Nasal stimulation devices and methods

• US 9,440,065 B2
• Filed: 06/24/2014
• Issued: 09/13/2016
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Original Assignee: Oculeve Incorporated (Abbvie Incorporated)
• Inventors: Franke, Manfred, Ackermann, Douglas Michael, Loudin, James Donald, Wardle, John, Baldwin, Jarren Armond, Hamilton, Daniel N., Kuzma, Janusz, Stivers, Christopher William
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/313,937
• Publication Number:
  US 20140371812A1
• Time in Patent Office: 812 Days
• Field of Search: 607/53, 607/61, 607/72, 607/135
• US Class Current: 1/1
• 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:

delivering an electrical stimulus to the nasal tissue to activate a nerve,

wherein the electrical stimulus is delivered from a device, the device comprising;

a stimulator body; and

a stimulator probe connected to the stimulator body, wherein the stimulator probe comprises a nasal insertion prong for insertion into a nasal cavity of the subject and a base member configured as a stop that restricts the distance that the nasal insertion prong can be inserted into the nasal cavity, and

wherein the stimulator body comprises a control subsystem to control the electrical stimulus to be delivered to the subject via the stimulator probe.

2. The method of claim 1, wherein the stimulus has a waveform with varying peak-to-peak amplitude.

3. The method of claim 2, wherein the peak-to-peak amplitude varies over time according to a pre-determined plan.

4. The method of claim 3, wherein the peak-to-peak amplitude varies over time according to a sinusoidal function.

5. The method of claim 3, wherein the peak-to-peak amplitude varies over time by increasing linearly from a minimum value to a maximum value, dropping to a minimum value, and repeating.

6. The method of claim 2, wherein the peak-to-peak amplitude varies randomly over time.

7. The method of claim 1, wherein the stimulus has a waveform with varying frequency.

8. The method of claim 7, wherein the frequency varies over time according to a pre-determined plan.

9. The method of claim 7, wherein the frequency varies randomly over time.

10. The method of claim 1, wherein the stimulus has a waveform with varying pulse width.

11. The method of claim 1, wherein the stimulus is pulse-based.

12. The method of claim 11, wherein the pulse-based stimulus has a pattern of 1 second on and 1 second off.

13. The method of claim 11, wherein the pulse-based stimulus has a pattern of 5 seconds on and 5 seconds off.

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

15. The method of claim 14, wherein the frequency of the biphasic pulse waveform is between about 130 Hz and about 170 Hz.

16. The method of claim 14, wherein the frequency of the biphasic pulse waveform is between about 145 Hz and about 155 Hz.

17. The method of claim 1, wherein the stimulus is controlled by the subject during delivery.

18. The method of claim 17, wherein the stimulus causes paresthesia during delivery.

19. The method of claim 1, wherein the stimulator probe is releasably connected to the stimulator body, and wherein the device comprises a mechanism for measuring how long the stimulator probe has been connected to the stimulator body.

21. The method of claim 1, wherein the stop restricts the distance that the nasal insertion prong can be inserted into the nasal cavity to a maximum distance of between 25 mm and 45 mm.

22. The method of claim 1, wherein the nasal insertion prong can reach nasal mucosa at an interface of a nasal bone and an upper lateral cartilage of the subject when inserted into the nasal cavity.

23. The method of claim 1, wherein the stimulus comprises a waveform having a frequency between about 0.1 Hz and about 200 Hz.

24. The method of claim 1, wherein the stimulus comprises a waveform having a frequency between about 10 Hz and about 60 Hz.

25. The method of claim 1, wherein the stimulus comprises a waveform having a maximum current between about 1 mA and about 30 mA.

26. The method of claim 1, wherein the stimulus comprises a waveform having a maximum current between about 0.1 mA and about 10 mA.

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

a stimulator comprising

a stimulator probe comprising a nasal insertion prong; and

a stimulator body comprising a rechargeable power source and a control subsystem to control a stimulus to be delivered to the subject via the nasal insertion prong; and

a base station to recharge the rechargeable power source, comprising one or more electrical contacts configured to connect to the stimulator body,

wherein the stimulator probe is releasably connected to the stimulator body, and wherein the stimulator comprises a disabling mechanism that prevents stimulus delivery to the subject after at least one of a predetermined time from attachment of the stimulator probe, a predetermined number of treatment sessions, a predetermined duration of stimulus delivery, or reconnection of the stimulator probe to the stimulator body after being disconnected from the stimulator body.

27. A device for stimulating a nerve, comprising:

a reusable, handheld stimulator body configured to generate a stimulus, comprising a power source and a user interface;

a disposable stimulator probe having a corresponding and complementary shape to the stimulator body and being reversibly connectable to the stimulator body, wherein the stimulator probe comprises a nasal insertion prong comprising an electrode; and

a disabling mechanism configured to prevent use of the disposable stimulator probe after at least one of a predetermined time from attachment of the stimulator probe, a predetermined number of treatment sessions, a predetermined duration of stimulus delivery, or reconnection of the stimulator probe to the stimulator body after being disconnected from the stimulator body,

wherein the device comprises a current-limiter having a current limit between about 1 mA and about 30 mA.