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

• US 7,813,809 B2
• Filed: 06/10/2005
• Issued: 10/12/2010
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/150,535
• Publication Number:
  US 20050278000A1
• Time in Patent Office: 1,950 Days
• Field of Search: 607 29- 38, 607 59- 61, 128897-899, 128/903, 128/904
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry

Abstract

An implantable pulse generator for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination is sized and configured to be implanted in subcutaneous tissue. 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, non-inductive wireless telemetry circuitry, and a microcontroller for control of the implantable pulse generator. A stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination comprises at least one electrically conductive surface, a lead connected to the electrically conductive surface, and an implantable pulse generator electrically connected to the lead.

Claims

1. A neuromuscular stimulation system comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region;

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue; and

an implantable pulse generator including a rechargeable battery, wherein the implantable pulse generator is sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface,

the implantable pulse generator comprising a non-inductive wireless telemetry circuitry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from a patient, and being adapted to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator, the inductive wireless telemetry circuitry including a coil adapted to receive the magnetic field from an external controller to recharge the rechargeable battery,

the implantable pulse generator adapted to communicate with the external controller using the non-inductive wireless telemetry to instruct the external controller to increase or decrease the strength of the magnetic field during recharging for optimal battery charging, while at the same time, the implantable pulse generator adapted to receive the magnetic field to recharge the rechargeable battery, and

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.

2. A system according to claim 1, wherein the implantable pulse generator includes an antenna for transmission and reception of the non-inductive wireless telemetry signals.

3. A system according to claim 1, further including the external controller, wherein the external controller is adapted to download program stimulus parameters and stimulus sequence parameters into the implantable pulse generator, and to upload operational data from the implantable pulse generator, the external controller acting as a master and utilizing the non-inductive wireless telemetry for all communications with the implantable pulse generator.

4. A system according to claim 1,

wherein the implantable pulse generator includes a lead connection header for electrically coupling the lead to the implantable pulse generator, the lead connection header enabling reliable replacement of the implantable pulse generator.

5. A system according to claim 1,

wherein the implantable pulse generator is sized and configured for implanting in subcutaneous tissue at an implant depth of between about 0.5 cm and about 1.5 cm.

6. A system according to claim 1,

wherein the implantable pulse generator includes at least one power management operating mode.

7. A system according to claim 1,

wherein the implantable pulse generator includes at least three power management operating modes including an active mode, an idle mode, and a dormant mode.

8. A system according to claim 1,

wherein the implantable pulse generator outputs a pulse having a biphasic waveform, the biphasic waveform including a net DC current of less than about 10 μ

A, an interphase delay, an amplitude of up to about 15 mA, and a pulse duration up to about 500 μ

sec.

9. A system according to claim 1,

wherein the implantable pulse generator provides stimulus pulses for the treatment of indications selected from the group consisting of urinary incontinence, fecal incontinence, micturition/retention, defecation/constipation, restoration of sexual function, pelvic floor muscle activity, pelvic pain, deep brain stimulation, obstructive sleep apnea, gastric function, and restoration of motor control.

10. A system according to claim 1, wherein the implantable pulse generator comprises a case having a size between about 5 mm and about 10 mm thick, between about 15 mm and about 25 mm wide, and between about 40 mm and about 50 mm long.

11. A system according to claim 1, wherein the implantable pulse generator further comprises a housing having a metallic portion and a non-metallic portion, and an antenna located at least partially inside the non-metallic portion, the antenna for transmission and reception of the non-inductive wireless telemetry signals.

12. A system according to claim 11, wherein the non-metallic portion comprises a non-metallic lead connection header.

26. A system according to claim 1 or 20 or 24,

wherein the predetermined rate ranges from more than one listen per second to one listen every other second.

27. A system according to claim 1 or 20 or 24,

wherein the timing of the synchronization is controlled by a time base established by a crystal.

28. A system according to claim 1 or 20 or 24, further including the external controller, wherein the

external controller comprises non-inductive wireless telemetry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the external controller adapted to time when the implantable pulse generator responds to a command and then to synchronize its commands with when the implantable pulse generator will be listening for commands, while at the same time, the external controller adapted to provide the magnetic field to the implantable pulse generator to recharge the rechargeable battery.

13. A method of using a neuromuscular stimulation system comprising:

providing at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region, the at least one electrically conductive surface including a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue;

providing an implantable pulse generator including a rechargeable battery, wherein the implantable pulse generator is sized and configured to be positioned in subcutaneous tissue remote from the at least one electrically conductive surface, the implantable pulse generator comprising non-inductive wireless telemetry circuitry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from a patient, and being adapted to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator, the non-inductive wireless telemetry circuitry including a transceiver to listen for commands from an 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, the inductive wireless telemetry circuitry including a coil for receiving the magnetic field from an external controller for recharging the rechargeable battery;

implanting the at least one electrically conductive surface in a targeted neural or muscular tissue region;

implanting the lead in subcutaneous tissue;

implanting the pulse generator in a region remote from the at least one electrically conductive surface;

coupling the pulse generator to the lead implanted in subcutaneous tissue;

operating the pulse generator to use the non-inductive wireless telemetry to be listening for commands from the external controller at the predetermined rate and to be responding to the commands in synchronization with when the external controller is listening for the response; and

operating the implantable pulse generator to be responding to the external controller using the non-inductive wireless telemetry and instructing the external controller to increase or decrease the strength of the magnetic field during recharging, while at the same time, the implantable pulse generator receiving the magnetic field and recharging the rechargeable battery.

14. A method according to claim 13,

wherein the predetermined rate ranges from listening more than once per second to listening once every other second.

15. A method according to claim 13,

wherein the timing of the synchronization is controlled by a time base established by a crystal.

16. A method according to claim 13, further including:

providing an external controller comprising a non-inductive wireless telemetry using VHF/UHF signals, and an inductive wireless telemetry circuitry using a radio frequency magnetic field, and

wherein the external controller is configured to time when the implantable pulse generator responds to a command such that the external controller synchronizes its commands with when the implantable pulse generator will be listening for commands, while at the same time, the external controller is configured to provide the magnetic field to the implantable pulse generator to recharge the rechargeable battery.

17. A method according to claim 13, wherein the implantable pulse generator comprises a case having a size between about 5 mm and about 10 mm thick, between about 15 mm and about 25 mm wide, and between about 40 mm and about 50 mm long.

18. A method according to claim 13, wherein the implantable pulse generator further comprises a housing having a metallic portion and a non-metallic portion, and an antenna located at least partially inside the non-metallic portion, the antenna being configured for transmission and reception of the non-inductive wireless telemetry signals.

19. A method according to claim 18, wherein the non-metallic portion comprises a non-metallic lead connection header.

20. A neuromuscular stimulation system comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region;

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue; and

an implantable pulse generator including a rechargeable battery, wherein the implantable pulse generator is sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface,

the implantable pulse generator comprising non-inductive wireless telemetry circuitry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from a patient, and being adapted to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator, the inductive wireless telemetry circuitry including a coil adapted to receive the magnetic field from an external controller to recharge the rechargeable battery,

the non-inductive wireless telemetry circuitry including a transceiver to listen for commands from the external controller at a predetermined rate,

the non-inductive wireless telemetry circuitry including a transceiver to listen for commands and not respond to 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, and

the implantable pulse generator adapted to communicate with the external controller using the non-inductive wireless telemetry to instruct the external controller to increase or decrease the strength of the magnetic field during recharging for optimal battery charging, while at the same time, the implantable pulse generator adapted to receive the magnetic field to recharge the rechargeable battery.

21. A system according to claim 20, wherein the implantable pulse generator comprises a case having a size between about 5 mm and about 10 mm thick, between about 15 mm and about 25 mm wide, and between about 40 mm and about 50 mm long.

22. A system according to claim 20, wherein the implantable pulse generator further comprises a housing having a metallic portion and a non-metallic portion, and an antenna located at least partially inside the non-metallic portion, the antenna being configured for transmission and reception of the non-inductive wireless telemetry signals.

23. A system according to claim 22, wherein the non-metallic portion comprises a non-metallic lead connection header.

24. A neuromuscular stimulation system comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region;

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue; and

an implantable pulse generator including a rechargeable battery, wherein the implantable pulse generator is sized and configured to be coupled to the lead and positioned in subcutaneous tissue remote from the at least one electrically conductive surface,

the implantable pulse generator comprising non-inductive wireless telemetry circuitry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from a patient, and being adapted to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator, the inductive wireless telemetry circuitry including a coil adapted to receive the magnetic field from an external controller to recharge the rechargeable battery,

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,

the non-inductive wireless telemetry circuitry configured to have commands issued from the external controller within a predetermined time of a last command to be received by the implantable pulse generator without having the external controller broadcast an idle or pause signal for the predetermined rate before issuing the command in order to know that the implantable pulse generator will have enabled its transceiver and received the command, and

the implantable pulse generator adapted to communicate with the external controller using the non-inductive wireless telemetry to instruct the external controller to increase or decrease the strength of the magnetic field during recharging for optimal battery charging, while at the same time, the implantable pulse generator adapted to receive the magnetic field to recharge the rechargeable battery.

25. A system according to claim 24,

wherein the predetermined time ranges from one command issued per second to one command issued per five minutes.

29. A system according to claim 24, wherein the implantable pulse generator comprises a case having a size between about 5 mm and about 10 mm thick, between about 15 mm and about 25 mm wide, and between about 40 mm and about 50 mm long.

30. A system according to claim 24, wherein the implantable pulse generator further comprises a housing having a metallic portion and a non-metallic portion, and an antenna located at least partially inside the non-metallic portion, the antenna being configured for transmission and reception of the non-inductive wireless telemetry signals.

31. A system according to claim 30, wherein the non-metallic portion comprises a non-metallic lead connection header.

32. A method of using a neuromuscular stimulation system comprising:

providing at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region, the at least one electrically conductive surface including a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned in subcutaneous tissue;

providing an implantable pulse generator including a rechargeable battery, wherein the implantable pulse generator is sized and configured to be positioned in subcutaneous tissue remote from the at least one electrically conductive surface, the implantable pulse generator comprising non-inductive wireless telemetry circuitry using VHF/UHF signals, and inductive wireless telemetry circuitry using a radio frequency magnetic field, the non-inductive wireless telemetry circuitry being functional at a distance as far as arm'"'"'s reach away from a patient, and being adapted to receive and transmit VHF/UHF signals for programming and interrogation of the implantable pulse generator, the inductive wireless telemetry circuitry including a coil for receiving the magnetic field from an external controller for recharging the rechargeable battery;

implanting the at least one electrically conductive surface in a targeted neural or muscular tissue region;

implanting the lead in subcutaneous tissue;

implanting the pulse generator in a region remote from the at least one electrically conductive surface;

coupling the pulse generator to the lead implanted in subcutaneous tissue; and

operating the implantable pulse generator to be responding to the external controller using the non-inductive wireless telemetry and instructing the external controller to increase or decrease the strength of the magnetic field during recharging, while simultaneously, the implantable pulse generator receiving the magnetic field and recharging the rechargeable battery.

33. A method according to claim 32, wherein the implantable pulse generator comprises a case having a size between about 5 mm and about 10 mm thick, between about 15 mm and about 25 mm wide, and between about 40 mm and about 50 mm long.

34. A method according to claim 32, wherein the implantable pulse generator further comprises a housing having a metallic portion and a non-metallic portion, and an antenna located at least partially inside the non-metallic portion, the antenna being configured for transmission and reception of the non-inductive wireless telemetry signals.

35. A method according to claim 34, wherein the non-metallic portion comprises a non-metallic lead connection header.