Multi-catheter system for treating heart failure

Abstract

The present disclosure provides a balloon catheter system for treating heart failure in a subject. The balloon catheter system of the present disclosure forms a low pressure region beneath the subclavian vein and above the renal vein, which promotes blood and lymphatic flow back to the heart. In addition, the balloon catheter system stimulates the vagus nerve, thereby reducing activation of the sympathetic nervous system and improving cardiac remodeling.

Description

[0001] Cross-reference

[0002] The subject matter of this patent application is related to the subject matter of U.S. Provisional Patent Application No. 63 / 349,975, filed on June 7, 2022, U.S. Provisional Patent Application No. 63 / 397,289, filed on August 11, 2022, and U.S. Provisional Patent Application No. 63 / 469,278, filed on May 26, 2023, the contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION

[0003] Heart failure is a prevalent disease that affects approximately 1% to 2% of the world's population. The causes and phenotypes of heart failure vary widely. After cardiac injury (e.g., myocardial infarction, increased preload or afterload), cellular, structural, and neurohumoral adaptations occur, affecting the phenotype presented. These processes affect cell function, including intracellular and intercellular behavior. Consequently, activation of the sympathetic adrenergic system and the renin-angiotensin-aldosterone system occurs, leading to adaptive mechanisms accompanied by volume overload, tachycardia, dyspnea, and further deterioration of cell function, which is known in the art as the vicious cycle of heart failure. There are currently no heart failure-specific clinical signs, and clinical symptoms manifest as acute or chronic progressive deterioration. As a measure of cell dysfunction, levels of neurohormones (e.g., norepinephrine) and natriuretic peptides (e.g., NT-pro BNP) are elevated. To diagnose heart failure, non-invasive (e.g., echocardiogram, NMR, NT-pro BNP) and invasive (e.g., cardiac catheterization, biopsy) diagnostic procedures are implemented. Adjusting the activated systems with beta-blockers, ACE inhibitors, and / or ARNIs can improve the prognosis and symptoms of heart failure patients with left ventricular dysfunction. Interventional and surgical treatment options are also available. However, there is still a need to improve systems, devices, and methods for treating heart failure. SUMMARY OF THE INVENTION

[0004] The present disclosure provides a balloon catheter system for treating heart failure, such as acute decompensated heart failure (ADHF) (i.e., rapid onset of fluid volume overload).

[0005] In one aspect, the present disclosure provides a catheter system for treating cardiovascular diseases. The catheter system may include a first catheter. The first catheter may include a first balloon. The first catheter may include a first lumen configured to inflate the first balloon. The first catheter may include a second lumen. The first catheter may include a third lumen.

[0006] The catheter system may include a second catheter. The second catheter may include a second balloon. The second catheter may include an inflation lumen configured to inflate the second balloon. The first catheter may be configured to receive the second catheter for advancement and retraction therethrough. A third lumen of the first catheter may be configured to receive a third catheter for advancement and retraction therethrough. The third catheter may include a third balloon. The third catheter may include an inflation lumen configured to inflate the third balloon.

[0007] In some embodiments, the first balloon is configured to be positioned and inflated at or near the renal vein of the subject. In some embodiments, the second balloon is configured to be positioned at or near the subclavian vein of the subject. In some embodiments, the third balloon is a floating balloon. In some embodiments, the third balloon is configured to be positioned and inflated at or near the pulmonary artery of the subject.

[0008] In some embodiments, when the second balloon is positioned and inflated in the left internal jugular vein and / or the thoracic duct, the second balloon creates a low pressure zone at or near the left internal jugular vein and / or the thoracic duct. In some embodiments, inflation of the second balloon stimulates the vagus nerve of the subject. In some embodiments, inflation of the first balloon creates a low pressure zone at or near the renal vein of the subject. In some embodiments, inflation of the first balloon stimulates the vagus nerve of the subject. In some embodiments, the third balloon monitors at least one hemodynamic parameter of the subject. In some embodiments, the at least one hemodynamic parameter is one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance.

[0009] In some embodiments, the first catheter has a distal port coupled to the second lumen, and the second catheter extends out of the first catheter through the distal port. In some embodiments, the first catheter has a side port near the distal end of the first catheter, and the third catheter extends out of the first catheter through the side port.

[0010] In some embodiments, the first balloon has a diameter of about 18 mm to about 25 mm when inflated. In some embodiments, the first balloon has a length of about 10 mm when inflated. In some embodiments, the first balloon is configured to be inflated to a pressure of about 1 atm to about 2 atm. In some embodiments, the pressure of the first balloon is proportional or related to the low pressure at the low pressure zone at or near the renal vein of the subject.

[0011] In some embodiments, the second balloon has a diameter of about 8 mm to about 10 mm when inflated. In some embodiments, the second balloon has a length of about 10 mm when inflated. In some embodiments, the second balloon is configured to be inflated to a pressure of about 1 atm to about 2 atm.

[0012] In some embodiments, the diameter of the first lumen is about 2 Fr. In some embodiments, the diameter of the second lumen is about 7 Fr. In some embodiments, the diameter of the third lumen is about 7 Fr.

[0013] In some embodiments, the outer diameter of the second catheter is about 6 Fr. In some embodiments, the length of the second catheter is about 80 cm.

[0014] In some embodiments, the second catheter is configured to be connected to a subclavian pressure line. In some embodiments, the subclavian pressure line is configured to measure the subclavian vein pressure of a subject. In some embodiments, the subclavian pressure is used to determine whether to inflate or deflate the second balloon.

[0015] In some embodiments, the second catheter further includes a pressure measurement lumen separated from the inflation lumen of the second balloon.

[0016] In some embodiments, the outer diameter of the third catheter is about 6 F.

[0017] In some embodiments, the third catheter is a pulmonary artery catheter. In some embodiments, the third catheter is configured to be connected to one or more of a femoral artery pressure line or a pulmonary artery pressure line. In some embodiments, the femoral artery pressure line is configured to measure the pressure at the femoral vein. In some embodiments, the pulmonary artery pressure line is configured to measure the pressure at the pulmonary artery. In some embodiments, one or more of the measured femoral vein pressure or the pressure at the pulmonary artery are used to determine whether to inflate or deflate the first balloon.

[0018] In some embodiments, the third catheter includes a balloon inflation lumen, a first pressure measurement lumen, and a second pressure measurement lumen. The first pressure measurement lumen can be in fluid communication with the distal port of the third catheter to facilitate pressure measurement at the pulmonary artery. The second pressure measurement lumen can be in fluid communication with the side port of the third catheter to facilitate pressure measurement at the right atrium.

[0019] In some embodiments, the system includes a third catheter.

[0020] In some embodiments, the catheter system can further include a detachable sheath. In some embodiments, the detachable sheath has a shaft length of about 35 cm. In some embodiments, the detachable sheath is configured to be inserted into the femoral vein of a subject. In some embodiments, the detachable sheath includes a tapered dilator. In some embodiments, the tapered dilator is configured to expand the puncture site.

[0021] In some embodiments, the catheter system may further include at least one pump configured to be coupled to one or more of the first catheter, the second catheter, or the third catheter to inflate and deflate one or more of the first balloon, the second balloon, or the third balloon.

[0022] In some embodiments, the second lumen of the first catheter has a circular or annular cross-section to receive the second catheter for advancement and retraction therethrough. In some embodiments, the third lumen of the first catheter has a circular or annular cross-section to receive the third catheter for advancement and retraction therethrough. In some embodiments, the first catheter further includes a fourth lumen for measuring pressure. The fourth lumen may be in fluid communication with a side port of the first catheter to facilitate pressure measurement at one or more of the inferior vena cava or the femoral vein.

[0023] In some embodiments, one or more of the first catheter, the second catheter, or the third catheter includes at least one radiopaque marker.

[0024] In some embodiments, one or more of the first catheter, the second catheter, or the third catheter is configured to be advanced through the vasculature of a subject along one or more guidewires. In some embodiments, the radiopaque marker may be used to guide one or more of the first catheter, the second catheter, or the third catheter through the vasculature of the subject to a target location. In some embodiments, the target location is one or more of the renal vein, the pulmonary artery, and / or the subclavian vein.

[0025] In some embodiments, the cardiovascular disease to be treated is heart failure or acute heart failure.

[0026] In another aspect, the present disclosure provides a method of treating a cardiovascular disease using the catheter system of the present disclosure.

[0027] The method may include the step of inserting the catheter system into the femoral vein of a subject. The method may include the step of positioning the tip of the first catheter of the catheter system at or near the renal vein of the subject. The method may include the step of positioning the second balloon of the second catheter of the multi-catheter system at or near the subclavian vein of the subject. The method may include the step of inflating the first balloon and the second balloon, wherein inflation of the second balloon creates a low-pressure zone at the left internal jugular vein and the thoracic duct of the subject, and wherein inflation of the first balloon creates a low-pressure zone at the renal vein of the subject.

[0028] In some embodiments, the method may further include the step of measuring the pressure at the subclavian vein of a subject using a catheter system. In some embodiments, the method may further include the step of adjusting the inflation of one or more of the first balloon or the second balloon in response to the measured subclavian vein pressure. In some embodiments, adjusting the inflation of the first balloon adjusts the pressure at the renal vein. In some embodiments, adjusting the inflation of the second balloon adjusts the pressure at the left internal jugular vein and the thoracic duct. In some embodiments, the inflation of the second balloon stimulates the vagus nerve of the subject. In some embodiments, the inflation of the first balloon stimulates the vagus nerve of the subject.

[0029] In some embodiments, inflating the first balloon includes maintaining the inflation of the first balloon for 20 - 40 seconds before deflating the first balloon. In some embodiments, inflating the second balloon includes maintaining the inflation of the second balloon for 10 - 30 seconds before deflating the second balloon.

[0030] In some embodiments, positioning the tip of the first catheter at or near the renal vein includes advancing the first catheter through the vasculature of the subject along a guide wire. In some embodiments, positioning the second balloon at or near the subclavian vein of the subject includes advancing the second catheter through the vasculature of the subject along a guide wire.

[0031] In some embodiments, the method may further include the step of inserting a third catheter including a third balloon into a third lumen of the catheter system. In some embodiments, the method may further include the step of positioning the third balloon of the third catheter at or near the pulmonary artery. In some embodiments, the method may further include the step of inflating the third balloon. In some embodiments, the method may further include the step of measuring the pulmonary artery pressure of the subject.

[0032] In some embodiments, positioning the third balloon of the third catheter at or near the pulmonary artery includes advancing the third catheter through the vasculature of the subject along a guide wire.

[0033] In some embodiments, the method further includes monitoring at least one hemodynamic parameter of the subject using the third catheter. The at least one hemodynamic parameter may be one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance.

[0034] In some embodiments, the method further includes monitoring the pressure at the right atrium of the subject using the catheter system. In some embodiments, the method further includes monitoring the pressure at one or more of the inferior vena cava or the femoral vein using the catheter system.

[0035] In some embodiments, the cardiovascular disease to be treated is heart failure or acute heart failure.

[0036] In another aspect, the present disclosure provides a method for treating a cardiovascular disease in a subject. The method can include the step of advancing a first catheter into the femoral vein of the subject. The method can include the step of positioning a first balloon of the first catheter at or near the renal vein of the subject at the inferior vena cava. The method can include the step of advancing a second catheter through the first catheter. The method can include the step of positioning a second balloon of the second catheter at the subclavian vein of the subject. The method can include the step of inflating the second balloon, thereby creating a low-pressure zone at one or more of the left internal jugular vein or the thoracic duct of the subject. One or more of the first catheter or the second catheter can be advanced through the vasculature of the subject along one or more guidewires.

[0037] In some embodiments, inflating the second balloon includes stimulating the vagus nerve of the subject or minimizing activation of the sympathetic nerves of the subject.

[0038] In some embodiments, the method can further include the step of inflating the first balloon at or near the renal vein of the subject. In some embodiments, inflating the first balloon creates a low-pressure zone at the renal vein. In some embodiments, inflating the first balloon includes stimulating the vagus nerve of the subject.

[0039] In some embodiments, inflating the first balloon includes maintaining the inflation of the first balloon for about 20 seconds to about 40 seconds before deflating the first balloon. In some embodiments, inflating the second balloon includes maintaining the inflation of the second balloon for about 10 seconds to about 30 seconds before deflating the second balloon.

[0040] In some embodiments, the method further includes advancing a third catheter including a third balloon at or near the pulmonary artery, inflating the third balloon, and monitoring the pulmonary artery pressure of the subject. In some embodiments, the method further includes monitoring at least one hemodynamic parameter of the subject with the third catheter. The at least one hemodynamic parameter can be one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance. In some embodiments, the method can further include measuring the pressure at the pulmonary artery or the right atrium. In some embodiments, the method further includes visualizing the third catheter by means of at least one radiopaque marker of the third catheter.

[0041] In some embodiments, the method further includes measuring the pressure at the subclavian vein of the subject and adjusting the inflation of one or more of the first balloon or the second balloon in response to the measured subclavian vein pressure. Adjusting the inflation of the first balloon can adjust the pressure at the renal vein. Adjusting the inflation of the second balloon can adjust the pressure at the left internal jugular vein and the thoracic duct.

[0042] In some embodiments, the method may further include measuring pressure at one or more locations in the inferior vena cava or femoral artery.

[0043] In some embodiments, the method further includes visualizing one or more of the first catheter or the second catheter by means of at least one radiopaque marker of the first catheter or the second catheter.

[0044] In some embodiments, the cardiovascular disease to be treated is heart failure or acute heart failure.

[0045] On the other hand, the present disclosure provides a method for treating a cardiovascular disease in a subject, the method may include creating a low-pressure region at the left internal jugular vein and / or the thoracic duct of the subject and creating a low-pressure region at the renal vein of the subject.

[0046] In some embodiments, creating a low-pressure region at the renal vein of the subject includes intermittently occluding the inferior vena cava of the subject at or near the renal vein. Intermittently occluding the inferior vena cava of the subject at or near the renal vein may include advancing a first catheter from the femoral vein of the subject to the location at or near the renal vein and inflating a balloon of the first catheter at the inferior vena cava. Inflating the balloon of the first catheter may include maintaining the inflation of the balloon for about 20 seconds to about 40 seconds before deflating the balloon.

[0047] In some embodiments, creating a low-pressure region at the left internal jugular vein and the thoracic duct includes intermittently occluding the subclavian vein of the subject. Intermittently occluding the subclavian vein may include advancing a second catheter from the femoral vein of the subject to the subclavian vein and inflating a balloon of the second catheter at the inferior vena cava. Inflating the balloon of the second catheter may include maintaining the inflation of the balloon for about 10 seconds to about 30 seconds before deflating the balloon.

[0048] In some embodiments, creating a low-pressure region at the left internal jugular vein and / or the thoracic duct increases the lymphatic return of the subject, reduces fluid retention in the subject, or both.

[0049] In some embodiments, creating a low-pressure region at the renal vein of the subject may promote renal circulation, accelerate urination of the subject, or reduce one or more of fluid retention in the subject.

[0050] In some embodiments, creating a low-pressure region at the left internal jugular vein and / or the thoracic duct, creating a low-pressure region at the renal vein catheter, or both stimulate the vagus nerve of the subject. Stimulating the vagus nerve of the subject may cause dilation of one or more of the subclavian vein, the left internal jugular vein and / or the thoracic duct, the inferior vena cava, or the renal vein. Stimulating the vagus nerve of the subject may reduce the return of venous blood to the heart of the subject, reduce the pumping burden of the heart of the subject, or both.

[0051] In some embodiments, the cardiovascular disease to be treated is heart failure or acute heart failure.

[0052] In another aspect, the present disclosure provides a method for treating a cardiovascular disease in a subject. The method may include intermittently occluding one or more veins to reduce the venous blood return to the subject's heart and relieve the heart pumping burden. Intermittently occluding one or more veins may include one or more of the following: intermittently occluding the subclavian vein of the subject, thereby creating a low-pressure area at the left internal jugular vein and / or thoracic duct of the subject; or intermittently occluding the inferior vena cava of the subject, thereby creating a low-pressure area at the renal vein of the subject. The subclavian vein may be occluded for 10 to 30 seconds. The inferior vena cava may be occluded for 20 to 40 seconds.

[0053] One or more veins may be intermittently occluded by expanding one or more balloons of a catheter system at or near the one or more veins. Intermittently occluding one or more veins may stimulate the vagus nerve of the subject. Intermittently occluding one or more veins may increase the lymphatic return of the subject, reduce the fluid retention in the subject's body, promote renal circulation or accelerate the urination of the subject. In some embodiments, the cardiovascular disease to be treated is heart failure or acute heart failure.

[0054] Those skilled in the art will readily appreciate additional aspects and advantages of the present disclosure from the following detailed description, in which only illustrative embodiments of the present disclosure are shown and described. As will be recognized, the present disclosure is capable of other different embodiments, and several details thereof can be modified in various obvious aspects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative rather than restrictive.

[0055] Incorporated by reference

[0056] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference. If the cited publications, patents, or patent applications conflict with the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The novel features of the present disclosure are set forth in detail in the appended claims. The features and advantages of the present disclosure will be better understood by reference to the following detailed description, which sets forth illustrative embodiments that utilize the principles of the present disclosure, as well as the accompanying drawings (also referred to herein as "FIGURES" and "DRAWINGS"), where:

[0058] Figure 1Ais a perspective view depicting a balloon catheter system according to some embodiments.

[0059] Figure 1B depicts according to some embodiments Figure 1A The balloon catheter system in [reference] has a perspective view of the balloon in an inflated configuration.

[0060] Figure 1C is a side view depicting a balloon catheter system according to some embodiments.

[0061] Figures 2A to 2B is a schematic view of a cross-section of a first balloon catheter of a balloon catheter system according to some embodiments.

[0062] Figure 3A is a schematic side view of an elongate body of a first balloon catheter according to some embodiments, having an inlet for receiving a third catheter into a third lumen and an outlet allowing the third catheter to exit the third lumen, Figure 3B is a side view depicting a first balloon catheter according to some embodiments, Figure 3C is a perspective view depicting a balloon and a distal tip of a first balloon catheter according to some embodiments, and Figure 3D is a side view depicting a connector for a first balloon catheter according to some embodiments.

[0063] Figure 4A is a perspective view of a schematic view of a second balloon catheter of a balloon catheter system according to some embodiments, Figure 4B is a side view depicting a second balloon catheter according to some embodiments, Figure 4C is a perspective view depicting a balloon and a distal tip of a second balloon catheter according to some embodiments, Figure 4D is a cross-sectional view depicting a second balloon catheter according to some embodiments, and Figure 4E is a side view depicting a connector of a second balloon catheter according to some embodiments.

[0064] Figure 5 is a front view depicting a third balloon catheter of a balloon catheter system according to some embodiments.

[0065] Figure 6 is a front view depicting a detachable sheath for inserting a balloon catheter system according to some embodiments.

[0066] Figure 7 is a schematic view depicting a balloon catheter system for treating heart failure according to some embodiments.

[0067] Figures 8A to 8DA series of cross-sectional views depict a method of treating heart failure using the balloon catheter system described herein, according to some embodiments.

[0068] Figures 9A to 9D A series of cross-sectional views depict a method of advancing a pulmonary artery catheter to a third target location at the pulmonary artery. Detailed Description

[0069] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like symbols generally represent like components unless the context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used, and other changes may be made without departing from the scope of the subject matter presented herein. It is readily understood that aspects of the present disclosure, as generally described and illustrated herein, can be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are explicitly contemplated herein.

[0070] Although certain embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Accordingly, the scope of the appended claims is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be executed in any suitable order and are not necessarily limited to any particular disclosed order. The various operations may be described sequentially as a plurality of discrete operations, which may be helpful in understanding certain embodiments, however, the order of the description should not be construed as implying that these operations are order-dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or separate components.

[0071] For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, the various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages taught herein, without necessarily achieving other aspects or advantages taught or suggested herein.

[0072] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. As used herein, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. Any reference to "or" herein is intended to cover "and / or" unless otherwise indicated. It should be further understood that when the terms "comprises" and / or "comprising" are used in this specification, they specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0073] For ease of description, spatial relative terms such as "below", "beneath", "lower", "above", "upper", etc. may be used herein to describe the relationship of one element or feature to another element or feature, as shown in the figures. It should be understood that, in addition to the directions shown in the figures, spatial relative terms are also intended to encompass different directions of the device during use or operation. For example, if the device in the figures is inverted, an element described as "below" or "beneath" another element or feature will be positioned "above" the other element or feature. Thus, the exemplary term "below" can encompass both upward and downward directions. The device may be positioned otherwise (rotated 90 degrees or other orientations), and the spatial relative descriptors used herein can be interpreted accordingly. Similarly, unless otherwise clearly stated, the terms "upward", "downward", "vertical", "horizontal", etc. used herein are for explanatory purposes only.

[0074] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise dictates. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element without departing from the teachings of this disclosure.

[0075] In this specification and the claims that follow, unless the context requires otherwise, the word "comprises" and its variants, such as "comprises" and "comprising", mean that various components may be used together in a method and an article (such as a composition and an apparatus that includes devices and methods). For example, the term "comprises" should be understood to imply the inclusion of any stated element or step, but not the exclusion of any other element or step.

[0076] Whenever the terms "at least", "greater than", or "greater than or equal to" precede the first value in two or more numerical series, the term "at least", "greater than", or "greater than or equal to" applies to each value in that numerical series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0077] Whenever the terms "not exceeding", "less than", "less than or equal to", or "at most" precede the first value in two or more numerical series, the terms "not exceeding", "less than", "less than or equal to", or "at most" apply to each value in that numerical series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0078] When a value is described as a range, it should be understood that such disclosure includes all possible sub-ranges within such range, as well as the specific values that fall within such range, whether or not the specific values or specific sub-ranges are explicitly stated.

[0079] The present disclosure describes a balloon catheter system and method for treating heart failure. Heart failure is often accompanied by autonomic dysregulation, which is characterized by enhanced sympathetic activity and loss of parasympathetic control. Autonomic dysregulation has long been recognized as an important mediator of increased mortality and morbidity in myocardial infarction and heart failure. The persistent increase in sympathetic drive, the decrease in parasympathetic activity, and the activation of the renin-angiotensin-aldosterone system ("RAAS") in heart failure also lead to progressive left ventricular dysfunction, progressive left ventricular remodeling, end-organ damage, and ultimately death. The mechanisms responsible for the persistent sympathetic excitation in heart failure are not fully understood. It is generally believed that arterial reflexes, including the carotid sinus baroreflex, which normally have an inhibitory effect on the system, are less sensitive in heart failure, thus allowing uncontrolled sympathetic outflow. Multiple studies have shown abnormal reduction of arterial baroreflex control in heart failure. This autonomic maladaptation in heart failure can lead to increased heart rate, dysregulation of key components of the cardiac beta-adrenergic receptor signaling pathway, dysregulation of nitric oxide signaling, and the development of life-threatening ventricular arrhythmias. The balloon catheter system and method of the present disclosure promote baroreceptor activation, which can reduce sympathetic overdrive and enhance parasympathetic control, thereby reducing heart rate, improving adrenergic receptor and nitric oxide signaling, increasing the threshold for lethal ventricular arrhythmias, improving overall left ventricular function, and partially reversing left ventricular cavity remodeling.

[0080] Catheter Systems and Devices

[0081] As described herein, the present disclosure provides a balloon catheter system for treating heart failure. Figure 1Ais a schematic diagram depicting a balloon catheter system 100 according to some embodiments.

[0082] Systemic venous congestion is one of the hallmarks of heart failure syndrome. In some cases, venous congestion can lead to impaired renal perfusion and activation of the renin-angiotensin-aldosterone system (“RAAS”), both of which can result in renal dysfunction in heart failure patients. Additionally, higher venous pressures can impede blood and lymphatic return in the lower extremities and abdomen. The balloon catheter system 100 can include a first balloon catheter 101 configured to create a low-pressure zone at or below the renal vein, thereby improving blood and lymphatic return as well as organ function. The first balloon catheter 101 can further stimulate the vagus nerve, resulting in enhanced blood accommodation in the lower extremities and abdomen.

[0083] The first balloon catheter 101 can include an elongate body 102 and a first balloon 103 located at the distal end of the elongate body 102. The first balloon catheter 101 can be configured to be inserted into the femoral vein of a subject such that the first balloon 103 can be advanced to a first target location at the inferior vena cava (“IVC”) near the left renal vein or the right renal vein. The first balloon catheter 101 can also include a first Y-connector 104 having a first port 121 and a second port 122, the first port 121 configured to receive a second balloon catheter 111 therethrough and the second port 122 for attaching a pump. After the first balloon 103 is placed in the first target location, the first balloon 103 can be inflated using the second port 122 of the first Y-connector 104. Figure 1B is a schematic diagram depicting the balloon catheter system 100 with the balloon in an inflated configuration according to some embodiments. The first balloon 103 can be inflated by connecting a first pump 105 (e.g., an infusion pump) to the second port 122 of the first Y-connector 104. The first pump 105 can be used to inflate or deflate the first balloon 103. The first balloon 103 of the first balloon catheter 101 can include a multi-layer structure to prevent rupture of the balloon upon inflation.

[0084] In some embodiments, the first balloon catheter 101 is a disposable device made of a biocompatible material. In some embodiments, the elongate body 102 of the first balloon catheter 101 comprises a material selected from polyethylene terephthalate, polyethylene, polyamide, or combinations thereof. In some embodiments, the first balloon 103 of the first balloon catheter 101 is made of silica and / or nylon material. In some embodiments, the first balloon 103 of the first balloon catheter 101 is made of a polyolefin material. In some embodiments, the first balloon 103 of the first balloon catheter 101 is made of polyvinyl chloride. In some embodiments, the elongate body 102 is provided with one or more of a hydrophilic coating, an anticoagulant coating, an anti-thrombotic coating, or a lubricating coating. The coating can be made of, for example, polyvinylpyrrolidone (PVP).

[0085] In some embodiments, the length of the elongate body 102 of the first balloon catheter 101 can be at least about 5 centimeters ("cm"), 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95 cm, 100 cm, 105 cm, 110 cm, or any value therebetween. In some embodiments, the length of the elongate body 102 of the first balloon catheter 101 can be at most about 110 cm, 105 cm, 100 cm, 95 cm, 90 cm, 85 cm, 80 cm, 75 cm, 70 cm, 65 cm, 60 cm, 55 cm, 50 cm, 45 cm, 40 cm, 35 cm, 30 cm, 25 cm, 20 cm, 15 cm, 10 cm, 5 cm, or any value therebetween. In some embodiments, the length of the elongate body 102 of the first balloon catheter 101 can be from about 40 cm to about 110 cm.

[0086] In some embodiments, the elongate body 102 of the first balloon catheter 101 can have an outer diameter of at least about 2 French ("Fr"), 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr, or any value therebetween. In some embodiments, the outer diameter of the elongate body 102 of the first balloon catheter 101 can be at most about 30 Fr, 28 Fr, 26 Fr, 24 Fr, 22 Fr, 20 Fr, 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 11 Fr, 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, 2 Fr, or any value therebetween. In some embodiments, the elongate body 102 of the first balloon catheter 101 can have an outer diameter of from about 10 Fr to about 20 Fr. In some embodiments, the elongate body 102 of the first balloon catheter 101 can have an outer diameter of from about 13 Fr to about 17 Fr. In some embodiments, the elongate body 102 of the first balloon catheter 101 can have an outer diameter of about 16 Fr. In some embodiments, the elongate body 102 of the first balloon catheter 101 can have an outer diameter of about 15 Fr.

[0087] In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be at least about 1 millimeter ("mm"), 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, or any value therebetween. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be at most about 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or any value therebetween. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be from about 5 mm to about 20 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be from about 5 mm to about 15 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 5 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 6 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 7 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 8 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 9 mm. In some embodiments, the length of the first balloon 103 of the first balloon catheter 101 can be about 10 mm.

[0088] In some embodiments, the inflated diameter of the first balloon 103 of the first balloon catheter 101 can be at least about 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm or any value therebetween. In some embodiments, the inflated diameter of the first balloon 103 of the first balloon catheter 101 can be at most about 40 mm, 39 mm, 38 mm, 37 mm, 36 mm, 35 mm, 34 mm, 33 mm, 32 mm, 31 mm, 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm or any value therebetween. In some embodiments, the inflated diameter of the first balloon 103 of the first balloon catheter 101 can be from about 15 mm to about 35 mm. In some embodiments, the inflated diameter of the first balloon 103 of the first balloon catheter 101 can be from about 15 mm to about 30 mm. In some embodiments, the inflated diameter of the first balloon 103 of the first balloon catheter 101 can be from about 18 mm to about 25 mm.

[0089] In some embodiments, the first balloon 103 of the first balloon catheter 101 can be inflated to a pressure of at least about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, 0.5 atm, 0.6 atm, 0.7 atm, 0.8 atm, 0.9 atm, 1 atm, 2 atm, 3 atm, 4 atm, 5 atm, 6 atm, 7 atm, 9 atm, 10 atm or any value therebetween. In some embodiments, the first balloon 103 of the first balloon catheter 101 can be inflated to a pressure of at most about 10 atm, 9 atm, 8 atm, 7 atm, 6 atm, 5 atm, 4 atm, 3 atm, 2 atm, 1 atm, 0.9 atm, 0.8 atm, 0.7 atm, 0.6 atm, 0.5 atm, 0.4 atm, 0.3 atm, 0.2 atm, 0.1 atm or any value therebetween. In some embodiments, the first balloon 103 of the first balloon catheter 101 can be inflated to a pressure from about 0.1 atm to about 2 atm. In some embodiments, the first balloon 103 of the first balloon catheter 101 can be inflated to a pressure from about 1 atm to about 2 atm.

[0090] In some embodiments, the first balloon 103 of the first balloon catheter 101 is made of a highly flexible material. In some embodiments, the fatigue strength of the first balloon 103 of the first balloon catheter 101 can be at least 100, 150, 200, 250, 300, 350, 400, 450, 500 or more inflation and deflation cycles (i.e., the magnitude or range of cyclic stress that can be applied to the material without causing fatigue failure).

[0091] The balloon catheter system 100 may further include a second balloon catheter 111 configured to create a low-pressure zone near the left internal jugular vein and / or the thoracic duct, thereby improving the return flow of the superior vena cava ("SVC") and the right atrium of the heart. The second balloon catheter 111 may also be configured to stimulate the vagus nerve, resulting in improved cardiac remodeling and function. Stimulation of the vagus nerve can cause vasodilation, which can increase blood accommodation in the venous bed and reduce cardiac preload.

[0092] The second balloon catheter 111 may include an elongate body 112 and a second balloon 113 located at the distal end of the elongate body 112. The second balloon catheter 111 may also include a lumen for inflating the second balloon 113. The second balloon catheter 111 may be configured to be inserted into the first port 121 of the first Y-connector 104 such that it can be advanced through the lumen in the first balloon catheter 101, through the IVC and to a second target location near the left or right subclavian vein. After the second balloon 113 is placed in the second target location, the second balloon 113 can be inflated using a second Y-connector 114. The second Y-connector 114 may include a first port 131 for receiving a guide wire and a second port 132 for attaching a pump. By connecting a second pump 115 (e.g., an infusion pump) to the second port 132 of the second Y-connector 114, the second balloon 113 can be inflated. The second pump 115 can be used to inflate or deflate the second balloon 113. The second balloon 113 of the second balloon catheter 111 may include a multi-layer structure to prevent balloon rupture during inflation.

[0093] In some embodiments, the second balloon catheter 111 is a single-use device made of a biocompatible material. In some embodiments, the elongate body 112 of the second balloon catheter 111 is made of polyvinyl chloride. In some embodiments, the second balloon 113 of the second balloon catheter 111 is made of polyvinyl chloride. In some embodiments, the second balloon 113 of the second balloon catheter 111 is made of silica and / or nylon material. In some embodiments, the second balloon 113 of the second balloon catheter 111 is made of polyolefin material. In some embodiments, the elongate body 112 is provided with one or more of a hydrophilic coating, an anticoagulant coating, an anti-coagulation coating or a lubricating coating. The coating may be made of, for example, polyvinylpyrrolidone (PVP).

[0094] In some embodiments, the length of the elongate body 112 of the second balloon catheter 111 can be at least about 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95 cm, 100 cm, 105 cm, 110 cm, 115 cm, 120 cm, 125 cm, 130 cm, 135 cm, 140 cm, 145 cm, 150 cm, 155 cm, 160 cm, 165 cm, 170 cm, 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, 200 cm or any value therebetween. In some embodiments, the length of the elongate body 112 of the second balloon catheter 111 can be at most about 200 cm, 195 cm, 190 cm, 185 cm, 180 cm, 175 cm, 170 cm, 165 cm, 160 cm, 155 cm, 150 cm, 145 cm, 140 cm, 135 cm, 130 cm, 125 cm, 120 cm, 115 cm, 110 cm, 105 cm, 100 cm, 95 cm, 90 cm, 85 cm, 80 cm, 75 cm, 70 cm, 65 cm, 60 cm, 55 cm, 50 cm, 45 cm, 40 cm, 35 cm, 30 cm, 25 cm, 20 cm, 10 cm, 5 cm or any value therebetween. In some embodiments, the length of the elongate body 112 of the second balloon catheter 111 can be from about 50 cm to about 100 cm. In some embodiments, the length of the elongate body 112 of the second balloon catheter 111 can be from about 70 cm to about 90 cm. In some embodiments, the length of the elongate body 112 of the second balloon catheter 111 can be about 80 cm.

[0095] In some embodiments, the outer diameter of the elongate body 112 of the second balloon catheter 111 can be at least about 2Fr, 3Fr, 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 18Fr, 19Fr, 20Fr, 21Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr or any value therebetween. In some embodiments, the outer diameter of the elongate body 112 of the second balloon catheter 111 can be at most about 30Fr, 28Fr, 26Fr, 24Fr, 22Fr, 20Fr, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 11Fr, 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr, 2Fr or any value therebetween. In some embodiments, the outer diameter of the elongate body 112 of the second balloon catheter 111 can be from about 2Fr to about 12Fr. In some embodiments, the outer diameter of the elongate body 112 of the second balloon catheter 111 can be from about 4Fr to about 10Fr. In some embodiments, the outer diameter of the elongate body 112 of the second balloon catheter 111 can be about 6Fr.

[0096] In some embodiments, the length of the second balloon 113 of the second balloon catheter 111 can be at least about 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm or any value therebetween. In some embodiments, the length of the second balloon 113 of the second balloon catheter 111 can be at most about 30mm, 29mm, 28mm, 27mm, 26mm, 25mm, 24mm, 23mm, 22mm, 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm, 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm, 3mm, 2mm, 1mm or any value therebetween. In some embodiments, the length of the second balloon 113 of the second balloon catheter 111 can be between about 5mm and about 20mm. In some embodiments, the length of the second balloon 113 of the second balloon catheter 111 can be from about 5mm to about 15mm. In some embodiments, the length of the second balloon 113 of the second balloon catheter 111 can be about 10mm.

[0097] In some embodiments, the inflated diameter of the second balloon 113 of the second balloon catheter 111 can be at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, or any value therebetween. In some embodiments, the inflated diameter of the second balloon 113 of the second balloon catheter 111 can be at most about 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or any value therebetween. In some embodiments, the inflated diameter of the second balloon 113 of the second balloon catheter 111 can be from about 1 mm to about 20 mm. In some embodiments, the inflated diameter of the second balloon 113 of the second balloon catheter 111 can be from about 5 mm to about 15 mm. In some embodiments, the inflated diameter of the second balloon 113 of the second balloon catheter 111 can be from about 8 mm to about 10 mm.

[0098] In some embodiments, the second balloon 113 of the second balloon catheter 111 can be inflated to a pressure of at least about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, 0.5 atm, 0.6 atm, 0.7, 0.8 atm, 0.9 atm, 1 atm, 2 atm, 3 atm, 4 atm, 5 atm, 6 atm, 7 atm, 9 atm, 10 atm, or any value therebetween. In some embodiments, the second balloon 113 of the second balloon catheter 111 can be inflated to a pressure of at most about 10 atm, 9 atm, 8 atm, 7 atm, 6 atm, 5 atm, 4 atm, 3 atm, 2 atm, 1 atm, 0.9 atm, 0.8 atm, 0.7 atm, 0.6 atm, 0.5 atm, 0.4 atm, 0.3 atm, 0.2 atm, 0.1 atm, or any value therebetween. In some embodiments, the second balloon 113 of the second balloon catheter 111 can be inflated to a pressure from about 0.1 atm to about 2 atm. In some embodiments, the second balloon 113 of the second balloon catheter 111 can be inflated to a pressure from about 1 atm to about 2 atm.

[0099] In some embodiments, the second balloon 113 of the second balloon catheter 111 is made of a highly flexible material. In some embodiments, the fatigue strength of the second balloon 113 of the second balloon catheter 111 can be at least 100, 150, 200, 250, 300, 350, 400, 450, 500 or more inflation and deflation cycles.

[0100] Figures 2A to 2B is a schematic cross-sectional view depicting the first balloon catheter 101 of the balloon catheter system 100 according to some embodiments. Figure 2A and Figure 2B shows an alternative configuration of the lumen. In some embodiments, the first balloon catheter 101 includes a plurality of lumens. In some embodiments, the first balloon catheter 101 includes at least 2 lumens. In some embodiments, the first balloon catheter 101 includes at least 3 lumens. In some embodiments, the first balloon catheter 101 includes at least 4 lumens. In some embodiments, the first balloon catheter 101 includes at least 5 lumens. In some embodiments, the first balloon catheter 101 includes at least 6 lumens.

[0101] The first balloon catheter 101 may include a first lumen 201 configured to inflate the first balloon 103. In some embodiments, the inner diameter of the first lumen 201 of the first balloon catheter 101 can be at least about 2Fr, 3Fr, 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 18Fr, 19Fr, 20Fr, 21Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr or any value therebetween. In some embodiments, the inner diameter of the first lumen 201 of the first balloon catheter 101 can be at most about 30Fr, 28Fr, 26Fr, 24Fr, 22Fr, 20Fr, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 11Fr, 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr, 2Fr or any value therebetween. In some embodiments, the inner diameter of the first lumen 201 of the first balloon catheter 101 can be from about 2Fr to about 10Fr. In some embodiments, the inner diameter of the first lumen 201 of the first balloon catheter 101 can be from about 2Fr to about 6Fr. In some embodiments, the inner diameter of the first lumen 201 of the first balloon catheter 101 can be about 2Fr.

[0102] The first balloon catheter 101 may include a second lumen 202 configured to allow the second balloon catheter 111 to be advanced therethrough. In some embodiments, the inner diameter of the second lumen 202 of the first balloon catheter 101 may be at least about 2Fr, 3Fr, 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 18Fr, 19Fr, 20Fr, 21Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or any value therebetween. In some embodiments, the inner diameter of the second lumen 202 of the first balloon catheter 101 may be at most about 30Fr, 28Fr, 26Fr, 24Fr, 22Fr, 20Fr, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 11Fr, 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr, 2Fr, or any value therebetween. In some embodiments, the inner diameter of the second lumen 202 of the first balloon catheter 101 may be from about 2Fr to about 10Fr. In some embodiments, the inner diameter of the second lumen 202 of the first balloon catheter 101 may be from about 4Fr to about 8Fr. In some embodiments, the inner diameter of the second lumen 202 of the first balloon catheter 101 may be about 7Fr. In some embodiments, the second lumen 202 terminates at a distal port 321 at the distal end or tip of the first balloon catheter 101, from which the second balloon catheter 111 may protrude (see Figure 1C and Figure 3C ).

[0103] The first balloon catheter 101 may include a third lumen 203 that is configured to allow a third catheter to be advanced therethrough. In some embodiments, the inner diameter of the third lumen 203 of the first balloon catheter 101 may be at least about 2Fr, 3Fr, 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 18Fr, 19Fr, 20Fr, 21Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or any value therebetween. In some embodiments, the inner diameter of the third lumen 203 of the first balloon catheter 101 may be at most about 30Fr, 28Fr, 26Fr, 24Fr, 22Fr, 20Fr, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 11Fr, 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr, 2Fr, or any value therebetween. In some embodiments, the inner diameter of the third lumen 203 of the first balloon catheter 101 may be from about 2Fr to about 10Fr. In some embodiments, the inner diameter of the third lumen 203 of the first balloon catheter 101 may be from about 4Fr to about 8Fr. In some embodiments, the inner diameter of the third lumen 203 of the first balloon catheter 101 may be about 7Fr.

[0104] The first balloon catheter 101 may include a fourth lumen 204 that may be in fluid communication with a port 323 on the body of the first balloon catheter 101 to serve as a pressure sensing line (see Figure 3B)。For example, the port 323 can be located at about 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm near the first balloon 103 so that the pressure at the inferior vena cava (“IVC”) and / or the femoral vein can be measured. In some embodiments, the inner diameter of the fourth lumen 204 of the first balloon catheter 101 can be at least about 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr, or any value therebetween. In some embodiments, the inner diameter of the fourth lumen 204 of the first balloon catheter 101 can be at most about 30 Fr, 28 Fr, 26 Fr, 24 Fr, 22 Fr, 20 Fr, 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 11 Fr, 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, 2 Fr, or any value therebetween. In some embodiments, the inner diameter of the fourth lumen 204 of the first balloon catheter 101 can be from about 2 Fr to about 10 Fr. In some embodiments, the inner diameter of the fourth lumen 204 of the first balloon catheter 101 can be from about 4 Fr to about 8 Fr. In some embodiments, the inner diameter of the fourth lumen 204 of the first balloon catheter 101 can be about 7 Fr.

[0105] Figures 3A to 3D is a schematic diagram depicting the elongate body 102 of the first balloon catheter 101 according to some embodiments, which has an inlet 301 for receiving a third catheter into the third lumen 203 and an outlet 302 allowing the third catheter to exit the third lumen 203 (see Figure 3A and Figure 3C ). The inlet 301 can be located at the proximal end of the elongate body 102 of the first balloon catheter 101 (e.g., the end closest to the user of the balloon catheter system 100), e.g., Figure 3AAs shown. In some embodiments, the inlet distance 321 (e.g., the distance between the inlet 301 and the first balloon 103) is at least about 1 cm, 2 cm, 4 cm, 6 cm, 8 cm, 10 cm, 12 cm, 14 cm, 16 cm, 18 cm, 20 cm, 22 cm, 24 cm, 26 cm, 28 cm, 30 cm or any value therebetween. In some embodiments, the inlet distance 321 is at most about 30 cm, 28 cm, 26 cm, 24 cm, 22 cm, 20 cm, 18 cm, 16 cm, 14 cm, 12 cm, 10 cm, 8 cm, 6 cm, 4 cm, 2 cm, 1 cm or any value therebetween. In some embodiments, the inlet distance 321 is from about 4 cm to about 18 cm. In some embodiments, the inlet distance 321 is from about 6 cm to about 14 cm. In some embodiments, the inlet distance 321 is from about 8 cm to about 12 cm. In some embodiments, the inlet distance 321 is about 10 cm. In some embodiments, as Figure 3B and Figure 3D shown, the inlet 301 is located at the Y-connector 104. The Y-connector 104 can also be connected to another connector (e.g., a Luer connector) including a port 123 to be in fluid communication with the port 323 through the fourth lumen 204 to measure the pressure at the inferior vena cava and / or the femoral vein.

[0106] In some embodiments, the diameter of the inlet 301 of the first balloon catheter 101 can be at least about 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr or any value therebetween. In some embodiments, the diameter of the inlet 301 of the first balloon catheter 101 can be at most about 30 Fr, 28 Fr, 26 Fr, 24 Fr, 22 Fr, 20 Fr, 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 11 Fr, 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, 2 Fr or any value therebetween. In some embodiments, the diameter of the inlet 301 of the first balloon catheter 101 can be from about 2 Fr to about 10 Fr. In some embodiments, the diameter of the inlet 301 of the first balloon catheter 101 can be from about 4 Fr to about 8 Fr. In some embodiments, the diameter of the inlet 301 of the first balloon catheter 101 can be about 7 Fr.

[0107] The outlet 302 can be located at the distal end of the elongate body 102 of the first balloon catheter 101 (e.g., the end farthest from the user of the balloon catheter system 100). In some embodiments, the outlet 302 can be located on a sidewall near the distal end of the elongate body 102. In some embodiments, the outlet distance 322 (e.g., the distance between the outlet 302 and the first balloon 103) is at least about 0.1 cm, 0.2 cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm or any value therebetween. In some embodiments, the outlet distance 322 is at most about 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0.1 cm or any value therebetween. In some embodiments, the outlet distance 322 is from about 0.1 cm to about 5 cm. In some embodiments, the outlet distance 322 is about 0.2 cm to about 4 cm. In some embodiments, the outlet distance 322 is about 0.4 cm to about 2 cm. In some embodiments, the outlet distance 321 is about 1 cm.

[0108] In some embodiments, the diameter of the outlet 302 of the first balloon catheter 101 can be at least about 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr or any value therebetween. In some embodiments, the diameter of the outlet 302 of the first balloon catheter 101 can be at most about 30 Fr, 28 Fr, 26 Fr, 24 Fr, 22 Fr, 20 Fr, 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 11 Fr, 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, 2 Fr or any value therebetween. In some embodiments, the diameter of the outlet 302 of the first balloon catheter 101 can be from about 2 Fr to about 10 Fr. In some embodiments, the diameter of the outlet 302 of the first balloon catheter 101 can be from about 4 Fr to about 8 Fr. In some embodiments, the diameter of the outlet 302 of the first balloon catheter 101 can be about 7 Fr.

[0109] The first balloon 103 of the first balloon catheter 101 may also have at least one radiopaque marker 311, which allows the user to visualize the first balloon 103 under radiography or fluoroscopy, as Figure 1C shown. In some embodiments, the radiopaque marker 311 is a metal marker. In some embodiments, the first balloon 101 includes two radiopaque markers 311. In some embodiments, the radiopaque marker 311 is located at one or more proximal or distal ends of the first balloon 103. In some embodiments, as Figure 1C shown, the radiopaque marker 311 is located at or near the first balloon 103 and at or near the outlet port 302 of the third balloon catheter 501. In some embodiments, there may be a radiopaque marker 311 located at or near the distal end or tip of the first balloon catheter 101. In some embodiments, the radiopaque marker 311 is in the form of a ring, such as a thin-walled ring. In some embodiments, the radiopaque marker 311 is made of a radiopaque material, including but not limited to platinum, platinum-iridium, gold, and their alloys. In some embodiments, the radiopaque marker is used to guide any of the first balloons through the patient's blood vessel to a target location at or near the renal vein.

[0110] Figures 4A to 4E FIG. is a schematic diagram of a second balloon catheter 111 of the balloon catheter system 100 according to some embodiments. The second balloon catheter 111 may also include a lumen for advancing a guide wire. The guide wire may assist in advancing the second balloon 113 to a second target location. According to one aspect, the guide wire may be formed of a flexible material to accommodate anatomical complications such as complex and tortuous blood vessels. The second Y-connector 114 of the second balloon catheter 111 may include a first port 411 for inserting the guide wire into the lumen. The second Y-connector 114 of the second balloon catheter 111 may include a second port 412 for connecting a pump (e.g., an injection pump) to inflate the second balloon 113. The second balloon catheter 111 may also include a lumen 421 for measuring the subclavian pressure, which is configured to be connected to a pressure measurement device. The lumen 412 may be in fluid communication with the first port 411. The second balloon catheter 111 may also include a lumen 422 for inflating the second balloon 113. The lumen 422 may be in fluid communication with the second port 412. The pressure measurement device may continuously or discretely measure the pressure in the region near the second balloon 113 (e.g., the subclavian pressure).

[0111] The second balloon 113 of the balloon catheter 111 may also have at least one radiopaque marker 401, which allows the user to visualize the second balloon 113 under radiography or fluoroscopy, as Figure 1CAs shown. In some embodiments, the radiopaque marker 401 is a metal marker. In some embodiments, the second balloon 113 includes two radiopaque markers 401. In some embodiments, the radiopaque markers 401 are positioned at one or more proximal or distal ends of the second balloon 113. In some embodiments, the radiopaque marker 401 is in the form of a ring, such as a thin-walled ring. In some embodiments, the radiopaque marker 401 is made of a radiopaque material, including but not limited to platinum, platinum iridium, gold, and their alloys. In some embodiments, the radiopaque marker is used to guide any one of the first balloons through the patient's vasculature to a target location at or near the subclavian vein.

[0112] Figure 5 FIG. 4 is a schematic diagram depicting a third balloon catheter 501 of the balloon catheter system 100 according to some embodiments. Heart failure is typically associated with elevated pulmonary artery pressure ("PAP") and pulmonary capillary wedge pressure ("PCWP"), and thus treating heart failure requires monitoring hemodynamics. The third balloon catheter 501 can be used to measure hemodynamics during the treatment of heart failure.

[0113] The third balloon catheter 501 can be a floating balloon catheter. The third balloon catheter 501 can be a pulmonary artery catheter ("PAC"), such as a Swan-Ganz catheter, or any other catheter that allows for hemodynamic monitoring. The third balloon catheter 501 can include an elongate body 502 and a third balloon 503 located at the distal end of the elongate body 502. The third balloon catheter can also include a lumen for inflating the third balloon 503. The third balloon catheter 501 can be configured to be inserted into the inlet 301 of the first balloon catheter 101 such that it can be advanced through the third lumen 203 and through the outlet 302 to a third target location near the pulmonary artery. The third balloon catheter 501 can also include a lumen that is configured to receive a guide wire passing therethrough. The guide wire can facilitate the advancement of the third balloon 503 to the third target location. According to one aspect, the guide wire is formed of a flexible material to accommodate anatomical complications such as a complex and tortuous vasculature. After the third balloon 503 is placed in the third target location, the third balloon 503 can be inflated using an inflation line 504. The third balloon 503 can be inflated by connecting a third pump 505 (e.g., a syringe pump) to the inflation line 504. The third pump 505 can be used to inflate or deflate the third balloon 503. The third balloon 503 of the third balloon catheter 501 can include a multi-layer structure to prevent the balloon from rupturing during inflation.

[0114] The third balloon catheter 501 may further include a lumen for measuring pulmonary artery pressure, which is configured to be connected to the distal pressure line 506. The distal pressure line 506 may be configured to be connected to a pressure measuring device that continuously or discretely measures the pressure at the third balloon 503 (e.g., pulmonary artery pressure). The third balloon catheter 501 may further include a lumen for measuring femoral vein pressure, which has an opening 508 at the proximal end of the third balloon catheter 501 (e.g., the end closest to the user of the balloon catheter system 100). During the operation of the balloon catheter system 100, the third balloon catheter 501 is advanced through the first balloon catheter via the inlet 301 such that the opening 508 is located near the femoral vein. The lumen for measuring femoral vein pressure may be configured to be connected to the proximal pressure line 507. The proximal pressure line 507 may be configured to be connected to a pressure measuring device that continuously or discretely measures the pressure at the inlet 301 (e.g., femoral vein pressure). The body of the third balloon catheter 501 may have one or more side ports and / or distal ends to facilitate such pressure measurements. The third catheter may have separate lumens for inflation of the third balloon 503, pressure measurement at the pulmonary artery, pressure measurement at the inferior vena cava and / or femoral vein (e.g., for measuring central venous pressure), and for facilitating advancement along a guidewire. The guidewire lumen may also be used as the pressure measurement lumen at the pulmonary artery.

[0115] In some embodiments, the third balloon catheter 501 is a single-use device made of a biocompatible material. In some embodiments, the elongate body 502 of the third balloon catheter 501 is made of polyvinyl chloride. In some embodiments, the third balloon 503 of the third balloon catheter 501 is made of polyvinyl chloride. In some embodiments, the third balloon 503 of the third balloon catheter 501 is made of a latex material. In some embodiments, the elongate body 502 is provided with one or more of a hydrophilic coating, an anticoagulant coating, an anti-clotting coating, or a lubricating coating. The coating may be made of, for example, polyvinylpyrrolidone (PVP).

[0116] In some embodiments, the length of the elongate body 502 of the third balloon catheter 501 can be at least about 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, 65 cm, 70 cm, 75 cm, 80 cm, 85 cm, 90 cm, 95 cm, 100 cm, 105 cm, 110 cm, 115 cm, 120 cm, 125 cm, 130 cm, 135 cm, 140 cm, 145 cm, 150 cm, 155 cm, 160 cm, 165 cm, 170 cm, 175 cm, 180 cm, 185 cm, 190 cm, 195 cm, 200 cm, 205 cm, 210 cm, 215 cm, 220 cm or any value therebetween. In some embodiments, the length of the elongate body 502 of the third balloon catheter 501 can be at most about 220 cm, 215 cm, 210 cm, 205 cm, 200 cm, 195 cm, 190 cm, 185 cm, 180 cm, 175 cm, 170 cm, 165 cm, 160 cm, 155 cm, 150 cm, 145 cm, 140 cm, 135 cm, 130 cm, 125 cm, 120 cm, 115 cm, 110 cm, 105 cm, 100 cm, 95 cm, 90 cm, 85 cm, 80 cm, 75 cm, 70 cm, 65 cm, 60 cm, 55 cm, 50 cm, 45 cm, 40 cm, 35 cm, 30 cm, 25 cm, 20 cm, 15 cm, 10 cm, 5 cm or any value therebetween. In some embodiments, the length of the elongate body 502 of the third balloon catheter 501 can be from about 50 cm to about 120 cm. In some embodiments, the length of the elongate body 502 of the third balloon catheter 501 can be from about 70 cm to about 120 cm. In some embodiments, the length of the elongate body 502 of the third balloon catheter 501 can be about 110 cm.

[0117] In some embodiments, the outer diameter of the elongate body 502 of the third balloon catheter 501 can be at least about 2Fr, 3Fr, 4Fr, 5Fr, 6Fr, 7Fr, 8Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 18Fr, 19Fr, 20Fr, 21Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr or any value therebetween. In some embodiments, the outer diameter of the elongate body 502 of the third balloon catheter 501 can be at most about 30Fr, 28Fr, 26Fr, 24Fr, 22Fr, 20Fr, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 11Fr, 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr, 2Fr, or any value therebetween. In some embodiments, the outer diameter of the elongate body 502 of the third balloon catheter 501 can be from about 2Fr to about 12Fr. In some embodiments, the outer diameter of the elongate body 502 of the third balloon catheter 501 can be from about 4Fr to about 10Fr. In some embodiments, the outer diameter of the elongate body 502 of the third balloon catheter 501 can be about 6Fr.

[0118] In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm or any value therebetween. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be at most about 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm or any value therebetween. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be from about 1 mm to about 10 mm. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be from about 3 mm to about 5 mm. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be about 3 mm. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be about 4 mm. In some embodiments, the length of the third balloon 503 of the third balloon catheter 501 can be about 5 mm.

[0119] In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm or any value therebetween. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be at most about 30 mm, 29 mm, 28 mm, 27 mm, 26 mm, 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm or any value therebetween. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be from about 1 mm to about 20 mm. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be from about 1 mm to about 10 mm. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be from about 3 mm to about 5 mm. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be about 3 mm. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be about 4 mm. In some embodiments, the inflated diameter of the third balloon 503 of the third balloon catheter 501 can be about 5 mm.

[0120] In some embodiments, the third balloon 503 of the third balloon catheter 501 can be inflated to a pressure of at least about 0.1 atm, 0.2 atm, 0.3 atm, 0.4 atm, 0.5 atm, 0.6 atm, 0.7 atm, 0.8 atm, 0.9 atm, 1 atm, 2 atm, 3 atm, 4 atm, 5 atm, 6 atm, 7 atm, 9 atm, 10 atm or any value therebetween. In some embodiments, the third balloon 503 of the third balloon catheter 501 can be inflated to a pressure of at most about 10 atm, 9 atm, 8 atm, 7 atm, 6 atm, 5 atm, 4 atm, 3 atm, 2 atm, 1 atm, 0.9 atm, 0.8 atm, 0.7 atm, 0.6 atm, 0.5 atm, 0.4 atm, 0.3 atm, 0.2 atm, 0.1 atm or any value therebetween. In some embodiments, the third balloon 503 of the third balloon catheter 501 can be inflated to a pressure of about 0.1 atm to about 2 atm. In some embodiments, the third balloon 503 of the third balloon catheter 501 can be inflated to a pressure of about 1 atm to about 2 atm.

[0121] In some embodiments, the third balloon 503 of the third balloon catheter 501 is made of a highly flexible material. In some embodiments, the fatigue strength of the third balloon 503 of the third balloon catheter 501 can be at least 100, 150, 200, 250, 300, 350, 400, 450, 500 or more inflation and deflation cycles.

[0122] The third balloon 503 of the third balloon catheter 501 may further have at least one radiopaque marker that allows a user to see the third balloon 503 under radiography or fluoroscopy. In some embodiments, the radiopaque marker is a metal marker. In some embodiments, the radiopaque marker 501 is in the form of a ring, such as a thin-walled ring. In some embodiments, the radiopaque marker 501 is made of a radiopaque material, including but not limited to platinum, platinum iridium, gold and their alloys. In some embodiments, the radiopaque marker is used to guide any one of the first balloons through a patient's blood vessel to a target location at or near the pulmonary artery.

[0123] The balloon catheter system 100 may further include a tearable or detachable sheath puncture kit and consumable accessories. Figure 6 FIG. is a schematic diagram depicting a detachable sheath 601 for inserting the balloon catheter system 100 according to some embodiments. The detachable sheath 601 is configured to be inserted into a puncture site at the femoral vein of a subject. The detachable sheath 601 may include a first detachable arm 602 and a second detachable arm 603 that allow the detachable sheath to be torn and removed after the first balloon 103 is placed at the first target location.

[0124] The detachable sheath 601 may further include a tapered dilator 604 for enlarging the insertion site at the femoral vein. In some embodiments, the shaft length 605 of the tapered dilator 604 may be at least about 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 12 cm, 14 cm, 16 cm, 18 cm, 20 cm, 22 cm, 24 cm, 26 cm, 28 cm, 30 cm, 35 cm, 40 cm, 50 cm or any value therebetween. In some embodiments, the shaft length 605 of the tapered dilator 604 may be at most about 50 cm, 40 cm, 35 cm, 30 cm, 28 cm, 26 cm, 24 cm, 22 cm, 20 cm, 18 cm, 16 cm, 14 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm or any value therebetween. In some embodiments, the shaft length 605 of the tapered dilator 604 may be from about 10 cm to about 50 cm. In some embodiments, the shaft length 605 of the tapered dilator 604 may be from about 20 cm to about 40 cm. In some embodiments, the shaft length 605 of the tapered dilator 604 may be about 35 cm.

[0125] In some embodiments, the outer diameter of the tapered dilator 604 at its widest point is at least about 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, 16 Fr, 17 Fr, 18 Fr, 19 Fr, 20 Fr, 21 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr or any value therebetween. In some embodiments, the outer diameter of the tapered dilator 604 at its widest point is at most about 30 Fr, 28 Fr, 26 Fr, 24 Fr, 22 Fr, 20 Fr, 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 11 Fr, 10 Fr, 9 Fr, 8 Fr, 7 Fr, 6 Fr, 5 Fr, 4 Fr, 3 Fr, 2 Fr or any value therebetween. In some embodiments, the outer diameter of the tapered dilator 604 at its widest point is from about 10 Fr to about 20 Fr. In some embodiments, the outer diameter of the tapered dilator 604 at its widest point is from about 14 Fr to about 20 Fr. In some embodiments, the outer diameter of the tapered dilator 604 at its widest point is about 16 Fr.

[0126] Figure 7FIG. 0 is a schematic view depicting a balloon catheter system 100 for treating heart failure according to some embodiments. A first balloon catheter 101 may be mechanically connected to a first pump 105 configured to inflate a first balloon 103. The first pump 105 may be electronically or mechanically connected to a controller 701 configured to drive the first pump 105. In some embodiments, a user selects and inputs a desired inflation pressure of the first balloon 103 into the controller 701, and the controller drives the first pump 105 to inflate the first balloon 103.

[0127] A second balloon catheter 111 may be mechanically connected to a second pump 115 configured to inflate a second balloon 113. The second pump 115 may be electronically or mechanically connected to the controller 701 configured to drive the second pump 115. The second balloon catheter 111 may be electronically or mechanically connected to a monitor 702 (e.g., a pressure measuring device) configured to measure subclavian pressure. In some embodiments, a user selects and inputs a desired inflation pressure of the second balloon 113 into the controller 701, and the controller drives the second pump 115 to inflate the second balloon 113. The monitor 702 may continuously or discretely measure the pressure in the area near the second balloon 113 (e.g., subclavian pressure). In some embodiments, the user may deflate the second balloon 113 using the controller 701 in response to an increase in subclavian pressure. In some embodiments, the monitor 702 may be electronically or mechanically connected to the controller 701. In some embodiments, the monitor 702 is configured to transmit the subclavian pressure to the controller 701. In some embodiments, the controller 701 is configured to automatically deflate the second balloon 113 in response to an increase in subclavian pressure.

[0128] The third balloon catheter 501 can be mechanically connected to a third pump 505 configured to inflate a third balloon 503. The third pump 505 can be electronically or mechanically connected to a controller 701 configured to drive the third pump 505. The third balloon catheter 501 can be electronically or mechanically connected to a monitor 702 (e.g., a pressure measurement device) configured to measure pulmonary artery (“PA”) and femoral vein pressures. In some embodiments, a user selects a desired inflation pressure for the third balloon 503 and inputs it into the controller 701, which drives the third pump 505 to inflate the third balloon 503. The monitor 702 can continuously or discretely measure the pressure in the area near the third balloon 503 (e.g., pulmonary artery pressure). The monitor 702 can continuously or discretely measure the pressure in the area near the inlet 301 of the first catheter 101 (e.g., femoral vein pressure). In some embodiments, the user can use the controller 701 to deflate the third balloon 503 in response to an increase in pulmonary artery pressure or femoral vein pressure. In some embodiments, the monitor 702 can be electronically or mechanically connected to the controller 701. In some embodiments, the monitor 702 is configured to transmit the pulmonary artery and femoral vein pressures to the controller 701. In some embodiments, the controller 701 is configured to automatically deflate the third balloon 503 in response to an increase in pulmonary artery or femoral vein pressure.

[0129] Catheter-based treatment method

[0130] As described herein, the present disclosure provides methods for treating heart failure, particularly acute decompensated heart failure (ADHF), using a balloon catheter system. Under the guidance of hemodynamic parameter indicators, the vein can be intermittently occluded by balloon inflation to reduce the amount of blood returning to the heart, which can reduce the preload of the heart and thus relieve one or more symptoms of heart failure. For example, studies conducted by the inventors have shown that patient fluid retention can be improved by using the catheter systems described and specified herein.

[0131] Figures 8A to 8D is a schematic diagram depicting a method for treating heart failure using the balloon catheter system described herein according to some embodiments. Figure 8A Shows the step of introducing the balloon catheter system 100 into the femoral vein through a puncture site. Figure 8B Shows the step of advancing the first balloon 103 of the first balloon catheter 101 to a first target position in the inferior vena cava (“IVC”) near the left renal vein or the right renal vein. Figure 8C Shows the step of advancing the second balloon 113 of the second balloon catheter 111 to a second target position near the left subclavian vein or the right subclavian vein. Figure 8DIllustrates the steps of inflating the first balloon 103 and the second balloon 113 of the balloon catheter system 100.

[0132] In some embodiments, the method further includes using a detachable sheath 601 to expand the puncture site and advancing the first balloon 103 of the first balloon catheter 101 through the detachable sheath 601 to a first target position. After the first balloon 103 is positioned at the first target position, the detachable sheath 601 can be removed, for example, by tearing the detachable sheath 601 using a first detachable arm 602 and a second detachable arm 603.

[0133] In some embodiments, the first balloon 103 is advanced to the first target position using a guide wire. In some embodiments, the second balloon 113 is advanced to a second target position using a guide wire (“GW”).

[0134] In some embodiments, the first balloon 103 further includes at least one radiopaque marker 311 that allows the user to see the first balloon 103 under radiography or fluoroscopy, such that the user can accurately guide the first balloon 103 to the first target position. In some embodiments, the second balloon 113 further includes at least one radiopaque marker 401 that allows the user to see the second balloon 113 under radiography or fluoroscopy, such that the user can accurately guide the second balloon 113 to the second target position.

[0135] In some embodiments, intermittently occluding one or more veins reduces the venous blood return to the heart and / or reduces the pumping burden on the heart. In some embodiments, inflation of the first balloon 103 creates a low-pressure zone at or below the renal vein, thereby improving blood and lymphatic return and organ function. For example, with the first balloon 103 inflated, the blood pressure at or below the renal vein measured by the first balloon catheter 101 can be reduced by about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or any range therebetween. In some embodiments, the low-pressure zone in the renal vein promotes renal circulation, accelerates urination, and / or reduces fluid retention in the body. In some embodiments, inflation of the first balloon 103 stimulates the vagus nerve, resulting in enhanced blood accommodation in the lower extremities and abdomen. In some embodiments, stimulation of the vagus nerve can reduce the venous blood return to the heart, thereby reducing the pumping burden on the heart.

[0136] In some embodiments, the first balloon 103 of the first balloon catheter 101 is located at a first target position in the inferior vena cava ("IVC") near the left renal vein or the right renal vein. In some embodiments, the first balloon 103 is located at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm or any value therebetween from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 is located at most about 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm or any value therebetween from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 may be located about 1 mm to about 25 mm from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 may be located about 5 mm to about 25 mm from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 may be located about 10 mm to about 25 mm from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 may be located about 15 mm to about 25 mm from the left renal vein or the right renal vein. In some embodiments, the first balloon 103 may be located about 15 mm to about 20 mm from the left renal vein or the right renal vein.

[0137] In some embodiments, the period during which the first balloon 103 can be inflated is at least about 1 second ("sec"), 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 80 seconds, 100 seconds or any value therebetween. In some embodiments, the period during which the first balloon 103 can be inflated is at most about 100 seconds, 90 seconds, 80 seconds, 70 seconds, 60 seconds, 50 seconds, 40 seconds, 30 seconds, 20 seconds, 10 seconds, 9 seconds, 8 seconds, 7 seconds, 6 seconds, 5 seconds, 4 seconds, 3 seconds, 2 seconds, 1 second or any value therebetween. In some embodiments, the period during which the first balloon 103 can be inflated is about 1 second to about 60 seconds. In some embodiments, the period during which the first balloon 103 can be inflated is about 10 seconds to about 40 seconds. In some embodiments, the period during which the first balloon 103 can be inflated is about 20 seconds to about 40 seconds. Inflation of the first balloon 103 can occlude the inferior vena cava near the renal vein by about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or any range therebetween.

[0138] In some embodiments, intermittently occluding one or more veins reduces venous blood return to the heart and / or reduces the pumping burden on the heart. In some embodiments, inflation of the second balloon 113 creates a low-pressure area near the left internal jugular vein and the thoracic duct, improving blood return to the SVC and the right atrium of the heart, increasing lymphatic return, and / or reducing fluid retention in the body. For example, with the second balloon 113 inflated, the blood pressure near the left internal jugular vein and the thoracic duct measured by the second balloon catheter 111 can be reduced by about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or any range therebetween. In some embodiments, inflation of the second balloon stimulates the vagus nerve, resulting in improved cardiac remodeling and function. Stimulating the vagus nerve can cause vasodilation, which can increase blood accommodation in the venous bed and reduce cardiac preload. In some embodiments, stimulating the vagus nerve can reduce venous blood return to the heart and reduce the pumping burden on the heart.

[0139] In some embodiments, the period for which the second balloon 113 can be inflated is at least about 1 second ("sec"), 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 7 seconds, 8 seconds, 9 seconds, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 80 seconds, 100 seconds or any value therebetween. In some embodiments, the period for which the second balloon 113 can be inflated is at most about 100 seconds, 90 seconds, 80 seconds, 70 seconds, 60 seconds, 50 seconds, 40 seconds, 30 seconds, 20 seconds, 10 seconds, 9 seconds, 8 seconds, 7 seconds, 6 seconds, 5 seconds, 4 seconds, 3 seconds, 2 seconds, 1 second or any value therebetween. In some embodiments, the period for which the second balloon 113 can be inflated is from about 1 second to about 60 seconds. In some embodiments, the period for which the second balloon 113 can be inflated is from about 10 seconds to about 40 seconds. In some embodiments, the period for which the first balloon 113 can be inflated is from about 10 seconds to about 30 seconds. Inflation of the second balloon 113 can occlude the subclavian vein by about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or any range therebetween.

[0140] In some embodiments, the method further includes the step of measuring the pressure at the subclavian vein using a second balloon catheter 111. The measured pressure can be used to determine whether to inflate or deflate the first balloon 103 and / or the second balloon 113. Inflation or deflation of the first balloon 103 can cause a pressure change (e.g., pressure regulation) at or below the renal vein. For example, inflation of the first balloon 103 can cause an increase in the pressure below the renal vein. In some embodiments, the first balloon 103 is deflated when the pressure at the renal vein increases by about 1 mmHg, 2 mmHg, 3 mmHg, 4 mmHg, 5 mmHg, 6 mmHg, 7 mmHg, 8 mmHg, 9 mmHg, 10 mmHg, or any value therebetween. In some embodiments, the first balloon 103 is deflated when the pressure at the renal vein increases by about 1 mmHg to about 10 mmHg. In some embodiments, the first balloon 103 is deflated when the pressure at the renal vein increases by about 3 mmHg to about 5 mmHg.

[0141] Inflation or deflation of the second balloon 113 can cause a pressure change (e.g., pressure regulation) near the left internal jugular vein and the thoracic duct. For example, inflation of the second balloon 113 can cause an increase in the pressure near the left internal jugular vein and the thoracic duct. In some embodiments, the second balloon 113 is deflated when the pressure at the left internal jugular vein and the thoracic duct increases by about 1 mmHg, 2 mmHg, 3 mmHg, 4 mmHg, 5 mmHg, 6 mmHg, 7 mmHg, 8 mmHg, 9 mmHg, 10 mmHg, or any value therebetween. In some embodiments, the second balloon 113 is deflated when the pressure at the left internal jugular vein and the thoracic duct increases by about 1 mmHg to about 10 mmHg. In some embodiments, the second balloon 113 is deflated when the pressure at the left internal jugular vein and the thoracic duct increases by about 5 mmHg to about 10 mmHg.

[0142] Figures 9A to 9D is a schematic diagram depicting a method of advancing a pulmonary artery catheter to a third target position at the pulmonary artery. Figure 9A shows the step of introducing a third balloon catheter 501 into the inlet 301 of the first balloon catheter 101. The third balloon catheter 501 is advanced through the third lumen 203 of the first balloon catheter 101 until it exits through the outlet 302 of the first balloon catheter 101, as Figure 9B shown. Figure 9C shows the step of advancing the third balloon 503 of the third balloon catheter 501 to the third target position at the proximal pulmonary artery. Once positioned at the third target position, the third balloon 503 is inflated, and the pressure at one or more of the pulmonary artery or the right atrium can be measured. Figure 9D shows the final positioning of the balloon catheter system for treating heart failure.

[0143] In some embodiments, a guide wire is used to advance the third balloon 503 to the third target position.

[0144] In some embodiments, the outlet 302 of the first balloon catheter 101 is located in the inferior vena cava below the left renal vein or the right renal vein. In some embodiments, the outlet 302 is located at least about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm or any value therebetween below the left renal vein or the right renal vein. In some embodiments, the outlet 302 is located at most about 25 mm, 24 mm, 23 mm, 22 mm, 21 mm, 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm or any value therebetween below the left renal vein or the right renal vein. In some embodiments, the outlet 302 may be located about 1 mm to about 25 mm below the left renal vein or the right renal vein. In some embodiments, the outlet 302 may be located about 5 mm to about 20 mm below the left renal vein or the right renal vein. In some embodiments, the outlet 302 may be located about 5 mm to about 15 mm below the left renal vein or the right renal vein. In some embodiments, the outlet 302 is located about 10 mm below the left renal vein or the right renal vein.

[0145] In some embodiments, the third balloon 503 further includes at least one radiopaque marker that allows a user to see the third balloon 503 under radiography or fluoroscopy, such that the user can accurately guide the third balloon 503 to the second target position.

[0146] Although the preferred embodiments of the present disclosure have been shown and described herein, those skilled in the art will understand that these embodiments are provided by way of example only. The present disclosure is not intended to be limited by the specific examples provided in the specification. Although the present disclosure has been described with reference to the above specification, the description and illustration of the embodiments herein are not intended to be construed in a limiting sense. Those skilled in the art will now conceive of many variations, changes, and substitutions without departing from the present disclosure. In addition, it should be understood that all aspects of the present disclosure are not limited to the specific descriptions, configurations, or relative proportions described herein, which depend on various conditions and variables. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. Accordingly, it is contemplated that the present disclosure should also cover any such alternatives, modifications, variations, or equivalents. It is contemplated that the following claims define the scope of the present disclosure, and that the methods and structures within the scope of these claims and their equivalents are thereby covered.

Claims

1. A catheter system for treating a cardiovascular disease in a subject, the catheter system comprising: A first catheter, comprising: A first balloon, A first lumen configured to inflate the first balloon, A second lumen, and A third lumen, A second catheter, comprising a second balloon and an inflation lumen configured to inflate the second balloon, wherein the second lumen of the first catheter is configured to receive the second catheter for advancement and retraction therethrough, and wherein the third lumen of the first catheter is configured to receive a third catheter for advancement and retraction therethrough, wherein the third catheter comprises a third balloon and an inflation lumen configured to inflate the third balloon.

2. The catheter system according to claim 1, wherein the first balloon is configured to be positioned and inflated at or near the renal vein of the subject.

3. The catheter system according to claim 1 or 2, wherein the second balloon is configured to be positioned at or near the subclavian vein of the subject.

4. The catheter system according to any one of claims 1 to 3, wherein the third balloon is a floating balloon.

5. The catheter system according to any one of claims 1 to 4, wherein the third balloon is configured to be positioned and inflated at or near the pulmonary artery of the subject.

6. The catheter system according to any one of claims 1 to 5, wherein when the second balloon is positioned and inflated in the left internal jugular vein and the thoracic duct, the second balloon creates a low pressure zone at or near the left internal jugular vein and the thoracic duct.

7. The catheter system according to any one of claims 1 to 6, wherein inflation of the second balloon stimulates the vagus nerve of the subject.

8. The catheter system according to any one of claims 1 to 7, wherein inflation of the first balloon creates a low pressure zone at or near the renal vein of the subject.

9. The catheter system according to any one of claims 1 to 8, wherein inflation of the first balloon stimulates the vagus nerve of the subject.

10. The catheter system according to any one of claims 1 to 9, wherein the third balloon monitors at least one hemodynamic parameter of the subject.

11. The catheter system according to claim 10, wherein the at least one hemodynamic parameter is one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance.

12. The catheter system according to any one of claims 1 to 11, wherein the first catheter has a distal port coupled to the second lumen, and wherein the second catheter extends out of the first catheter through the distal port.

13. The catheter system according to any one of claims 1 to 12, wherein the first catheter has a side port near the distal end of the first catheter, and wherein the third catheter extends out of the first catheter through the side port.

14. The catheter system according to any one of claims 1 to 13, wherein the first balloon has a diameter of about 18 mm to about 25 mm when inflated.

15. The catheter system according to any one of claims 1 to 14, wherein the first balloon has a length of approximately 10 mm when inflated.

16. The catheter system according to any one of claims 1 to 15, wherein the first balloon is configured to be inflated to a pressure of approximately 1 atm to approximately 2 atm.

17. The catheter system according to any one of claims 1 to 16, wherein the second balloon has a diameter of approximately 8 mm to approximately 10 mm when inflated.

18. The catheter system according to any one of claims 1 to 17, wherein the second balloon has a length of approximately 10 mm when inflated.

19. The catheter system according to any one of claims 1 to 18, wherein the second balloon is configured to be inflated to a pressure of approximately 1 atm to approximately 2 atm.

20. The catheter system according to any one of claims 1 to 19, wherein the diameter of the first lumen is approximately 2 Fr.

21. The catheter system according to any one of claims 1 to 20, wherein the diameter of the second lumen is approximately 7 Fr.

22. The catheter system according to any one of claims 1 to 21, wherein the diameter of the third lumen is approximately 7 Fr.

23. The catheter system according to any one of claims 1 to 22, wherein the outer diameter of the second catheter is approximately 6 Fr.

24. The catheter system according to any one of claims 1 to 23, wherein the length of the second catheter is approximately 80 cm.

25. The catheter system according to any one of claims 1 to 24, wherein the second catheter is configured to be connected to a subclavian pressure line.

26. The catheter system according to claim 25, wherein the subclavian pressure line is configured to measure the subclavian vein pressure of the subject.

27. The catheter system according to claim 26, wherein the subclavian pressure is used to determine whether to inflate or deflate the second balloon.

28. The catheter system according to any one of claims 1 to 27, wherein the second catheter further includes a pressure measurement lumen separated from the inflation lumen of the second balloon.

29. The catheter system according to any one of claims 1 to 28, wherein the outer diameter of the third catheter is approximately 6 F.

30. The catheter system according to any one of claims 1 to 29, wherein the third catheter is a pulmonary artery catheter.

31. The catheter system according to any one of claims 1 to 30, wherein the third catheter is configured to be connected to one or more of a femoral artery pressure line or a pulmonary artery pressure line.

32. The catheter system according to claim 31, wherein the femoral pressure line is configured to measure the pressure at the femoral vein.

33. The catheter system according to claim 31, wherein the pulmonary artery pressure line is configured to measure the pressure at the pulmonary artery.

34. The catheter system according to any one of claims 31 to 33, wherein one or more of the measured pressure at the femoral vein or the pressure at the pulmonary artery are used to determine whether to inflate or deflate the first balloon.

35. The catheter system according to any one of claims 1 to 34, wherein the third catheter includes a balloon inflation lumen, a first pressure measurement lumen, and a second pressure measurement lumen.

36. The catheter system according to claim 35, wherein the first pressure measurement lumen is in fluid communication with the distal port of the third catheter to facilitate pressure measurement at the pulmonary artery.

37. The catheter system according to claim 35 or 36, wherein the second pressure measurement lumen is in fluid communication with the side port of the third catheter to facilitate pressure measurement at the right atrium.

38. The catheter system according to any one of claims 1 to 37, further comprising the third catheter.

39. The catheter system according to any one of claims 1 to 38, further comprising a detachable sheath.

40. The catheter system according to claim 39, wherein the detachable sheath has a shaft length of approximately 35 cm.

41. The catheter system according to claim 39 or 40, wherein the detachable sheath is configured to be inserted into the femoral vein of a subject.

42. The catheter system according to any one of claims 39 to 41, wherein the detachable sheath includes a tapered dilator.

43. The catheter system according to claim 42, wherein the tapered dilator is configured to expand the puncture site.

44. The catheter system according to any one of claims 1 to 43, further comprising at least one pump configured to be coupled to one or more of the first catheter, the second catheter, or the third catheter to inflate and deflate one or more of the first balloon, the second balloon, or the third balloon.

45. The catheter system according to any one of claims 1 to 44, wherein the second lumen of the first catheter has a circular or annular cross-section to receive the second catheter for advancement and retraction therethrough.

46. The catheter system according to any one of claims 1 to 45, wherein the third lumen of the first catheter has a circular or annular cross-section to receive the third catheter for advancement and retraction therethrough.

47. The catheter system according to any one of claims 1 to 46, wherein the first catheter further includes a fourth lumen for measuring pressure.

48. The catheter system according to claim 47, wherein the fourth lumen is in fluid communication with the side port of the first catheter to facilitate pressure measurement at one or more of the inferior vena cava or the femoral vein.

49. The catheter system according to any one of claims 1 to 48, wherein one or more of the first catheter, the second catheter, or the third catheter includes at least one radiopaque marker.

50. The catheter system according to any one of claims 1 to 49, wherein one or more of the first catheter, the second catheter, or the third catheter is configured to be advanced through the vasculature of the subject along one or more guidewires.

51. The catheter system according to any one of claims 1 to 50, wherein the cardiovascular disease is heart failure or acute heart failure.

52. A method for treating heart failure, comprising using the catheter system according to any one of claims 1 to 51.

53. A method for treating a cardiovascular disease in a subject, the method comprising: inserting the catheter system according to any one of claims 1 to 52 into the femoral vein of the subject; positioning the tip of the first catheter of the catheter system at or near the renal vein of the subject; positioning the second balloon of the second catheter of the catheter system at or near the subclavian vein of the subject; and inflating the first balloon and the second balloon; wherein inflation of the second balloon creates a low-pressure zone at the left internal jugular vein and the thoracic duct of the subject, and wherein inflation of the first balloon creates a low-pressure zone at the renal vein of the subject.

54. The method according to claim 53, further comprising: measuring the pressure at the subclavian vein of the subject using the catheter system; and regulating the inflation of one or more of the first balloon or the second balloon in response to the measured subclavian vein pressure; wherein regulating the inflation of the first balloon adjusts the pressure at the renal vein, and wherein regulating the inflation of the second balloon adjusts the pressure at the left internal jugular vein and the thoracic duct.

55. The method according to claim 53 or 54, wherein inflation of the second balloon stimulates the vagus nerve of the subject.

56. The method according to any one of claims 53 to 55, wherein inflation of the first balloon stimulates the vagus nerve of the subject.

57. The method according to any one of claims 53 to 56, wherein inflating the first balloon comprises maintaining the inflation of the first balloon for 20 - 40 seconds before deflating the first balloon.

58. The method according to any one of claims 53 to 57, wherein inflating the second balloon comprises maintaining the inflation of the third balloon for 10 - 30 seconds before deflating the first balloon.

59. The method according to any one of claims 53 to 58, wherein positioning the tip of the first catheter at or near the renal vein comprises advancing the first catheter through the vasculature of the subject along a guide wire.

60. The method according to any one of claims 53 to 59, wherein positioning the second balloon at or near the subclavian vein of the subject comprises advancing the second catheter through the vasculature of the subject along a guide wire.

61. The method according to any one of claims 53 to 60, further comprising: inserting a third catheter including a third balloon into the third lumen of the catheter system; positioning the third balloon of the third catheter at or near the pulmonary artery; inflating the third balloon; and measuring the pulmonary artery pressure of the subject using the catheter system.

62. The method according to claim 61, wherein positioning the third balloon of the third catheter at or near the pulmonary artery includes advancing the third catheter through the vasculature of the subject along a guide wire.

63. The method according to claim 61 or 62, further comprising monitoring at least one hemodynamic parameter of the subject with the third catheter.

64. The method according to claim 63, wherein the at least one hemodynamic parameter is one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance.

65. The method according to any one of claims 61 to 64, further comprising monitoring the pressure at the right atrium of the subject with the catheter system.

66. The method according to any one of claims 53 to 65, further comprising monitoring the pressure at one or more of the inferior vena cava or the femoral vein with the catheter system.

67. The method according to any one of claims 53 to 66, wherein the cardiovascular disease is heart failure or acute heart failure.

68. A method for treating a cardiovascular disease in a subject, the method comprising: advancing a first catheter into the femoral vein of the subject; positioning a first balloon of the first catheter at or near the renal vein of the subject at the inferior vena cava (IVC); advancing a second catheter through the first catheter; positioning a second balloon of the second catheter at the subclavian vein of the subject; and inflating the second balloon to create a low pressure zone at one or more of the left internal jugular vein or the thoracic duct of the subject.

69. The method according to claim 68, wherein one or more of the first catheter or the second catheter are advanced through the vasculature of the subject along one or more guide wires.

70. The method according to claim 68 or 69, wherein inflating the second balloon includes stimulating the vagus nerve of the subject or minimizing activation of the sympathetic nerve of the subject being examined.

71. The method according to any one of claims 68 to 70, further comprising inflating the first balloon at or near the renal vein of the subject.

72. The method according to claim 71, wherein inflating the first balloon creates a low pressure zone at the renal vein.

73. The method according to claim 68 or 72, wherein inflating the first balloon includes stimulating the vagus nerve of the subject.

74. The method according to any one of claims 68 to 73, wherein inflating the first balloon includes maintaining the inflation of the first balloon for about 20 seconds to about 40 seconds before deflating the first balloon.

75. The method according to any one of claims 68 to 74, wherein inflating the second balloon includes maintaining the inflation of the second balloon for about 10 seconds to about 30 seconds before deflating the second balloon.

76. The method according to any one of claims 68 to 75, further comprising advancing a third catheter including a third balloon at or near the pulmonary artery, inflating the third balloon, and monitoring the pulmonary artery pressure of the subject.

77. The method according to claim 76, further comprising monitoring at least one hemodynamic parameter of the subject with the third catheter.

78. The method according to claim 77, wherein the at least one hemodynamic parameter is one or more of heart rate, blood pressure, stroke volume, cardiac output, or total peripheral resistance.

79. The method according to any one of claims 76 to 78, further comprising measuring the pressure at the pulmonary artery or the right atrium.

80. The method according to any one of claims 76 to 79, further comprising visualizing the third catheter by means of at least one radiopaque marker of the third catheter.

81. The method according to any one of claims 68 to 80, further comprising measuring the pressure at the subclavian vein of the subject and adjusting the inflation of one or more of the first balloon or the second balloon in response to the measured subclavian vein pressure, wherein adjusting the inflation of the first balloon adjusts the pressure at the renal vein, and wherein adjusting the inflation of the second balloon adjusts the pressure at the left internal jugular vein and / or the thoracic duct.

82. The method according to any one of claims 68 to 81, further comprising measuring the pressure at one or more of the inferior vena cava or the femoral artery.

83. The method according to any one of claims 68 to 81, further comprising visualizing one or more of the first catheter or the second catheter by means of at least one radiopaque marker of the first catheter or the second catheter.

84. The method according to any one of claims 68 to 83, wherein the cardiovascular disease is heart failure or acute heart failure.

85. A method for treating a cardiovascular disease of a subject, the method comprising: creating a low-pressure zone at the left internal jugular vein and / or the thoracic duct of the subject; and creating a low-pressure zone at the renal vein of the subject.

86. The method according to claim 85, wherein creating the low-pressure zone at the renal vein of the subject comprises intermittently occluding the inferior vena cava of the subject at or near the renal vein.

87. The method according to claim 86, wherein intermittently occluding the inferior vena cava of the subject at or near the renal vein comprises advancing a first catheter from the femoral vein of the subject to or near the renal vein and inflating a balloon of the first catheter at the inferior vena cava.

88. The method according to claim 87, wherein inflating the balloon of the first catheter comprises maintaining the inflation of the balloon for about 20 seconds to about 40 seconds before deflating the balloon.

89. The method according to any one of claims 85 to 88, wherein creating the low-pressure zone at the left internal jugular vein and / or the thoracic duct comprises intermittently occluding the subclavian vein of the subject.

90. The method according to claim 89, wherein intermittently occluding the subclavian vein comprises advancing a second catheter from the femoral vein of the subject to the subclavian vein and inflating a balloon of the second catheter at the inferior vena cava.

91. The method according to claim 90, wherein inflating the balloon of the second catheter comprises maintaining inflation of the balloon for about 10 seconds to about 30 seconds before deflating the balloon.

92. The method according to any one of claims 85 to 91, wherein creating the low pressure zone at the left internal jugular vein and / or the thoracic duct increases lymphatic return in the subject, reduces fluid retention in the subject, or both.

93. The method according to any one of claims 85 to 92, wherein creating a low pressure zone at the renal vein of the subject promotes renal circulation, accelerates urination in the subject being examined, or reduces one or more of fluid retention in the subject being tested.

94. The method according to any one of claims 85 to 93, wherein creating the low pressure zone at the left internal jugular vein and / or the thoracic duct, creating the low pressure zone at the renal vein catheter, or both stimulate the vagus nerve of the subject.

95. The method according to claim 94, wherein stimulating the vagus nerve of the subject causes dilation of one or more of the subclavian vein, the left internal jugular vein and / or the thoracic duct, the inferior vena cava, or the renal vein.

96. The method according to claim 94 or 95, wherein stimulating the vagus nerve of the subject reduces venous blood return to the heart of the subject being examined, reduces the heart pumping burden of the subject being tested, or both.

97. The method according to any one of claims 85 to 96, wherein the cardiovascular disease is heart failure or acute heart failure.

98. A method of treating a cardiovascular disease in a subject, the method comprising intermittently occluding one or more veins to reduce venous blood return to the heart of the subject and relieve the heart pumping burden.

99. The method according to claim 98, wherein intermittently occluding the one or more veins comprises one or more of the following: Intermittently occluding the subclavian vein of the subject, thereby creating a low pressure zone at the left internal jugular vein and / or the thoracic duct of the subject; or Intermittently occluding the inferior vena cava of the subject, thereby creating a low pressure zone at the renal vein of the subject.

100. The method according to claim 99, wherein intermittently occluding the subclavian vein comprises occluding the subclavian vein for 10 to 30 seconds.

101. The method according to claim 99 or 100, wherein intermittently occluding the inferior vena cava comprises occluding the inferior vena cava for 20 to 40 seconds.

102. The method according to claim 98 or 101, wherein intermittently occluding the one or more veins comprises expanding one or more balloons of a catheter system at or near the one or more veins.

103. The method according to any one of claims 98 to 102, wherein intermittently occluding the one or more veins stimulates the vagus nerve of the subject.

104. The method according to any one of claims 98 to 103, wherein intermittently occluding the one or more veins increases lymphatic return in the subject, reduces fluid retention in the subject, promotes renal circulation, or accelerates urination in the subject.

105. The method according to any one of claims 98 to 104, wherein the cardiovascular disease is heart failure or acute heart failure.

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