Nasal stimulation devices and methods

• US 8,996,137 B2
• Filed: 04/18/2014
• Issued: 03/31/2015
• 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, Kuzma, Janusz, Baldwin, Jarren Armond, Hamilton, Daniel N., Stivers, Christopher William
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/256,915
• Publication Number:
  US 20140316485A1
• Time in Patent Office: 347 Days
• Field of Search: 607/135, 607/53, 607/61, 607/72
• US Class Current: 607/135
• 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 for stimulating nasal tissue of a subject, comprising:

inserting a first nasal insertion prong of a stimulator probe into a first nostril of a nose of the subject and a second nasal insertion prong of the stimulator probe into a second nostril of the nose, such that the electrodes are positioned adjacent to a septum of the subject,

wherein the stimulator probe is connected to a stimulator body, wherein the stimulator body comprises a control subsystem to control an electrical stimulus to be delivered to the subject via the stimulator probe; and

delivering the stimulus to activate a nerve, wherein the stimulus has a maximum amplitude between 10 μ

A and 100 mA and is delivered in a bipolar configuration between the first and second electrodes.

2. The method of claim 1, wherein the nasal insertion prongs self-align toward the septum by flexing medially during insertion into the nostrils of the subject.

3. The method of claim 1, wherein the electrodes comprise a hydrogel.

4. The method of claim 1, wherein the electrodes comprise one or more of platinum, platinum-iridium, gold, or stainless steel.

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

6. The method of claim 5, wherein the biphasic pulse waveform is symmetrical.

7. The method of claim 1, wherein the stimulus comprises a waveform having a frequency between 20 Hz and 80 Hz.

8. The method of claim 1, wherein the stimulator probe is releasably connected to the stimulator body, and wherein the stimulator probe and stimulator body have corresponding and complementary shapes, such that they form a contiguous device when connected.

9. The method of claim 8, wherein the device comprises a disabling mechanism that prevents stimulus delivery to the subject when the stimulator probe is reconnected to the stimulator body after being disconnected from the stimulator body.

10. The method of claim 8, wherein the device comprises a lockout mechanism that prevents the stimulator probe from being reconnected to the stimulator body after being disconnected from the stimulator body.

11. The method of claim 8, wherein the stimulator body is reusable and the stimulator probe is disposable.

12. The method of claim 1, further comprising a detachable protective cap.

13. The method of claim 1, further comprising a user interface.

14. The method of claim 13, wherein delivering the stimulus to activate a nerve comprises using the user interface to turn on the stimulus or to adjust one or more parameters of the stimulus, wherein the user interface is used by the subject.

15. The method of claim 13, further comprising adjusting one or more parameters of the stimulus, wherein the parameters are adjusted by the subject.

19. The method of claim 1, wherein the electrodes are directed at least partially toward a front of the nose.

20. The method of claim 1, wherein the first and second nasal insertion prongs are inserted into the nostrils by the subject.

21. The method of claim 15, wherein adjusting one or more parameters of the stimulus comprises increasing or decreasing the intensity of the stimulus.

22. The method of claim 1, wherein the subject is a human.

16. A system for stimulating nasal tissue of a subject, comprising:

a handheld stimulator comprising;

a stimulator probe comprising a first nasal insertion prong comprising a first electrode and a second nasal insertion prong comprising a second electrode, wherein the first and second electrodes are directed at least partially toward each other, such that the angle between the center of each electrode and an axis intersecting the first and second nasal insertion prongs is between 0 degrees and 90 degrees; and

a stimulator body comprising a rechargeable power source and a control subsystem to allow the subject to control a stimulus to be delivered to the subject via the nasal insertion prong, wherein the control subsystem is configured to deliver a stimulus having a maximum amplitude between 10 μ

A and 100 mA.

17. The system of claim 16, wherein the stimulator comprises memory to store data, and the stimulator is configured to transfer the data to an external device.

18. The system of claim 16, wherein the stimulator probe is removably connectable to the stimulator body, and wherein the stimulator probe blocks access to the rechargeable power source when connected to the stimulator body.

23. The system of claim 16, further comprising a base station to recharge the rechargeable power source.