# US 12,213,912 B2 · Methods and devices for handling a fluid and delivering the fluid to the eye

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- Number: US 12,213,912 B2
- Document ID: US12213912B2
- Status: Granted
- Kind: B2
- Application number: 18/593,828
- Filed: 2024-03-01
- Published: 2024-08-29
- Granted: 2025-02-04
- Earliest claimed: 2017-06-10
- Assignees: Eyenovia, Inc.
- Applicants: Eyenovia, Inc.
- Inventors: Matthew Newell; Luke Clauson; Nicholas Lewis; Michael Raye
- Web page: https://patentgrep.com/patent/US12213912B2

## CPC

- A61F 9/0008: {Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00)}
- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 15/0036: {hollow piercing means}
- A61M 2205/123: with incorporated reservoirs
- A61M 2205/3306: Optical measuring means
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/8206: battery-operated
- A61M 2210/0612: Eyes
- B05B 17/0646: {Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto}
- 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)
- 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)}
- B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D)

## Abstract

Methods and devices for handling a fluid and delivering the fluid to the eye. The device has a vibrating element with a plurality of openings through which a fluid is ejected when the vibrated. An enclosure defines a chamber which holds a single application of the fluid. The enclosure may be biased against the vibrating element with a spring load developed in whole or part by the resilient structure of the enclosure. The chamber may be substantially empty after the single application.

## Claims

### Claim 1

A device for delivering a volume of fluid to an eye, comprising:
a fluid ejector comprising a vibrating element with a plurality of openings, the vibrating element having a fluid side and a delivery side with the plurality of openings extending from the fluid side to the delivery side, the fluid ejector ejecting fluid from the fluid side through the plurality of openings to the delivery side when the vibrating element is vibrated; and
an enclosure comprising a wall and a resilient lip positioned adjacent the fluid side of the vibrating element, the lip extending around the plurality of openings, the enclosure and the vibrating element together forming a chamber; and
a pump comprising a first part and a second part movably coupled to one another to change a size of a variable volume cavity of the pump to draw a discrete dose of liquid from a fluid container into the variable volume cavity and eject the discrete dose of liquid into the chamber during a cycle of the pump,
wherein the resilient lip is configured to separate from the vibrating element to vent air from the chamber as the discrete dose of liquid is ejected into the chamber.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first part and the second part of the pump are configured to reciprocate between a stored position, a partial stroke position, and a full forward stroke position, wherein, when the first part and the second part of the pump are moved from the stored position toward the partial stroke position, the first part moves away from the second part and the cavity increases in size to draw the discrete dose of liquid from the fluid container into the cavity.

### Claim 3 (depends on 2)

The device of claim 2, wherein, when the first part and the second part of the pump are in the full forward stroke position, the first part and the second part are at a greatest displacement from one another, the cavity is at maximum size and aligned with a lumen into the fluid ejector to eject the discrete dose from the cavity into the chamber at a pressure.

### Claim 4 (depends on 3)

The device of claim 3, wherein, when the first part and second part are moved from the full forward stroke position toward the stored position, the first part and the second part of the pump move toward one another and the cavity decreases in size to eject the discrete dose into the lumen.

### Claim 5 (depends on 3)

The device of claim 3, wherein the pressure the discrete dose is ejected from the cavity into the chamber is at least 200 psi.

### Claim 6 (depends on 5)

The device of claim 5, wherein surface tension forces in the chamber holds the discrete dose together as a droplet prior to the vibrating element being vibrated.

### Claim 7 (depends on 1)

The device of claim 1, wherein the lip is spaced apart from the fluid side of the vibrating element by less than 150 microns.

### Claim 8 (depends on 1)

The device of claim 1, wherein the vibrating element has a maximum amplitude which is less than an average separation distance between the lip and the vibrating element.

### Claim 9 (depends on 1)

The device of claim 1, wherein the vibrating element has a thickness measured from the fluid side to the delivery side of 100-180 microns.

### Claim 10 (depends on 1)

The device of claim 1, wherein the lip is in contact with the vibrating element around at least 270 degrees of the plurality of openings when viewed along a central axis, to hold the fluid in the enclosure.

### Claim 11 (depends on 1)

The device of claim 1, wherein the lip is spaced apart from the vibrating element by a separation distance of at least 125 microns and no more than 250 microns around at least 270 degrees of the plurality of openings when viewed along a central axis of the vibrating element.

### Claim 12 (depends on 1)

The device of claim 1, wherein the enclosure does not include a vent opening to vent air into the enclosure when the fluid is ejected through the openings other than between the lip and the vibrating element and through at least some of the plurality of openings.

### Claim 13 (depends on 1)

The device of claim 1, wherein the fluid container fluidly couples to the chamber of the enclosure, and has a fluid carrying capacity which is at least 150 times the volume of the enclosure; and wherein the pump delivers one dose size only.

### Claim 14 (depends on 1)

The device of claim 1, wherein the vibrating element defines an enclosed border positioned adjacent to a surface of the lip, the enclosed border defining an enclosed feed area bounded by the enclosed border, the openings in the vibrating element encompassing and defining a delivery area of the vibrating element.

### Claim 15 (depends on 1)

The device of claim 1, wherein the enclosure has a sidewall and a main inlet which receives fluid, the enclosure also having a first inlet and a second inlet through which fluid enters the chamber, the first inlet and the second inlet leading to the chamber and both oriented to direct fluid at a sidewall of the enclosure before being directed at the plurality of openings.

### Claim 16 (depends on 1)

The device of claim 1, wherein the first part of the pump has a main body and a first extension and the second part of the pump has a main body and a second extension, wherein the first extension extends toward the second extension and the second extension interlocks with the first extension, the first part driving the second part through the cycle.

### Claim 17 (depends on 1)

The device of claim 1, wherein the variable volume cavity of the pump holds a volume of 7-12 microliters which is delivered to the enclosure during use.

### Claim 18 (depends on 1)

The device of claim 1, wherein the lip has a PTFE coating adjacent to the vibrating element to reduce friction therebetween, the coating extending around at least 270 degrees of the lip when viewed along a central axis of the vibrating element.

### Claim 19 (depends on 1)

The device of claim 1, wherein the vibrating element has a PTFE coating adjacent to the lip to reduce friction therebetween, the coating extending around at least 270 degrees when viewed along a central axis of the vibrating element.

### Claim 20 (depends on 1)

The device of claim 1, wherein an inner surface of the enclosure is hydrophobic over at least 70% of the inner surface in contact with fluid.

### Claim 21 (depends on 1)

The device of claim 1, further comprising a wall opening for venting the chamber extending through the wall to expose the chamber and wherein a radial dimension of the wall opening is not more than 10% of an equivalent circumference of the lip.

### Claim 22 (depends on 21)

The device of claim 21, wherein the wall opening forms a gap in the lip.

### Claim 23 (depends on 21)

The device of claim 21, wherein the wall opening has a longitudinal dimension measured from the lip in the direction of a central axis and a radial dimension measured in a radial direction relative to the central axis, the enclosure having an internal wall with a side facing the openings in the vibrating element which is spaced apart from the openings by a separation.

### Claim 24 (depends on 21)

The device of claim 21, wherein the wall includes a frustoconical portion, the wall opening extending proximally from the lip for at least 80% of a length of the frustoconical portion.

### Claim 25 (depends on 23)

The device of claim 23, wherein the longitudinal dimension of the wall opening is at least 80% of the separation between the vibrating element and the side of the enclosure facing the openings.

### Claim 26 (depends on 1)

A method of delivering a volume of fluid to an eye using the device of claim 1, comprising: delivering the discrete dose of liquid into the chamber; and vibrating the vibrating element so that the discrete dose of liquid in the chamber is ejected through the plurality of openings toward an eye.

### Claim 27 (depends on 26)

The method of claim 26, wherein the discrete dose being delivered is 7-12 microliters.