Systems and methods for implantable leadless spine stimulation

• US 8,494,642 B2
• Filed: 01/14/2011
• Issued: 07/23/2013
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark W., Riley, Richard E., Brisken, Axel F., Echt, Debra S.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/007,419
• Publication Number:
  US 20110166621A1
• Time in Patent Office: 921 Days
• Field of Search: 607/33, 607/46, 607/60, 607/61
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Systems and methods are disclosed to stimulate spine tissue to treat medical conditions such as pain and spinal injury. The invention uses electrical stimulation of the spine, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined brain site. The vibrational energy is generated by a controller-transmitter, which could be located either externally or implanted. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on around the spine. The implantable receiver-stimulator stimulates different locations in the spine region to provide therapeutic benefit.

Claims

1. A system for stimulating the spinal cord, said system comprising:

an acoustic controller-transmitter configured to transmit acoustic energy, wherein the controller-transmitter comprises acoustic transducers disposed in a housing and one or more sensors disposed on an external surface of the housing; and

an implantable acoustic receiver-stimulator having a stimulation electrode assembly adapted to be in direct contact with epidural tissue, wherein the receiver-stimulator is configured to receive and convert the acoustic energy into an electrical stimulation output delivered to the epidural tissue by the stimulation electrode assembly, wherein the electrical stimulation output has at least one of pulse amplitude, pulse duration, duty cycle, and timing based on energy and signal information included in the generated acoustic energy;

wherein the controller-transmitter is configured to sense the electrical stimulation output of the receiver-stimulator using one or more of the sensors and adjust acoustic energy transmission from the controller-transmitter accordingly in order to compensate for changes in electrical stimulation output of the receiver-stimulator.

2. The system as in claim 1, wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, means for converting the alternating current to a pre-determined waveform, and the electrode assembly adapted to deliver the pre-determined waveform to stimulate the spine.

3. The system as in claim 2, wherein the implantable receiver-stimulator is adapted to be implanted and secured at a predetermined spine stimulation site, said predetermined spine stimulation site being selected to treat peripheral nerves from the group consisting of trigeminal ganglion or ganglia, one or more trigeminal nerves, one or more branches of a trigeminal nerve, or one or more branches of any of these neural structures.

4. The system as in claim 3, wherein the implantable receiver-stimulator is adapted to be placed and secured to stimulate nerves effective in alleviating pain as a therapeutic treatment.

5. The system as in claim 4, further comprising at least one additional receiver-stimulator device.

6. The system as in claim 5, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

7. The system as in claim 5, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

8. The system as in claim 3, further comprising at least one additional receiver-stimulator device.

9. The system as in claim 8, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

10. The system as in claim 8, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

11. The system as in claim 1, wherein the controller-transmitter comprises a power source, control and timing circuitry to provide a stimulation signal, means for converting the stimulation signal to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-stimulator.

12. The system as in claim 11, wherein control circuitry includes one or more means to adjust the electrical stimulation output with one or more parameters chosen from pulse amplitude, pulse duration, duty cycle, or timing.

13. The system as in claim 11, wherein the controller-transmitter is adapted to be implantable.

14. The system as in claim 1, further comprising at least one additional receiver-stimulator device.

15. The system as in claim 14, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

16. The system as in claim 14, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

17. The system as in claim 1, adapted to transmit and receive acoustic energy wherein the frequency of the acoustic energy is between 20 kHz and 10 MHz, the burst length is between 3 cycles and a continuous burst, the duty cycle is between 0.01% and 100.00%, and the mechanical index is less than 1.9.