# US 9,737,702 B2 · Nasal stimulation devices and methods

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- Number: US 9,737,702 B2
- Document ID: US9737702B2
- Status: Granted
- Kind: B2
- Application number: 15/256,392
- Filed: 2016-09-02
- Published: 2016-12-22
- Granted: 2017-08-22
- 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
- Web page: https://patentgrep.com/patent/US9737702B2

## 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 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 3)

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

### Claim 5 (depends on 3)

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

### Claim 6 (depends on 3)

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

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 3)

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

### Claim 11 (depends on 10)

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

### Claim 12 (depends on 9)

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

### Claim 13 (depends on 3)

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.

### Claim 14 (depends on 3)

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.

### Claim 15 (depends on 3)

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.

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 3)

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.

### Claim 18 (depends on 17)

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.

### Claim 19 (depends on 3)

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

### Claim 20 (depends on 19)

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