IMPLANTABLE NASAL STIMULATOR SYSTEMS AND METHODS

• US 20160114163A1
• Filed: 10/22/2015
• Published: 04/28/2016
• Est. Priority Date: 10/22/2014
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Original Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Inventors: FRANKE, Manfred, LOUDIN, James Donald, KUZMA, Janusz, ACKERMANN, Douglas Michael, YUN, Paul Taehyun
• Granted Patent: US 10,207,108 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36046 of the eye
• 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 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

Described here are systems, devices, and methods for implanting a nasal stimulator into nasal tissue and electrically stimulating nasal tissue. In some variations, a nasal microstimulator implantation system may comprise an implantation tool and an implantable microstimulator. An implantation tool may comprise a shaft and features to releasably attach a microstimulator. A microstimulator may comprise a passive stimulation circuit and one or more electrodes. In other variations, a nasal implantation system may additionally comprise one or more additional devices, such as a controller, an electrical probe, and/or a dissection tool.

Claims

1. A method of tear production in a patient, comprising:

implanting a microstimulator into nasal tissue; and

delivering an electrical stimulus via the microstimulator to produce tears.

2. The method of claim 1, wherein the electrical stimulus is pulsed.

3. The method of claim 2, wherein the electrical stimulus comprises a biphasic symmetric pulse waveform.

4. The method of claim 3, wherein the frequency of the biphasic pulse waveform is between 20 Hz and 80 Hz.

5. The method of claim 2, wherein the electrical stimulus has a waveform with a varying pulse width.

6. The method of claim 2, wherein the electrical stimulus has a waveform with a varying frequency.

7. The method of claim 2, wherein the electrical stimulus has a waveform with a varying amplitude.

8. A method for delivering a microstimulator into nasal tissue of a patient, comprising:

identifying an implantation site in the nasal tissue;

forming a pocket in the nasal tissue at the implantation site; and

inserting a microstimulator into the pocket.

9. The method of claim 8, wherein at least a portion of the pocket is located adjacent to the anterior ethmoidal nerve.

10. The method of claim 8, wherein identifying an implantation site comprises electrically stimulating the nasal tissue at at least one location, and observing or recording a response to electrically stimulating the nasal tissue at the at least one location.

11. The method of claim 10, wherein an electrical probe comprising an endoscope and an electrode coupled to the endoscope is used to electrically stimulate the nasal tissue.

12. The method of claim 10, wherein the response comprises one or more of tearing, sneezing, and paresthesia.

13. The method of claim 8, wherein the pocket is substantially between a mucosal layer and the nasal septum.

14. The method of claim 8, wherein forming the pocket comprises incising the nasal tissue to create a pocket opening and extending the pocket from the pocket opening.

15. The method of claim 14, wherein the pocket is extended using a dissection tool comprising a shaft, a blade at a first end of the shaft, and a suction opening extending through a portion of the blade.

16. The method of claim 14, wherein the pocket is extended using a dissection tool, comprising:

a shaft comprising a distal end and a proximal end;

a blade positioned at the distal end of the shaft; and

a lumen, wherein the lumen extends distally from an opening at the proximal end of the shaft, and wherein the lumen is configured to receive an endoscope shaft therewithin.

17. The method of claim 16, wherein the dissection tool further comprises a compressible section configured to change a diameter of the lumen in order to releasably attach the dissection tool to the endoscope shaft.

18. The method of claim 8, wherein an implantation tool comprising a retractable cover is used to insert the microstimulator into the pocket.

19. The method of claim 8, wherein a device used to perform the method comprises a depth stop to indicate a distance relative to a distal end of the device.

20. The method of claim 8, further comprising testing the microstimulator before inserting the microstimulator into the pocket.