Neurostimulation in the Treatment of Congestive Heart Failure

A patent application has been filed in the US Patent & Trademark Office (USPTO) entitled, “MODULATION OF AUTONOMIC NERVOUS SYSTEM ACTIVITY AND INTEGRATED ELECTRODE ASSEMBLIES FOR TRIGEMINAL NEUROSTIMULATION . An Abstract, Background and Summary or Description of said filing follows:


Cutaneous and subcutaneous TNS embodiments are disclosed for addressing autonomic nervous system imbalances. A cutaneous electrode assembly is applied to a patient’s forehead, and a current is pulsed through the electrode assembly to stimulate the supraorbital and supratrochlear nerves on the patient to increase activity for the patient’s parasympathetic nervous system. Pulsing the current increases the power spectral density for the patient’s heart rate variability in a 0.1 to 0.15 Hz frequency


The peripheral nervous system comprises pairs of cord-like nerves arising from the brain and the spinal cord and includes both a somatic portion and an autonomic portion. In contrast to the somatic portion, the autonomic portion of the peripheral nervous system is not subject to direct voluntary control. It is the autonomic nervous system that controls functions such as digestion, heart rate, and respiratory rate. To provide this control, the autonomic nervous system (ANS) is in turn composed of the sympathetic and parasympathetic nervous systems. These two systems are thought to act somewhat in opposition to each other. The sympathetic nervous system controls “fight or flight” reflexes whereas the parasympathetic system controls “rest and digest” functions. While this is most certainly an over-simplification, there is no doubt that these two components of the ANS have different functions and exert control over a wide range of organ systems that operate below the level of conscious control. Furthermore, imbalances of the autonomic nervous system have been associated with a wide range of disease states. The best characterized of these is cardiac autonomic dysfunction, which is characterized by increased activity of sympathetic nervous system activity and decreased activity of the parasympathetic nervous system.


A large body of evidence has conclusively demonstrated that patients with congestive heart failure (CHF) have decreased activity of the parasympathetic nervous system and that these changes have been observed following acute myocardial infarction, and in patients with ischemic heart disease. Indeed, loss of parasympathetic nervous system activity is an independent predictor of sudden death, development of lethal cardiac arrhythmias and the likelihood of adverse cardiac events. In addition to its role in cardiac disease, imbalances of the ANS have been associated with a number of other disorders including the metabolic syndrome, Type 1 and 2 diabetes, autoimmune disorders, and anxiety disorders (such as post-traumatic stress disorder or PTSD).

This application, or a related application, on the above technology is currently pending in the USPTO. Selected portions taken from the file wrapper of the application, including the last action by the patent examiner, last response by applicants attorney and cited art, may be downloaded directly from Patentfox. This presentation and download will provide the reader with an in depth, current, detailed disclosure on advances in this leading edge technology that may not be fully exposed in other published literature.

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