Systems and methods for treatment of dry eye

• US 10,143,846 B2
• Filed: 12/01/2017
• Issued: 12/04/2018
• Est. Priority Date: 11/16/2010
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Ackermann, Douglas Michael, Palanker, Daniel, Loudin, James Donald, Smith, Garrett Cale, McCray, Victor Wayne, Felkins, Brandon McNary
• Primary Examiner(s): HULBERT, AMANDA K
• Application Number:
  US15/828,950
• Publication Number:
  US 20180154161A1
• Time in Patent Office: 368 Days
• 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 a condition of the eye comprising:

delivering a stimulus to an anatomical target to produce lacrimation, wherein the stimulus is delivered by an implanted microstimulator, wherein the microstimulator comprises a body and one or more electrodes integrated into the body,

wherein at least one of an amplitude and a pulse width of the stimulus is ramped over a ramp period, and wherein the stimulus does not activate pain sensation resulting from delivery of the stimulus.

2. The method of claim 1, wherein the microstimulator further comprises a passive stimulation circuit.

3. The method of claim 2, wherein the microstimulator is configured to stimulate the anatomical target via the one or more electrodes in response to a magnetic field.

4. The method of claim 3, further comprising generating the magnetic field with an external controller.

5. The method of claim 4, wherein the magnetic field is adjusted based at least in part on input from the user.

6. The method of claim 1, wherein the microstimulator is pliable.

7. The method of claim 1, wherein the body of the microstimulator has a length of about 6 mm to about 15 mm, and a width of about 1 mm to about 1.5 mm.

8. The method of claim 1, wherein the amplitude of the stimulus is ramped from a low amplitude to a higher amplitude over the ramp period.

9. The method of claim 1, wherein the amplitude of the stimulus is ramped from a high amplitude to a lower amplitude over the ramp period.

10. The method of claim 1, wherein the pulse width of the stimulus is ramped from a low pulse width to a higher pulse width over the ramp period.

11. The method of claim 1, wherein the pulse width of the stimulus is ramped from a high pulse width to a lower pulse width over the ramp period.

12. The method of claim 1, wherein the ramp period is between 1 second and 15 minutes.

13. The method of claim 12, wherein the ramp period is between 5 seconds and 30 seconds.

14. The method of claim 1, wherein the stimulus includes a current having a pulse amplitude between about 500 μ

A and about 25 mA.

15. The method of claim 1, wherein the stimulus has a pulse frequency between about 2 Hz and about 200 Hz.

16. The method of claim 1, wherein the stimulus has a pulse width between about 50 μ

s and about 2700 μ

s.

17. The method of claim 1, wherein the stimulus is delivered to one or more nerves that innervates lacrimal gland tissue.