Methods and devices for modulating excitable tissue of the exiting spinal nerves

• US 8,903,502 B2
• Filed: 05/19/2013
• Issued: 12/02/2014
• Est. Priority Date: 05/21/2012
• Status: Active Grant

• Current Assignee: Curonix Company Limited
• Original Assignee: Micron Devices LLC
• Inventors: Perryman, Laura Tyler, Andresen, Chad, King, Gary, Yeung, Anthony
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/897,427
• Publication Number:
  US 20130310901A1
• Time in Patent Office: 562 Days
• Field of Search: 607/72
• US Class Current: 607/72
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method for modulating nerve tissue in a body of a patient includes implanting a wireless stimulation device in proximity to a dorsal root ganglion or an exiting nerve root such that an electrode, circuitry and a receiving antenna are positioned completely within the body of the patient. An input signal containing electrical energy and waveform parameters is transmitted to the receiving antenna(s) from a control device located outside of the patient'"'"'s body via radiative coupling. The circuitry within the stimulation device generates one or more electrical impulses and applies the electrical impulses to the dorsal root ganglion or the exiting nerve roots through the electrode.

Claims

1. A method for modulating excitable tissue in a body of a patient comprising:

implanting a wireless stimulator device in proximity to an exiting nerve root or a dorsal root ganglion, the wireless stimulator device including one or more electrodes, circuitry, and one or more receiving antennas;

transmitting electrical energy and waveform parameters from a pulse generator located outside of the body to the one or more receiving antennas within the wireless stimulator device through radiative coupling such that the circuitry within the wireless stimulator device generates one or more electrical impulses solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, and applies the electrical impulses to tissue adjacent to or near the exiting nerve root or the dorsal root ganglion through the electrodes.

2. The method of claim 1 wherein implanting the wireless stimulator device in proximity to an exiting nerve root or a dorsal root ganglion comprises implanting the wireless stimulator device such that the wireless stimulator device is completely contained with the body of the patient.

3. The method of claim 1 wherein the electrical impulses have a frequency equal to or less than 1 KHZ and a duty cycle of less than 10%.

4. The method of claim 2 wherein implanting the wireless stimulator device comprises implanting a wireless stimulator device that has a diameter equal to or less than 1.8 mm.

5. The method of claim 2 wherein implanting the wireless stimulator device comprises:

advancing at least a portion of the wireless stimulator device through an intervertebral foramen into Kambin'"'"'s triangle; and

anchoring said portion of the wireless stimulator device in Kambin'"'"'s triangle and in proximity to the exiting nerve root or the dorsal root ganglion.

6. The method of claim 5 wherein advancing at least a portion of the wireless stimulator device comprises:

placing a lumen near an opening of the intervertebral foramen; and

advancing said portion of the wireless stimulator device through the lumen and out of a distal opening of the lumen distal to the opening of the intervertebral foramen.

7. The method of claim 6 wherein the lumen is part of a cannula, spinal needle or endoscope.

8. The method of claim 5 wherein anchoring said portion of the stimulator device comprises suturing said portion of the wireless stimulator device to tissue or bone adjacent to or near Kambin'"'"'s triangle.

9. The method of claim 8 wherein the tissue or bone includes one of a facet joint, a vertebral body, a pedicle, an annulus or a facet capsule.

10. The method of claim 8 wherein anchoring said portion of the wireless stimulator device further comprises embedding one or more fixation prongs on said portion of the lead in tissue.

11. The method of claim 2 wherein implanting the wireless stimulator device comprises implanting the wireless stimulator device at a dermatome level from L5 to T10 and at an angle of no greater than 45 degrees.

12. The method of claim 2 wherein implanting the wireless stimulator device comprises advancing the wireless stimulator device through a sacral hiatus.

13. The method of claim 12 further comprising implanting the wireless stimulator device at a dermatome level from L5 to T12.

14. The method of claim 2 wherein the wireless stimulator device comprises one of a suturing addendum, a fixation prong or a screw-tip.

15. A method for modulating excitable tissue within a body of a patient comprising:

implanting a wireless stimulator device through an intervertebral foramen opening into Kambin'"'"'s triangle, the wireless stimulator device including one or more electrodes, circuitry, and one or more receiving antennas;

anchoring the electrodes in close proximity to a nerve or a nerve ganglion; and

transmitting electrical energy and waveform parameters from a pulse generator located outside the body of the patient to the one or more receiving antennas within the wireless stimulator device through radiative coupling such that the circuitry within the wireless stimulator device generates one or more electrical impulses solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, and applies the electrical impulses to tissue adjacent to or near the nerve root or the nerve ganglion in surrounding tissue through the electrodes.

16. The method of claim 15, wherein anchoring the electrodes comprises fixating at least a distal portion of the wireless stimulator device such that the electrodes, the circuitry and the receiving antenna are completely contained within the patient'"'"'s body.

17. The method of claim 16 wherein implanting the wireless stimulator device further comprises:

advancing the wireless stimulator device through a lumen and out of a distal end of the lumen such that said distal portion of the wireless stimulator device passes through the intervertebral foramen opening.

18. The method of claim 16 wherein anchoring the electrodes further comprises suturing said portion of the wireless stimulator device to tissue or bone adjacent to or near Kambin'"'"'s triangle.

19. The method of claim 18 wherein the tissue or bone comprises one of a facet joint, a vertebral body, a pedicle, an annulus or a facet capsule.

20. The method of claim 16 wherein anchoring the electrodes further comprises embedding fixation prongs on the wireless stimulator device into tissue in the Kambin'"'"'s triangle.

21. The method of claim 20 wherein embedding fixation prongs further comprises rotating screw-tips on the wireless stimulator device into tissue in the Kambin'"'"'s triangle.

22. A method for modulating excitable tissue in a body of a patient comprising:

implanting a wireless stimulator device through a sacral hiatus opening into an epidural space of a spinal cord of the patient, the wireless stimulator device including one or more electrodes, circuitry, and one or more receiving antennas;

positioning the electrodes in an intervertebral foraminal space in close proximity to a nerve or a nerve ganglion; and

transmitting electrical energy and waveform parameters from a pulse generator located outside the body of the patient to the one or more receiving antennas through radiative coupling such that the circuitry within the wireless stimulator device generates one or more electrical impulses solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, and applies the electrical impulses to tissue adjacent to or near the nerve root or the nerve ganglion through the electrodes.

23. The method of claim 22 wherein anchoring the electrodes comprises fixating at least a distal portion of the wireless stimulator device such that the electrodes, the circuitry and the receiving antennas are completely contained within the patient'"'"'s body.

24. A device for modulating excitable tissue in a patient'"'"'s body comprising:

a wireless stimulator device comprising one or more electrodes, circuitry and a receiving antenna, the wireless stimulator device sized and configured for placement in close proximity to an exiting nerve root or a dorsal root ganglion;

wherein the receiving antenna is configured to receive an input signal containing electrical energy and waveform parameters through radiative coupling from a transmitter located outside of the patient'"'"'s body; and

wherein the circuitry is configured to generate an electrical impulse solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, the electrical impulse being sufficient to modulate a nerve or a nerve ganglion at the target site.

25. The device of claim 24 wherein the wireless stimulator device has a diameter of less than 1.8 mm.

26. The device of claim 24 wherein the electrical impulse has a frequency of 1 KHZ or less and a duty cycle of less than 10%.

27. The device of claim 24 wherein the distal portion of the wireless stimulator device is sized and shaped for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

28. The device of claim 27 wherein the distal portion of the wireless stimulator device further comprises one or more fixation elements for attaching said distal portion to tissue or bone adjacent to or near the Kambin'"'"'s triangle.

29. The device of claim 28 wherein the fixation elements comprise one of a suturing addendum, a rotating screw-tip or a fixation prong.

30. The device of claim 24 wherein the wireless stimulator device comprises a distal portion containing the electrodes, the circuitry and the receiving antenna, said distal portion being sized and shaped for advancement through a sacral hiatus opening into an epidural space of a spinal cord of the patient and positioning within an intervertebral foraminal space.

31. A device for treating pain in a body of a patient comprising:

a wireless stimulator device comprising a distal portion containing one or more electrodes, circuitry and a receiving antenna, said distal portion having a diameter less than 1.8 mm; and

wherein the receiving antenna is configured to receive an input signal containing electrical energy and waveform parameters through radiative coupling from a transmitter located outside of the patient'"'"'s body; and

wherein the circuitry is configured to generate an electrical impulse solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, the electrical impulse being sufficient to modulate a nerve or a nerve ganglion at a target site with the patient'"'"'s body.

32. The device of claim 31 wherein the target site is located at least 10 cm beneath an outer skin surface of the patient'"'"'s body.

33. The device of claim 31 wherein the target site is located about 13 cm beneath an outer skin of the patient'"'"'s body.

34. The device of claim 31 wherein the distal portion of the wireless stimulator device is sized and configured for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

35. The device of claim 31 wherein the distal portion of the wireless stimulator device further comprises one or more fixation elements for attaching said distal portion to tissue or bone adjacent to or near the Kambin'"'"'s triangle.

36. The device of claim 35 wherein the fixation elements comprise one of a suturing addendum, a rotating screw-tip or a fixation prong.

37. The device of claim 31 wherein the receiving antenna comprises a dipole antenna.

38. A system for modulating excitable tissue in a body of a patient comprising:

a wireless stimulator device comprising one or more electrodes and a receiving antenna, the wireless stimulator device sized and configured for placement in close proximity to an exiting nerve root or a dorsal root ganglion; and

a control device having a transmitter located outside of the patient'"'"'s body and configured to transmit an input signal containing electrical energy and waveform parameters to the receiving antenna through radiative coupling; and

wherein the wireless stimulator device is configured to generate an electrical impulse solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, the electrical impulse being sufficient to modulate a nerve or a nerve ganglion at a target site within the patient'"'"'s body.

39. The system of claim 38 wherein the control device comprises a transmitting antenna configured to transmit the input signal through a carrier signal having a frequency between about 800 KHz and 5.8 GHz.

40. The system of claim 38 wherein the control device comprises a pulse generator configured to generate an electrical impulse with a frequency of about 10 to 500 Hz.

41. The system of claim 38 wherein the control device is configured to transmit the input signal at least 10 cm from an outer skin surface of the patient through tissue to the target site.

42. The system of claim 38 wherein the control device is configured to transmit the input signal 13 cm from an outer skin surface of the patient through the tissue to the target site.

43. The system of claim 38 wherein the wireless stimulator device comprises a distal portion having a diameter less than about 1.8 mm.

44. The system of claim 38 wherein the wireless stimulator device is sized and configured for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

45. A method for modulating excitable tissue within a body of a patient comprising:

applying one or more nerve blocks to one or more target areas within the body of the patient;

selecting one of the one or more target areas based on feedback from the patient;

positioning a wireless stimulator device at the selected target areas, the wireless stimulator device including one or more electrodes, circuitry, and one or more receiving antennas;

transmitting an input signal containing energy and waveform parameters from a pulse generator located outside the body of the patient to the wireless stimulator device through radiative coupling such that the circuitry within the wireless stimulator device generates an electrical impulse solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, and applies the electrical impulse to excitable tissue at the target areas through one or more electrodes on the wireless stimulator device to treat pain.

46. A method for treating post-operative pain comprising:

performing a surgical procedure at a target site in a body of a patient;

positioning a wireless stimulator device at the target site, the wireless stimulator device including one or more electrodes, circuitry, and one or more receiving antennas and;

transmitting an input signal containing energy and waveform parameters from a pulse generator outside the body of the patient to the wireless stimulator device through radiative coupling such that the circuitry within the wireless stimulator device generates the electrical impulse solely based on the externally supplied electrical energy and according to the externally supplied waveform parameters, and applies the electrical impulse to excitable tissue at the target site through the one or more electrodes on the wireless stimulator device to mitigate the post-operative pain.