US2018001087A1PendingUtilityA1

Implantable Electro-Medical Device Programmable for Improved Operational Life

50
Assignee: ENDOSTIM INCPriority: Nov 17, 2014Filed: May 15, 2017Published: Jan 4, 2018
Est. expiryNov 17, 2034(~8.3 yrs left)· nominal 20-yr term from priority
A61N 1/36135A61N 1/36125A61N 1/3787G01R 31/382G06F 1/3203A61N 1/36007A61N 1/378A61N 1/3708G01R 31/3606
50
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Claims

Abstract

A device for electrically stimulating one or more anatomical target sites in a patient and for use in the treatment of a plurality of biological conditions of the patient. The device has a pulse generator providing electrical stimulation to the anatomical target sites; a power source for powering the pulse generator; stimulator electrodes connected to the pulse generator for stimulating the anatomical target sites; one or more optional sensing electrodes for monitoring physiological parameters with reference to the anatomical target sites; and a microprocessor programmed to vary a plurality of therapy protocol parameters governing the electrical stimulation to thereby modify operational life parameters of the power source.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A device for electrical stimulation of one or more anatomical target sites in a patient and for use in the treatment of a plurality of biological conditions of the patient, said device comprising:
 a pulse generator providing electrical stimulation to said one or more anatomical target sites, wherein said electrical stimulation comprises a stimulation current;   a power source for powering said pulse generator;   at least one stimulator electrode connected to said pulse generator for stimulating said one or more anatomical target sites; and,   a microprocessor programmed to vary a plurality of therapy protocol parameters governing the electrical stimulation to thereby modify operational life parameters of the power source, wherein the therapy protocol parameters and the operational life of the power source are associated according to the following relations:   
       
         
           
             
               
                 
                   L 
                   BAT 
                 
                 = 
                 
                   
                     
                       CAP 
                       BAT 
                     
                     · 
                     
                       eff 
                       USE 
                     
                   
                   
                     I 
                     BAT 
                   
                 
               
               , 
               
                 
 
               
                
               where 
             
           
         
         
           
             
               
                 I 
                 BAT 
               
               = 
               
                 [ 
                 
                   
                     
                       [ 
                       
                         
                           ( 
                           
                             
                               eff 
                               TH 
                             
                             · 
                             
                               I 
                               TH 
                             
                             · 
                             
                               
                                 
                                   V 
                                   TH 
                                 
                                 + 
                                 
                                   V 
                                   OH 
                                 
                               
                               
                                 V 
                                 BAT 
                               
                             
                             · 
                             PRF 
                             · 
                             PW 
                           
                           ) 
                         
                         + 
                         
                           I 
                           SOH 
                         
                       
                       ] 
                     
                     · 
                     
                       DC 
                       TH 
                     
                   
                   + 
                   
                     
                       I 
                       SLP 
                     
                     · 
                     
                       ( 
                       
                         1 
                         - 
                         
                           DC 
                           TH 
                         
                       
                       ) 
                     
                   
                   + 
                   
                     I 
                     TM 
                   
                 
                 ] 
               
             
           
         
         wherein eff TH  is a function of an output stimulation circuit current divided by an input stimulation circuit current; wherein I SOH  is equal to an amount of current required to run the device and not including the stimulation current; wherein L BAT  is a function of power source service life; wherein CAP BAT  is a function of power source capacity; wherein eff USE  is a function of a usable efficiency of power source; wherein I BAT  is a function of power source current; wherein I TH  is a function of a level of current exiting the device from an output terminal; wherein V TH  is a function of a level of voltage at an output terminal of the device; wherein V OH  is a function of an overhead output voltage; wherein V BAT  is a function of a power source voltage; wherein PRF is a function of a pulse repetition frequency; wherein PW is a function of a pulse width; wherein DC TH  is a function of a duty cycle; wherein I SLP  is a function of sleep current; and wherein I TM  is a function of average telemetry current. 
       
     
     
         2 . The device of  claim 1 , wherein said power source is a battery. 
     
     
         3 . The device of  claim 2 , wherein said battery is rechargeable. 
     
     
         4 . The device of  claim 2 , wherein said battery is non-rechargeable. 
     
     
         5 . The device of  claim 2 , wherein the operational life parameters of the battery comprise battery capacity, usable efficiency of battery due to end of life efficiency, and battery current. 
     
     
         6 . The device of  claim 1 , wherein said power source is a capacitor. 
     
     
         7 . The device of  claim 1 , wherein said therapy protocol parameters, for an electrical stimulation pulse train, comprise: number of pulses, shape of pulses, interval between pulse train repetitions, duration of a pulse, timing and amplitude of pulses, amperage to be provided to said one or more anatomical target sites, potential to be provided to said one or more anatomical target sites, and duty cycles. 
     
     
         8 . The device of  claim 1 , further comprising at least one sensor for monitoring at least one physiological parameter of said patient. 
     
     
         9 . The device of  claim 8 , wherein said microprocessor modifies said therapy protocol parameters based upon physiological information sensed by said at least one sensor. 
     
     
         10 . A device for electrical stimulation of one or more anatomical target sites in a patient and for use in the treatment of a plurality of biological conditions of the patient, said device comprising:
 a pulse generator providing electrical stimulation to said one or more anatomical target sites;   a power source for powering said pulse generator;   at least one stimulator electrode connected to said pulse generator for stimulating said one or more anatomical target sites;   a microprocessor programmed to vary a plurality of therapy protocol parameters governing the electrical stimulation to thereby modify operational life parameters of the power source, wherein the therapy protocol parameters and the operational life of the power source are associated according to the following relations:   
       
         
           
             
               
                 
                   L 
                   BAT 
                 
                 = 
                 
                   
                     
                       CAP 
                       BAT 
                     
                     · 
                     
                       eff 
                       USE 
                     
                   
                   
                     I 
                     BAT 
                   
                 
               
               , 
               
                 
 
               
                
               where 
             
           
         
         
           
             
               
                 
                   I 
                   BAT 
                 
                 = 
                 
                   [ 
                   
                     
                       
                         [ 
                         
                           
                             ( 
                             
                               
                                 eff 
                                 TH 
                               
                               · 
                               
                                 I 
                                 TH 
                               
                               · 
                               
                                 
                                   
                                     V 
                                     TH 
                                   
                                   + 
                                   
                                     V 
                                     OH 
                                   
                                 
                                 
                                   V 
                                   BAT 
                                 
                               
                               · 
                               PRF 
                               · 
                               PW 
                             
                             ) 
                           
                           + 
                           
                             I 
                             SOH 
                           
                         
                         ] 
                       
                       · 
                       
                         DC 
                         TH 
                       
                     
                     + 
                     
                       
                         I 
                         SLP 
                       
                       · 
                       
                         ( 
                         
                           1 
                           - 
                           
                             DC 
                             TH 
                           
                         
                         ) 
                       
                     
                     + 
                     
                       I 
                       TM 
                     
                   
                   ] 
                 
               
               ; 
             
           
         
       
       and,
 at least one sensor connected to said microprocessor for sensing at least one physiological parameter of said patient; 
 wherein eff TH  is a function of an output stimulation circuit current divided by an input stimulation circuit current; wherein I SOH  is equal to an amount of current required to run the device and not including the stimulation current; wherein L BAT  is a function of power source service life; wherein CAP BAT  is a function of power source capacity; wherein eff USE  is a function of a usable efficiency of power source; wherein I BAT  is a function of power source current; wherein I TH  is a function of a level of current exiting the device from an output terminal; wherein V TH  is a function of a level of voltage at an output terminal of the device; wherein V OH  is a function of an overhead output voltage; wherein V BAT  is a function of a power source voltage; wherein PRF is a function of a pulse repetition frequency; wherein PW is a function of a pulse width; wherein DC TH  is a function of a duty cycle; wherein I SLP  is a function of sleep current; and wherein I TM  is a function of average telemetry current. 
 
     
     
         11 . The device of  claim 10 , wherein said power source is a battery. 
     
     
         12 . The device of  claim 11 , wherein said battery is rechargeable. 
     
     
         13 . The device of  claim 11 , wherein said battery is non-rechargeable. 
     
     
         14 . The device of  claim 11 , wherein the operational life parameters of the battery comprise battery capacity, usable efficiency of battery due to end of life efficiency, and battery current. 
     
     
         15 . The device of  claim 10 , wherein said power source is a capacitor. 
     
     
         16 . The device of  claim 10 , wherein said therapy protocol parameters, for an electrical stimulation pulse train, comprise: number of pulses, shape of pulses, interval between pulse train repetitions, duration of a pulse, timing and amplitude of pulses, amperage to be provided to said one or more anatomical target sites, potential to be provided to said one or more anatomical target sites, and duty cycles. 
     
     
         17 . A system for electrical stimulation of one or more anatomical target sites in a patient and for use in the treatment of a plurality of biological conditions of the patient, said system comprising:
 a pulse generator providing electrical stimulation to said one or more anatomical target sites;   a power source for powering said pulse generator;   at least one stimulator electrode connected to said pulse generator for stimulating said one or more anatomical target sites; and,   a microprocessor programmed to vary a plurality of therapy protocol parameters governing the electrical stimulation to thereby modify operational life parameters of the power source, wherein the therapy protocol parameters and the operational life of the power source are associated according to the following relations:   
       
         
           
             
               
                 
                   L 
                   BAT 
                 
                 = 
                 
                   
                     
                       CAP 
                       BAT 
                     
                     · 
                     
                       eff 
                       USE 
                     
                   
                   
                     I 
                     BAT 
                   
                 
               
               , 
               
                 
 
               
                
               where 
             
           
         
         
           
             
               
                 I 
                 BAT 
               
               = 
               
                 [ 
                 
                   
                     
                       [ 
                       
                         
                           ( 
                           
                             
                               eff 
                               TH 
                             
                             · 
                             
                               I 
                               TH 
                             
                             · 
                             
                               
                                 
                                   V 
                                   TH 
                                 
                                 + 
                                 
                                   V 
                                   OH 
                                 
                               
                               
                                 V 
                                 BAT 
                               
                             
                             · 
                             PRF 
                             · 
                             PW 
                           
                           ) 
                         
                         + 
                         
                           I 
                           SOH 
                         
                       
                       ] 
                     
                     · 
                     
                       DC 
                       TH 
                     
                   
                   + 
                   
                     
                       I 
                       SLP 
                     
                     · 
                     
                       ( 
                       
                         1 
                         - 
                         
                           DC 
                           TH 
                         
                       
                       ) 
                     
                   
                   + 
                   
                     I 
                     TM 
                   
                 
                 ] 
               
             
           
         
         wherein eff TH  is a function of an output stimulation circuit current divided by an input stimulation circuit current; wherein I SOH  is equal to an amount of current required to run the device and not including the stimulation current; wherein L BAT  is a function of power source service life; wherein CAP BAT  is a function of power source capacity; wherein eff USE  is a function of a usable efficiency of power source; wherein I BAT  is a function of power source current; wherein I TH  is a function of a level of current exiting the device from an output terminal; wherein V TH  is a function of a level of voltage at an output terminal of the device; wherein V OH  is a function of an overhead output voltage; wherein V BAT  is a function of a power source voltage; wherein PRF is a function of a pulse repetition frequency; wherein PW is a function of a pulse width; wherein DC TH  is a function of a duty cycle; wherein I SLP  is a function of sleep current; and wherein I TM  is a function of average telemetry current. 
       
     
     
         18 . The system of  claim 17 , wherein said power source is a battery. 
     
     
         19 . The system of  claim 18 , wherein said battery is rechargeable. 
     
     
         20 . The system of  claim 18 , wherein said battery is non-rechargeable.

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