Systems and methods for treatment of dry eye
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.
1. A method for treating a condition of an eye of a user, comprising:
positioning a flexible microstimulator adjacent to an anatomical target selected to produce lacrimation;
conforming a portion of the flexible microstimulator to an anatomical structure of the patient; and
delivering a stimulus to the anatomical target when the user depresses a button, the stimulus provided using an electrode of the micro stimulator to increase a volume of tears in the eye of the user without stimulating an ocular muscle.
2. The method of claim 1 wherein during the positioning step the flexible microstimulator is advanced adjacent into a region of a user skull to provide access to the anatomical target.
3. The method of claim 2 wherein the region of the skull is a sphenoid bone, an inferior orbital fissure, a portion of the nasal-maxillary area or a nasal cavity.
4. The method of claim 1 wherein the delivering the stimulus step does not activate a pain sensation in the user.
5. The method of claim 1 wherein after the conforming step a rounded end of the electrode of the microstimulator is on or adjacent to the anatomical target selected to produce lacrimation.
6. The method of claim 1 , wherein the stimulus has a pulse amplitude, a pulse width, and a pulse frequency, and wherein one or more of the pulse amplitude, pulse width, or pulse frequency is varied over the user treatment period.
7. The method of claim 6 , wherein the amplitude of the stimulus is ramped from a low amplitude to a higher amplitude over the user treatment period.
8. The method of claim 6 , wherein the amplitude of the stimulus is ramped from a high amplitude to a lower amplitude over the user treatment period.
9. The method of claim 6 , wherein the pulse width of the stimulus is ramped from a low pulse width to a higher pulse width over the user treatment period.
10. The method of claim 6 , wherein the pulse width of the stimulus is ramped from a high pulse width to a lower pulse width over the user treatment period.
11. The method of claim 1 further comprising: performing the delivering a stimulation step for between 1 second and 15 minutes after the user depresses a button.
12. The method of claim 1 further comprising: performing the delivering a stimulation step for between 5 seconds and 30 seconds after the user depresses a button.
13. The method of claim 1 , wherein the stimulus includes a current having a pulse amplitude between about 500 μA and about 25 mA.
14. The method of claim 1 , wherein the stimulus has a pulse frequency between about 2 Hz and about 200 Hz.
15. The method of claim 1 , wherein the stimulus has a pulse width between about 50 μs and about 2700 μs.
16. The method of claim 1 , wherein the anatomical target is one or more nerves that innervates lacrimal gland tissue.