Implantable energy devices and methods

Abstract

Disclosed herein are systems and methods for treating certain medical conditions by implanting a specialized implant within a patient and applying electrical current, ultrasound, or both to a kidney or locations adjacent to a kidney to stimulate kidney activity. In some examples, electroporation, sonoporation, and / or transient nerve block may be created to selectively improve kidney function and thereby treat a variety of different diseases.

Description

IMPLANTABLE ENERGY DEVICES AND METHODSRELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Application Serial No. 63 / 520,057 filed August 16, 2023 entitled Implantable Ultrasonic Device and Methods for Treating Renal Function, which is hereby incorporated herein by reference in its entirety.BACKGROUND

[0002] Various approaches have been developed for treating end stage kidney disease, cardiorenal heart failure, hypertension, and similar diseases, which often involve invasive procedures or pharmaceutical interventions. Traditional treatments for these conditions may include dialysis for end stage kidney disease, medication management for heart failure and hypertension, and in severe cases, organ transplantation. While these treatments can be effective in managing symptoms and improving quality of life, they may not address the underlying causes of the diseases or provide long-term solutions.

[0003] In recent years, there has been growing interest in exploring alternative therapies for managing kidney disease, heart failure, and hypertension. Some approaches have focused on the use of implantable devices to deliver targeted therapies directly to the affected organs or tissues. For example, implantable devices such as pacemakers and defibrillators have been used to regulate heart function in patients with heart failure. However, these devices are typically not designed to specifically target kidney function or address the complex interplay between the kidneys and the cardiovascular system in conditions such as cardiorenal heart failure.SUMMARY

[0004] In some aspects, the techniques described herein relate to a treatment system, including: an energy distribution device configured for chronic implantation within a patient; the energy distribution device having an active state in which energy is distributedto one or more kidneys of the patient; and, a controller connected to the energy distribution device via one or more wires supplying electrical current to the energy distribution device.

[0005] In some aspects, the techniques described herein relate to a treatment system, wherein the energy distribution device includes a first electrical wire having a first electrode and a second electrical wire having a second electrode.

[0006] In some aspects, the techniques described herein relate to a treatment system, wherein the energy distribution device includes a third electrical wire having a third electrode.

[0007] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical current to at least the first electrical wire and the second electrical wire that produces electroporation in the surrounding area near the first electrode and the second electrode.

[0008] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical current at a frequency within an inclusive range of about 1 to 10 Hz.

[0009] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical energy sufficient to produce an electric field within an inclusive range of about 100 V / cm to 3,000 V / cm.

[0010] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical current to at least the first electrical wire and the second electrical wire that produces transient nerve block near the first electrode and the second electrode.

[0011] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical current within an inclusive range of 1-80 kHz, at amplitudes within an inclusive range of about 0-20 mA, and 0-20 Vpp.

[0012] In some aspects, the techniques described herein relate to a treatment system, wherein the first electrode and the second electrode are connected to a stent-like structure.

[0013] In some aspects, the techniques described herein relate to a treatment system, wherein the stent-like structure has a radially expanded diameter within an inclusive range of about 3 mm to about 20 mm.

[0014] In some aspects, the techniques described herein relate to a treatment system, wherein the stent-like structure includes a plurality of electrodes, including the first electrode and the second electrode, that alternate in polarity along a length of the stentlike structure.

[0015] In some aspects, the techniques described herein relate to a treatment system, wherein the controller supplies electrical current to at least the first electrical wire and the second electrical wire that produces sodium / potassium pump stimulation.

[0016] In some aspects, the techniques described herein relate to a treatment system, wherein the energy distribution device includes an ultrasound transducer.

[0017] In some aspects, the techniques described herein relate to a treatment system, wherein the energy distribution device has a diameter within an inclusive range of about 3 mm to about 20 mm.

[0018] In some aspects, the techniques described herein relate to a treatment system, further including a perfusion passage extending between ends of the ultrasound transducer.

[0019] In some aspects, the techniques described herein relate to a treatment system, wherein the perfusion passage has a diameter within an inclusive range of about 2 mm to about 18 mm.

[0020] In some aspects, the techniques described herein relate to a treatment system, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 0.25 MHz to 3.5 Mhz.

[0021] In some aspects, the techniques described herein relate to a treatment system, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 160 kHz to about 360 kHz.

[0022] In some aspects, the techniques described herein relate to a treatment system, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 20 Hz to about 4,500 Hz.

[0023] In some aspects, the techniques described herein relate to a treatment system, wherein the ultrasound transducer includes an assembly of two or more discrete transducers forming a phased array and configured to cause constructive / destructive interference with each other to direct ultrasound energy.

[0024] In some aspects, the techniques described herein relate to a treatment system, further including one or more of the following sensors in communication with or incorporated into the controller: a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels, and / or a sensor measuring glucose levels.

[0025] In some aspects, the techniques described herein relate to a treatment system, wherein the controller and ultrasound transducer are configured to create sonoporation with the ultrasound transducer.

[0026] In some aspects, the techniques described herein relate to a treatment system, wherein the controller and ultrasound transducer are configured to create transient nerve block to one or more kidneys.

[0027] In some aspects, the techniques described herein relate to a treatment system, wherein the energy distribution device includes an intravascular lithotripsy device.

[0028] In some aspects, the techniques described herein relate to a treatment system, wherein the intravascular lithotripsy device includes a balloon on a catheter and one or more lithotripsy emitters positioned within the balloon.

[0029] In some aspects, the techniques described herein relate to a method of treating a patient, including: implanting a first energy distribution device within a patient; implanting a controller within the patient; chronically supplying energy from the controller to the first energy distribution device to stimulate kidney activity.

[0030] In some aspects, the techniques described herein relate to a method, wherein implanting the first energy distribution device within a patient includes implanting the first energy distribution device within a first renal artery, a first renal vein, a first major calyx, a first minor calyx, a first interlobular vein, a first interlobular artery, a first arcuate vein, a first arcuate arteries, or a first ureter.

[0031] In some aspects, the techniques described herein relate to a method, further including implanting a second energy distribution device within a patient, wherein implanting the first energy distribution device within a patient includes implanting the energy distribution device within the first renal artery, the first renal vein, the first major calyx, the first minor calyx, the first interlobular vein, the first interlobular artery, the first arcuate vein, the first arcuate arteries, the first ureter, a second renal artery, a second renal vein, a second major calyx, a second minor calyx, a second interlobular vein, a second interlobular artery, a second arcuate vein, a second arcuate arteries, or a second ureter.

[0032] In some aspects, the techniques described herein relate to a method, wherein implanting the first energy distribution device within a patient includes implanting at least a first electrode and a second electrode within a lumen of a kidney, tissue of a kidney, a renal vein, a renal artery, or a ureter.

[0033] In some aspects, the techniques described herein relate to a method, wherein the first energy distribution device is a stent including at least a first electrode and asecond electrode connected to the controller; and wherein the stent is implanted in a renal vein or renal artery.

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

[0035] In some aspects, the techniques described herein relate to a method, wherein supplying energy includes supplying electrical current to the first energy distribution device at a frequency within an inclusive range of about 1 to 10 Hz.

[0036] In some aspects, the techniques described herein relate to a method, wherein supplying energy includes supplying electrical current to the first energy distribution device to create an electric field within an inclusive range of about 100 V / cm to 3,000 V / cm.

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

[0038] In some aspects, the techniques described herein relate to a method, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes supplying electrical current within an inclusive range of 1-80 kHz, at amplitudes within an inclusive range of about 0-20 mA, and 0-20 Vpp.

[0039] In some aspects, the techniques described herein relate to a method, wherein supplying energy further includes supplying electrical current to a renal artery and blocking nerve signals to the first kidney.

[0040] In some aspects, the techniques described herein relate to a method, wherein implanting the first energy distribution device further includes implanting a stent including at least a first electrode and a second electrode; wherein the stent has a radially expanded state with a diameter within an inclusive range of about 3 mm to about 20 mm.

[0041] In some aspects, the techniques described herein relate to a method, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes creating an electric field that produces sodium / potassium pump stimulation.

[0042] In some aspects, the techniques described herein relate to a method, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes creating ultrasound within the first kidney with a first ultrasound transducer to produce sonoporation.

[0043] In some aspects, the techniques described herein relate to a method, wherein creating ultrasound within the first kidney includes creating acoustic frequency within an inclusive range of about 0.25 MHz to 3.5 Mhz.

[0044] In some aspects, the techniques described herein relate to a method, wherein creating ultrasound within the first kidney includes creating acoustic frequency within an inclusive range of about 160 kHz to about 360 kHz.

[0045] In some aspects, the techniques described herein relate to a method, wherein creating ultrasound within the first kidney includes operating a phased array of at least the first ultrasound transducer and a second ultrasound transducer of the energy distribution device to cause constructive / destructive interference with each other to direct ultrasound energy.

[0046] In some aspects, the techniques described herein relate to a method, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes creating ultrasound with a first ultrasound transducer to produce transient nerve block to one or more kidneys.

[0047] In some aspects, the techniques described herein relate to a method, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity includes creating shockwaves within the first kidney with intravascular lithotripsy device.

[0048] In some aspects, the techniques described herein relate to a method, further including implanting a second energy distribution device within a patient and chronically supplying energy from the controller to the second energy distribution device.

[0049] In some aspects, the techniques described herein relate to a method, wherein the first energy distribution device stimulates a first kidney and a second energy distribution device stimulates a second kidney.

[0050] In some aspects, the techniques described herein relate to a method, wherein the first energy distribution device stimulates a first kidney and a second energy distribution device also stimulates the first kidney.

[0051] In some aspects, the techniques described herein relate to a method of treating a patient, including: implanting a first energy distribution device within a patient; implanting a controller within the patient; performing a measurement with a sensor in a patient; comparing sensor data from the measurement to a first threshold; activating an energy distribution device chronically implanted within the patient to stimulate kidney activity when the first threshold is triggered by the sensor data.

[0052] In some aspects, the techniques described herein relate to a method, wherein comparing the sensor data from the measurement to the first threshold is performed by the controller.

[0053] In some aspects, the techniques described herein relate to a method, wherein performing the measurement with the sensor is performed by a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels (e.g., in the 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, sensor for sensing kidney electrical signals, a pH sensor, and similar sensors.

[0054] In some aspects, the techniques described herein relate to a method, wherein the sensor is integrated with the controller, with the energy distribution device, or in a location away from the controller or energy distribution device.

[0055] In some aspects, the techniques described herein relate to a method, wherein activating the energy distribution device includes performing electroporation, sonoporation, or transient nerve blocking with the energy distribution device.

[0056] In some aspects, the techniques described herein relate to a method of treating a patient, including: activating an energy distribution device at a first treatment level where the energy distribution device is chronically implanted within a patient; performing a measurement with a sensor in a patient; analyzing sensor data from the measurement; if the measurement meets a predetermined threshold and / or is improved over prior sensor measurements, the first treatment level is continued with the energy distribution device; if the measurement does not meet a predetermined threshold and / or is not improved over prior sensor measurements, the energy distribution device is activated at a second treatment level that is higher than the first treatment level.

[0057] In some aspects, the techniques described herein relate to a method, wherein the second treatment level includes more frequent activations of the energy distribution device, activating the energy distribution device at a higher performance level, or both.

[0058] In some aspects, the techniques described herein relate to a method, wherein the first treatment level and the second treatment level include creating electroporation or sonoporation within a kidney of the patient.

[0059] In some aspects, the techniques described herein relate to a method, wherein the first treatment level and the second treatment level include creating transient nerve block to renal nerves between a central nervous system and a kidney of a patient.

[0060] In some aspects, the techniques described herein relate to a method of treating a patient, including: performing a first medical procedure on a patient; determining that improved kidney performance may be helpful to the first procedure; at least partiallyinserting an energy distribution device into a patient; activating a controller connected to the energy distribution device outside the patient; and, applying energy with the energy distribution device to improve kidney function.BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The following figures are included to illustrate certain example aspects of the present disclosure and should not be viewed as exclusive or limiting. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to one having ordinary skill in the art and having the benefit of this disclosure. The present disclosure references the drawings as follows:

[0062] Fig. 1 illustrates a cross-sectional side view of a kidney 10 in which an energy distribution device 100 has been implanted or placed in for stimulating kidney activity.

[0063] Fig. 2 illustrates a cross-sectional side view of a kidney 10 in which an energy distribution device 110 has been implanted or placed in for stimulating kidney activity.

[0064] Fig. 3 illustrates a cross-sectional view of a kidney 10 in which an energy distribution device 120 has been implanted or placed in for stimulating kidney activity.

[0065] Fig. 4 illustrates a cross-sectional view of a kidney 10 and an energy distribution device 130 for stimulating kidney activity.

[0066] Fig. 5 illustrates a view of a renal vein 12 and the energy distribution device 130.

[0067] Fig. 6 illustrates another implantation location of the ultrasound transducer 132 within the renal artery 14 at a location near the kidney 10.

[0068] Fig. 7 illustrates another implantation location of the ultrasound transducer 132 within both the major calyxes 34 and minor calyxes 36.

[0069] Fig. 8 illustrates a cross-sectional view of a kidney 10 with an energy distribution device 140 implanted nearby.

[0070] Fig. 9 illustrates a human body and a treatment system 160.

[0071] Fig. 10 illustrates a treatment system 170 in which a controller 162 is implanted in an upper portion of the patient's trunk, such as beneath skin and near a clavicle (e.g., similar to a pacemaker placement).

[0072] Fig. 11 illustrates a treatment system 180 in which a controller 162 is implanted under the skin of the buttocks or at the iliac crest.

[0073] Fig. 12 illustrates a physician accessing a femoral artery 22 or a femoral vein (not shown) with a delivery device catheter 50.

[0074] Fig. 13 illustrates an energy distribution device 130 with an ultrasound transducer 132 placed in each renal vein 12 of each of the two kidneys 10.

[0075] Fig. 14 illustrates an energy distribution device 120 with a plurality of electrical wires (e.g., a first electrical wire 102, a second electrical wire 104, a third electrical wire 106) placed in various areas (e.g., arteries, veins, calyxes, etc.) of each of the kidneys 10.

[0076] Fig. 15 illustrates an energy distribution device 140 with a stent-like structure 142 placed in each renal vein 12 of each of the kidneys 10.

[0077] Fig. 16 illustrates one example of kidneys 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, second electrical wire 104, third electrical wire 106) as well as the energy distribution device 130 comprising one or more of the ultrasound transducers 132.

[0078] Fig. 17 illustrates another example of kidney 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, secondelectrical wire 104, third electrical wire 106) as well as the energy distribution device 140 comprising one or more stent-like structures 142.

[0079] Fig. 18 illustrates another example of kidney 10 with the energy distribution device 130 comprising one or more ultrasound transducers 132 as well as the energy distribution device 140 comprising one or more stent-like structures 142.

[0080] Fig. 19 illustrates another example of kidney 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, second electrical wire 104, third electrical wire 106), energy distribution device 130 comprising one or more ultrasound transducers 132, as well as the energy distribution device 140 comprising one or more stent-like structures 142.

[0081] Fig. 20 illustrates a transcutaneous energy distribution device 190 (generally similar to energy distribution device 110) in which the first electrical wire 102 and the second electrical wire 104 are placed or implanted through the skin and into the kidney 10 transcutaneously at any of the locations discussed in this specification for other energy distribution devices.

[0082] Fig. 21 illustrates an intravascular lithotripsy device according to some examples.

[0083] Fig. 22 illustrates a flow chart of a method of treatment.

[0084] Fig. 23 illustrates a flow chart of a method of treatment.DETAILED DESCRIPTION

[0085] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. A variety of modifications and variations are possible in view of the teachings herein without departing their scope, spirit, or intent.

[0086] While different examples may be described in this specification, it is specifically contemplated that any of the features from the different examples can be used and brought together in any combination. In other words, the features of different examples can be mixed and matched with each other. Hence, while every permutation of features from different examples may not be explicitly shown or described, it is the intention of this disclosure to cover any such combinations, especially as may be appreciated by one of skill in the art.

[0087] The terminology used in this disclosure should be interpreted in a permissive manner and is not intended to be limiting. In the drawings, like numbers refer to like elements. Unless otherwise noted, all of the accompanying drawings are not to scale. Unless otherwise noted, the term “about” is defined to mean plus-or-minus 5% of a stated value.

[0088] The terms distal or distally generally refer to a direction or area towards an end of a device within a patient (e.g., away from a physician / clinician), while the terms proximal or proximally refer to a direction or area toward an end of a device that remains outside of a patient (e.g., toward or closer to a physician / clinician or handle / hub of a device).

[0089] The present specification is directed to treatment systems and methods of treatment comprising a chronically implanted device that selectively emits energy within a patient to improve kidney function, such as urine output, glomerular filtration rate, ion / toxin filtering, creatinine clearance, glucose clearance, and similar functionality. Such systems and methods may help reduce the need for diuretics, dialysis, and / or other treatments for chronic kidney disease, end stage kidney disease, acute kidney injury, cardiorenal heart failure, hypertension, or other kidney-related diseases. The systems and methods may also be helpful for producing weight loss and renal blood flow.

[0090] For the purposes of this specification, the term chronically implanted device refers to a device that is at least partially implanted within a patient for a period of time longer than a typical interventional or surgical procedure. In other words, the chronicallyimplanted device remains in the patient after a procedure to implant it. Such a time period may be several days, several months, or several years.

[0091] In some examples, the device and methods include implanting at least part of a treatment device in or near one or more kidneys and then selectively applying energy to the location in or near the kidneys. Depending on the type of energy, its application may therapeutically stimulate the one or more kidneys to increase urine output.

[0092] In some examples, the energy is electricity provided at frequencies and amounts sufficient to produce electroporation. The electroporation energy may cause the renal cell membranes to electroporate and thereby increase the fluid flow through the kidney.

[0093]

[0094] In some examples, the energy is electricity provided at frequencies and amounts sufficient to stimulate sodium / potassium pumping in one or more kidneys.

[0095] In some examples, the energy is sound provided at ultrasound frequencies (e.g., frequencies / amounts sufficient to produce sonoporation). The sonoporation energy may cause the renal cell membranes to sonoporate and thereby increase the fluid flow through the kidney.

[0096] In some examples, microbubbles or nanobubbles may be used in combination with some of the energy types of this specification (e.g., sonoporation). Microbubbles are typically used in sonoporation to increase the poration efficacy / permeability of cell membranes. These microbubbles are typically within an inclusive range of about 2 to 20 micrometers in diameter and may consist of an outer shell made of denatured albumin, surfactants, phospholipids, or polymers. This outer shell encapsulates gasses which are usually air, perfluorocarbons, or sulphur hexafluoride. Nanobubbles may also be used, which are similar but may have an average diameter of about 100 nanometers in diameter. These nanobubbles may move into smaller blood vessels and can thereforemay be able to travel further into a kidney. These micro / nano bubbles may need to be injected into the bloodstream (e.g., artery or vein).

[0097] In some examples, the energy is sound provided at frequencies that may create a shockwave. Such shockwaves are currently used for Intravascular Lithotripsy (IVL), such as the C2 Shockwave Medical Coronary IVL system (Shockwave Medical) which consists of three components: a power supply / generator (e.g., a controller); a connector cable and a sterile catheter incorporating the lithotripsy emitters enclosed in a semi- compliant balloon. IVL typically produces low levels of electric energy, leading to the formation and rapid expansion of vapor bubbles, resulting in acoustic pressure waves that radiate circumferentially and transmurally in an unfocused manner. When applied to the kidney (e.g., through the renal vein or within the kidney), the appropriate level of shock wave energy may also modify tissue to stimulate kidney function.

[0098] In some examples, the energy is electricity at frequencies and amounts that block or stimulate nerve signals from the kidney to the central nervous system (e.g., transient nerve block).

[0099] The treatment system may include a controller that is configured to supply power and / or control signals to one or more energy distribution devices, such as electroporation devices, sonoporation devices, electrical leads, stents, electrical catheters, or any combination of these devices.

[0100] The 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 positions in vasculature immediately leading to a kidney, such as a renal artery or renal vein. The 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 at locations that may otherwise affect performance of at least one kidney. For example, one or more of an arcuate artery, arcuate vein, interlobular artery, interlobular vein, renal calyxes (e.g., major and minor), renal pelvis, medulla (renal pyramids), renal papilla, renalcortex, portions of the ureter near the kidney, or other vessels, tissue, or spaces within a kidney.

[0101] The controller, which may be connected to the energy distribution devices, may be implanted within a patient. In some examples, the controller is positioned at a location different than the energy distribution device(s) and is connected to the energy distribution device(s) via one or more electrical wires. In some examples, the controller may be implanted in cavities of the patient (e g., the abdominal cavity or near iliac crest), beneath the skin in an upper trunk portion (e.g., at locations where pacemakers are typically implanted, such as near clavicle), or beneath the skin in a lower trunk portion (e.g., under the skin of the buttocks). In other examples, the controller may be mounted or supported on the outside of the patient’s skin while wires pass through the skin, into the patient, and to the energy distribution device(s).

[0102] In some examples, one or more energy distribution devices may be positioned in or near only one kidney. In other examples, one or more energy distribution devices may be placed at or near each of the two kidneys of a patient.

[0103] In some examples, the one or more energy distribution devices may provide multiple types of energy to the patient. For example, electroporation energy and sonoporation energy. In another example, electroporation energy and electrical blocking energy. In another example, sonoporation energy and electrical blocking energy. In another example, electroporation, sonoporation, and electrical blocking energy may be delivered. These energies may be delivered simultaneously, at different non-overlapping times, or both simultaneously and at different non-overlapping times.

[0104] In some examples, the controller may also be coupled, either directly or indirectly, with a sensor. Sensor data may be used to control when the energy distribution device(s) are activated. Example sensors may include a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels (e.g., in the 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 (SCIPsensor), a central venous pressure sensor, an impedance sensor, a heart rate sensor, a temperature sensor, sensor for sensing kidney electrical signals, a pH sensor, and similar sensors. In other examples, either a patient or physician may specify operational runtimes, levels, and similar functionality (e.g., via a phone app or other wireless device that communicates with a controller).

[0105] In some examples, the treatment system may operate continuously, intermittently, or adaptively (e.g., based on sensor data or user / physician input). In addition to certain operation times, the level of operation (i.e. , how strongly the system may be stimulating a kidney) may also be increased or decreased.

[0106] Aspects of different example treatment systems are illustrated in the figures and discussed in greater detail below. While certain figures may show only a portion of an entire treatment system, it should be understood that these examples may be used with any of the other examples. In other words, any example shown in a figure may be mixed and matched with any other examples from the other figures. For example, certain example energy distribution devices may be used with any of the controllers and methods of operation shown and described elsewhere in the specification / figures. In another example, certain example energy distribution devices may be used with other example energy distribution devices (e.g., a combination of multiple types of devices). Hence, while the figures may show only a specific example, broader uses and combination are specifically contemplated and disclosed.

[0107] In some examples, the energy distribution devices may comprise one or more electrical wires / leads connected to a controller that are configured to provide electrical energy / current configured to create electroporation in tissue of a kidney.

[0108] In one example, Fig. 1 illustrates a cross-sectional side view of a kidney 10 in which an energy distribution device 100 has been implanted or placed in for stimulating kidney activity. The energy distribution device 100 may comprise at least a first electrical wire 102 and a second electrical wire 104 that each extend out of the kidney 10 to the location of the controller (discussed later in this specification). Generally, the firstelectrical wire 102 and second electrical wire 104 may be composed of an electrically conductive material and coated with an insulating material along its outside surface. One or more electrodes, such as electrode 102A or electrode 104A, may be located at distal portions of the first electrical wire 102 and second electrical wire 104, respectively, to convey electrical current from the conductive material in the wires to the tissue within the kidney 10.

[0109] In the present example, the first electrical wire 102 and second electrical wire 104 are located within vessels of the kidney 10. Specifically, both the first electrical wire 102 and the second electrical wire 104 may pass through the renal vein 12 such that the one or more electrodes 102A and one or more electrodes 104A are located within different interlobular veins 18. Alternatively, the one or more electrodes 102A and one or more electrodes 104A may be located in any other vein within the kidney 10, such as the arcuate vein 16.

[0110] Alternatively, the first electrical wire 102 and second electrical wire 104 may be positioned through the renal artery 14 and into any other artery within the kidney 10, such as the interlobular arteries 22 or the arcuate arteries 20. In some examples, a first electrical wire 102 may be located in an artery and a second electrical wire 104 may be located in a vein.

[0111] In another alternative example, the one or more electrodes 102A and one or more electrodes 104A may be positioned within renal calyxes (e.g., major calyxes or minor calyxes) or within a portion of ureter 26 near the kidney 10. Again, both the one or more electrodes 102A and one or more electrodes 104A need not be positioned in the same type of structure. Any of the structures mentioned (e.g., arteries, veins, calyxes, ureter) may be used in any combination.

[0112] The distal portion of the first electrical wire 102 and second electrical wire 104 may include one or more anchors that help anchor the first electrical wire 102 and second electrical wire 104 in their respective positions. In some examples, anchors may include one or more barbs, one or more hooks, one or more high friction surfaces, a radiallyexpandable spiral wire, a radially expandable tubular stent-like structure, or similar anchoring structure.

[0113] While the first electrical wire 102 and second electrical wire 104 may at least have an electrically conductive wire and an insulating material on its outer surface, additional structural elements may also be included, similar to those found in some stents. For example, structural coils, mesh layers, multiple polymer layers, and similar components may also be included.

[0114] In the present example, the first electrical wire 102 and second electrical wire 104 may be connected to a controller such that the two wires complete a circuit (e.g., one wire represents a positive electrical connection and the other a negative / ground electrical connection). Alternatively, both the first electrical wire 102 and second electrical wire 104 may be configured to be positive while a third external patch electrode or similar connection is connected to the controller to complete an electrical circuit.

[0115] The energy distribution device 100 may be configured to create electroporation within the kidney 10. In some examples, the controller, the first electrical wire 102, and the second electrical wire 104 produce an electric field in the kidney 10 which may porate the renal cell membranes, increasing the fluid flow through the kidney 10. In some examples, electroporation may generally occur at a frequency within an inclusive range of about 1 -10 Hz and an electric field strength within an inclusive range of about 100 V / cm to 3,000 V / cm. In some examples, a bipolar or unipolar square wave may be used, as well as an exponential wave and / or sine wave.

[0116] Alternatively, the energy distribution device 100 may be configured to create a transient nerve block via direct application of electrical energy / current to the renal nerves between the central nervous system and the kidney. In some examples, transient nerve block may generally occur at electrical frequencies within an inclusive range of 1-80 kHz at amplitudes within an inclusive range of about 0-20 mA and 0-20 Vpp. In such a transient nerve block example, it may be desirable for the one or more electrodes 102A and the one or more electrodes 104A to be located close to or within the renal vein 12 orrenal artery 14, since most or all of the nerves leading to the kidney 10 pass through these regions. A variety of different wave forms are possible such as bipolar square waves and sine waves. The kidney has chemosensors and barosensors that help regulate the reninangiotensin system (RAAS). When communication from the kidney to the central nervous system is blocked (e.g., by interrupting the renal nerves that extend along the renal artery 14), it may interrupt the RAAS, decreases renin output, and eventually the amount of angiotensin II in the blood stream is decreased. One of the known effects of angiotensin II in the kidney is chloride, sodium, and water reabsorption. Hence, blocking the renal nerves may tend to increase urine output, among other possible benefits.

[0117] Alternatively or additionally, the energy distribution device 100 may be configured to create a transient nerve stimulation via direct application of electrical energy / current to the renal nerves between the central nervous system and the kidney. In some examples, transient nerve stimulation may generally occur at electrical frequencies within an inclusive range of 1-10 Hz at amplitudes within an inclusive range of about 0-20 mA and 0-20 Vpp. In such a transient nerve stimulation example, it may be desirable for the one or more electrodes 102A and the one or more electrodes 104A to be located close to 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 regions. A variety of different wave forms are possible such as bipolar square waves and sine waves. Again, 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 electrical stimulation of the renal nerves that extend along the renal artery 14), it may stimulate the RAAS, increase renin output, and eventually the amount of angiotensin II in the blood stream is increased. One of the known effects of angiotensin II in the kidney is chloride, sodium, and water reabsorption. Hence, stimulating the renal nerves may tend to decrease urine output, among other possible benefits.

[0118] In one example, the controller connected to the energy distribution device 100 may alternate between transient nerve block to increase kidney function (e.g., urine output) during certain times and transient nerve stimulation to decrease kidney function(e.g., urine output) during certain times. For example, the renal nerve may be stimulated at night (e.g., 1-10 Hz) to reduce urine output and the need for the patient to go to the bathroom and blocked during the day (e.g., 10-80 kHz) to increase urine output at times when sleep is less likely to be interrupted.

[0119] Alternatively or additionally, the energy distribution device 100 may be configured to synchronize sodium / potassium pump frequency and direction, as well as increase or decrease the pump frequency. In the kidney, the glomerulus pumps an excess of fluid from the blood stream into the renal tubule. The renal tubule absorbs sodium, potassium, other ions, and water back into the blood stream. Diuretic medications act along this renal tubule to decrease the amount of sodium reabsorption, and because water follows sodium, increases the amount of urine output. There are hundreds of thousands of sodium-potassium (Na / K) pumps in each cell. Normally, they pump at different rates and in different directions (into / out of the cell). Certain waveforms may “capture” all or most of these Na / K pumps, synchronizes their pump rates and orients them in the same direction. In some examples, this may be performed with the 3rd Gen SMEF wave at 50 Hz. Then, with all the pumps synchronized, we can decrease their pump rate to about 10-20 Hz. This may decrease the Na / K pumps along the tubule to act as an electrical diuretic. In some examples, the frequency of the electrical energy is within an inclusive range of about 0 to about 150 Hz. In some examples, the voltage is within an inclusive range of about -160 mV to about 160 mV. The amplitude of the waveform may be configured to perform biomimicry, mimicking the voltage range naturally produced by each stage of the sodium / potassium pump cycle. Further details on such sodium / potassium pump manipulation, including the 3rd Gen SMEF waveform / algorithm / method, may be found in U.S. Pat. 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.

[0120] In one example, Fig. 2 illustrates a cross-sectional side view of a kidney 10 in which an energy distribution device 110 has been implanted or placed in for stimulating kidney activity. Generally, the energy distribution device 110 is similar to the previously described energy distribution device 100 in which electricity is supplied via the first electrical wire 102 and second electrical wire 104 (e.g., for electroporation or transient nerve blocking). However, instead of placing the one or more electrodes 102A and the one or more electrodes 104A within an artery, vein, space (e.g., calyxes), or ureter of the kidney 10, one or both of the one or more electrodes 102A and one or more electrodes 104A may be inserted or implanted into kidney tissue. For example, in Fig. 2, the one or more electrodes 102A and one or more electrodes 104A are placed into renal cortex tissue 24. In an alternative example, the one or more electrodes 102A and 104A may be placed in the renal fibrous capsule 28, the renal medulla 30 (pyramids), renal papilla 32, or other tissues of the kidney 10. Additionally, any tissue immediately surrounding the kidney 10 may also be used. Both the one or more electrodes 102A and the one or more electrodes 104A may be placed into any combination of tissue locations or any combination of tissue locations, arteries, veins, calyxes, ureter, or similar areas of the kidney 10.

[0121] Anchors configured to anchor the distal end of the first electrical wire 102 and second electrical wire 104 into the tissue may also be included on the distal ends. For example, barbs, hooks or similar structural features may be included.

[0122] The distal ends of the first electrical wire 102 and second electrical wire 104 may have pointed and / or conical ends for better piercing the tissue of the kidney 10 and may be inserted and released from a catheter. For example, pacemaker electrodes / leads.

[0123] While only a first electrical wire 102 and a second electrical wire 104 are shown in Figs. 1 and 2, more than two electrical wires may be used in either embodiment. For example, 3, 4, 5, 6, 7, 8, or more electrical wires may be used. Fig. 3 illustrates a cross- sectional view of a kidney 10 in which an energy distribution device 120 has been implanted or placed in for stimulating kidney activity. The present example is similar tothe energy distribution device 100 and energy distribution device 110, however, the energy distribution device 120 may comprise a first electrical wire 102, a second electrical wire 104, and a third electrical wire 106 (also comprising one or more electrodes 106A). Two of these wires may be connected or configured to be a first polarity during operation (e.g. positive) and one of these wires may be connected or configured to be a second polarity (e.g., negative / ground). If additional electrical wires are included (i.e. , more than three), these additional wires may be configured to be either polarity such that only one second polarity wire is included in the total number of wires or that each polarity has multiple wires.

[0124] In some examples, an energy distribution device may include an ultrasound transducer. For example, Fig. 4 illustrates a cross-sectional view of a kidney 10 and an energy distribution device 130 for stimulating kidney activity and Fig. 5 illustrates a view of a renal vein 12 and the energy distribution device 130. In the present example, the energy distribution device 130 comprises an ultrasound transducer 132 implanted within the renal vein 12.

[0125] A first electrical wire 134 and a second electrical wire 136 may be connected to the ultrasound transducer 132 and to a controller located elsewhere in / on the patient, providing power and / or control signals. Alternatively, the ultrasound transducer 132 may include a battery, a wireless charging system for wirelessly charging the battery, and a wireless communication system for communicating with a controller (and / or phone).

[0126] In some examples, the ultrasound transducer 132 may include a perfusion passage 132A extending between and opening at a first and second end of the ultrasound transducer 132 to allow passage of fluids (e.g., blood) therethrough. Hence, the ultrasound transducer 132 may have a generally tubular shape. The perfusion passage 132A may have a diameter that allows sufficient blood / fluid to pass through.

[0127] In some examples, the ultrasound transducer 132 may include anchors along its outer surface to help maintain the location of the ultrasound transducer 132. For example, barbs, hooks, coils, stents, and similar anchoring devices may be included.

[0128] In some examples, the ultrasound transducer 132 may be an assembly that includes two or more discrete transducers that are controlled to create a phased array. The controller may manipulate the ultrasound waves being emitted to cause constructive / destructive interference with each other. This can allow the controller to “point”, “move”, and / or “steer” the acoustic wave’s most intense point. Hence, the controller may change the acoustic wave’s most intense point to, for example, push / draw fluid from the renal cortex to the renal medulla.

[0129] In some examples, one or more sensors may be included in the ultrasound transducer 132. Any of the sensors disclosed in this specification may be included, including a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels, a sensor 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 a surface of the perfusion passage 132A to contact blood / fluid as it passes through.

[0130] The ultrasound transducer 132 may be configured to produce a variety of different ultrasound acoustic frequencies. In one example, the ultrasound transducer 132 may produce frequencies sufficient to create sonoporation within the renal cell membranes to increase fluid flow through the kidney 10. Sonoporation may generally occur at a frequency in an inclusive range of about 0.25 MHz to 3.5 Mhz. In one specific example, sonoporation may be performed within an inclusive range of about 160 kHz to about 360 kHz (e.g., about 260 kHz). In another example, microvibrations may be generated within an inclusive range of about 20 Hz to about 4,500 Hz. A variety of different wave forms are also possible, such as sine waves, triangular waves, square waves, sawtooth waves or similar combinations and variations. Typically, an ultrasound transducer 132 of a relatively small size as shown may be currently capable of producing about 0.1 W / cmA2 to 1 W / cmA2 of acoustic energy density, though further improvements to this technology may provide further energy density improvements. Additionally, two or more ultrasound transducers 132 may also be used to further increase acoustic energy density and therefore further stimulate / improve kidney function. A variety of differentwave forms are also possible, such as sine waves, triangular waves, square waves, sawtooth waves or similar combinations and variations.

[0131] In another example, the ultrasound transducer 132 may produce frequencies sufficient to create transient nerve block to the kidney 10. Typically, such frequencies may occur at a frequency in an inclusive range of about 1 to 3 Mhz and about 0.1 W / cmA2 to 1 W / cmA2 of acoustic energy density. Typically, relatively high acoustic intensities can inhibit nerve signal conduction. Relatively low intensities can stimulate the nerves. A variety of different wave forms are also possible, such as sine waves, triangular waves, square waves, sawtooth waves or similar combinations and variations.

[0132] As seen in Figs. 4 and 5, the ultrasound transducer 132 may be implanted within the renal vein 12 at a location near the kidney 10. Fig. 6 illustrates another implantation location of the ultrasound transducer 132 within the renal artery 14 at a location near the kidney 10. Again, the perfusion passage 132A may allow blood to pass out of the kidney 10.

[0133] Fig. 7 illustrates another implantation location of the ultrasound transducer 132 within both the major calyxes 34 and minor calyxes 36. However, depending on the size of the ultrasound transducer 132, it may be positioned solely in either the major calyxes 34 or the minor calyxes 36. The ultrasound transducer 132 may also be positioned within the ureter 26, such as near the kidney 10, where the perfusion passage 132A allows urine to pass through.

[0134] In some examples, 1 , 2, 3, 4, or more ultrasound transducer 132 may be used and connected to the controller in any combination of positions described in this specification, such as the renal artery 14, the renal vein 12, locations within the kidney 10 (e.g., major calyxes 34, minor calyxes 36, interlobular veins 18, interlobular arteries 22, arcuate vein 16, arcuate arteries 20, etc.), the ureter 26, or similar locations. Alternatively or additionally, one or more of the ultrasound transducers 132 may be used with any of the other energy distribution devices disclosed in this specification, such as thosedescribed with regard to sonoporation, electroporation, transient nerve block, or other variations.

[0135] In some examples, the ultrasound transducer 132 may have a diameter sized to fit within a renal vein 12, such as with an inclusive range of about 3 mm to about 20 mm and may have a length within an inclusive range of about 17 mm to about 75 mm. These sizes may allow it to fit within some of the other (i.e., non-renal vein 12) example locations specified as well. In some examples, the perfusion passage 132A may have a diameter within an inclusive range of about 2 mm to about 18 mm.

[0136] In addition to those previously discussed, certain locations and structures may be particularly helpful for creating transient nerve block to a kidney 10. For example, Fig. 8 illustrates a cross-sectional view of a kidney 10 with an energy distribution device 140 implanted nearby. The energy distribution device 140 may comprise a stent-like structure 142 that includes one or a plurality of electrodes 142A. The plurality of electrodes 142A may be connected to a first electrical wire 144 and a second electrical wire 146 that are both connected to a controller located within / on a patient’s body.

[0137] Most of the nerves leading to a kidney 10 extend from the aorticorenal ganglia along the renal plexus, and then to the kidney 10. In that respect, most of the nerves controlling a kidney 10 pass along the renal artery 14. The stent-like structure 142 may be particularly effective when implanted at a location within the renal artery 14 due to its proximity to these renal nerves for transient nerve block.

[0138] Alternatively, the ultrasound transducer 132 may instead be an intravascular lithotripsy device 192, as seen in Fig. 21 , such as the C2 Shockwave Medical Coronary IVL system (Shockwave Medical) that is used for Intravascular Lithotripsy (IVL). An Intravascular Lithotripsy device 192 may comprise a power supply (e.g., within the controller); a connector cable, lithotripsy emitters 194, and a balloon 196 positioned around the lithotripsy emitters 194. Lithotripsy emitters 194 may produce electric sparks that create vapor bubbles in the surrounding fluid medium in the balloon 196. This electric energy may lead to the formation and rapid expansion of vapor bubbles, resulting inacoustic pressure waves that radiate circumferentially and transmurally in an unfocused manner. When applied to the kidney (e.g., through the renal vein or within the kidney), the appropriate level of shock wave energy may also modify tissue to stimulate kidney function. While not shown in Fig. 21 , the intravascular lithotripsy device 192 may have a perfusion lumen extending longitudinally through it similar to the ultrasound transducer 132. Additionally, the intravascular lithotripsy device 192 may be placed in any of the locations previously described in this specification, such as the renal artery 14, the renal vein 12, locations within the kidney 10 (e.g., major calyxes 34, minor calyxes 36, interlobular veins 18, interlobular arteries 22, arcuate vein 16, arcuate arteries 20, etc.), the ureter 26, or similar locations.

[0139] As previously discussed, the stent-like structure 142 may have a plurality of electrodes 142A. These plurality of electrodes 142A may be located along an outer surface of the 142, an inner surface of the stent-like structure 142 (e.g., a surface of its internal lumen), or woven / incorporated within a layer of the stent-like structure 142.

[0140] In some examples, one, some, or all of the plurality of electrodes 142A may be circular loop shapes of similar size to a circumference or inner lumen diameter of the stent-like structure 142. In other examples, the plurality of electrodes 142A may be other shapes, such as a part circular shape, elongated strips extending partially or fully along a length of the stent-like structure 142, or discrete tubular segments of the stent-like structure 142.

[0141] In some examples, the stent-like structure 142 may be a woven / braided tubular structure or laser-cut tubular structure. In another example, the stent-like structure 142 may be composed longitudinal structs connecting the plurality of electrodes 142A in the form of a plurality of loops.

[0142] In some examples, the stent-like structure 142 may have a radially expanded diameter sized to fit within the renal vein 12. In some examples, this diameter falls within an inclusive range of about 3 mm to about 20 mm.

[0143] The plurality of electrodes 142A may have several different configurations. For example, the plurality of electrodes 142A may comprise a first electrode and a second electrode that are each positioned near opposite ends of the stent-like structure 142 and that are connected to different wires such that each electrode may be configured to have different polarity (e.g., positive / negative). If three or more electrodes are included, the electrodes may have positions that alternate in polarity along the length of the stent-like structure 142 or may have uneven numbers of the two polarities (e.g., three positive electrodes and one negative / ground electrode).

[0144] The controller may be connected to the stent-like structure 142 and may provide electrical current sufficient to create transient nerve block, as discussed elsewhere in this specification.

[0145] Any of the energy distribution devices from this specification may be connected to a controller that powers and / or controls operation of the energy distribution devices. In some examples, the controller may have a housing, a power source (e.g., a battery), a processor configured to execute software code, memory configured to store software code, and an interface connected via electrical wire to the energy distribution device or devices.

[0146] The power source of the controller may be wirelessly recharged. For example, Fig. 9 illustrates a human body and a treatment system 160. The treatment system 160 may comprise a controller 162 implanted within the patient (in this example, within an abdomen of the patient) and a wireless charging system 164. The wireless charging system 164 may, for example, charge the power source (e.g., battery) of the controller 162 via induction (e.g., coils in both devices). Alternatively, the controller 162 may include a charging wire that passes through the patient’s skin and allows a power source to be connected to it.

[0147] The controller may be implanted in a variety of different locations, especially subcutaneously. For example, the controller 162 in Fig. 9 is implanted within an abdomen of a patient. In another example, Fig. 10 illustrates a treatment system 170 in which acontroller 162 is implanted in an upper portion of the patient’s trunk, such as beneath skin and near a clavicle (e.g., similar to a pacemaker placement). In another example, Fig. 11 illustrates a treatment system 180 in which a controller 162 is implanted under the skin of the buttocks or at the iliac crest.

[0148] The energy distribution devices and their respective wires may be implanted in a number of different ways, including via a catheter delivery device. For example, Fig. 12 illustrates a physician accessing a femoral artery 22 or a femoral vein (not shown) with a delivery device catheter 50. A distal end of the delivery device catheter 50 may be advanced to one or more of the locations described elsewhere in this specification, such as the renal artery 14, the renal vein 12, locations within the kidney 10 (e.g. , major calyxes 34, minor calyxes 36, interlobular veins 18, interlobular arteries 22, arcuate vein 16, arcuate arteries 20, etc.), the ureter 26, or similar locations.. If the energy distribution devices are placed within the ureter, a catheter delivery device may be advanced up the ureter until it reaches a desired location, such as near the kidney 10.

[0149] As previously discussed, any of the energy distribution devices of this specification (including any of their implantation locations), may be implanted in or near only one kidney 10 or both kidneys 10. For example, Fig. 13 illustrates an energy distribution device 130 with an ultrasound transducer 132 placed in each renal vein 12 of each of the two kidneys 10. Similarly, Fig. 14 illustrates an energy distribution device 120 with a plurality of electrical wires (e.g., a first electrical wire 102, a second electrical wire 104, a third electrical wire 106) placed in various areas (e.g., arteries, veins, calyxes, etc.) of each of the kidneys 10. Similarly, Fig. 15 illustrates an energy distribution device 140 with a stent-like structure 142 placed in each renal vein 12 of each of the kidneys 10. In some of these examples, the electrical wires connecting to the controller may split at the inferior vena cava or similar vessel location, depending on the configuration.

[0150] As also discussed, any combination of the energy distribution devices of this specification may be used in combination with each other. Fig. 16 illustrates one example of kidneys 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, second electrical wire 104, third electrical wire 106)as well as the energy distribution device 130 comprising one or more of the ultrasound transducers 132. These devices may be connected to the same controller implanted elsewhere in the patient and both energy distribution device 120 and energy distribution device 130 may be operated simultaneously, at different times, or at overlapping times.

[0151] Fig. 17 illustrates another example of kidney 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, second electrical wire 104, third electrical wire 106) as well as the energy distribution device 140 comprising one or more stent-like structures 142. These devices may be connected to the same controller implanted elsewhere in the patient and both energy distribution device 120 and energy distribution device 140 may be operated simultaneously, at different times, or at overlapping times.

[0152] Fig. 18 illustrates another example of kidney 10 with the energy distribution device 130 comprising one or more ultrasound transducers 132 as well as the energy distribution device 140 comprising one or more stent-like structures 142. These devices may be connected to the same controller implanted elsewhere in the patient and both energy distribution device 130 and energy distribution device 140 may be operated simultaneously, at different times, or at overlapping times.

[0153] Fig. 19 illustrates another example of a kidney 10 with the energy distribution device 120 comprising a plurality of electrical wires (e.g., first electrical wire 102, second electrical wire 104, third electrical wire 106), energy distribution device 130 comprising one or more ultrasound transducers 132, as well as the energy distribution device 140 comprising one or more stent-like structures 142. These devices may be connected to the same controller implanted elsewhere in the patient and both energy distribution device 120 and energy distribution device 140 may be operated simultaneously, at different times, or at overlapping times.

[0154] While most of the examples, discussed in this application are directed to energy distribution devices that are completely internal to the patient, some partially external devices are also possible. For example, Fig. 20 illustrates a transcutaneous energydistribution device 190 (generally similar to energy distribution device 110) in which the first electrical wire 102 and the second electrical wire 104 are placed or implanted through the skin and into the kidney 10 transcutaneously at any of the locations discussed in this specification for other energy distribution devices. Ultrasound and nerve blocking examples may also be delivered transcutaneously in a similar manner. The wires 102 / 104 and / or electrodes 102A / 104A may be needles or similar instruments.

[0155] The partially external energy distribution device 190 may be particularly useful for acute treatment (e.g., for several minutes or hours during an existing procedure). In such an example, the controller and wires may remain outside the body and only portions of the wires / electrodes may be advanced into a patient (e.g., in a kidney 10, near a kidney 10, or in an area that may control aspects of kidney performance). For example, too much of a drug or similar agent may be administered to a patient during procedure or prior to a procedure, or a patient may have an adverse reaction to a drug / agent. One specific example of this is contrast-induced nephropathy in which a sudden change in kidney function occurs during angiography or other interventional procedures, primarily because of contrast-induced acute kidney injury or contrast-induced nephropathy. Increasing the kidney activity to help clear the drug / agent (e.g., contrast) may reduce any potential complications. One example method may include performing a medical procedure on a patient, determining that improved kidney performance may be helpful to the procedure, at least partially inserting an energy distribution device 190 into a patient, activating a controller connected to the energy distribution device 190 outside the patient, and applying energy with 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 stimulated kidney function is no longer needed.

[0156] The treatment systems described in this specification may be used for various methods of treatment of a patient. For example, a general method may include activating one or more of any of the energy distribution devices of this specification that are implanted within a patient at any of the locations disclosed in this specification. Again,the activation may include producing electrical current within one or more kidneys to create electroporation, producing acoustic ultrasound waves / energy to produce sonoporation, or producing electrical current within a renal vein or renal artery to produce transient nerve block of the one or more kidneys.

[0157] The treatment systems described in this specification may be used for various methods of treatment of a patient with measured sensor data. For example, Fig. 22 illustrates a flow chart of a method of treatment. Specifically, the method may comprise performing a measurement with a sensor on a patient in step 200, comparing sensor data from the measurement to a threshold in step 202, and activating an energy distribution device within the patient and within or near one or more kidneys of the patient in step 204.

[0158] Referring first to step 200, a measurement may be performed in several different ways. In one example, a device separate from a treatment device may be used to perform a measurement. The measurement may be performed by one or more of a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels (e.g., in the 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, sensor for sensing kidney electrical signals, a pH sensor, and similar sensors; any of which may be directly implanted and connected / integrated with the controller or energy distribution device. In other examples the sensor data may be input via a user or physician or either a patient or physician may specify operational runtimes, levels, and similar functionality (e.g., via a phone app or other wireless device that communicates with a controller). Alternatively, a controller from the present specification may include a similar sensor or be wired / wirelessly connected to such a sensor. Hence, the controller may be configured to store measured sensor data of the patient.

[0159] Referring to step 202, the sensor data from the measurement may be compared to a threshold. The threshold may be a specific predetermined value, a relative value (e.g., a relative increased or decreased value based on a prior sensor reading), apercentage value, a value based on other factors (e.g., time of day, activity level, etc.), a range, or similar values. The threshold may also be only a single measured sensor value type (e.g., just blood pressure) or thresholds for several measured sensor types / values (e.g., a blood pressure threshold and a blood glucose threshold that both must be met to trigger therapeutic activity of the system). Several thresholds for a single type of sensor measurement may also be possible, where different thresholds result in different lengths of treatments and / or strengths of treatment (e.g., step 204). Hence, the severity of the sensor measurement may be correlated with a length of treatment time and / or treatment strength. In some examples, the controller may compare the sensor data to determine if it meets / exceeds a threshold.

[0160] Referring to step 204, if the threshold (or thresholds) are met by the measured sensor data, the controller may activate the energy distribution device(s) that are within or near one or more kidneys. As previously discussed in this specification, activation of the energy distribution device(s) may include producing electroporation within one or more kidneys, producing ultrasound (e.g., sonoporation) within one or more kidneys, and / or creating transient electrical nerve block to one or more kidneys. Again, the energy distribution device(s) may all be at least partially implanted within or near (e.g., adjacent to) one or more kidneys. The activation of the energy distribution device(s) may continue until a subsequent sensor measurement produces a data value that is below the threshold(s). Additionally or alternatively, the activation may proceed for a predetermined period of time. Some of the treatments discussed in this specification may produce durable treatment effects that last beyond the activation time of the energy distribution device. Hence, these trailing therapeutic effects may be factored into any treatment lengths and for purposes such as maintaining power efficiency to maximize battery life (e.g., determining a desired treatment effect, determining an active treatment time and non-active treatment time, and then activating the energy distribution device for only the active treatment time).

[0161] In some examples, the sensor measurement may be performed periodically (e.g., at regular time intervals such as hourly or daily).

[0162] Fig. 23 illustrates another treatment method that may be used with any or several of the treatment systems described in this specification. In step 210, a baseline level of treatment / therapy (e.g., a first treatment level) may be performed with any or several of the treatment systems described in this specification. This step may occur after initial testing by a physician determining that the patient may benefit from implantation of one of the treatment systems of this specification. This step may be continuous or periodic.

[0163] After a period of time (e.g., hours, days, weeks), one or more sensors may perform measurements on one or more aspects of the patient and that data may be analyzed. Any of the sensor values described in this specification may be used and the sensors may be on a specific energy distribution device, the controller, connected to the controller, or separate from the controller. The analysis may be similar to that of Fig. 22 in which various measurements are compared against a threshold and / or are compared against prior measurements to determine if the measured data is improving. The controller may perform this analysis, a separate device / application may perform this analysis (e.g., a phone / app), and / or a physician may perform this analysis and manually control the controller.

[0164] In step 214, if the measured data meets a predetermined threshold and / or is improved over prior measurements, the baseline level of therapy continues to be performed as in step 210 and periodic measurements are further taken and analyzed as in step 212.

[0165] In step 216, if the measured data does not meet a predetermined threshold and / or is not improving over prior measurements, an increasing level of therapy (e.g., a second treatment level higher than the first treatment level) may be performed. This may take the form of more frequent activation of the energy distribution device and / or activating the energy distribution device at a higher performance level (e.g., higher energy level, higher energy frequency, etc.).

[0166] In step 218, the process returns to step 212 periodically to measure and analyze data from one or more sensors. Depending on this data, steps 214 / 210 or 216 are returned to. Hence, the treatment system may utilize sensor data to maintain a certain treatment level (e.g., treatment time, frequency, or energy characteristic) or increase the treatment level based on data from one or more sensors.

[0167] In any of the examples discussed in this specification, the therapeutic effect may be confirmed via contrast injection / visualization of the bladder, chemical tests, electronic sensor measurements, or measurement on the amount of urine excreted by the patient.

[0168] While electrical wires are discussed in this specification between energy distribution devices and a controller, these electrical wires may also be catheters or similar devices. In other words, they may include electrically conductive elements but also additional structural reinforcement found in some catheters. However, any electrically conductive element with an insulative jacket, coating, or similar material is possible.

[0169] While several examples discussed in this specification disclose and illustrate multiple discrete electrical wires, these wires may be incorporated into a single physical wire. In other words, a device may be connected to a single physical wire with a plurality of electrically isolated conductive wires within an insulated outer sleeve.

[0170] The treatment systems and methods described in this specification may be particularly helpful for treating end stage kidney disease, cardiorenal heart failure, hypertension, and similar diseases. These treatment systems may also be used to improve renal blood flow and for weight loss (e.g., diabetic management, glucose excretion, etc.).

[0171] The treatment systems of the present specification may include a controller connected to a single energy distribution device comprising electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system of the present specification may include a controller connected to any two energy distribution devicescomprising electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system of the present specification may include a controller connected to any three energy distribution devices comprising electrodes, an ultrasound transducer, or an intravascular lithotripsy device. The treatment system of the present specification may include a controller connected to any four energy distribution devices comprising electrodes, an ultrasound transducer, or an intravascular lithotripsy device.

Claims

What is claimed is:1 . A treatment system, comprising: an energy distribution device configured for chronic implantation within a patient; the energy distribution device having an active 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 electrical current to the energy distribution device.

2. The treatment system of claim 1 , wherein the energy distribution device comprises a first electrical wire having a first electrode and a second electrical wire having a second electrode.

3. The treatment system of claim 2, wherein the energy distribution device comprises a third electrical wire having a third electrode.

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

5. The treatment system of claim 4, wherein the controller supplies electrical current at a frequency within an inclusive range of about 1 to 10 Hz.

6. The treatment system of claim 5, wherein the controller supplies electrical energy sufficient to produce an electric field within an inclusive range of about 100 V / cm to 3,000 V / cm.

7. The treatment system of claim 2, wherein the controller supplies electrical current to at least the first electrical wire and the second electrical wire that produces transient nerve block near the first electrode and the second electrode.

8. The treatment system of claim 7, wherein the controller supplies electrical current within an inclusive range of 1-80 kHz, at amplitudes within an inclusive range of about 0- 20 mA, and 0-20 Vpp.

9. The treatment system of claim 8, wherein the first electrode and the second electrode are connected to a stent-like structure.

10. The treatment system of claim 9, wherein the stent-like structure has a radially expanded diameter within an inclusive range of about 3 mm to about 20 mm.

11. The treatment system of claim 10, wherein the stent-like structure comprises a plurality of electrodes, including the first electrode and the second electrode, that alternate in polarity along a length of the stent-like structure.

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

13. The treatment system of claim 1 , wherein the energy distribution device comprises an ultrasound transducer.

14. The treatment system of claim 13, wherein the energy distribution device has a diameter within an inclusive range of about 3 mm to about 20 mm.

15. The treatment system of claim 13, further comprising a perfusion passage extending between ends of the ultrasound transducer.

16. The treatment system of claim 15, wherein the perfusion passage has a diameter within an inclusive range of about 2 mm to about 18 mm.

17. The treatment system of claim 13, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 0.25 MHz to 3.5 Mhz.

18. The treatment system of claim 13, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 160 kHz to about 360 kHz.

19. The treatment system of claim 13, wherein the ultrasound transducer produces acoustic frequency within an inclusive range of about 20 Hz to about 4,500 Hz.

20. The treatment system of claim 13, wherein the ultrasound transducer comprises an assembly of two or more discrete transducers forming a phased array and configured to cause constructive / destructive interference with each other to direct ultrasound energy.21 . The treatment system of claim 13, further comprising one or more of the following sensors in communication with or incorporated into the controller: a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels, and / or a sensor measuring glucose levels.

22. The treatment system of claim 13, wherein the controller and ultrasound transducer are configured to create sonoporation with the ultrasound transducer.

23. The treatment system of claim 22, wherein the controller and ultrasound transducer are configured to create transient nerve block to one or more kidneys.

24. The treatment system of claim 1 , wherein the energy distribution device comprises an intravascular lithotripsy device.

25. The treatment system of claim 24, wherein the intravascular lithotripsy device comprises a balloon on a catheter and one or more lithotripsy emitters positioned within the balloon.

26. A method of treating a patient, comprising: implanting a first energy distribution device within a patient; implanting a controller within the patient;chronically supplying energy from the controller to the first energy distribution device to stimulate kidney activity.

27. The method of claim 26, wherein implanting the first energy distribution device within a patient comprises implanting the first energy distribution device within a first renal artery, a first renal vein, a first major calyx, a first minor calyx, a first interlobular vein, a first interlobular artery, a first arcuate vein, a first arcuate arteries, or a first ureter.

28. The method of claim 27, further comprising implanting a second energy distribution device within a patient, wherein implanting the first energy distribution device within a patient comprises implanting the energy distribution device within the first renal artery, the first renal vein, the first major calyx, the first minor calyx, the first interlobular vein, the first interlobular artery, the first arcuate vein, the first arcuate arteries, the first ureter, a second renal artery, a second renal vein, a second major calyx, a second minor calyx, a second interlobular vein, a second interlobular artery, a second arcuate vein, a second arcuate arteries, or a second ureter.

29. The method of claim 27, wherein implanting the first energy distribution device within a patient comprises implanting at least a first electrode and a second electrode within a lumen of a kidney, tissue of a kidney, a renal vein, a renal artery, or a ureter.

30. The method of claim 27, wherein the first energy distribution device is a stent comprising 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 of claim 26, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity comprises performing electroporation within a first kidney.

32. The method of claim 31 , wherein supplying energy comprises supplying electrical current to the first energy distribution device at a frequency within an inclusive range of about 1 to 10 Hz.

33. The method of claim 32, wherein supplying energy comprises supplying electrical current to the first energy distribution device to create an electric field within an inclusive range of about 100 V / cm to 3,000 V / cm.

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

35. The method of claim 34, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity comprises supplying electrical current within an inclusive range of 1 -80 kHz, at amplitudes within an inclusive range of about 0-20 mA, and 0-20 Vpp.

36. The method of claim 35, wherein supplying energy further comprises supplying electrical current to a renal artery and blocking nerve signals to the first kidney.

37. The method of claim 36, wherein implanting the first energy distribution device further comprises implanting a stent comprising at least a first electrode and a second electrode; wherein the stent has a radially expanded state with a diameter within an inclusive range of about 3 mm to about 20 mm.

38. The method of claim 27, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity comprises creating an electric field that produces sodium / potassium pump stimulation.

39. The method of claim 26, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity comprises creating ultrasound within the first kidney with a first ultrasound transducer to produce sonoporation.

40. The method of claim 39, wherein creating ultrasound within the first kidney comprises creating acoustic frequency within an inclusive range of about 0.25 MHz to 3.5 Mhz.

41. The method of claim 39, wherein creating ultrasound within the first kidney comprises creating acoustic frequency within an inclusive range of about 160 kHz to about 360 kHz.

42. The method of claim 41 , wherein creating ultrasound within the first kidney comprises operating a phased array of at least the first ultrasound transducer and a second ultrasound transducer of the energy distribution device to cause constructive / destructive interference with each other to direct ultrasound energy.

43. The method of claim 26, wherein supplying energy from the controller to the first energy distribution device to stimulate kidney activity comprises creating ultrasound with a first ultrasound transducer to produce transient nerve block to 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 comprises creating shockwaves within the first kidney with intravascular lithotripsy device.

45. The method of claim 26, further comprising implanting a second energy distribution device within a patient and chronically supplying energy from the controller to the second energy distribution device.

46. The method of claim 45, wherein the first energy distribution device stimulates a first kidney and a second energy distribution device stimulates a second kidney.

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

48. A method of treating a patient, comprising: implanting a first energy distribution device within a patient; implanting a controller within the patient; performing a measurement with a sensor in a patient; comparing sensor data from the measurement to a first threshold; activating an energy distribution device chronically implanted within the patient to stimulate kidney activity when the first threshold is triggered by the sensor data.

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

50. The method of claim 49, wherein performing the measurement with the sensor is performed by a blood pressure sensor, a sensor measuring sodium concentration, a sensor measuring protein levels (e.g., in the 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, sensor for sensing kidney electrical signals, a pH sensor, and similar sensors.

51. The method of claim 50, wherein the sensor is integrated with the controller, with the energy distribution device, or in a location away from the controller or energy distribution device.

52. The method of claim 51 , wherein activating the energy distribution device comprises performing electroporation, sonoporation, or transient nerve blocking with the energy distribution device.

53. A method of treating a patient, comprising: activating an energy distribution device at a first treatment level where the energy distribution device is chronically implanted within a patient;performing a measurement with a sensor in a patient; analyzing sensor data from the measurement; if the measurement meets a predetermined threshold and / or is improved over prior sensor measurements, the first treatment level is continued with the energy distribution device; if the measurement does not meet a predetermined threshold and / or is not improved over prior sensor measurements, the energy distribution device is activated at a second treatment level that is higher than the first treatment level.

54. The method of claim 53, wherein the second treatment level comprises more frequent activations of the energy distribution device, activating the energy distribution device at a higher performance level, or both.

55. The method of claim 54, wherein the first treatment level and the second treatment level comprise creating electroporation or sonoporation within a kidney of the patient.

56. The method of claim 54, wherein the first treatment level and the second treatment level comprise creating transient nerve block to renal nerves between a central nervous system and a kidney of a patient.

57. A method of treating a patient, comprising: performing a first medical procedure on a patient; determining that improved kidney performance may be helpful to the first procedure; at least partially inserting an energy distribution device into a patient; activating a controller connected to the energy distribution device outside the patient; and, applying energy with the energy distribution device to improve kidney function.

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