NASAL STIMULATION DEVICES AND METHODS

• US 20160158548A1
• Filed: 02/11/2016
• Published: 06/09/2016
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Original Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Inventors: Ackermann, Douglas Michael, Loudin, James Donald
• Granted Patent: US 10,238,861 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61H 1/00 Apparatus for passive exercising A61H5/00 takes precedence; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61H 2201/0153 hand-held
• CPC Class Codes: A61H 2201/0173 Means for preventing injuries
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/0214 cooled
• CPC Class Codes: A61H 2201/025 by direct air flow on the patient's body
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5002 Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2205/023 Nose
• CPC Class Codes: A61H 2205/024 Eyes
• CPC Class Codes: A61H 23/02 with electric or magnetic drive
• CPC Class Codes: A61H 23/0218 with alternating magnetic fields producing a translating or oscillating movement
• CPC Class Codes: A61H 23/0245 : with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61H 23/0263 : using rotating unbalanced masses
• CPC Class Codes: A61H 9/0071 : by localized pressure, e.g. air streams or jets
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/0456 : Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0546 : Nasal electrodes
• CPC Class Codes: A61N 1/36014 : External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36046 : of the eye
• CPC Class Codes: A61N 1/36071 : Pain
• CPC Class Codes: A61N 1/36132 : using patient feedback
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/3615 : Intensity
• CPC Class Codes: A61N 1/36171 : Frequency
• CPC Class Codes: A61N 1/36175 : Pulse width or duty cycle
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: H02J 7/0044 : specially adapted for holding portable devices containing batteries H02J7/0045 takes precedence

Abstract

Described here are devices, systems, and methods for treating one or more conditions (such as dry eye) or improving ocular health by providing stimulation to nasal or sinus tissue. Generally, the devices may be handheld or implantable. In some variations, the handheld devices may have a stimulator body and a stimulator probe having one or more nasal insertion prongs. When the devices and systems are used to treat dry eye, nasal or sinus tissue may be stimulated to increase tear production, reduce the symptoms of dry eye, and/or improve ocular surface health.

Claims

1. A method for treating meibomian gland dysfunction, comprising:

delivering an electrical stimulus via an electrode to treat meibomian gland dysfunction in a patient in need thereof,

wherein the electrode is in contact with nasal tissue of the patient during delivery of the electrical stimulus.

2. The method of claim 1, wherein the nasal tissue is external nasal tissue.

3. The method of claim 1, wherein the nasal tissue is nasal mucosa.

4. The method of claim 3, wherein the nasal mucosa is adjacent to the nasal septum.

5. The method of claim 1, wherein the electrode is a hydrogel electrode.

6. The method of claim 1, wherein the electrode is electrically connected to a control subsystem configured to control the electrical stimulus delivered via the electrode.

7. The method of claim 6, wherein the electrode is positioned on a stimulator probe and the control subsystem is positioned in a stimulator body, and wherein the stimulator probe is releasably connected to the stimulator body.

8. The method of claim 1, wherein the electrical stimulus is a biphasic pulse waveform.

9. A method of treating dry eye, comprising:

delivering an electrical stimulus to external nasal tissue of a subject to improve dysfunction of the Meibomian glands of the subject,

wherein the electrical stimulus is delivered by an electrode of a stimulator comprising a control subsystem to control the electrical stimulus.

10. The method of claim 9, wherein the electrical stimulus is pulsed.

11. The method of claim 9, wherein the electrical stimulus is delivered at least once daily during a treatment period.

12. The method of claim 9, wherein the electrical stimulus is a biphasic pulse waveform.

13. The method of claim 12, wherein the biphasic pulse waveform is symmetrical.

14. The method of claim 12, wherein the waveform has a varying peak to peak amplitude.

15. The method of claim 12, wherein the waveform has a varying frequency.

16. The method of claim 9, wherein the stimulator is configured to be hand held.

17. The method of claim 9, wherein delivering the electrical stimulus to external nasal tissue activates the ophthalmic branch of the trigeminal nerve.