Implantable energy device and method

Abstract

Disclosed herein are systems and methods for treating certain medical conditions by implanting a specialized implant in a patient and applying electrical current, ultrasound, or both to a location near or in the kidney to stimulate kidney activity. In some examples, electroporation, sonoporation, and / or transient nerve block can be produced to selectively improve kidney function, thereby treating a variety of different conditions.

Description

Cross-reference to related applications

[0001] This application claims the benefit and priority of U.S. Provisional Application Serial No. 63 / 520,057, filed August 16, 2023, entitled “Implantable Ultrasonic Device and Methods for Treating Renal Function,” the entire contents of which are incorporated herein by reference. Background Technology

[0002] Various approaches have been developed to treat end-stage renal disease, cardiorenal heart failure, hypertension, and similar conditions, often involving invasive procedures or pharmacological interventions. Traditional treatments for these diseases may include dialysis for end-stage renal disease, pharmacological therapy for heart failure and hypertension, and organ transplantation in severe cases. While these treatments can effectively control symptoms and improve quality of life, they may not address the underlying cause of the disease or provide a long-term solution.

[0003] In recent years, there has been increasing interest in exploring alternative therapies for kidney disease, heart failure, and hypertension. Some approaches focus on delivering targeted therapies directly to the affected organs or tissues using implantable devices. For example, implantable devices such as pacemakers and defibrillators have been used to modulate cardiac function in patients with heart failure. However, these devices are not typically designed specifically for kidney function or to address the complex interactions between the kidneys and cardiovascular system in conditions such as cardiorenal heart failure. Summary of the Invention

[0004] In some aspects, the technology described herein relates to a treatment system comprising: an energy distribution device configured for long-term implantation in a patient; the energy distribution device having an activated state in which energy is distributed to one or more kidneys of the patient; and a controller connected to the energy distribution device via one or more wires supplying current to the energy distribution device.

[0005] In some respects, the technology described herein relates to a treatment system in which an energy distribution device includes a first wire having a first electrode and a second wire having a second electrode.

[0006] In some respects, the technology described herein relates to a treatment system in which the energy distribution device includes a third wire having a third electrode.

[0007] In some respects, the techniques described herein relate to a treatment system in which a controller supplies current to at least a first wire and a second wire, the current generating electroporation in the surrounding area near the first and second electrodes.

[0008] In some respects, the techniques described herein relate to therapeutic systems in which a controller supplies current at frequencies ranging from approximately 1 to 10 Hz, including the end-value range.

[0009] In some respects, the techniques described herein relate to therapeutic systems in which a controller supplies electrical energy sufficient to generate an electric field ranging from approximately 100 V / cm to 3000 V / cm, including the range of terminal values.

[0010] In some respects, the techniques described herein relate to therapeutic systems in which a controller supplies current to at least a first wire and a second wire, generating transient nerve block in the vicinity of the first and second electrodes.

[0011] In some respects, the techniques described herein relate to therapeutic systems in which a controller supplies current in the range of 1–80 kHz at amplitudes in the range of approximately 0–20 mA and 0–20 Vpp.

[0012] In some respects, the techniques described herein relate to treatment systems in which a first electrode and a second electrode are connected to a scaffold-like structure.

[0013] In some respects, the techniques described herein relate to treatment systems in which the scaffold-like structure has a radially expanded diameter ranging from about 3 mm to about 20 mm, including the end values.

[0014] In some respects, the techniques described herein relate to therapeutic systems in which a scaffold structure includes multiple electrodes, including a first electrode and a second electrode, which have alternating polarities along the length of the scaffold structure.

[0015] In some respects, the techniques described herein relate to therapeutic systems in which a controller supplies current to at least a first wire and a second wire, which generates sodium / potassium pump stimulation.

[0016] In some respects, the technology described herein relates to therapeutic systems in which the energy distribution device includes an ultrasound transducer.

[0017] In some respects, the techniques described herein relate to therapeutic systems in which the diameter of the energy distribution device is in the range of approximately 3 mm to approximately 20 mm, including end values.

[0018] In some respects, the techniques described herein relate to treatment systems and also include perfusion channels extending between the ends of ultrasound transducers.

[0019] In some respects, the techniques described herein relate to treatment systems in which the diameter of the infusion channel is in the range of about 2 mm to about 18 mm, including the end value.

[0020] In some respects, the techniques described herein relate to therapeutic systems in which an ultrasound transducer generates sound frequencies ranging from approximately 0.25 MHz to 3.5 MHz, including the end-value range.

[0021] In some respects, the techniques described herein relate to therapeutic systems in which an ultrasound transducer generates sound frequencies ranging from approximately 160 kHz to approximately 360 kHz, including the end-value range.

[0022] In some respects, the techniques described herein relate to therapeutic systems in which an ultrasound transducer generates sound frequencies ranging from approximately 20 Hz to approximately 4500 Hz, including the end-value range.

[0023] In some respects, the techniques described herein relate to therapeutic systems in which an ultrasound transducer comprises an assembly of two or more discrete transducers forming a phased array and configured to generate constructive / destructive interference with each other to guide ultrasound energy.

[0024] In some respects, the techniques described herein relate to therapeutic systems and also include one or more of the following sensors that communicate with or are incorporated into the controller: a blood pressure sensor, a sensor for measuring sodium concentration, a sensor for measuring protein levels, and / or a sensor for measuring glucose levels.

[0025] In some respects, the techniques described herein relate to therapeutic systems in which a controller and an ultrasonic transducer are configured to utilize the ultrasonic transducer to generate an acoustic aperture effect.

[0026] In some respects, the techniques described herein relate to therapeutic systems in which a controller and an ultrasound transducer are configured to produce transient nerve blockade on one or more kidneys.

[0027] In some respects, the technology described herein relates to treatment systems in which the energy distribution device includes an intravascular lithotripsy device.

[0028] In some respects, the technology described herein relates to a treatment system in which an intravascular lithotripsy device includes a balloon on a catheter and one or more lithotripsy emitters located within the balloon.

[0029] In some respects, the techniques described herein relate to methods of treating patients, including: implanting a first energy distribution device into the patient; implanting a controller into the patient; and supplying energy from the controller to the first energy distribution device over a long period to stimulate kidney activity.

[0030] In some respects, the technology described herein relates to methods in which implanting a first energy distribution device into a patient includes implanting the first energy distribution device into a first renal artery, first renal vein, first major renal calyx, first minor renal calyx, first interlobular vein, first interlobular artery, first arcuate vein, first arcuate artery, or first ureter.

[0031] In some respects, the techniques described herein relate to methods that also include implanting a second energy distribution device into a patient, wherein implanting the first energy distribution device into the patient includes implanting the energy distribution device into a first renal artery, a first renal vein, a first major renal calyx, a first minor renal calyx, a first interlobular vein, a first interlobular artery, a first arcuate vein, a first arcuate artery, a first ureter, a second renal artery, a second renal vein, a second major renal calyx, a second minor renal calyx, a second interlobular vein, a second interlobular artery, a second arcuate vein, a second arcuate artery, or a second ureter.

[0032] In some respects, the techniques described herein relate to methods in which implanting a first energy distribution device into a patient includes implanting at least a first electrode and a second electrode into the renal cavity, renal tissue, renal vein, renal artery, or ureter.

[0033] In some respects, the technology described herein relates to a method in which a first energy distribution device is a stent comprising at least a first electrode and a second electrode connected to a controller; and wherein the stent is implanted in a renal vein or renal artery.

[0034] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes performing electroporation within the first kidney.

[0035] In some respects, the techniques described herein relate to methods in which supplying energy includes supplying current to a first energy distribution device at a frequency including the end-value range of about 1 to 10 Hz.

[0036] In some respects, the technology described herein relates to a method in which supplying energy includes supplying current to a first energy distribution device to generate an electric field ranging from approximately 100 V / cm to 3000 V / cm, including the terminal range.

[0037] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes performing a transient nerve block within the first kidney.

[0038] In some respects, the technology described herein relates to a method in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity comprises supplying a current in the range of 1-80 kHz with an amplitude in the range of 0-20 mA and 0-20 Vpp.

[0039] In some respects, the techniques described herein relate to methods in which supplying energy also includes supplying an electric current to the renal artery and blocking nerve signals to the first kidney.

[0040] In some respects, the techniques described herein relate to methods in which the implantation of a first energy distribution device further includes an implantation stent comprising at least a first electrode and a second electrode; wherein the stent has a radially expanded state and its diameter is in the range of about 3 mm to about 20 mm, including end values.

[0041] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes generating an electric field that produces sodium / potassium pump stimulation.

[0042] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes generating ultrasound within a first kidney using a first ultrasonic transducer to produce an acoustic aperture effect.

[0043] In some respects, the techniques described herein relate to methods in which generating ultrasound within a first kidney includes generating an acoustic frequency ranging from approximately 0.25 MHz to 3.5 MHz, encompassing the end-value range.

[0044] In some respects, the techniques described herein relate to methods in which generating ultrasound within a first kidney includes generating an acoustic frequency ranging from about 160 kHz to about 360 kHz, encompassing an end-value range.

[0045] In some respects, the techniques described herein relate to methods in which generating ultrasound within a first kidney comprises a phased array of at least a first and a second ultrasound transducer operating an energy distribution device to generate constructive / destructive interference with each other, thereby guiding ultrasound energy.

[0046] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes generating ultrasound using a first ultrasonic transducer to induce transient nerve block in one or more kidneys.

[0047] In some respects, the techniques described herein relate to methods in which supplying energy from a controller to a first energy distribution device to stimulate kidney activity includes generating shock waves within the first kidney using an intravascular lithotripsy device.

[0048] In some respects, the technology described herein relates to a method that also includes implanting a second energy distribution device into a patient and supplying energy from a controller to the second energy distribution device over a long period of time.

[0049] In some respects, the techniques described herein relate to methods in which a first energy distribution device stimulates a first kidney and a second energy distribution device stimulates a second kidney.

[0050] In some respects, the technology described herein relates to a method in which a first energy distribution device stimulates a first kidney, and a second energy distribution device also stimulates the first kidney.

[0051] In some respects, the techniques described herein relate to methods of treating a patient, including: implanting a first energy distribution device in the patient; implanting a controller in the patient; performing measurements in the patient using sensors; comparing sensor data from the measurements with a first threshold; and activating the energy distribution device implanted permanently in the patient to stimulate kidney activity when the sensor data triggers the first threshold.

[0052] In some respects, the techniques described herein relate to methods in which the comparison of sensor data from measurements with a first threshold is performed by a controller.

[0053] In some respects, the techniques described herein relate to methods in which measurements are performed by sensors including blood pressure sensors, sensors for measuring sodium concentration, sensors for measuring protein levels (e.g., in blood or urine), sensors for measuring glucose levels, clocks (e.g., for determining night / day), accelerometers (for sensing activity), subcutaneous interstitial pressure sensors (SCIP sensors), central venous pressure sensors, impedance sensors, heart rate sensors, temperature sensors, sensors for sensing renal electrical signals, pH sensors, and similar sensors.

[0054] In some respects, the techniques described herein relate to methods in which sensors are integrated with controllers, energy distribution devices, or located remotely from controllers or energy distribution devices.

[0055] In some respects, the techniques described herein relate to methods in which activating an energy distribution device includes using the energy distribution device to perform electroporation, acoustic hole effects, or transient neural blockade.

[0056] In some aspects, the technology described herein relates to a method of treating a patient, comprising: activating an energy distribution device at a first treatment level, wherein the energy distribution device is permanently implanted in the patient; performing measurements within the patient using sensors; analyzing sensor data from the measurements; maintaining the first treatment level using the energy distribution device if the measurements meet a predetermined threshold and / or are an improvement over previous sensor measurements; and activating the energy distribution device at a second treatment level above the first treatment level if the measurements do not meet the predetermined threshold and / or are not an improvement over previous sensor measurements.

[0057] In some respects, the techniques described herein relate to methods in which the second level of treatment includes activating the energy distribution device more frequently, activating the energy distribution device at a higher performance level, or both.

[0058] In some respects, the techniques described herein relate to methods in which a first treatment level and a second treatment level include generating an electroporation or acoustic hole effect within the patient's kidney.

[0059] In some respects, the techniques described herein relate to methods in which the first and second treatment levels involve a transient nerve blockade of the renal nerve between the patient's central nervous system and the kidney.

[0060] In some respects, the techniques described herein relate to methods of treating a patient, including: performing a first medical procedure on the patient; determining that improved kidney function can contribute to the first procedure; inserting an energy distribution device into the patient at least partially; activating a controller located outside the patient and connected to the energy distribution device; and applying energy using the energy distribution device to improve kidney function. Attached Figure Description

[0061] The following figures are included to illustrate certain exemplary aspects of this disclosure and should not be considered exclusive or limiting. The disclosed subject matter is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to those skilled in the art based on the content of this disclosure. This disclosure references the following figures: Figure 1 A cross-sectional side view of the kidney 10 is shown, in which an energy distribution device 100 has been implanted or placed to stimulate kidney activity.

[0062] Figure 2 A cross-sectional side view of the kidney 10 is shown, in which an energy distribution device 110 has been implanted or placed to stimulate kidney activity.

[0063] Figure 3 A cross-sectional view of the kidney 10 is shown, in which an energy distribution device 120 has been implanted or placed to stimulate kidney activity.

[0064] Figure 4 A cross-sectional view of the kidney 10 and the energy distribution device 130 for stimulating kidney activity is shown.

[0065] Figure 5 A view of the renal vein 12 and the energy distribution device 130 is shown.

[0066] Figure 6 Another implantation site of the ultrasound transducer 132 is shown within the renal artery 14 near the kidney 10.

[0067] Figure 7 Another implantation site of the ultrasound transducer 132 is shown in the greater calyx 34 and lesser calyx 36 of the kidney.

[0068] Figure 8 A cross-sectional view of the kidney 10 is shown, with an energy distribution device 140 implanted nearby.

[0069] Figure 9 The human body and treatment system 160 are shown.

[0070] Figure 10 A treatment system 170 is shown, wherein a controller 162 is implanted in the upper part of the patient's torso, such as under the skin and near the clavicle (e.g., similar to pacemaker placement).

[0071] Figure 11 The treatment system 180 is shown, wherein the controller 162 is implanted under the skin of the buttock or at the iliac crest.

[0072] Figure 12 The image shows a doctor using a delivery device catheter 50 to enter the femoral artery 22 or femoral vein (not shown).

[0073] Figure 13 An energy distribution device 130 with an ultrasonic transducer 132 is shown, which is placed in each renal vein 12 of each of the two kidneys 10.

[0074] Figure 14 An energy distribution device 120 is shown, which has multiple wires (e.g., first wire 102, second wire 104, third wire 106) placed in different regions (e.g., arteries, veins, renal calyces, etc.) of each kidney 10.

[0075] Figure 15 An energy distribution device 140 is shown, which has a support structure 142 placed in each renal vein 12 of each kidney 10.

[0076] Figure 16 An example of a kidney 10 is shown, which has an energy distribution device 120 including multiple wires (e.g., first wire 102, second wire 104, third wire 106) and an energy distribution device 130 including one or more ultrasonic transducers 132.

[0077] Figure 17 Another example of a kidney 10 is shown, which has an energy distribution device 120 including multiple wires (e.g., first wire 102, second wire 104, third wire 106) and an energy distribution device 140 including one or more support-like structures 142.

[0078] Figure 18 Another example of a kidney 10 is shown, which has an energy distribution device 130 including one or more ultrasound transducers 132 and an energy distribution device 140 including one or more scaffold-like structures 142.

[0079] Figure 19 Another example of a kidney 10 is shown, which has an energy distribution device 120 including multiple wires (e.g., first wire 102, second wire 104, third wire 106), an energy distribution device 130 including one or more ultrasound transducers 132, and an energy distribution device 140 including one or more support structures 142.

[0080] Figure 20 A percutaneous energy distribution device 190 (generally similar to energy distribution device 110) is shown, wherein a first wire 102 and a second wire 104 are placed or implanted through the skin and percutaneously into the kidney 10, at any location discussed in this specification for other energy distribution devices.

[0081] Figure 21 An intravascular lithotripsy device is shown according to some examples.

[0082] Figure 22 A flowchart of the treatment method is shown.

[0083] Figure 23 A flowchart of the treatment method is shown. Detailed Implementation

[0084] Those skilled in the art will understand that this disclosure is not limited to what has been specifically shown and described herein. In view of the teachings herein, various modifications and variations are possible without departing from its scope, spirit, or intent.

[0085] While different examples may be described in this specification, it is specifically contemplated that any features from different examples can be used and combined in any combination. In other words, features from different examples can be mixed and matched with each other. Therefore, although every permutation of features from different examples may not be explicitly shown or described, this disclosure is intended to cover any such combination, especially combinations that can be understood by those skilled in the art.

[0086] The terminology used in this disclosure should be interpreted in a licence-based manner and is not intended to be limiting. In the accompanying drawings, the same numerals denote the same elements. Unless otherwise stated, all drawings are not drawn to scale. Unless otherwise stated, the term "about" is defined as ±5% of the stated value.

[0087] The term “distal” or “far-side” generally refers to the direction or area toward the end of the device inside the patient’s body (e.g., away from the doctor / clinician), while the term “proximal” or “proximal” refers to the direction or area toward the end of the device that is held outside the patient’s body (e.g., toward or closer to the doctor / clinician or the handle / hub of the device).

[0088] This specification relates to treatment systems and methods, including long-term implantable devices that selectively release energy within a patient to improve renal function, such as urine output, glomerular filtration rate, ion / toxin filtration, creatinine clearance, glucose clearance, and similar functions. Such systems and methods can help reduce the need for diuretics, dialysis, and / or other treatments for chronic kidney disease, end-stage renal disease, acute kidney injury, cardiorenal heart failure, hypertension, or other kidney-related conditions. These systems and methods may also contribute to weight loss and increased renal blood flow.

[0089] For the purposes of this specification, the term "long-term implantable device" refers to a device that remains in the patient's body for a period longer than a typical interventional or surgical procedure, at least partially. In other words, a long-term implantable device remains in the patient's body after the implantation procedure. This period can be days, months, or years.

[0090] In some examples, the device and method involve implanting at least a portion of a therapeutic device into or near one or more kidneys, and then selectively applying energy to or near the kidneys. Depending on the type of energy, the application can therapeutically stimulate one or more kidneys to increase urine output.

[0091] In some examples, the energy is electrical power provided at a frequency and amount sufficient to produce electroporation. Electroporation energy can cause electroporation of the kidney cell membrane, thereby increasing the flow of fluid through the kidney.

[0092] In some examples, the energy is electrical energy provided at a frequency and amount sufficient to stimulate sodium / potassium pumping in one or more kidneys.

[0093] In some examples, the energy is acoustic energy delivered at ultrasonic frequencies (e.g., frequencies / amounts sufficient to produce an acoustic aperture effect). Acoustic aperture effect energy can cause acoustic perforation of the renal cell membrane, thereby increasing the fluid flow through the kidney.

[0094] In some examples, microbubbles or nanobubbles can be used in conjunction with some of the energy types described in this specification, such as acoustic pore effects. Microbubbles are commonly used for acoustic pore effects to increase the permeability / permeability of cell membranes. These microbubbles typically have a diameter in the range of about 2 to 20 micrometers and can consist of a shell made of denatured albumin, surfactants, phospholipids, or polymers. This shell encapsulates a gas, typically air, perfluorocarbon, or sulfur hexafluoride. Similar nanobubbles can also be used, but their average diameter can be about 100 nanometers. These nanobubbles can enter smaller blood vessels and are therefore able to penetrate further into the kidneys. These microbubbles / nanobubbles may need to be injected into the bloodstream (e.g., arteries or veins).

[0095] In some examples, the energy is acoustic energy delivered at frequencies capable of generating shock waves. This type of shock wave is currently used in intravascular lithotripsy (IVL), such as the C2 Shockwave Medical coronary IVL system, which consists of three components: a power source / generator (e.g., a controller); a connecting cable; and a sterile catheter containing a lithotripter encapsulated within a semi-compliant balloon. IVL typically generates low levels of electrical energy, causing the formation and rapid expansion of a bubble, producing sound pressure waves that radiate circumferentially and transmurally in a non-focused manner. When applied to the kidneys (e.g., via the renal vein or within the kidney), appropriate levels of shock wave energy can also alter tissue to stimulate kidney function.

[0096] In some examples, the energy is electrical energy of a specific frequency and amount that can block or stimulate nerve signals from the kidneys to the central nervous system (e.g., transient nerve block).

[0097] The treatment system may include a controller configured to provide energy and / or control signals to one or more energy distribution devices, such as electroporation devices, acoustic effect devices, electrical leads, stents, electrical conduits, or any combination of these devices.

[0098] One or more energy distribution devices may be located at one or more locations near at least one kidney. For example, an energy distribution device may be located within one or more locations in the vascular system that leads directly to the kidney, such as the renal artery or renal vein. One or more energy distribution devices may be located at one or more locations within at least one kidney, near at least one kidney, or in locations that may affect the function of at least one kidney. For example, one or more of the following: arcuate arteries, arcuate veins, interlobular arteries, interlobular veins, renal calyces (e.g., major and minor calyces), renal pelvis, medulla (renal pyramid), renal papillae, renal cortex, the portion of the ureter near the kidney, or other blood vessels, tissues, or spaces within the kidney.

[0099] A controller that can be connected to a power distribution device can be implanted in the patient. In some examples, the controller is located in a different location from the power distribution device and is connected to the power distribution device via one or more wires. In some examples, the controller can be implanted inside a patient's cavity (e.g., near the abdominal cavity or iliac crest), under the skin of the upper trunk (e.g., where a pacemaker is typically implanted, such as near the clavicle), or under the skin of the lower trunk (e.g., under the skin of the buttocks). In other examples, the controller can be mounted or supported externally on the patient's skin, while the wires pass through the skin into the patient's body and reach the power distribution device.

[0100] In some examples, one or more energy distribution devices may be located in or near only one kidney. In other examples, one or more energy distribution devices may be placed in or near each of the patient's two kidneys.

[0101] In some examples, one or more energy distribution devices can provide multiple types of energy to the patient. For example, electroporation energy and acoustic aperture effect energy. In another example, electroporation energy and electrical disconnection energy. In yet another example, acoustic aperture effect energy and electrical disconnection energy. In yet another example, electroporation energy, acoustic aperture effect energy, and electrical disconnection energy can be delivered. These energies can be delivered simultaneously, at different non-overlapping times, or simultaneously and at different non-overlapping times.

[0102] In some examples, the controller may also be coupled directly or indirectly to sensors. Sensor data can be used to control when the energy distribution device is activated. Example sensors may include blood pressure sensors, sensors that measure sodium concentration, sensors that measure protein levels (e.g., in blood or urine), sensors that measure glucose levels, clocks (e.g., for determining night / day), accelerometers (for sensing activity), subcutaneous interstitial pressure sensors (SCIP sensors), central venous pressure sensors, impedance sensors, heart rate sensors, temperature sensors, sensors for sensing renal electrical signals, pH sensors, and similar sensors. In other examples, a patient or physician may specify the operating time, level, and similar functionality (e.g., via a mobile app or other wireless devices communicating with the controller).

[0103] In some examples, the treatment system can operate continuously, intermittently, or adaptively (e.g., based on sensor data or user / doctor input). In addition to certain operating times, the level of operation (i.e., the intensity of the system's stimulation of the kidneys) can also be increased or decreased.

[0104] Aspects of different example treatment systems are illustrated in the accompanying drawings and discussed in more detail below. While some drawings may show only a portion of the entire treatment system, it should be understood that these examples can be used with any other examples. In other words, any example shown in the figures can be mixed and matched with any other example from other figures. For example, some example energy distribution devices can be used with any controllers and operating methods shown and described elsewhere in the specification / drawings. In another example, some example energy distribution devices can be used with other example energy distribution devices (e.g., combinations of multiple types of devices). Thus, while the drawings may show only specific examples, broader uses and combinations are clearly contemplated and disclosed.

[0105] In some examples, the energy distribution device may include one or more wires / conductors connected to a controller configured to provide electrical energy / current that is configured to create electroporation in kidney tissue.

[0106] In one example Figure 1 A cross-sectional side view of the kidney 10 is shown, in which an energy distribution device 100 has been implanted or placed in the kidney to stimulate kidney activity. The energy distribution device 100 may include at least a first wire 102 and a second wire 104, each extending from the kidney 10 to a location of a controller (discussed later in this specification). Typically, the first wire 102 and the second wire 104 may be made of a conductive material and coated with an insulating material along their outer surfaces. One or more electrodes, such as electrode 102A or electrode 104A, may be located at the distal portions of the first wire 102 and the second wire 104, respectively, to transmit current from the conductive material in the wires to the tissue within the kidney 10.

[0107] In this example, the first wire 102 and the second wire 104 are located within the blood vessels of the kidney 10. Specifically, both the first wire 102 and the second wire 104 can pass through the renal vein 12, such that one or more electrodes 102A and one or more electrodes 104A are located within different interlobular veins 18. Alternatively, one or more electrodes 102A and one or more electrodes 104A can be located in any other vein within the kidney 10, such as the arcuate vein 16.

[0108] Alternatively, the first wire 102 and the second wire 104 may be positioned to pass through the renal artery 14 and enter any other artery within the kidney 10, such as the interlobular artery 22 or the arcuate artery 20. In some examples, the first wire 102 may be located in an artery, and the second wire 104 may be located in a vein.

[0109] In another alternative embodiment, one or more electrodes 102A and one or more electrodes 104A may be located within a renal calyx (e.g., a major or minor calyx) or within a portion of the ureter 26 near the kidney 10. Similarly, one or more electrodes 102A and one or more electrodes 104A need not be located in the same type of structure. Any of the aforementioned structures (e.g., arteries, veins, renal calyces, ureters) may be used in any combination.

[0110] The distal portions of the first wire 102 and the second wire 104 may include one or more anchoring elements that facilitate anchoring the first wire 102 and the second wire 104 in their respective locations. In some examples, the anchoring elements may include one or more barbs, one or more hooks, one or more high-friction surfaces, radially expandable helical wires, radially expandable tubular support structures, or similar anchoring structures.

[0111] While the first wire 102 and the second wire 104 may at least have conductive wires and insulating material on their outer surfaces, they may also include additional structural elements, similar to those found in some supports. For example, they may also include structural coils, mesh layers, multilayer polymer layers, and similar components.

[0112] In this example, the first wire 102 and the second wire 104 can be connected to the controller such that the two wires form a loop (e.g., one wire represents a positive electrical connection and the other represents a negative / ground electrical connection). Alternatively, both the first wire 102 and the second wire 104 can be configured as positive, and a third external patch electrode or similar connector is connected to the controller to complete the electrical loop.

[0113] The energy distribution device 100 can be configured to generate electroporation within the kidney 10. In some examples, a controller, a first wire 102, and a second wire 104 generate an electric field in the kidney 10 that can perforate the renal cell membrane, increasing fluid flow through the kidney 10. In some examples, electroporation can typically occur at frequencies including the extreme values ​​of about 1-10 Hz and electric field strengths including the extreme values ​​of about 100 V / cm to 3000 V / cm. In some examples, bipolar or unipolar square waves, as well as exponential and / or sine waves, can be used.

[0114] Optionally, the energy distribution device 100 can be configured to produce transient nerve block by directly applying electrical energy / current to the renal nerve between the central nervous system and the kidney. In some examples, the transient nerve block can typically occur at electrical frequencies including the end-value range of 1–80 kHz and amplitudes including the end-value range of approximately 0–20 mA and 0–20 Vpp. In such examples of transient nerve block, it may be desirable for one or more electrodes 102A and one or more electrodes 104A to be located near or within the renal vein 12 or renal artery 14, as most or all of the nerves leading to the kidney 10 pass through these areas. Various waveforms are possible, such as bipolar square waves and sine waves. The kidney has chemosensors and barosensors that help regulate the renin-angiotensin system (RAAS). When communication from the kidney to the central nervous system is blocked (e.g., by blocking the renal nerve extending along the renal artery 14), the RAAS may be blocked, reducing renin output and ultimately decreasing the amount of angiotensin II in the bloodstream. One of the known functions of angiotensin II in the kidneys is the reabsorption of chloride, sodium, and water. Therefore, blocking the renal nerves may increase urine output, among other potential benefits.

[0115] Alternatively or additionally, the energy distribution device 100 may be configured to generate transient neural stimulation by directly applying electrical energy / current to the renal nerve between the central nervous system and the kidney. In some embodiments, the transient neural stimulation may typically occur at an electrical frequency including the end-value range of 1-10 Hz and an amplitude including the end-value range of about 0-20 mA and 0-20 Vpp. In such an example of transient neural stimulation, it may be desirable for one or more electrodes 102A and one or more electrodes 104A to be located near or within the renal vein 12 or renal artery 14, since most or all of the nerves leading to the kidney 10 pass through these areas. Various different waveforms are possible, such as bipolar square waves and sine waves. Similarly, the kidney has chemosensors and barosensors that help regulate the renin-angiotensin system (RAAS). When communication from the kidney to the central nervous system is stimulated (e.g., by electrically stimulating the renal nerve extending along the renal artery 14), the RAAS can be stimulated, increasing renin output and ultimately increasing the amount of angiotensin II in the bloodstream. One of the known functions of angiotensin II in the kidneys is the reabsorption of chloride, sodium, and water. Therefore, stimulating the renal nerves may reduce urine output, among other potential benefits.

[0116] In one example, a controller connected to the energy distribution device 100 can alternate between transient nerve blockade that increases renal function (e.g., urine output) during certain periods and transient nerve stimulation that decreases renal function (e.g., urine output) during certain periods. For example, renal nerves can be stimulated at night (e.g., 1-10 Hz) to reduce urine output and the patient's need to use the restroom, and renal nerves can be blocked during the day (e.g., 10-80 kHz) to increase urine output when sleep is less likely to be interrupted.

[0117] Alternatively or additionally, the energy distribution device 100 can be configured to synchronize the frequency and direction of the sodium / potassium pumps, and to increase or decrease the pump frequency. In the kidney, the glomerulus pumps excess fluid from the bloodstream into the renal tubules. The renal tubules reabsorb sodium, potassium, other ions, and water back into the bloodstream. Diuretic drugs act along this renal tubule to reduce sodium reabsorption, as water follows sodium, increasing urine volume. There are thousands of sodium / potassium pumps in each cell. Typically, they pump into / out of the cell at different rates and in different directions. Certain waveforms can “capture” all or most of the sodium / potassium pumps, synchronizing their pumping rates and orienting them in the same direction. In some examples, this can be performed using a 50 Hz third-generation SMEF wave. Then, with all pumps synchronized, their pumping rates can be reduced to approximately 10–20 Hz. This may reduce sodium / potassium pump activity along the renal tubules, thus acting as an electrodiuretic. In some examples, the frequency of the electrical energy is in the range of approximately 0 to approximately 150 Hz, including the extreme values. In some examples, the voltage ranges from approximately -160 mV to approximately 160 mV, including the terminal values. The amplitude of the waveform can be configured to perform biosimulation, mimicking the voltage range naturally generated at each stage of the sodium / potassium pump cycle. Further details regarding this sodium / potassium pump manipulation, including the third-generation SMEF waveform / algorithm / method, can be found in U.S. Patent No. 8,073,549 and the journal article “Reducing ischemic kidney injury through application of a synchronization modulation electric field to maintain Na+ / K+-ATPase functions,” Chen et al., Science Translational Medicine 14, eabj4906 (2022), both of which are incorporated herein by reference.

[0118] In one example Figure 2 A cross-sectional side view of the kidney 10 is shown, in which an energy distribution device 110 has been implanted or placed for stimulating kidney activity. Typically, the energy distribution device 110 is similar to the aforementioned energy distribution device 100, wherein it is powered via a first wire 102 and a second wire 104 (e.g., for electroporation or transient nerve block). However, instead of placing one or more electrodes 102A and one or more electrodes 104A within the arteries, veins, spaces (e.g., renal calyces), or ureters of the kidney 10, one or both of the electrodes 102A and one or more electrodes 104A can be inserted or implanted into the kidney tissue. For example, in Figure 2In this embodiment, one or more electrodes 102A and one or more electrodes 104A are placed in the renal cortical tissue 24. In an alternative example, one or more electrodes 102A and 104A may be placed in the renal fibrous capsule 28, the renal medulla 30 (pyramidal body), the renal papilla 32, or other tissues of the kidney 10. Furthermore, any tissue directly surrounding the kidney 10 may also be used. One or more electrodes 102A and one or more electrodes 104A may be placed in any combination of tissue locations, or in any combination of tissue locations, arteries, veins, renal calyces, ureters, or similar regions of the kidney 10.

[0119] An anchoring element, configured to anchor the distal ends of the first wire 102 and the second wire 104 into the tissue, may also be included at the distal end. For example, it may include barbs, hooks, or similar structural features.

[0120] The distal ends of the first wire 102 and the second wire 104 may have pointed and / or tapered ends to better puncture the tissue of the kidney 10 and to allow insertion into and release from a catheter. For example, pacemaker electrodes / leads.

[0121] Although Figure 1 and Figure 2 Only the first wire 102 and the second wire 104 are shown in the diagram, but more than two wires may be used in any embodiment. For example, three, four, five, six, seven, eight or more wires may be used. Figure 3 A cross-sectional view of kidney 10 is shown, in which an energy distribution device 120 has been implanted or placed for stimulating kidney activity. This example is similar to energy distribution devices 100 and 110; however, energy distribution device 120 may include a first wire 102, a second wire 104, and a third wire 106 (also including one or more electrodes 106A). Two of these wires may be connected or configured to a first polarity (e.g., positive) during operation, and one of these wires may be connected or configured to a second polarity (e.g., negative / ground). If additional wires are included (i.e., more than three), these additional wires may be configured to any polarity such that only one second polarity wire is included in the total number of wires, or multiple wires are included for each polarity.

[0122] In some examples, the energy distribution device may include an ultrasonic transducer. For example, Figure 4 A cross-sectional view of the kidney 10 and the energy distribution device 130 for stimulating kidney activity is shown. Figure 5 A view of the renal vein 12 and the energy distribution device 130 is shown. In this example, the energy distribution device 130 includes an ultrasound transducer 132 implanted within the renal vein 12.

[0123] The first wire 134 and the second wire 136 can be connected to the ultrasound transducer 132 and to a controller located at other locations inside / on the patient's body to provide power and / or control signals. Optionally, the ultrasound transducer 132 may include a battery, a wireless charging system for the wirelessly charged battery, and a wireless communication system for communicating with the controller (and / or a mobile phone).

[0124] In some examples, the ultrasound transducer 132 may include a perfusion channel 132A extending between a first end and a second end of the ultrasound transducer 132 and opening at both ends to allow fluid (e.g., blood) to flow through. Therefore, the ultrasound transducer 132 may have a generally tubular shape. The perfusion channel 132A may have a diameter that allows sufficient blood / fluid to pass through.

[0125] In some examples, the ultrasonic transducer 132 may include anchors along its outer surface to help maintain the position of the ultrasonic transducer 132. For example, it may include barbs, hooks, coils, supports, and similar anchoring devices.

[0126] In some examples, the ultrasound transducer 132 may be a component comprising two or more discrete transducers controlled to create a phased array. The controller can manipulate the emitted ultrasound waves to induce constructive / destructive interference between them. This allows the controller to "point," "move," and / or "manipulate" the point of maximum intensity of the sound waves. Therefore, the controller can alter the point of maximum intensity of the sound waves, for example, to push / draw fluid from the renal cortex to the renal medulla.

[0127] In some examples, the ultrasonic transducer 132 may include one or more sensors. These may include any sensors disclosed in this specification, including a blood pressure sensor, a sensor for measuring sodium concentration, a sensor for measuring protein levels, a sensor for measuring glucose levels, and / or a clock (e.g., for determining night / day). In some examples, portions of the sensors (e.g., electrodes) may be located on the surface of the perfusion channel 132A to contact the blood / fluid as it passes through.

[0128] The ultrasonic transducer 132 can be configured to generate a variety of different ultrasonic frequencies. In one example, the ultrasonic transducer 132 can generate frequencies sufficient to induce an acoustic aperture effect within the renal cell membrane to increase fluid flow through the kidney 10. The acoustic aperture effect typically occurs at frequencies ranging from about 0.25 MHz to 3.5 MHz, including the end-value range. In a specific example, the acoustic aperture effect can occur at frequencies ranging from about 160 kHz to about 360 kHz (e.g., about 260 kHz), including the end-value range. In another example, micro-vibrations can be generated at frequencies ranging from about 20 Hz to about 4500 Hz, including the end-value range. Various different waveforms are also possible, such as sine waves, triangle waves, square waves, sawtooth waves, or similar combinations and variations. Typically, the relatively small ultrasonic transducer 132 shown in the figure is currently capable of generating acoustic energy densities of approximately 0.1 W / cm² to 1 W / cm², although further improvements to the technology could provide further improvements in energy density. Furthermore, two or more ultrasound transducers 132 can be used to further increase the acoustic energy density and thus further stimulate / improve kidney function. Various different waveforms are also possible, such as sine waves, triangle waves, square waves, sawtooth waves, or similar combinations and variations.

[0129] In another example, the ultrasound transducer 132 can generate frequencies sufficient to induce transient nerve block in the kidney 10. Typically, such frequencies can occur in the range of approximately 1 to 3 MHz, including extreme values, and at acoustic energy densities of approximately 0.1 W / cm² to 1 W / cm². Generally, relatively high sound intensities inhibit nerve signal transmission. Relatively low intensities can stimulate nerves. Various different waveforms are also possible, such as sine waves, triangle waves, square waves, sawtooth waves, or similar combinations and variations.

[0130] like Figure 4 and 5 As shown, the ultrasound transducer 132 can be implanted in the renal vein 12 near the kidney 10. Figure 6 Another implantation site of the ultrasound transducer 132 is shown within the renal artery 14, close to the kidney 10. Similarly, the perfusion channel 132A allows blood to flow out of the kidney 10.

[0131] Figure 7 Another implantation location of the ultrasound transducer 132 within the major calyx 34 and minor calyx 36 of the kidney is shown. However, depending on the size of the ultrasound transducer 132, it may be located only in the major calyx 34 or the minor calyx 36. The ultrasound transducer 132 may also be located within the ureter 26, for example, near the kidney 10, with an irrigation channel 132A allowing urine to pass through.

[0132] In some examples, one, two, three, four, or more ultrasound transducers 132 may be used, and the ultrasound transducers 132 may be connected to the controller in any combination of locations described in this specification, such as the renal artery 14, renal vein 12, locations within the kidney 10 (e.g., major calyx 34, minor calyx 36, interlobular vein 18, interlobular artery 22, arcuate vein 16, arcuate artery 20, etc.), ureter 26, or similar locations. Optionally or additionally, one or more ultrasound transducers 132 may be used with any other energy distribution device disclosed in this specification, such as those described with respect to acoustic aperture effects, electroporation, transient nerve block, or other variations.

[0133] In some examples, the diameter of the ultrasound transducer 132 may be adapted to fit within the renal vein 12, for example, in the range of about 3 mm to about 20 mm including the end value, and may have a length in the range of about 17 mm to about 75 mm including the end value. These dimensions may also allow it to fit into some of the other specified example locations (i.e., non-renal vein 12). In some examples, the perfusion channel 132A may have a diameter in the range of about 2 mm to about 18 mm including the end value.

[0134] In addition to those previously discussed, certain locations and structures may be particularly helpful in producing transient nerve blockade of the kidney 10. For example, Figure 8 A cross-sectional view of a kidney 10 with an implanted energy distribution device 140 is shown. The energy distribution device 140 may include a support-like structure 142, which includes one or more electrodes 142A. The plurality of electrodes 142A may be connected to a first wire 144 and a second wire 146, both of which are connected to a controller located inside / on the patient's body.

[0135] Most of the nerves leading to the kidney 10 extend from the aortic renal ganglion along the renal plexus and then reach the kidney 10. In this respect, most of the nerves controlling the kidney 10 pass along the renal artery 14. The scaffold structure 142 may be particularly effective when implanted within the renal artery 14 because it is close to these renal nerves to provide transient nerve block.

[0136] Alternatively, the ultrasound transducer 132 can be replaced by an intravascular lithotripsy device 192, such as... Figure 21As shown, for example, is the C2 Shockwave Medical Coronary IVL System (Shockwave Medical) for intravascular lithotripsy (IVL). The intravascular lithotripsy device 192 may include a power source (e.g., within a controller); a connector cable; a lithotripter 194; and a balloon 196 located around the lithotripter 194. The lithotripter 194 can generate an electrical spark, thereby creating bubbles in the surrounding fluid medium within the balloon 196. This electrical energy may cause the bubbles to form and rapidly expand, generating sound pressure waves that radiate circumferentially and transmurally in a non-focused manner. When applied to the kidneys (e.g., via the renal vein or within the kidney), appropriate levels of shockwave energy can also alter tissue to stimulate kidney function. Although in Figure 21 Not shown, but the intravascular lithotripsy device 192 may have a perfusion cavity extending longitudinally through it, similar to that of the ultrasound transducer 132. Furthermore, the intravascular lithotripsy device 192 may be placed in any of the locations previously described in this specification, such as the renal artery 14, renal vein 12, locations within the kidney 10 (e.g., major calyx 34, minor calyx 36, interlobular vein 18, interlobular artery 22, arcuate vein 16, arcuate artery 20, etc.), ureter 26, or similar locations.

[0137] As previously described, the scaffold structure 142 may have a plurality of electrodes 142A. These plurality of electrodes 142A may be positioned along the outer surface of the scaffold structure 142, the inner surface of the scaffold structure 142 (e.g., the surface of its inner cavity), or woven / bonded within the layers of the scaffold structure 142.

[0138] In some examples, one, some, or all of the plurality of electrodes 142A may be an annular shape similar in size to the circumference or inner diameter of the support structure 142. In other examples, the plurality of electrodes 142A may be other shapes, such as partially circular, elongated strips extending partially or entirely along the length of the support structure 142, or discrete tubular segments of the support structure 142.

[0139] In some examples, the support structure 142 may be a braided / knitted tubular structure or a laser-cut tubular structure. In another example, the support structure 142 may consist of a longitudinal structure in which multiple electrodes 142A are connected in the form of multiple rings.

[0140] In some examples, the stent-like structure 142 may have a radially expanded diameter, the size of which is adapted for installation within the renal vein 12. In some examples, this diameter ranges from about 3 mm to about 20 mm, including the end value.

[0141] The multiple electrodes 142A can have a variety of different configurations. For example, the multiple electrodes 142A may include a first electrode and a second electrode, each located near opposite ends of the support structure 142 and connected to different wires, such that each electrode can be configured to have a different polarity (e.g., positive / negative). If three or more electrodes are included, the electrodes may have alternating polarities along the length of the support structure 142, or may have an unequal number of the two polarities (e.g., three positive electrodes and one negative / ground electrode).

[0142] The controller can be connected to the support structure 142 and can provide a current sufficient to produce a transient nerve block, as described elsewhere in this specification.

[0143] Any energy distribution device in this specification can be connected to a controller that powers and / or controls the operation of the energy distribution device. In some examples, the controller may have a housing, a power source (e.g., a battery), a processor configured to execute software code, a memory configured to store the software code, and an interface connected via wires to one or more energy distribution devices.

[0144] The controller can be wirelessly charged. For example, Figure 9 A human body and a treatment system 160 are shown. The treatment system 160 may include a controller 162 implanted in the patient's body (in this example, in the patient's abdomen) and a wireless charging system 164. The wireless charging system 164 may charge the power source (e.g., a battery) of the controller 162, for example, through induction (e.g., coils in both devices). Optionally, the controller 162 may include a charging cable that passes through the patient's skin and allows the power source to connect to it.

[0145] The controller can be implanted in various locations, especially subcutaneously. For example, Figure 9 The controller 162 is implanted in the patient's abdomen. In another example, Figure 10 A treatment system 170 is shown, in which a controller 162 is implanted in the upper part of the patient's torso, such as under the skin and near the clavicle (e.g., similar to pacemaker placement). In another example, Figure 11 The treatment system 180 is shown, wherein the controller 162 is implanted under the skin of the buttock or at the iliac crest.

[0146] Energy distribution devices and their respective wiring can be implanted in a variety of different ways, including via conduit delivery. For example, Figure 12The illustration shows a physician using a delivery device catheter 50 to enter the femoral artery 22 or femoral vein (not shown). The distal end of the delivery device catheter 50 can be advanced to one or more locations described elsewhere in this specification, such as the renal artery 14, renal vein 12, locations within the kidney 10 (e.g., major calyx 34, minor calyx 36, interlobular vein 18, interlobular artery 22, arcuate vein 16, arcuate artery 20, etc.), ureter 26, or similar locations. If the energy distribution device is placed within the ureter, the catheter delivery device can be advanced up the ureter until the desired location is reached, for example, near the kidney 10.

[0147] As previously stated, any energy distribution device in this specification (including any implantation site thereof) may be implanted in or near one or both kidneys 10. For example, Figure 13 An energy distribution device 130 with an ultrasonic transducer 132 is shown, the ultrasonic transducer 132 being placed in each renal vein 12 of each of the two kidneys 10. Similarly, Figure 14 An energy distribution device 120 is shown, having multiple wires (e.g., first wire 102, second wire 104, third wire 106) placed in various regions (e.g., arteries, veins, renal calyces, etc.) of each kidney 10. Similarly, Figure 15 An energy distribution device 140 is shown, having a support-like structure 142 placed in each renal vein 12 of each kidney 10. In some of these examples, the wires connecting to the controller may be separated at the inferior vena cava or a similar vascular location, depending on the configuration.

[0148] As also discussed, any combination of energy distribution devices in this specification can be used in combination with each other. Figure 16 An example of a kidney 10 is shown, wherein an energy distribution device 120 includes multiple wires (e.g., a first wire 102, a second wire 104, a third wire 106), and an energy distribution device 130 includes one or more ultrasound transducers 132. These devices can be connected to the same controller implanted elsewhere in the patient's body, and the energy distribution devices 120 and 130 can operate simultaneously, at different times, or at overlapping times.

[0149] Figure 17 Another example of the kidney 10 is shown, wherein the energy distribution device 120 includes multiple wires (e.g., first wire 102, second wire 104, third wire 106), and the energy distribution device 140 includes one or more scaffold-like structures 142. These devices can be connected to the same controller implanted elsewhere in the patient's body, and the energy distribution devices 120 and 140 can operate simultaneously, at different times, or at overlapping times.

[0150] Figure 18 Another example of the kidney 10 is shown, wherein the energy distribution device 130 includes one or more ultrasound transducers 132 and the energy distribution device 140 includes one or more scaffold-like structures 142. These devices can be connected to the same controller implanted elsewhere in the patient's body, and the energy distribution devices 130 and 140 can operate simultaneously, at different times, or at overlapping times.

[0151] Figure 19 Another example of the kidney 10 is shown, wherein the energy distribution device 120 includes multiple wires (e.g., first wire 102, second wire 104, third wire 106), the energy distribution device 130 includes one or more ultrasound transducers 132, and the energy distribution device 140 includes one or more scaffold structures 142. These devices can be connected to the same controller implanted elsewhere in the patient's body, and the energy distribution devices 120 and 140 can operate simultaneously, at different times, or at overlapping times.

[0152] While most of the examples discussed in this application involve energy distribution devices that are entirely within the patient's body, some devices with external components are also possible. For example, Figure 20 A percutaneous energy distribution device 190 (generally similar to energy distribution device 110) is shown, wherein a first wire 102 and a second wire 104 are percutaneously placed or implanted through the skin and into the kidney 10 at any location discussed in this specification for other energy distribution devices. Examples of ultrasound and nerve blocks can also be delivered percutaneously in a similar manner. Wires 102 / 104 and / or electrodes 102A / 104A can be needles or similar instruments.

[0153] Partially external energy distribution devices 190 can be particularly useful for acute treatments (e.g., lasting for minutes or hours during an existing procedure). In such an example, the controller and wires can be kept outside the body, and only a portion of the wires / electrodes can be advanced into the patient's body (e.g., in, near, or in an area where kidney function can be controlled). For example, during or before a procedure, the patient may have been given an excessive amount of medication or similar agents, or the patient may have an adverse reaction to the medication / agent. A specific example of this is contrast-induced nephropathy, where a sudden change in kidney function occurs during angiography or other interventions, primarily due to contrast-induced acute kidney injury or contrast-induced nephropathy. Increasing kidney activity to help clear medication / agents (e.g., contrast agents) can reduce any potential complications. An example method may include performing a medical procedure on a patient, determining that improved kidney function may be helpful to the procedure, inserting an energy distribution device 190 into the patient at least partially, activating a controller connected to the energy distribution device 190 outside the patient, applying energy to the energy distribution device 190 in any manner discussed in this specification, and then optionally removing the energy distribution device 190 after the original procedure is completed or after the kidney function that is no longer needed to be stimulated.

[0154] The treatment system described in this specification can be used in a variety of ways to treat a patient. For example, a general approach may include activating one or more energy distribution devices as described in this specification, implanted in the patient at any location disclosed in this specification. Similarly, activation may include generating an electric current within one or more kidneys to produce electroporation, generating acoustic ultrasound / energy to produce an acoustic aperture effect, or generating an electric current within a renal vein or renal artery to produce a transient nerve block in one or more kidneys.

[0155] The treatment system described in this specification can be used in various methods of treating patients using measured sensor data. For example, Figure 22 A flowchart of the treatment method is shown. Specifically, the method may include performing measurements on the patient with sensors in step 200, comparing the sensor data from the measurements with a threshold in step 202, and activating energy distribution devices within or near the patient and in one or more of the patient's kidneys in step 204.

[0156] Referring first to step 200, measurements can be performed in several different ways. In one example, a device detached from the treatment device can be used to perform the measurement. This measurement can be performed by one or more of the following: a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels (e.g., in blood or urine), a sensor measuring glucose levels, a clock (e.g., for determining night / day), an accelerometer (for sensing activity), a subcutaneous interstitial pressure sensor (SCIP sensor), a central venous pressure sensor, an impedance sensor, a heart rate sensor, a temperature sensor, a sensor for sensing renal electrical signals, a pH sensor, and similar sensors; any of these can be directly implanted and connected / integrated with a controller or energy distribution device. In other examples, sensor data can be input via a user or physician, or the patient or physician can specify the operating time, level, and similar functions (e.g., via a mobile application or other wireless device communicating with the controller). Optionally, the controller of this specification may include similar sensors or be wired / wirelessly connected to such sensors. Therefore, the controller can be configured to store the patient's measurement sensor data.

[0157] Referring to step 202, the sensor data from the measurement can be compared to a threshold. The threshold can be a specific predetermined value, a relative value (e.g., a value based on a relative increase or decrease in previous sensor readings), a percentage value, a value based on other factors (e.g., time of day, activity level, etc.), a range, or a similar value. The threshold can also be simply a single sensor value type (e.g., just blood pressure) or a threshold for multiple sensor types / values ​​(e.g., a blood pressure threshold and a blood glucose threshold, both of which must be met to trigger the system's treatment activity). Several thresholds for a single type of sensor measurement are also possible, where different thresholds result in different treatment durations and / or treatment intensities (e.g., step 204). Therefore, the severity of the sensor measurement can be correlated with the length of treatment time and / or the intensity of treatment. In some examples, the controller can compare sensor data to determine whether it meets / exceeds a threshold.

[0158] Referring to step 204, if the measured sensor data meets a threshold (or multiple thresholds), the controller may activate an energy distribution device in or near one or more kidneys. As previously discussed in this specification, activation of the energy distribution device may include inducing electroporation in one or more kidneys, generating ultrasound waves (e.g., acoustic aperture effect) in one or more kidneys, and / or inducing transient electrical nerve blockade in one or more kidneys. Similarly, the energy distribution device may be implanted wholly or at least partially in or near one or more kidneys (e.g., adjacent). Activation of the energy distribution device may continue until subsequent sensor measurements produce data values ​​below the threshold. Additionally or alternatively, activation may continue for a predetermined period of time. Some treatments discussed in this specification can produce durable therapeutic effects that last beyond the activation time of the energy distribution device. Therefore, these subsequent therapeutic effects can be incorporated into any treatment duration and used for purposes such as maintaining power efficiency to maximize battery life (e.g., determining desired therapeutic effects, determining active and inactive treatment times, and then activating the energy distribution device only during active treatment times).

[0159] In some examples, sensor measurements can be performed periodically (e.g., at regular time intervals, such as hourly or daily).

[0160] Figure 23 Another treatment method is shown, which can be used in conjunction with any or more treatment systems described in this specification. In step 210, a baseline level of treatment / therapy (e.g., a first treatment level) can be performed using any or more treatment systems described in this specification. This step can be performed after an initial test by a physician to determine if the patient can benefit from implanting one of the treatment systems described in this specification. This step can be continuous or periodic.

[0161] After a period of time (e.g., hours, days, weeks), one or more sensors can measure one or more aspects of the patient, and the data can be analyzed. Any sensor values ​​described in this specification can be used, and the sensors can be located on, on, connected to, or detached from a specific energy distribution device or controller. The analysis can be similar to... Figure 22 The analysis involves comparing various measurements to thresholds and / or to previous measurements to determine if the measurement data is improving. This analysis can be performed by a controller, a separate device / application (e.g., a phone / app), and / or by a doctor who can perform the analysis and manually control the controller.

[0162] In step 214, if the measured data meets a predetermined threshold and / or shows improvement relative to previous measurements, treatment at the baseline level continues as in step 210, and periodic measurements and analyses are further performed as in step 212.

[0163] In step 216, if the measured data does not meet a predetermined threshold and / or shows no improvement relative to previous measurements, an increased treatment level (e.g., a second treatment level higher than the first treatment level) can be implemented. This can take the form of activating the energy distribution device more frequently and / or activating the energy distribution device at a higher performance level (e.g., a higher energy level, a higher energy frequency, etc.).

[0164] In step 218, the process periodically returns to step 212 to measure and analyze data from one or more sensors. Based on this data, it returns to steps 214 / 210 or 216. Therefore, the treatment system can utilize sensor data to maintain a certain level of treatment (e.g., treatment time, frequency, or energy characteristics) or to enhance the level of treatment based on data from one or more sensors.

[0165] In any of the examples discussed in this specification, the therapeutic effect can be confirmed by contrast agent injection / visualization of the bladder, chemical testing, electronic sensor measurement, or measurement of the amount of urine excreted by the patient.

[0166] While wiring between the energy distribution device and the controller has been discussed in this specification, such wiring may also be conduits or similar devices. In other words, they may include conductive elements and additional structural reinforcements found in some conduits. However, any conductive element with an insulating sheath, coating, or similar material is possible.

[0167] Although the various examples discussed in this specification disclose and illustrate multiple discrete wires, these wires can be incorporated into a single physical wire. In other words, the device can be connected to a single physical wire, which has multiple electrically insulated conductors within an insulating outer sheath.

[0168] The treatment systems and methods described in this manual are particularly helpful in treating end-stage renal disease, cardiorenal heart failure, hypertension, and similar conditions. These treatment systems can also be used to improve renal blood flow and for weight loss (e.g., diabetes management, glucose excretion, etc.).

[0169] The treatment system described in this specification may include a controller connected to a single energy distribution device, which includes electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system described in this specification may include a controller connected to any two energy distribution devices, which include electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system described in this specification may include a controller connected to any three energy distribution devices, which include electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system described in this specification may include a controller connected to any four energy distribution devices, which include electrodes, an ultrasound transducer, or an intravascular lithotripsy device.

Claims

1. A treatment system comprising: An energy distribution device configured to be implanted in a patient for a long period of time; The energy distribution device has an active state in which energy is distributed to one or more kidneys of the patient. as well as, A controller is connected to the energy distribution device via one or more wires that supply current to the energy distribution device.

2. The treatment system according to claim 1, wherein, The energy distribution device includes a first wire having a first electrode and a second wire having a second electrode.

3. The treatment system according to claim 2, wherein, The energy distribution device includes a third wire having a third electrode.

4. The treatment system according to claim 2, wherein, The controller supplies current to at least the first wire and the second wire, and the current causes electroporation in the surrounding area near the first electrode and the second electrode.

5. The treatment system according to claim 4, wherein, The controller supplies current at a frequency ranging from approximately 1 to 10 Hz, including the terminal value range.

6. The treatment system according to claim 5, wherein, The controller supplies sufficient electrical energy to generate an electric field ranging from approximately 100 V / cm to 3000 V / cm, including the terminal values.

7. The treatment system according to claim 2, wherein, The controller supplies current to at least the first wire and the second wire, the current producing a transient neural blockade in the vicinity of the first electrode and the second electrode.

8. The treatment system according to claim 7, wherein, The controller supplies current in the range of 1-80 kHz with amplitudes in the range of approximately 0-20 mA and 0-20 Vpp.

9. The treatment system according to claim 8, wherein, The first electrode and the second electrode are connected to the support structure.

10. The treatment system according to claim 9, wherein, The support-like structure has a radial expansion diameter ranging from about 3 mm to about 20 mm, including the end value range.

11. The treatment system according to claim 10, wherein, The support structure includes multiple electrodes, including a first electrode and a second electrode, the electrodes having alternating polarities along the length of the support structure.

12. The treatment system according to claim 2, wherein, The controller supplies current to at least the first wire and the second wire, and the current generates sodium / potassium pump stimulation.

13. The treatment system according to claim 1, wherein, The energy distribution device includes an ultrasonic transducer.

14. The treatment system according to claim 13, wherein, The energy distribution device has a diameter ranging from about 3 mm to about 20 mm, including the end value range.

15. The treatment system of claim 13 further includes an infusion channel extending between the ends of the ultrasonic transducers.

16. The treatment system according to claim 15, wherein, The diameter of the infusion channel is in the range of approximately 2 mm to approximately 18 mm, including the end values.

17. The treatment system according to claim 13, wherein, The ultrasonic transducer generates an acoustic frequency range of approximately 0.25 MHz to 3.5 MHz, including the end values.

18. The treatment system according to claim 13, wherein, The ultrasonic transducer generates audio frequencies ranging from approximately 160 kHz to approximately 360 kHz, including the end-value range.

19. The treatment system according to claim 13, wherein, The ultrasonic transducer generates sound frequencies ranging from approximately 20 Hz to approximately 4500 Hz, including the end-value range.

20. The treatment system according to claim 13, wherein, The ultrasonic transducer comprises an assembly of two or more discrete transducers forming a phased array and configured to generate constructive / destructive interference with each other to guide ultrasonic energy.

21. The treatment system of claim 13 further comprises one or more of the following sensors communicating with or incorporated into the controller: a blood pressure sensor, a sensor for measuring sodium concentration, a sensor for measuring protein levels, and / or a sensor for measuring glucose levels.

22. The treatment system according to claim 13, wherein, The controller and ultrasonic transducer are configured to generate an acoustic aperture effect using the ultrasonic transducer.

23. The treatment system according to claim 22, wherein, The controller and ultrasonic transducer are configured to produce transient nerve blockade on one or more kidneys.

24. The treatment system according to claim 1, wherein, The energy distribution device includes an intravascular lithotripsy device.

25. The treatment system according to claim 24, wherein, The intravascular lithotripsy device includes a balloon on a catheter and one or more lithotripsy ejectors located within the balloon.

26. A method of treating a patient, comprising: The first energy distribution device was implanted into the patient's body; The controller was implanted into the patient's body; The controller supplies energy to the first energy distribution device over a long period of time to stimulate kidney activity.

27. The method according to claim 26, wherein, Implanting the first energy distribution device into the patient's body includes implanting the first energy distribution device into the first renal artery, first renal vein, first major renal calyx, first minor renal calyx, first interlobular vein, first interlobular artery, first arcuate vein, first arcuate artery, or first ureter.

28. The method of claim 27, further comprising implanting a second energy distribution device into the patient, wherein, Implanting the first energy distribution device into the patient's body includes implanting the energy distribution device into the first renal artery, first renal vein, first major renal calyx, first minor renal calyx, first interlobular vein, first interlobular artery, first arcuate vein, first arcuate artery, first ureter, second renal artery, second renal vein, second major renal calyx, second minor renal calyx, second interlobular vein, second interlobular artery, second arcuate vein, second arcuate artery, or second ureter.

29. The method according to claim 27, wherein, Implanting the first energy distribution device into a patient includes implanting at least a first electrode and a second electrode into the renal cavity, renal tissue, renal vein, renal artery, or ureter.

30. The method according to claim 27, wherein, The first energy distribution device is a stent, which includes at least a first electrode and a second electrode connected to the controller; and wherein the stent is implanted in a renal vein or renal artery.

31. The method according to claim 26, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes electroporation within the first kidney.

32. The method according to claim 31, wherein, The energy supply includes supplying current to the first energy distribution device at a frequency including the end value range of about 1 to 10 Hz.

33. The method according to claim 32, wherein, The energy supply includes supplying current to the first energy distribution device to generate an electric field ranging from approximately 100 V / cm to 3000 V / cm, including the terminal values.

34. The method according to claim 26, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes performing a transient nerve block within the first kidney.

35. The method of claim 34, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes supplying a current in the range of 1-80 kHz with an amplitude in the range of approximately 0-20 mA and 0-20 Vpp.

36. The method according to claim 35, wherein, The energy supply further includes supplying an electric current to the renal artery and blocking nerve signals to the first kidney.

37. The method of claim 36, wherein, The implanted first energy distribution device further includes an implantable stent, the stent comprising at least a first electrode and a second electrode; wherein the stent has a radially expanded state and its diameter is in the range of approximately 3 mm to approximately 20 mm.

38. The method according to claim 27, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes generating an electric field that produces a sodium / potassium pump stimulation.

39. The method according to claim 26, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes generating ultrasound within the first kidney using a first ultrasonic transducer to produce an acoustic aperture effect.

40. The method according to claim 39, wherein, Generating ultrasound within the first kidney includes generating sound frequencies ranging from approximately 0.25 MHz to 3.5 MHz, encompassing the end-value range.

41. The method of claim 39, wherein, Generating ultrasound within the first kidney includes generating an audio frequency ranging from about 160 kHz to about 360 kHz, encompassing the end-value range.

42. The method according to claim 41, wherein, Generating ultrasound within the first kidney includes operating a phased array of at least the first and second ultrasound transducers of the energy distribution device to generate constructive / destructive interference with each other, thereby guiding ultrasound energy.

43. The method according to claim 26, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes generating ultrasound with a first ultrasound transducer to induce transient nerve blockade in one or more kidneys.

44. The method of claim 26, wherein, Supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes generating shock waves within the first kidney using an intravascular lithotripsy device.

45. The method of claim 26 further includes implanting a second energy distribution device in the patient and supplying energy to the second energy distribution device from the controller for an extended period.

46. ​​The method according to claim 45, wherein, The first energy distribution device stimulates the first kidney, and the second energy distribution device stimulates the second kidney.

47. The method according to claim 45, wherein, The first energy distribution device stimulates the first kidney, and the second energy distribution device also stimulates the first kidney.

48. A method of treating a patient, comprising: The first energy distribution device was implanted into the patient's body; The controller was implanted into the patient's body; Measurements are performed inside the patient using sensors; The sensor data from the measurement is compared with a first threshold; When the sensor data triggers the first threshold, the energy distribution device implanted long-term in the patient is activated to stimulate kidney activity.

49. The method according to claim 48, wherein, The comparison of the sensor data from the measurement with the first threshold is performed by the controller.

50. The method according to claim 49, wherein, The measurements performed using the aforementioned sensors are performed by blood pressure sensors, sensors for measuring sodium concentration, sensors for measuring protein levels (e.g., in blood or urine), sensors for measuring glucose levels, clocks (e.g., for determining night / day), accelerometers (for sensing activity), subcutaneous interstitial pressure sensors (SCIP sensors), central venous pressure sensors, impedance sensors, heart rate sensors, temperature sensors, sensors for sensing renal electrical signals, pH sensors, and similar sensors.

51. The method according to claim 50, wherein, The sensor is integrated with the controller and the energy distribution device, or is located away from the controller or the energy distribution device.

52. The method according to claim 51, wherein, Activating the energy distribution device includes using the energy distribution device to perform electroporation, acoustic hole effect, or transient nerve block.

53. A method of treating a patient, comprising: The energy distribution device is activated at the first treatment level, wherein the energy distribution device is permanently implanted in the patient. Measurements are performed inside the patient using sensors; Analyze the sensor data from the measurements; If the measurement meets a predetermined threshold and / or is an improvement over previous sensor measurements, the first treatment level is maintained using the energy distribution device; If the measurement does not meet a predetermined threshold and / or does not improve compared to previous sensor measurements, the energy distribution device is activated at a second treatment level higher than the first treatment level.

54. The method according to claim 53, wherein, The second level of treatment includes activating the energy distribution device more frequently, activating the energy distribution device at a higher performance level, or both.

55. The method according to claim 54, wherein, The first and second treatment levels include producing an electroporation or acoustic hole effect within the patient's kidney.

56. The method according to claim 54, wherein, The first and second treatment levels include a transient nerve blockade of the renal nerve between the patient's central nervous system and the kidney.

57. A method of treating a patient, comprising: Perform the first medical procedure on the patient; Determining that improved kidney function can aid in the first course of treatment; The energy distribution device is inserted into the patient's body, at least partially. Activate the controller located outside the patient's body and connected to the energy distribution device; and, Energy is applied using the energy distribution device to improve kidney function.

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