Combined vagus-phrenic nerve stimulation device

Abstract

An implantable pulse generator (IPG) includes a respiration activity sensing unit configured to generate a signal representing respiration activity, a stimulation unit configured to generate nerve stimulation electric pulses, and a control unit configured to trigger delivery of the nerve stimulation electric pulses via a stimulation electrode on a stimulation lead connected to the implantable pulse generator. The triggering of the stimulation pulse delivery depends on the signal representing respiration activity.

What is claimed is: 
     
         1 . An implantable pulse generator ( 106 ) connected or connectable to a stimulation lead ( 100 ) having a stimulation electrode ( 107 ), the implantable pulse generator ( 106 ) including:
 a. a respiration activity sensing unit ( 54 ,  60 ) configured to generate a signal representing respiration activity,   b. a control unit ( 50 ) configured to trigger delivery of nerve stimulation electrical pulses via the stimulation electrode ( 107 ), wherein triggering of delivery depends on the signal representing respiration activity.   
     
     
         2 . The implantable pulse generator ( 106 ) of  claim 1  wherein the control unit ( 50 ) is configured to:
 a. generate a predictive respiration pattern from the signal representing respiration activity, and 
 b. trigger the stimulation pulses in dependence on the predictive respiration pattern. 
 
     
     
         3 . The implantable pulse generator ( 106 ) of  claim 1 :
 a. further including the stimulation lead ( 100 ), wherein the stimulation lead ( 100 ) has several stimulation electrodes ( 107 ),   b. the control unit ( 50 ) is configured to:
 (1) select one or more of the stimulation electrodes ( 107 ), and 
 (2) trigger delivery of nerve stimulation electrical pulses via the selected electrodes ( 107 ). 
   
     
     
         4 . The implantable pulse generator ( 106 ) of  claim 3  wherein at least some of the stimulation electrodes ( 107 ) are situated in a left superior intercostal vein ( 101 ) between a phrenic nerve ( 103 ) and a vagus nerve ( 104 ). 
     
     
         5 . The implantable pulse generator ( 106 ) of  claim 3  wherein one or more of the stimulation electrodes ( 107 ) extend about no more than half of the outer circumference of the stimulation lead ( 100 ). 
     
     
         6 . The implantable pulse generator ( 106 ) of  claim 1  wherein the control unit ( 50 ) is configured to trigger delivery of nerve stimulation electrical pulses when the signal representing respiration activity indicates a breathing pause. 
     
     
         7 . The implantable pulse generator ( 106 ) of  claim 1  wherein the control unit ( 50 ) is configured to trigger delivery of nerve stimulation electrical pulses when the signal representing respiration activity indicates decreased inspiration and expiration amplitudes. 
     
     
         8 . The implantable pulse generator ( 106 ) of  claim 1  wherein the signal representing respiration activity is a chest Respiration Effort Signal (REFFS). 
     
     
         9 . The implantable pulse generator ( 106 ) of  claim 8  wherein the respiration activity sensing unit ( 54 ):
 a. includes or is connected to an accelerometer, and 
 b. is configured to generate the chest Respiration Effort Signal (REFFS) from a signal from the accelerometer. 
 
     
     
         10 . The implantable pulse generator ( 106 ) of  claim 1  wherein the respiration activity sensing unit ( 60 ):
 a. includes or is connected to an impedance measurement unit ( 60 ) configured to generate an impedance signal representing intrathoracic impedance, and 
 b. is configured to generate the chest Respiration Effort Signal (REFFS) from the impedance signal. 
 
     
     
         11 . The implantable pulse generator ( 106 ) of  claim 1  further including a telemetry unit ( 72 ) configured to:
 a. receive programming, and/or 
 b. transmit recorded data and/or status information. 
 
     
     
         12 . The implantable pulse generator ( 106 ) of  claim 1  further including a heart monitoring unit that is configured to determine at least a heart rate. 
     
     
         13 . The implantable pulse generator ( 106 ) of  claim 1  further including:
 a. a case ( 20 ) enclosing at least a portion of the implantable pulse generator ( 106 ), wherein at least a portion of the case is electrically conductive; 
 b. a far-field electrogram (ff-EGM) sensing unit ( 56 ) connected to:
 (1) the case ( 20 ), and 
 (2) a stimulation electrode ( 107 ) of the stimulation lead ( 100 ), the far-field electrogram (ff-EGM) sensing unit ( 56 ) being configured to sense ff-EGM ( 600 ) signals. 
 
 
     
     
         14 . The implantable pulse generator ( 106 ) of  claim 1 :
 a. further including the stimulation lead ( 100 ),   b. wherein the stimulation lead ( 100 ) is a multi-electrode lead configured for placement in a left superior intercostal vein.   
     
     
         15 . A method for nerve stimulation including the steps of:
 a. sensing respiration activity,   b. delivering nerve stimulation electrical pulses via a stimulation electrode ( 107 ), wherein delivery is dependent on the sensed respiration activity.   
     
     
         16 . The method of  claim 15 :
 a. further including the step of determining a predictive respiration pattern based on the sensed respiration activity, and   b. wherein the delivery of the nerve stimulation electrical pulses is also dependent on the predictive respiration pattern.   
     
     
         17 . The method of  claim 15  wherein the nerve stimulation electrical pulses are delivered to a vagus nerve and/or a phrenic nerve. 
     
     
         18 . The method of  claim 15  wherein the nerve stimulation electrical pulses are delivered during a breathing pause ( 504 ). 
     
     
         19 . The method of  claim 15  wherein:
 a. the nerve stimulation electrical pulses are delivered via several stimulation electrodes ( 107 ) on a stimulation lead ( 100 ), 
 b. the several stimulation electrodes ( 107 ) are situated:
 (1) in a left superior intercostal vein ( 101 ), 
 (2) between a phrenic nerve ( 103 ) and a vagus nerve ( 104 ). 
 
 
     
     
         20 . An implantable pulse generator ( 106 )
 a. a respiration activity sensing unit ( 54 ,  60 ) configured to generate a signal representing respiration activity;   b. a stimulation lead ( 100 ) having a stimulation electrode ( 107 ) situated within a left superior intercostal vein between a phrenic nerve ( 103 ) and a vagus nerve ( 104 );   d. a control unit ( 50 ) configured to trigger delivery of electric stimulation pulses via the stimulation electrode ( 107 ) when the signal representing respiration activity indicates a breathing pause.