METHODS AND DEVICES FOR MODULATING EXCITABLE TISSUE OF THE EXITING SPINAL NERVES

• US 20130310901A1
• Filed: 05/19/2013
• Published: 11/21/2013
• Est. Priority Date: 05/21/2012
• Status: Active Grant

• Current Assignee: Curonix Company Limited
• Original Assignee: Neural Diabetes, LLC
• Inventors: Perryman, Laura Tyler, Andresen, Chad, King, Gary, Yeung, Anthony
• Granted Patent: US 8,903,502 B2
• Time in Patent Office: Days
• 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:

positioning one or more electrodes adjacent to or near an exiting nerve root or a dorsal root ganglion;

transmitting electrical energy and waveform parameters from a pulse generator located outside of the body to the electrodes through radiative coupling; and

generating one or more electrical impulses through the electrodes using the pulse generator as the only source of power, the electrical impulses being sufficient to modulate excitable tissue adjacent to or near the exiting nerve root or the dorsal root ganglion.

2. The method of claim 1 wherein the positioning step is carried out by implanting a lead containing the electrodes, circuitry and a receiving antenna adjacent to or near the exiting nerve root or the dorsal root ganglion such that the lead 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 then 10%.

4. The method of claim 2 wherein the lead has a diameter equal to or less than 1.8 mm.

5. The method of claim 2 wherein the positioning step comprises:

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

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

6. The method of claim 5 wherein the advancing step comprises:

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

advancing said portion of the lead 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 the anchoring step is carried out by suturing said portion of the lead 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 the anchoring step is further carried out by embedding one or more fixation prongs on said portion of the lead in tissue.

11. The method of claim 2 wherein the positioning step is carried out by implanting the lead 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 the positioning step is carried out by advancing the lead through a sacral hiatus.

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

14. The method of claim 2 wherein the lead 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:

advancing one or more electrodes through an intervertebral foramen opening into Kambin'"'"'s triangle;

anchoring the electrodes adjacent to or near a nerve or a nerve ganglion; and

applying an electrical impulse to the electrodes sufficient to modulate the nerve or the nerve ganglion.

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

17. The method of claim 15 wherein the applying step is carried out by:

transmitting an input signal containing electrical energy from a control device outside of the patient'"'"'s body to the receiving antenna via radiative coupling; and

generating the electrical impulse from the electrical energy.

18. The method of claim 16 wherein the advancing step is carried out by advancing the lead through a lumen and out of a distal end of the lumen such that said portion of the lead passes through the intervertebral foramen opening.

19. The method of claim 16 wherein the anchoring step further comprises suturing said portion of the lead to tissue or bone adjacent to or near Kambin'"'"'s triangle.

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

21. The method of claim 16 wherein the anchoring step further comprises embedding fixation prongs on the lead into tissue in the Kambin'"'"'s triangle.

22. The method of claim 21 wherein the embedding step further comprises rotating screw-tips on the lead into tissue in the Kambin'"'"'s triangle.

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

advancing one or more electrodes through a sacral hiatus opening into an epidural space of a spinal cord of the patient;

positioning the electrodes in an intervertebral foraminal space adjacent to or near a nerve or a nerve ganglion; and

applying an electrical impulse to the electrodes sufficient to modulate the nerve or the nerve ganglion.

24. The method of claim 23 further comprising a lead containing the electrodes, a receiving antenna and circuitry, wherein the positioning step comprises positioning at least a distal portion of the lead such that the electrodes, the circuitry and the receiving antenna are completely contained within the patient'"'"'s body.

25. The method of claim 24 wherein the applying step is carried out by:

transmitting an input signal containing electrical energy from a control device outside of the patient'"'"'s body to the receiving antenna via radiative coupling; and

generating the electrical impulse from the electrical energy

32. The device of claim 25 wherein the lead 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.

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

a lead comprising one or more electrodes, circuitry and a receiving antenna and being sized and configured for placement adjacent to or near a target site at 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 from the input signal sufficient to modulate a nerve or a nerve ganglion at the target site.

27. The device of claim 26 wherein the lead has a diameter of less than 1.8 mm.

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

29. The device of claim 26 wherein the distal portion of the lead is sized and shaped for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

30. The device of claim 29 wherein the distal portion of the lead further comprises one or more fixation elements for attaching said distal portion to tissue or bone adjacent to or near the Kambin'"'"'s triangle.

31. The device of claim 30 wherein the fixation elements comprise one of a suturing addendum, a rotating screw-tip or a fixation prong.

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

a lead 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 from the input signal sufficient to modulate a nerve or a nerve ganglion at a target site with the patient'"'"'s body.

34. The device of claim 33 wherein the target site is located at least 10 cm beneath an outer skin surface of the patient'"'"'s body.

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

36. The device of claim 33 wherein the distal portion of the lead is sized and configured for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

37. The device of claim 33 wherein the distal portion of the lead further comprises one or more fixation elements for attaching said distal portion to tissue or bone adjacent to or near the Kambin'"'"'s triangle.

38. The device of claim 37 wherein the fixation elements comprise one of a suturing addendum, a rotating screw-tip or a fixation prong.

39. The device of claim 33 wherein the receiving antenna comprises a dipole antenna.

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

a lead comprising one or more electrodes and a receiving antenna and being sized and configured for placement adjacent to or near a target site at 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 lead is configured to generate an electrical impulse from the input signal sufficient to modulate a nerve or a nerve ganglion at a target site within the patient'"'"'s body.

41. The system of claim 40 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.

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

43. The system of claim 40 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.

44. The system of claim 40 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.

45. The system of claim 40 wherein the lead comprises a distal portion having a diameter less than about 1.8 mm.

46. The system of claim 40 wherein the lead is sized and configured for advancement through an intervertebral foramen into Kambin'"'"'s triangle.

47. 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 as an optimal target site based on feedback from the patient;

positioning a lead at the optimal target site;

transmitting an input signal containing energy and waveform parameters to the lead through radiative coupling; and

applying an electrical impulse to excitable tissue at the optimal target site through one or more electrodes on the lead, wherein the electrical impulse is sufficient to modulate one or more nerves at the optimal target site to treat pain.

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

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

positioning a lead at the target site;

transmitting an input signal containing energy and waveform parameters to the lead through radiative coupling; and

applying an electrical impulse to excitable tissue at the target site through one or more electrodes on the lead, wherein the electrical impulse is sufficient to modulate one or more nerves at the target site and mitigate the post-operative pain.