Systems and methods for interrupting neuronal activity to treat medical conditions

Abstract

Devices, systems, and methods are provided for treating or preventing heart failure or symptoms of heart failure by coordinated disruption of neural activity to one or more target nerves. A device disclosed herein may include a vascular catheter comprising a retractable needle assembly configured to puncture vascular tissue in contact with the catheter, the needle assembly comprising one or more electrodes configured to deliver electrical energy to tissue in contact with one or more electrodes. A method may include treating or preventing heart failure or symptoms of heart failure by inserting the catheter into the vascular tissue of a patient, guiding the catheter toward the greater splanchnic nerve, puncturing the patient's vascular tissue with a retractable needle assembly extending outward from the catheter toward the target nerve, and dissecting the target nerve by delivering stimulating energy to the target nerve using one or more electrodes.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 521,270, titled "SYSTEMS AND METHODS FOR INTRARUPTING NERVE ACTIVITY TO TREAT A MEDICAL CONDITION," filed on June 15, 2023.

Background Art

[0002] Background of the Invention

[0002] Heart failure affects more than six million people. In some cases, heart failure is characterized by inefficient heart pumping due to reduced muscle strength. As a result, in some cases of heart failure, forward blood flow is poor, which can cause blood pooling and the accumulation of pressure within the heart and pulmonary circuits. Therefore, intracardiac pressure may increase, leading to symptoms such as the onset of congestion, shortness of breath, and / or respiratory failure. In some cases, conventional methods for reducing the pressure - volume load on the cardiopulmonary circuit include removing fluid accumulation (e.g., fluid in blood vessels and tissues), thereby reducing heart failure symptoms. However, for most patients, the current standard treatment for treating heart failure patients is often limited to pharmaceuticals such as ACE inhibitors, angiotensin II receptor blockers (ARBs), β - blockers, mineralocorticoid receptor antagonists, diuretics, ivabradine, sacubitril valsartan, hydralazine + nitrate combination, and / or digoxin, which aim to reduce the pressure - volume load on the cardiopulmonary circuit. There is still a need in the art for alternative methods of treating heart failure other than drug therapy.

Summary of the Invention

Means for Solving the Problems

[0003] Summary of the Invention

[0003] This invention was made with government support under Contract No. 2213155, granted by the National Science Foundation (NSF). The government has certain rights to this invention.

[0004]

[0004] The inventors recognize that the treatment of heart failure or its symptoms can be achieved by nerve ablation of the branches of visceral nerves, and that such alternative treatments may be superior to the current standard of drug therapy for patients with heart failure. Furthermore, the inventors recognize that the current standard of drug therapy is inadequate for many patients with heart failure, and that the treatment of heart failure can be improved by nerve ablation.

[0005]

[0005] For example, common symptoms of heart failure include increased intracardiac pressure and accumulation of blood in the cardiopulmonary circuit. When a patient is suffering from advanced heart failure, standard medications may take too long to reduce intracardiac pressure and prevent hospitalization, for example, due to the low bioavailability of drug therapy or the considerable time it takes to pharmacologically reduce fluid accumulation in the body. Other patients prescribed standard medications to reduce intracardiac pressure may not respond to the medication, may be unable to receive certain medications due to drug interactions or other comorbidities, or may require non-standardized doses of medication to achieve efficacy, all of which can limit the effectiveness of the medication. In other cases, patients suffering from early-stage heart failure may not meet the criteria for hospitalization to treat heart failure, and hospitalization may be refused until the patient's condition becomes critical. Almost all heart failure patients can benefit from non-pharmacological approaches to treating heart failure or its symptoms, particularly those at risk of worsening heart failure but who do not yet meet hospitalization criteria, such as those rated 2-3 on the New York Heart Association's 1-4 scale.

[0006]

[0006] Accordingly, a method for treating heart failure or its symptoms by inactivating the greater splanchnic nerve is disclosed herein. Neural ablation of the greater splanchnic nerve inactivates aspects of the sympathetic nervous system, reduces intracardiac pressure and blood accumulation in the cardiopulmonary circuit, does not require pharmacological intervention, and may reduce the likelihood that heart failure patients will require hospitalization.

[0007]

[0007] Furthermore, current devices and methods for ablation of the greater splanchnic nerve may utilize electrode assemblies, which are recognized by the inventors as being prone to failure or causing unnecessary trauma to vascular and surrounding tissues compared to those required for nerve ablation. For example, a current method of destroying the greater splanchnic nerve is open cardiac surgery, which requires opening the sternum, reflexes of vital organs (including the heart and lungs) to reach the splanchnic nerve, and physical dissolution of the nerve with a scalpel or other device. Such a procedure is highly invasive and places a greater burden on the patient's heart, which is unacceptable for patients already suffering from heart failure. Another method used for ablation of the greater splanchnic nerve involves puncturing the patient's back with a needle and advancing the needle through the patient's aorta to access the greater splanchnic nerve, which poses considerable risk to surrounding organs, including the lungs, heart, and aorta. In other cases, non-stretchable electrode assemblies used for nerve ablation may induce sharp trauma to vascular tissue and the tissue surrounding the target nerve. Accordingly, embodiments disclosed herein provide a nerve ablation catheter device comprising an improved needle assembly that can be used to access the greater splanchnic nerve through the vascular system of a patient, eliminating the need to puncture the aorta with a needle to access the greater splanchnic nerve. Such a device may be particularly useful in performing methods for treating heart failure or symptoms described herein by enabling nerve ablation of splanchnic nerve branches with less invasiveness, minimizing the burden on the patient's heart and sharp trauma to vascular tissue and surrounding tissue of the target nerve. Furthermore, such an improved needle assembly may be easier to manufacture and may have a reduced error rate by preventing tissue adhesion to the inner surface of the needle assembly.

[0008]

[0008] Embodiments disclosed herein provide a method for treating or preventing heart failure or symptoms of heart failure in a patient in need, comprising: inserting a catheter into a vascular lumen defined by the patient's vascular tissue; guiding the catheter toward a location proximal to a target nerve, wherein the target nerve includes the greater splanchnic nerve; puncturing the patient's vascular tissue with a retractable needle assembly extending outward from the catheter toward the target nerve, wherein the retractable needle assembly comprises an electrode assembly, the retractable needle assembly having a first section surrounding a second section, the second section extending outward from the first section; and delivering stimulating energy to the target nerve using the electrode assembly, thereby completely or partially resecting the target nerve, thereby treating or preventing heart failure or symptoms of heart failure in the patient. In some embodiments, treating or preventing heart failure or symptoms of heart failure in a patient includes reducing intracardiac pressure or reducing blood accumulation in the patient's cardiopulmonary circuit. In some embodiments, the method further includes delivering a pre-stimulation energy to a target nerve before puncturing the vascular tissue of the patient, or after puncturing the vascular tissue of the patient, or a combination thereof, and measuring the physiological response corresponding to the pre-stimulation energy to indicate whether the proximal position of the target nerve is sufficiently close to the target nerve. In some embodiments, the physiological response includes adverse changes in nerve activity, muscle movement, cardiac activity, pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, increased or decreased palmar sweating, increased or decreased temperature related to rectal and / or skin measurements, increased or decreased renal output related to changes in vasodilation, decreased metabolism, decreased glucose release, decreased glucagon release, or increased brain natriuretic peptide. In some embodiments, the physiological response includes measuring action potentials through the target nerve. In some embodiments, an insufficient physiological response corresponding to the pre-stimulation energy is measured to indicate that the proximal position of the target nerve is not sufficiently close to the target nerve.In some embodiments, the method further includes reguiding the catheter toward a second location proximal to the target nerve, where the second location is closer to the target nerve than the first location. In some embodiments, a sufficient physiological response corresponding to the preliminary stimulation energy is measured to indicate that the location proximal to the target nerve is sufficiently close to the target nerve. In some embodiments, sufficient stimulation energy to resect the target nerve includes electrical stimulation. In some embodiments, delivering sufficient stimulation energy to resect the target nerve using an electrode assembly includes heating the target nerve or a portion thereof to about 50, 55, 60, 65, 70, 75, 80, 85, or 90°C. In some embodiments, the method further includes orienting the catheter within the vascular tissue of the patient so that the catheter is oriented to align the needle assembly with the target nerve. In some embodiments, the method further includes using a radiometric marker to orient the catheter within the vascular tissue of the patient so that the catheter is oriented to align the needle assembly with the target nerve. In some embodiments, catheter orientation includes orienting the needle assembly in a direction that aligns the electrode assembly with the target nerve. In some embodiments, catheter orientation includes rotating the catheter so that the needle assembly extends from the catheter to the target nerve. In some embodiments, the method further includes delivering confirmation stimulus energy after the target nerve has been resected and measuring the physiological response or change in physiological response corresponding to the confirmation stimulus energy to confirm the interruption of the target nerve's neural activity. In some embodiments, the physiological response corresponding to the confirmation stimulus energy is measured to indicate that the ablation of the target nerve was unsuccessful. In some embodiments, the method further includes delivering stimulus energy to the target nerve using the electrode assembly to repeat the ablation of the target nerve. In some embodiments, the target nerve is the greater splanchnic nerve. In some embodiments, the target nerve is the left branch, right branch, twig, or minor branch of the greater splanchnic nerve.In some embodiments, guiding the catheter towards a proximal position of the target nerve includes guiding the catheter towards the 9th thoracic vertebra (T9), 10th thoracic vertebra (T10), 11th thoracic vertebra (T11), 12th thoracic vertebra (T12), or 1st lumbar vertebra (L1). In some embodiments, the stimulation energy is approximately 10W to approximately 100W. In some embodiments, the stimulation energy is approximately 25W to approximately 75W. In some embodiments, the stimulation energy is approximately 30, 35, 40, 45, 50, 55, 60, 65, or 70W. In some embodiments, the stimulation energy is approximately 50W.

[0009]

[0009] Embodiments disclosed herein provide a vascular catheter comprising a needle assembly lumen comprising a catheter shaft having a longitudinal axis, a distal end, a proximal end, and an exit port, and a retractable needle assembly extending through the exit port and configured to puncture vascular tissue in contact with the catheter, wherein the needle assembly comprises one or more electrodes configured to deliver electrical energy to tissue in contact with one or more electrodes, and the retractable needle assembly comprises a needle assembly lumen comprising a first section surrounding a second section, the second section extending outward from the first section, a guidewire lumen, and a catheter tip. In some embodiments, the vascular catheter further comprises a contrast-enhanced lumen. In some embodiments, the exit port is located on the side of the catheter shaft. In some embodiments, the catheter further includes an electrical surface on the needle assembly. In some embodiments, the catheter further includes a base electrode on the outer surface of the catheter. In some embodiments, the base electrode is positioned on the outer surface of the vascular catheter at a radial angle of 0 to 90 degrees on the outer surface of the vascular catheter with respect to the longitudinal axis of the vascular catheter. In some embodiments, the catheter further includes a plurality of base electrodes on the outer surface of the catheter. In some embodiments, the catheter further includes a first electrical circuit electrically coupled to one or more electrodes. In some embodiments, the catheter further includes a second electrical circuit electrically coupled to the base electrode. In some embodiments, the catheter is configured to provide electrical energy of different frequencies to the first and second electrical circuits. In some embodiments, the needle assembly includes one or more tubular bodies, a distal end, a first electrode, a second electrode, a wire connecting the first and second electrodes to a power source, and insulating material that insulates the first electrode, the second electrode, and the wire from the vascular catheter. In some embodiments, the wire includes an enameled wire or a multi-strain braid. In some embodiments, a first section comprises a first tubular body, and a second section comprises a second tubular body, the first tubular body extending outward from the second tubular body, and the first tubular body is nested within the second tubular body, thereby the tubular body being fully or partially housed within the first tubular body.In some embodiments, the needle assembly further comprises a third section having a sharp distal point, the second section enclosing the third section, and the third section extending outward from the second section. In some embodiments, the first electrode is positioned on the first tube and the second electrode is positioned on the second tube. In some embodiments, the first and second electrodes are positioned on the first tube or on the second tube. In some embodiments, the needle assembly further comprises an electrical insulating material within the needle assembly, the electrical insulating material comprising a dielectric insulator between the first tube and the second tube. In some embodiments, the needle assembly further comprises an electrical insulating material within the needle assembly, the electrical insulating material comprising an insulator or dielectric washer positioned between the first tube and the second tube along the circular cross-section of the first tube or the second tube. In some embodiments, one or more electrodes include only a single electrode. In some embodiments, one or more electrodes include two electrodes. In some embodiments, one or more electrodes include three electrodes. In some embodiments, the three electrodes are arranged such that the second electrode is between the first and third electrodes, with the second electrode being the negative electrode and the first and third electrodes being the positive electrodes, or adjacent electrodes having opposite polarities. In some embodiments, the three electrodes are arranged such that the second electrode is between the first and third electrodes, with the second electrode being the positive electrode and the first and third electrodes being the negative electrodes. In some embodiments, the catheter is configured to allow ablation between the first and second electrodes, or between the second and third electrodes. In some embodiments, the needle assembly further comprises an electrical insulating material within the needle assembly. In some embodiments, the electrical insulating material includes a dielectric, a dielectric washer, or a polyimide liner. In some embodiments, the needle assembly further comprises a third electrode. In some embodiments, the needle assembly further comprises a separate electrical circuit for each electrode. In some embodiments, the needle assembly is configured such that, when extended a predetermined distance from the exit port, close to the target nerve, and energized, the vascular catheter excises a length of the target nerve that is at least the same as or longer than the deployed distance between the first and second tubes.In some embodiments, the insulating material includes a dielectric washer. In some embodiments, the first electrode and the second electrode are electrically insulated from each other. In some embodiments, the needle assembly is configured to deliver charge in a bipolar manner. In some embodiments, the first electrode and / or the second electrode are operably in communication with a controller configured to modulate power delivered by an energy source. In some embodiments, one or more electrodes include an electrode manufactured by silkscreen. In some embodiments, one or more electrodes include an electrode manufactured by additive manufacturing. In some embodiments, one or more electrodes include an electrode manufactured by subtractive manufacturing. In some embodiments, the catheter further includes a base configured at the proximal end of the vascular catheter to allow manipulation of the vascular catheter. In some embodiments, the catheter further includes a vascular catheter rotation knob configured to rotate the vascular catheter. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter or needle assembly. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter, needle assembly, guidewire port, or contrast port. In some embodiments, the catheter further includes a rotary electrical connector configured to rotate the catheter or a rotary control knob. In some embodiments, the catheter further includes a rotary coupler configured to rotate the vascular catheter. In some embodiments, the catheter further includes an electrode advancement section configured to extend the needle assembly and one or more electrodes through an exit port. In some embodiments, the catheter further includes a guidewire port. In some embodiments, the catheter further includes a contrast port. In some embodiments, the catheter further includes a dielectric material that insulates one or more electrodes from the vascular catheter. In some embodiments, the dielectric material includes polyimide.In some embodiments, the vascular catheter shaft includes braided reinforced Pebax, extruded material, nylon, fibrous material, wire, multi-strain braid, or material configured to transmit force through the longitudinal axis. In some embodiments, the needle assembly further comprises one or more marker bands. In some embodiments, the marker bands are configured to provide indications for the positioning of the catheter relative to a vein by fluoroscopic imaging, or to indicate the relative position of the catheter within a vein, artery, or blood vessel. In some embodiments, the needle assembly further comprises a branched configuration comprising a second tube terminating at a sharp point, the first and second tubes being separated when the needle assembly is extended, the first electrode being on the first tube and the second electrode being on the second tube.

[0010] Brief explanation of the drawing

[0010] For a more complete understanding of the present invention, including its features and advantages, a detailed description of the invention is hereby referred to with the accompanying drawings. [Brief explanation of the drawing]

[0011] [Figure 1]

[0011] This figure provides an exemplary flowchart illustrating a method for treating a medical condition according to embodiments described herein. [Figure 2]

[0012] This figure shows an exemplary first embodiment of a device used to treat a medical condition, as described herein. [Figure 3]

[0013] This figure shows an exemplary needle assembly of the device according to Figure 2, before it is branched. [Figure 4]

[0014] This figure shows an example needle assembly of the device shown in Figure 2 after it has been branched. [Figure 5]

[0015] Figure 2 shows an exemplary embodiment of the device with the needle assembly extending toward the target nerve. [Figure 6]

[0016] FIG. 2 is a diagram showing an exemplary embodiment of the device in a state where the needle assembly extends in a branched configuration toward the target nerve. [Figure 7]

[0017] FIG. [X] is a diagram showing an exemplary second embodiment of the device used to treat the medical conditions described herein. [Figure 8]

[0018] FIG. 7 is a diagram showing an exemplary needle assembly of the device before branching. [Figure 9]

[0019] FIG. 7 is a diagram showing an exemplary needle assembly of the device after branching. [Figure 10]

[0020] FIG. 7 is a diagram showing an exemplary embodiment of the device before balloon inflation. [Figure 11]

[0021] FIG. 7 is a diagram showing an exemplary embodiment of the device after balloon inflation. [Figure 12]

[0022] FIG. 7 is a diagram showing an exemplary embodiment of the device comprising a needle assembly that has punctured the vein wall. [Figure 13]

[0023] FIG. 7 is a diagram showing an exemplary embodiment of the device comprising a branched needle assembly extending toward the target nerve. [Figure 14]

[0024] FIG. [X] is a diagram showing an exemplary third embodiment of the device used to treat the medical conditions described herein. [Figure 15]

[0025] FIG. 14 is a diagram showing an exemplary needle assembly of the device. [Figure 16]

[0026] FIG. 14 is a diagram showing an exemplary embodiment of the device comprising a needle assembly that has punctured the vein wall. [Figure 17]

[0027] FIG. 14 is a diagram showing an exemplary embodiment of the device comprising a needle assembly extending toward the target nerve. [Figure 18]

[0028] Note: The 'FIG. [X]' notations in the translation are placeholders as the original text seems to have some missing figure numbers which should be filled in according to the actual context. Also, the 7-digit tags -

[0028] are preserved as they are.This figure provides an example of an exemplary method for treating a medical condition according to the embodiments described herein, which offer various options such as different ablation modalities. [Figure 19]

[0028] This figure provides an example of an exemplary method for treating a medical condition according to the embodiments described herein, which offer various options such as different ablation modalities. [Figure 20]

[0028] This figure provides an example of an exemplary method for treating a medical condition according to the embodiments described herein, which offer various options such as different ablation modalities. [Figure 21]

[0028] This figure provides an example of an exemplary method for treating a medical condition according to the embodiments described herein, which offer various options such as different ablation modalities. [Figure 22]

[0029] This figure provides an illustrative diagram of the location of the greater splanchnic nerve relative to other identifiers. [Figure 23A]

[0030] This figure shows an exemplary device used to treat medical conditions, as described herein. [Figure 23B]

[0031] This figure shows an exemplary device used to treat a medical condition as described herein, with the needle assembly in an extended state. [Figure 24A]

[0032] This is a high-magnification cross-sectional view of an exemplary device used to treat a medical condition, as described herein. [Figure 24B]

[0033] This is a cross-sectional view of an exemplary device used to treat a medical condition, as described herein. [Figure 25A]

[0034] This is an exploded view of a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 25B]

[0035] This figure shows a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 26A]

[0036] This is an exploded view of a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 26B]

[0037] This figure shows a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 27A]

[0038] This is a cross-sectional view of a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 27B]

[0039] This is a longitudinal cross-sectional view of a needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 28]

[0040] This figure shows an exemplary second catheter tip of an exemplary device used to treat a medical condition, as described herein. [Figure 29A]

[0041] This figure shows a second exemplary needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 29B]

[0042] This is an exploded view of a second exemplary needle assembly of an exemplary device used to treat a medical condition, as described herein. [Figure 30A]

[0043] This figure shows an example of a graph of thermal area diameter after various treatment times. [Figure 30B]

[0043] This figure shows an example of a graph of thermal area diameter after various treatment times. [Figure 31A]

[0044] This figure shows an example of a graph of thermal region length after various treatment times. [Figure 31B]

[0044] This figure shows an example of a graph of thermal area length after various treatment times. [Figure 31C]

[0044] This figure shows an example of a graph of thermal area length after various treatment times. [Figure 32A]

[0045] This figure shows an example of a graph of thermal area diameter at various treatment power levels. [Figure 32B]

[0045] This figure shows an example of a graph of thermal area diameter at various treatment outputs. [Figure 32C]

[0045] This figure shows an example of a graph of thermal area diameter at various treatment outputs. [Figure 33A]

[0046] This figure shows an example of a graph of thermal region length at various treatment power levels. [Figure 33B]

[0046] This figure shows an example of a graph of thermal area length at various treatment outputs. [Figure 33C]

[0046] This figure shows an example of a graph of thermal area length at various treatment outputs. [Modes for carrying out the invention]

[0012] Detailed description of the invention

[0047] Devices, systems, and methods for treating medical conditions by coordinated disruption of neural activity relating to one or more target nerves are provided herein. In some embodiments, the disruption of neural activity induces a response to treat the medical condition, including alleviation of the symptoms of the medical condition. In some embodiments, the disruption of neural activity includes destroying a portion of one or more target nerves. In some embodiments, destroying a portion of one or more target nerves includes enabling such destruction by targeting the target nerve at one or more different locations. In some embodiments, a branched needle assembly having two needles with spaced-apart tips (e.g., needle electrodes as described herein) is introduced using a device (e.g., a catheter-based device) to enable ablation of the target nerve at one or more different locations, providing an ablation of a desired length along the length of the target nerve, resulting in an extension of the treatment period for the medical condition and further minimizing collateral damage. In some embodiments, the location of the target nerve is confirmed by any combination of fluoroscopy, nerve stimulation, and / or nerve sensing to ensure precise ablation of the target nerve. For example, in some embodiments, nerve stimulation enables real-time or substantially real-time confirmation of the target nerve location.

[0013]

[0048] In some embodiments, the medical condition includes heart failure such as inefficient cardiac pumping, and disruption of target nerves such as visceral nerves (e.g., denervation of target nerves) allows for the removal of fluid from blood vessels and tissues (e.g., blood accumulation in the heart), thereby easing cardiac blood pressure by sending the removed fluid into the abdominal cavity.

[0014] Medical condition

[0049] In some embodiments, the systems, devices, and methods described herein are used to treat medical conditions. In some embodiments, as described herein, the medical conditions include heart failure, constipation, metabolic syndrome (including obesity), hyperhidrosis, hypertension, or other conditions known in the art to be affected by disruption of the neural activity of one or more target nerves, or combinations thereof.

[0015]

[0050] Heart failure affects more than 6 million people. In some cases, heart failure is characterized by inefficient cardiac pumping action due to muscle weakness. As a result, in some cases of heart failure, anterior blood flow is poor, which can lead to blood stagnation and pressure buildup in the cardiac and pulmonary circuits. Therefore, intracardiac pressure can increase, leading to symptoms such as congestion, shortness of breath, and / or respiratory failure. In some cases, conventional methods to reduce the pressure-volume load on the cardiopulmonary circuits involve removing fluid (e.g., fluid buildup such as blood) from blood vessels and tissues, thereby potentially alleviating heart failure symptoms.

[0016]

[0051] In some cases, patients are in a state of compensated heart failure with no cardiopulmonary pressure or symptoms. In some cases, cardiac recovery from such a state of compensated heart failure occurs with drug therapy. In some cases, patients become trapped in a vicious cycle of volume accumulation, hospitalization for fluid removal, and discharge, and cardiac recovery does not occur. In some cases, such patients do not respond to conventional drug therapy.

[0017]

[0052] Accordingly, in some embodiments, the systems, methods, and devices described herein are configured to provide a mechanical reduction of intracardiac pressure, for example, by redistributing fluid away from the heart (e.g., blood), in order to alleviate intracardiac pressure.

[0018]

[0053] In some embodiments, a fluid (e.g., blood) is redistributed away from the heart to one or more body cavities (e.g., blood vessels within the body cavities) within the patient being treated. In some examples, the abdominal cavity has high vascular function for absorbing fluid. Therefore, in some examples, benefits to the heart can be obtained by introducing a mechanism to redistribute fluid from the cardiopulmonary circuit to the abdominal cavity. In some examples, vascular function is determined by various factors, including autonomic nervous system activity. Some of the sympathetic nerves innervating the abdominal cavity include visceral nerves, which originate from sympathetic nerve chains in the thoracic cavity, proceed to the abdominal cavity, and synapse there on various ganglia. Sympathetic visceral nerve activity results in vasoconstriction in the abdominal cavity. Therefore, in some embodiments, the systems, methods, and devices described herein are configured to inactivate sympathetic nerve activity (visceral nerves) to vasodilate the visceral vascular network, thereby drawing fluid into the abdominal cavity. In some examples, there are several types of interventions to interrupt visceral nerve activity in order to achieve visceral vasodilation. In some embodiments, such multiple types include percutaneous means, transvascular means, and / or surgical means.

[0019] Methods to lower heart blood pressure

[0054] Figure 1 provides an exemplary method for lowering cardiac blood pressure by redistributing fluid (e.g., blood) from the heart to one or more body cavities. In some embodiments, the method includes interrupting (e.g., denervating) the neural activity of one or more target nerves. In some embodiments, one or more target nerves are first identified and / or confirmed by one or more sensing techniques described herein, and then the neural activity of one or more target nerves is interrupted. In some embodiments, a device described herein (e.g., a catheter-based device) is used to identify and / or confirm the location of one or more target nerves and / or to interrupt the neural activity relating to one or more target nerves. As described herein, one or more target nerves include visceral nerves, lumbar sympathetic nerves, stellate ganglia, other target nerves known in the art, or any combination thereof. As described herein, in some embodiments, visceral nerves enable (as described herein) the treatment of heart failure. Examples of splanchnic nerve branches include the greater splanchnic nerve (GSN), the lesser splanchnic nerve, and the least splanchnic nerve, all of which can be targeted (in combination or individually) for the treatment of medical conditions. For example, in some cases, the GSN is a branch of the thoracic sympathetic nerve and is therefore configured to provide sympathetic innervation to the abdominal cavity. The GSN traverses the thoracic cavity, passes through synapses of the aortic hiatus and the celiac ganglion, and from there can innervate several target organs, including the abdominal vascular network. Therefore, inactivating the GSN dilates the abdominal vascular network, thereby drawing blood volume from the circulatory system. As described herein, in some cases, the volume drawn from the heart reduces the pressure load in the cardiopulmonary system, which can be demonstrated, for example, by a decrease in pulmonary capillary wedge pressure (PCWP), as described herein.

[0020]

[0055] In some embodiments, targeting the lumbar sympathetic nerves makes it possible to treat peripheral artery disease. In some embodiments, targeting the sympathetic ganglia makes it possible to treat ventricular arrhythmias.

[0021]

[0056] In the exemplary method described in Figure 1, the target nerves include visceral nerves, and the body cavity receiving the redistributed fluid (e.g., blood flow) includes the abdominal cavity.

[0022] Identification of target nerves

[0057] In some embodiments, the location of the target nerve is first approximated using a device described herein (e.g., a catheter-based device), and then the target nerve is identified and / or confirmed to ensure that the correct nerve is targeted for disruption of nerve activity to obtain the desired effect. In some embodiments, confirmation of disruption of nerve activity at the target nerve serves as an exemplary identifier that the desired effect (e.g., treatment of a medical condition such as a decrease in intracardiac pressure) has occurred within the patient being treated.

[0023]

[0058] In some embodiments, the device is used to access target nerves (e.g., visceral nerves) within the patient. In some embodiments, the device described herein is used. In some embodiments, the device is a catheter-based device. In some embodiments, the device is inserted into the patient 102. In some embodiments, the device is used to access the vascular system (e.g., via the femoral and / or subclavian). In some embodiments, the device accesses the vascular system to inactivate sympathetic nerve activity. In some embodiments, the device accesses the vascular system by the Seldinger technique. In some examples, access points for the vascular system in the upper limbs include the jugular vein and / or subclavian vein. In some examples, access points for the vascular system in lower limb access include the femoral vein. Thus, in some embodiments, the device described herein is configured to advance from either the jugular vein, subclavian vein, and / or femoral vein to the superior vena cava. In some embodiments, the device is advanced under fluoroscopic guidance. Figure 22 provides an illustrative illustration of the anatomical structures of visceral nerves and veins.

[0024]

[0059] In some embodiments, the device is first advanced to a predetermined location of the target nerve within the patient being treated (104). In some embodiments, such a predetermined location is based on the use of anatomical landmarks. In some embodiments, the device is guided to the predetermined location of the target nerve under fluoroscopy in view of anatomical landmarks. In some embodiments, the anatomical landmarks include radiopaque anatomical landmarks. For example, in some embodiments, the device accesses the azygos vein 2202, a branch of the superior vena cava (via an access point described herein). In some embodiments, the device is configured to enter the left and / or right intercostal venous branches 2204. In some embodiments, the device enters the left and / or right intercostal venous branches via anatomical landmarks. In some embodiments, the anatomical landmark includes the ninth thoracic vertebra (T9) 2208 (depicted as being located behind the intersection of the greater splanchnic nerve (GSN) 2206 and the left and / or right intercostal vein branches 2204), and the exemplary target nerve, the greater splanchnic nerve (GSN) 2206, is located near T9. Thus, the location of the GSN can be determined by T9. As described herein, in some embodiments, the device is further configured to confirm the location of the target nerve (e.g., the GSN) by direct nerve sensing and / or nerve stimulation while measuring the physiological response.

[0025]

[0060] In some embodiments, in addition to or instead of using anatomical landmarks to approximate the location of a target nerve, the devices described herein approximate the location of a target nerve using neurosensory information. In some embodiments, the device includes a neurosensory region configured to detect action potential signals indicating the presence of a nearby nerve (relative to the device). In some embodiments, as described herein, the neurosensory region includes one or more neurosensory electrodes.

[0026]

[0061] In some embodiments, the devices described herein are configured to stimulate a target nerve to induce a nerve response, thereby allowing the location and / or identification of the target nerve to be confirmed (106). In some embodiments, the device includes a nerve stimulation component for stimulating a target nerve. In some embodiments, the device is configured to deliver an electric charge to a patient by the nerve stimulation component in order to induce a nerve response from a target nerve (e.g., GSN). In some embodiments, the nerve stimulation component is configured to deliver the electric charge via one or more nerve stimulation electrodes. In some embodiments, the nerve stimulation component (e.g., one or more nerve stimulation electrodes) is configured to deliver the electric charge intravascularly (e.g., vein, artery, or intravascular) and / or extravascularly (e.g., vein). In some embodiments, the device is configured to puncture a blood vessel (e.g., vein) and position one or more nerve stimulation electrodes to be in contact with the target nerve or to position the nerve stimulation electrodes in close proximity to the target nerve in order to deliver the electric charge. In some embodiments, the device is configured to deliver an electric charge that is strong enough to induce a neuronal response but not strong enough to damage tissue (e.g., target nerve tissue and / or surrounding tissue). In some embodiments, proximity of the device to a target nerve (e.g., GSN) is confirmed by inducing one or more sympathetic responses by delivering the electric charge (107). In some embodiments, such sympathetic responses may be detected via measured physiological responses. Examples of detecting sympathetic responses of a GSN via measured physiological changes in some embodiments include adverse changes in pulmonary capillary wedge pressure (PCWP) (e.g., increased PCWP), gastrointestinal changes including increased motility, decreased palmar sweating, abnormal changes in temperature related to rectal and / or skin measurements, abnormal changes in renal output related to changes in vasodilation, metabolic changes (i.e., decreased glucose and glucose release), and / or increased brain natriuretic peptide. In some embodiments, the devices described herein are configured to detect and measure any such indicators of sympathetic response.In some embodiments, any such indicator relating to the sympathetic nervous system response is detected by using medical techniques and / or devices known in the Art.

[0027]

[0062] For example, in some cases, PCWP is obtained during right cardiac catheterization procedures routinely performed in hospitals. An example of such a right cardiac catheterization procedure involves percutaneous access of the catheter through the jugular vein in a sterile manner (e.g., by using the Seldinger technique). In some embodiments, the catheter (for obtaining PCWP) may include a Swan-Ganz catheter that has a balloon. In some embodiments, the balloon of the Swan-Ganz catheter is inflated and passed through the superior vena cava, right atrium, and right ventricle to the pulmonary outflow tract. In some embodiments, the inflated balloon carries the catheter to the pulmonary artery, where it is wedged, and the pressure detected is called the pulmonary capillary wedge pressure. In some embodiments, PCWP is considered equal to left atrial pressure. In some embodiments, left atrial pressure is a surrogate measure of left ventricular end-diastolic pressure. Thus, in some embodiments, PCWP is a measure of the severity of heart failure, with higher PCWP indicating worsening of the severity of heart failure.

[0028]

[0063] In some embodiments, the location of a target nerve can be determined by detecting action potentials from the target nerve using a neurosensory region, in addition to or instead of detecting physiological responses to determine the location of the target nerve.

[0029]

[0064] As described herein, in some embodiments, the detection of each of the other responses induced by stimulation of a target nerve is measured by the devices described herein and / or other respective devices and methods known in the Art.

[0030]

[0065] In some embodiments, the devices described herein (e.g., catheter devices) are configured to sense the presence of a nerve (e.g., a target nerve), deliver an electric charge to provide nerve stimulation to the target nerve, thereby inducing a sympathetic response, and / or to detect and measure the sympathetic response and / or action potential from the target nerve. For example, in some embodiments, the device is configured to directly sense the target nerve via a neurosensory region as described herein, the neurosensory region may include one or more neurosensory electrodes. In some embodiments, one or more neurosensory electrodes and one or more neurostimulating electrodes (electrodes for delivering electric charge to the target nerve as described herein) constitute a separate electrode set. In some embodiments, one or more neurostimulating electrodes are also configured to function as neurosensory electrodes. In some embodiments, where the device has separate electrode sets for neurosensory and neurostimulatory functions or the same electrode set for the above functions, the device is further configured to switch from a neurosensory mode to a neurostimulatory mode for stimulating a target nerve. In some embodiments, the methods described herein include placing the device into the neurosensory mode when it is positioned proximal to a GSN (e.g., by a T9 landmark) to confirm the presence of a nearby nerve (of the device). In some embodiments, the device is configured to operate simultaneously in neurosensory and neurostimulatory modes. In some embodiments, as described herein, when the device is in neurosensory mode, it uses electrodes and / or other components to detect action potentials representing the presence of a nearby nerve. In some embodiments, the devices described herein (e.g., catheter-based devices) are operable to communicate with a computing device. In some embodiments, data from the neurostimulatory component and / or neurosensory component (of the same device) are communicated to the computing device. In some embodiments, data from the neurostimulatory component and / or neurosensory component are aggregated to indicate that the device is positioned to perform nerve destruction to interrupt nerve activity.

[0031] Interruption of target neural activity

[0066] In some embodiments, once the location of a target nerve (e.g., GSN) is confirmed (e.g., by nerve stimulation and / or neurosensing as described herein), nerve activity relating to the target nerve is interrupted (108). In some embodiments, such confirmation of target nerve location includes measuring the response to the stimulated target nerve (e.g., sympathetic response) by physiological response as described herein (107), and / or detecting the action potential of the target nerve. In some embodiments, confirmation of target nerve location includes a combination of nerve stimulation and nerve sensing functions evaluated by software components of a computing device as described herein.

[0032]

[0067] In some embodiments, interrupting nerve activity includes resecting a target nerve. In some embodiments, the devices described herein are configured to resecte a portion of a target nerve (e.g., GSN). In some embodiments, ablation of a target nerve includes circumferential dissolution of the target nerve. As described herein, the devices may be configured to resecte a portion of a target nerve using a number of different methods. For example, in some embodiments, the device includes a vascular puncture mechanism for performing ablation. In some embodiments, the vascular puncture mechanism is activated in the direction of the nerve to perform ablation. In some embodiments, the vascular puncture mechanism is also configured to confirm the position of the device using a combination of fluoroscopy that identifies 1) nerve sensing, 2) nerve stimulation with a physiological response, and / or 3) anatomical landmarks (e.g., the 9th thoracic vertebra (T9), the 10th thoracic vertebra (T10), the 11th thoracic vertebra (T11), the 12th thoracic vertebra (T12), or the 1st lumbar vertebra (L1)). In some embodiments, the device is configured to destroy a portion of a target nerve (a portion of a GSN) using one or more of the following modalities: radiofrequency ablation, chemical ablation (carbon dioxide, ethanol, liquid nitrogen), or cryotherapy ablation. In some embodiments, in addition to or instead of resecting the target nerve, the device described herein is configured to suppress a portion of the target nerve.

[0033]

[0068] As described herein, destroying a portion of a target nerve (e.g., by ablation) corresponds to destroying a portion of the nerve tissue of the target nerve. In some embodiments, such a portion of the target nerve (e.g., GSN) that is destroyed (e.g., ablated) can regenerate. Thus, in some embodiments, the length of the portion of the target nerve to be destroyed can be specified or predetermined. In some embodiments, the duration of the effect for providing relief of a medical condition (e.g., heart failure) is related to the length of the nerve tissue of the destroyed target nerve. In some embodiments, the length of target nerve (GSN) destruction is an important factor for providing relief of heart failure symptoms, and destroying a longer target nerve (e.g., by a vascular puncture mechanism and compared to intravascular ablation) results in a longer duration of sympathetic nerve activity reduction, thereby allowing the patient to experience relief of heart failure symptoms for a longer period. In some embodiments, vascular puncture (e.g., using the devices described herein) is configured to control the direction of the ablation modality. Thus, in some embodiments, the device is configured to target the ablation of the target nerve to a specific portion and length of the corresponding nerve tissue. In some embodiments, the systems, methods, and devices described herein are configured to minimize collateral damage to other organs when a target nerve is resected. In some embodiments, collateral damage to other organs when a target nerve is resected is made possible by 1) positioning one or more ablation electrodes in close proximity to or in contact with the target nerve, 2) delivering ablation energy by a bipolar configuration (which helps to control the shape and distribution of the ablation energy (e.g., radio frequency energy)), and / or 3) reducing the amount of ablation energy required to interrupt the neural activity of the target nerve. In some embodiments, the ablation energy (e.g., radio frequency energy, microwave energy) delivered to the target nerve is about 0.1 W to about 100 W. In some embodiments, the temperature provided for resecting the target nerve is about -200°C to about 100°C.As described herein, in some embodiments, a needle assembly comprising two needles (e.g., two needle electrodes) is used to allow multiple electrodes to contact or be positioned in close proximity to a target nerve at two different locations, thereby enabling the resection of a length of target nerve tissue.

[0034]

[0069] In some embodiments, the success of the methods described herein for treating a medical condition (e.g., heart failure) by nerve disruption is determined by the detection of nerve stimulation and physiological responses (as described herein). In some embodiments, nerve sensing (e.g., measurement of action potentials of a target nerve) is also performed in combination with or alternately with nerve stimulation. For example, in some embodiments, once a portion of a target nerve (e.g., GSN) is destroyed (e.g., by ablation), the device is configured to subsequently provide nerve stimulation to confirm the absence of a sympathetic response (110). In some embodiments, providing nerve stimulation, as described herein, involves delivering a charge (e.g., by a nerve stimulation component) through electrodes that is strong enough to induce a nerve response but not strong enough to damage tissue (nerve tissue or surrounding tissue). In some embodiments, the presence of a sympathetic response in the GSN is then monitored, for example, via physiological responses (as described herein).

[0035]

[0070] In some embodiments, after a portion of the target nerve is destroyed (e.g., excised), physiological parameters are fixed and used as a baseline for detecting changes after the target nerve has been stimulated (e.g., by the nerve stimulation component described herein) as an indicator of sympathetic response. For example, as described herein, in some embodiments, the presence of a sympathetic response includes detecting adverse changes in pulmonary capillary wedge pressure (PCWP) (e.g., an increase in PCWP), gastrointestinal changes including increased motility, changes in palmar sweating, abnormal changes in temperature related to rectal and / or skin measurements, abnormal changes in renal output related to changes in vasodilation, metabolic changes (i.e., decreased glucose and glucose release), and / or an increase in brain natriuretic peptide. In some embodiments, the nerve sensing component of the device detects the absence of nerve activity (e.g., by detecting arbitrary action potentials) thereby indicating that nerve ablation has been successful (e.g., successful circumferential dissolution) (112). In some embodiments, detection of a decrease in PCWP (e.g., by the method described herein) indicates that ablation has been successful when blood is being drawn from the heart into the abdominal cavity. In some embodiments, detection of a sympathetic response (e.g., a physiological response as described herein, or measurement of an action potential from the target nerve) may indicate that the target portion of the target nerve was not successfully destroyed (e.g., ablation), and therefore the treatment of the medical condition may be considered incomplete. In some embodiments where the treatment is deemed incomplete, the method described herein (e.g., Figure 1) is repeated to locate and destroy a portion of the target nerve as described herein.

[0036] device

[0071] As described herein, in some embodiments, the devices described herein are configured to treat a medical condition by interrupting the neural activity of one or more target nerves. In some embodiments, the devices are configured to destroy (e.g., by ablation) a portion of the neural tissue of one or more target nerves. In some embodiments, the devices are configured to target a specific portion of the target nerve for the above destruction. In some embodiments, the devices are configured to provide neural stimulation to the target nerve, sense neural activity from the target nerve, and / or excise a portion of the target nerve.

[0037]

[0072] In some embodiments, the device includes a catheter-based device. In some embodiments, the catheter-based device comprises a device body configured to advance within a patient. In some embodiments, the device body comprises a radiopaque region (see, for example, reference numeral 204 in Figure 2). In some embodiments, the radiopaque region allows for fluoroscopic guidance of the device within the patient. In some embodiments, the device body operably communicates with a power supply, controller, actuator, and / or computing device to initiate and / or terminate or pause the operation of the device. In some embodiments, the device is configured to operably communicate with a power supply via a cord (e.g., a cord plugged into a power supply). In some embodiments, the device is configured to operably communicate with a controller and / or actuator via a cord (e.g., a cord plugged into a power supply). In some embodiments, the device is configured to operably communicate with a computing device, power supply, controller, and / or actuator via a wireless component (e.g., Bluetooth®).

[0038]

[0073] In some embodiments, the catheter-based device comprises a vascular puncture mechanism, a mechanism for biasing the catheter against a vein wall (within the patient), one or more ablation electrodes, one or more nerve stimulating electrodes, a nerve sensory region, or a combination thereof. In some embodiments, the vascular puncture mechanism comprises one or more needles or needle arrays of varying sizes. In some embodiments, the device is configured to position one or more ablation electrodes so as to contact or be positioned in close proximity to a target nerve, using the vascular puncture mechanism. In some embodiments, the device provides nerve stimulation to a target nerve using one or more nerve stimulating electrodes. In some embodiments, the device is configured to sense the activity of the target nerve via a nerve sensory region. In some embodiments, the nerve sensory region comprises one or more nerve sensory electrodes. In some embodiments, the nerve sensory region comprises one or more sensors configured to sense nerve activity (such as action potentials). In some embodiments, the device is configured to excise a portion of the target nerve using one or more ablation electrodes. In some embodiments, the ablation electrode is configured to excise at least a portion of the target nerve using radiofrequency energy, microwave energy, or a combination thereof. In some embodiments, the device is configured to excise a portion of the target nerve without an ablation electrode (e.g., chemical ablation, cryoablation, etc.).

[0039]

[0074] In some embodiments, one or more ablation electrodes, one or more nerve stimulation electrodes, and one or more nerve sensory electrodes are provided as separate electrodes on the device. In some embodiments, one or more ablation electrodes, one or more nerve stimulation electrodes, one or more nerve sensory electrodes, or any combination thereof, include the same electrode. In some embodiments, the ablation electrodes, nerve stimulation electrodes, nerve sensory electrodes, or any combination thereof, include the same electrode or different electrodes based on the placement and / or positioning of the device body (e.g., catheter tip) within the patient being treated.

[0040] Vascular puncture mechanism

[0075] In some embodiments, as described herein, the device includes a vascular puncture mechanism (e.g., a venous puncture mechanism) configured to position a needle assembly (e.g., including a needle and an electrode) to contact or be in close proximity to a target nerve (as described herein). In some embodiments, the vascular puncture mechanism includes a needle assembly configured to puncture a vein or artery. In some embodiments, the needle assembly includes one or more needles (e.g., needle electrodes or hollow needles as described herein) configured to puncture a vein or artery. In some embodiments, the needle assembly includes an ablation electrode, a nerve sensory electrode, and / or a nerve stimulating electrode. In some embodiments, one or more ablation electrodes are disposed together with the needle assembly. In some embodiments, the needle assembly is configured to extend from the device body of the device toward the target nerve.

[0041]

[0076] In some embodiments, the needle assembly is configured to extend from within the device body of a device (e.g., a catheter-based device) toward a target nerve (e.g., see Figures 2-6). In some embodiments, the needle assembly is configured to extend through a vascular wall (e.g., a vein wall) and puncture. In some embodiments, the needle assembly is configured to extend from the device body by a needle assembly pushing mechanism that can be operated and / or moved from a location outside the patient (e.g., a location outside the patient that is accessible to the user). In some embodiments, the orientation of the needle assembly extending through the vascular wall toward the target nerve is adjustable by adjusting the orientation of the device body within the patient (e.g., rotating the device body). In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, radiopaque marks appear differently every 90 degrees on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, laterally / medially, and / or cranially / caudally. In some embodiments, the radiopaque appearance of the radiopaque mark under fluoroscopy changes as the device body rotates, which can help guide the device body and position the needle assembly. In some embodiments, the position on the device body from which the needle assembly extends and / or the orientation from which the needle assembly extends correlates with the positions of 1) radiopaque marks, 2) one or more nerve stimulation electrodes, and / or 3) neurosensory regions (e.g., neurosensory electrodes, nerve sensors, etc.). In some embodiments, the device body has a longitudinal axis, and the needle assembly is configured to extend at a non-zero angle with respect to the longitudinal axis.

[0042]

[0077] In some embodiments, the needle assembly extends from the device body of the device into a needle tube located within the needle lumen of the device body or outside the device body. In some embodiments, the needle tube is configured to extend until its end abuts against or is positioned close to a blood vessel wall (e.g., a vein wall). In some embodiments, the needle tube is configured to extend from the device body via a tube pushing mechanism that can be operated and / or moved from a position outside the patient (e.g., pushed outside the patient by a user). In some embodiments, the needle assembly is configured to extend through an opening at the end of the tube to puncture the blood vessel wall. In some embodiments, the needle assembly is configured to extend from the tube via a needle assembly pushing mechanism that can be operated and / or moved from a position outside the patient. In some embodiments, the orientation in which the needle assembly extends through the blood vessel wall toward the target nerve is adjustable by adjusting the orientation of the device body within the patient (e.g., rotating the device body).

[0043]

[0078] In some embodiments, the device (e.g., a catheter-based device) is configured to provide stepwise stimulation of a target nerve. For example, in some embodiments, the ablation electrode is the same electrode as the nerve stimulation electrode, the needle assembly is located within the needle tube, and the device is configured to stimulate the target nerve 1) when the needle tube and needle assembly are disposed within the device body (i.e., before they are deployed and extended from the device body), and 2) after the needle tube and needle assembly are deployed from the device body and the needle tube has contacted the vessel wall. Thus, in some embodiments, the device is configured to further confirm the location of the target nerve by stimulation provided from a closer position (e.g., at the vessel wall) before puncturing the vessel. In some embodiments, the stimulation is provided only at the vessel wall (i.e., not stepwise stimulation).

[0044]

[0079] In some embodiments, the device body comprises one or more lumens located internally (e.g., needle lumens as described herein). In some embodiments, the needle lumen extends within the device to an opening in the device body. In some embodiments, the opening is a lateral opening in the device body. In some embodiments, the needle lumen extends substantially parallel to the longitudinal axis of the catheter body. In some embodiments, the needle lumen curves to terminate at the lateral opening.

[0045]

[0080] In some embodiments, the needle assembly is at least partially disposed on the external portion of the device body. In some embodiments, the needle assembly is configured to be biased against a vascular wall (e.g., a venous wall) by a balloon, thereby allowing the needle assembly to puncture the vascular wall and extend toward a target nerve (see, for example, Figures 7-20 described herein). In some embodiments, the inflatable balloon is positioned around at least a portion of the outer surface of the device body of the device described herein (e.g., a catheter-based device). In some embodiments, the needle assembly is disposed on the device body such that the needle assembly is moved and biased toward a vascular wall by inflating (or deflating) the balloon. In some embodiments, the needle assembly is biased toward a vascular wall but does not puncture it. In some embodiments, the needle assembly is biased toward a vascular wall and punctures the vessel. In some embodiments, the balloon is inflated or deflated by methods known in the art, such as providing an inflation medium via an inflation tube that is in fluid communication with the inflatable balloon. In some embodiments, the inflation medium includes air, another gas, a liquid, saline solution, or other fluids known in the art. In some embodiments, the inflation medium is supplied by a source located outside the patient being treated. In some embodiments, the needle assembly is configured to puncture the blood vessel wall and extend toward the target nerve by a needle assembly pushing mechanism that can be operated and / or moved from a location outside the patient being treated. In some embodiments, the direction in which the needle assembly extends through the blood vessel wall toward the target nerve is adjustable by adjusting the orientation of the device body within the patient (e.g., by rotating the device body).

[0046]

[0081] In some embodiments, the device body comprises one or more lumens located inside. In some embodiments, the expansion tube is located within the expansion lumen in the device body. In some embodiments, the expansion lumen extends into the device, allowing fluid communication between the inflatable balloon and the expansion tube.

[0047] Needle Assembly

[0082] In some embodiments, as described herein, a needle assembly for any device described herein (e.g., a catheter-based device) (including any vascular puncture mechanism) comprises one or more needle electrodes (see, for example, Figures 4 and 9). In some embodiments, each needle electrode comprises a needle shaft and one or more electrodes. In some embodiments, the needle shaft and one or more electrodes with respect to each needle electrode are integrated together as a single component. In some embodiments, the needle shaft and one or more electrodes are coupled to each other with respect to each needle electrode, and this coupling may be a removable coupling. In some embodiments, one or more electrodes with respect to each needle electrode include one or more ablation electrodes. In some embodiments, one or more electrodes with respect to each needle electrode include one or more ablation electrodes, one or more nerve stimulation electrodes, and / or one or more nerve sensory electrodes. In some embodiments, one or more electrodes are disposed at any position on each needle electrode. In some embodiments, at least one electrode is located at the distal end of a needle electrode, the distal end of the needle electrode stem is in contact with or near a target nerve (e.g., GSN), and the proximal end of the needle electrode is in contact with, within, and / or near the device body of the device. In some embodiments, at least one needle electrode includes a single electrode. In some embodiments, at least one needle electrode includes multiple electrodes. In some embodiments, the multiple electrodes include an electrode array. In some embodiments, the electrode array is arranged in a linear configuration. In some embodiments, the electrode array includes multiple electrodes that are spaced apart from each other and / or electrically insulated. As described herein, in some embodiments, the multiple electrodes (e.g., ablation electrodes) are configured to provide ablation energy in a bipolar manner.

[0048]

[0083] In some embodiments, the needle assembly comprises two or more needle electrodes, and the needle electrodes are configured to be constrained and / or compressed toward each other in the pre-deployment configuration (e.g., when the needle assembly is positioned within the device body, when it is positioned within the needle tube, before it is biased against the vessel wall, before it punctures the vessel wall, or any combination thereof). For example, in some embodiments, two or more needle electrodes are configured to be constrained and / or compressed toward each other when the device body is used to advance to a desired location near a target nerve (e.g., GSN). In some embodiments, two or more needle electrodes remain constrained and / or compressed toward each other in the pre-implantation configuration (e.g., a non-branching configuration as described herein). In some embodiments, the needle assembly is held in the pre-implantation configuration by a needle assembly tube (as described herein), and the needle assembly is positioned within the needle assembly tube (e.g., the inner wall of the needle assembly tube prevents the needle assembly from branching). In some embodiments, two or more needle electrodes are configured to separate from each other at their distal ends when the needle assembly extends a predetermined length from the device body. For example, in some embodiments, the needle assembly comprises two needles configured to branch at the distal end of the needle assembly (see, for example, Figures 3-4 and 8-9), thereby allowing the needle assembly to contact or be positioned in close proximity to the target nerve at two different locations of the two branched distal ends of the needle electrodes. Thus, in some embodiments, the needle assembly is configured to target ablation (e.g., via radio frequency or microwave energy using the needle electrodes) at two or more locations on the target nerve, thereby allowing the length of the target nerve to be resected between and / or around the two or more locations. In some embodiments, the ability of the needle electrode branching makes it possible to alter the shape of the thermal area along the length of the target nerve, thereby maintaining the intended benefit for a longer period.

[0049]

[0084] In some embodiments, the distance between the tips of two needles (e.g., needle electrodes) in a needle assembly in a branched configuration is identified as the deployment distance. As used herein, in some examples, the term “branched configuration” is used interchangeably with the term “branching position.” In some embodiments, the deployment distance is about 1 mm to about 10 cm. In some embodiments, the distance between the tips of two needles (e.g., needle electrodes) in a needle assembly in a non-branched configuration (as described herein) is identified as the non-branching distance. In some embodiments, the deployment distance is greater than the non-branching distance. In some embodiments, the non-branching distance is none (e.g., 0 mm) or substantially none. In some embodiments, as described herein, the device is configured to excise a length of target nerve that is at least the length of the deployment distance.

[0050]

[0085] As described herein, in some embodiments, target nerve ablation includes complete periphery ablation of the target nerve along a given length. In some embodiments, needle electrodes are configured to separate (e.g., branch) from each other by a predetermined length at the distal end of the needle assembly. In some embodiments, needle electrodes are configured to separate (e.g., branch) from each other in a predetermined orientation such that the separation (e.g., branching) (e.g., deployment distance) of the needle electrodes is aligned with the length of the target nerve. For example, in some examples, the target nerve (e.g., GSN) extends perpendicular to the vein described herein, and therefore the needle electrodes separate along the axis of the target nerve when and / or after puncturing the vein wall. In some examples, the target nerve extends parallel to the vein, and therefore the needle electrodes separate along the direction parallel to the target nerve. In some embodiments, each needle electrode of the needle assembly is electrically insulated from each other. In some embodiments, the needle assembly is configured to deliver energy bipolarly. In some embodiments, for example with respect to a branched needle assembly, the radiofrequency energy is configured to be delivered bipolarly through both needle electrodes, which can destroy longer nerves (compared to, for example, intravascular ablation).

[0051]

[0086] In some embodiments, the needle assembly comprises three needles, and the needle assembly is configured to move from a pre-implantation configuration (as described herein) to a configuration in which the tips of the three needles are spaced apart from each other. In some embodiments, the needles are configured to be spaced apart from each other in any direction (e.g., in three dimensions), thereby configuring them to target three locations on the target nerve for ablation.

[0052]

[0087] In some embodiments, the needle assembly comprises one or more needle electrodes having an electrode array disposed thereon. In some embodiments, the electrode array includes multiple electrodes. In some embodiments, the multiple electrodes are electrically insulated from one another. In some embodiments, the electrode array is arranged in a linear configuration on the same side of the needle electrode. In some embodiments, the device is configured to introduce a linear electrode array that moves in one direction along the length of the nerve after venipuncture. The electrode array creates multiple small thermal zones to destroy a long section of the nerve. This can increase the precision and length of nerve destruction. In exemplary embodiments, the linear electrode array is used from within a vein, artery, or blood vessel (e.g., the major azygos vein) that may run parallel to the target nerve (e.g., a visceral nerve), and the linear electrode array is configured to create multiple small thermal zones to destroy a long section of the nerve. This can increase the precision and length of nerve destruction. In some embodiments, a linear electrode array positioned within the target nerve is also configured to stimulate the target nerve.

[0053]

[0088] In some embodiments, the electrode array is arranged spaced apart from one another so that each electrode is configured to target ablation at a corresponding location on the target nerve (for example, after the needle electrode has penetrated the blood vessel wall). Thus, in some embodiments, the needle electrode is configured to target ablation over a length of the target nerve corresponding to at least one length of the electrode array arranged on the needle electrode. In some embodiments, multiple electrodes are arranged on one side of the needle electrode to differentially alter the thermal map of the ablation area, thereby directing the ablation area specifically to the target nerve.

[0054]

[0089] In some embodiments, each needle electrode is operably in communication with a power source (as described herein). In some embodiments, the same power source is configured to deliver power to each needle electrode. In some embodiments, two or more power sources are configured to deliver power to multiple needle electrodes. In some embodiments, the power source is located outside the patient being treated. In some embodiments, the power source includes a controller for modulating the power delivered to the electrodes on the needle assembly. In some embodiments, the power source operably communicates with the controller to modulate the power delivered to the electrodes. In some embodiments, the controller is located on and / or within the device body. In some embodiments, the controller includes a computing device. In some embodiments, the power supplied to each needle electrode of the needle assembly is sufficient to exsect a portion of the target nerve. As described herein, in some embodiments, the power supplied to each needle electrode emits high-frequency energy (e.g.) that generates heat, thereby excising a portion of the target nerve. In some embodiments, the power source and controller are configured to modulate the power delivered to the device in order to vary the amount of high-frequency energy delivered by each needle electrode. In some embodiments, the power source is located within the device itself (e.g., a battery located within or around the device body), either instead of or in combination with an external power source. In some embodiments where the power source is located within the device, the user can modulate the power delivered to and by each needle electrode via an external modulation controller that communicates operably with the device.

[0055]

[0090] In some embodiments, the device is configured to deliver a chemical to a target nerve in order to chemically excise the target nerve. In some embodiments, the device is configured to deliver a controlled amount of fluid to and / or around the target nerve in order to interrupt the neural activity of the target nerve. In some embodiments, the fluid includes a chemical. In some embodiments, the fluid includes one or more fluids. In some embodiments, one or more fluids are gaseous and / or liquid. In some embodiments, the fluid includes carbon dioxide, ethanol, liquid nitrogen, conductive materials (e.g., saline solution, special hydrogels, etc.), alcohol, lidocaine, lidocaine analogs, or combinations thereof. In some embodiments, the needle assembly comprises one or more hollow needles (see, for example, Figure 15). In some embodiments, each hollow needle has an opening disposed at any position on the hollow needle. In some embodiments, each hollow needle is configured to quantify the supply of fluid (e.g., a chemical) through the opening. In some embodiments, each hollow needle is configured to facilitate chemical ablation of a portion of a target nerve by quantitatively supplying fluid on and / or around the target nerve. In some embodiments, the fluid to be delivered is stored within the hollow needle before its placement. In some embodiments, each hollow needle is in fluid communication with a fluid source. In some embodiments, each hollow needle is configured to quantitatively supply fluid in a controlled manner to chemically excise a predetermined or minimal portion of the target nerve.

[0056]

[0091] In some embodiments, the device is configured to lower the temperature of the target nerve and / or the temperature around the target nerve in order to generate an ice ball in the target nerve in response to cryotherapy ablation. In some embodiments, the needle assembly comprises a hollow needle, as described herein, for forming an ice ball to destroy a portion of the target nerve tissue. In some embodiments, the hollow needle is configured to supply a quantifiable amount of cold fluid to and / or around the target nerve, thereby enabling the destruction of a portion of the target nerve.

[0057]

[0092] In some embodiments, a needle assembly comprising a hollow needle is configured to separate at the distal end, as described herein for the needle electrode, thereby targeting chemical ablation and / or cryoablation at a specific location of the target nerve, thereby enabling longer-duration target nerve ablation.

[0058]

[0093] In some embodiments, the device is configured to operate other types of ablation modalities, such as ultrasonic ablation and / or alcohol ablation (in addition to or instead of radiofrequency ablation, microwave ablation, chemical ablation, and / or cryoablation).

[0059] Nerve stimulation and nerve sensation

[0094] In some embodiments, as described herein, the device is configured to stimulate a target nerve and / or to sense activity by the target nerve. In some embodiments, the device comprises one or more nerve stimulating electrodes for stimulating the target nerve. In some embodiments, the device comprises a nerve sensory region configured to sense the target nerve. In some embodiments, one or more nerve stimulating electrodes and one or more nerve sensory regions are located on the device body of the device. In some embodiments, the nerve sensory region, one or more nerve stimulating electrodes, and / or one or more ablation electrodes are located at any position on the device body of the device (e.g., a catheter). In some embodiments, the nerve sensory region comprises a sensor for detecting action potentials from the target nerve. In some embodiments, the nerve sensory region comprises one or more nerve sensory electrodes for detecting action potentials from the target nerve. In some embodiments, one or more nerve sensory electrodes and one or more nerve stimulating electrodes comprise different electrodes. In some embodiments, one or more nerve sensory electrodes and one or more nerve stimulating electrodes share the same electrode. In some embodiments, one or more nerve stimulation electrodes are configured to provide unipolar stimulation to a target nerve. In some embodiments, one or more nerve stimulation electrodes are configured to provide bipolar stimulation to a target nerve.

[0060]

[0095] In some embodiments, as described herein, the device is configured to alternate between a neurosensory operating mode (e.g., sensing the action potential of a target nerve) and a neurostimulating operating mode (e.g., providing stimulation to a target nerve). Instead of, or in addition to, alternating the operating modes of the device, in some embodiments the device is configured to operate simultaneously in neurosensory and neurostimulating modes.

[0061]

[0096] As described herein, in some embodiments, the nerve stimulation mode includes one or more nerve stimulation electrodes configured to stimulate a target nerve to induce nerve activity (e.g., nerve action potentials) and / or physiological changes (e.g., sympathetic response). As described herein, in some embodiments, one or more physiological monitoring devices are provided to measure, sense, and / or detect nerve activity and / or physiological changes (e.g., sympathetic response) based on stimulation of a target nerve (as described herein). For example, as described herein, in some embodiments, one or more physiological monitoring devices include a Swan-Ganz catheter for PCWP measurement. In some embodiments, one or more physiological monitoring devices are configured to read and interpret the following physiological signals in real time or substantially real time in the methods described herein: gastrointestinal changes, palmar sweating, PCWP, temperature related to rectal and / or skin measurements, renal output related to vasodilation changes, metabolic changes, and / or brain natriuretic peptide levels. In some embodiments, based on measured physiological readings, a user (e.g., a physician or other healthcare professional) can provide and / or modulate nerve stimulation by the device to stimulate a target nerve, thereby inducing a desired effect (e.g., increasing sympathetic nerve activity to the abdominal vascular system). In some embodiments, by causing the following changes, a user (e.g., a physician or other healthcare professional) can read and interpret the corresponding physiological signals, thereby confirming that the device (e.g., a catheter-based device) is in the correct position: detection of gastrointestinal changes including decreased motility, detection of changes in palmar sweating, detection of increased PCWP, changes in temperature related to rectal and / or skin measurements, changes in renal output related to changes in vasodilation, changes in metabolism (e.g., increased glucose and glucose release), and / or detection of increased brain natriuretic peptide. In some embodiments, based on the lack of sufficient physiological changes detected by any combination of the above physiological signals, the user then repositions the device within the patient, re-determines the location of the target nerve, and provides stimulation again to detect physiological changes.

[0062]

[0097] In some embodiments, one or more physiological monitoring devices operably communicate with a computing device and / or display to output measured physiological readings and / or changes. In some embodiments, at least one physiological monitoring device is integrated with a catheter-based device as described herein.

[0063]

[0098] In some embodiments, after nerve destruction, the nerve is restimulated (as described herein) using a device (e.g., a catheter-based device). In some embodiments, the destroyed portion of the target nerve results in a lack of physiological changes when stimulated (e.g., by a nerve stimulation component as described herein). In some embodiments, after a portion of the target nerve is destroyed (e.g., ablation), the following physiological parameters are fixed and used as a baseline for detecting changes after the target nerve is stimulated (e.g., by a nerve stimulation component as described herein): detection of gastrointestinal changes including increased motility, detection of changes in palmar sweating, detection of decreased PCWP, changes in temperature related to rectal and / or skin measurements, changes in renal output related to changes in vasodilation, metabolic changes (e.g., decreased glucose and glucose release), and / or detection of decreased brain natriuretic peptide. In some embodiments, detection of decreased PCWP is an indicator of GSN activity disruption, as it suggests that blood is being drawn from the heart.

[0064]

[0099] In some embodiments, one or more nerve sensory electrodes are configured to detect action potentials from a target nerve. In some embodiments, one or more nerve sensory electrodes are configured to output the detection of action potentials to a user via an external device, a computing device, or other mechanism known in the art.

[0065] Power supply and control

[0100] As described herein, in some embodiments, the device described herein (e.g., a catheter-based device) operably communicates with a power source to receive power from it. In some embodiments, the power source (e.g., a generator) is configured to modulate the power delivered to the device. In some embodiments, the power source is configured to 1) provide nerve stimulation energy to the nerve stimulation electrode, 2) provide ablation energy to the ablation electrode, and / or 3) enable the device to detect, read, and / or interpret nerve signals via a neurosensory region (e.g., via a sensor or neurosensory electrode). In some embodiments, the power source includes and / or communicates with a controller configured to modulate the power supplied to the device. In some embodiments, the controller includes a computing device and / or a display for outputting information. In some embodiments, a separate power source and / or controller is configured to provide power to the ablation electrode, the nerve stimulation electrode, and / or the neurosensory region, respectively.

[0066]

[0101] In some embodiments, a power source (e.g., a generator) is configured to provide high-frequency energy to create a thermal ablation area in nerve tissue. In some embodiments, the thermal ablation area receives heat generated by the high-frequency energy provided, for example, by one or more ablation electrodes. In some embodiments, providing high-frequency energy includes alternating current (e.g., in the range of 350 to 500 kHz). In some embodiments, the device is configured to destroy at least a portion of the target nerve and venous tissue (e.g., by a generator and / or electrodes located in the device that punctures the vein wall to contact the target nerve or is positioned in close proximity to the target nerve). In some embodiments, the device is configured to provide high-frequency energy to stimulate a target nerve or group of nerves without damaging the nerve tissue and / or surrounding tissue of the target nerve.

[0067]

[0102] In some embodiments, the device (e.g., a catheter-based device) and / or power supply (e.g., a generator) are configured to modulate voltage and current outputs according to a desired power of ablation energy (e.g., radio frequency energy, microwave energy) delivered to the target nerve (via ablation electrodes). In some embodiments, the power supply operably communicates with a controller to modulate the voltage and current outputs. In some embodiments, the device includes a controller located internally (e.g., within and / or on the device body). In some embodiments, the ablation energy is provided with sufficient voltage and current to generate sufficient heat (transmitted to the target nerve) to destroy at least a portion of the target nerve. In some embodiments, the power supply is configured to provide the device with power ranging from about 1W to about 100W. In some embodiments, at least a portion of the target nerve is destroyed around its entire circumference (as described herein). In some embodiments, the device and / or power supply is further configured to modulate the power of ablation energy (e.g., radio frequency energy, microwave energy) delivered so as to destroy venous tissue and cause angiosclerosis, thereby the device described herein is further configured to reduce, prevent, and / or stop bleeding. In some embodiments, such destruction of venous tissue and angiosclerosis is by an ablation electrode and / or another set of electrodes.

[0068]

[0103] Various examples of ablation energy delivery to target neurons and the resulting thermal ablation areas are shown in Figures 30A–33C. Ablation energy delivery includes delivery of 6W, 7W, or 8W over 30 seconds, 60 seconds, or 90 seconds. As seen in Figures 30A–30B, the diameter of the thermal ablation area increases with increasing energy for both 30-second and 60-second bursts. Similarly, as seen in Figures 31A–31C, the length of the area also increases with increasing power over the same energy application duration for both 30-second and 60-second durations. However, for an energy application duration of approximately 90 seconds, the length of the area is substantially similar across different energy application levels. As seen in Figures 32A–32C, the diameter of the area increases with increasing energy application duration for the same power output. Similarly, as seen in Figures 33A–33C, the length of the area also increases with increasing energy application duration for the same power output. In some embodiments, the desired ablation energy delivery may be about 6W over about 90 seconds. In some embodiments, the desired ablation energy delivery may be about 7W over about 60 seconds.

[0069]

[0104] In some embodiments, the ablation energy delivery may include delivering 4W, 5W, 6W, 7W, or 8W over a period of about 30 seconds, about 60 seconds, about 90 seconds, or about 120 seconds.

[0070]

[0105] In some embodiments, the power supply is configured to deliver a charge that is strong enough to stimulate a nerve (e.g., by a nerve stimulating electrode) but not strong enough to damage tissue (e.g., target nerve tissue and / or surrounding tissue). In some embodiments, the controller described herein is configured to modulate the charge delivered by the nerve stimulating electrode.

[0071]

[0106] In some embodiments, the power supply receives power from the exterior wall unit. Alternatively or additionally, in some embodiments, the power supply (e.g., a generator) comprises one or more internally located power supplies (e.g., batteries).

[0072]

[0107] Figures 2–27B show exemplary embodiments of the devices described herein (e.g., catheter-based devices) for use in conjunction with the methods described herein. In some embodiments, any such exemplary device embodiment includes any combination of the features and components described herein.

[0073]

[0108] Figures 2–6 provide illustrative illustrations of a first embodiment of the device 200 described herein, in which a needle assembly comprising two needle electrodes is used to excise a portion of a target nerve. In some embodiments, referring to Figure 2, the device includes a device body (e.g., a catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 from which the needle assembly 206 extends, and an electrode region 207 (for, for, nerve stimulation). In some embodiments, the opening 208 is a lateral opening. In some embodiments, the device body 210 has a longitudinal axis (203). In some embodiments, as described herein, the electrode region may also be located at any location on the catheter body 210, and may be in the same position as the neurosensory region (for, for, measuring action potentials). In some embodiments, the electrode region 207 is provided on the catheter body 210. In some embodiments, the device includes a radiopaque region 204, which may be used to help track the position of the device within the patient being treated. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / inward, and / or cranial / caudal directions.

[0074]

[0109] Referring to Figures 3-4, exemplary illustrations of a needle assembly 206 protruding from an opening 208 of the device 200 are shown (e.g., implanted). In some embodiments, the device body 210 comprises a needle lumen, which extends into the device body and terminates at a lateral opening 208. In some embodiments, the needle assembly is located within the needle lumen. In some embodiments, the needle assembly comprises two needle electrodes, each comprising a separate needle shaft 214, 215. In some embodiments, each needle electrode comprises a corresponding electrode 212, 213 at the distal end of the needle assembly. In some embodiments, the electrodes are configured to be positioned at any position on each needle electrode. As described herein, in some embodiments, each electrode 212, 213 is an ablation electrode configured to provide radiofrequency or microwave energy to excise at least a portion of a target nerve. In some embodiments, the electrodes 212, 213 are configured to act as nerve stimulating electrodes and / or nerve sensory electrodes. In some embodiments, the needle assembly 206 is positioned within the catheter body in a compressed configuration, thereby pressing the needle shafts 214, 215 and, in some examples, the electrodes 212, 213 against each other. In some embodiments, the needle assembly 206 is configured to branch out upon exiting the opening 208, such that at least a portion of the electrodes 212, 213 and needle shafts 214, 215 of the corresponding needle electrodes separate from each other (e.g., separate into a "V" shape) upon extending from the opening 208. In some embodiments, the needle assembly is provided with shape memory to be configured to branch out upon exiting the opening 208 and reaching an open space. In some embodiments, the needle assembly 206 is configured to branch based on an actuation mechanism. In some embodiments, the actuation mechanism includes automatic and / or manual actuation (e.g., actuation by the user). In some embodiments, the needle assembly 206 branches along or approximates the length of the target nerve, thereby allowing each electrode 212, 213 to be in contact with or positioned in close proximity to two different locations on the target nerve.

[0075]

[0110] As described herein, in some embodiments, a needle assembly push stem (or other structure) is provided within the catheter body 210 and configured to engage with the needle assembly to push the needle assembly 206 through the opening 208. In some embodiments, the push stem is located within the catheter body 210 and configured to actuate to automatically push the needle assembly 206 out of the opening 208. In some embodiments, the automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user. In some embodiments, the push stem is configured to be manually pushed out by the user (via a mechanism extending from the device to the outside of the patient). In some embodiments, the needle assembly, e.g., electrodes 212, 213, is configured to extend a predetermined distance from the opening to puncture the vein wall and be positioned in contact with or in close proximity to a target nerve (e.g., a GSN as described herein).

[0076]

[0111] In some embodiments, as described herein, the needle assembly 206 is provided within a needle assembly tube (not shown) located within the catheter body 210. In some embodiments, the tube is configured to extend from an opening 208 to the vein wall, and the needle assembly is then configured to extend from the end of the tube and puncture the vein wall. In some embodiments, the needle assembly tube is similar to the tube shown by reference numeral 309 in Figures 7-11.

[0077]

[0112] In some embodiments, the catheter body 210 is configured to rotate so that the needle assembly is oriented in a predetermined direction relative to the target nerve. In some embodiments, the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the position of a radiopaque marker (e.g., 204), and the orientation and position of the electrodes on the extended needle assembly may correlate with the position of the radiopaque marker.

[0078]

[0113] Figures 5-6 show exemplary illustrations of the device 200 positioned within a vein, artery, or blood vessel 218 (e.g., the left and / or right intercostal vein branches 2204 in Figure 22), where the needle assembly 206 extends from the opening 208 and contacts the target nerve (e.g., GSN) in a branched configuration at two different positions located between two portions of the target nerve 220, 221 (see Figure 6). As described herein, in some embodiments, the needle assembly 206 branches along the length of the target nerve. As described herein, the catheter body 210 is configured to be rotatable to position the branched needle shafts 214, 215 along the length of the target nerve. In some embodiments, the needle assembly extends at a non-zero angle with respect to the longitudinal axis 203. For example, in Figure 6, where the catheter body 210 is characterized as being positioned along the x-axis, the needle shafts 214, 215 branch along the z-axis, corresponding to the length of the target nerve between the two positions 220, 221. Therefore, electrodes 212 and 213 are configured to excise (e.g., dissolve circumferentially) a length of the target nerve that is at least from target nerve position 220 to target nerve position 221. In some embodiments, the outer periphery 220 and 221 of the target nerve represent the ablation region (at a given position), and the portion of the target nerve between portions 220 and 221 represents the length of the ablation region. In some embodiments, as described herein, a longer length of the ablation region provides a longer treatment period for the medical conditions described herein (e.g., heart failure).

[0079]

[0114] In some embodiments, the electrode area 207 is configured to provide stimulation to a target nerve (e.g., via nerve stimulation electrodes as described herein). In some embodiments, the electrode area is positioned within the patient (e.g., by radiopaque markers and / or neurosensory areas) at a location corresponding to the target nerve (e.g., the location may be such that nerve stimulation is provided to the target nerve in a direction perpendicular to the axis of the catheter body 210). Thus, in some embodiments, stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode area 207.

[0080]

[0115] Figures 7–13 provide illustrative illustrations of a second embodiment of the device 300 described herein, in which a needle assembly comprising two needle electrodes is used with a balloon to excise a target nerve. In some embodiments, the balloon is configured to inflate. In some embodiments, referring to Figure 7, the device includes a device body (e.g., a catheter body) 310, a catheter tip 302, a needle assembly 306 configured to be disposed with a balloon 308 positioned around the catheter body 310, and an electrode region 307 (e.g., for nerve stimulation). In some embodiments, the device body 310 has a longitudinal axis (303). In some embodiments, as described herein, the electrode region may be located at any location on the catheter body 310, and may also be located at the same location as the nerve sensory region. In some embodiments, the electrode region 307 is disposed on the balloon 308. In some embodiments, the device 300 further comprises a needle assembly tube 309, configured such that at least a portion of the needle assembly 306 is located inside the needle assembly tube 309 and further configured to extend from the needle assembly tube 306. In some embodiments, the needle assembly tube 309 is embedded in and protrudes from the balloon 308. In some embodiments, the device 300 does not have a needle assembly tube, and instead, the needle assembly 306 is located on the balloon 308, at least partially located inside the balloon, or a combination thereof. In some embodiments, the needle assembly tube is at least partially located inside the device body 310. In some embodiments, the device comprises a radiopaque region 304, which may be used to help track the position of the device within a patient being treated. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / medial, and / or cranial / caudal directions.

[0081]

[0116] Referring to Figures 8-9, exemplary illustrations of the needle assembly 306 of device 300 are shown. In some embodiments, the needle assembly 306 comprises two separate needle electrodes, each comprising a needle shaft 314, 315. In some embodiments, each needle electrode includes a corresponding electrode 312, 313 at the distal end of the needle assembly. In some embodiments, the electrodes are configured to be positioned at any position on each needle electrode. As described herein, in some embodiments, each electrode 312, 313 is an ablation electrode configured to provide high-frequency energy to excise at least a portion of a target nerve. In some embodiments, the electrodes 312, 313 are configured to act as nerve stimulating electrodes and / or nerve sensory electrodes. In some embodiments, when the device is advanced to a desired position in the patient, at least a portion of the needle assembly 306 is located within the needle assembly lumen 309. In some embodiments, the needle assembly 306 is configured to extend from the needle assembly tube 309. In some embodiments, the needle assembly 306 is configured to be provided in a compressed configuration, thereby pressing the needle stems 314, 315 and, in some examples, the electrodes 312, 313, against each other. In some embodiments, the needle assembly 306 is configured to branch out as it extends from the needle assembly lumen 309, so that at least a portion of the electrodes 312, 313 of the needle electrodes and the needle stems 314, 315 are separated from each other (e.g., the needle assembly includes a "V-shaped" configuration). In some embodiments, the needle assembly 306 has shape memory so that it is configured to branch out as it extends a predetermined length from the needle assembly tube 309. In some embodiments, the needle assembly 306 is configured to branch based on an actuation mechanism. In some embodiments, the actuation mechanism includes automatic and / or manual actuation (e.g., user actuation). In some embodiments, the actuation mechanism includes automatic and / or manual actuation. In some embodiments, the needle assembly 306 is branched along the length of the target nerve, thereby allowing each electrode 312, 313 to be in contact with or positioned in close proximity to two different locations on the target nerve.

[0082]

[0117] Figures 10-11 show exemplary illustrations of a device 300 positioned within a vein, artery, or blood vessel 316 (e.g., the left and / or right intercostal venous branches 2204 in Figure 22) and close to the location of a target nerve 318. Figure 10 shows the balloon 308 in a deflated state before deployment of the needle assembly 306, and Figure 11 shows the balloon 308 in an inflated configuration. In some embodiments, the needle assembly 306 is positioned such that the inflation of the balloon 308 pushes out the needle assembly tube 309, thereby allowing the needle assembly 306 to puncture the wall of the vein 316 (see Figure 11). In some embodiments, the inflation of the balloon 308 biases the needle assembly tube 309 against the vessel wall, thereby configuring the needle assembly tube 306 to puncture the vessel wall as it extends from the needle assembly tube. In some embodiments, the inflation of the balloon 308 biases the needle assembly tube 309 against the vessel wall, but the needle assembly 306 does not yet puncture the vessel wall unless it extends from the needle assembly tube. In alternative embodiments, the needle assembly is configured to bias against the vessel wall by means other than an inflatable balloon (as known in the art).

[0083]

[0118] In some embodiments, the balloon 308 is in fluid communication with an inflation medium that enables the balloon to be inflated. In some embodiments, the device body 310 includes an inflation tube that extends inside and is in fluid communication with an inflation medium source. In some embodiments, the inflation medium includes a fluid, such as a gas (e.g., air) and / or a liquid (e.g., water, saline solution). In some embodiments, the inflation medium source is located outside the patient being treated. In some embodiments, the device includes a storage and supply source for the inflation medium to inflate the balloon 308. In some embodiments, the inflation medium is supplied via an automatic controller. In some embodiments, the inflation medium is supplied via manual input.

[0084]

[0119] Figures 12-13 show exemplary embodiments of a needle assembly 306 extending toward a target nerve 318. In some embodiments, balloon inflation enables the needle assembly 306 to extend toward the target nerve. As described herein, in some embodiments, a needle assembly push stem (or other structure) is provided within the catheter body 310 and configured to engage with the needle assembly 306 and push through the vessel wall and / or toward the target nerve. In some embodiments, the push stem is located within the catheter body 310 and configured to actuate to automatically push the needle assembly 306. In some embodiments, the automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user. In some embodiments, the push stem is configured to be manually pushed out by the user (via a mechanism extending from the device to the outside of the patient). In some embodiments, the needle assembly 306, for example, electrodes 312, 313, is configured to extend a predetermined distance from the lumen 309 of the needle assembly so as to be in contact with or in close proximity to the target nerve 318 (e.g., a GSN as described herein).

[0085]

[0120] In some embodiments, the catheter body 310 is configured to rotate so that the needle assembly 306 is oriented in a predetermined direction relative to the target nerve. In some embodiments, the needle assembly is configured to extend from the catheter body according to a specific configuration corresponding to the position of a radiopaque marker (e.g., 304), and the orientation and position of the electrodes on the needle assembly when extended may correlate with the position of the radiopaque marker.

[0086]

[0121] Figure 13 shows an exemplary illustration of a needle assembly 306 that extends in a branched configuration to contact a target nerve (e.g., GSN) at two different positions located between two portions 318, 319 of the target nerve. As described herein, in some embodiments, the needle assembly 306 branches along the length of the target nerve. In some embodiments, the needle assembly 306 extends at a non-zero angle with respect to the longitudinal axis 303. As described herein, the needle assembly 306 is configured to be rotatable around the needle assembly axis so as to position the branched needle shafts 314, 315 of the needle electrodes along the length of the target nerve. For example, in Figure 13, characterized in that the catheter body 310 is positioned along the x-axis, the needle shafts 314, 315 branch along the z-axis, corresponding to the length of the target nerve between the two positions 318, 319. Therefore, electrodes 312, 313 are configured to excise (e.g., dissolve circumferentially) a length of the target nerve that is at least from target nerve position 318 to target nerve position 319. In some embodiments, the outer circumference 318, 319 of the target nerve represents the ablation region at a given position, and the portion of the target nerve between portions 318, 319 represents the length of the ablation region. In some embodiments, as described herein, the longer the length of the ablation region, the longer the treatment period for the medical condition described herein (e.g., heart failure).

[0087]

[0122] In some embodiments, the electrode area 307 is configured to provide stimulation to a target nerve (e.g., via nerve stimulation electrodes as described herein). In some embodiments, the electrode area is positioned within the patient (e.g., for use with radiopaque markers and / or neurosensory areas) at a location corresponding to the target nerve (e.g., the location may be such that nerve stimulation is provided to the target nerve in a direction perpendicular to the axis of the catheter body 310). Thus, in some embodiments, stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode area 307.

[0088]

[0123] Figures 14-17 provide illustrative illustrations of a third embodiment of the device 400 described herein, the device configured to chemically excise a target nerve. In some embodiments, referring to Figure 14, the device includes a device body (catheter body) 410, a catheter tip 402, a needle assembly 406 configured to be disposed together with a stretchable balloon 408 located around the catheter body 410, and an electrode region 407 (for, for, nerve stimulation). In some embodiments, the device body 410 has a longitudinal axis (403). In some embodiments, as described herein, the electrode region is also in the same position as the nerve sensory region and can be located anywhere on the catheter body 410. In some embodiments, the electrode region 407 is disposed on the stretchable balloon 408. In some embodiments, the device 400 further comprises a needle assembly tube 409, configured so that at least a portion of the needle assembly 406 is located inside the needle assembly tube 409 and further configured to extend from the needle assembly tube 406. In some embodiments, the needle assembly tube 409 is embedded in and protrudes from an expandable balloon 408. In some embodiments, the device includes a radiopaque region 404, which may be used to help track the position of the device within the patient being treated. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / inward, and / or cranial / caudal directions.

[0089]

[0124] Referring to Figure 15, an exemplary illustration of the needle assembly 406 of device 400 is shown. In some embodiments, the needle assembly includes a needle stem 414 and a needle port 412. In some embodiments, the needle stem is hollow. In some embodiments, the device is configured to quantitatively deliver a chemical through the needle port 412. In some embodiments, the chemical is configured to excise a target nerve. In some embodiments, the device is configured to quantitatively deliver the chemical in a controlled distribution to achieve a desired ablation length of the target nerve. In some embodiments, when the device is advanced to a desired position in the patient's body, at least a portion of the needle assembly 406 is located within the needle assembly lumen 409. In some embodiments, the needle assembly 406 is configured to extend from the needle assembly lumen 409.

[0090]

[0125] Figures 16-17 show exemplary illustrations of a device 400 located within a vein, artery, or blood vessel 416 (e.g., the left and / or right intercostal venous branches 2204 in Figure 22) and close to the location of a target nerve 418. Figure 16 provides an exemplary illustration of an extensible balloon 408 in an extensible configuration, where the needle assembly tube 409 is biased toward the vein wall 416, thereby causing the needle assembly 406 to puncture the vein wall 416. In some embodiments, the stretching of the extensible balloon 408 is configured such that the needle assembly tube 406 is biased toward the blood vessel wall, thereby causing the needle assembly tube 409 to puncture the blood vessel wall as it extends from the needle assembly tube. In some embodiments, the extensible balloon 408 is operably connected to a mechanism configured to supply gas (e.g., air) to the extensible balloon, thereby causing the extensible balloon to stretch. In some embodiments, the gas is supplied through a supply line connecting a gas source (e.g., outside the patient) to the device. In some embodiments, the device includes a gas storage and supply unit for extending the expandable balloon 408. In some embodiments, the gas is supplied by an automatic controller. In some embodiments, the gas is supplied by manual input.

[0091]

[0126] Figure 17 shows an exemplary embodiment of a needle assembly 406 extending toward a target nerve 418. In some embodiments, extension of the balloon 408 allows the needle assembly 406 to extend toward the target nerve. As described herein, in some embodiments, a needle assembly push stem (or other structure) is provided within the catheter body 410 and configured to engage with the needle assembly 406 and push toward the target nerve. In some embodiments, the push stem is located within the catheter body 410 and configured to actuate to automatically push the needle assembly 406. In some embodiments, the automatic actuation of the push stem is initiated by a wireless or wired signal provided by the user. In some embodiments, the push stem is configured to be manually pushed out by the user (via a mechanism extending from the device to the outside of the patient). In some embodiments, the needle assembly 406, e.g., the needle port 412, is configured to extend a predetermined distance from the needle assembly lumen 409 so as to be located in contact with or in close proximity to the target nerve 418 (e.g., a GSN as described herein). In some embodiments, the needle assembly is configured to extend at a non-zero angle with respect to the longitudinal axis 403. In some embodiments, the needle assembly 406 is configured to rotate around the needle assembly axis. In some embodiments, the needle assembly is configured to rotate by a push stem. In some embodiments, the needle assembly 406 is configured to be rotatably guided until the needle is positioned in the direction of a target nerve (e.g., GSN).

[0092]

[0127] Continuing to refer to Figure 17, the needle assembly 406 extends toward the target nerve at a position between two portions of the target nerve 418, 419. As described herein, the catheter body 410 is configured to be rotatable so as to orient the needle assembly 406, including the needle port 412, in a predetermined direction (relative to the target nerve). In some embodiments, the needle port 412 penetrates the target nerve to deliver chemical ablation into the target nerve. In some embodiments, the needle port 412 delivers chemical ablation on and around the outer surface of the target nerve. Thus, chemical delivery enables ablation (e.g., circumferential dissolution) of the target nerve along the length from target nerve position 418 to target nerve position 419. In some embodiments, the outer periphery 418, 419 of the target nerve represents the ablation region at a given position, and the portion of the target nerve between portions 418, 419 represents the length of the ablation region. In some embodiments, as described herein, a longer ablation region length provides a longer treatment duration for the medical conditions described herein (e.g., heart failure).

[0093]

[0128] In some embodiments, the hollow needle stem 414 is operationally in communication with a mechanism configured to supply chemicals to the needle assembly. In some embodiments, the chemicals are supplied through a supply line connecting a chemical source (e.g., outside the patient) to the device. In some embodiments, the device includes a storage source for the chemicals to be delivered to or around the target nerve. In some embodiments, the chemicals are supplied via an automatic controller. In some embodiments, the chemicals are supplied via manual input. In some embodiments, the chemicals include carbon dioxide, ethanol, liquid nitrogen, conductive materials (e.g., saline solution, special hydrogels, etc.), or combinations thereof.

[0094]

[0129] In some embodiments, the electrode area 407 is configured to provide stimulation to a target nerve (e.g., via nerve stimulation electrodes as described herein). In some embodiments, the electrode area is positioned within the patient (e.g., using radiopaque markers and / or neurosensory areas) at a location corresponding to the target nerve (e.g., the location may be perpendicular to the axis of the catheter body 410). Thus, in some embodiments, stimulation is provided via a signal delivered perpendicularly. In some embodiments, the configuration of the needle assembly extending from the catheter body correlates with the positioning of the electrode area 407.

[0095]

[0130] Figures 18–21 illustrate exemplary processes for treating medical conditions as described herein, and the processes are categorized into four components: diagnosis, general procedure, positioning / confirmation, and ablation. Figure 19 illustrates exemplary steps in the general procedure category, including patient preparation steps such as introducing a device (e.g., a catheter device) into the patient and advancing the device to a predetermined position.

[0096]

[0131] Figure 20 shows exemplary steps for the location recognition / confirmation category, which involves confirming the location of a target nerve by nerve stimulation and the detected corresponding nerve activity and / or physiological changes (e.g., sympathetic response). Figure 21 shows exemplary steps for the ablation category, which includes various ablation modalities such as ablation from veins, arteries, or intravascular sources (e.g., ultrasound, linear electrode arrays), ablation through venous walls, and ablation within venous walls (e.g., see Figures 6, 13, and 17).

[0097]

[0132] Figures 23A–27B show exemplary illustrations of the device 2300 described herein, the extendable needle assembly comprising an extendable needle and an electrode assembly, the first section enclosing a second section, the second section extending outward from the first section, and used to resect a target nerve. Referring to some embodiments, Figures 23A / D, the device comprises a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advance section 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a maker band 2317, a second marker band 2315, and a needle assembly 2313 with one or more electrodes (e.g., nerve stimulation or nerve ablation). Figure 23B shows a needle assembly 2319 fully extended from the device. In some embodiments, the catheter, ablation needle, guidewire port 2302, contrast port 2301, and rear connector 2305 rotate simultaneously. In some embodiments, the guidewire is inserted into the guidewire port 2302 and used to drive the catheter within the vascular lumen. In some embodiments, the contrast port 2302 is used for inserting a fluoroscopic contrast. In some embodiments, the rear connector includes pins for two ablation poles and three nerve stimulation and nerve monitoring leads. In some embodiments, a keyway in the handle 2306 connects the rotation of the control knob and control catheter to the rear electrical connector, defining the path of the electrical connection to allow continuous rotation. In some embodiments, the electrode advancement section provides sufficient movement for the distal end of the ablation needle (e.g., needle assembly) to extend about 1–2 cm, and in some cases 1.5 cm, from the catheter midline. In some embodiments, needle assemblies with one or more electrodes are not extended. In some embodiments, a needle assembly comprising one or more electrodes is extended. In some embodiments, the electrode advance portion 2304 is used to extend the electrode assembly into vascular tissue, for example, to puncture vascular tissue.In some embodiments, a guidewire is inserted into the guidewire lumen to advance the catheter tip 2316 into the intravascular space. In some embodiments, an electrode advancer advances the first tube of a needle assembly with a first proximal electrode, and then the second tube extends from the first tube, and the length of extension of the retractable electrode assembly can be controlled by the user. In some embodiments, the guidewire is advanced separately from the needle assembly with one or more electrodes. In some embodiments, the rear electrical connector has three pins for nerve sensing and two bipolar ablation poles. In some embodiments, the length of the catheter is approximately 25 to 150 cm, and in some examples, 120 cm. In some embodiments, the nerve sensing element is one or more electrodes on the catheter shaft substrate that are wrapped around the catheter shaft 2311 and coupled in place. In some embodiments, one or more electrodes on the needle assembly are the nerve sensing element. In some embodiments, one or more electrodes on the catheter shaft, or one or more electrodes on the needle assembly, are used to confirm needle placement before ablation by low-power stimulation to observe the patient's heart rate. In some embodiments, the device includes a radiopaque region 404, which may be used to help track the position of the device within the patient's body. In some embodiments, the radiopaque region is located anywhere on the catheter body. In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear differently every 90 degrees on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / medial, and / or cranial / caudal directions. In some embodiments, a charge is delivered from a first electrode, which may be positive, to a second electrode, which may be negative, thereby delivering energy to nearby vascular tissue and heating it to about 40°C, 50°C, or 60°C.

[0098]

[0133] Referring to Figures 24A / B, an exemplary illustration of the catheter tip 2400 of device 2420 is shown. In some embodiments, referring to Figure 24, the catheter tip comprises a guidewire lumen 2401, marker bands 2402 / 2403, an ablation needle exit port 2404, and a needle assembly 2313 having one or more electrodes, e.g., silkscreen electrodes. In some embodiments, referring to Figure 24B, device 2420 comprises a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advancer 2304, a rotary electrical connector 2305, a rotary coupler 2421, and a rotary coupler 2422. In some embodiments, device 2420 is device 2300. In some embodiments, device 2420 does not have a contrast port 2301.

[0099]

[0134] Referring to Figure 28, an illustration of an exemplary second catheter tip 2800 is shown. In some embodiments, the second catheter tip 2800 comprises a guidewire lumen 2820 and an ablation needle lumen 2810 having an ablation needle exit port 2811. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is about 1:1 to about 3:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is at least about 1:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is at most about 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is in the range of 1:1 to 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is 1:1, 2:1, 3:1, or 4:1. In some embodiments, the ratio of the radius of curvature of the ablation needle lumen 2810 proximal to the ablation needle exit port 2811 to the diameter of the ablation needle lumen 2810 is approximately 1.8. In some embodiments, this ratio reduces the mechanical stress and resulting force required to implant the needle while allowing the use of a larger needle. In some embodiments, the radius of curvature of the needle assembly passage is 0.09''. In some embodiments, a larger radius of curvature of the needle assembly passage allows for smoother insertion and withdrawal of the telescopic needle assembly. In some embodiments, a larger radius of curvature of the needle assembly passage allows for a contact point between the telescopic needle assembly and the target tissue at a substantially orthogonal angle.In some embodiments, a larger radius of curvature and a larger angle of curvature of the needle assembly lumen biases the vascular catheter in a vein against a single extension direction of the telescopic needle assembly, preventing movement of the vascular catheter in the vein when the telescopic needle assembly is extended, and allowing for precise insertion of the needle to target an area close to the target nerve. In some embodiments, the inner diameter of the needle assembly passage is at least 0.033''. In some embodiments, the inner diameter of the needle assembly passage is 0.033''. In some embodiments, the guidewire lumen is linear and does not curve around the needle assembly passage and has the same width as at least a portion of the needle assembly passage. In some embodiments, a linear guidewire lumen having the same width as a portion of the needle assembly lumen is more easily positioned and guided into place as a result of the linear guidewire lumen, which does not require the guidewire to bend in the shaft when force is applied to the catheter device and it is advanced through the vein.

[0100]

[0135] Referring to Figures 25A / B, an exemplary illustration of the retractable needle assembly 2500 of device 2300 is shown. In some embodiments, referring to Figure 25A, the needle assembly includes an enamel-coated wire 2501, a proximal laser-cut hypotube 2502 which may be tubular, a proximal laser-cut hypotube polyimide insulator 2503, a first electrode band 2504, a second electrode band 2510, a laser-cut hypotube dielectric washer 2506, an inner polyimide linear 2505, a distal polyimide cover 2509, a distal laser-cut hypotube 2508 which may be tubular, and solder paste or laser welding 2507. The needle assembly may be terminated at a point configured to puncture vascular tissue. In some embodiments, the enamel-coated wire 2501 conducts electricity to one or more electrodes positioned on the outer surface of the needle assembly, for example, on the outer surface of the proximal laser-cut hypotube 2502 (e.g., a tube), or on the outer surface of the distal laser-cut hypotube 2508 (e.g., a tube). In some embodiments, the laser-cut hypotube dielectric washer 2506 and the inner polyimide linear 2505 are insulating. In some embodiments, one or more electrodes 2504 / 2510 are electrical electrodes on the ablation needle assembly 2500 and may be marker bands. In some embodiments, referring to Figure 25B, the needle assembly comprises a longitudinal axis 2512, a distal laser-cut hypotube 2508 (e.g., a tube), a first electrode 2504, a second electrode 2510, and a proximal laser-cut hypotube 2502 (e.g., a tube).

[0101]

[0136] Referring to Figure 26A / B, an illustrative illustration of the telescopic needle assembly 2600 of device 2300 is shown. The telescopic needle assembly may comprise a first section surrounding a second section, the second section extending outward from the first section. In some embodiments, the first section comprises a first tubular body, and the second section comprises a second tubular body, the first tubular body extending outward from the second tubular body, and the first tubular body is nested within the second tubular body, thereby the tubular body being fully or partially housed within the first tubular body. In some embodiments, referring to Figure 26A, the needle assembly comprises a multi-strain braid 2601 which may be conductive, a proximal laser-cut hypotube 2502 (e.g., a tubular body), a proximal laser-cut hypotube polyimide insulator 2503, a first electrode 2504, a second electrode 2510, a laser-cut hypotube dielectric washer 2506, an inner polyimide linear 2505, a distal polyimide cover 2509, a distal laser-cut hypotube 2508 (e.g., a tubular body), and solder paste or laser welding 2507. The needle assembly may be terminated at a point configured to puncture vascular tissue. In some embodiments, the multi-strain braid 2601 conducts electricity to one or more electrodes 2504 / 2510 positioned on the outer surface of the needle assembly, for example, on the outer surface of the proximal laser-cut hypotube 2502 (e.g., the tube) or on the outer surface of the distal laser-cut hypotube 2508 (e.g., the tube). In some embodiments, the laser-cut hypotube dielectric washer 2506 and the inner polyimide linear 2505 are insulating. In some embodiments, one or more electrodes 2504 / 2510 are electrical electrodes on the ablation needle assembly 2600 and may be marker bands. In some embodiments, referring to Figure 26B, the needle assembly comprises a longitudinal axis 2512, a distal laser-cut hypotube 2508, a marker band 2504, a marker band 2510, and a proximal laser-cut hypotube 2502. In some embodiments, the needle assembly further comprises a third section having a sharp distal end, the second section surrounding the third section, and the third section extending outward from the second section.

[0102]

[0137] Referring to Figure 27, an exemplary illustration of a telescopic needle assembly comprising an electrode assembly 2700 of device 2300 is shown. In some embodiments, the telescopic needle assembly comprises a first section surrounding a second section, the second section extending outward from the first section. In some embodiments, the first section comprises a first tube, the second section comprises a second tube, the first tube extending outward from the second tube, and the first tube nesting within the second tube, thereby housing the tube completely or partially within the first tube. In some embodiments, the needle assembly further comprises a third section having a sharp distal point, the second section surrounding the third section, the third section extending outward from the second section. In some embodiments, referring to Figure 27A, the electrode assembly comprises enamel-coated wires 2701 / 2702, a rear keyway 2703, a front keyway 2704, a rotating hub 2705, a proximal support tube 2706 (e.g., a tubular body), a distal laser-cut hypotube 2707 (e.g., a tubular body), and a distal laser-cut hypotube tip 2708 (e.g., a tubular body that can terminate at a single point). In some embodiments, the distal laser-cut hypotube 2707 (e.g., a tubular body) is bonded to the support tube 2706 with conductive epoxy. In some embodiments, the proximal enamel-coated wires 2702 are tin-plated and placed between the proximal support tube 2706 and the rotating hub 2705, after which they are also bonded using conductive epoxy. In some embodiments, the distal laser-cut hypotube 2707 (e.g., the tubular body) is extended to a first length, at which point the tip portion 2708 (e.g., the tubular body) of the distal laser-cut hypotube is extended. In some embodiments, referring to Figure 27B, there is a cross-sectional view of 2700. In some embodiments, the cross-sectional view has a vertical axis 2710. In some embodiments, the cross-sectional view includes a needle lumen 2314, an enamel-coated wire 2701, a proximal support tube 2706, a distal laser-cut hypotube 2707, and an inner polyimide linear 2505. Figure 27B illustrates the telescopic nesting structure of several embodiments of the needle assembly.In some embodiments, a needle lumen may be present, the needle lumen enclosing a proximal support tube 2706 (e.g., a tubular body) inside, the proximal support tube 2706 (e.g., a tubular body) enclosing a distal laser-cut hypotube 2707 (e.g., a tubular body) inside, the distal laser-cut hypotube 2707 enclosing a proximal support tube 2706 (e.g., a tubular body) inside, and the proximal support tube 2706 enclosing a conductive wire, e.g., an enamel-coated wire 2701 inside. The distal laser-cut hypotube 2707 (e.g., a tubular body) extends furthest from the longitudinal axis of the catheter and can puncture the wall of a vascular lumen in which the catheter is positioned. When the proximal support tube 2706 (e.g., the tubular body) is fully extended, the distal laser-cut hypotube 2707 (e.g., the tubular body) may extend outward from the proximal support tube 2706, thereby allowing the needle assembly to be fully extended. The needle may itself be nested in a nested configuration, with the distal laser-cut hypotube 2707 (e.g., the tubular body) extending from inside the proximal support tube 2706 (e.g., the tubular body), and the proximal support tube 2706 (e.g., the tubular body) extending outward from the catheter.

[0103]

[0138] Referring to Figure 29A / B, an exemplary illustration of the telescopic needle assembly 2900 of the device is shown. The telescopic needle assembly 2900 may comprise a jacketed wire 2901, a distal laser-cut hypotube 2902, a proximal laser-cut hypotube 2903, a first jacket 2904, a second jacket 2905, a pole separator 2906, a marker van 2908 positioned within the laser-cut hypotube, and an end cap 2907. In some embodiments, the first jacket may be omitted. In some embodiments, larger diameters of the distal laser-cut hypotube 2902 and proximal laser-cut hypotube 2903 increase the outer electrode surface area, distributing the applied current over a wider tissue area and thus allowing for the application of greater energy while reducing the risk / opportunity of burning or carbonizing the tissue receiving the current. Such burnt or carbonized tissue would adhere to the electrode surface and be pulled out with the needle assembly during retraction. In some embodiments, the ratio of the diameter of the distal laser-cut hypotube 2902, the proximal laser-cut hypotube 2903, or both thereof, to the surface area per inch is about 0.05 to about 0.4. In some embodiments, the ratio of the diameter of the distal laser-cut hypotube 2902, the proximal laser-cut hypotube 2903, or both thereof, to the surface area per inch is about 0.32. In some embodiments, the ratio of the diameter of the distal laser-cut hypotube 2902, the proximal laser-cut hypotube 2903, or both thereof, to the surface area per inch is approximately 0.05, 0.1, 0.2, 0.3, or 0.4, including increments between them. In some embodiments, the ratio of the diameter of the telescopic needle assembly and one or more electrodes to the surface area per inch is at least 0.05. In some embodiments, the ratio of the diameter of the telescopic needle assembly and one or more electrodes to the surface area per inch is approximately 0.05 to 0.15. In some embodiments, the ratio of the diameter of the telescopic needle assembly and one or more electrodes to the surface area per inch is at most 0.15. In some embodiments, the ratio of the diameter of the telescopic needle assembly and one or more electrodes to the surface area per inch is at most 0.15. In some embodiments, the distal laser-cut hypotube 2902 and the proximal laser-cut hypotube 2903 are flexible and provide both axial stiffness for tissue penetration and tensile strength to prevent the ablation needle pole from stretching / extending during retraction into the catheter. In some embodiments, the marker van 2907 allows visualization of the telescopic needle assembly 2900 in use, and its placement inside the hypotube prevents snagging on tissue, reduces transitions around the outer surface of the hypotube, and maintains a smooth surface around the outer surface of the hypotube.In some embodiments, the electrode separator 2906, the first jacket 2904, the second jacket 2905, or any combination thereof, is made of a non-ferrous electrical insulating material.

[0104]

[0139] In some embodiments, each of one or more electrodes is at least about 0.01 in 2 , 0.0125in 2 , 0.015in 2 , 0.0175in 2, or having a larger surface area, including increments therein. In some embodiments, one or more electrodes have a surface area of ​​about 0.02 square inches to about 0.03 square inches. In some embodiments, one or more electrodes have a surface area of ​​about 0.02 square inches to about 0.021 square inches, about 0.02 square inches to about 0.022 square inches, about 0.02 square inches to about 0.023 square inches, about 0.02 square inches to about 0.025 square inches, about 0.02 square inches to about 0.0255 square inches, about 0.02 square inches to about 0.026 square inches, about 0.02 square inches to about 0.0275 square inches, about 0.02 square inches to about 0.028 square inches, about 0.02 square inches to about 0.029 square inches Inches, approximately 0.02 square inches to approximately 0.03 square inches, approximately 0.021 square inches to approximately 0.022 square inches, approximately 0.021 square inches to approximately 0.023 square inches, approximately 0.021 square inches to approximately 0.025 square inches, approximately 0.021 square inches to approximately 0.0255 square inches, approximately 0.021 square inches to approximately 0.026 square inches, approximately 0.021 square inches to approximately 0.0275 square inches, approximately 0.021 square inches to approximately 0.028 square inches, approximately 0.021 square inches to approximately 0.029 square inches, approximately 0.021 square inches 1 inch to approximately 0.03 square inch, approximately 0.022 square inches to approximately 0.023 square inches, approximately 0.022 square inches to approximately 0.025 square inches, approximately 0.022 square inches to approximately 0.0255 square inches, approximately 0.022 square inches to approximately 0.026 square inches, approximately 0.022 square inches to approximately 0.0275 square inches, approximately 0.022 square inches to approximately 0.028 square inches, approximately 0.022 square inches to approximately 0.029 square inches, approximately 0.022 square inches to approximately 0.03 square inches, approximately 0.023 square inches to approximately 0.025 Square inches, approximately 0.023 square inches to approximately 0.0255 square inches, approximately 0.023 square inches to approximately 0.026 square inches, approximately 0.023 square inches to approximately 0.0275 square inches, approximately 0.023 square inches to approximately 0.028 square inches, approximately 0.023 square inches to approximately 0.029 square inches, approximately 0.023 square inches to approximately 0.03 square inches, approximately 0.025 square inches to approximately 0.0255 square inches, approximately 0.025 square inches to approximately 0.026 square inches, approximately 0.025 square inches to approximately 0.0275 square inches, approximately 0.0.25 square inches to approximately 0.028 square inches, approximately 0.025 square inches to approximately 0.029 square inches, approximately 0.025 to approximately 0.03 square inches, approximately 0.0255 square inches to approximately 0.026 square inches, approximately 0.0255 square inches to approximately 0.0275 square inches, approximately 0.0255 square inches to approximately 0.028 square inches, approximately 0.0255 square inches to approximately 0.029 square inches, approximately 0.0255 to approximately 0.03 square inches, approximately 0.0260 square inches to approximately 0.0275 square inches, approximately 0.026 square inches to approximately 0. Having a surface area of ​​0.028 square inches, approximately 0.026 square inches to approximately 0.029 square inches, approximately 0.026 square inches to approximately 0.03 square inches, approximately 0.0275 square inches to approximately 0.028 square inches, approximately 0.0275 square inches to approximately 0.029 square inches, approximately 0.0275 square inches to approximately 0.03 square inches, approximately 0.028 square inches to approximately 0.029 square inches, approximately 0.028 square inches to approximately 0.03 square inches, or approximately 0.029 square inches to approximately 0.03 square inches, including increments within those areas. In some embodiments, one or more electrodes have a surface area of ​​approximately 0.02 square inches, approximately 0.021 square inches, approximately 0.022 square inches, approximately 0.023 square inches, approximately 0.025 square inches, approximately 0.0255 square inches, approximately 0.026 square inches, approximately 0.0275 square inches, approximately 0.028 square inches, approximately 0.029 square inches, or approximately 0.03 square inches. In some embodiments, one or more electrodes have a surface area of ​​at least approximately 0.02 square inches, approximately 0.021 square inches, approximately 0.022 square inches, approximately 0.023 square inches, approximately 0.025 square inches, approximately 0.0255 square inches, approximately 0.026 square inches, approximately 0.0275 square inches, approximately 0.028 square inches, or approximately 0.029 square inches. In some embodiments, one or more electrodes have a surface area of ​​up to approximately 0.021 square inches, approximately 0.022 square inches, approximately 0.023 square inches, approximately 0.025 square inches, approximately 0.0255 square inches, approximately 0.026 square inches, approximately 0.0275 square inches, approximately 0.028 square inches, approximately 0.029 square inches, or approximately 0.03 square inches.

[0105]

[0140] There are many beneficial technical effects of the retractable needle assemblies disclosed herein, including improved ablation, reduced trauma, smoother insertion and withdrawal of the needle assembly, ease of manufacture, and greater control over ablation parameters and ablation length. For example, the retractable configuration of the needle assembly may be advantageous over alternative configurations in that, when the needle assembly is extended, it can minimize sharp trauma to the vascular tissue through which the needle assembly penetrates, and to other tissues surrounding the target nerve. This is because the needle assembly can extend primarily in a linear (or relatively linear) vector, without displacing tissue adjacent to the retractable needle assembly. Furthermore, retractable configurations may be more likely to extend and contract appropriately without trapping vascular tissue within or between components of the needle assembly compared to branched configurations. In some cases, the length of extension of a retractable needle assembly with an electrode assembly can be controlled by the operator, the distance between electrodes on the retractable needle assembly can be varied, the ablation length can be increased for configurations with greater displacement between electrodes, or decreased for configurations with smaller displacement between electrodes. In some embodiments, the ease of extension of the telescopic needle assembly can improve the operator's ability to achieve or maintain desired electrode displacements to achieve desired ablation parameters, such as desired electrode displacements or desired displacements from or near the target nerve. Telescopic needle assemblies may also be easier to manufacture compared to branched assemblies, and the first section may be nested within a second section of the needle assembly. [Examples]

[0106] Examples Example 1: Nerve ablation catheter with branched needle assembly

[0141] A vascular catheter device comprising a needle assembly is provided. Referring to Figures 2-3, the device comprises a device body (e.g., catheter body) 210, a catheter tip 202, a needle assembly 206 configured to be disposed within the catheter body, an opening 208 from which the needle assembly 206 extends, and an electrode region 207 (e.g., for nerve stimulation). The opening 208 is a lateral opening, and the device body 210 has a longitudinal axis (203). The electrode region is also in the same location as the neurosensory region (e.g., for measuring action potentials), and can be located anywhere on the catheter body 210. The device comprises a radiopaque region 204, which may be used to help track the position of the device within the patient being treated. The radiopaque region is located anywhere on the catheter body and helps to achieve rotational precision for positioning the needle assembly (as described herein). The device further comprises radiopaque marks on the catheter body at different positions every 90 degrees, thereby helping to orient the needle assembly upward / downward, forward / backward, laterally / medially, and / or cranially / caudally. The device body further comprises a needle lumen, which extends into the device body and terminates at a lateral opening. The needle assembly comprises two needle electrodes, each with a separate needle.

[0107]

[0142] A needle assembly push stem (or other structure) is provided within the catheter body 210 and is configured to engage with the needle assembly to push the needle assembly 206 through the opening 208. In some embodiments, the push stem is located within the catheter body 210 and is configured to be actuated by a handle device actuating member to automatically push the needle assembly 206 out of the opening 208 when actuated by the user. The needle assembly 206 is provided within a needle assembly tube located within the catheter body 210. The tube is configured to extend from the opening 208 to the vein wall, and the needle assembly is then configured to extend from the end of the tube and puncture the vein wall.

[0108]

[0143] The catheter body 310 is configured to rotate so that the needle assembly 306 is oriented in a predetermined direction relative to the target nerve. In some embodiments, the needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the position of a radiopaque marker (e.g., 304), and the orientation and position of the electrodes on the extended needle assembly may correlate with the position of the radiopaque marker. Radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). The radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, laterally / medially, and / or cranially / caudally.

[0109]

[0144] Electrodes 212 and 213 are configured to excise (e.g., dissolve circumferentially) a length of the target nerve that is at least from target nerve position 220 to target nerve position 221. The outer periphery 220 and 221 of the target nerve represent the ablation region (at a given position), and the portion of the target nerve between portions 220 and 221 represents the length of the ablation region. As described herein, a longer ablation region provides a longer treatment duration for the medical conditions described herein (e.g., heart failure).

[0110] Example 2: Nerve ablation catheter with retractable needle assembly

[0145] A vascular catheter device comprising a needle assembly is provided. Referring to Figures 23–27, the device comprises a catheter shaft 2311, a handle 2306, a contrast port 2301, a guidewire port 2302, a catheter rotation knob 2303, an electrode advance section 2304, a rotary electrical connector 2305, a catheter tip 2316, an ablation needle exit port 2312, an ablation needle lumen 2314, a guidewire lumen 2318, a marker band 2317, two marker bands 2315, and a silkscreen electrode 2313 (e.g., for nerve stimulation). A retractable needle assembly having one or more electrodes may be extended as shown in Figure 23B (2319). The retractable needle assembly comprises a first section surrounding a second section, the second section extending outward from the first section. The first section comprises a first tubular body, and the second section comprises a second tubular body, the first tubular body extending outward from the second tubular body, and the first tubular body is nested within the second tubular body, thereby the tubular body being fully or partially housed within the first tubular body. In some embodiments, the needle assembly further comprises a third section having a sharp distal point, the second section surrounding the third section, and the third section extending outward from the second section. In some embodiments, the catheter, ablation needle, guidewire port 2302, contrast port 2301, and rear connector 2305 spin simultaneously. In some embodiments, a guidewire may be inserted into the guidewire port 2302 to drive the catheter into vascular tissue. In some embodiments, the contrast port 2302 is used for fluoroscopic contrast. In some embodiments, the rear connector comprises pins for two ablation poles and three nerve stimulation and nerve monitoring leads. In some embodiments, a keyway in the handle 2306 connects the rotation of the control knob and control catheter to a rear electrical connector, defining the path of the electrical connection to allow continuous rotation. In some embodiments, the electrode advancement section provides sufficient movement for the distal end of the ablation needle to extend approximately 1.5 cm from the catheter midline.In some embodiments, an electrode advancer 2304 is used to extend the electrode assembly into vascular tissue, for example, to puncture the lumen of a blood vessel in which the catheter is located, and the length of extension of the retractable electrode assembly can be controlled by the user. In some embodiments, a guidewire is inserted into the guidewire lumen to advance the catheter tip 2316 into the intravascular space. In some embodiments, the electrode advancer advances the outermost electrode, and then the second portion extends from the first portion. In some embodiments, the guidewire advances separately from the electrodes. In some embodiments, the rear electrical connector has three pins for nerve sensing and two bipolar ablation poles. In some embodiments, the catheter length is approximately 120 cm. In some embodiments, the nerve sensing element is an electrode 2313 on a catheter shaft substrate that is wrapped around the catheter shaft 2311 and joined in place. In some embodiments, one or more electrodes on the needle assembly are used to confirm needle placement before ablation by low-power stimulation to observe the patient's heart rate. In some embodiments, the device includes a radiopaque region 404, which may be used to help track the position of the device within the patient being treated. In some embodiments, the radiopaque region is located at any location on the catheter body. In some embodiments, radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). In some embodiments, the radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / inward, and / or cranial / caudal directions. In some embodiments, an electric charge is delivered from a first electrode, which may be positive, to a second electrode, thereby delivering energy to nearby vascular tissue, heating that tissue to approximately 40°C, 50°C, or 60°C.

[0111]

[0146] A needle assembly push stem (or other structure) is provided within the catheter shaft 2311 and is configured to engage with the needle assembly to push the needle assembly 2500, or in other embodiments, the needle assembly 2600, through the ablation needle exit port 2315. In some embodiments, the push stem is located within the catheter shaft 2311 and is configured to actuate the needle assembly 2500, or in other embodiments, the needle assembly 2600, forward from the ablation needle exit port 2315 when actuated by the user by an actuating member of a handle device. The needle assembly 2500, or in other embodiments, the needle assembly 2600, is provided within a catheter assembly tube located within the catheter shaft 2311. The electrodes within the needle assembly 2500, or in other embodiments, the needle assembly 2600, are configured to extend from the ablation needle exit port 2315 to the vein wall, and the needle assembly is then configured to extend from the end of the tube and puncture the vein wall.

[0112]

[0147] The catheter shaft 2311 is configured to rotate the needle assembly 2500, or in other embodiments, the needle assembly 2600, so as to orient it toward a target nerve in a predetermined direction. The needle assembly is configured to extend from the catheter body according to a specific configuration, which corresponds to the position of a radiopaque marker (e.g., 304), and the orientation and position of the electrodes on the extended needle assembly may correlate with the position of the radiopaque marker. Radiopaqueness helps to achieve rotational precision for positioning the needle assembly (as described herein). The radiopaque marks appear differently at 90-degree intervals on the catheter body, thereby helping to orient the needle assembly upward / downward, forward / backward, outward / medial, and / or cranial / caudal directions.

[0113]

[0148] The electrode configuration 2700 is configured to excise (e.g., dissolve circumferentially) a length of the target nerve. As described herein, the longer the length of the ablation area, the longer the treatment period for the medical conditions described herein (e.g., heart failure).

[0114]

[0149] Compared to the non-extendable needle assembly of Example 1, the extendable needle assembly can result in improved ablation, reduced trauma to vascular tissue and surrounding tissue of the target nerve, smoother insertion and withdrawal of the needle assembly, ease of manufacture, and greater control over ablation parameters and ablation length. For example, the extendable configuration of the needle assembly minimizes sharp trauma to the vascular tissue through which the needle assembly penetrates and to other tissues surrounding the target nerve when the needle assembly is extended. This is because the needle assembly extends within a straight (or relatively straight) vector that does not displace tissue adjacent to the extendable needle assembly. Furthermore, the extendable configuration has a greater tendency to extend and withdraw appropriately without trapping vascular tissue within or between components of the needle assembly compared to the branched configuration. Moreover, the extension length of the extendable needle assembly with an electrode assembly can be controlled by the operator, and the displacement between electrodes on the extendable needle assembly can be changed, allowing the ablation length to be increased for configurations with greater displacement between electrodes, or decreased for configurations with smaller displacement between electrodes. The ease of extension of the retractable needle assembly improves the operator's ability to achieve or maintain desired electrode displacements for each electrode to achieve desired ablation parameters, for example, by achieving desired electrode displacements. Similarly, the ease of extension of the retractable needle assembly improves the operator's ability to achieve desired displacements from or near the target nerve by allowing the operator to change the insertion depth of the retractable needle assembly. In summary, these features may allow surgeons to take into account the changing anatomical structure of patients when using retractable needle assemblies. Retractable needle assemblies may also be easier to manufacture compared to branched assemblies, and the first section may be nested within a second section of the needle assembly.

[0115] Example 3: Outpatient treatment of treatment-resistant heart failure

[0150] A patient with treatment-resistant heart failure presents to a cardiology clinic. The patient reports to the doctor that they no longer have the same energy levels as before and often experience shortness of breath or difficulty breathing even after minimal physical activity, such as walking one block of town or climbing stairs for one flight. The patient may have previously been evaluated by another physician and subsequently referred to a cardiology clinic. The patient presents with other symptoms suggestive of heart failure, such as early fatigue, orthopnea, paroxysmal nocturnal dyspnea, exertional dyspnea, or tachycardia episodes. The patient reports that they were previously able to walk more than one mile without experiencing the symptoms they are now reporting. The patient is already using Lasix (a diuretic or liquid), antihypertensive drugs, their generics, or combinations thereof, but has not seen improvement in their symptoms. At this point, there are no additional drug therapy options. Physical examination reveals evidence of volume overload (fluid in the lungs, leg swelling, elevated carotid pressure / pulsation). The cardiologist records the patient as having a New York Heart Association (NYHA) Class II or Class III severity level, depending on their exercise capacity. Other criteria or indicators of HF severity include brain natural peptide levels and the number of hospitalizations over the recent timeframe (at least one hospitalization in the past year). The patient may or may not have common comorbidities, including, among others, hypertension, kidney disease, liver disease, high cholesterol, and diabetes. The cardiologist then refers the patient to a visceral nerve ablation procedure performed in the outpatient catheterization laboratory attached to the clinic.

[0116]

[0151] The catheter-based device described in Example 2 is used. The catheter device accesses the vascular system through the jugular vein using the Seldinger technique. The access sheath is advanced into the superior vena cava under fluoroscopic guidance. The sheath is inserted into the superior vena cava and proceeds through the vein, with the guidewire crossing the azygos vein. The sheath is inserted into the azygos vein from the superior vena cava, and the guidewire crosses the azygos vein. Using the anatomical landmark T9, the guidewire can enter the left intercostal venous branch and / or the right intercostal venous branch. The greater splanchnic nerve (GSN) is assumed to be nearby here, and the device is introduced to this location via the guidewire.

[0117]

[0152] When the device reaches a location observable by fluoroscopy (bones, blood vessels, etc.) which can be confirmed by using a marker band on the catheter device, proximity to the target nerve is optionally confirmed by applying stimulating energy to that location and measuring the physiological response to the stimulation, such as muscle response in the abdomen or GI canal, nerve activity, or cardiac activity. In some cases, the operator uses the nerve stimulation component of the device to deliver a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting adverse changes in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, changes in palmar sweating, changes in temperature related to rectal and / or skin measurements, changes in renal output associated with changes in vasodilation, metabolic changes (i.e., decreased glucose and glucose release), and an increase in brain natriuretic peptide. By inducing these responses, the user can confirm proximity to the target nerve. PCWP is obtained during right cardiac catheterization procedures routinely performed in hospitals. Right cardiac catheterization may involve percutaneous access through the jugular vein using the Seldinger technique in a sterile manner. A Swan-Ganz catheter has an inflated balloon, which is guided through the superior vena cava, right atrium, right ventricle, and into the pulmonary outflow tract. The inflated balloon carries the catheter to the pulmonary artery, where it is wedged. The pressure detected here is called pulmonary capillary wedge pressure and is considered equivalent to left atrial pressure. Left atrial pressure is a surrogate measure of left ventricular end-diastolic pressure. Assuming the absence of mitral valve disease, PCWP is a measure of the severity of heart failure. Higher PCWP indicates worsening of heart failure severity. Other responses are measured by specific aspects of the device, respectively.

[0118]

[0153] The operator may optionally use another component of the device to directly sense nerves, using the same electrodes employed by the nerve stimulation component. If the operator can position the device at an approximate location on the GSN using anatomical landmarks, the device generator is switched to “nerve sensing” mode. In nerve sensing mode, electrodes are used to read action potentials through the GSN. These electrodes may be separate electrodes positioned on the surface of the catheter device, or one or more electrodes within the needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated to inform the operator that the device is positioned to perform nerve destruction.

[0119]

[0154] After the nerve's location is confirmed by a combination of nerve stimulation and nerve sensing functions evaluated by the generator's software components, the vascular puncture mechanism is activated in the direction of the nerve to perform ablation. The puncture mechanism may optionally confirm its location using a combination of nerve sensing, nerve stimulation with physiological responses, and fluoroscopy to identify anatomical landmarks, as described herein.

[0120]

[0155] Next, the nerve is severed by radiofrequency ablation by applying electrical stimulation to the electrode assembly. Electrical energy of approximately 15W or less is transmitted from the power source to the electrode assembly on the needle assembly adjacent to the target nerve, heating the target nerve and surrounding tissue to approximately 90°C.

[0121]

[0156] Since nerves can regenerate, the duration of the effect is fundamentally related to the length of the destroyed nerve tissue. In some cases, it is desirable to excise longer nerves (compared to endovascular ablation) to prolong the duration of sympathetic nerve activity elimination. This allows the patient to experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By aligning the ablation modality with the length of the nerve, the operator can minimize collateral damage to other organs.

[0122]

[0157] Next, the success of the procedure can be assessed by repeating the combination of nerve sensing and nerve stimulation accompanied by a physiological response. The nerve stimulation component of the device delivers a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage the tissue. The sympathetic response of the GSN is measured by the physiological changes described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has been successfully dissolved circumferentially. If there is a physiological response and / or nerve activity sensed by the catheter device, the procedure is considered incomplete. The procedure is repeated at the same or different sites between two pairs of intercostal nerves to dissolve the nerve circumferentially.

[0123]

[0158] After the procedure, the patient is re-evaluated at the clinic one month later. Here, the patient is found to have more energy and exercise levels, and is able to walk several blocks of stairs without rest. The cardiologist confirms that the patient has improved to one NYHA severity class lower, with a lower likelihood of hospitalization.

[0124] Example 4: Inpatient treatment of heart failure

[0159] The patient is hospitalized due to worsening heart failure caused by volume overload and has recently been in and out of the hospital. The patient requires respiratory support (i.e., oxygen, external ventilation, or intubation) and is receiving intravascular diuretics to remove excess fluid, as well as other standard treatments. The patient may or may not have common comorbidities, including, among others, hypertension, renal disease, hepatic disease, high cholesterol, and diabetes. In this case, intravascular treatment is insufficient to remove the fluid, and the patient still shows signs of volume overload and / or respiratory failure. A decision is made to perform visceral nerve ablation during hospitalization.

[0125]

[0160] The catheter-based device described in Example 2 is used. The catheter device accesses the vascular system through the jugular vein using the Seldinger technique. The access sheath is advanced into the superior vena cava under fluoroscopic guidance. The sheath is inserted into the superior vena cava and proceeds through the vein, with the guidewire crossing the azygos vein. The sheath is inserted into the azygos vein from the superior vena cava, and the guidewire crosses the azygos vein. Using the anatomical landmark T9, the guidewire can enter the left intercostal venous branch and / or the right intercostal venous branch. The greater splanchnic nerve (GSN) is assumed to be nearby here, and the device is introduced to this location via the guidewire.

[0126]

[0161] When the device reaches a location observable by fluoroscopy (bones, blood vessels, etc.) which can be confirmed by using a marker band on the catheter device, proximity to the target nerve is optionally confirmed by applying stimulating energy to that location and measuring the physiological response to the stimulation, such as muscle response in the abdomen or GI canal, nerve activity, or cardiac activity. In some cases, the operator uses the nerve stimulation component of the device to deliver a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting adverse changes in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, changes in palmar sweating, changes in temperature related to rectal and / or skin measurements, changes in renal output associated with changes in vasodilation, metabolic changes (i.e., decreased glucose and glucose release), and an increase in brain natriuretic peptide. By inducing these responses, the user can confirm proximity to the target nerve. PCWP is obtained during right cardiac catheterization procedures routinely performed in hospitals. Right cardiac catheterization involves a percutaneous access through the jugular vein using the Seldinger technique in a sterile manner. A Swan-Ganz catheter has a balloon, which is inflated and inserted through the superior vena cava, right atrium, right ventricle, and into the pulmonary outflow tract. The inflated balloon carries the catheter to the pulmonary artery, where it is wedged. The pressure detected here is called the pulmonary capillary wedge pressure and is considered equal to the left atrial pressure. Left atrial pressure is a surrogate measure of left ventricular end-diastolic pressure. Assuming the absence of mitral valve disease, PCWP is a measure of the severity of heart failure. Higher PCWP indicates worsening of heart failure severity. Other responses are measured by specific aspects of the device, respectively.

[0127]

[0162] The operator may optionally use another component of the device to directly sense nerves, using the same electrodes employed by the nerve stimulation component. If the operator can position the device at an approximate location on the GSN using anatomical landmarks, the device generator is switched to “nerve sensing” mode. In nerve sensing mode, electrodes are used to read action potentials through the GSN. These electrodes may be separate electrodes positioned on the surface of the catheter device, or one or more electrodes within the needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated to inform the operator that the device is positioned to perform nerve destruction.

[0128]

[0163] After the nerve's location is confirmed by a combination of nerve stimulation and nerve sensing functions, the vascular puncture mechanism is activated in the direction of the nerve to perform ablation. The puncture mechanism may optionally confirm its location using a combination of nerve sensing, nerve stimulation with physiological responses, and fluoroscopy to identify anatomical landmarks.

[0129]

[0164] Next, the nerve is severed by radiofrequency ablation by applying electrical stimulation to the electrode assembly. Electrical energy of approximately 15W or less is transmitted from the power source to the electrode assembly on the needle assembly adjacent to the target nerve, heating the target nerve and surrounding tissue to approximately 90°C.

[0130]

[0165] Since nerves can regenerate, the duration of the effect is fundamentally related to the length of the destroyed nerve tissue. In some cases, it is desirable to excise longer nerves (compared to endovascular ablation) to prolong the duration of sympathetic nerve activity elimination. This allows the patient to experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By aligning the ablation modality with the length of the nerve, the operator can minimize collateral damage to other organs.

[0131]

[0166] Next, the success of the procedure can be assessed by repeating the combination of nerve sensing and nerve stimulation accompanied by a physiological response. The nerve stimulation component of the device delivers a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage the tissue. The sympathetic response of the GSN is measured by the physiological changes described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has been successfully dissolved circumferentially. If there is a physiological response and / or nerve activity sensed by the catheter device, the procedure is considered incomplete. The procedure is repeated at the same or different sites between two pairs of intercostal nerves to dissolve the nerve circumferentially.

[0132]

[0167] After the procedure, the patient's capacity improves, and the patient is re-evaluated at the clinic one month later. Here, the patient is found to have more energy and exercise levels, and is able to walk several blocks of stairs without rest. The cardiologist confirms that the patient has improved to one NYHA severity class lower, with a lower likelihood of hospitalization.

[0133] Example 5: Inpatient treatment of heart failure using alternative surgical methods

[0168] The patient is hospitalized due to worsening heart failure caused by volume overload and has recently been in and out of the hospital. The patient requires respiratory support (i.e., oxygen, external ventilation, or intubation) and is receiving intravascular diuretics to remove excess fluid, as well as other standard treatments. The patient may or may not have common comorbidities, including, among others, hypertension, renal disease, hepatic disease, high cholesterol, and diabetes. In this case, intravascular treatment is insufficient to remove the fluid, and the patient still shows signs of volume overload and / or respiratory failure. A decision is made to perform visceral nerve ablation during hospitalization.

[0134]

[0169] The catheter-based device described in Example 2 is used. The catheter device accesses the vascular system via the brachial vein, femoral vein, and subclavian vein using the Seldinger technique. The catheter device may be elongated in proportion to the vein selected for entry. The access sheath is advanced into the superior vena cava under fluoroscopic guidance. The sheath is inserted into the superior vena cava and proceeds through the vein, with the guidewire crossing its azygos vein. The sheath is inserted into the azygos vein from the superior vena cava, with the guidewire crossing the azygos vein. Using the anatomical landmark T10 from within the azygos vein, the device is rotated towards the right side of the patient, using a radiographic marker to confirm its position and orientation, thereby orienting the needle towards the right side of the patient. Here, the guidewire can enter between two pairs of intercostal nerves, e.g., T9 and T10, T10 and T11, T11 and T12, and / or T12 and L1. Here, it is assumed that the greater splanchnic nerve (GSN) is nearby, and the device is introduced to this position via the guidewire.

[0135]

[0170] When the device reaches a location observable by fluoroscopy (bones, blood vessels, etc.) which can be confirmed by using a marker band on the catheter device, proximity to the target nerve is optionally confirmed by applying stimulating energy to that location and measuring the physiological response to the stimulation, such as muscle response, nerve activity, or cardiac activity in the abdomen or GI canal. In some cases, the operator uses the nerve stimulation component of the device to deliver a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage tissue. The sympathetic response of the GSN is measured by detecting adverse changes in pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, changes in palmar sweating, changes in temperature related to rectal and / or skin measurements, changes in renal output associated with changes in vasodilation, changes in metabolism (i.e., decreased glucose and glucose release), and an increase in brain natriuretic peptide. By inducing these responses, the user can confirm proximity to the target nerve. The detected pressure is called pulmonary capillary wedge pressure and is considered equivalent to left atrial pressure. Left atrial pressure is a surrogate measure of left ventricular end-diastolic pressure. Assuming the absence of mitral valve disease, PCWP is a measure of the severity of heart failure. Higher PCWP indicates worsening of heart failure severity. Other responses are each measured by specific aspects of the device.

[0136]

[0171] The operator may optionally use another component of the device to directly sense nerves, using the same electrodes employed by the nerve stimulation component. If the operator can position the device at an approximate location on the GSN using anatomical landmarks, the device generator is switched to “nerve sensing” mode. In nerve sensing mode, electrodes are used to read action potentials through the GSN. These electrodes may be separate electrodes positioned on the surface of the catheter device, or one or more electrodes within the needle assembly. Data from the nerve stimulation component and the nerve sensing device are aggregated to inform the operator that the device is positioned to perform nerve destruction.

[0137]

[0172] After the nerve's location is confirmed by a combination of nerve stimulation and nerve sensing functions evaluated by the generator's software components, the vascular puncture mechanism is activated in the direction of the nerve to perform ablation. The puncture mechanism may optionally confirm its location using a combination of nerve sensing, nerve stimulation with physiological responses, and fluoroscopy to identify anatomical landmarks.

[0138]

[0173] Next, the nerve is severed by radiofrequency ablation by applying electrical stimulation to the electrode assembly. Electrical energy of approximately 15W or less is transmitted from the power source to the electrode assembly on the needle assembly adjacent to the target nerve, heating the target nerve and surrounding tissue to approximately 90°C.

[0139]

[0174] Since nerves can regenerate, the duration of the effect is fundamentally related to the length of the destroyed nerve tissue. In some cases, it is desirable to excise longer nerves (compared to endovascular ablation) to prolong the duration of sympathetic nerve activity elimination. This allows the patient to experience relief from heart failure symptoms for a longer period. In some cases, it is desirable to control the direction of the ablation modality. By aligning the ablation modality with the length of the nerve, the operator can minimize collateral damage to other organs.

[0140]

[0175] Next, the success of the procedure can be assessed by repeating the combination of nerve sensing and nerve stimulation accompanied by a physiological response. The nerve stimulation component of the device delivers a charge through the electrodes that is strong enough to induce a nerve response but not strong enough to damage the tissue. The sympathetic response of the GSN is measured by the physiological changes described above. The nerve sensing component detects the absence of nerve activity, indicating that the nerve has been successfully dissolved circumferentially. If there is a physiological response and / or nerve activity sensed by the catheter device, the procedure is considered incomplete. The procedure is repeated at the same or different sites between two pairs of intercostal nerves to dissolve the nerve circumferentially.

[0141]

[0176] After the procedure, the patient's capacity improves, and the patient is re-evaluated at the clinic one month later. Here, the patient is found to have more energy and exercise levels, and is able to walk several blocks of stairs without rest. The cardiologist confirms that the patient has improved to one NYHA severity class lower, with a lower likelihood of hospitalization.

[0142] Example 6: Nerve ablation catheter with a retractable needle assembly having an increased electrode surface area

[0177] A first vascular catheter device was provided, comprising an ablation needle, a retractable needle assembly comprising two electrodes separated by a PEEK electrode separator, an end cap, a core wire, a swivel coupler, and a proximal laser-cut hypotube. The needle had an outer diameter of approximately 0.025 inches, and each electrode had a length of approximately 0.33 inches. The end cap and core wire were made from stainless steel, the core wire having a diameter of approximately 0.007 inches, and covered with a polyimide inner insulating jacket. The distal and proximal electrodes were measured to have resistances of approximately 62 Ω and approximately 12.8 Ω, respectively.

[0143]

[0178] A second vascular catheter device was also provided, comprising an ablation needle assembly with a retractable needle assembly comprising an ablation needle, two electrodes separated by a PEEK electrode separator, an end cap, a core wire, a swivel coupler, and a proximal laser-cut hypotube, but differing in the outer diameter of the retractable needle assembly, the length of the electrodes on the retractable needle assembly, and the distal and proximal electrode resistances. The needle had an outer diameter of approximately 0.018 inches, with each zone having a length of approximately 0.39 inches. The core wire was formed from nitmol, had a diameter of approximately 0.007 inches, and was covered with a polyimide inner insulating jacket. The swivel coupler was formed from Pebax and polyimide. The distal and proximal electrodes were measured to have resistances of approximately 42.5 Ω and approximately 44.8 Ω, respectively.

[0144]

[0179] A first vascular catheter device and a second vascular catheter device, each equipped with a retractable needle assembly, were tested in a poultry tissue model to evaluate the effectiveness of tissue ablation resulting from the improved electrode design.

[0145]

[0180] The first vascular catheter device was tested by inserting a retractable needle assembly into chicken breast and delivering electrical energy to the electrodes. After applying 8W for approximately 30 seconds, no audible sound of water evaporation or signs of plasma generation were recorded, and the laser-scribed hypotubule was smoothly removed without tissue adhesion. After applying 9W for approximately 30 seconds, no audible sound of water evaporation or signs of plasma generation were recorded, and the laser-scribed hypotubule was removed with only slight tissue adhesion. After applying 10W for 27 seconds, an audible sound of water evaporation was recorded without signs of plasma generation, and after extraction, small clumps of tissue adhered to the laser-scribed hypotubule. Applying 10W for a further 14 seconds generated a sound of water evaporation, and after 28 seconds, visible plasma and a cooking odor were reported. Applying 10W to a fresh section of tissue for approximately 20 seconds produced a sound of water evaporation without signs of plasma. After 30 seconds, the laser-scribed hypotube was easily removed, and the length and diameter of the ablation zone were measured to be 18.6 mm and 8.34 mm, respectively.

[0146]

[0181] A second vascular catheter device was tested, and a retractable needle assembly was inserted into chicken breast meat, delivering electrical energy to the electrodes. After applying 8W for approximately 30 seconds, no audible water evaporation or signs of plasma generation were recorded, and the laser-scribed hypotubule was smoothly removed without any signs of tissue adhesion or ablation. After applying 9W for approximately 30 seconds, no audible water evaporation or signs of plasma generation were recorded, and the laser-scribed hypotubule was removed with slight tissue adhesion. After applying 10W for 30 seconds, an audible water evaporation was recorded without signs of plasma generation, and after extraction, small clumps of tissue adhered to the laser-scribed hypotubule. The length and diameter of the ablation zone were measured at 15.2 mm and 5.37 mm, respectively.

[0147]

[0182] Comparing the above results, it is observed that the first nerve ablation catheter according to this specification, having an increased electrode surface area, can adequately excise tissue without plasma-induced carbonization damage and remove the tissue from the ablation area without damaging the surrounding tissue. Despite having a shorter electrode surface length that defines a shorter ablation area (8.4 mm) than the second vascular catheter device (9.9 mm), the first vascular catheter device has a 55% larger diameter and forms a 22% longer ablation area than the ablation area formed by the second vascular catheter device. Therefore, the first vascular catheter device exhibits a 195% larger ablation area compared to the second vascular catheter device (1016 mm for the first catheter). 3 In contrast, the second catheter has a 344 mm 3 Furthermore, tissue adhesion to the needle assembly is also reduced, showing decreased tissue adhesion to the ablation needle when operated under equivalent conditions of 9 watts applied for 30 seconds. Thus, the improved ablation volume provided by the first vascular catheter device with increased surface area offers surgeons greater flexibility when performing ablation procedures, allowing for the removal of relatively large volumes over longer periods, while also reducing tissue adhesion to the ablation needle, which poses a significant post-ablation injury risk during needle retraction.

[0148] Example 7: Telescopic needle assembly with increased needle lumen curvature, and nerve ablation catheter with a linear guidewire lumen.

[0183] A first vascular catheter device is provided, comprising an expandable needle assembly comprising an ablation needle, two electrodes separated by a PEEK electrode separator, an end cap, a core wire, a swivel coupler, and a proximal laser-cut hypotube. This vascular catheter device comprises a needle assembly lumen having an inner diameter of 0.033 inches and a radius of curvature of 0.09 inches from which the expandable needle assembly extends, and a linear guidewire lumen having the same width as a portion of the needle assembly lumen. The resulting exit port of the needle assembly lumen is positioned at substantially orthogonal angles. The first vascular catheter device further comprises a tubular body configured to bias the vascular catheter in a single extension direction when the expandable needle assembly is extended, thereby preventing the vascular catheter from moving within the vascular tissue.

[0149]

[0184] A second vascular catheter device was provided, comprising an expandable needle assembly comprising an ablation needle, two electrodes separated by a PEEK electrode separator, an end cap, a core wire, a swivel coupler, and a proximal laser-cut hypotube. This vascular catheter device comprises a needle assembly lumen having an inner diameter of 0.03 inches with a radius of curvature of 0.055 inches from which the expandable needle assembly extends, and a linear guidewire lumen having the same width as a portion of the needle assembly lumen. The exit port of the resulting needle assembly lumen is positioned at an angle that is not as orthogonal as in the first vascular catheter device.

[0150]

[0185] The delivery of the catheter device is tested in a pig model. The catheter is positioned by the movement of the guidewire around the guidewire lumen. A first vascular catheter device having a straight guidewire lumen with the same width as a portion of the needle assembly lumen is observed to be more easily positioned and guided into place compared to a second catheter device with a non-straight portion guidewire lumen, where the guidewire needs to bend in the shaft when the catheter device is forced forward through the vein, due to the straight guidewire lumen, which does not require the guidewire to bend in the shaft when the catheter device is forced forward through the vein.

[0151]

[0186] The extension of the retractable needle assembly is tested in a pig model. It is observed that the increased radius of curvature and angle of curvature of the needle assembly lumen bias the vascular catheter in the vein against a single extension direction of the retractable needle assembly when the retractable needle assembly is extended, preventing the vascular catheter from moving within the vein.

[0152] Embodiment

[0187] Embodiment 1. An embodiment comprising a device for treating a medical condition, wherein the device is a catheter having a needle lumen having a longitudinal axis and substantially parallel to or substantially coincident with the longitudinal axis of the catheter, the needle lumen terminating at a lateral opening in the distal portion of the catheter; and a needle assembly configured to extend into and / or out of the needle lumen, comprising a first needle having a first tip and a second needle having a second tip, the first and second needles being disposed at the distal end of the needle assembly, and the needle assembly having a non-branched configuration before at least partially extending from the needle lumen and / or lateral opening, and a branched configuration when the needle assembly is in a branched configuration. Embodiments comprising: a needle assembly in which, when the first tip and the second tip are spaced apart by an unfolded distance measured from the first tip and the second tip, and the needle assembly is in a non-branched configuration, the first tip and the second tip are spaced apart by an unfolded distance measured from the first tip and the second tip, and the unfolded distance is greater than the unfolded distance, and the needle assembly is in a branched configuration, the first needle and the second needle are at a non-zero angle with respect to the longitudinal axis of the catheter; a first ablation electrode disposed on the first needle, which is electrically in communication with a first energy source; and a second ablation electrode disposed on the second needle, which is electrically in communication with a first energy source and / or a second energy source.

[0153]

[0188] Embodiment 2. The device according to Embodiment 1, wherein the needle assembly extends from the needle lumen, is in close proximity to the target nerve, and when energized, the device is configured to excise a length of the target nerve that is at least the same as or longer than the deployed distance between the first tip and the second tip.

[0154]

[0189] Embodiment 3. The device according to Embodiment 1 or 2, further comprising a needle tube inside and / or extending from the needle lumen, wherein the needle assembly is at least partially disposed inside the needle tube and has a branching configuration when at least partially extending from the needle tube.

[0155]

[0190] Embodiment 4. An embodiment comprising a device for treating a medical condition, wherein the device comprises: a catheter having a longitudinal axis; a balloon having a proximal shoulder at the distal portion of the catheter, which is in fluid communication with an inflation medium and configured to be inflated by the inflation medium; a needle tube disposed on the outer surface of the balloon; and a needle assembly configured to be inside and / or extending from the needle tube, comprising a first needle having a first tip and a second needle having a second tip, wherein the first and second needles are disposed at the distal end of the needle assembly, and the needle assembly has a non-branched configuration before extending a predetermined distance from the needle tube, and a branched configuration when extending a predetermined distance from the needle tube, and when the needle assembly is in a branched configuration, An embodiment comprising: a needle assembly in which the tip of a first needle and a second tip are spaced apart by an unfolded distance measured from the first tip and the second tip, and when the needle assembly is in a non-branched configuration, the first tip and the second tip are spaced apart by an unbranched distance measured from the first tip and the second tip, and the unfolded distance is greater than the unbranched distance; a first ablation electrode disposed on the first needle, which is electrically in communication with a first energy source; and a second ablation electrode disposed on the second needle, which is electrically in communication with a first energy source and / or a second energy source, wherein when the balloon is inflated, the needle tube moves at a non-zero angle with respect to the longitudinal axis of the catheter. The device according to Embodiment 4, wherein the needle assembly extends a predetermined distance from the needle tube, is in close proximity to the target nerve, and is energized, and the device is configured to excise a length of the target nerve that is at least the same length as or longer than the deployed distance between the first tip and the second tip.

[0156]

[0191] Embodiment 5. The device according to Embodiment 4 or 5, wherein the balloon is in fluid communication with an inflatable medium via an expansion tube.

[0157]

[0192] Embodiment 6. The device according to any one of Embodiments 4 to 6, wherein the expansion medium includes a gas or a liquid.

[0158]

[0193] Embodiment 7. The device according to Embodiment 7, wherein the expansion medium includes air, saline solution, or water.

[0159]

[0194] Embodiment 8. The device according to any one of Embodiments 1 to 8, wherein the first ablation electrode and the second ablation electrode are electrically insulated from each other.

[0160]

[0195] Embodiment 9. The device according to any one of Embodiments 1 to 9, wherein the needle assembly is configured to deliver charge in a bipolar manner.

[0161]

[0196] Embodiment 10. The device according to any one of Embodiments 1 to 10, wherein a first ablation electrode and / or a second ablation electrode are operably in communication with a controller to modulate power delivered by a first and / or second energy source.

[0162]

[0197] Embodiment 11. The device according to Embodiment 2 or 5, wherein the length of the target nerve to be resected is 10% to 1000% longer than the deployment distance.

[0163]

[0198] Embodiment 12. The device according to any one of Embodiments 1 to 12, wherein the deployment distance is approximately 1 mm to approximately 10 cm.

[0164]

[0199] Embodiment 13. The device according to any one of Embodiments 1 to 13, wherein the first and second needles include a memory material and allow the needle assembly to change into a branched configuration when they are not confined within the lumen of the needle assembly.

[0165]

[0200] Embodiment 14. The device according to any one of Embodiments 1 to 14, further comprising a nerve stimulating electrode disposed on an external catheter, wherein the nerve stimulating electrode is configured to electrically communicate with a first, second, or third energy source located at the proximal end of the device to stimulate a target nerve.

[0166]

[0201] Embodiment 15. The device according to Embodiment 15, wherein the nerve stimulation electrode is positioned on the outer surface of the catheter at a position within 0 to 90 degrees radially on the outer surface of the catheter with respect to the longitudinal axis of the catheter.

[0167]

[0202] Embodiment 16. The device according to Embodiment 16, wherein two or more of the first, second, and third energy sources are the same or different energy sources.

[0168]

[0203] Embodiment 17. The device according to Embodiment 17, wherein two or more of the first, second, and third energy sources have different energy parameters or the same energy parameters (X, Y, Z, etc.).

[0169]

[0204] Embodiment 18. Embodiments comprising a device for treating a medical condition, wherein the device comprises: a catheter having a longitudinal axis; a balloon having a proximal shoulder at the distal portion of the catheter, which is in fluid communication with an inflatable medium and configured to be inflated with the inflatable medium; a needle tube disposed on the outer surface of the balloon; a hollow needle having a longitudinal axis of the needle, which is configured to extend into and / or out of the needle tube, which is in fluid communication with an ablation medium and has a lateral policy opening for delivering the ablation medium therefrom; and a nerve stimulator electrode disposed on the outer surface of the catheter, which is in electrical communication with a first energy source and configured to stimulate a target nerve, wherein when the balloon is inflated, the needle tube moves at a non-zero angle with respect to the longitudinal axis of the catheter, and the device is configured to resect a length of the target nerve by delivery of the ablation medium through the lateral policy opening.

[0170]

[0205] Embodiment 19. The device according to Embodiment 19, wherein the balloon is in fluid communication with an inflatable medium via an expansion tube.

[0171]

[0206] Embodiment 20. The device according to either Embodiment 19 or 20, wherein the expansion medium includes a gas or a liquid.

[0172]

[0207] Embodiment 21. The device according to Embodiment 21, wherein the expansion medium comprises air, saline solution, or water.

[0173]

[0208] Embodiment 22. The device according to any one of Embodiments 19 to 22, wherein the ablation medium comprises a liquid and / or a gas.

[0174]

[0209] Embodiment 23. The device according to any one of Embodiments 19 to 23, wherein the ablation medium comprises carbon dioxide, ethanol, liquid nitrogen, a conductive material (e.g., physiological saline, a special hydrogel, etc.), alcohol, lidocaine, a lidocaine analog, or a combination thereof.

[0175]

[0210] Embodiment 24. The device according to any one of Embodiments 19 to 24, wherein the nerve stimulating electrode is positioned on the outer surface of the catheter at a position within 0 to 90 degrees radially on the outer surface of the catheter with respect to the longitudinal axis of the catheter.

[0176]

[0211] Embodiment 25. The device according to any one of Embodiments 1 to 25, further comprising a neurosensory region configured to sense the neural activity of a target nerve.

[0177]

[0212] Embodiment 26. The device according to Embodiment 26, wherein the neuronal sensory region is configured to sense the action potential of a target nerve.

[0178]

[0213] Embodiment 27. The device according to Embodiment 26 or 27, wherein the nerve sensory region comprises nerve sensory electrodes.

[0179]

[0214] Embodiment 28. The device according to any one of Embodiments 1 to 28, wherein the catheter further comprises a radiopaque region.

[0180]

[0215] Embodiment 29. An embodiment comprising a method for treating a medical condition, the method comprising: inserting a catheter into a patient, wherein the catheter has an opening in its distal portion; guiding the catheter to a first location in the patient using anatomical landmarks to determine the location of a target nerve; delivering a first stimulus to the target nerve via nerve stimulation electrodes disposed on the catheter; and measuring the physiological response corresponding to the first stimulus to confirm the location of the target nerve.

[0181]

[0216] Embodiment 30. The method according to Embodiment 30, further comprising (a) monitoring physiological parameters, (b) moving the catheter to a second location within the patient to determine the location of the target nerve, and (c) delivering a second stimulus to the target nerve via a nerve stimulating electrode, prior to step (d).

[0182]

[0217] Embodiment 31. The method according to Embodiment 30 or 31, further comprising sensing the neural activity of a target nerve using a neurosensory region disposed on the catheter before delivering a first stimulus.

[0183]

[0218] Embodiment 32. The method according to any one of Embodiments 30 to 32, further comprising: extending a needle assembly from a catheter to a target nerve; and excising a length of the target nerve to provide treatment for a medical condition.

[0184]

[0219] Embodiment 33. The method according to Embodiment 33, wherein the needle assembly comprises an ablation electrode.

[0185]

[0220] Embodiment 34. The method according to Embodiment 33, further comprising branching the needle assembly such that the tip of the first needle of the first needle is separated from the tip of the second needle of the second needle before resecting the length of the target nerve, wherein a first ablation electrode is disposed on the first needle, a second ablation electrode is disposed on the second needle, and the ablation is performed via the first ablation electrode and the second ablation electrode.

[0186]

[0221] Embodiment 35. The method according to Embodiment 35, wherein the length of the target nerve is at least the same as or longer than the distance between the first needle tip and the second needle tip after the needle assembly has been branched.

[0187]

[0222] Embodiment 36. The method according to Embodiment 35 or 36, further comprising extending a balloon positioned on the catheter so as to orient the needle assembly in a direction that aligns each ablation electrode with a target nerve, before extending the needle assembly from the catheter.

[0188]

[0223] Embodiment 37. The method according to any one of Embodiments 35 to 37, wherein the method comprises excising at least a portion of the target nerve to deliver radiofrequency energy, microwave energy, or both to the target nerve.

[0189]

[0224] Embodiment 38. The method according to Embodiment 33, wherein the needle assembly comprises a hollow needle having a fluid port, and the hollow needle is in fluid communication with the ablation medium.

[0190]

[0225] Embodiment 39. The method according to Embodiment 39, wherein the length of the target nerve is resected, and the ablation medium is delivered to the target nerve through a fluid port.

[0191]

[0226] Embodiment 40. The method according to Embodiment 40, wherein the ablation medium comprises carbon dioxide, ethanol, liquid nitrogen, a conductive substance (e.g., physiological saline, a special hydrogel, etc.), alcohol, lidocaine, a lidocaine analog, or a combination thereof.

[0192]

[0227] Embodiment 41. The method according to any one of Embodiments 33 to 41, further comprising: delivering a third stimulus to a target nerve via a nerve stimulating electrode; and confirming the interruption of neural activity of the target nerve.

[0193]

[0228] Embodiment 42. The method according to Embodiment 42, wherein confirming the interruption of neural activity is used to detect the absence or insignificant physiological changes after the delivery of a third stimulus.

[0194]

[0229] Embodiment 43. The method according to any one of Embodiments 33 to 43, further comprising rotating the catheter to position the needle assembly so that the needle assembly extends from the catheter to the target nerve.

[0195]

[0230] Embodiment 44. The method according to any one of Embodiments 30 to 44, wherein guiding the catheter includes using fluoroscopy that utilizes a radiopaque area on the catheter.

[0196]

[0231] Embodiment 45. The method according to any one of Embodiments 30 to 45, wherein the anatomical landmark includes the 9th thoracic vertebra (T9).

[0197]

[0232] While the present invention has been described with reference to exemplary embodiments, this specification is not intended to be constrained. Various modifications and combinations of the exemplary embodiments, as well as other embodiments of the invention, will become apparent to those skilled in the art by reference to this specification. Accordingly, the appended claims are intended to encompass such modifications and extensions.

Claims

1. It is a vascular catheter, Longitudinal axis and, The distal end and The proximal end and A catheter shaft equipped with an exit port, A telescopic needle assembly lumen comprising a telescopic needle assembly extending through the exit port and configured to puncture vascular tissue in contact with the catheter, wherein the telescopic needle assembly comprises one or more electrodes configured to deliver electrical energy to tissue in contact with one or more electrodes, the telescopic needle assembly comprising a first section surrounding a second section, the second section extending outward from the first section, and the one or more electrodes having at least 0.02 in per electrode ２ The lumen of the telescopic needle assembly, including the surface area, Guidewire lumen, Catheter tip and A vascular catheter equipped with [a specific feature / equipment].

2. The one or more electrodes described above have at least 0.022 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

3. The one or more electrodes described above have at least 0.0225 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

4. The one or more electrodes described above have at least 0.025 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

5. The one or more electrodes described above have at least 0.026 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

6. The one or more electrodes described above have at least 0.0275 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

7. The one or more electrodes described above have at least 0.028 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

8. The one or more electrodes described above have at least 0.029 in per electrode. ２ A vascular catheter according to claim 1, including the surface area.

9. The one or more electrodes each include a surface area of at least 0.03 in per electrode ２ The vascular catheter according to claim 1

10. The vascular catheter according to claim 1, wherein the cross-section of the catheter shaft is less than 0.091 inches.

11. The vascular catheter according to claim 1, wherein the inner diameter of the lumen of the needle assembly is at least 0.033 inches.

12. The vascular catheter according to claim 1, wherein the retractable needle assembly has a smooth outer surface around the retractable needle assembly.

13. The vascular catheter according to claim 1, wherein the retractable needle assembly includes a smooth outer surface around the retractable needle assembly, and the transition portion around the outer surface of the surface around the retractable needle assembly is limited to an electrode pole separator and an end cap of the retractable needle assembly.

14. The vascular catheter according to claim 1, wherein the retractable needle assembly extends 1.2 to 1.7 inches from the side of the catheter shaft.

15. The vascular catheter according to claim 1, wherein the lumen of the needle assembly has a radius of curvature of at least 0.55 inches.

16. The vascular catheter according to claim 1, wherein the lumen of the needle assembly has a radius of curvature of at least 0.6 inches.

17. The vascular catheter according to claim 1, wherein the lumen of the guidewire is defined by a linear vector extending longitudinally through the length of the catheter.

18. The vascular catheter according to claim 1, wherein the lumen of the guidewire is not curved around its length.

19. The vascular catheter according to claim 1, wherein the guide wire lumen has the same extent as at least a portion of the needle assembly lumen.

20. The vascular catheter according to claim 1, wherein the retractable needle assembly extends in an arc shape from the lumen of the needle assembly.

21. The vascular catheter according to claim 1, wherein the arc has a length of approximately 1.2 to 1.7 inches.

22. The vascular catheter according to claim 1, wherein the lumen of the needle assembly provides an angle of curvature of at least 80 degrees, and the telescopic needle assembly bends around the angle of curvature to exit the lumen of the needle assembly.

23. The vascular catheter according to claim 1, wherein the outlet port is positioned on the side surface of the catheter shaft.

24. The vascular catheter according to claim 23, wherein the lumen of the needle assembly has a radius of curvature of at least 0.7 inches.

25. The vascular catheter according to claim 23, wherein the lumen of the needle assembly has a radius of curvature of at least 0.8 inches.

26. The vascular catheter according to claim 23, wherein the lumen of the needle assembly has a radius of curvature of at least 0.9 inches.

27. The vascular catheter according to any one of claims 23 to 26, wherein the outlet port is contained within a tubular body having a side surface facing the outlet port, and the tubular body is configured to stabilize the vascular catheter when the telescopic needle assembly is extended.

28. The vascular catheter according to claim 27, wherein the vascular catheter comprises only one needle assembly.

29. The vascular catheter according to claim 28, wherein the retractable needle assembly extends unilaterally in a single extension direction relative to the catheter shaft.

30. The vascular catheter according to claim 29, wherein the tubular body is configured to bias the vascular catheter in the single extension direction.

31. The vascular catheter according to claim 29, wherein the tubular body is configured to bias the vascular catheter in the single extension direction when the telescopic needle assembly is extended, thereby preventing the vascular catheter from moving within the vascular tissue.

32. The vascular catheter according to any one of claims 15 to 16 or 24 to 26, wherein the radius of curvature of the lumen of the needle assembly and the angle of curvature of the lumen of the needle assembly are configured to bias the vascular catheter in the single extension direction when the telescopic needle assembly is extended, thereby preventing the movement of the vascular catheter within the vascular tissue.

33. The vascular catheter according to claim 1, further comprising an electrical surface on the needle assembly.

34. The vascular catheter according to claim 1, further comprising a base electrode on the outer surface of the catheter.

35. The vascular catheter according to claim 1, wherein the base electrode is positioned on the outer surface of the vascular catheter at a position within 0 to 90 degrees radially on the outer surface of the vascular catheter with respect to the longitudinal axis of the vascular catheter.

36. The vascular catheter according to claim 1, further comprising a plurality of base electrodes on the outer surface of the catheter.

37. The vascular catheter according to claim 1, further comprising a first electrical circuit electrically coupled to one or more electrodes.

38. The vascular catheter according to claim 37, further comprising a second electrical circuit electrically coupled to the base electrode.

39. The vascular catheter according to claim 38, wherein the catheter is configured to provide electrical energy of different frequencies to the first electrical circuit and the second electrical circuit.

40. The needle assembly, The distal point on the second section, The first electrode and The second electrode and A wire connecting the first electrode and the second electrode to a power source, An insulating material that insulates the first electrode, the second electrode, and the wire from the vascular catheter. A vascular catheter according to claim 1, comprising:

41. The vascular catheter according to claim 40, wherein the wire includes an enamel-coated wire or a multi-strand braid.

42. The vascular catheter according to claim 1, wherein the first section comprises a first tubular body, and the second section comprises a second tubular body, the first tubular body extending outward from the second tubular body, and the first tubular body is nested within the second tubular body, thereby the tubular body being fully or partially housed within the first tubular body.

43. The vascular catheter according to claim 36, wherein the needle assembly further comprises a third section having a sharp distal end, the second section enclosing the third section, and the third section extending outward from the second section.

44. The vascular catheter according to claim 43, wherein the first electrode is positioned on the first tube and the second electrode is positioned on the second tube.

45. The vascular catheter according to claim 43, wherein the first electrode and the second electrode are positioned on the first tube or the second tube.

46. The vascular catheter according to claim 43, wherein the needle assembly further comprises an electrical insulating material within the needle assembly, and the electrical insulating material comprises a dielectric insulator between the first tube and the second tube.

47. The vascular catheter according to claim 43, wherein the needle assembly further comprises an electrical insulating material within the needle assembly, the electrical insulating material comprising an insulator or dielectric washer positioned between the first and second tubes along the circular cross-section of the first or second tube.

48. The vascular catheter according to claim 1, wherein the one or more electrodes include only a single electrode.

49. The vascular catheter according to claim 1, wherein the one or more electrodes include two electrodes.

50. The vascular catheter according to claim 1, wherein the one or more electrodes include three electrodes.

51. The vascular catheter according to claim 50, wherein the three electrodes are arranged such that the second electrode is between the first electrode and the third electrode, the second electrode is the negative electrode, the first electrode and the third electrode are the positive electrodes, or adjacent electrodes have opposite polarities.

52. The vascular catheter according to claim 50, wherein the three electrodes are arranged such that the second electrode is between the first electrode and the third electrode, the second electrode is the positive electrode, and the first electrode and the third electrode are the negative electrodes.

53. The vascular catheter according to claim 51 or 52, wherein the catheter is configured to enable ablation between the first electrode and the second electrode, or between the second electrode and the third electrode.

54. The vascular catheter according to claim 1, wherein the needle assembly further comprises an electrically insulating material within the needle assembly.

55. The vascular catheter according to claim 1, wherein the electrical insulating material comprises a dielectric, a dielectric washer, or a polyimide liner.

56. The vascular catheter according to claim 40, wherein the needle assembly further comprises a third electrode.

57. The vascular catheter according to claim 56, wherein the needle assembly further comprises a separate electrical circuit for each electrode.

58. The vascular catheter according to claim 1, wherein when the needle assembly extends a predetermined distance from the exit port, is in close proximity to the target nerve, and is energized, the vascular catheter is configured to excise a length of the target nerve that is at least the same as or longer than the deployed distance between the first and second tubes.

59. The vascular catheter according to claim 1, wherein the insulating material includes a dielectric washer.

60. The vascular catheter according to claim 40, wherein the first electrode and the second electrode are electrically insulated from each other.

61. The vascular catheter according to claim 1, wherein the needle assembly is configured to deliver electric charge in a bipolar manner.

62. The vascular catheter according to claim 40, wherein the first electrode and / or the second electrode are operably in communication with a controller configured to modulate power delivered by an energy source.

63. The vascular catheter according to claim 1, wherein one or more electrodes include a silkscreen electrode.

64. The vascular catheter according to claim 1, wherein the one or more electrodes include additively manufactured electrodes.

65. The vascular catheter according to claim 1, wherein one or more electrodes include electrodes manufactured by removal processing.

66. The vascular catheter according to claim 1, further comprising a base at the proximal end of the vascular catheter configured to enable manipulation of the vascular catheter.

67. The vascular catheter according to claim 1, further comprising a vascular catheter rotation knob configured to rotate the vascular catheter.

68. The vascular catheter according to claim 1, further comprising a rotary electrical connector configured to rotate the catheter or the needle assembly.

69. The vascular catheter according to claim 1, further comprising a rotary electrical connector configured to rotate the catheter, the needle assembly, the guidewire port, or the contrast port.

70. The vascular catheter according to claim 1, further comprising a rotary electrical connector configured to rotate the catheter or the rotary control knob.

71. The vascular catheter according to claim 1, further comprising a rotating coupler configured to rotate the vascular catheter.

72. The vascular catheter according to claim 1, further comprising an electrode advance portion configured to extend the needle assembly and one or more electrodes through the exit port.

73. The vascular catheter according to claim 1, further comprising a guidewire port.

74. The vascular catheter according to claim 1, further comprising a contrast port.

75. The vascular catheter according to claim 1, further comprising a dielectric material for insulating one or more electrodes from the vascular catheter.

76. The vascular catheter according to claim 75, wherein the dielectric material includes polyimide.

77. The vascular catheter according to claim 1, wherein the vascular catheter shaft comprises braided reinforced Pebax, extruded material, nylon, fiber material, wire, multi-strain braid, or a material configured to transmit force through the longitudinal axis.

78. The vascular catheter according to claim 1, wherein the needle assembly further comprises one or more marker bands.

79. The vascular catheter according to claim 78, wherein one or more marker bands are configured to provide instructions regarding the positioning of the catheter relative to a vein by fluoroscopic imaging, or to indicate the relative position of the catheter within a vein, artery, or blood vessel.

80. The vascular catheter according to claim 78, wherein one or more marker bands are positioned together with the retractable needle assembly.

81. The vascular catheter according to claim 1, wherein the ratio of the radius of curvature of the ablation needle lumen proximal to the outlet port to the diameter of the ablation needle lumen is at least about 1:

1.

82. The vascular catheter according to claim 1, wherein the ratio of the radius of curvature of the ablation needle lumen proximal to the exit port to the diameter of the ablation needle lumen is about 1:1 to about 4:

1.

83. The vascular catheter according to claim 1, wherein the ratio of the radius of curvature of the ablation needle lumen proximal to the exit port to the diameter of the ablation needle lumen is up to about 4:

1.

84. The vascular catheter according to claim 1, wherein the ratio of the diameter to the surface area per inch of the retractable needle assembly and the one or more electrodes is at least 0.

05.

85. The vascular catheter according to claim 1, wherein the ratio of the diameter to the surface area per inch of the retractable needle assembly and the one or more electrodes is about 0.05 to about 0.

4.

86. The vascular catheter according to claim 1, wherein the ratio of the diameter to the surface area per inch of the retractable needle assembly and the one or more electrodes is up to 0.

15.

87. A method for treating or preventing heart failure or symptoms of heart failure in patients who require treatment, Inserting a catheter into the vascular lumen defined by the vascular tissue of the patient being treated, Guiding the catheter toward a position proximal to the target nerve, wherein the target nerve includes the greater splanchnic nerve, The procedure involves puncturing the vascular tissue of the patient with a retractable needle assembly that extends outward from the catheter toward the target nerve, wherein the retractable needle assembly comprises an electrode assembly, and the retractable needle assembly comprises a first section surrounding a second section, and the second section extends outward from the first section, and the procedure involves puncturing. The electrode assembly is used to deliver stimulating energy to the target nerve, thereby completely or partially resecting the target nerve, and treating or preventing heart failure or symptoms of heart failure in the patient. A method that includes this.

88. The method according to claim 87, wherein treating or preventing heart failure or symptoms of heart failure in the subject to treatment includes reducing intracardiac pressure or reducing the accumulation of blood in the cardiopulmonary circuit of the subject to treatment.

89. Delivering preliminary stimulation energy to the target nerve before puncturing the vascular tissue of the subject to treatment, or delivering preliminary stimulation energy to the target nerve after puncturing the vascular tissue of the subject to treatment, or a combination thereof. The physiological response corresponding to the aforementioned preliminary stimulation energy is measured, thereby indicating whether the aforementioned position proximal to the target nerve is sufficiently close to the target nerve. The method according to claim 87, further comprising:

90. The method according to claim 87, wherein the physiological response includes adverse changes in nerve activity, muscle movement, cardiac activity, pulmonary capillary wedge pressure (PCWP), gastrointestinal changes including increased motility, increased or decreased palmar sweating, increased or decreased temperature as measured by rectal and / or skin, increased or decreased renal output associated with changes in vasodilation, decreased metabolism, decreased glucose release, decreased glucagon release, or increased brain natriuretic peptide.

91. The method according to claim 87, wherein the physiological response includes the measurement of an action potential through the target nerve.

92. The method according to claim 87, wherein an insufficient physiological response corresponding to the pre-stimulation energy is measured, indicating that the position proximal to the target nerve is not sufficiently close to the target nerve.

93. The method according to claim 87, further comprising reguiding the catheter toward a second location proximal to the target nerve, wherein the second location is closer to the target nerve than the first location.

94. The method according to claim 87, wherein a sufficient physiological response corresponding to the pre-stimulation energy is measured, and the position adjacent to the target nerve is shown to be sufficiently close to the target nerve.

95. The method according to claim 87, wherein the stimulation energy sufficient to resect the target nerve includes electrical stimulation.

96. The method according to claim 87, wherein delivering sufficient stimulating energy to the target nerve to excise the target nerve using the electrode assembly includes heating the target nerve or a portion thereof to about 50, 55, 60, 65, 70, 75, 80, 85, or 90°C.

97. The method according to claim 87, further comprising orienting the catheter within the vascular tissue of the patient to be treated such that the catheter is oriented in a direction that aligns the needle assembly with the target nerve.

98. The method according to claim 87, further comprising using a radiometric marker to orient the catheter within the vascular tissue of the patient so that the catheter is oriented in a direction that aligns the needle assembly with the target nerve.

99. The method according to claim 98, wherein oriented the catheter includes oriented the needle assembly in a direction that aligns the electrode assembly with the target nerve.

100. The method according to claim 99, wherein directing the catheter includes rotating the catheter so that the needle assembly extends from the catheter to the target nerve.

101. After the target nerve is resected, confirmation stimulation energy is delivered, The physiological response or change in the physiological response corresponding to the aforementioned confirmation stimulus energy is measured, thereby confirming the interruption of the neural activity of the target nerve. The method according to claim 87, further comprising:

102. The method according to claim 101, wherein a physiological response corresponding to the confirmation stimulus energy is measured, indicating that the ablation of the target nerve was unsuccessful.

103. The method according to claim 101, further comprising delivering the stimulating energy to the target nerve using the electrode assembly, thereby repeatedly ablating the target nerve.

104. The method according to claim 87, wherein the target nerve is the greater splanchnic nerve.

105. The method according to claim 104, wherein the target nerve is the left branch, right branch, twig, or minor branch of the greater splanchnic nerve.

106. The method according to claim 1, wherein guiding the catheter toward the position proximal to the target nerve includes guiding the catheter toward the ninth thoracic vertebra (T9), the tenth thoracic vertebra (T10), the eleventh thoracic vertebra (T11), the twelfth thoracic vertebra (T12), or the first lumbar vertebra (L1).

107. The method according to claim 87, wherein the stimulation energy is approximately 1 W to approximately 100 W.

108. The method according to claim 87, wherein the stimulation energy is approximately 25 W to approximately 75 W.

109. The method according to claim 87, wherein the stimulation energy is approximately 30, 35, 40, 45, 50, 55, 60, 65, or 70 W.

110. The method according to claim 87, wherein the stimulation energy is approximately 50 W.

111. The method according to claim 87, wherein the stimulation energy is approximately 6 W or approximately 7 W.

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