Nasal stimulation devices and methods

• US 9,737,702 B2
• Filed: 09/02/2016
• Issued: 08/22/2017
• 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, Wardle, John, Baldwin, Jarren Armond, Hamilton, Daniel N., Kuzma, Janusz
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US15/256,392
• Publication Number:
  US 20160367795A1
• Time in Patent Office: 354 Days
• Field of Search: 607135, 607 53, 607 61, 607 72
• 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 system for stimulating nasal tissue of a subject, comprising:

a disposable stimulator probe, wherein the stimulator probe comprises

a first nasal insertion prong comprising a first lead;

a second nasal insertion prong comprising a second lead,

wherein the first nasal insertion prong comprises a first electrode at a distal end of the first lead and the second nasal insertion prong comprises a second electrode at a distal end of a second lead; and

a fuse positioned proximal to the first and second leads, wherein the fuse comprises a conductive material and is configured to cause a short circuit upon first use.

2. The system of claim 1, wherein the fuse comprises aluminum.

3. The system of claim 1, further comprising a stimulator body comprising stimulator circuitry, wherein the stimulator probe is connectable to the stimulator body.

4. The system of claim 3, wherein the stimulator body is reusable.

5. The system of claim 3, wherein first use comprises the first connection of the stimulator probe to the stimulator body.

6. The system of claim 3, wherein causing a short circuit comprises short circuiting the stimulator circuitry.

7. The system of claim 6, wherein the short circuit is temporary.

8. The system of claim 1, wherein the fuse is an electrical fuse.

9. The system of claim 1, wherein the fuse is a mechanical fuse.

10. The system of claim 3, wherein the stimulator body is configured to break the fuse upon first use.

11. The system of claim 10, wherein the stimulator body comprises a protrusion configured to break the fuse.

12. The system of claim 9, wherein the fuse is attached to a proximal surface of the stimulator probe with an adhesive.

13. The system of claim 3, wherein the system is configured to provide an alert if the stimulator probe has been previously attached to any stimulator body.

14. The system of claim 3, wherein the system is configured to be non-operational if the stimulator probe has been previously attached to any stimulator body.

15. The device of claim 3, wherein the system comprises a safety feature for measuring a duration of attachment between the stimulator probe and stimulator body.

16. The system of claim 15, wherein the safety feature renders the system non-operational after a predetermined duration of attachment.

17. The system of claim 3, wherein the system comprises a safety feature for measuring a duration of time from a first stimulus delivery using the stimulator probe.

18. The system of claim 17, wherein the safety feature renders the system non-operational after a predetermined duration of time from the first stimulus delivery.

19. The system of claim 3, wherein the system comprises a safety feature for measuring a duration of stimulation delivered by the stimulator probe.

20. The system of claim 19, wherein the safety feature renders the system non-operational after a predetermined duration of stimulation.