# US 2018/0021574 A1 · Methods and Apparatus for Multi-Vessel Renal Neuromodulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021574 A1 - Document ID: US20180021574A1 - Status: Published application - Kind: A1 - Application number: 15/689,608 - Filed: 2017-08-29 - Published: 2018-01-25 - Earliest claimed: 2004-10-05 - Assignees: Medtronic Ardian Luxembourg S.a.r.l. - Applicants: Medtronic Ardian Luxembourg S.a.r.l. - Inventors: Denise Zarins - Web page: https://patentgrep.com/patent/US20180021574A1 ## CPC - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61B 18/1206: {Generators therefor} - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/205: {for promoting a biological process} - A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation} - A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system} - A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)} - A61N 1/36117: {for treating hypertension} - A61B 2018/0022: {Balloons} - A61B 2018/00267: {having a basket shaped structure} - 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 7/10: Cooling bags, e.g. ice-bags - A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels} - A61N 1/0507: {Electrodes for the digestive system} - A61N 1/0558: {Anchoring or fixation means therefor} - A61N 1/323: {Interference currents, i.e. treatment by several currents summed in the body} - A61N 1/326: {for promoting growth of cells, e.g. bone cells} - 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) - 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) ## Abstract Methods and apparatus are provided for multi-vessel neuromodulation, e.g., via a pulsed electric field. Such multi-vessel 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, the multi-vessel neuromodulation is applied to neural fibers that contribute to renal function. Such multi-vessel neuromodulation optionally may be performed bilaterally. ## Claims ### Claim at position 1 1-32. (canceled) ### Claim 33 A method of assessing efficacy of a renal neuromodulation procedure in a human patient, the method comprising: determining a baseline level of one or more biomarkers in plasma or urine collected from the patient; attenuating neural traffic along a renal nerve of the patient via energy delivery from an intravascularly-positioned neuromodulation assembly; determining a post-neuromodulation level for the biomarker(s) in plasma or urine collected from the human patient; and comparing the post-neuromodulation level to the baseline level, wherein the neuromodulation procedure is classified as at least partially successful if the post-neuromodulation level differs from the baseline level. ### Claim 34 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes a catecholamine. ### Claim 35 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes norepinephrine. ### Claim 36 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes norepinephrine in urine collected from the human patient. ### Claim 37 (depends on 33) The method of claim 33 wherein: determining a baseline level of one or more biomarkers includes determining a baseline level of one or more catecholamines in urine collected from the human patient; and determining a post-neuromodulation level for the biomarker(s) includes determining a post-neuromodulation level of the one or more catecholamines in urine collected from the human patient. ### Claim 38 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes norepinephrine in plasma collected from the human patient. ### Claim 39 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes total sodium excreted in urine collected from the human patient. ### Claim 40 (depends on 33) The method of claim 33 wherein the one or more biomarkers includes renin in plasma collected from the human patient. ### Claim 41 (depends on 33) The method of claim 33 wherein the baseline level is higher than the post-neuromodulation level. ### Claim 42 (depends on 33) The method of claim 33 wherein the baseline level is lower than the post-neuromodulation level. ### Claim 43 (depends on 33) The method of claim 33 wherein attenuating neural traffic along a renal nerve of the patient comprises ablating the renal nerve via energy delivery from the neuromodulation assembly. ### Claim 44 (depends on 33) The method of claim 33 wherein attenuating neural traffic along a renal nerve of the patient via energy delivery comprises delivering radio frequency (RF) energy via the neuromodulation assembly. ### Claim 45 (depends on 33) The method of claim 33 wherein the neuromodulation assembly is intravascularly positioned within a renal blood vessel of the patient, and wherein attenuating neural traffic along the renal nerve of the patient comprises delivering an electric field sufficient to at least partially ablate the renal nerve from within the renal blood vessel. ### Claim 46 (depends on 33) The method of claim 33 wherein the neuromodulation assembly comprises an intravascularly positioned catheter carrying a first electrode positioned at least proximate to the renal nerve within a first portion of a renal artery of the patient and a second electrode positioned within a second portion of the renal artery, and wherein the first and second portions of the renal artery are in different locations and are both connected to the same kidney of the human patient. ### Claim 47 (depends on 33) The method of claim 33 wherein the neuromodulation assembly is intravascularly positioned within a renal blood vessel of the patient, and wherein attenuating neural traffic along a renal nerve of the patient comprises thermally modulating the renal nerve via energy delivery from the neuromodulation assembly within the renal blood vessel. ### Claim 48 A method of assessing efficacy of a renal neuromodulation procedure in a human patient, the method comprising: transluminally positioning a catheter within a target renal blood vessel of the patient and adjacent to target neural fibers innervating a kidney of the patient; delivering an electric field via one or more electrodes of the catheter to induce renal neuromodulation; determining a post-neuromodulation level for one or more biomarker(s) in plasma or urine collected from the patient following the renal neuromodulation procedure, wherein the level of biomarker(s) directly or indirectly correlates with sympathetic nervous activity in the patient; and comparing the post-neuromodulation level to a pre-determined threshold level for the biomarker(s), wherein the renal neuromodulation procedure is classified as at least partially successful if the post-neuromodulation level is less than the pre-determined threshold level. ### Claim 49 (depends on 48) The method of claim 48 wherein the one or more biomarker(s) includes a catecholamine. ### Claim 50 (depends on 48) The method of claim 48 wherein the one or more biomarkers includes norepinephrine in plasma collected from the patient. ### Claim 51 (depends on 48) The method of claim 48 wherein the one or more biomarkers includes norepinephrine in urine collected from the patient. ### Claim 52 (depends on 48) The method of claim 48 wherein the one or more biomarkers includes renin in plasma collected from the patient. ### Claim 53 (depends on 48) The method of claim 48 wherein transluminally positioning a catheter within a target renal blood vessel of the patient comprises positioning a first electrode carried by the catheter within a first part of the renal blood vessel or a first vessel branching from the renal blood vessel, and wherein the method further comprises: positioning a second electrode carried by the catheter within a second part of the renal blood vessel, the first vessel branching from the renal blood vessel, or a second, different vessel branching from the renal blood vessel, wherein the second electrode is positioned in a location different from the first electrode; and delivering an electric field via one or more electrodes comprises delivering the electric field from the first and second electrodes of the catheter to induce renal neuromodulation in the patient. ### Claim 54 (depends on 48) The method of claim 48 wherein the pre-determined threshold level is a baseline level for the biomarker(s) collected from the patient prior to the renal neuromodulation procedure. ### Claim 55 (depends on 48) The method of claim 48 wherein the level of biomarker(s) directly or indirectly correlates with blood pressure in the patient.