# US 9,439,726 B2 · Methods for therapeutic renal neuromodulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,439,726 B2 - Document ID: US9439726B2 - Status: Granted - Kind: B2 - Application number: 15/069,830 - Filed: 2016-03-14 - Published: 2016-07-07 - Granted: 2016-09-13 - Earliest claimed: 2002-04-08 - Assignees: Medtronic Ardian Luxembourg S.a.r.l. - Applicants: Medtronic Ardian Luxembourg S.a.r.l. - Inventors: Denise Zarins; Hanson Gifford, III; Mark Deem; Douglas Sutton; Howard R. Levin; Mark Gelfand - Web page: https://patentgrep.com/patent/US9439726B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61F 7/12: Devices for heating or cooling internal body cavities - A61M 5/14276: {specially adapted for implantation} - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation} - A61N 1/36017: {with leads or electrodes penetrating the skin} - A61N 1/36117: {for treating hypertension} - A61N 1/36121: {Production of neurotransmitters; Modulation of genes expression} - A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092}) - A61N 7/02: Localised ultrasound hyperthermia - A61B 2018/0022: {Balloons} - A61B 2018/00267: {having a basket shaped structure} - A61B 2018/00351: {Heart} - A61B 2018/00404: {Blood vessels other than those in or around the heart} - A61B 2018/00434: {Neural system} - A61B 2018/00511: {Kidney} - A61B 2018/00577: {Ablation} - A61B 2018/00613: {Irreversible electroporation} - A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels} - A61M 2210/1082: Kidney - A61M 2210/12: Blood circulatory system - A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)} - A61N 2007/0021: {Neural system treatment} - A61N 2007/003: {Destruction of nerve tissue} - A61N 2007/025: {interstitial} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Methods and apparatus are provided for treating hypertension, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney. ## Claims ### Claim 1 A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising: positioning a nerve modulation device within renal vasculature of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and reducing neural communication to and from the kidney by at least partially ablating the neural fibers of the patient via the nerve modulation device, wherein the kidney continues to secrete renin in the patient after reducing neural communication with the nerve modulation device, wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient. ### Claim 2 (depends on 1) The method of claim 1 wherein positioning a nerve modulation device within renal vasculature comprises positioning the nerve modulation device within a renal artery of the patient. ### Claim 3 (depends on 1) The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises heating afferent and efferent renal nerves of the patient with RF energy delivered via the nerve modulation device. ### Claim 4 A method for treating a human patient with diagnosed hypertension, the method comprising: positioning a nerve modulation device within a renal blood vessel of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and directing a neuromodulatory energy from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney, wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient, wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device. ### Claim 5 (depends on 4) The method of claim 4 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient. ### Claim 6 A method for treatment of a human patient via renal denervation, the method comprising: positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and directing a neuromodulatory energy from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney, wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient. ### Claim 7 (depends on 6) The method of claim 6 wherein the neuromodulatory energy comprises RF energy. ### Claim 8 A method for catheter-based renal neuromodulation, the method comprising: positioning a catheter having a therapeutic element within a renal artery of a human patient; directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and removing the catheter from the patient after the attenuation of neural traffic to and/or from the kidney. ### Claim 9 (depends on 8) The method of claim 8 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery. ### Claim 10 (depends on 9) The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve. ### Claim 11 (depends on 9) The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve. ### Claim 12 (depends on 8) The method of claim 8 wherein the neuromodulatory energy comprises RF energy. ### Claim 13 (depends on 8) The method of claim 8 wherein: positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and wherein directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient. ### Claim 14 A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising: delivering an energy element to an intravascular location within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and partially ablating the neural fibers of the patient via energy from the energy element, wherein partially ablating the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient. ### Claim 15 A method for treating a human patient with diagnosed hypertension, the method comprising: positioning a nerve modulation device within a renal blood vessel of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and directing one or more neuromodulatory agents or drugs from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney, wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient, wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device. ### Claim 16 (depends on 15) The method of claim 15 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient. ### Claim 17 A method for treatment of a human patient via renal denervation, the method comprising: positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and directing one or more neuromodulatory agents or drugs from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney, wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient. ### Claim 18 A method for catheter-based renal neuromodulation, the method comprising: positioning a catheter having a therapeutic element within a renal artery of a human patient; directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and removing the catheter from the patient after attenuating neural traffic to and/or from the kidney. ### Claim 19 (depends on 18) The method of claim 18 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery. ### Claim 20 (depends on 19) The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve. ### Claim 21 (depends on 19) The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve. ### Claim 22 (depends on 18) The method of claim 18 wherein: positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.