Method and system for providing electrical pulses for neuromodulation of vagus nerve(s), using rechargeable implanted pulse generator

Abstract

A method and system of providing electrical pulses to vagal nerve(s) using rechargeable implantable pulse generator for stimulation and/or blocking to provide therapy for neurological and neuropsychiatric disorders comprises implantable and external components. These disorders include (but are not limited to) epilepsy, partial complex epilepsy, generalized epilepsy, and involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure (CHF). The implantable components are a lead and an implantable pulse generator, comprising rechargeable 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. The implanted stimulus-receiver is adapted to work in conjunction with an external stimulator. In another embodiment, the implanted pulse generator is adapted to be rechargeable, utilizing inductive coupling with an external recharger. Existing vagal nerve stimulators may also be adapted to be used with rechargeable power sources as disclosed herein. The implanted system may also use a lead with two or more electrodes, for vagus nerve(s) modulation with selective stimulation and/or blocking.

1 . A method of providing electrical pulses with a rechargeable implantable pulse generator for stimulation and/or blocking of vagus nerve(s) and/or its branches or part thereof, for treating or alleviating the symptoms for at least one of neurological, neuropsychiatric disorders, comprising the steps of: 
 providing said implantable rechargeable 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 vagus nerve(s) or its branches or part thereof, 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 neurological, neuropsychiatric disorders comprises at least one of epilepsy, partial complex epilepsy, generalized epilepsy, involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure (CHF).  
   
   
       3 . A method of  claim 1 , wherein said coil is also used for bidirectional telemetry.  
   
   
       4 . 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.  
   
   
       5 . A method of  claim 4 , wherein said implantable rechargeable pulse generator does not require magnetic shielding between said coil and said titanium case.  
   
   
       6 . A method of  claim 1 , wherein said rechargeable implanted pulse generator further comprises one or two feedthrough(s) for unipolar or bipolar configurations respectively.  
   
   
       7 . A method of  claim 1 , wherein said implantable rechargeable pulse generator further comprises means stimulus-receiver means such that, said implantable rechargeable pulse generator can function in conjunction with an external stimulator, to provide said stimulation and/or blocking to said vagus nerve(s) and/or its branches.  
   
   
       8 . A method of  claim 1 , wherein said at least two electrodes are of a material selected from the group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.  
   
   
       9 . A method of  claim 1 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       10 . A method of modulating vagus nerve(s) and/or its branches or part thereof with electrical pulses for treating or alleviating the symptoms of neurological, or neuropsychiatric disorders, comprising at least one of epilepsy, partial complex epilepsy, generalized epilepsy, involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure (CHF), and further 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.    providing an external programmer to program the said rechargeable implantable pulse generator.    
   
   
       11 . A method of  claim 10 , wherein said rechargeable implantable pulse generator can function in conjunction with an external stimulator, to provide said stimulation and/or blocking to said vagus nerve(s) and/or its branches.  
   
   
       12 . A method of  claim 10 , wherein said coil used in recharging said pulse generator is around said implantable rechargeable pulse generator case in a slicone enclosure.  
   
   
       13 . A method of  claim 10 , wherein said rechargeable implantable pulse generator can be recharged using an external recharger or an external stimulator.  
   
   
       14 . A method of  claim 10 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       15 . A vagus nerve(s) stimulation and/or blocking system for providing electrical pulses to vagus nerve(s) or its branches or part thereof for treating or alleviating the symptoms for at least one of neurological, and neuropsychiatric disorders, 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 vagus nerve(s) or its branches or part thereof 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.    
   
   
       16 . A system of  claim 15 , wherein said at least one of neurological and neuropsychiatric disorders comprises at least one of epilepsy, partial complex epilepsy, generalized epilepsy, and involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure (CHF).  
   
   
       17 . A system of  claim 15 , wherein said coil is used for bidirectional telemetry, or receiving electrical pulses from said external stimulator.  
   
   
       18 . A system of  claim 15 , wherein said coil used in recharging said pulse generator is around said rechargeable implantable pulse generator case in a silicone enclosure.  
   
   
       19 . A system of  claim 15 , wherein said rechargeable implantable pulse generator does not require a magnetic shield between said coil and said titanium case.  
   
   
       20 . A system of  claim 15 , wherein said rechargeable implantable rechargeable pulse generator does require a magnetic shield between said coil and said titanium case.  
   
   
       21 . A system of  claim 15 , wherein said rechargeable implanted pulse generator further comprises one or two feedthrough(s) for unipolar or bipolar configurations respectively.  
   
   
       22 . A system of  claim 15 , wherein said implantable rechargeable pulse generator further comprises means such that said implantable rechargeable pulse generator can also function in conjunction with an external stimulator, to provide said stimulation and/or blocking to said vagus nerve(s) and/or its branches.  
   
   
       23 . A system of  claim 15 , wherein said at least two electrodes are 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 15 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       25 . A system for modulating the vagus nerve(s) and/or its branches or part thereof with electrical pulses, for treating or for alleviating the symptoms for at least one of epilepsy, partial complex epilepsy, generalized epilepsy, involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure (CHF), comprising: 
 a rechargeable implantable pulse generator, comprising a microprocessor, pulse generation circuitry, rechargeable battery, and stimulus-receiver means;    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;    an external power source to charge implantable rechargeable pulse generator; and    an external programmer to program the said rechargeable implantable pulse generator.    
   
   
       25 . A system of  claim 25 , wherein said implantable rechargeable pulse generator can function in conjunction with an external stimulator, to provide said stimulation and/or blocking to said vagus nerve(s) and/or its branches.  
   
   
       26 . A system of  claim 25 , wherein said coil used in recharging said pulse generator is around said implantable rechargeable pulse generator case in a silicone enclosure.  
   
   
       27 . A system of  claim 25 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.