Method and system for providing electrical pulses to gastric wall of a patient with rechargeable implantable pulse generator for treating or controlling obesity and eating disorders

Abstract

Method and system for providing electrical pulses to the gastric wall of a patient to provide therapy for obesity/eating disorders comprises implantable and external components. The implantable components are a lead and rechargeable 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 rechargeable implanted pulse generator of this embodiment is also 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 gastric 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 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 at one or more sites to the gastric wall of a patient for treating, controlling or alleviating the symptoms for at least one of obesity, inducing weight loss, eating disorders, obsessive compulsive disorders, and motility disorders, 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 gastric wall of a patient, 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 coil used in recharging said pulse generator is around said implantable rechargeable pulse generator case, in a silicone enclosure.  
   
   
       3 . A method of  claim 1 , wherein said implantable rechargeable pulse generator does not require magnetic shielding between said coil and said titanium case.  
   
   
       4 . A method of  claim 1 , wherein said rechargeable implanted pulse generator further comprises one or two feed-through(s) for unipolar or bipolar configurations respectively.  
   
   
       5 . A method of  claim 1 , wherein said implantable rechargeable pulse generator further comprises stimulus-receiver means such that, said implantable rechargeable pulse generator can function in conjunction with an external stimulator, to provide said electrical pulses to said gastric wall of a patient.  
   
   
       6 . A method of  claim 1 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       7 . The method of  claim 1 , wherein the amplitude of said electrical pulses delivered to the gastric wall can range from 0.5 volt to 25 volts.  
   
   
       8 . The method of  claim 1 , wherein the pulse width of said electrical pulses delivered to the gastric wall can range from 5 milliseconds to 2 seconds.  
   
   
       9 . The method of  claim 1 , wherein the frequency of said electrical pulses delivered to the gastric wall can range from 1 cycle/min. to 100 cycles/min.  
   
   
       10 . The 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.  
   
   
       11 . A method of providing pulsed electrical therapy to gastric muscle wall for treating or controlling at least one of eating disorders, obesity, or inducing weight loss in a patient, comprising the steps of: 
 providing an implantable rechargeable pulse generator, wherein said rechargeable implantable 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, 
 whereby said electric pulses provide said therapy.  
   
   
   
       12 . A method of  claim 11 , wherein said rechargeable implantable pulse generator can be recharged using an external re-charger or an external stimulator.  
   
   
       13 . A method of  claim 11 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       14 . A system for providing electrical pulses at one or more sites to the gastric wall of a patient for treating, controlling or alleviating the symptoms for at least one of obesity, inducing weight loss, eating disorders, obsessive compulsive disorders, and motility 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 the gastric wall in a patient 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.    
   
   
       15 . A system of  claim 14 , wherein the amplitude of said electrical pulses delivered to the gastric wall can range from 0.5 volt to 25 volts.  
   
   
       16 . A system of  claim 14 , wherein the pulse width of said electrical pulses delivered to the gastric wall can range from 5 milliseconds to 2 seconds.  
   
   
       17 . A system of  claim 14 , wherein the frequency of said electrical pulses delivered to the gastric wall can range from 1 cycle/min. to 100 cycles/min.  
   
   
       18 . A system of  claim 14 , wherein said rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer batteries.  
   
   
       19 . A system of  claim 14 , wherein said coil is used for bi-directional telemetry, or receiving electrical pulses from said external stimulator.  
   
   
       20 . A system of  claim 14 , 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 14 , wherein said rechargeable implanted pulse generator further comprises one or two feed-through(s) for unipolar or bipolar configurations respectively.  
   
   
       22 . A system of  claim 14 , 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 electrical pulses to said gastric wall of a patient.  
   
   
       23 . A system of  claim 14 , 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 14 , 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.