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.

1 . (canceled) 
     
     
         2 . An apparatus or system for treating an inflammatory disorder in a patient, the apparatus or system comprising:
 at least one transducer configured to apply a stimulatory signal to at least one of the splenic nerves or SMP; and   a controller coupled to the at least one transducer, the controller controlling the stimulatory signal to be applied by the at least one transducer, such that the stimulatory signal increases the neural activity of the nerve to which it is applied to produce an increase in local sympathetic tone in the spleen or gut of the patient.   
     
     
         3 - 4 . (canceled) 
     
     
         5 . The apparatus or system according to  claim 2 , wherein the at least one transducer comprises a first transducer to apply a first signal to the splenic nerve and a second transducer to apply a second signal to the SMP. 
     
     
         6 . (canceled) 
     
     
         7 . The apparatus or system according to  claim 5 , wherein the first signal applied by the first transducer and the second signal applied by the second transducer are independently selected. 
     
     
         8 - 17 . (canceled) 
     
     
         18 . The apparatus or system according to  claim 2 , wherein the apparatus or system further comprises a detector element to detect one or more physiological parameters in the patient. 
     
     
         19 . The apparatus or system according to  claim 18 , wherein the controller is coupled to the detector element, and the controller causes the one or more transducers each to apply the signal when the physiological parameter is detected to be meeting or exceeding a predefined threshold value. 
     
     
         20 - 24 . (canceled) 
     
     
         25 . The apparatus or system according to  claim 2 , wherein the stimulation in neural activity is corrective. 
     
     
         26 . (canceled) 
     
     
         27 . A method of treating colitis in a patient comprising:
 i. implanting in the patient an apparatus or system according to  claim 2 ;   ii. positioning at least one transducer of the apparatus or system in signalling contact with at least one of the splenic nerve or SMP of the patient;   iii. activating the apparatus or system to apply at least one signal to the splenic nerve or SMP;   thereby modulating neural activity of the splenic nerve or SMP of the patient.   
     
     
         28 . (canceled) 
     
     
         29 . The method according to  claim 27 , wherein the method is a method of treating Inflammatory Bowel Disease, Crohn's Disease or ulcerative colitis. 
     
     
         30 . A method of treating IBD in a patient, the method comprising applying a signal to the splenic nerve and/or the superior mesenteric plexus (SMP) of the patient to modulate the neural activity of the nerve in the patient. 
     
     
         31 . The method according to  claim 30 , wherein a first signal is applied to the splenic nerve and a second signal is applied to the SMP. 
     
     
         32 . The method according to  claim 30 , wherein the signal or signals are independent of vagus nerve stimulation. 
     
     
         33 . The method according to  claim 30 , wherein the signal or signals are applied by a neuromodulation device comprising a transducer configured to apply the signal. 
     
     
         34 . The method according to  claim 33 , wherein when a first and second signal are applied, both signals are applied by the same neuromodulation device. 
     
     
         35 . The method according to  claim 30 , wherein at least one device or apparatus comprising the transducer is at least partially implanted in the patient. 
     
     
         36 - 57 . (canceled) 
     
     
         58 . The method according to  claim 30 , further comprising administering an anti-inflammatory agent to the patient. 
     
     
         59 . An anti-inflammatory agent for use in a method of treating colitis in a patient, wherein the method comprises: (i) applying a signal to at least one of a splenic nerve or a superior mesenteric plexus of the patient to modulate neural activity in the nerve in the patient; and (ii) administering the anti-inflammatory agent to the patient. 
     
     
         60 . The anti-inflammatory agent according to  claim 59 , wherein the anti-inflammatory agent is selected from a steroid, a 5-ASA, methotrexate, azathioprine, cyclosporine, and an anti-TNF agent. 
     
     
         61 . (canceled) 
     
     
         62 . The anti-inflammatory agent according to  claim 59 , wherein the signal or signals are applied by a neuromodulation device comprising a transducer configured to apply the signal or signals. 
     
     
         63 . The anti-inflammatory agent according to  claim 59 , wherein the neuromodulation device is at least partially implanted in the patient, such as wholly implanted in the patient. 
     
     
         64 . The anti-inflammatory agent according to  claim 59 , wherein the signal or signals applied increase neural activity in the nerve to which it is applied. 
     
     
         65 - 69 . (canceled)