# US 2024/0197495 A1 · Interbody Implants And Instrumentation

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- Number: US 2024/0197495 A1
- Document ID: US20240197495A1
- Status: Published application
- Kind: A1
- Application number: 18/438,135
- Filed: 2024-02-09
- Published: 2024-06-20
- Earliest claimed: 2019-01-31
- Assignees: K2M, Inc.
- Applicants: K2M, Inc.
- Inventors: Bryan D. Milz; Brian Haight; Justyna Zielinska; Shawn Graham; Christian Karl Schultz
- Web page: https://patentgrep.com/patent/US20240197495A1

## CPC

- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61F 2/4611: {of spinal prostheses}
- A61B 17/1757: {for the spine}
- A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)}
- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61F 2002/30481: {using a locking clip}
- A61F 2002/30514: {using a locking washer}
- A61F 2002/30517: {using a locking plate}
- A61F 2002/30593: {hollow}
- A61F 2002/30782: {inclined obliquely}
- A61F 2002/30904: {serrated profile, i.e. saw-toothed}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/4627: {with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument}
- 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

In some embodiments, the present disclosure relates to a system that includes an insertion tool and a drill guide. The insertion tool includes a body with a distal portion and a distal end. The body has a first engagement feature extending longitudinally along the distal portion and two arms extending longitudinally from the distal end of the body. The drill guide includes two bores and an open faced channel therebetween. The open faced channel includes a second engagement feature slidably engageable with the first engagement feature on the body of the insertion tool. The two bores are adapted for the disposal of a fastener driver tool therethrough.

## Claims

### Claim at position 1

1-22. (canceled)

### Claim 23

A graft clip, comprising:
an upper grip arm including:
an upper grip arm proximal end,
an upper grip arm distal end, and
an upper grip inner surface;
a lower grip arm including:
a lower grip arm proximal end,
a lower grip arm distal end, and
a lower grip inner surface;
a connective element, joined to an upper grip arm side and a lower grip arm side;
an internal space between the upper grip arm and the lower grip arm, configured to accommodate disposal of an outer shaft.

### Claim 24 (depends on 23)

The graft clip of claim 23, wherein:
the upper grip inner surface is disposed at the upper grip arm proximal end;
the lower grip inner surface is disposed at the lower grip arm proximal end;
the upper grip inner surface and the lower grip inner surface are rounded, sized, and configured for snap-in engagement of the outer shaft and for securing the outer shaft to the graft clip;
the connective element connects to the upper grip arm distal end;
the connective element connects to the lower grip arm distal end;
the connective element connects to the upper grip inner surface;
the connective element connects to the lower grip inner surface; and
the upper grip arm, the lower grip arm, and the connective element partially enclose the internal space.

### Claim 25 (depends on 23)

The graft clip of claim 23, wherein:
the upper grip arm comprises:
an upper proximal portion,
an upper distal portion, and
an angled portion, disposed between the upper proximal portion and the upper distal portion;
the lower grip arm comprises:
a lower proximal portion, and
a lower distal portion,
the upper proximal portion is further from the upper grip arm distal end than the angled portion is from the upper grip arm distal end;
the upper distal portion is further from the upper grip arm proximal end than the angled portion is from the upper grip arm proximal end;
the upper proximal portion is a first average distance from the lower proximal portion;
the upper distal portion is a second average distance from the lower distal portion; and
the second average distance is greater than the first average distance.

### Claim 26 (depends on 25)

The graft clip of claim 25, wherein:
the upper distal portion includes an upper taper;
the lower distal portion includes a lower taper;
the upper taper and the lower taper both taper towards one another at the distal end.

### Claim 27 (depends on 26)

The graft clip of claim 26, wherein the upper taper and the lower taper are configured to provide a lead-in for an implant to a disc space.

### Claim 28 (depends on 25)

The graft clip of claim 25, wherein:
the upper distal portion includes an upper paddle;
the lower distal portion includes a lower paddle;
the upper distal portion includes an average upper distal portion width;
the lower distal portion includes an average lower distal portion width;
an upper paddle width is greater than the average upper distal portion width;
a lower paddle width is greater than the average lower distal portion width;

### Claim 29 (depends on 28)

The graft clip of claim 28, wherein:
the upper paddle includes an upper stop feature;
the lower paddle includes a lower stop feature;
the upper stop feature protrudes from the upper paddle with a first increasingly deviating distance toward the distal end;
the lower stop feature protrudes from the lower paddle with a second increasingly deviating distance toward the distal end;

### Claim 30 (depends on 23)

The graft clip of claim 23, wherein the internal space is configured to accommodate an insertion tool comprising the outer shaft.

### Claim 31 (depends on 30)

The graft clip of claim 30, wherein the accommodated insertion tool further comprises:
a handle;
an inner shaft; and
a lever arm;
wherein:
the outer shaft is axially aligned with the handle;
the outer shaft is cannulated and configured to dispose the inner shaft in an enclosed passage; and
rotation of the lever arm is configured to move the inner shaft axially.

### Claim 32 (depends on 30)

The graft clip of claim 30, wherein:
the graft clip is configured to:
attach to both an implant and the accommodated insertion tool, the implant being attached to the accommodated insertion tool;
once attached, sliding down the outer shaft of the insertion tool until paddles of the graft clip cover the implant.

### Claim 33 (depends on 30)

The graft clip of claim 30, wherein:
being configured to attach to both an implant and the accommodated insertion tool further comprises being configured to:
accept direction of an open side of the graft clip over the outer shaft;
accept rotation of the graft clip;
after accepting rotation of the graft clip, snap the graft clip fixedly onto the accommodated insertion tool via an upper grip inner surface disposed at the upper grip arm proximal end and a lower grip inner surface disposed at the lower grip arm proximal end.

### Claim 34 (depends on 30)

The graft clip of claim 30, wherein the graft clip is further configured to be inserted into a disc space while attached to the accommodated insertion tool.

### Claim 35 (depends on 34)

The graft clip of claim 34, further comprising paddles, wherein:
the paddles are configured to bottom out on bone of at least one vertebrae adjacent to the disc space when the graft clip is inserted into the disc space with an implant, and to remain bottomed out while the implant continues to be advanced into the disc space.

### Claim 36 (depends on 23)

The graft clip of claim 23, wherein the graft clip is configured to be attached together with a drill guide to an instrument comprising the outer shaft.

### Claim 37

A method, comprising:
directing an open side of a graft clip over an outer shaft of an insertion tool;
rotating the graft clip;
after rotating the graft clip, snapping the graft clip fixedly onto the insertion tool, the graft clip thereby being attached to both an implant and the insertion tool, the implant being attached to the insertion tool;
once attached, sliding down an outer shaft of the insertion tool until paddles of the graft clip cover the implant.

### Claim 38 (depends on 37)

The method of claim 37, wherein snapping the graft clip fixedly onto the accommodated insertion tool further comprises snapping the graft clip fixedly onto the accommodated insertion tool via an upper grip inner surface disposed at an upper grip arm proximal end of the graft clip and a lower grip inner surface disposed at a lower grip arm proximal end of the graft clip.

### Claim 39 (depends on 37)

The method of claim 37, further comprising the step of inserting the graft clip into a disc space while attached to the insertion tool.

### Claim 40 (depends on 39)

The method of claim 39, further comprising the step of, when the graft clip is inserted into the disc space, bottoming-out paddles of the graft clip on bone of at least one vertebrae adjacent to the disc space.

### Claim 41 (depends on 40)

The method of claim 40, wherein the paddles of the graft clip remain bottomed out while the implant continues to be advanced into the disc space.

### Claim 42 (depends on 39)

The method of claim 39, wherein the step of inserting the graft clip into a disc space while attached to the insertion tool further includes inserting the graft clip into a disc space with the implant while attached to the insertion tool.
