# US 11,432,962 B2 · Ocular treatment devices and related methods of use

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- Number: US 11,432,962 B2
- Document ID: US11432962B2
- Status: Granted
- Kind: B2
- Application number: 17/362,585
- Filed: 2021-06-29
- Published: 2021-10-21
- Granted: 2022-09-06
- Earliest claimed: 2016-12-19
- Assignees: New World Medical, Inc.
- Applicants: New World Medical, Inc.
- Inventors: Malik Y. Kahook
- Web page: https://patentgrep.com/patent/US11432962B2

## CPC

- A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)}
- 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)}
- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61M 5/178: Syringes
- A61M 5/3286: {Needle tip design, e.g. for improved penetration}
- A61M 5/3291: {Shafts with additional lateral openings}
- 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

Apparatus and methods for ocular treatment are provided. The apparatus can comprise a microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis. The apparatus can include a handle coupled to the proximal end of the microcannula. The apparatus can include multiple orifices extending circumferentially about the microcannula distal end, each of the orifices defining a channel extending transverse to the central longitudinal axis, and one or more grooves about a circumference of the microcannula.

## Claims

### Claim 1

A medical device comprising:
an outer sheath;
a microcannula movably housed within the outer sheath and having a proximal end, a distal tip, a cavity and a central longitudinal axis;
a handle coupled to the proximal end of the microcannula and comprising a track;
an actuator coupled to the microcannula and comprising a slide disposed within the track and configured to linearly slide along the track, the actuator configured to extend the distal tip of the microcannula out of the opening of the outer sheath; and
a plurality of orifices extending circumferentially about the distal tip of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice configured to deliver a substance radially outwardly from the distal tip of the microcannula,
wherein the distal tip of the microcannula is configured to extend out from a distal opening of the outer sheath when the microcannula is in an extended position and to be completely housed within the outer sheath when the microcannula is in a retracted position,
wherein the track has a width perpendicular to the central longitudinal axis and a plurality of narrowed sections defined by opposing pairs of flanges protruding inwardly towards the central longitudinal axis, wherein an axial spacing between adjacent pairs of flanges correlates to an amount of the substance to be injected via the microcannula.

### Claim 2 (depends on 1)

The medical device of claim 1, further comprising a control mechanism coupled to the handle, the control mechanism configured to extend and retract the distal tip of the microcannula out of and into the opening of the outer sheath, respectively.

### Claim 3 (depends on 1)

The medical device of claim 1, wherein the actuator is configured to extend the distal tip of the microcannula out of the opening of the outer sheath upon receiving a threshold amount of force.

### Claim 4 (depends on 1)

The medical device of claim 1, wherein the distal tip is configured to be extended to penetrate trabecular meshwork of an eye while the outer sheath remains outside of the trabecular meshwork.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein a first portion of the slide is one of bent and folded, and wherein the first portion of the slide extends radially outwardly of the central longitudinal axis through the track.

### Claim 6 (depends on 1)

The medical device of claim 1, wherein a first orifice among the plurality of orifices is spaced 180 degrees apart from a second orifice among the plurality of orifices.

### Claim 7 (depends on 1)

The medical device of claim 1, wherein the plurality of orifices are disposed at the same distance from the distal tip on the central longitudinal axis.

### Claim 8 (depends on 1)

The medical device of claim 1, wherein the substance is a viscoelastic fluid, wherein the handle comprises a reservoir containing the viscoelastic fluid and an actuator configured to eject the viscoelastic fluid radially outwardly through the orifices.

### Claim 9 (depends on 1)

The medical device of claim 1, wherein for each of the plurality of orifices, a radially outer end is positioned distal to a radially inner end, such that each of the orifices is configured to deliver the substance distally and radially outwardly from the microcannula.

### Claim 10 (depends on 1)

The medical device of claim 1, further comprising:
one or more first protrusions extending circumferentially inward at a distal end of the outer sheath; and
one or more second protrusions located on an outer circumferential surface of the microcannula.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein one of:
the first and second protrusions each include multiple protrusions equidistantly spaced apart;
the second protrusions are proximal to the first protrusions when the distal tip of the microcannula is in the retracted position; and
the second protrusions are distal to the first protrusions when the distal tip of the microcannula is in the extended position.

### Claim 12 (depends on 1)

A method of delivering fluid, comprising:
inserting the medical device of claim 1 through an incision in an anterior chamber of an eye;
extending the distal tip of the microcannula out of the distal opening of the outer sheath, through a trabecular meshwork of the eye and into a Schlemm's canal of the eye; and
delivering fluid through the microcannula and out of the plurality of orifices positioned within the Schlemm's canal.

### Claim 13

A medical device comprising:
a microcannula having a proximal end, a distal tip, a cavity and a central longitudinal axis;
an outer sheath movably housed around the microcannula;
a handle coupled to the proximal end of the microcannula and comprising a track, wherein the track has a width perpendicular to the central longitudinal axis and a plurality of narrowed sections defined by opposing pairs of flanges protruding inwardly towards the central longitudinal axis; and
a plurality of orifices extending circumferentially about the distal tip of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice configured to deliver a substance radially outwardly from the distal tip of the microcannula,
wherein the distal tip of the microcannula is configured to extend out from a distal opening of the outer sheath when the outer sheath is in a retracted position and to be completely housed within the outer sheath when the outer sheath is in an extended position,
wherein the outer sheath is configured to move in a proximal direction when a distal portion of the outer sheath is pressed against trabecular meshwork of an eye.

### Claim 14 (depends on 13)

The medical device of claim 13, wherein one of:
a first orifice among the plurality of orifices is spaced 180 degrees apart from a second orifice among the plurality of orifices;
the plurality of orifices are disposed at the same distance from the distal tip on the central longitudinal axis; and
for each of the plurality of orifices, a radially outer end is positioned distal to a radially inner end, such that each of the orifices is configured to deliver the substance distally and radially outwardly from the microcannula.

### Claim 15 (depends on 13)

The medical device of claim 13, wherein the substance is a viscoelastic fluid, wherein the handle comprises a reservoir containing the viscoelastic fluid and an actuator configured to eject the viscoelastic fluid radially outwardly through the orifices.

### Claim 16 (depends on 13)

A method of delivering fluid, comprising:
inserting the medical device of claim 13 through an incision in an anterior chamber of an eye;
pressing a distal portion of the outer sheath against a trabecular meshwork of the eye;
moving the outer sheath in a proximal direction;
advancing the distal tip through the trabecular meshwork and into a Schlemm's canal of the eye; and
delivering fluid through the microcannula and out of the plurality of orifices positioned within the Schlemm's canal.

### Claim 17

A medical device comprising:
an outer sheath;
a microcannula movably housed within the outer sheath and having a proximal end, a distal tip, a cavity and a central longitudinal axis;
one or more first protrusions extending circumferentially inward at a distal end of the outer sheath;
one or more second protrusions located on an outer circumferential surface of the microcannula;
a handle coupled to the proximal end of the microcannula and comprising a track;
an actuator coupled to the microcannula and comprising a slide disposed within the track and configured to linearly slide along the track, the actuator configured to extend the distal tip of the microcannula out of the opening of the outer sheath; and
a plurality of orifices extending circumferentially about the distal tip of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice configured to deliver a substance radially outwardly from the distal tip of the microcannula,
wherein the distal tip of the microcannula is configured to extend out from a distal opening of the outer sheath when the microcannula is in an extended position and to be completely housed within the outer sheath when the microcannula is in a retracted position.

### Claim 18 (depends on 17)

A method of delivering fluid, comprising:
inserting the medical device of claim 17 through an incision in an anterior chamber of an eye;
extending the distal tip of the microcannula out of the distal opening of the outer sheath, through a trabecular meshwork of the eye and into a Schlemm's canal of the eye; and
delivering fluid through the microcannula and out of the plurality of orifices positioned within the Schlemm's canal.
