SYSTEMS AND METHODS FOR IMPLANTABLE LEADLESS NERVE STIMULATION

• US 20070293906A1
• 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: Riley, Richard E., Cowan, Mark W., Brisken, Axel F., Echt, Debra S.
• Granted Patent: US 7,894,907 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

Systems and methods are disclosed to stimulate nerves to treat medical conditions such as pain, and other conditions, such as, CHF, obesity, incontinence, etc., that could be controlled by the stimulation of the vagal nerves. The invention uses electrical stimulation of the nerve, 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 nerve site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the nerve that needs to be stimulated. The implantable receiver-stimulator stimulates different nerves and regions of a nerve to provide therapeutic benefit.

Claims

1. A method for stimulating a nerve comprising:

generating acoustic energy at an implantation site;

receiving the acoustic energy at a nerve stimulation site; and

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

2. A method as in claim 1 wherein the nerve stimulation further comprises:

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

implanting a receiver-stimulator at the nerve stimulation site, wherein the receiver-stimulator comprises one or more stimulation electrodes, such that the stimulation electrodes lie in electrical communication with the predetermined nerve stimulation site;

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

wherein the predetermined nerve stimulation site is chosen to treat one or more medical conditions chosen from the list comprising headache;

facial pain;

pelvic pain;

heart failure;

hypertension;

obesity;

migraine;

neuropsychiatric disorders;

urinary, gastrointestinal, urge or stress urinary incontinence, and fecal incontinence.

3. A method of claim 1, wherein receiving comprises receiving the energy at two or more nerve stimulation sites.

4. A method of claim 3, wherein the signal information stimulates different sites sequentially.

5. A method of claim 3, wherein the signal information stimulates different sites simultaneously.

6. A system for nerve stimulation therapy comprising:

an implantable acoustic controller-transmitter; and

an implantable acoustic receiver-stimulator having an electrode assembly adapted to be in direct contact with the nerve, 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 nerve.

7. A system of claim 6, 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 nerve.

8. A system of claim 7, wherein the implantable receiver-stimulator is adapted to be located in close proximity to the nerve stimulation site.

9. A system of claim 7 wherein the implantable receiver-stimulator is adapted to be located at a predetermined nerve stimulation site, and stimulate the nerve site for achieving a therapeutic effect, wherein said predetermined nerve stimulation site is selected for treating one or more medical conditions chosen from the list comprising headache;

facial pain;

pelvic pain heart failure;

hypertension;

obestity;

migraine;

neuropsychiatric disorders;

urinary, gastrointestinal, urge or stress urinary incontinence, and fecal incontinence.

10. A system of claim 6, 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.

11. A system of claim 10, wherein the control circuitry include one or more means for sensing physiologic variables to vary the stimulation signal.

12. A system of claim 9, further comprising two or more receiver-stimulator devices.

13. A system of claim 12, wherein the system is programmed to activate the receiver stimulator devices sequentially.

14. A system of claim 12, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

15. A system of claim 6, 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.

16. A system for nerve stimulation therapy comprising:

an externally applied acoustic controller-transmitter; and

an implantable acoustic receiver-stimulator having an electrode assembly adapted to be in direct contact with nerve, wherein the transmitter and receiver-stimulator are adapted to transmit and receive acoustic energy which provides both energy and signal information to the receiver-stimulator sufficient to provide electrical stimulation to the nerve.

17. A system of claim 16, wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, means for converting the alternating current to a to a pre-determined waveform, and electrodes adapted to deliver the pre-determined waveform to stimulate the nerve.

18. A system of claim 16 wherein the implantable receiver-stimulator is adapted to be located at a location in close proximity to the nerve stimulation site.

19. A system of claim 16 wherein the implantable receiver-stimulator is adapted to be located at a predetermined nerve stimulation site, said predetermined nerve stimulation site selected for treating one or more medical conditions chosen from the list comprising headache;

facial pain;

pelvic pain heart failure;

hypertension;

obesity;

migraine;

neuropsychiatric disorders;

urinary, gastrointestinal, urge or stress urinary incontinence, and fecal incontinence.

20. A system of claim 16, wherein the externally applied 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.

21. A system of claim 20 wherein control circuitry includes one or more means for sensing physiologic variables to vary the stimulation signal.

22. A system of claim 19, further comprising two or more receiver-stimulator device.

23. A system of claim 22, wherein the system is programmed to activate the receiver stimulator devices sequentially.

24. A system of claim 22, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

25. A system for stimulating nerve as in claim 16, 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.

26. A method for stimulating a nerve comprising:

generating acoustic energy using a controller-transmitter;

receiving the acoustic energy at a gastrointestinal tissue stimulation site by means of an implanted receiver-stimulator;

converting the received acoustic energy into electrical gastrointestinal tissue stimulation energy based on energy and signal information included in the generated acoustic energy, operating the controller-transmitter such that electrical gastrointestinal tissue stimulation energy is generated by the receiver-stimulator at the predetermined gastrointestinal tissue stimulation site;

wherein the receiver-stimulator comprises one or more stimulation electrodes, such that the stimulation electrodes lie in electrical communication with the predetermined gastrointestinal tissue stimulation site, and the predetermined gastrointestinal tissue stimulation site is chosen to treat one or more medical conditions chosen from the list comprising headache;

facial pain;

pelvic pain;

heart failure;

hypertension;

obesity;

migraine;

neuropsychiatric disorders;

urinary, gastrointestinal, urge or stress urinary incontinence, and fecal incontinence.

27. A method of claim 26 wherein the controller-transmitter is externally located.