Implantable pulse generator for providing functional and/or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue

Abstract

Improved assemblies, systems, and methods provide an implantable pulse generator for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The implantable pulse generator is sized and configured to be implanted subcutaneously in a tissue region. The implantable pulse generator includes an electrically conductive laser welded titanium case. Control circuitry is located within the case, and includes a primary cell or rechargeable power source, a receive coil for receiving an RF magnetic field to recharge the rechargeable power source, and a microcontroller for control of the implantable pulse generator. Improved assemblies, systems, and methods also provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system provides at least one electrically conductive surface, a lead connected to the electrically conductive surface, and an implantable pulse generator electrically connected to the lead.

1 - 13 . (canceled) 
     
     
         14 . A stimulation system comprising:
 at least one electrode; and   an implantable pulse generator including a rechargeable battery,   wherein the implantable pulse generator is configured to deliver electrical stimulation via the at least one electrode,   wherein the implantable pulse generator comprises non-inductive wireless telemetry circuitry and inductive wireless telemetry circuitry, the inductive wireless telemetry circuitry comprising a power receiving coil configured to transcutaneously receive a radio frequency magnetic field from an external controller to recharge the rechargeable battery, and   wherein the implantable pulse generator is configured to communicate with the external controller via the non-inductive wireless telemetry circuitry during recharging of the rechargeable battery.   
     
     
         15 . The system of  claim 14 , wherein the non-inductive wireless telemetry circuitry of the implantable pulse generator is configured to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator. 
     
     
         16 . The system of  claim 15 , wherein the VHF/UHF signals are defined by a frequency in the Medical Implant Communications Service (MICS) band between about 402 MHz and about 405 MHz. 
     
     
         17 . The system of  claim 14 , wherein the implantable pulse generator is configured to communicate with the external controller via the non-inductive wireless telemetry circuitry to instruct the external controller to increase or decrease the strength of the radio frequency magnetic field during recharging of the rechargeable battery. 
     
     
         18 . The system of  claim 14 , wherein the radio frequency magnetic field comprises a frequency between about 30 KHz and about 300 KHz. 
     
     
         19 . The system of  claim 14 , wherein a thickness of a pulse generator housing is between about 5 mm and 15 mm, a width of the pulse generator housing is between about 45 mm and 60 mm, and a length of the pulse generator housing is between about 45 mm and 60 mm. 
     
     
         20 . The system of  claim 14 , wherein the non-inductive wireless telemetry circuitry including a transceiver to listen for commands from the external controller at a predetermined rate and to respond to the commands in synchronization with when the external controller is configured to listen for the response 
     
     
         21 . The system of  claim 14 , wherein the pulse generator includes at least three power management operating modes including an active mode, an active and charging mode, and a dormant mode. 
     
     
         22 . The system of  claim 14 , further comprising the external controller. 
     
     
         23 . A method comprising:
 recharging a rechargeable battery of an implantable pulse generator,   wherein the implantable pulse generator comprises non-inductive wireless telemetry circuitry and inductive wireless telemetry circuitry, the inductive wireless telemetry circuitry comprising a power receiving coil,   wherein recharging the rechargeable battery comprises transcutaneously receiving a radio frequency magnetic field from an external controller via the power receiving coil of the inductive wireless telemetry circuitry; and   communicating with the external controller via the non-inductive wireless telemetry circuitry during at least a portion of the recharging of the rechargeable battery.   
     
     
         24 . The method of  claim 23 , wherein the non-inductive wireless telemetry circuitry of the implantable pulse generator receives and transmits VHF/UHF signals for programming and interrogation of the implantable pulse generator. 
     
     
         25 . The method of  claim 24 , wherein the VHF/UHF signals are defined by a frequency in the MICS (Medical Implant Communications Service) band between about 402 MHz and about 405 MHz. 
     
     
         26 . The method of  claim 23 , wherein communicating with the external controller via the non-inductive wireless telemetry circuitry during recharging of the rechargeable battery comprises instructing the external controller to increase or decrease the strength of the radio frequency magnetic field during recharging of the rechargeable battery. 
     
     
         27 . The method of  claim 23 , wherein the radio frequency magnetic field comprises a frequency between about 30 KHz and about 300 KHz. 
     
     
         28 . The method of  claim 23 , wherein a thickness of the pulse generator housing is between about 5 mm and 15 mm, a width of the pulse generator housing is between about 45 mm and 60 mm, and a length of the pulse generator housing is between about 45 mm and 60 mm. 
     
     
         29 . The method of  claim 23 , wherein the non-inductive wireless telemetry circuitry includes a transceiver configured to listen for commands from the external controller at a predetermined rate and to respond to the commands in synchronization with when the external controller is configured to listen for the response. 
     
     
         30 . The method of  claim 23 , wherein the pulse generator includes at least three power management operating modes including an active mode, an active and charging mode, and a dormant mode. 
     
     
         31 . The method of  claim 23 , further comprising transmitting the radio frequency magnetic field via the external controller. 
     
     
         32 . A neuromuscular stimulation system comprising:
 at least one electrode; and   means for delivering electrical stimulation via the at least one electrode, the means for delivering electrical stimulation including:
 a rechargeable battery, 
 means for transcutaneously receiving a radio frequency magnetic field from an external controller to recharge the rechargeable battery, the means for transcutaneously receiving the radio frequency magnetic field from the external controller comprising means for transcutaneously receiving the magnetic field via inductive wireless telemetry, and 
 means for communicating with the external controller via non-inductive wireless telemetry during recharging of the rechargeable battery. 
   
     
     
         33 . The system of  claim 32 , wherein the means for communicating with the external controller via non-inductive wireless telemetry comprises means for receiving and transmitting VHF/UHF signals for programming and interrogation of the means for delivering electrical stimulation via the at least one electrode. 
     
     
         34 . The system of  claim 32 , wherein the means for delivering electrical stimulation via the at least one electrode is configured to communicate with the external controller via the means for communicating with the external controller via non-inductive wireless telemetry to instruct the external controller to increase or decrease the strength of the radio frequency magnetic field during recharging of the rechargeable battery.