Systems and methods for treatment of dry eye

• US 8,918,181 B2
• Filed: 11/16/2011
• Issued: 12/23/2014
• Est. Priority Date: 11/16/2010
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Ackermann, Douglas Michael, Palanker, Daniel, Loudin, James Donald, Smith, Garrett Cale, McCray, Victor Wayne, Felkins, Brandon McNary
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/298,042
• Publication Number:
  US 20120130398A1
• Time in Patent Office: 1,133 Days
• Field of Search: 607 53- 54
• US Class Current: 607/53
• CPC Class Codes: A61N 1/36046 of the eye
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A stimulation system stimulates anatomical targets in a patient for treatment of dry eye. The system may include a controller and a microstimulator. The controller may be implemented externally to or internally within the microstimulator. The components of the controller and microstimulator may be implemented in a single unit or in separate devices. When implemented separately, the controller and microstimulator may communicate wirelessly or via a wired connection. The microstimulator may generate pulses from a controller signal and apply the signal via one or more electrodes to an anatomical target. The microstimulator may not have any intelligence or logic to shape or modify a signal. The microstimulator may be a passive device configured to generate a pulse based on a signal received from the controller. The microstimulator may shape or modify a signal. Waveforms having different frequency, amplitude and period characteristics may stimulate different anatomical targets in a patient.

Claims

1. A method for treating dry eye by stimulating one or more nerves that innervate lacrimal gland tissue comprising:

implanting a microstimulator adjacent to the lacrimal gland; and

applying stimulation to the lacrimal gland, wherein the microstimulator is implanted using a 12 or larger gauge needle.

2. The method of claim 1, wherein the microstimulator is adjacent the lacrimal gland fully implanted within an orbit of a patient'"'"'s eye.

3. The method of claim 1, wherein the microstimulator is adjacent and directly contacting the lacrimal gland.

4. The method of claim 1, wherein the microstimulator is adjacent to and at least partially penetrating into the lacrimal gland.

5. The method of claim 1, wherein the microstimulator is adjacent to and fully implanted into or completely within the lacrimal gland.

6. The method of claim 1, wherein adjacent to the lacrimal gland is about, within or partially in the lacrimal gland.

7. The method of claim 1, wherein the microstimulator is fully implanted within the orbit of the eye.

8. The method of claim 1, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland.

9. The method of claim 8, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without moving the eye in the vertical or horizontal direction.

10. The method of claim 8, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without stimulating the ocular muscles.

11. The method of claim 8, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without stimulating the superior rectus, lateral rectus, levator palpebrae superioris, retina or corresponding motor nerves.

12. The method of claim 8, wherein the autonomic efferent fibers are selectively stimulated over the sensory afferent fibers.

13. The method of claim 8, wherein the autonomic efferent fibers are selectively stimulated over the A-delta pain fibers.

14. The method of claim 8, wherein the autonomic efferent fibers are selectively stimulated over the C pain fibers.

15. The method of claim 1, wherein the stimulation only stimulates the one or more nerves that innervate the lacrimal gland.

16. The method of claim 1, wherein after the implanting step the microstimulator is implanted into the fossa for the lacrimal gland.

17. The method of claim 1, wherein after the implantation step the microstimulator conforms to the fossa for the lacrimal gland after implantation.

18. The method of claim 1, wherein the microstimulator conforms to an exterior aspect of a lacrimal gland after implantation.

19. The method of claim 1, the implanting step further comprising conforming the microstimulator to an exterior aspect of the fossa for the lacrimal gland.

20. The method of claim 1, wherein after the implanting step the microstimulator may conform to an exterior aspect of the fossa for the lacrimal gland.

21. The method of claim 1 further comprising:

loading the microstimulator into a 12 or larger gauge needle;

inserting the needle tip using an anatomical landmark at the corner of the eye;

positioning the needle in proximity to the lacrimal gland; and

deploying the microstimulator using the needle.

22. The method of claim 21, wherein the anatomical landmark is the temporal aspect of the orbit into the superior lateral aspect of the orbit and through the orbital septum.

23. The method of claim 1, wherein the stimulation comprises a current having a pulse amplitude between about 500 μ

A to about 25 mA.

24. The method of claim 1, wherein the stimulation comprises a pulse amplitude, a pulse width, and a pulse frequency, and one or more of the pulse amplitude, pulse width, or pulse frequency is varied over the treatment period.

25. The method of claim 1, wherein the stimulation has a pulse frequency between about 2 Hz to about 270 Hz.

26. The method of claim 1, wherein the stimulation has a pulse frequency between about 30 Hz to about 40 Hz.

27. The method of claim 1, wherein the stimulation comprises a current having a pulse width between about 50 μ

sec to about 2700 μ

sec.

28. The method of claim 1, the implanting step further comprising:

identifying an insertion point for implantation based upon a feature of the orbit.

29. The method of claim 1, wherein the stimulation is adjusted in response to a measured variable.

30. The method of claim 1, wherein the stimulation is delivered in bursts.

31. The method of claim 1, wherein the stimulation comprises a current having a pulse width between about 500 μ

sec to about 1000 μ

sec.

32. The method of claim 1, further comprising positioning a controller in proximity to the microstimulator.

33. The method of claim 32, further comprising generating a magnetic field with the controller.

34. The method of claim 33, wherein the magnetic field is adjusted based on input from the user.

35. The method of claim 33, wherein the magnetic field is adjusted based on the degree of coupling to the microstimulator.

36. The method of claim 33, wherein the magnetic field is coupled to the microstimulator to generate the stimulation.

37. The method of claim 33, wherein the magnetic field is generated in bursts.

38. The method of claim 33, wherein the magnetic field has a frequency of about 10 kHz to about 100 MHz.

39. The method of claim 33, wherein the magnetic field has a frequency of about 100 kHz to about 5 MHz.

40. A method for treating dry eye by stimulating one or more nerves that innervate lacrimal gland tissue comprising:

implanting a microstimulator adjacent to the lacrimal gland;

positioning a controller in proximity to the microstimulator; and

applying stimulation to the lacrimal gland.

41. The method of claim 40, wherein the microstimulator is adjacent the lacrimal gland fully implanted within an orbit of a patient'"'"'s eye.

42. The method of claim 40, wherein the microstimulator is adjacent and directly contacting the lacrimal gland.

43. The method of claim 40, wherein the microstimulator is adjacent to and at least partially penetrating into the lacrimal gland.

44. The method of claim 40, wherein the microstimulator is adjacent to and fully implanted into or completely within the lacrimal gland.

45. The method of claim 40, wherein adjacent to the lacrimal gland is about, within or partially in the lacrimal gland.

46. The method of claim 40, wherein the microstimulator is fully implanted within the orbit of the eye.

47. The method of claim 40, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland.

48. The method of claim 47, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without moving the eye in the vertical or horizontal direction.

49. The method of claim 47, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without stimulating the ocular muscles.

50. The method of claim 47, wherein the stimulation selectively stimulates the one or more nerves that innervate the lacrimal gland without stimulating the superior rectus, lateral rectus, levator palpebrae superioris, retina or corresponding motor nerves.

51. The method of claim 47, wherein the autonomic efferent fibers are selectively stimulated over the sensory afferent fibers.

52. The method of claim 47, wherein the autonomic efferent fibers are selectively stimulated over the A-delta pain fibers.

53. The method of claim 47, wherein the autonomic efferent fibers are selectively stimulated over the C pain fibers.

54. The method of claim 40, wherein the stimulation only stimulates the one or more nerves that innervate the lacrimal gland.

55. The method of claim 40, wherein after the implanting step the microstimulator is implanted into the fossa for the lacrimal gland.

56. The method of claim 40, wherein after the implantation step the microstimulator conforms to the fossa for the lacrimal gland after implantation.

57. The method of claim 40, wherein the microstimulator conforms to an exterior aspect of a lacrimal gland after implantation.

58. The method of claim 40, the implanting step further comprising conforming the microstimulator to an exterior aspect of the fossa for the lacrimal gland.

59. The method of claim 40, wherein after the implanting step the microstimulator may conform to an exterior aspect of the fossa for the lacrimal gland.

60. The method of claim 40, wherein the microstimulator is implanted using a 12 or larger gauge needle.

61. The method of claim 40 further comprising:

loading the microstimulator into a 12 or larger gauge needle;

inserting the needle tip using an anatomical landmark at the corner of the eye;

positioning the needle in proximity to the lacrimal gland; and

deploying the microstimulator using the needle.

62. The method of claim 61, wherein the anatomical landmark is the temporal aspect of the orbit into the superior lateral aspect of the orbit and through the orbital septum.

63. The method of claim 40, wherein the stimulation comprises a current having a pulse amplitude between about 500 μ

A to about 25 mA.

64. The method of claim 40, wherein the stimulation comprises a pulse amplitude, a pulse width, and a pulse frequency, and one or more of the pulse amplitude, pulse width, or pulse frequency is varied over the treatment period.

65. The method of claim 40, wherein the stimulation has a pulse frequency between about 2 Hz to about 270 Hz.

66. The method of claim 40, wherein the stimulation has a pulse frequency between about 30 Hz to about 40 Hz.

67. The method of claim 40, wherein the stimulation comprises a current having a pulse width between about 50 μ

sec to about 2700 μ

sec.

68. The method of claim 40, the implanting step further comprising:

identifying an insertion point for implantation based upon a feature of the orbit.

69. The method of claim 40, wherein the stimulation is adjusted in response to a measured variable.

70. The method of claim 40, wherein the stimulation is delivered in bursts.

71. The method of claim 40, wherein the stimulation comprises a current having a pulse width between about 500 μ

sec to about 1000 μ

sec.

72. The method of claim 40, further comprising generating a magnetic field with the controller.

73. The method of claim 72, wherein the magnetic field is adjusted based on input from the user.

74. The method of claim 72, wherein the magnetic field is adjusted based on the degree of coupling to the microstimulator.

75. The method of claim 72, wherein the magnetic field is coupled to the microstimulator to generate the stimulation.

76. The method of claim 72, wherein the magnetic field is generated in bursts.

77. The method of claim 72, wherein the magnetic field has a frequency of about 10 kHz to about 100 MHz.

78. The method of claim 72, wherein the magnetic field has a frequency of about 100 kHz to about 5 MHz.