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A Study of Vagus Nerve Stimulation Issues and Techniques for Hemodynamic Control

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A Study of Vagus Nerve Stimulation Issues and Techniques for Hemodynamic Control A Study of Vagus Nerve Stimulation Issues and Techniques for Hemodynamic Control A THESIS SUBMITTED TO THE FACULTY OF THE GRADUATE SCHOOL OF THE UNIVERSITY OF MINNESOTA By George Daniel O’Clock, Jr. IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE THESIS FACULTY ADVISOR: A.G. Talkachova (E.G. Tolkacheva) THESIS CO-ADVISOR: B.H. KenKnight May, 2018 © GEORGE DANIEL O'CLOCK, JR. 2018 Acknowledgements I would like to thank the members of the thesis committee, Dr. Alena Talkachova for her guidance, insight, and patience; Dr. Victor Barocas who gave me some very good advice as I began this odyssey at the U of MN; and Dr. Bruce KenKnight, who opened the door for me during a Cardiovascular Device course when he looked at my class paper and said, "George, it looks like you have a thesis." This committee is part of the group of more than 30 people who have mentored me for the past 55 years. They include Dr. Warren Warwick (dec.), Department of Pediatrics, U of MN Medical School, Minneapolis, MN; Dr. Björn E.W. Nordenström (dec.), Head of Diagnostic Radiology, Karolinska Inst., Stockholm, Sweden; Dr. Xin Yuling, Chief Specialist of Thoracic Surgery, Friendship Hospital, Beijing, PRC; Dr. Stuart R. Taylor, Dept. of Pharmacology, Mayo Graduate School, Rochester, MN; Dr. Lyle D. Feisel, Dean of Engineering, SUNY Binghamton, Binghamton, NY; Dr. William Hixon (dec.) and Cyrus Cox, Electrical Engineering, South Dakota School of Mines & Technology, Rapid City, S.D., Dr. Mark Lyte, Health Sciences Center, Texas Tech, Abilene, TX, Dr. Robert M. Williams (dec.), Economics Dept., UCLA, Los Angeles, CA; Dr. Donovan Nielsen, Biological Sciences, Minnesota State University-Mankato, Mankato, MN; Robert C. Dixon (dec.), RCD&A Consulting, Colorado Springs, CO, Carl Hildebrand (dec.), Perkin-Elmer, Norwalk, CT, Gene Turechek (dec.), Eastman Kodak, Rochester, NY; R.J. Dauphinee (dec.), TRW Systems, Redondo Beach, CA, family members, and two very supportive parents. Without the generous help and support they all gave, I could not have achieved my goals, and could not have arrived at this place in my lifetime. i Abstract Approximately 75 million adults in the U.S. have hypertension. With appropriate adjustments, neuromodulation therapy, or more specifically vagus nerve stimulation (VNS), can provide cardiovascular condition and performance improvements for this segment of the U.S. population. In designing and developing VNS devices and protocols for cardiovascular disorders; the needs and preferences of the patient and the health care practitioner who treats the patient must be considered. They should be the in the group of primary design drivers for both the device and the protocol. With the patient and health care practitioner in mind, it appears that both implanted and non-invasive VNS approaches will have their own unique roles in treating cardiovascular disease. Under that scenario, new and more comfortable VNS implant designs and protocols can benefit from non- invasive VNS (NI-VNS) device and protocol advances. NI-VNS can provide a relatively safe, convenient, and effective way to obtain useful clinical study information to help define and establish proposed mechanisms-of- action associated with VNS regulation and control of blood pressure and heart rate. Also, VNS device development can be assisted and advanced even further with new and improved design tools. Included in that category are modeling/simulation tools and techniques that can help provide insights into the responses and sensitivities associated with VNS-cardiovascular- neurological interfaces and associated functional relationships. ii TABLE OF CONTENTS List of Tables . vi List of Figures . vii 1. Introduction . 1 1.1 Vagus Nerve-Parasympathetic Nervous System Relationship . 1 1.2 Vagus Nerve Stimulation (Mechanical) . 2 1.3 Vagus Nerve Stimulation (Electrical) . 3 1.4 Recent Vagus Nerve Stimulation Implant Clinical Results for Heart Disease Applications . 4 2. Background . 7 3. Aim, Objectives, and Mission . 10 4. Methods . 12 4.1 NI-VNS Clinical Study . 12 4.2 Model and Simulation of VNS Device-Neurological- Cardiovascular System Interface: Block Diagram . 13 4.3 Model and Simulation of VNS Device-Neurological- Cardiovascular System Interface: Mathematical Basis . 16 4.4 Graphical Tools . 17 iii 5. Results . .18 5.1 Clinical Study Results: How They Relate to the Simulation . 18 5.1.1 VNI-VNS Hemodynamic Parameter Improvement Comparisons Between NI-VNS and VNS Implants: BP and HR . 18 5.1.2 Comparison of Clinical Results (This Study and Literature) and Simulation Results . 20 5.1.3 NI-VNS Hemodynamic Improvement Comparisons Between NI-VNS and VNS Implants: BP vs. HR, BP & HR vs. Time . 22 5.2 VNS Modeling/Simulation Results . 25 5.2.1 Comparison of Phase-Lock Loop and Nerve Conduction Model With Windkessel and Conventional Nerve Conduction Models . 25 5.2.2 Validation/Relevance of the Phase-Frequency Lock Loop Model . 28 5.2.3 Simulated Response to a Therapeutic Input . 28 5.2.4 The Effects of Feedback Strength on Simulated Responses . 31 6. Discussion . 34 6.1 Overview of Clinical Study and Simulation Implications . 34 6.2 Critique of Model and Simulation . 36 6.3 Interpretation . 39 6.3.1 VNS Design Verification Issues . 39 6.3.2 VNS Design Validation . 39 6.3.3 Mechanism-of-Action Issues . 40 iv 7.0 Conclusions . 41 7.1 NI-VNS vs.VNS Implants . 41 7.2 VNS Implant Design Improvement Considerations . 42 7.3 Improvements for the Hemodynamic Regulation-Control Model . 42 7.4 Mechanism-of-Action Clues . 43 References . 46 v List of Tables Table I. Summary of VNS Implant Clinical Studies for Heart Disease Treatment Up to 2014 . .. 6 Table II. NI-VNS Hemodynamic Improvement Results for a Single Subject With Hypertension: All Results Achieved in Less Than Two Weeks of Treatment . 19 vi List of Figures Figure 1. Pneumatic/mechanical system for the introduction of pneumatically driven trapezoidal pressure pulses to the thoracic system (including the left and right vagus nerves) for cardio- pulmonary benefits . 3 Figure 2. Cyberonics (now LivaNova) Vagus Nerve (VNS) device implanted on the left side vagus nerve using a programmable pulse generator . 8 Figure 3. One form of transcutaneous VNS (t-VNS) . 9 Figure 4. First order phase-lock loop cardiac model . 15 Figure 5. 2 D Scatter plots and linear regression line plots of systolic BP vs. HR . 23 Figure 6. Moving average of systolic BP shown along with the moving average of HR over a relatively long time frame . 24 Figure 7. Oscilloscope upper trace showing simulated baroreceptor activity (murine model), and lower trace showing multiplier output from the simulation . 26 vii Figure 8. Oscilloscope display of BP (upper trace) and VNS device excitation (lower trace) . 27 Figure 9. Simulated oscilloscope display showing an arrhythmia (upper trace) and the result of applying a therapeutic signal that corrects the arrhythmia problem (lower trace) . 29 Figure 10. Before-and-after NI-VNS treatment line graph of systolic and diastolic BP vs. time for 4 to 6 NI-VNS treatments . 30 Figure 11. Murine simulation plots of HR vs. VNS implant frequency for different levels of neurological feedback . 31 Figure 12. Murine simulation plots of HR vs. VNS implant current intensity for different levels of neurological feedback . 33 viii 1. Introduction 1.1 Vagus Nerve-Parasympathetic Nervous System Relationship The vagus nerve is often described as a “mind-body connection;” that influences relaxation responses, pain mitigation, digestion, intestinal inflammatory response, for example, with a neural pathway that “wanders” from the medulla oblongata to the abdomen. The vagus nerve is the longest of the twelve cranial nerves and operates as a distributed command-control- communication network within the parasympathetic arm of the autonomic nervous system. To get some idea of where and how the vagus nerve fits in with nervous system form and function, we need to start with a macroscopic view. The major parts of the human nervous system consist of the central nervous system (brain and spinal cord); and the peripheral nervous system (myelinated sensory and motor neurons that branch out from the spinal cord to various appendages) that extend to and serve all parts of the body. Included in the peripheral nervous system is the sympathetic nervous system (prepares the body for activity, mediates fight or flight response, maintains homeostasis) and the parasympathetic nervous system (restoration, repair, feed, breed, rest, and digest). The sympathetic nervous system and the parasympathetic nervous system are part of the autonomic nervous system (ANS) that addresses involuntary functions within the body trunk (heart, lungs, pancreas, gastrointestinal tract, etc.) that do not require thought to take action. The autonomic nervous system is the primary neural mediator of physiological responses to internal and external stimuli. The sympathetic 1 nervous system regulates catabolic responses and the parasympathetic nervous system, with the vagus nerve (cranial nerve X of the parasympathetic nervous system) regulating anabolic responses (Teff, K.L., 2008). The right and left vagus nerves mediate parasympathetic heart activity, with the right vagus nerve innervating the sinoatrial node (heart’s pacemaker) and the left vagus nerve innervating the atrioventricular node (mediates heart electrical current and conduction velocity). 1.2 Vagus Nerve Stimulation (Mechanical) Mechanical compression of the vagus nerve for various nervous system disorders predates the application of an electrical approach by more than 90 years (Yuan, H. and Silberstein, S.B., 2015; Corning, 1884). The mechanical vagus nerve stimulation (VNS) approach, using hand, thumb, finger, and belt pressure, was popular in the 1800s (Waller, A., 1870). A mechanical non-invasive vagus nerve stimulation (NI-VNS) technique, that can be quite effective in controlling heart rate (HR) and reducing blood pressure (BP), utilizes a pneumatically pulsed vest (employing 1 Hz to 2.5 Hz trapezoidal shaped pulses) that stimulates the entire thoracic region, along with the right and left vagus nerve network on both sides of the neck and thorax (O’Clock, G.D., et al.., 2012).
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