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 10,434,320 B2
• Filed: 08/07/2017
• Issued: 10/08/2019
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Inventors: Strother, Robert B., Thrope, Geoffrey B., Pack, Danny R.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US15/670,712
• Publication Number:
  US 20180021587A1
• Time in Patent Office: 792 Days
• 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. A system comprising

an implantable electrical stimulation generator comprising:

a housing,

first circuitry carried within the housing and configured for wireless telemetry using at least one of UHF signals or VHF signals,

an antenna coupled to the first circuitry and configured to at least one of receive or transmit the at least one of UHF signals or VHF signals of the wireless telemetry,

a rechargeable battery carried within the housing, and

a power receiving coil carried within the housing, the power receiving coil configured to transcutaneously receive an externally generated radio frequency magnetic field, wherein the rechargeable battery is configured to be recharged via the transcutaneously received externally generated radio frequency magnetic field;

an external controller including second circuitry; and

a charging coil configured to generate the radio frequency magnetic field, and

wherein, during a battery recharge period, and using the wireless telemetry, the implantable electrical stimulation generator is configured to transmit status information back to the external controller, wherein the status information includes at least one of an indication of a magnitude of power recovered by the power receiving coil, an indication of a magnitude of a voltage of the rechargeable battery, or an indication of a magnitude of a DC voltage recovered from the radio frequency magnetic field,

wherein the external controller is configured to control a temperature of the system by automatically causing the charging coil to adjust a magnitude of the generated radio frequency magnetic field based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

2. The system of claim 1, wherein the external controller is configured to limit a temperature rise in the implantable electrical stimulation generator during the battery recharge period by automatically causing the charging coil to adjust the magnitude of the generated radio frequency magnetic field based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

3. The system of claim 1, wherein the external controller is configured to limit a temperature rise of an outer surface of the implantable electrical stimulation generator during the battery recharge period by automatically causing the charging coil to adjust the magnitude of the generated radio frequency magnetic field based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

4. The system of claim 3, wherein the external controller is configured to limit the temperature rise of the outer surface of the implantable electrical stimulation generator during the battery recharge period to two degrees Celsius or less by automatically causing the charging coil to adjust the magnitude of the generated radio frequency magnetic field based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

5. The system of claim 1, wherein, during the battery recharge period, the charging coil maintains a temperature at or below about 41 degrees Celsius.

6. The system of claim 1, wherein the external controller is configured to automatically cause the charging coil to increase the magnitude of the generated radio frequency magnetic field during the battery recharge period based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

7. The system of claim 1, wherein the external controller is configured to automatically cause the charging coil to decrease the magnitude of the generated radio frequency magnetic field during the battery recharge period based on the at least one of the indication of the magnitude of power recovered by the power receiving coil, the indication of the magnitude of a voltage of the rechargeable battery, or the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

8. The system of claim 1, wherein the transcutaneously received externally generated radio frequency magnetic field is configured to fully recharge the rechargeable battery in a time period of not more than six hours.

9. The system of claim 1, wherein the external controller is configured to generate feedback to a user based on the transmitted status information.

10. The system of claim 1, wherein the external controller is configured to generate instructions to a user to reposition the charging coil based on the transmitted status information.

11. The system of claim 10, wherein the instructions to the user comprise a visual instruction.

12. The system of claim 10, wherein the instructions to the user comprise an audio instruction.

13. The system of claim 1, wherein the charging coil is coupled to the external controller via at least a cable.

14. The system of claim 1, wherein the status information includes the indication of a magnitude of power recovered by the power receiving coil, and wherein the external controller is configured to control a temperature of the system by automatically causing the charging coil to adjust a magnitude of the generated radio frequency magnetic field based on the indication of the magnitude of power recovered by the power receiving coil.

15. The system of claim 1, wherein the status information includes the indication of a magnitude of a voltage of the rechargeable battery, and wherein the external controller is configured to control a temperature of the system by automatically causing the charging coil to adjust a magnitude of the generated radio frequency magnetic field based on the indication of the magnitude of a voltage of the rechargeable battery.

16. The system of claim 1, wherein the status information includes the indication of a magnitude of a DC voltage recovered from the radio frequency magnetic field, and wherein the external controller is configured to control a temperature of the system by automatically causing the charging coil to adjust a magnitude of the generated radio frequency magnetic field based on the indication of the magnitude of a DC voltage recovered from the radio frequency magnetic field.

17. The system of claim 1, wherein the rechargeable battery includes a lithium ion battery.

18. The system of claim 1, wherein the antenna is carried within the housing of the implantable electrical stimulation generator.

19. A system comprising:

an implantable electrical stimulation generator comprising;

a housing,

first circuitry carried within the housing and configured for wireless telemetry using at least one of UHF signals or VHF signals,

an antenna coupled to the first circuitry and configured to at least one of receive or transmit the at least one of UHF signals or VHF signals of the wireless telemetry,

a rechargeable battery carried within the housing, and

a power receiving coil carried within the housing, the power receiving coil configured to transcutaneously receive an externally generated radio frequency magnetic field, wherein the rechargeable battery is configured to be recharged via the transcutaneously received externally generated radio frequency magnetic field;

an external controller including second circuitry; and

a charging coil configured to generate the radio frequency magnetic field, and

wherein, during a battery recharge period, and using wireless telemetry, the implantable electrical stimulation generator is configured to transmit an indication of a magnitude of power recovered by the power receiving coil back to the external controller,

wherein the external controller is configured to control a temperature of the system by automatically causing the charging coil to adjust a magnitude of the generated radio frequency magnetic field based on the indication of the magnitude of power recovered by the power receiving coil.