STIMULATION DEVICES AND METHODS

• US 20130006326A1
• Filed: 04/06/2012
• Published: 01/03/2013
• Est. Priority Date: 11/16/2010
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated), 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: PALANKER, Daniel, ACKERMANN, Douglas Michael, LOUDIN, James Donald, KUZMA, Janusz, WETENKAMP, Scott Franklin
• Granted Patent: US 9,821,159 B2
• Time in Patent Office: Days
• 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 1/37205 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

Abstract

Described here are stimulation systems and methods for stimulating one or more anatomical targets in a patient for treatment conditions such as dry eye. The stimulation system may include a controller and a 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 signal received from the controller and apply the signal via one or more electrodes to an anatomical target. In some variations, the microstimulator may include a passive generation circuit configured to generate a pulse based on a signal received from the controller.

Claims

1. An implantable microstimulator for treating conditions of the eye comprising:

a housing, wherein the housing comprises a passive stimulation circuit; and

a flexible extension connected to the housing, wherein the flexible extension comprises at least one electrode.

2. The implantable microstimulator of claim 1 further comprising a coil positioned within the flexible extension.

3. The implantable microstimulator of claim 1 wherein the at least one electrode comprises a first electrode and a second electrode.

4. The implantable microstimulator of claim 3 wherein the first and second electrodes are positioned on a first side of the flexible extension.

5. The implantable microstimulator of claim 3 wherein the first electrode is positioned on a first side of the flexible extension, and the second electrode is positioned on a second side of the flexible extension.

6. The implantable microstimulator of claim 1, wherein at least one of the at least one electrodes is textured or patterned.

7. The implantable microstimulator of claim 1, wherein at least one of the at least one electrodes is recessed.

8. The implantable microstimulator of claim 1 wherein the first electrode and a second electrode are positioned on a first side of the flexible extension.

9. The implantable microstimulator of claim 1 wherein the passive stimulation circuit comprises a ramping control unit.

10. The implantable microstimulator of claim 1 wherein the microstimulator comprises one or more coatings.

11. The implantable microstimulator of claim 10 wherein at least one of the one or more coatings is configured to enhance charge injection capacity.

12. The implantable microstimulator of claim 10 wherein at least one of the one or more coatings is an insulating coating.

13. The implantable microstimulator of claim 1 wherein the microstimulator comprises one or more fixation elements.

14. An implantable microstimulator for treating one or more conditions comprising a passive stimulation circuit, wherein the passive stimulation circuit comprises a ramping control unit.

15. The implantable microstimulator of claim 14 wherein the passive stimulation circuit further comprises a receiving unit configured to receive an output signal.

16. The implantable microstimulator of claim 15 wherein the passive stimulation circuit comprises a signal conditioning unit configured to condition the output signal received by the receiving unit.

17. The implantable micro stimulator of claim 16 wherein the signal conditioning unit comprises a rectifying unit.

18. The implantable micro stimulator of claim 17 wherein the signal conditioning unit comprises one or more amplitude limiting units.

19. The implantable microstimulator of claim 17 wherein the passive stimulation circuit comprises one or more charge limiting units.

20. The implantable microstimulator of claim 17 wherein the passive stimulation circuit comprises one or more voltage limiting units.

21. The implantable microstimulator of claim 17 wherein the passive stimulation circuit comprises one or more current limiting units.

22. The implantable micro stimulator of claim 16 wherein the passive stimulation circuit comprises an output unit configured to receive the conditioned output signal from the signal conditioning unit, and is further configured to supply a stimulation signal to one or more electrodes.

23. The implantable microstimulator of claim 14, wherein the ramping control unit controls the amplitude of the of the conditioned output signal received by the output unit.

24. The implantable micro stimulator of claim 23 wherein the ramping control unit comprises a charging unit and a field-effect transistor, and wherein the field-effect transistor connects the signal conditioning unit to the output unit.

25. A system for treating a condition comprising:

an implantable micro stimulator; and

a controller set comprising a plurality of controllers, each of the plurality of controllers configured to transmit an output signal to the implantable micro stimulator.

26. The system of claim 25 wherein the implantable microstimulator comprises a passive stimulation circuit.

27. The system of claim 25 wherein the plurality of controllers is releasably connected to a base member.

28. The system of claim 27 wherein each of the plurality of controller is configured to generate an output signal when the controller is removed from the base member.

29. The system of claim 25 wherein the plurality of controllers comprises a plurality of patches, wherein each of the plurality of patches comprises an adhesive layer.

30. A method of implanting a microstimulator adjacent to a lacrimal gland of a patient comprising:

lifting an eyelid of the patient;

forming an insertion pathway through the conjunctiva under the eyelid; and

advancing the microstimulator into the insertion pathway.

31. The method of claim 30 wherein forming the insertion pathway comprises piercing the conjunctiva with a dissection tool.

32. The method of claim 31 wherein advancing the microstimulator comprises advancing an insertion device loaded with the microstimulator.

33. The method of claim 32 further comprising releasing the microstimulator from the insertion device.

34. The method of claim 32 wherein the insertion device and the dissection tool are separate devices.

35. The method of claim 30 wherein forming an insertion pathway comprises forming an insertion pathway between the periosteum and the lacrimal gland.

36. The method of claim 30 wherein forming an insertion pathway comprises forming an insertion pathway between the periosteum and the orbital bone.

37. A method for treating dry eye comprising:

implanting a microstimulator adjacent to a lacrimal gland, wherein the microstimulator comprises a passive stimulation circuit; and

applying ramped stimulation to the lacrimal gland.

38. The method of claim 37 wherein the passive stimulation circuit comprises a ramping control unit.

39. The method of claim 37 wherein the microstimulator is implanted into a fossa for the lacrimal gland.

40. The method of claim 37 further comprising positioning a controller in proximity to the microstimulator.

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

42. The method of claim 41 wherein the magnetic field is generated in bursts.

43. An implantable microstimulator for treating one or more conditions comprising a passive stimulation circuit.

44. A method for treating dry eye comprising:

implanting a microstimulator adjacent to a lacrimal gland, wherein the microstimulator comprises a passive stimulation circuit; and

applying a stimulation signal to the lacrimal gland.