184.

[0118] In an example, the pressurized fluid causes the pressurizing element 134 to pressurize the therapeutic agent held in the therapeutic agent reservoir 132 defined by the therapeutic agent container 130. When the pressurizing element 134 pressurizes the therapeutic agent, the therapeutic agent may be discharged to the injection element 113 of the therapeutic element 112. In an example, when the inflation fluid establishes the internal pressure PI in the balloon interior volume 116, the balloon 114 positions the injection element 113 and / or the therapeutic element 112 in contact with and / or in proximity to the vessel wall 104 of the blood vessel 102 of the patient 106. In an example, when the balloon 114 positions the injection element 113 and / or the therapeutic element 112 in juxtaposition with, proximity to, and / or within the vessel wall 104, the balloon 114 mechanically supports the injection element 113 and / or the therapeutic element 112 using the balloon exterior surface 154 and / or the balloon body 158.

[0119] In an example, the valve manifold 140 receives pressurized fluid from a pressurized fluid container 136 that defines a pressurized fluid reservoir 138. A sealing member 210 can fluidly isolate the pressurized fluid reservoir 138 from an inlet flow path 142. An actuation member 212 can be moved (e.g., by a clinician) to pierce and / or otherwise act on the sealing member 210 such that the pressurized fluid reservoir 138 is fluidly coupled to the inlet flow path 142. In some examples, the system 100 uses one or more regulators to reduce and / or regulate the pressure of the pressurized fluid.

[0120] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

[0121] Embodiment 1. A medical system, the medical system comprising: a first valve, the first valve being biased to a first valve closed position; a valve manifold, the valve manifold defining an inlet flow path and an outlet flow path, the valve manifold defining a pressure chamber, the pressure chamber being configured to induce pressure of a fluid in the pressure chamber to move the first valve from the first valve closed position to a first valve open position; a second valve; and an actuator, the actuator being configured to position the second valve in one of a second valve open position or a second valve closed position, wherein the first valve and the second valve are configured to fluidically couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and wherein the first valve and the second valve are configured to fluidically isolate the inlet flow path and the outlet flow path when the first valve is in the first valve closed position or the second valve is in the second valve closed position.

[0122] Example 2. A medical system according to Example 1, wherein the first valve defines a first valve outlet that is fluidly coupled to a first valve inlet, wherein the second valve defines a second valve inlet that is fluidly coupled to a second valve outlet, and wherein the first valve and the second valve are configured to fluidly couple the first valve outlet and the second valve inlet when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path.

[0123] Example 3. A medical system according to Example 1 or Example 2, wherein the second valve defines a second valve outlet, the second valve outlet is configured to be fluidly coupled to the outlet flow path when the second valve is in the second valve open position, and wherein the first valve is configured to fluidly couple the inlet flow path and the second valve outlet when the first valve is in the first valve open position.

[0124] Embodiment 4. A medical system according to any one of Embodiments 1 to 3, wherein the fluid is a first fluid, and wherein: when the first valve and the second valve fluidically couple the inlet flow path and the outlet flow path, the first valve and the second valve define a flow path of a second fluid from the inlet flow path to the outlet flow path, and the pressure chamber is configured to fluidically isolate the first fluid and the second fluid.

[0125] Example 5. A medical system according to any one of Examples 1 to 4, wherein the medical system also includes a balloon configured to be positioned within a patient's body, and wherein the pressure chamber is configured such that the pressure of the fluid in the pressure chamber indicates the pressure in the internal volume defined by the balloon.

[0126] Example 6. The medical system of Example 5, wherein the pressure chamber is fluidly coupled to the interior volume defined by the balloon.

[0127] Example 7. A medical system according to Example 5 or Example 6, wherein the medical system also includes a catheter, the catheter defining an inflation chamber, the inflation chamber being configured to deliver an inflation fluid to the interior volume of the balloon to induce the pressure in the interior volume of the balloon.

[0128] Example 8. According to any one of Examples 1 to 7, the medical system further includes a biasing element, which is configured to bias the first valve to the first valve closed position, wherein the pressure chamber is configured to cause the pressure of the fluid in the pressure chamber to move the first valve from the first valve closed position to the first valve open position when the pressure of the fluid is greater than or equal to a pressure threshold.

[0129] Example 9. A medical system according to Example 8, wherein: the pressure chamber is configured so that the pressure of the fluid in the pressure chamber applies an opening force on the first valve to move the first valve from the first valve closed position to the first valve open position, the biasing element is configured to apply a closing force on the first valve to bias the first valve to the first valve closed position, and when the opening force overcomes the closing force, the opening force causes the first valve to assume an open position.

[0130] Example 10. A medical system according to any one of Examples 1 to 9, the medical system further comprising: a container containing a therapeutic agent; a pressurizing element connected to the container fluid, wherein the second valve is configured to fluidically couple the second valve outlet and the pressurizing element so that the pressurizing element pressurizes the therapeutic agent when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path; and a fluid delivery tube configured to deliver the therapeutic agent to a target site in the patient's body when the pressurizing element pressurizes the therapeutic agent.

[0131] Example 11. A medical system according to Example 10, wherein the second valve is configured to fluidly couple the second valve outlet and the pressurizing element when the second valve is positioned in the second valve open position, and wherein the second valve is configured to fluidly isolate the second valve outlet and the pressurizing element when the second valve is positioned in the second valve closed position.

[0132] Example 12. A medical system according to any one of Examples 1 to 11, wherein the actuator is configured to be positioned in a first position so that the second valve is positioned in the second valve closed position, and wherein the actuator is configured to be positioned in a second position so that the second valve is positioned in the second valve open position, and the medical system also includes a switch configured to establish a locking position and a firing position, wherein the switch is configured to: prevent the actuator from transitioning from the first position to the second position when the switch is in the locking position, and allow the actuator to transition from the first position to the second position when the switch is in the firing position.

[0133] Example 13. A medical system according to Example 12, wherein the medical system also includes a positioning element, which is configured to apply a first force on the switch, wherein the first force tends to cause the switch to establish the locked position, and wherein the switch is configured to establish the firing position when a second force on the switch overcomes the first force.

[0134] Example 14. A medical system according to any one of Examples 1 to 13, the medical system further comprising: a fluid container, the fluid container defining a reservoir, wherein the fluid container includes a sealing member, the sealing member is configured to isolate the reservoir from the first valve inlet fluid; and an actuating member, the actuating member is configured to be positioned to pierce the sealing member to fluidically couple the reservoir and the first valve inlet.

[0135] Example 15. A medical system according to any one of Examples 1 to 14, wherein the first valve includes a valve core, which is configured to translate in a first direction to cause the first valve to assume the first valve closed position, and is configured to translate in a second direction substantially opposite to the first direction to assume the first valve open position.

[0136] Example 16. According to the medical system of Example 15, the medical system also includes a biasing element, which is configured to bias the first valve to the first valve closed position, wherein the biasing element is configured to cause the valve core to translate in a second direction substantially opposite to the first direction.

[0137] Example 17. A medical system according to any one of Examples 1 to 16, wherein the medical system also includes a piston, wherein the pressure chamber is configured to cause the pressure of the fluid to translate the piston, and wherein the piston is configured to apply an opening force on the first valve when the piston translates to move the first valve from the first valve closed position to the first valve open position.

[0138] Embodiment 18. The medical system of Embodiment 17, further comprising a resistance element positioned on a periphery of the piston, wherein the resistance element is configured to reduce a speed of the translation of the piston.

[0139] Example 19. A medical system according to any one of Examples 1 to 18, wherein the medical system also includes a diaphragm, wherein the pressure chamber is configured to cause the pressure of the fluid to deflect the diaphragm, and wherein the diaphragm is configured to exert an opening force on the first valve when the diaphragm is deflected to move the first valve from the first valve closed position to the first valve open position.

[0140] Embodiment 20. A method, the method comprising: pressurizing an interior volume of a balloon using an inflation fluid using an inflation catheter, wherein the inflation fluid is configured to establish a pressure in a pressure chamber of a valve manifold, the pressure being sufficient to move a first valve from a first valve closed position to a first valve open position, the first valve being biased to the first valve closed position; and fluidly coupling an inlet flow path of the valve manifold to an outlet flow path of the valve manifold by transitioning at least a second valve from a second valve closed position to a second valve open position using an actuator, wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and wherein the first valve and the second valve are configured to fluidly isolate the inlet flow path and the outlet flow path when at least one of the first valve is in the first valve closed position or the second valve is in the second valve closed position.

[0141] Example 21. The method according to claim 20 further includes: transitioning the switch from a locked position to a firing position; and when the switch is transitioned to the firing position, positioning the actuator from a first position to a second position, wherein the actuator is configured to position the second valve in the second valve closed position in the first position, and is configured to position the second valve in the second valve open position in the second position, and wherein the switch is configured to prevent the actuator from transitioning from the first position to the second position when the switch is in the locked position, and is configured to allow the actuator to transition from the first position to the second position when the switch is in the firing position.

[0142] Embodiment 22. The method of embodiment 21, further comprising applying a first force on the switch using a positioning element, wherein the first force causes the switch to establish the locked position.

[0143] Embodiment 23. A method according to any one of Embodiments 20 to 22, wherein when the inlet flow path and the outlet flow path are fluidly coupled, a first flow path defined by a first valve body of the first valve and a second flow path defined by a second valve body of the second valve are fluidly coupled.

[0144] Embodiment 24. A method according to any one of Embodiments 20 to 23, wherein when the inlet flow path and the outlet flow path are fluidly coupled, the first valve and the second valve define a flow path for a second fluid; and wherein the fluid in the pressure chamber is fluidly isolated from the second fluid.

[0145] Embodiment 25. The method of any one of embodiments 20 to 24, further comprising applying a closing force on the first valve using a biasing element to bias the first valve in the first valve closed position.

[0146] Embodiment 26. A method according to any one of Embodiments 20 to 25, the method further comprising positioning the first valve in the first valve closed position using the bias of the first valve when the pressure of the fluid in the pressure chamber decreases below a pressure threshold.

[0147] Example 27. The method according to any one of claims 20 to 26, further comprising: pressurizing the therapeutic agent in the container using a pressurizing element connected to the container fluid when the first valve and the second valve fluid couple the inlet flow path and the outlet flow path; and delivering the pressurized therapeutic agent to a target site in the patient's body using a fluid delivery tube.

[0148] Embodiment 28. The method according to claim 27, wherein: when the valve actuator positions the second valve in the second valve open position, the second valve outlet of the second valve and the pressurizing element are fluidly coupled; or when the valve actuator positions the second valve in the second valve closed position, the second valve outlet and the pressurizing element are fluidly isolated.

[0149] Embodiment 29. The medical system of any one of Embodiments 20 to 28, further comprising piercing a sealing member of a fluid container defining a reservoir using an actuation member to fluidly couple the reservoir and the valve inlet.

[0150] Further disclosed herein are the subject of the following clauses:

[0151] 1. A medical system, comprising:

[0152] a first valve biased to a first valve closed position;

[0153] a valve manifold defining an inlet flow path and an outlet flow path, the valve manifold defining a pressure chamber configured to induce pressure of a fluid in the pressure chamber to move the first valve from the first valve closed position to a first valve open position;

[0154] a second valve; and

[0155] an actuator configured to position the second valve in one of a second valve open position or a second valve closed position,

[0156] wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and

[0157] The first valve and the second valve are configured to fluidly isolate the inlet flow path from the outlet flow path when the first valve is in the first valve closed position or the second valve is in the second valve closed position.

[0158] 2. A medical system according to clause 1,

[0159] wherein the first valve defines a first valve outlet fluidly coupled to a first valve inlet,

[0160] wherein the second valve defines a second valve inlet fluidly coupled to a second valve outlet, and

[0161] Wherein the first valve and the second valve are configured to fluidly couple the first valve outlet and the second valve inlet when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path.

[0162] 3. A medical system according to clause 1 or clause 2,

[0163] wherein the second valve defines a second valve outlet configured to be fluidly coupled to the outlet flow path when the second valve is in the second valve open position, and

[0164] Wherein the first valve is configured to fluidly couple the inlet flow path and the second valve outlet and the first valve is in the first valve open position.

[0165] 4. The medical system of any one of clauses 1 to 3, wherein the fluid is a first fluid, and wherein:

[0166] When the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path, the first valve and the second valve define a flow path of a second fluid from the inlet flow path to the outlet flow path, and

[0167] The pressure chamber is configured to fluidly isolate the first fluid from the second fluid.

[0168] 5. A medical system according to any one of clauses 1 to 4, further comprising a balloon configured to be positioned within a patient's body, and wherein the pressure chamber is configured such that the pressure of the fluid in the pressure chamber indicates the pressure in an internal volume defined by the balloon.

[0169] 6. A medical system according to claim 5, wherein the pressure chamber is fluidly coupled to the internal volume defined by the balloon.

[0170] 7. The medical system of clause 5 or clause 6, further comprising a catheter defining an inflation lumen configured to deliver an inflation fluid to the interior volume of the balloon to induce the pressure in the interior volume of the balloon.

[0171] 8. A medical system according to any one of clauses 1 to 7, wherein the medical system further comprises a biasing element configured to bias the first valve to the first valve closed position, wherein the pressure chamber is configured to cause the pressure of the fluid in the pressure chamber to cause the first valve to move from the first valve closed position to the first valve open position when the pressure of the fluid is greater than or equal to a pressure threshold.

[0172] 9. A medical system according to clause 8, wherein:

[0173] the pressure chamber being configured such that the pressure of the fluid in the pressure chamber exerts an opening force on the first valve to move the first valve from the first valve closed position to the first valve open position,

[0174] The biasing element is configured to exert a closing force on the first valve to bias the first valve to the first valve closed position, and

[0175] The opening force causes the first valve to assume an open position when the opening force overcomes the closing force.

[0176] 10. The medical system according to any one of clauses 1 to 9, further comprising:

[0177] a container containing a therapeutic agent;

[0178] a pressurizing element in fluid communication with the container, wherein the second valve is configured to fluidly couple the second valve outlet and the pressurizing element so that the pressurizing element pressurizes the therapeutic agent when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path; and

[0179] A fluid delivery tube is configured to deliver the therapeutic agent to a target site in a patient's body when the pressurizing element pressurizes the therapeutic agent.

[0180] 11. A medical system according to clause 10,

[0181] wherein the second valve is configured to fluidly couple the second valve outlet and the pressurizing element when the second valve is positioned in the second valve open position, and

[0182] Wherein the second valve is configured to fluidly isolate the second valve outlet from the pressurizing element when the second valve is positioned in the second valve closed position.

[0183] 12. A medical system according to any one of clauses 1 to 11, wherein the actuator is configured to be positioned in a first position to position the second valve in the second valve closed position, and wherein the actuator is configured to be positioned in a second position to position the second valve in the second valve open position, and the medical system further comprises a switch configured to establish a locked position and a fired position, wherein the switch is configured to:

[0184] preventing the actuator from transitioning from the first position to the second position when the switch is in the locked position, and

[0185] The actuator is permitted to transition from the first position to the second position when the switch is in the fired position.

[0186] 13. A medical system according to claim 12, wherein the medical system also includes a positioning element, which is configured to apply a first force on the switch, wherein the first force tends to cause the switch to establish the locked position, and wherein the switch is configured to establish the firing position when a second force on the switch overcomes the first force.

[0187] 14. The medical system according to any one of clauses 1 to 13, further comprising:

[0188] a fluid container defining a reservoir, wherein the fluid container includes a sealing member configured to fluidly isolate the reservoir from the first valve inlet; and

[0189] An actuation member is configured and positioned to pierce the sealing member to fluidly couple the reservoir and the first valve inlet.

[0190] 15. A medical system according to any one of clauses 1 to 14, wherein the first valve includes a valve core, which is configured to translate in a first direction to cause the first valve to assume the first valve closed position, and is configured to translate in a second direction substantially opposite to the first direction to assume the first valve open position.

[0191] 16. The medical system of clause 15, further comprising a biasing element configured to bias the first valve to the first valve closed position, wherein the biasing element is configured to translate the valve core in a second direction substantially opposite to the first direction.

[0192] 17. A medical system according to any one of clauses 1 to 16, wherein the medical system also includes a piston, wherein the pressure chamber is configured to cause the pressure of the fluid to translate the piston, and wherein the piston is configured to apply an opening force on the first valve when the piston translates to move the first valve from the first valve closed position to the first valve open position.

[0193] 18. The medical system of clause 17, further comprising a resistance element positioned on a periphery of the piston, wherein the resistance element is configured to reduce a speed of the translation of the piston.

[0194] 19. A medical system according to any one of clauses 1 to 18, further comprising a diaphragm, wherein the pressure chamber is configured to cause the pressure of the fluid to deflect the diaphragm, and wherein the diaphragm is configured to exert an opening force on the first valve when the diaphragm is deflected so as to move the first valve from the first valve closed position to the first valve open position.

[0195] 20. A method comprising:

[0196] using an inflation catheter to pressurize an interior volume of the balloon using an inflation fluid, wherein the inflation fluid is configured to establish a pressure in a pressure chamber of a valve manifold sufficient to move a first valve from a first valve closed position to a first valve open position, the first valve being biased to the first valve closed position; and

[0197] fluidly coupling an inlet flow path of the valve manifold to an outlet flow path of the valve manifold by transitioning at least the second valve from a second valve closed position to a second valve open position using an actuator,

[0198] wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and

[0199] Wherein the first valve and the second valve are configured to fluidly isolate the inlet flow path and the outlet flow path valve when at least one of the first valve is in the first valve closed position or the second valve is in the second valve closed position.

[0200] 21. The method according to clause 20, further comprising:

[0201] transitioning the switch from the locked position to the fired position; and

[0202] allowing the actuator to be positioned from a first position to a second position when the switch is transitioned to the firing position,

[0203] wherein the actuator is configured to position the second valve in the second valve closed position in the first position, and is configured to position the second valve in the second valve open position in the second position, and

[0204] The switch is configured to prevent the actuator from transitioning from the first position to the second position when the switch is in the locked position, and is configured to allow the actuator to transition from the first position to the second position when the switch is in the fired position.

[0205] 22. The method of clause 21, further comprising applying a first force on the switch using a positioning element, wherein the first force causes the switch to establish the locked position.

[0206] 23. The method of any one of clauses 20 to 22, wherein a first flow path defined by a first valve body of the first valve and a second flow path defined by a second valve body of the second valve are fluidly coupled when the inlet flow path and the outlet flow path are fluidly coupled.

[0207] 24. A method according to any one of clauses 20 to 23,

[0208] wherein the first valve and the second valve define a flow path for a second fluid when the inlet flow path and the outlet flow path are fluidly coupled; and

[0209] The fluid in the pressure chamber is fluidly isolated from the second fluid.

[0210] 25. The method of any of clauses 20 to 24, further comprising exerting a closing force on the first valve using a biasing element to bias the first valve in the first valve closed position.

[0211] 26. The method of any one of clauses 20 to 25, further comprising positioning the first valve in the first valve closed position using the bias of the first valve when the pressure of the fluid in the pressure chamber decreases below a pressure threshold.

[0212] 27. The method according to any one of clauses 20 to 26, further comprising:

[0213] pressurizing a therapeutic agent in the container using a pressurizing element in fluid communication with the container when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path; and

[0214] The pressurized therapeutic agent is delivered to a target site within the patient using a fluid delivery tube.

[0215] 28. A method according to clause 27, wherein:

[0216] When the valve actuator positions the second valve in the second valve open position, the second valve outlet of the second valve and the pressurizing element are fluidly coupled; or

[0217] When the valve actuator positions the second valve in the second valve closed position, the second valve outlet and the pressurizing element are fluidly isolated.

[0218] 29. The medical system of any of clauses 20 to 28, further comprising piercing a sealing member of a fluid container defining a reservoir using an actuation member to fluidly couple the reservoir and the valve inlet.

Claims

1. A medical system, comprising: a first valve biased to a first valve closed position; a valve manifold defining an inlet flow path and an outlet flow path, the valve manifold defining a pressure chamber configured to induce pressure of a fluid in the pressure chamber to move the first valve from the first valve closed position to a first valve open position; Second valve; and an actuator configured to position the second valve in one of a second valve open position or a second valve closed position, wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and The first valve and the second valve are configured to fluidly isolate the inlet flow path from the outlet flow path when the first valve is in the first valve closed position or the second valve is in the second valve closed position.

2. The medical system according to claim 1, wherein the first valve defines a first valve outlet fluidly coupled to a first valve inlet, wherein the second valve defines a second valve inlet fluidly coupled to a second valve outlet, and Wherein the first valve and the second valve are configured to fluidly couple the first valve outlet and the second valve inlet when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path.

3. The medical system according to claim 1 or claim 2, wherein the second valve defines a second valve outlet configured to be fluidly coupled to the outlet flow path when the second valve is in the second valve open position, and Wherein the first valve is configured to fluidly couple the inlet flow path and the second valve outlet and the first valve is in the first valve open position.

4. The medical system according to any one of claims 1 to 3, wherein the fluid is a first fluid, and wherein: When the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path, the first valve and the second valve define a flow path of a second fluid from the inlet flow path to the outlet flow path, and The pressure chamber is configured to fluidly isolate the first fluid from the second fluid.

5. A medical system according to any one of claims 1 to 4, further comprising a balloon configured to be positioned within a patient's body, and wherein the pressure chamber is configured such that the pressure of the fluid in the pressure chamber indicates the pressure in the internal volume defined by the balloon.

6. The medical system of claim 5, wherein the pressure chamber is fluidly coupled to the interior volume defined by the balloon.

7. The medical system of claim 5 or claim 6, further comprising a catheter defining an inflation lumen configured to deliver an inflation fluid to the interior volume of the balloon to induce the pressure in the interior volume of the balloon.

8. A medical system according to any one of claims 1 to 7, further comprising a biasing element configured to bias the first valve to the first valve closed position, wherein the pressure chamber is configured to cause the pressure of the fluid in the pressure chamber to cause the first valve to move from the first valve closed position to the first valve open position when the pressure of the fluid is greater than or equal to a pressure threshold.

9. The medical system of claim 8, wherein: the pressure chamber being configured such that the pressure of the fluid in the pressure chamber exerts an opening force on the first valve to move the first valve from the first valve closed position to the first valve open position, The biasing element is configured to exert a closing force on the first valve to bias the first valve to the first valve closed position, and The opening force causes the first valve to assume an open position when the opening force overcomes the closing force.

10. The medical system according to any one of claims 1 to 9, further comprising: a container containing a therapeutic agent; a pressurizing element in fluid communication with the container, wherein the second valve is configured to fluidly couple the second valve outlet and the pressurizing element to cause the pressurizing element to pressurize the therapeutic agent when the first valve and the second valve fluidly couple the inlet flow path and the outlet flow path; and A fluid delivery tube is configured to deliver the therapeutic agent to a target site in a patient's body when the pressurizing element pressurizes the therapeutic agent.

11. The medical system according to claim 10, wherein the second valve is configured to fluidly couple the second valve outlet and the pressurizing element when the second valve is positioned in the second valve open position, and Wherein the second valve is configured to fluidly isolate the second valve outlet from the pressurizing element when the second valve is positioned in the second valve closed position.

12. The medical system of any one of claims 1 to 11, wherein the actuator is configured to be positioned in a first position to position the second valve in the second valve closed position, and wherein the actuator is configured to be positioned in a second position to position the second valve in the second valve open position, and the medical system further comprises a switch configured to establish a locked position and a fired position, wherein the switch is configured to: preventing the actuator from transitioning from the first position to the second position when the switch is in the locked position, and The actuator is permitted to transition from the first position to the second position when the switch is in the fired position.

13. The medical system of claim 12, further comprising a positioning element configured to apply a first force on the switch, wherein the first force tends to cause the switch to establish the locked position, and wherein the switch is configured to establish the fired position when a second force on the switch overcomes the first force.

14. The medical system according to any one of claims 1 to 13, further comprising: a fluid container defining a reservoir, wherein the fluid container includes a sealing member configured to fluidly isolate the reservoir from the first valve inlet; and An actuation member is configured and positioned to pierce the sealing member to fluidly couple the reservoir and the first valve inlet.

15. A medical system according to any one of claims 1 to 14, wherein the first valve includes a valve core, which is configured to translate in a first direction to cause the first valve to assume the first valve closed position, and is configured to translate in a second direction substantially opposite to the first direction to assume the first valve open position.

16. The medical system of claim 15, further comprising a biasing element configured to bias the first valve to the first valve closed position, wherein the biasing element is configured to translate the valve core in a second direction substantially opposite to the first direction.

17. A medical system according to any one of claims 1 to 16, further comprising a piston, wherein the pressure chamber is configured to cause the pressure of the fluid to translate the piston, and wherein the piston is configured to apply an opening force on the first valve when the piston translates to move the first valve from the first valve closed position to the first valve open position.

18. The medical system of claim 17, further comprising a resistance element positioned on a periphery of the piston, wherein the resistance element is configured to reduce a speed of the translation of the piston.

19. A medical system according to any one of claims 1 to 18, further comprising a diaphragm, wherein the pressure chamber is configured to cause the pressure of the fluid to deflect the diaphragm, and wherein the diaphragm is configured to exert an opening force on the first valve when the diaphragm is deflected to move the first valve from the first valve closed position to a first valve open position.

20. A method comprising: pressurizing an interior volume of the balloon using an inflation fluid using an inflation catheter, wherein the inflation fluid is configured to establish a pressure in a pressure chamber of a valve manifold sufficient to move a first valve from a first valve closed position to a first valve open position, the first valve being biased to the first valve closed position; as well as fluidly coupling an inlet flow path of the valve manifold to an outlet flow path of the valve manifold by transitioning at least the second valve from a second valve closed position to a second valve open position using an actuator, wherein the first valve and the second valve are configured to fluidly couple the inlet flow path and the outlet flow path when the first valve is in the first valve open position and the second valve is in the second valve open position, and Wherein the first valve and the second valve are configured to fluidly isolate the inlet flow path and the outlet flow path valve when at least one of the first valve is in the first valve closed position or the second valve is in the second valve closed position.

Images