# US 9,440,065 B2 · Nasal stimulation devices and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,440,065 B2 - Document ID: US9440065B2 - Status: Granted - Kind: B2 - Application number: 14/313,937 - Filed: 2014-06-24 - Published: 2014-12-18 - Granted: 2016-09-13 - Earliest claimed: 2013-04-19 - Assignees: Oculeve, Inc. - Applicants: Oculeve, Inc. - Inventors: Douglas Michael Ackermann; James Donald Loudin; John Wardle; Jarren Armond Baldwin; Daniel N. Hamilton; Janusz Kuzma; Christopher William Stivers; Manfred Franke - Web page: https://patentgrep.com/patent/US9440065B2 ## CPC - A61N 1/0546: {Nasal electrodes} - A61F 7/12: Devices for heating or cooling internal body cavities - 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 - A61H 9/0071: {by localized pressure, e.g. air streams or jets} - 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} - A61H 23/02: with electric or magnetic drive - A61H 23/0218: {with alternating magnetic fields producing a translating or oscillating movement} - A61H 23/0245: {with ultrasonic transducers, e.g. piezoelectric} - A61H 23/0263: {using rotating unbalanced masses} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/36046: {of the eye} - A61N 1/36071: {Pain} - A61N 1/36132: {using patient feedback} - A61N 1/36146: {specified by the stimulation parameters} - A61N 1/3615: {Intensity} - A61N 1/36171: {Frequency} - A61N 1/36175: {Pulse width or duty cycle} - A61N 1/3787: {from an external energy source} - 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}) - H02J 7/731: {specially adapted for holding portable devices containing batteries (H02J7/751 takes precedence)} - A61H 2201/0153: hand-held - A61H 2201/0173: Means for preventing injuries - A61H 2201/0207: heated - A61H 2201/0214: cooled - A61H 2201/025: by direct air flow on the patient's body - A61H 2201/10: with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy - A61H 2201/165: Wearable interfaces - A61H 2201/5002: Means for controlling a set of similar massage devices acting in sequence at different locations on a patient - A61H 2201/5005: for controlling frequency distribution, modulation or interference of a driving signal - A61H 2201/5015: using specific interfaces or standards, e.g. USB, serial, parallel - A61H 2201/5035: Several programs selectable - A61H 2201/5038: freely programmable by the user - A61H 2201/5043: Displays - A61H 2205/023: Nose - A61H 2205/024: Eyes - 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}) - A61N 2007/0043: {intra-cavitary} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N) - H02J: ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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 ### Claim 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. ### Claim 2 (depends on 1) The method of claim 1, wherein the stimulus has a waveform with varying peak-to-peak amplitude. ### Claim 3 (depends on 2) The method of claim 2, wherein the peak-to-peak amplitude varies over time according to a pre-determined plan. ### Claim 4 (depends on 3) The method of claim 3, wherein the peak-to-peak amplitude varies over time according to a sinusoidal function. ### Claim 5 (depends on 3) 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. ### Claim 6 (depends on 2) The method of claim 2, wherein the peak-to-peak amplitude varies randomly over time. ### Claim 7 (depends on 1) The method of claim 1, wherein the stimulus has a waveform with varying frequency. ### Claim 8 (depends on 7) The method of claim 7, wherein the frequency varies over time according to a pre-determined plan. ### Claim 9 (depends on 7) The method of claim 7, wherein the frequency varies randomly over time. ### Claim 10 (depends on 1) The method of claim 1, wherein the stimulus has a waveform with varying pulse width. ### Claim 11 (depends on 1) The method of claim 1, wherein the stimulus is pulse-based. ### Claim 12 (depends on 11) The method of claim 11, wherein the pulse-based stimulus has a pattern of 1 second on and 1 second off. ### Claim 13 (depends on 11) The method of claim 11, wherein the pulse-based stimulus has a pattern of 5 seconds on and 5 seconds off. ### Claim 14 (depends on 1) The method of claim 1, wherein the stimulus is a biphasic pulse waveform. ### Claim 15 (depends on 14) The method of claim 14, wherein the frequency of the biphasic pulse waveform is between about 130 Hz and about 170 Hz. ### Claim 16 (depends on 14) The method of claim 14, wherein the frequency of the biphasic pulse waveform is between about 145 Hz and about 155 Hz. ### Claim 17 (depends on 1) The method of claim 1, wherein the stimulus is controlled by the subject during delivery. ### Claim 18 (depends on 17) The method of claim 17, wherein the stimulus causes paresthesia during delivery. ### Claim 19 (depends on 1) 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. ### Claim 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. ### Claim 21 (depends on 1) 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. ### Claim 22 (depends on 1) 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. ### Claim 23 (depends on 1) The method of claim 1, wherein the stimulus comprises a waveform having a frequency between about 0.1 Hz and about 200 Hz. ### Claim 24 (depends on 1) The method of claim 1, wherein the stimulus comprises a waveform having a frequency between about 10 Hz and about 60 Hz. ### Claim 25 (depends on 1) The method of claim 1, wherein the stimulus comprises a waveform having a maximum current between about 1 mA and about 30 mA. ### Claim 26 (depends on 1) The method of claim 1, wherein the stimulus comprises a waveform having a maximum current between about 0.1 mA and about 10 mA. ### Claim 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.