MINIMALLY INVASIVE IMPLANTABLE NEUROSTIMULATION SYSTEM

• US 20140163644A1
• Filed: 12/06/2013
• Published: 06/12/2014
• Est. Priority Date: 12/07/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Scott, Erik R., Kast, John E., Wei, Xuan K., Smith, Todd V., Anderson, Joel A., Pape, Forrest C.M., Bourget, Duane L., Denison, Timothy J., Dinsmoor, David A., Roles, Randy S., Roddy, Stephen J.
• Granted Patent: US 9,826,963 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61N 1/02 Details
• 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 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• 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: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated

Abstract

An external medical device generates a drive signal inductively coupled to an implantable coil from an external coil. A regulator module coupled to the implantable coil generates an output signal in response to the inductively coupled signal and a feedback signal correlated to an amplitude of the inductively coupled signal. A signal generator receives the output signal for generating a therapeutic electrical stimulation signal. The control module adjusts the drive signal in response to the feedback signal to control the electrical stimulation signal.

Claims

1. A system, comprising:

an external medical device comprising;

a control module for generating a drive signal;

an electrically conductive external coil coupled to the control module for receiving the drive signal; and

an external telemetry module; and

an implantable medical device comprising;

an electrically conductive implantable coil for receiving an inductively coupled signal in response to the drive signal being applied to the external coil;

a regulator module coupled to the implantable coil and configured to generate an output signal in response to the inductively coupled signal and to generate a feedback control signal correlated to an amplitude of the inductively coupled signal;

a signal generator coupled to the regulator module to receive the output signal for powering generation of a therapeutic electrical stimulation signal;

a plurality of electrodes coupled to the signal generator for delivering the therapeutic electrical stimulation signal to a targeted therapy site; and

an implantable telemetry module for transmitting the feedback control signal to the external telemetry module,

the control module configured to receive the feedback control signal and adjust the drive signal in response to the feedback control signal.

2. The system of claim 1, wherein the external coil comprises a plurality of external coils, the control module being configured to select, in response to the feedback control signal, an external coil from the plurality of external coils for inductive coupling to the implantable coil.

3. The system of claim 2, wherein the plurality of external coils comprises one of a plurality of coaxial coils and an array of coils.

4. The system of claim 2, wherein the plurality of external coils comprises a first coil having a first diameter and a second coil having a second diameter smaller than the first coil.

5. The system of claim 2, wherein the control module is configured to couple the drive signal to selected ones of the plurality of external coils in a plurality of combinations comprising at least one coil in each of the plurality of combinations and use the feedback control signal to select at least one of the plurality of coils for inductive coupling to the implantable coil for generating the output signal.

6. The system of claim 1, wherein the external device further comprises a display for displaying to a user an indication of the feedback control signal.

7. The system of claim 1, wherein the regulator module is configured to rectify the inductively coupled signal to produce the output signal and generate the feedback control signal correlated to an amplitude of the output signal.

8. The system of claim 1, wherein the regulator module is configured to monitor the therapeutic electrical stimulation signal and generate the feedback control signal correlated to an amplitude of the electrical stimulation signal,

the control module configured to adjust the drive signal to maintain the amplitude of the electrical stimulation signal at a desired level.

9. The system of claim 1, further comprising a physiological sensor for sensing a response to the electrical stimulation signal, the regulator module configured to receive a signal from the physiological sensor for generating the feedback control signal in response to the physiological sensor signal.

10. The system of claim 1, wherein the control module being configured to apply the drive signal to the external coil in a pattern that establishes a therapeutic electrical stimulation control parameter.

11. The system of claim 1, wherein the control module applies the drive signal having an amplitude, a pulse rate, and a pulse width,

the regulator module configured to rectify the received power signal to generate the output signal,

the signal generator configured to deliver the rectified output signal to the plurality of electrodes.

12. The system of claim 11, wherein the control module being configured to adjust the electrical stimulation signal by adjusting one of the amplitude, the pulse rate and the pulse width of the drive signal.

13. The system of claim 1, further comprising an activity sensor,

the external device and the implantable device configured to cooperatively detect an activity state in response to an activity sensor signal and inhibit the therapeutic electrical stimulation by withholding the drive signal in response to a detected activity state.

14. The system of claim 13, wherein the external device being adapted to position the external coil for inducing an electromagnetic field along a tibial nerve region,

the implantable medical device being configured to deliver the therapeutic electrical stimulation signal to a tibial nerve,

the activity state corresponding to an intrinsic activation of the tibial nerve.

15. A method, comprising:

generating a drive signal applied to an electrically conductive external coil;

generating an output signal in response to an inductively coupled signal received by an electrically conductive implantable coil when the drive signal is applied to the external coil;

coupling the output signal to a signal generator to enable the signal generator to generate a therapeutic electrical stimulation signal in response to the output signal;

delivering the therapeutic electrical stimulation signal to a targeted therapy site using a plurality of electrodes coupled to the signal generator;

generating a feedback control signal correlated to an amplitude of the inductively coupled signal; and

adjusting the drive signal in response to the feedback control signal.

16. The method of claim 15, further comprising selecting an external coil from a plurality of external coils for inductive coupling to the implantable coil in response to the feedback control signal.

17. The method of claim 16, wherein selecting an external coil comprises selecting a coil from one of a plurality of coaxial coils or an array of coils.

18. The method of claim 16, wherein selecting an external coil comprises selecting one of a first coil having a first diameter and a second coil having a second diameter smaller than the first coil.

19. The method of claim 16, further comprising:

coupling the drive signal to selected ones of the plurality of external coils in a plurality of combinations comprising at least one coil in each of the plurality of combinations;

monitoring feedback signals associated with each of the plurality of combinations; and

selecting at least one of the plurality of coils in response to the feedback signals for inductive coupling to the implantable coil for generating the output signal.

20. The method of claim 15, further comprising displaying an indication of the feedback control signal on a display.

21. The method of claim 15, further comprising:

rectifying the inductively coupled signal to produce the output signal; and

generating the feedback control signal correlated to an amplitude of the output signal.

22. The method of claim 15, further comprising:

monitoring the therapeutic electrical stimulation signal;

generating the feedback control signal correlated to an amplitude of the electrical stimulation signal; and

adjusting the drive signal to maintain the amplitude of the electrical stimulation signal at a desired level.

23. The method of claim 15, further comprising:

sensing a response to the electrical stimulation signal using a physiological sensor; and

generating the feedback control signal in response to the physiological sensor signal.

24. The method of claim 15, further comprising applying the drive signal to the external coil in a pattern that establishes a therapeutic electrical stimulation control parameter.

25. The method of claim 15, further comprising:

generating the drive signal having an amplitude, a pulse rate, and a pulse width;

rectifying the inductively coupled signal to generate the output signal; and

delivering the rectified output signal to the plurality of electrodes.

26. The method of claim 25, further comprising adjusting the electrical stimulation signal by adjusting one of the amplitude, the pulse rate and the pulse width of the drive signal.

27. The method of claim 15, further comprising:

detecting an activity state in response to an activity sensor signal; and

inhibiting the therapeutic electrical stimulation signal by withholding the drive signal in response to a detected activity state.

28. The method of claim 27, further comprising:

enabling an external device comprising the external coil to induce an electromagnetic field along a tibial nerve region of a patient when the drive signal is applied to the external coil;

delivering the therapeutic electrical stimulation signal to a tibial nerve; and

detecting the activity state corresponding to an intrinsic activation of the tibial nerve.

29. A medical device system, comprising:

an external primary coil;

a controller configured to apply a drive signal to the primary coil;

an implantable secondary coil receiving an inductively coupled signal in response to the drive signal being applied to the primary coil;

a regulator module coupled to the secondary coil and configured to generate an output signal in response to the inductively coupled signal; and

a signal generator generating a therapy signal in response to the output signal,

the regulator module and the controller configured to cooperatively adjust the therapy signal by generating a feedback signal correlated to the inductively coupled signal and adjusting the drive signal in response to the feedback signal.