Autonomic nervous system neuromodulation

Abstract

Autonomic Nervous System Neuromodulation represents a pioneering endeavour in neuromodulation technology. By selectively interfacing with the autonomic nervous system, this new technology offers a prospective avenue for ameliorating conditions characterised by autonomic dysregulation including but not limited to pain of head and neck, upper limb, chest, abdomen, pelvis, and lower limb, post-traumatic stress disorder (PTSD), acute and chronic heart failure, gastrointestinal and genitourinary system dysmotility, and peripheral vascular disease. By employing targeted stimulation of intricate autonomic neural pathways, it aspires to reinstate equilibrium with autonomic functions. This innovation bears the potential to significantly enhance the quality of life for individuals grappling with a spectrum of autonomic disorders, ushering in a paradigm shift in neurological therapies.

Description

[0001] TITLE OF YOUR INVENTION

[0002] Autonomic Nervous System Neuromodulation

[0003] TECHNICAL FIELD

[0004] This invention bridges neuroscience, medical technology, and biomedical engineering to potentially address conditions related to autonomic dysregulation.

[0005] BACKGROUND OF THE INVENTION

[0006] The autonomic nervous system (ANS) plays a pivotal role in maintaining internal homeostasis, regulating vital functions such as heart rate, blood pressure, digestion, and respiratory rate. However, disruptions in autonomic balance can lead to a range of debilitating conditions collectively referred to as autonomic dysregulation. These conditions encompass disorders like orthostatic hypotension, vasovagal syncope, and cardiac arrhythmias, which profoundly impact patients' quality of life and pose significant challenges for traditional therapeutic approaches. The ANS is also involved in our fight-flight response and subsequently in many painful conditions involving different body parts or organs, including but not limited to cluster or migraine headaches, Complex Regional Pain Syndrome (CRPS), visceral pain of chest, abdomen and or pelvis, and ischemic pain due to peripheral vascular disease.

[0007] Conventional treatment modalities for autonomic dysregulation often target symptoms rather than addressing underlying neural imbalances. Medications can be limited by side effects and have a temporary and partial effect. Chemical blocks using needle techniques may have temporary benefits. Surgical sympathectomies may carry significant risks. This calls for innovative interventions capable of recalibrating autonomic function while minimising invasiveness and adverse effects. Stimulation of Dorsal Root Ganglion (DRG-S) has been employed and postulated to be a useful technique in recruiting sympathetic chain in literature. DRG-S uses implantable electrodes over DRG of the spinal nerve roots (consisting of sensory / motor and sympathetic fibres) to achieve this. DRG-S is a technically challenging and a high-risk procedure. Stimulating DRG has its limitations such as unwanted motor stimulation, sensory stimulation (induction of paraesthesia) that can be intolerable for some patients and lead migration and fracture. Autonomic Nervous System Neuromodulation emerges as a promising solution to these challenges. By combining principles from neuroengineering, neuromodulation, and biomedical technology, this novel approach aims to restore autonomic equilibrium through targeted modulation of the sympathetic chain. This innovation holds the potential to revolutionise the treatment landscape in several ways:

[0008] Precise Modulation of Autonomic Pathways: Unlike broader systemic interventions, the stimulator employs targeted electrode placement and stimulation techniques to selectively target specific ANS neural pathways responsible for autonomic regulation. This precision enables tailored modulation and potential restoration of autonomic balance.

[0009] Minimally Invasive Approach: Surgical interventions for autonomic dysregulation can carry substantial risks. In our cadaveric studies of targeted ANS stimulation it was proven to be technically easier and need less skills compared to surgical sympathectomies or even DRG-Stim. Risk of lead migration and lead fracture will also be minimised. The ANS stimulator offers a less invasive alternative, utilising minimally invasive implantation techniques to minimize surgical complications and patient discomfort.

[0010] Holistic Impact on Autonomic Functions: By directly influencing the autonomic nervous system, this approach has the potential to impact multiple physiological processes simultaneously. This approach addresses the root causes of autonomic dysregulation in a more profound and direct way, potentially leading to more comprehensive and enduring therapeutic outcomes.

[0011] Patient-Centric Care: The stimulator's customisable parameters allow for individualised treatment, catering to the unique autonomic profiles of each patient. This patient-centric approach acknowledges the variability in autonomic dysfunction presentation and optimises treatment efficacy. Stimulators parameters such as mAmp, frequency, pulse width etc can be tailored to patients needs to achieve best outcomes.

[0012] Reduced Dependence on Pharmaceuticals: Patients with autonomic dysregulation often rely on a cocktail of medications with varying degrees of effectiveness. The stimulator offers the prospect of reducing or even eliminating dependence on pharmaceutical agents, thereby alleviating concerns about side effects and drug interactions. In conclusion, Autonomic Nervous System Neuromodulation represents an innovation poised to redefine the management of autonomic dysregulati on-related disorders. By leveraging the synergy of neuroengineering, neuromodulation, and biomedical technology, this approach holds the promise of providing patients with more effective, personalised, and minimally invasive treatment options. As ongoing research and clinical trials unfold, the potential advantages of this technology could lead to a paradigm shift in addressing autonomic dysregulation and enhancing the well-being of countless individuals.

[0013] SUMMARY OF THE INVENTION

[0014] The Autonomic Nervous System Neuromodulation is an innovative breakthrough in neuroengineering and neuromodulation technology designed to address autonomic dysregulati on-related disorders. This device operates on the fundamental principle of targeted neural modulation, interfacing with the autonomic nervous system through precise stimulation of the sympathetic chain based on the patient's symptoms and organ involvement. By offering a minimally invasive, patient-centric approach, this invention holds the potential to revolutionize the treatment landscape for conditions including but not limited to pain of head, neck, upper limb, chest, abdomen, pelvis and lower limb as well as acute and chronic heart failure, post-traumatic stress disorder (PTSD), gastrointestinal and genitourinary system disorders and dysfunctions including pain and dysmotility syndromes, and peripheral vascular disease and ischemic pain.

[0015] The stimulator employs biocompatible electrodes strategically positioned along the sympathetic chain, capitalizing on our understanding of autonomic pathways. It harnesses the intricate interplay between neural networks to selectively modulate autonomic functions. This principle is rooted in the concept of restoring equilibrium within the autonomic nervous system by stimulating key nodes associated with sympathetic nervous system function for example heart rate variability, vasomotor tone, sudomotor function and respiratory rhythm.

[0016] The invention is intended for individuals grappling with autonomic dysregulati on-related conditions, where conventional treatments have proven inadequate or fraught with failure or side effects. It finds application in both clinical and research settings. Clinically, it offers a novel therapeutic avenue for patients seeking relief from autonomic malfunctions. In research, it serves as a platform for further understanding of autonomic neurophysiology, it’s relationship to modulation of pain and other symptoms and refining stimulation techniques.

[0017] The stimulator's operation revolves around its ability to deliver precise electrical pulses to targeted regions of the autonomic nervous system from Tito T3 (Stellate Ganglion) to Splanchnic nerves (T10 / T11 / T12) to Lumbar sympathetic plexus (L2 / L3 / L4) to Superior Hypogastric Plexus (L5 / S1) to Ganglion Impar (Sacro-coccygeal plexus). Through a minimally invasive surgical procedure, the electrodes are implanted in proximity to autonomic neural pathways. These electrodes are then connected to a control unit (Impulse Generator- IPG) that allows for customisation of stimulation parameters. By manipulating pulse frequency, amplitude, pulse width and duty cycles, clinicians can tailor the stimulation to address specific autonomic imbalances. The device's ability to interface with the autonomic nervous system at a neural level enables real-time adjustment and optimisation.

[0018] DETAILED DESCRIPTION OF EMBODIMENTS

[0019] Autonomic Nervous System Neuromodulation (ANSNM) functions on principles like traditional spinal cord stimulators, DRG-Stimulattor used in pain medicine, but with a distinct focus on modulating autonomic functions rather than dorsal spinal column or DRG. Just as traditional stimulators involve electrode implantation on nerve sites to influence pain perception, the ANSNM employs a similar concept to target autonomic pathways for the regulation of physiological functions.

[0020] Electrode Placement: In the case of an ANSNM, electrodes are placed near specific autonomic nerve pathways along the vertebral bodies using a Touhey needle under direct fluoroscopy. These pathways are identified based on the patient's history, examination, advanced neuroimaging, and neurophysiological techniques, ensuring accurate targeting of autonomic nodes responsible for symptoms and organs involved. For example, a patient with lower limb CRPS, will receive ANSNM at L2 / L3 / L4 on the affected side or a person with chronic congestive heart failure will receive a T2 sympathetic ANSNM on the left side.

[0021] Neural Modulation: Both types of stimulators deliver controlled electrical pulses to the nerve via the implanted electrodes. In traditional stimulators, these pulses interfere with pain signals, creating a tingling sensation that "overrides" pain perception. In the ANSNM, the electrical pulses modulate autonomic nerve activity. By precisely stimulating or inhibiting certain autonomic pathways, the ANSNM aims to restore balance within the autonomic nervous system, improving its regulation of bodily functions.

[0022] Stimulation Parameters: The parameters of stimulation are crucial for both stimulator types. In traditional stimulators, factors such as pulse frequency, amplitude, and pulse width are adjusted to achieve optimal pain relief for the individual. Similarly, in the ANSNM, these parameters are customized to address specific autonomic dysregulation patterns. For example, altering the frequency and amplitude of electrical pulses can influence heart rate variability, while adjusting pulse width can impact vasomotor tone. 4. Individualized Treatment: Both stimulator types emphasize individualized treatment. Traditional stimulators allow patients to adjust stimulation settings based on their pain levels and preferences. Similarly, the ANSNM permits tailored modulation of autonomic functions, recognizing the variability in autonomic dysfunction presentations among individuals.

[0023] Minimally Invasive Implantation: The implantation procedure for both stimulator types is minimally invasive, involving the placement of electrodes through a surgical procedure. This approach reduces risks and promotes quicker recovery times for patients.

Claims

CLAIMS1. Neuromodulation which can specially stimulate autonomic nerves2. A plurality of biocompatible electrodes configured for implantation along the autonomic nerves3. An electrode control unit adapted to generate electrical pulses and control stimulation parameters4. Electrode pulse emission across the entire electromagnetic frequency spectrum5. A neural pathway mapping system for identifying autonomic neural pathways associated with physiological functions6. A user-friendly stimulation customisation interface allowing adjustment of pulse frequency, amplitude, and pulse width7. A closed-loop system to monitor autonomic responses and optimise stimulation settings depending on critical events8. A biofeedback integration which can integrate biometrics including but not limited to heart rate and respiration for bi-directional communication9. An autonomic regulation algorithm that adapts stimulation patterns based on real-time autonomic feedback, including but not limited to machine learning and artificial intelligence10. An anatomical imaging module to facilitate precise electrode placement along the spinal cord11. A multi-modal stimulation integrating other types of neuromodulation, including but not limited to transcranial magnetic stimulation or vagus nerve stimulation12. A patient-specific calibration module to tailor stimulation parameters to individual autonomic profiles13. A data storage and analysis module integration for historical autonomic responses14. A remote wireless programming interface enabling remote adjustments of stimulation parameters