USOO8868188B2 (12) United States Patent (10) Patent No.: US 8,868,188 B2 Hershey (45) Date of Patent: Oct. 21, 2014 (54) METHOD FORTREATING HYPERTENSION 8,019,439 B2 9/2011 Kuzma et al. VAELECTRICAL STIMULATION OF 2007/O150036 A1 6/2007 Anderson 2007. O168004 A1 7, 2007 Walter NEURAL STRUCTURES 2007/O168007 A1 7/2007 Kuzma et al. 2010/0298898 A1* 11/2010 Libbus .............................. 6O7/5 (71) Applicant: Boston Scientific Neuromodulation US Corporation, Valencia, CA (US) OTHER PUBLICATIONS (72) Inventor: Bradley L. Hershey, Valencia, CA (US) Botdorf, J. et al., Hypertension in Cadiovascular and Kidney Disease, O O Cardiorenal Med 2011, 1(3):183-192. (73) Assignee: Boston Scientific Neuromodulation Dibona, G.F. et al., Translational medicine: the antihypertensive Corporation, Valencia, CA (US) effect of renal denervation, Am J Physiol Regul Integr Comp Physiol 298(2): R245-R253 (2010). (*) Notice: Subject to any disclaimer, the term of this Egan, B.M. et al., US Trends in Prevalence, Awareness, Treatment, patent is extended or adjusted under 35 and Control of Hypertension, 1988-2008, JAMA, 303(20): 2043 U.S.C. 154(b) by 0 days. 2050 (May 26, 2010). Fields, L.E. et al., The Burden of Adult Hypertension in the United (21) Appl. No.: 14/026,646 States 1999 to 2000: A Rising Tide, Hypertension, 44(4): 398-404 (2004). (22) Filed: Sep. 13, 2013 (Continued) (65) Prior Publication Data US 2014/OO81345 A1 Mar 20, 2014 Primary Examiner — Nicole F Lavert s (74) Attorney, Agent, or Firm — Vista IP Law Group LLP Related U.S. Application Data (60) Provisional application No. 61/703,609, filed on Sep. (57) ABSTRACT 20, 2012. s A neuromodulation system comprises a sensor configured for (51) Int. Cl. sensing a blood pressure of a patient, modulation output A61N L/00 (2006.01) circuitry configured for conveying electrical modulation A6 IN L/36 (2006.01) energy to at least one electrode, and a controller/processor (52) U.S. Cl coupled to the sensor and the modulation output circuitry. The CPC A61N I/36117 (2013.01); A61N I/36 controller/processor is configured for comparing the blood - - - - - - - - - - - - - - • u. fs (2013.01) pressure sensed by the sensor to a first threshold blood pres USPC 6O7/30 607f5 Sure, and instructing the modulation output circuitry to con (58) Field of Classification search" vey the electrical modulation energy to the at least one elec USPC 60775, 30 trode if the sensed blood pressure is greater than the first . s threshold blood pressure. A method for treating chronic See application file for complete search history. hypertension comprises applying electrical modulation (56) References Cited energy to a neural target site, thereby modulating an afferent nerve innervating a patient's kidney, thereby treating the U.S. PATENT DOCUMENTS chronic hypertension. 6,895,280 B2 5, 2005 Meadows et al. 7,650,184 B2 1/2010 Walter 25 Claims, 9 Drawing Sheets 261) 12 2 2 -10 38 harge es Lead 24StimulationLeads Extensions 18 (es) 82 (e) Percutaneous Extensions 28 External Cable US 8,868,188 B2 Page 2 (56) References Cited Katholi, R. E. et al. The Role of Renal Sympathetic Nerves in Hypertension: Has Percutaneous Renal Denervation Refocused Attention on Their Clinical Significance?, Prog Cardiovasc Dis OTHER PUBLICATIONS 52(3): 243-248 (2009). Larkin, T.M. et al., Acute Renal Failure During a Trial of Spinal Cord Hajjar, I. et al., Trends in Prevalance, Awareness, Treatment, and Stimulation: Theories as to a Possible Connection, Pain Physician, Control of Hypertension in the United States, 1988-2000, JAMA, 11(5): 681-686 (2008). 290(2): 199-206 (Jul. 9, 2003). * cited by examiner U.S. Patent Oct. 21, 2014 Sheet 1 of 9 US 8,868,188 B2 38 14 24 Stimulation Lead Leads N PerCutaneous Extensions - External Cable FIG. 1 U.S. Patent Oct. 21, 2014 Sheet 2 of 9 US 8,868,188 B2 (ILE||ZESE7EGE9E3E| U.S. Patent Oct. 21, 2014 Sheet 3 of 9 US 8,868,188 B2 U.S. Patent Oct. 21, 2014 Sheet 4 of 9 US 8,868,188 B2 100 N FIG. 5 U.S. Patent Oct. 21, 2014 Sheet 5 Of 9 US 8,868,188 B2 114 128a FIG. 6A U.S. Patent Oct. 21, 2014 Sheet 6 of 9 US 8,868,188 B2 U.S. Patent Oct. 21, 2014 Sheet 7 Of 9 US 8,868,188 B2 114 128a FIG. 7 U.S. Patent Oct. 21, 2014 Sheet 8 of 9 US 8,868,188 B2 114 128a FIG. 8 U.S. Patent Oct. 21, 2014 Sheet 9 Of 9 US 8,868,188 B2 1OO N 305 ir FIG. 9 US 8,868,188 B2 1. 2 METHOD FOR TREATING HYPERTENSION Sure may enter into the range of hypertension i.e. greater than VAELECTRICAL STIMULATION OF 140 mm Hg systolic/90 mm Hg diastolic. NEURAL STRUCTURES It has been recognized that the kidneys play a key role in blood pressure regulation, and a number of hypertension RELATED APPLICATION DATA treatment approaches have focused on the kidneys, providing a number of pharmaceutical compounds aimed at promoting The present application claims the benefit under 35 U.S.C. blood to flow through these organs. One treatment option has S119 to U.S. provisional patent application Ser. No. 61/703, been to destroy some or all of the nerves innervating the 609, filed Sep. 20, 2012. The foregoing application is hereby kidneys through ablation, a process in which an ablation incorporated by reference into the present application in its 10 electrode, carried in an instrument such as an endoscope, is entirety. introduced into a patient's vasculature and navigated to a position within the renal artery. Electrical energy, operating at FIELD OF THE INVENTION radio frequencies, is applied to the electrode, resulting in destruction of the renal nerves. This process, of course, is 15 irreversible and carries the possibility of undesirable side The present invention relates to tissue stimulation systems, effects. The process is nonetheless effective in combating and more particularly, to electrical stimulation systems for hypertension. treating hypertension in patients. Thus, a need remains for a process that can ameliorate hypertension without permanently affecting the renal ner BACKGROUND OF THE INVENTION Vous system. Implantable neurostimulation systems have proven thera SUMMARY OF THE INVENTION peutic in a wide variety of diseases and disorders. For example, Spinal Cord Stimulation (SCS) techniques, which In accordance with another aspect of the present inven directly stimulate the spinal cord tissue of the patient, have 25 tions, a neuromodulation system may include a sensor con long been accepted as atherapeutic modality for the treatment figured for sensing a parameter correlatable to blood pressure of chronic neuropathic pain syndromes, and the application of of a patient, modulation output circuitry configured for con spinal cord stimulation has expanded to include additional veying electrical modulation energy to at least one electrode, applications, such as angina pectoralis, peripheral vascular and a controller/processor coupled to the sensor and the disease, and incontinence, among others. Spinal cord stimu 30 modulation output circuitry. The controller/processor is con lation is also a promising option for patients Suffering from figured for comparing the sensed parameter to a first thresh motor disorders, such as Parkinson's Disease, Dystonia and old and instructing the modulation output circuitry to convey essential tremor. the electrical modulation energy to the at least one electrode An implantable SCS system typically includes one or more based on the comparison. If the sensed parameter comprises electrode-carrying stimulation leads, which are implanted at 35 a sensed blood pressure, and the first threshold comprises a a stimulation site in proximity to the spinal cord tissue of the first threshold blood pressure (e.g., 140 mm Hg systolic/90 patient, and a neurostimulator implanted remotely from the mm Hg diastolic), the controller/processor may be configured stimulation site, but coupled either directly to the stimulation for instructing the modulation output circuitry to convey the lead(s) or indirectly to the stimulation lead(s) via a lead exten electrical modulation energy to the electrode(s) if the sensed Sion. The neurostimulation system may further include a 40 blood pressure is greater than the first threshold blood pres handheld patient programmer to remotely instruct the neuro Sure. In one embodiment, the controller/processor may be stimulator to generate electrical stimulation pulses in accor configured for comparing the blood pressure sensed by the dance with selected stimulation parameters. The handheld sensor to a second threshold blood pressure (e.g., a value less programmer may, itself, be programmed by a technician than the first threshold, e.g., in a range of 100-140 mm Hg attending the patient, for example, by using a Clinician’s 45 systolic/60-90 mm Hg), and instructing the stimulation out Programmer (CP), which typically includes a general pur put circuitry to cease conveying the electrical modulation pose computer, such as a laptop, with a programming soft energy to the at least one electrode if the sensed blood pres ware package installed thereon. sure is less than the second threshold blood pressure. The Thus, programmed electrical pulses can be delivered from neuromodulation system may include a biocompatible casing the neurostimulator to the stimulation lead(s) to stimulate or 50 housing the modulation output circuitry and the controller/ activate a Volume of the spinal cord tissue. In particular, processor. Further, the neuromodulation system may include electrical stimulation energy conveyed to the electrodes cre the electrode(s). ates an electrical field, which, when strong enough, depolar In accordance with another aspect of the present inven izes (or “stimulates') the neural fibers within the spinal cord tions, a method for treating a patient from chronic hyperten beyond a threshold level, thereby inducing the firing of action 55 sion is provided.