NASAL STIMULATION DEVICES AND METHODS

• US 20160367795A1
• Filed: 09/02/2016
• Published: 12/22/2016
• 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
• Granted Patent: US 9,737,702 B2
• Time in Patent Office: Days
• 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; 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 device for stimulating nasal tissue of a subject, comprising:

a stimulator body; and

a stimulator probe connected to the stimulator body, wherein the stimulator probe comprises a nasal insertion prong, and

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

17. The device of claim 1, wherein the stimulus is controllable by the subject during delivery.

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

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

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; and

a safety mechanism that prevents power delivery to the one or more electrical contacts when the stimulator body is not connected to the one or more electrical contacts.