# US 11,110,008 B2 · Intraocular device for dual incisions

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- Number: US 11,110,008 B2
- Document ID: US11110008B2
- Status: Granted
- Kind: B2
- Application number: 16/997,663
- Filed: 2020-08-19
- Published: 2020-12-03
- Granted: 2021-09-07
- Earliest claimed: 2012-04-24
- Assignees: The Regents of the University of Colorado
- Applicants: The Regents of the University of Colorado
- Inventors: Malik Y. Kahook
- Web page: https://patentgrep.com/patent/US11110008B2

## CPC

- A61F 9/0133: {Knives or scalpels specially adapted therefor}
- A61B 17/3209: Incision instruments
- A61F 9/00736: {Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments (A61F9/008 takes precedence)}
- A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A microsurgical device and methods of its use can be used for treatment of various conditions including eye diseases, such as glaucoma, using minimally invasive surgical techniques. A dual-blade device can be used for cutting the trabecular meshwork (“TM”) in the eye. The device tip provides entry into the Schlemm's canal via its size (i.e., for example, 0.2-0.3 mm width) and configuration where a ramp elevates the TM away from the outer wall of the Schlemm's canal and guides the TM to first and second lateral elements for creating first and second incisions through the TM. The dimensions and configuration of the blade is such that an entire strip of TM is removed without leaving TM leaflets behind and without causing collateral damage to adjacent tissues.

## Claims

### Claim 1

A device for incising a trabecular meshwork, the device comprising:
a shaft;
a distal member positioned at a distal end of the shaft, the distal member having a forward end and a rearward end;
a tip disposed at the forward end of the distal member, the tip comprising:
a foremost portion having a vertical face; and
right and left angled portions extending from opposing sides of the vertical face;
a right edge and a left edge extending towards the rearward end from the right and left angled portions of the tip, wherein the right edge and the left edge increase in height as they extend rearward; and
a gap rearward of the tip and between the right edge and the left edge,
wherein at least portions of the right and left edges are configured to cut trabecular meshwork tissue as the trabecular meshwork tissue advances in a rearward direction over the right and left edges,
wherein as the trabecular meshwork tissue advances over the right and left edges, an incline of the right and left edges is configured to cause the trabecular meshwork tissue to be lifted away from a back wall of a Schlemm's canal, and
wherein a width between the right and left angled portions of the tip increases as they extend rearward while not exceeding a width between the right and left edges defining the gap.

### Claim 2 (depends on 1)

The device of claim 1, wherein a width between the right and left edges increases from a first width at a forward-most portion of the distal member to a second width, greater than the first width, at a rearward portion of the distal member.

### Claim 3 (depends on 2)

The device of claim 2, wherein the second width is between 0.2 to 0.3 mm inclusive.

### Claim 4 (depends on 2)

The device of claim 2, wherein the increased width between the right and left edges is configured to transversely stretch the trabecular meshwork tissue as the trabecular meshwork tissue advances over the right and left edges.

### Claim 5 (depends on 1)

The device of claim 1, wherein the distal member further comprises a bottom surface that is transversely convex.

### Claim 6 (depends on 5)

The device of claim 5, wherein the distal member is configured so that when the distal member is advanced into the Schlemm's canal, the back wall of the Schlemm's canal is juxtaposed to the bottom surface.

### Claim 7 (depends on 5)

The device of claim 5, wherein the bottom surface has a maximum width that is less than a maximum width of the distal member.

### Claim 8 (depends on 1)

The device of claim 1, wherein a portion of each of the right edge and left edge is positioned at a first height and oriented at a first orientation that is substantially vertical.

### Claim 9 (depends on 1)

The device of claim 1, wherein at least portions of the right and left edges are angled between 20 and 90 degrees with respect to a bottom surface of the distal member.

### Claim 10 (depends on 1)

The device of claim 1, further comprising a handle coupled to a proximal end of the shaft, wherein the handle and the distal member are operably attached at an angle ranging between 90 and 120 degrees in a Y-Z plane.

### Claim 11 (depends on 1)

The device of claim 1, further comprising a handle coupled to a proximal end of the shaft, wherein the handle and the distal member are operably attached at an angle ranging between 90 and 180 degrees in a Y-Z plane.

### Claim 12 (depends on 1)

The device of claim 1, further comprising a handle coupled to a proximal end of the shaft, wherein the distal member rotates relative to the handle in a dimension selected from the group consisting of an X-Y dimension and a positive Z dimension.

### Claim 13 (depends on 1)

The device of claim 1, further comprising a handle coupled to a proximal end of the shaft, wherein the distal member remains at a fixed angle in the X-Y, X-Z, and Y-Z dimensions relative to the handle.

### Claim 14 (depends on 1)

The device of claim 1, wherein the right and left edges each form a convex portion of the distal member.

### Claim 15 (depends on 1)

The device of claim 1, wherein the right and left edges each connect to a top surface of the distal member with a bevel.

### Claim 16 (depends on 1)

The device of claim 1, wherein portions of the right and left edges are configured to stretch the trabecular meshwork tissue without cutting as the trabecular meshwork tissue advances over the right and left edges.

### Claim 17

A device for incising a trabecular meshwork, the device comprising:
a shaft;
a distal member positioned at a distal end of the shaft, the distal member having a forward end and a rearward end;
a tip disposed at the forward end of the distal member, the tip having a blunt forward face and right and left angled portions extending from opposing sides of the blunt forward face;
a right edge and a left edge extending towards the rearward end from the right and left angled portions of the tip, wherein the right edge and the left edge increase in height as they extend rearward; and
a gap rearward of the tip and between the right edge and the left edge,
wherein at least portions of the right and left edges are configured to cut trabecular meshwork tissue as the trabecular meshwork tissue advances in a rearward direction over the right and left edges,
wherein as the trabecular meshwork tissue advances over the right and left edges, an incline of the right and left edges is configured to cause the trabecular meshwork tissue to be lifted away from a back wall of a Schlemm's canal, and
wherein a width between the right and left angled portions of the tip increases as they extend rearward while not exceeding a width between the right and left edges defining the gap.

### Claim 18 (depends on 17)

The device of claim 17, wherein a width between the right and left edges increases from a first width at a forward-most portion of the right and left edges to a second width, greater than the first width, at a rearward portion of the right and left edges.

### Claim 19 (depends on 17)

The device of claim 17, wherein at least portions of the right and left edges are angled between 20 and 90 degrees with respect to a bottom surface of the distal member, and wherein the distal member further comprises a bottom surface that is transversely convex.