Method and system for vagal blocking with or without vagal stimulation to provide therapy for obesity and other gastrointestinal disorders using rechargeable implanted pulse generator

Abstract

Method and system to provide therapy for obesity and gastrointestinal disorders such as FGIDs, gastroparesis, gastro-esophageal reflex disease (GERD), pancreatitis and ileus comprises vagal blocking and/or vagal stimulation, utilizing implanted and external components. Vagal blocking may be in the afferent or efferent direction, and may be with or without selective stimulation. Blocking may be provided by one of a number of different electrical blocking techniques. The implantable components are a lead and an implantable pulse generator (IPG), comprising re-chargeable lithium-ion or lithium-ion polymer battery. The external components are a programmer and an external recharger. In one embodiment, the implanted pulse generator may also comprise stimulus-receiver means, and a pulse generator means with rechargeable battery. In another embodiment, the implanted pulse generator is adapted to be rechargeable, utilizing inductive coupling with an external recharger. Existing nerve stimulators may also be adapted to be used with rechargeable power sources as disclosed herein. The implanted system comprises a lead with two or more electrodes, for vagus nerve(s) modulation with selective stimulation and/or blocking. In another embodiment, the external stimulator and/or programmer may comprise an optional telemetry unit. The addition of the telemetry unit to the external stimulator and/or programmer provides the ability to remotely interrogate and change stimulation programs over a wide area network, as well as other networking capabilities.

1 . A method of providing electrical pulses with rechargeable implantable pulse generator for nerve blocking with or without selective electrical stimulation of vagus nerve(s) or its branches or part thereof for treating, controlling, or alleviating the symptoms for at least one of obesity, motility disorders, eating disorders, inducing weight loss, FGIDs, gastroparesis, gastro-esophageal reflex disease (GERD), pancreatitis, and ileus, comprising the steps of: 
 providing said rechargeable implantable pulse generator, comprising a microcontroller, pulse generation circuitry, rechargeable battery, battery recharging circuitry, and a coil;    providing a lead with at least two electrodes adapted to be in contact with said nerve tissue, and in electrical contact with said rechargeable implantable pulse generator;    providing an external power source to charge said rechargeable implantable pulse generator; and    providing an external programmer to program said rechargeable implantable pulse generator.    
   
   
       2 . A method of  claim 1 , wherein said nerve blocking comprises selective blocking of nerve impulses of a vagus nerve(s), its branch(es) or part thereof, at one or more sites with said electrical pulses.  
   
   
       3 . A method of  claim 1 , wherein said electrical pulses are for at least one of afferent block, efferent block, or organ block.  
   
   
       4 . A method of  claim 1 , wherein nerve blocking may also be provided to alleviate the side effects of nerve stimulation therapy.  
   
   
       5 . A method of  claim 1 , wherein said nerve blocking comprises at least one from a group consisting of: DC or anodal block, Wedenski block, and Collision block.  
   
   
       6 . A method of  claim 1 , wherein said rechargeable implantable pulse generator further comprises stimulus-receiver means such that, said implantable rechargeable pulse generator can also function in conjunction with an external stimulator, to provide said electrical pulses for said nerve blocking and/or stimulation.  
   
   
       7 . A method of  claim 1 , wherein said external power source to recharge said rechargeable implantable pulse generator can be an external re-charger or an external stimulator.  
   
   
       8 . A method of  claim 1 , wherein said coil used in recharging said pulse generator is around said implantable rechargeable pulse generator case in a silicone enclosure.  
   
   
       9 . A method of  claim 1 , wherein said rechargeable implanted pulse generator further comprises one or two feed-through(s) for externalizing coils, for unipolar or bipolar configurations respectively.  
   
   
       10 . A method of  claim 1 , wherein said at least two electrodes are made of a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.  
   
   
       11 . A method of  claim 1 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       12 . A method of  claim 1 , wherein said rechargeable implanted pulse generator is adapted to be remotely interrogated and/or programmed over a wide area network by an external interface means.  
   
   
       13 . A method of providing electrical pulses with rechargeable implantable pulse generator for vagal blocking with or without selective vagal stimulation for treating or alleviating the symptoms for at least one of obesity, eating disorders, inducing weight loss, FGIDs, gastroparesis, gastro-esophageal reflex disease (GERD), pancreatitis, and ileus, comprising the steps of: 
 providing an implantable rechargeable pulse generator, wherein said implantable rechargeable pulse generator comprises a stimulus-receiver means, and an implantable pulse generator means comprising a microcontroller, pulse generation circuitry, rechargeable battery, and battery recharging circuitry;    providing a lead with at least two electrodes adapted to be in contact with said vagus nerve(s) or its branches or part thereof, and in electrical contact with said implantable rechargeable pulse generator;    providing an external power source to charge rechargeable implantable pulse generator; and    providing an external programmer to program the said rechargeable implantable pulse generator.    
   
   
       14 . A method of  claim 13 , wherein said rechargeable implantable pulse generator can function in conjunction with an external stimulator, to provide said blocking to said vagus nerve(s) and/or its branches with or without said selective stimulation.  
   
   
       15 . A method of  claim 13 , wherein said coil used in recharging said pulse generator is around said rechargeable implantable pulse generator case in a silicone enclosure.  
   
   
       16 . A method of  claim 13 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       17 . A system for providing electrical pulses with rechargeable implantable pulse generator for nerve blocking with or without selective electrical stimulation of vagus nerve(s) or its branches or part thereof for treating, controlling, or alleviating the symptoms for at least one of obesity, motility disorders, eating disorders, inducing weight loss, FGIDs, gastroparesis, gastro-esophageal reflex disease (GERD), pancreatitis, and ileus, comprising: 
 a rechargeable implantable pulse generator, comprising, a microprocessor, pulse generation circuitry, rechargeable battery, battery recharging circuitry, and a coil;    a lead with at least two electrodes adapted to be in contact with said nerve tissue and in electrical contact with said implantable rechargeable pulse generator;    an external power source to charge said rechargeable implantable pulse generator; and    an external programmer to program said rechargeable implantable pulse generator.    
   
   
       18 . A system of  claim 17 , wherein said nerve blocking comprises at least one from a group consisting of: DC or anodal block, Wedenski block, and Collision block.  
   
   
       19 . A system of  claim 17 , wherein said coil is used for bidirectional telemetry, or receiving electrical pulses from said external stimulator.  
   
   
       20 . A system of  claim 17 , wherein said coil used in recharging said pulse generator is around said rechargeable implantable pulse generator case in a silicone enclosure.  
   
   
       21 . A system of  claim 17 , wherein said rechargeable implanted pulse generator further comprises one or two feed-through(s) for externalizing coils, for unipolar or bipolar configurations respectively.  
   
   
       22 . A system of  claim 17 , wherein said implantable rechargeable pulse generator further comprises stimulus receiver means such that said implantable rechargeable pulse generator can also function in conjunction with an external stimulator, to provide said blocking with or without stimulation to said vagus nerve(s) and/or its branches.  
   
   
       23 . A system of  claim 17 , wherein said at least two electrodes are made of a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.  
   
   
       24 . A system of  claim 17 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       25 . A system of  claim 17 , wherein said rechargeable implanted pulse generator is adapted to be remotely interrogated and/or programmed over a wide area network by an external interface means.