SYSTEMS AND METHODS FOR IMPLANTABLE LEADLESS SPINE STIMULATION

• US 20070293909A1
• Filed: 06/18/2007
• Published: 12/20/2007
• 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.
• Granted Patent: US 7,899,542 B2
• Time in Patent Office: Days
• 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 method for stimulating spine comprising:

generating acoustic energy at an implantation site;

receiving the acoustic energy at a spine stimulation site; and

converting the received acoustic energy into electrical spine stimulation energy based on energy and signal information included in the generated acoustic energy.

2. A method of claim 1 wherein stimulating the spine therapeutically treats patients in pain, the method further comprising:

implanting a controller-transmitter at the implantation site to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the spine of the patient, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter to stimulate the spine stimulation site,

whereby the patient'"'"'s pain is alleviated.

3. A method of claim 1 wherein stimulating spine therapeutically treats patients with headache, further comprising:

implanting a controller-transmitter at the implantation site to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat peripheral nerves consisting of trigeminal ganglion or ganglia, one or more trigeminal nerve, one or more branches of a trigeminal nerve or one or more branches of any of these neural structures;

whereby the headache pain is at least partly alleviated in the patient being treated.

4. A method of claim 1 wherein stimulating spine therapeutically treats patients with pelvic pain, comprising:

implanting a controller-transmitter at the implantation site to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat peripheral nerves in the sacrum;

whereby the pelvic pain is at least in part alleviated in the patient being treated.

5. A method of claim 1 wherein stimulating spine therapeutically treats patients with spinal injury comprising:

implanting a controller-transmitter at the first implantation site to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat any one of the cervical, thoracic, lumbar, sacrum, or coccyx segment of the spine;

whereby the pain is at least in part alleviated in the patient being treated.

6. A method as in claim 1, wherein receiving comprises receiving the energy at two or more spine stimulation sites.

7. A method as in claim 6, wherein the signal information stimulates different sites sequentially.

8. A method as in claim 6, wherein the signal information stimulates different sites simultaneously.

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

an acoustic controller-transmitter; and

an implantable acoustic receiver-stimulator having an electrode assembly adapted to be in direct contact with epidural tissue, wherein the controller-transmitter is adapted to transmit acoustic energy and the receiver-stimulator is adapted to receive acoustic energy and the controller-transmitter provides energy and signal information to the receiver-stimulator to provide electrical stimulation to the spinal cord or regions of the spine.

10. A system as in claim 9, 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 electrodes adapted to deliver the pre-determined waveform to stimulate the spine.

11. A system as in claim 10 wherein the implantable receiver-stimulator is adapted to be located at one of the following locations:

epidural layer of the spine, near the dura of the spine, on the dura of the spinal, or in tissue in close proximity to the spine.

12. A system as in claim 10 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.

13. A system as in claims 12 wherein the implantable receiver-stimulator is adapted to be placed and secured to stimulate nerves effective in alleviating pain as a therapeutic treatment.

14. A system as in claim 9, 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.

15. A system as in claim 14, wherein the controller-transmitter is adapted to be implantable.

16. A system as in claim 14 wherein control circuitry includes one or more means for sensing physiologic variables in order to adjust stimulation with one or more parameters chosen from pulse amplitude, pulse duration, duty cycle, or timing.

17. A system as in any one of claims 11-16, further comprising at least one additional receiver-stimulator device.

18. A system as in claim 17, wherein the system is programmed to activate the receiver-stimulator devices sequentially.

19. A system as in claim 17, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

20. A system for stimulating brain tissue as in claim 9, 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.

21. A method for stimulating the spine, said method comprising generating acoustic energy externally;

and receiving said acoustic energy at a spine stimulation site, wherein said acoustic energy is converted into electrical spine stimulation energy based on both energy and signal information included in the generated acoustic energy.

22. A method as in claim 21 wherein stimulating the spine therapeutically treats patients in pain, the method further comprising:

positioning on the patient'"'"'s body surface a controller-transmitter to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the spine of the patient, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter to stimulate the spine stimulation site,

whereby the patient'"'"'s pain is alleviated.

23. A method as in claim 21 wherein stimulating spine therapeutically treats patients with headache, further comprising:

positioning on the patient'"'"'s body surface a controller-transmitter to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat peripheral nerves consisting of trigeminal ganglion or ganglia, one or more trigeminal nerve, one or more branches of a trigeminal nerve or one or more branches of these neural structures;

whereby the headache is at least in part alleviated in the patient being treated.

24. A method as in claim 21 wherein stimulating spine therapeutically treats patients with pelvic pain, comprising:

positioning on the patient'"'"'s body surface a controller-transmitter to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat peripheral nerves in the sacrum;

whereby the pelvic pain is at least in part alleviated in the patient being treated.

25. A method as in claim 21 wherein stimulating spine therapeutically treats patients with spinal injury comprising:

positioning on the patient'"'"'s body surface a controller-transmitter to generate the acoustic energy;

implanting a receiver-stimulator in epidural tissue of the patient'"'"'s spine, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the spine stimulation site; and

operating the controller-transmitter such that electrical spine stimulation energy is generated by the receiver-stimulator at the predetermined spine stimulation site;

said predetermined spine stimulation site being selected to treat any one of the cervical, thoracic, lumbar, sacrum, or coccyx segment of the spine;

whereby the pain is at least in part alleviated in the patient being treated.

26. A method as in claim 21, wherein receiving comprises receiving the energy at two or more spine stimulation sites.

27. A method as in claim 26, wherein the signal information stimulates different sites sequentially.

28. A method as in claim 26, wherein the signal information stimulates different sites simultaneously.