Neuromodulation device

Abstract

The invention provides devices, apparatuses, systems and methods for treating and ameliorating inflammation of the gut. In particular, the invention provides devices, apparatuses and methods in which a neuromodulatory signal is delivered a splenic nerve and / or superior mesenteric plexus (SMP). The signal is able to treat inflammatory disorders, e.g., colitis, for example in Inflammatory Bowel Disease.

Description

BACKGROUND[0001]Neural mechanisms regulate all key functions of the gastrointestinal tract such as motility, secretion and vasoregulation. The autonomic nervous system (ANS), acting largely autonomously in that its activities are not under direct conscious control, represents the extrinsic control of the intestine, and is divided in sympathetic and parasympathetic branches. The ANS sympathetic and parasympathetic components originate in the central nervous system (CNS) (with cell bodies in the brainstem and spinal cord); while the enteric nervous system (ENS), resides within the wall of the gastrointestinal tract. The ANS forms the major efferent component of the peripheral nervous system containing integrative neuronal connections and even complete reflex arcs.[0002]Studies in neuroscience and immunology have identified a number of indications for bidirectional interactions between the nervous and immune systems. As with other organs, intestinal immune responses and the development...

AI Technical Summary

Benefits of technology

[0009]Therefore, by modulating the neural activity in these sympathetic nerves (particularly, fibers of the splenic nerve and SMP), the inventors have demonstrated that it is possible to treat (that is, reduce) inflammation associated with colitis. Such a treatment has a particular advantage over stimulation of the vagus nerve in treating inflammation of the colon (i.e., “colitis”), as the large intestine and colon have little parasympathetic vagal innervation, but do have sympathetic innervation. Targeting the splenic nerve and SMP therefore allows new areas of the body to be treated, increasing the specificity and efficacy of neuromodulation. Moreover, by targeting nerves more peripheral than the vagus nerve, the present invention seeks to avoid affecting other bodily systems and thereby reduces unwanted side effects. Thus, the present disclosure provides an apparatus or system for treating an inflammatory disorder in a patient. Favourably, the inflammatory disorder is an inflammatory disorder that includes colitis as a symptom, for example, IBD, such as ulcerative colitis (UC) or Crohn's Disease.

[0010]Therefore, in one aspect, the invention provides an apparatus or system for modulating the neural activity of the splenic nerve (or any nerve that innervates the spleen) and / or the SMP of a patient, the apparatus or system comprising: a first transducer configured to apply a first signal to the splenic nerve or SMP and optionally a second transducer to apply a second signal to the other of the SMP or splenic nerve; and a controller coupled to the transducer or transducers, the controller controlling the signal to be applied by the transducer or transducers, such that the signal modulates the neural activity of the nerve to which it is applied to produce a physiological response in the patient. In certain embodiments, the signal applied increases neural activity in the nerve to which the signal is applied.

[0022]In another aspect, the invention provides a neuromodulatory electrical waveform for use in treating colitis in a patient, wherein the waveform is an AC waveform having a frequency of 0.01-20 Hz, such that, when applied to a splenic nerve or SMP the waveform increases neural signalling in the nerve.

Problems solved by technology

This lack of distal innervation may lead to a limited ability to elicit an anti-inflammatory effect in the colon following vagus nerve (vagal) stimulation.

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