Systems and methods for treatment of dry eye

• US 9,095,723 B2
• Filed: 12/04/2014
• Issued: 08/04/2015
• Est. Priority Date: 11/16/2010
• Status: Expired due to Fees

• 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, Felkins, Brandon McNary, McCray, Victor Wayne
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/561,107
• Publication Number:
  US 20150088156A1
• Time in Patent Office: 243 Days
• US Class Current: 1/1
• 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, 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 having a length between 6 mm and 15 mm, and wherein one or more electrodes are integrated into the body of the device, and

wherein the microstimulator is implanted using an insertion device comprising a distal end and a device shaft, wherein the microstimulator can be secured at the distal end.

2. The method of claim 1, further comprising wirelessly delivering power to the microstimulator from a controller.

3. The method of claim 1, wherein the microstimulator comprises one or more features to facilitate minimally invasive retrieval.

4. The method of claim 3, where the one or more features comprises a recapture loop.

5. The method of claim 1, wherein the body has a width between 1 mm and 1.5 mm.

6. The method of claim 1, wherein the microstimulator comprises a coating.

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

8. The method of claim 1, wherein the stimulus has a current having a pulse amplitude between 500 μ

A and 25 mA.

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

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

s and 2700 μ

s.

11. 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 treatment period.

12. The method of claim 1, wherein the microstimulator comprises electrical safety features to limit charge delivery.