# US 12,214,160 B2 · Method and apparatus for subretinal injection

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- Number: US 12,214,160 B2
- Document ID: US12214160B2
- Status: Granted
- Kind: B2
- Application number: 17/647,884
- Filed: 2022-01-13
- Published: 2022-07-28
- Granted: 2025-02-04
- Earliest claimed: 2021-01-25
- Assignees: Alcon Inc.
- Applicants: Alcon Inc.
- Inventors: Niels Alexander Abt; Reto Grüebler
- Web page: https://patentgrep.com/patent/US12214160B2

## CPC

- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61M 5/1582: {Multi-lumen needles}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/16804: {Active flow controllers}
- 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})
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1588: {having means for monitoring, controlling or visual inspection, e.g. for patency check or for avoiding extravasation}
- A61M 2205/3306: Optical measuring means
- A61M 2210/0612: Eyes
- 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)}

## Abstract

In certain embodiments, an apparatus is provided for performing a subretinal injection into a subretinal space between a retina and a retinal pigment epithelium of an eye. The apparatus includes an injection needle having a proximal end and a distal end, the distal end configured to be insertable into the subretinal space at a position on a surface of the retina. The apparatus includes a multi-lumen tubing having a distal end coupled to the proximal end of the injection needle and a proximal end coupled to a fluid control unit. The apparatus includes a stabilizer configured to immobilize the injection needle at the position on the surface of the retina. The fluid control unit has a plurality of fluid reservoirs containing a non-treatment solution, a treatment solution, and a working fluid which are injectable into the eye via separate lumens of the multi-lumen tubing.

## Claims

### Claim 1

An apparatus for performing a subretinal injection into a subretinal space between a retina and a retinal pigment epithelium of an eye, the apparatus comprising:
an injection needle having a proximal end and a distal end, the distal end configured to be insertable into the subretinal space at a position on a surface of the retina;
a multi-lumen tubing having a distal end coupled to the proximal end of the injection needle and a proximal end coupled to a fluid control unit, the multi-lumen tubing having a first lumen and a second lumen;
a stabilizer configured to immobilize the injection needle at the position on the surface of the retina; and
the fluid control unit having a first fluid reservoir containing a non-treatment solution and a second fluid reservoir containing a treatment solution, wherein the fluid control unit is configured to inject the non-treatment solution from the first fluid reservoir to the subretinal space via the first lumen, and wherein the fluid control unit is configured to inject the treatment solution from the second fluid reservoir into the subretinal space via the second lumen;
wherein the stabilizer comprises a balloon, wherein the balloon is extended by filling with a liquid, and wherein, in the extended position, the balloon has first and second wings extending substantially along an axis perpendicular to a longitudinal axis of the distal end of the multi-lumen tubing;
wherein the balloon has a flattened profile such that a width of the balloon measured parallel to the surface of the retina is at least two times greater than a height of the balloon measured orthogonal to the surface of the retina; and
wherein the multi-lumen tubing further comprises a third lumen, wherein the stabilizer is coupled to a distal end of the third lumen, and wherein fluid applied through the third lumen is configured to extend the stabilizer beyond the distal end of the third lumen thereby placing the stabilizer on the surface of the retina.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the fluid control unit further comprises a third fluid reservoir, and wherein the fluid control unit is configured to inject a working fluid from the third fluid reservoir via the third lumen to extend the stabilizer.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the fluid control unit further comprises a pump configured to drive flow of each of the non-treatment and treatment solutions, the pump being at least one of a variable volume control pump, a syringe pump, a peristaltic pump, a venturi pump, a lever-actuated pump, a valve-actuated pump, or combinations thereof.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the fluid control unit is attachable to at least one of a surgical microscope or a patient forehead.

### Claim 5 (depends on 1)

The apparatus of claim 1, further comprising an inserter device, wherein the multi-lumen tubing is disposed through the inserter device.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein the inserter device comprises a slit extending longitudinally from a proximal end to a distal end thereof, and wherein the inserter device is configured to be decoupled from the multi-lumen tubing outside the eye by sliding the multi-lumen tubing through the slit.

### Claim 7 (depends on 5)

The apparatus of claim 5, wherein the inserter device comprises an enclosed bore extending longitudinally from a proximal end to a distal end thereof, and wherein the inserter device is configured to remain coupled to the multi-lumen tubing outside the eye.