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

• US 20070060980A1
• Filed: 09/07/2006
• Published: 03/15/2007
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, LLC
• Inventors: Thrope, Geoffrey, Pack, Danny, Strother, Robert
• Granted Patent: US 9,308,382 B2
• Time in Patent Office: Days
• US Class Current: 607/61
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37514 Brain implants
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system includes an implantable pulse generator and a lead sized and configured to be implanted subcutaneously in a tissue region. An external controller includes circuitry adapted for wireless telemetry and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge a rechargeable battery in the pulse generator. Using wireless telemetry, the pulse generator is adapted to transmit status information back to the external controller to allow the external controller to automatically adjust up or down the magnitude of the radio frequency magnetic field and/or to instruct a user to reposition the charging coil, the status information adapted to allow optimal recharging of the pulse generator rechargeable battery.

Claims

1. An implantable pulse generator system comprising

a pulse generator comprising a housing sized and configured for implantation in subcutaneous tissue,

circuitry carried within the housing and adapted for wireless telemetry,

a rechargeable battery coupled to the circuitry and carried within the housing, the battery having a voltage,

a power receiving coil carried within the housing and coupled to the circuitry, the power receiving coil for transcutaneously receiving an externally generated radio frequency magnetic field to recharge the rechargeable battery,

an external controller including circuitry adapted for wireless telemetry, and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge the rechargeable battery, and

wherein during a battery recharge period, and using wireless telemetry, the pulse generator is adapted to transmit status information back to the external controller to allow the external controller to automatically adjust up or down the magnitude of the radio frequency magnetic field and/or to instruct a user to reposition the charging coil, the status information adapted to allow optimal recharging of the pulse generator rechargeable battery.

2. A pulse generator according to claim 1

wherein the instruction to the user is a visual instruction and/or an audio instruction.

3. A pulse generator according to claim 1

wherein the adjustment of the magnitude of the radio frequency magnetic field comprises an adjustment of up to about 300 percent of the initial magnitude.

4. A pulse generator according to claim 1

wherein the status information includes an indication of the battery charge status and an indication of the magnitude of power recovered by the receive coil.

5. A pulse generator according to claim 1

wherein the status information includes a magnitude of the battery voltage and a magnitude of a DC voltage recovered from the radio frequency magnetic field.

6. A pulse generator according to claim 1

wherein the pulse generator is exclusively the wireless telemetry communications slave, with all wireless telemetry communications initiated by the external controller.

7. A pulse generator according to claim 1

wherein the charging coil is coupled via a cable to the external controller.

8. A pulse generator according to claim 1

wherein the radio frequency magnetic field comprises a frequency between about 30KHz and about 300 KHz.

9. A pulse generator according to claim 1

wherein the wireless telemetry communication between the external controller and the pulse generator operates in the MICS (Medical Implant Communications Service) band at between about 402 MHz to about 405 MHz.

10. A pulse generator according to claim 1

wherein the charging coil comprises an outside diameter in the range of about 40 millimeters to about 70 millimeters, and a thickness as measured perpendicular to the diameter in the range of about three millimeters to about eleven millimeters.

11. A pulse generator according to claim 1

wherein the charging coil is adapted to maintain a temperature at or below about 41 degrees Celsius during a charging period.

12. A pulse generator according to claim 1

wherein the battery includes a capacity of at least 30 mA-hr and recharging of the rechargeable battery is required less than weekly.

13. A pulse generator according to claim 1

wherein the transcutaneously applied radio frequency magnetic field fully recharges the rechargeable battery in a time period of not more than six hours.

14. A pulse generator according to claim 1

wherein the housing comprises a thickness of between about 5 mm and 15 mm, a width of between about 30 mm and 60 mm, and a length of between about 45 mm and 60 mm.

15. A pulse generator according to claim 1

wherein the power receiving coil includes a maximum outside dimension X, and

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth D, such that the ratio of X/D is between about 0.8 to 1 and about 4 to 1.

16. A pulse generator according to claim 1

wherein an outer surface of the housing maintains a two degrees Celsius or less temperature rise during the time period in which the power receiving coil is transcutaneously receiving the externally generated radio frequency magnetic field.

17. A pulse generator according to claim 1

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth of between about five millimeters and about twenty millimeters.

18. An implantable pulse generator system comprising

a pulse generator comprising a housing sized and configured for implantation in subcutaneous tissue,

circuitry carried within the housing and adapted for wireless telemetry,

a rechargeable battery coupled to the circuitry and carried within the housing,

a power receiving coil carried within the housing and coupled to the circuitry, the power receiving coil for transcutaneously receiving an externally generated radio frequency magnetic field to recharge the rechargeable battery,

an external controller including circuitry adapted for wireless telemetry, and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge the rechargeable battery, and

wherein the pulse generator wireless telemetry circuitry includes a transceiver chip, the transceiver chip adapted to be off about 99 percent or more of the time for efficient power management, and is pulsed on periodically to search for a command from the external controller.

19. A pulse generator according to claim 18

wherein the wireless telemetry is configured to have the external controller issue commands to the pulse generator at timed intervals to confirm that the generated radio frequency magnetic field is adequate for recharging the rechargeable battery.

20. A pulse generator according to claim 18

wherein the circuitry within the housing further includes power management circuitry, the power management circuitry comprising at least three operating modes relating to the operation of the pulse generator, the operating modes including pulse generator active, pulse generator dormant, and pulse generator active and charging.

21. A pulse generator according to claim 18

wherein the battery includes a capacity of at least 30 ma-hr and recharging of the rechargeable battery is required less than weekly.

22. A pulse generator according to claim 18

wherein the transcutaneously applied radio frequency magnetic field fully recharges the rechargeable battery in a time period of not more than six hours.

23. A pulse generator according to claim 18

wherein the housing comprises a thickness of between about 5 mm and 15 mm, a width of between about 30 mm and 60 mm, and a length of between about 45 mm and 60 mm.

24. A pulse generator according to claim 18

wherein the power receiving coil includes a maximum outside dimension X, and

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth D, such that the ratio of X/D is between about 0.8 to 1 and about 4 to 1.

25. A pulse generator according to claim 18

wherein an outer surface of the housing maintains a two degrees Celsius or less temperature rise during the time period in which the power receiving coil is transcutaneously receiving the externally generated radio frequency magnetic field.

26. A pulse generator according to claim 18

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth of between about five millimeters and about twenty millimeters.

27. A pulse generator according to claim 18

wherein the circuitry within the housing further includes a microcontroller, the microcontroller adapted to generate a serial data stream, the serial data stream being converted by the pulse generator wireless telemetry circuitry into a pulsing carrier signal during a transmit process, and the pulse generator wireless telemetry circuitry adapted to convert a varying radio frequency signal strength into a serial data stream during a receive process.

28. An implantable pulse generator system comprising

a pulse generator comprising a housing sized and configured for implantation in subcutaneous tissue,

circuitry carried within the housing and adapted for wireless telemetry,

a rechargeable battery coupled to the circuitry and carried within the housing,

a power receiving coil carried within the housing and coupled to the circuitry, the power receiving coil for transcutaneously receiving an externally generated radio frequency magnetic field to recharge the rechargeable battery,

an external controller including circuitry, a rechargeable battery coupled to the circuitry, and the circuitry adapted for wireless telemetry, a charging coil coupled to the external controller for generating the radio frequency magnetic field to transcutaneously recharge the rechargeable battery, and

wherein during a rechargeable battery recharge period, the external controller is adapted to be carried by a user with no connection to a power main to allow the user to be completely mobile.

29. A pulse generator according to claim 28

wherein the battery includes a capacity of at least 30 mA-hr and recharging of the rechargeable battery is required less than weekly.

30. A pulse generator according to claim 28

wherein the transcutaneously applied radio frequency magnetic field fully recharges the rechargeable battery in a time period of not more than six hours.

31. A pulse generator according to claim 28

wherein the housing comprises a thickness of between about 5 mm and 15 mm, a width of between about 30 mm and 60 mm, and a length of between about 45 mm and 60 mm.

32. A pulse generator according to claim 28 wherein the power receiving coil includes a maximum outside dimension X, and

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth D, such that the ratio of X/D is between about 0.8 to 1 and about 4 to 1.

33. A pulse generator according to claim 28

wherein an outer surface of the housing maintains a two degrees Celsius or less temperature rise during the time period in which the power receiving coil is transcutaneously receiving the externally generated radio frequency magnetic field.

34. A pulse generator according to claim 28

wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth of between about five millimeters and about twenty millimeters.

35. An implantable pulse generator comprising:

a stimulation component having an on state to generate a stimulation pulse and an off state,

a receiver component selectively enabled to receive information using wireless telemetry, and

a controller coupled to the stimulation component and the receiver component to enable operation of the receiver component only when the stimulation component is in the off state.

36. An implantable pulse generator comprising:

a case,

a rechargeable battery positioned within the case to provide operating power,

charge management circuitry positioned within the case and coupled to the rechargeable battery, the charge management circuitry implementing a constant current phase and a constant voltage phase charge regime,

a controller positioned within the case and coupled to the charge management circuitry, the controller for timing the constant voltage phase of the rechargeable battery charge regime,

a receive coil positioned in the case and coupled to the rechargeable battery, the receive coil receiving externally generated energy from a recharger to recharge the rechargeable battery,

wherein a fully discharged rechargeable battery is recharged in less than about six hours.

37. The implantable pulse generator according to claim 36

wherein the controller further monitors the rechargeable battery voltage and terminates the charge regime after the rechargeable battery voltage has been in the constant voltage phase for greater than a predetermined time period.

38. The implantable pulse generator according to claim 37

wherein the controller terminates the charge regime by wireless telemetry communication with the recharger and instructing the recharger to stop recharging.

39. A method of wireless telemetry communication of status information between an implanted pulse generator and an external controller comprising

providing a pulse generator comprising a housing sized and configured for implantation in subcutaneous tissue, circuitry carried within the housing and adapted for wireless telemetry, a rechargeable battery coupled to the circuitry and carried within the housing, the battery having a voltage, a power receiving coil carried within the housing and coupled to the circuitry, the power receiving coil for transcutaneously receiving an externally generated radio frequency magnetic field to recharge the rechargeable battery,

providing an external controller including circuitry adapted for wireless telemetry, and a charging coil for generating the radio frequency magnetic field to transcutaneously recharge the rechargeable battery, and

during a battery recharge period and using wireless telemetry, the pulse generator transmitting status information back to the external controller to allow the external controller to automatically adjust up or down the magnitude of the radio frequency magnetic field and/or to instruct a user to reposition the charging coil, the status information adapted to allow optimal recharging of the pulse generator rechargeable battery.

40. A method according to claim 39

wherein the instruction to the user is a visual instruction and/or an audio instruction.

41. A method according to claim 40 further comprising

providing an instruction sheet to the user, the instruction sheet defining how to reposition the charging coil for optimal recharging based on the visual and/or audio indication provided by the external controller.