Nasal stimulation devices and methods

• US 10,155,108 B2
• Filed: 04/18/2014
• Issued: 12/18/2018
• 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
• Primary Examiner(s): STANIS, TIMOTHY A
• Application Number:
  US14/256,916
• Publication Number:
  US 20140316310A1
• Time in Patent Office: 1,705 Days
• Field of Search: 601 15, 601 46, 601 48, 606201, 606204, 607 53, 607135
• 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 driving means for vibrating A61H23/00; 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 of tear production in a subject, comprising:

positioning an electrode in contact with a part of a nasal mucosa covering an upper lateral cartilage and adjacent a nasal bone of an anterior nasal cavity of the subject, wherein the subject is suffering from dry eye; and

delivering an electrical stimulus via the electrode in order to thereby treat the dry eye through tear production,

wherein the electrical stimulus comprises a waveform having a frequency between 0.1 Hz and 200 Hz.

2. The method of claim 1, further comprising positioning a second electrode in contact with the nasal mucosa of the subject.

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

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

5. The method of claim 1, wherein the electrical stimulus is delivered for a 5 minute period, and wherein a Schirmer score over the 5 minute period is at least 3 mm greater than a basal Schirmer score of the subject.

6. The method of claim 1, wherein the frequency is between 20 Hz and 80 Hz.

7. The method of claim 1, wherein the electrode is located on a stimulator configured for being hand-held by the subject.

8. The method of claim 7, wherein the stimulator includes a user interface for allowing one or more parameters of the electrical stimulus to be controlled.

9. The method of claim 1, wherein the electrode is directed at least partially toward a front of the anterior nasal cavity.

10. The method of claim 1, wherein the electrical stimulation is delivered in response to dry eye symptoms.

11. A method of improving ocular health in a patient, comprising:

positioning an electrode in contact with a part of a nasal mucosa covering an upper lateral cartilage and adjacent a nasal bone of an anterior nasal cavity of the patient, the patient in need of improvement in ocular health; and

delivering electrical stimulation to the part of the nasal mucosa of the patient via the electrode at least once daily during a treatment period comprising at least 2 days in order to thereby improve the ocular health of the patient,

wherein the electrical stimulation comprises a waveform having a frequency between 0.1 Hz and 200 Hz, and

wherein a metric for improved ocular health is one or more of decreased dry eye symptoms, decreased ocular surface staining, or increased tear production.

12. The method of claim 11, wherein the metric for improved ocular health includes a score associated with an Ocular Surface Disease Index, and wherein the score decreases by at least 10% within the treatment period, wherein the treatment period comprises 7 days.

13. The method of claim 11, wherein the metric for improved ocular health includes a score associated with an Ocular Surface Disease Index, and wherein the score decreases by at least 40% within the treatment period, wherein the treatment period comprises 90 days.

14. The method of claim 13, wherein the score decreases by at least 50% within the treatment period.

15. The method of claim 11, wherein the metric for improved ocular health is decreased ocular surface staining as measured by corneal staining, and wherein corneal staining decreases by at least 10% within the treatment period, wherein the treatment period comprises 7 days.

16. The method of claim 11, wherein the metric for improved ocular health is decreased ocular surface staining as measured by corneal staining, and wherein corneal staining decreases by at least 60% within the treatment period, wherein the treatment period comprises 90 days.

17. The method of claim 11, wherein the metric for improved ocular health is decreased ocular surface staining as measured by conjunctival staining, and wherein conjunctival staining decreases by at least 5% within the treatment period, wherein the treatment period comprises 7 days.

18. The method of claim 11, wherein the metric for improved ocular health is decreased ocular surface staining as measured by conjunctival staining, and wherein conjunctival staining decreases by at least 30% within the treatment period, wherein the treatment period comprises 90 days.

19. The method of claim 18, wherein conjunctival staining decreases by at least 40% within the treatment period.

20. The method of claim 11, wherein the metric for improved ocular health is increased tear production as measured by an increase in a basal tear production, and wherein the basal tear production increases by at least 1 mm on a Schirmer Tear Test within the treatment period, wherein the treatment period comprises 7 days.

21. The method of claim 11, wherein the metric for improved ocular health is increased tear production as measured by an increase in a basal tear production, and wherein the basal tear production increases by at least 2 mm on a Schirmer Tear Test within the treatment period, wherein the treatment period comprises 90 days.

22. The method of claim 21, wherein the basal tear production increases by at least 3 mm on the Schirmer Tear Test within the treatment period.

23. The method of claim 11, wherein the electrical stimulation activates a naso-lacrimal reflex.

24. The method of claim 11, wherein the electrode is located between 20 mm and 35 mm into the anterior nasal cavity of the patient.

25. The method of claim 11, further comprising positioning a second electrode in a second nasal cavity of the patient.

26. The method of claim 11, wherein the electrical stimulation comprises a biphasic symmetric pulse waveform.

27. The method of claim 26, wherein the frequency is between 20 Hz and 80 Hz.

28. The method of claim 11, wherein the frequency is between 20 Hz and 80 Hz.